TECHNICAL SPECS CATALOGUE

Enraf-Nonius B.V.
Vareseweg 127
3047 AT Rotterdam
The Netherlands
Tel: +31 (0)10 – 20 30 600
Fax: +31 (0)10 – 20 30 699
info@enraf-nonius.nl
www.enraf-nonius.com
Article number: 4411197_40
Update: March 27, 2018
Enraf-Nonius

Index
Index 2 
Introduction ............................................................................................ 5 
Read before use ............................................................................................................................................... 5 

Electrotherapy ........................................................................................ 6 
1600945 Sonopuls 692 .................................................................................................................................... 6 
1600955 Sonopuls 692V ............................................................................................................................... 10 
1600948 Sonopuls 692 S StatUS™ .............................................................................................................. 14 
1600957 Sonopuls 692V S StatUS ............................................................................................................... 19 
1600961 Sonopuls 690 S StatUS™ .............................................................................................................. 24 
1498911 Sonopuls 492 with multi-frequency treatment head, large 5cm2 ................................................... 27 
1498912 Sonopuls 492 with multi-frequency treatment head, small 0,8cm2 ................................................ 27 
1498913 Sonopuls 492 with 2 multi-freq. treatment heads, 5cm2 and 0,8cm2 ............................................ 27 
1498913 StatUS Pack 400 ............................................................................................................................ 29 
1498901 Sonopuls 490 with multi-frequency treatment head, large 5cm2 ................................................... 30 
1498902 Sonopuls 490 with multi-frequency treatment head, small 0,8cm2 ................................................ 30 
1498903 Sonopuls 490 with 2 multi-freq.treatment heads, 5cm2 and 0,8cm2 ............................................ 30 
1631901 Sonopuls 190 incl. 5 cm2 ultrasound head .................................................................................... 32 
1631902 Sonopuls 190 incl. 0,8 cm2 ultrasound head ................................................................................. 33 
1631903 Sonopuls 190 incl. 5 cm2 and 0,8 cm2 ultrasound head ............................................................... 35 
1631904 Sonopuls 190 incl. StatUSTM Pack 100 .......................................................................................... 37 
1629901 StatUSTM Pack 100 ......................................................................................................................... 39 
1600935 Endomed 684V ............................................................................................................................... 39 
1600915 Endomed 682V ............................................................................................................................... 43 
1498920 Endomed 482 ................................................................................................................................. 47 
1416920 Endomed 182 ................................................................................................................................. 51 
1498950 Vacotron 460 .................................................................................................................................. 53 
(only with Sonopuls 492 or Endomed 482, new models) ............................................................................... 53 
1416930 EN-Stim 4 ....................................................................................................................................... 54 
1600966 Myomed 632 X (excl. Myocombox) ................................................................................................ 55 
1600968 Myomed 632 UX (excl. Myocombox) ............................................................................................. 59 
1600971 Myomed 632V X (excl. Myocombox).............................................................................................. 64 
1600973 Myomed 632V UX (excl. Myocombox) ........................................................................................... 69 
1650900 Endopuls 811 .................................................................................................................................. 74 
1422911 EndoLaser 422 ............................................................................................................................... 75 
1468960 EN-Car U3 ...................................................................................................................................... 76 
1468950 EN-Car U II ..................................................................................................................................... 76 
1671901 Eltrac 471 ....................................................................................................................................... 77 

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1442911 EndoPress 442 ............................................................................................................................... 78 

1442912 EndoPress 442 ............................................................................................................................... 78 
1670901 Curapuls 670 .................................................................................................................................. 79 
1419942 Curapuls 970 .................................................................................................................................. 80 
1435901 Radarmed 650+ .............................................................................................................................. 81 
1435911 Radarmed 950+ .............................................................................................................................. 82 
3448162 Paraffin-bath ................................................................................................................................... 83 
3448163 Paraffin-bath ................................................................................................................................... 83 
3448191 Packheater ..................................................................................................................................... 84 
3448265 Packheater E-1 ............................................................................................................................... 84 
3448264 Packheater E-2 ............................................................................................................................... 85 
3448261 Packheater M-2 .............................................................................................................................. 85 
3448262 Packheater M-4 .............................................................................................................................. 86 
3448260 Packheater SS-2 ............................................................................................................................ 86 
3448401 Packheater WB 4-30 ...................................................................................................................... 86 
3448401 Packheater WB 6-50 ...................................................................................................................... 87 
3448401 Packheater WB 8-90 ...................................................................................................................... 87 
3448401 Packheater WB 16-130 .................................................................................................................. 88 
3448274 Chilling unit model C-5 ................................................................................................................... 88 
3441803 Halogen IR-radiator IRS-2 .............................................................................................................. 89 
3441804 Halogen IR-radiator IRS ................................................................................................................. 89 
3441821 Mobile stand SST ........................................................................................................................... 90 
3441822 Mobile stand SSU ........................................................................................................................... 90 
3441823 Mobile stand SSV ........................................................................................................................... 91 
3441824 Wall arm HWA ................................................................................................................................ 91 
3446188 Quadriceps Bench .......................................................................................................................... 91 
1427901 TENSMED S82............................................................................................................................... 92 
1427911 TENSMED S84............................................................................................................................... 92 

Treatment couches............................................................................... 94 

Manumed Technical Specifications ................................................................................................................ 94 
Manumed upholstery and foam ...................................................................................................................... 96 
Manumed ST 3-section .................................................................................................................................. 96 
Manumed ST 2-section head-section ............................................................................................................. 97 
Manumed ST 2-section back-section ............................................................................................................. 97 
ManuXelect 2-section back-section ................................................................................................................ 97 
ManuXelect 2-section head-section ............................................................................................................... 98 
ManuXelect 3-section ..................................................................................................................................... 99 
ManuXelect Traction (traction frame standard included) ............................................................................... 99 
5500723 Manumed Tilt 1-section (type 723) with leg fixation rail .............................................................. 100 
5500722 Manumed Tilt 1-section (type 722) ............................................................................................... 100 
5500724 Manumed Tilt 2-section (type 724) ............................................................................................... 101 

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5500725 Manumed Tilt 2-section (type 725) with leg fixation rails ............................................................. 101 
3450010 Manumed Basic 2-section / head section (type 001) ................................................................... 101 
3450001 Manumed Basic 2-section / back section (type 002).................................................................... 101 
3450007 Portable Massage Couch with head-section ................................................................................ 102 

Medical Fitness and Rehabilitation................................................... 103 

1665901 EN- Motion treadmill ..................................................................................................................... 103 
1665902 EN- Motion Plus............................................................................................................................ 104 
3446257 Parallel Bars ................................................................................................................................. 106 
1413922 Bike Reha ..................................................................................................................................... 106 
1419922 Bike Reha, incl. adjustable cranks ............................................................................................... 107 
1455925 EN-Dynamic Leg Extension ......................................................................................................... 108 
1455928 EN-Dynamic Adduction ................................................................................................................ 108 
1455929 EN-Dynamic Abduction ................................................................................................................ 109 
1455931 EN-Dynamic Total Hip .................................................................................................................. 110 
1455932 EN-Dynamic Seated Leg Curl ...................................................................................................... 110 
1455933 EN-Dynamic Seated Leg Press .................................................................................................... 111 
1455935 EN-Dynamic Squat ....................................................................................................................... 112 
1455921 EN-Dynamic Chest Press ............................................................................................................. 112 
1455923 EN-Dynamic Pull Down ................................................................................................................ 113 
1455926 EN-Dynamic Rowing .................................................................................................................... 114 
1455927 EN-Dynamic Shoulder Press ........................................................................................................ 114 
1455930 EN-Dynamic Fly............................................................................................................................ 115 
1455934 EN-Dynamic Triceps Dips ............................................................................................................ 116 
1455922 EN-Dynamic Low Back Trainer .................................................................................................... 116 
1455924 EN-Dynamic Abdominal Trainer ................................................................................................... 117 
1455936 EN-Dynamic Rotator..................................................................................................................... 118 
1446901 EN-Free ........................................................................................................................................ 118 
1412996 EN-TreeP Pulley ........................................................................................................................... 119 
3443354 EN-Tree Pulley Explosive 54 kg ................................................................................................... 119 
3443370 EN-Tree Pulley Explosive MDD 54 kg, with cover ....................................................................... 119 
3443353 EN-Tree Pulley 24 kg ................................................................................................................... 120 
3443369 EN-Tree Pulley MDD 24 kg, with cover ........................................................................................ 120 
3443356 EN-Tree Bench ............................................................................................................................. 120 
3443355 EN-Tree Train ............................................................................................................................... 121 
3443365 EN-TreeM Pulley MDD 24 kg, with cover ..................................................................................... 121 
3443367 EN-TreeM Pulley Explosive MDD 54 kg, with cover .................................................................... 121 

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Introduction

This is the Enraf-Nonius Technical Specs Catalogue. It can help you when you need to provide customers
with the exact (technical) specifications, or when pre-sales questions arise on performance of the Enraf-
Nonius products. You are free to distribute the information for your commercial purposes, but you are
always submitted to the “read before use” section.

For a number of units we also included an extensive specification listing as they can be found in the latest
Instructions for use of the product.

Read before use

To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or
resellers be liable for any indirect, special, incidental or consequential damages arising from the use of or
inability to use this catalogue, including, without limitation, damages for loss of goodwill, work and
productivity, computer failure or malfunction, or any and all other commercial damages or losses, even if
advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort or otherwise)
upon which the claim is based.

Enraf-Nonius can not be held liable for any consequence resulting from incorrect information provided by its
personnel, or errors incorporated in this catalogue and / or other accompanying documentation (including
commercial documentation). The opposing party (product’s user or its representative) shall disclaim Enraf-
Nonius from all claims arising from third parties, whatever nature or whatever relationship to the opposing
party.

Any information provided in this catalogue is subject to changes without prior notice. No rights can be
claimed upon the information provided in this document.

Technical modifications reserved for all products in this technical specs catalogue.

Rotterdam, March 2018

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 5

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Electrotherapy

1600945 Sonopuls 692

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC
Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

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Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

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Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps
of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA
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Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.
IEC 60601-2-40 : Particular requirements for the safety of electromyographs and
evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 9

Enraf-Nonius

1600955 Sonopuls 692V

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 10

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Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 11

Enraf-Nonius

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps
of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA
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Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Vacuum
Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable
Pulsed vacuum via vacuum range : adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.
IEC 60601-2-40 : Particular requirements for the safety of electromyographs and
evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.
The above mentioned technical specifications are copied from the IFU 1600751_4B

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 13

Enraf-Nonius

1600948 Sonopuls 692 S StatUS™

StatUS combines traditional ultrasound with stationary ultrasound

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 14

Enraf-Nonius

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 15

Enraf-Nonius

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps
of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA
Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 16
Enraf-Nonius

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Ultrasound
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100 Hz ± 1 % fixed

Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 17

Enraf-Nonius

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² ultrasound
treatment head at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the
ultrasound treatment head surface. This field distribution applies to the radiation emitted into the equivalent
of an infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±
10% of the rated value. The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the
Beam Non-uniformity Ratio (BNR).

The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound
Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the absence of high
and potentially dangerous energy concentrations.

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.
IEC 60601-2-40 : Particular requirements for the safety of electromyographs and
evoked response equipment.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 18

Enraf-Nonius

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1600957 Sonopuls 692V S StatUS

StatUS combines traditional ultrasound with stationary ultrasound

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Technical modifications reserved

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 19

Enraf-Nonius

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 20

Enraf-Nonius

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 Ma

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Enraf-Nonius

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps
of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Ultrasound
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 22

Enraf-Nonius

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100 Hz ± 1 % fixed

Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² ultrasound
treatment head at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the
ultrasound treatment head surface. This field distribution applies to the radiation emitted into the equivalent
of an infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±
10% of the rated value. The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the
Beam Non-uniformity Ratio (BNR).

The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 23

Enraf-Nonius

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound
Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the absence of high
and potentially dangerous energy concentrations.

Vacuum
Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable
Pulsed vacuum via vacuum range : adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.
IEC 60601-2-40 : Particular requirements for the safety of electromyographs and
evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1600961 Sonopuls 690 S StatUS™

StatUS combines traditional ultrasound with stationary ultrasound

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 24

Enraf-Nonius

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Ultrasound
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100 Hz ± 1 % fixed

Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA):20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 25

Enraf-Nonius

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² ultrasound
treatment head at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the
ultrasound treatment head surface. This field distribution applies to the radiation emitted into the equivalent
of an infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±
10% of the rated value. The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the
Beam Non-uniformity Ratio (BNR).

The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound
Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the absence of high
and potentially dangerous energy concentrations.

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.
IEC 60601-2-40 : Particular requirements for the safety of electromyographs and
evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 26

Enraf-Nonius

1498911 Sonopuls 492 with multi-frequency treatment head, large 5cm2

This information is the same as the 1498913 Sonopuls 492.

1498912 Sonopuls 492 with multi-frequency treatment head, small 0,8cm2

This information is the same as the 1498913 Sonopuls 492.

1498913 Sonopuls 492 with 2 multi-freq. treatment heads, 5cm2 and 0,8cm2

The Sonopuls 492 is a combination device, combining the functions of the Endomed 482 and the Sonopuls
490 in a single device. With the Sonopuls 492 the simultaneous application of ultrasound and lectrotherapy
(combination therapy) is also possible. The remaining electrotherapy channel can then be used
independently.

Perform DUAL CHANNEL ULTRASOUND: treat patients with 2 independent channels, either conventional
or with the unique handsfree StatUSTM. Plus, at the same time, the availability of 2 channels of
electrotherapy, also perfectly suitable for combination therapy (combining ultrasound and electrotherapy).

Mains voltage: 100 - 240 Volt ± 10%

Frequency: 50/60 Hz
Max, Power consumption: 100 VA
Patient leakage current: typically, 1 μA (requirement IEC < 10 μA)
idem single fault condition: typically, 2 μA (requirement IEC < 50 μA)

Main Unit Dimension Weight

(in cm) (WxDxH) (in grams)

Dimensions stand alone 24 x 32 x 12 2000g

Dimensions on inclination foot 24x 30.5x 18.2 3000g

Dimensions on Vacotron 24 x 30.5x 21.6 (incl optional

battery)

Dimension Weight
(in cm) (WxDxH) (in grams)

Vocatron 24 x 28.6 x 9.3 cm 2000g

Technical modifications reserved

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 27

Enraf-Nonius

Safety and Performance standards

Medical device classification IIa
IEC 60601-1 General requirements for the safety of electrical medical
systems, including Annex I, national differences for
Australia, Canada, and the United States.

IEC 60601-2-5 Particular requirements for the safety of ultrasonic

therapy equipment.
IEC 60601-2-10 Particular requirements for the safety of nerve and
muscle stimulators.

21 CFR 1050.10 This equipment complies with all requirements of 21

CFR 1050.10, Performance Standard for Ultrasonic
Therapy devices.

21 CFR 898 This equipment complies with all requirements of 21

CFR 898, Performance Standard for electrode lead
wires and patient leads.

Safety class according to IEC 60601-1 I

Applied parts Type BF Applied part for electrotherapy
Type B Applied part for Ultrasound therapy
This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).

Current Waveforms – Pain Management

For pain management, the following current waveforms are recommended.
 4-Polar Interferential Currents
 Biphasic Pulsed Currents (TENS)
 Premodulated
 Micro Current
 High Voltage
 Galvanic Current
 Träbert, 2 – 5 Current

Current Waveforms – Muscle Stimulation

For muscle stimulation, the following current waveforms are recommended.
 Biphasic Pulsed Currents (TENS)
o Asymmetrical and Alternating Asymmetrical
o Symmetrical
 Premodulated
 Russian Stimulation
 High Voltage
 Faradic Current
o Faradic Rectangular or Triangular pulsed current
These waveforms are often applied in combination with a surge program, which consists of a sequence of
exercise and rest periods. Two options are available here:
 Reciprocal application, where stimulation alternates between agonists and antagonists. This is
accomplished through asynchronous stimulation over two current channels with an appropriate delay
between the two channels.
 Co-contract application, where two channels operate synchronously to co-contract agonist and
antagonist or different sections of a larger muscle group.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 28

Enraf-Nonius

Current Waveforms – Muscle Stimulation

Combination therapy is available with all current waveforms, but limited to channel 2.

The above mentioned technical specifications are copied from the soon to be released IFU 1498751_46.
The information regarding Dual Channel is copied from the webleaflet 0498730_41 EN

1498913 StatUS Pack 400

The StatUS™ Pack 400 is a feature (accessory) for the application of StatUS™ therapy and works only
when connected to a Sonopuls 490 / 492 device. StatUS stands for Stationary Ultra Sound: the
application of ultrasound without moving the ultrasound treatment head (= stationary).
Comment: the StatUS™ Pack 400 is not designed for use in combination with the Vacotron 460.

Dimensions : 27 x 32 x 12 cm (b x d x h)
Weight : 1250 gr.

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 50 % (23°C contained in original packaging)
10 to 90 % (40°C contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non-condensing
Atmospheric pressure : 500 to 1060 hPa

Ultrasound parameters
Ultrasound treatment head 5 cm²
Ultrasound frequency:
1 MHz : 0.98 MHz ± 5 %
3 MHz : 3.1 MHz ± 5 %

ERA (Effective Radiation Area):

IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

The above mentioned technical specifications are copied from the IFU 1629761_42.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 29

Enraf-Nonius

1498901 Sonopuls 490 with multi-frequency treatment head, large 5cm2

This information is the same as the 1498903 Sonopuls 490.

1498902 Sonopuls 490 with multi-frequency treatment head, small 0,8cm2

This information is the same as the 1498903 Sonopuls 490.

1498903 Sonopuls 490 with 2 multi-freq.treatment heads, 5cm2 and 0,8cm2

The Sonopuls 490 is an ultrasound therapy device. The device provides two positions for attachment of an
ultrasound applicator. Depending on the device configuration ordered, the Sonopuls 490 comes with an
ultrasound head with a large contact area, an ultrasound treatment head with a small contact area or with
both applicators. The ultrasound head can operate in continuous or pulsed mode at an ultrasound
frequency of 1 MHz or 3 MHz Contact control suspends the application of ultrasonic energy when acoustical
contact with the treatment area becomes insufficient. The ultrasound heads are suitable for subaqual
treatments.

Sonopuls 490 devices are:

- standard equipped with 2 fully independent channels for ultrasound therapy
- including Dual Channel Ultrasound* (simultaneous application of 2 ultrasound treatments)
- offering you various options for dynamic and/or static ultrasound therapy (StatUSTM therapy)

Mains voltage: 100 - 240 Volt ± 10%

Frequency: 50/60 Hz
Max, Power consumption: 100 VA
Patient leakage current: typically, 1 μA (requirement IEC < 10 μA)
idem single fault condition: typically, 2 μA (requirement IEC < 50 μA)

Main Unit Dimension Weight

(in cm) (WxDxH) (in grams)

Dimensions stand alone 24 x 32 x 12 2000g

Dimensions on inclination foot 24x 30.5x 18.2 3000g

Dimensions on Vacotron 24 x 30.5x 21.6 (incl optional

battery)

Dimension Weight
(in cm) (WxDxH) (in grams)

Vocatron 24 x 28.6 x 9.3 cm 2000g

Technical modifications reserved

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 30

Enraf-Nonius

Safety and Performance standards

Medical device classification IIa
IEC 60601-1 General requirements for the safety of electrical medical
systems, including Annex I, national differences for
Australia, Canada, and the United States.

IEC 60601-2-5 Particular requirements for the safety of ultrasonic

therapy equipment.
IEC 60601-2-10 Particular requirements for the safety of nerve and
muscle stimulators.

21 CFR 1050.10 This equipment complies with all requirements of 21

CFR 1050.10, Performance Standard for Ultrasonic
Therapy devices.

21 CFR 898 This equipment complies with all requirements of 21

CFR 898, Performance Standard for electrode lead
wires and patient leads.

Safety class according to IEC 60601-1 I

Applied parts Type BF Applied part for electrotherapy
Type B Applied part for Ultrasound therapy
This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).

Current Waveforms – Pain Management

For pain management, the following current waveforms are recommended.
 4-Polar Interferential Currents
 Biphasic Pulsed Currents (TENS)
 Premodulated
 Micro Current
 High Voltage
 Galvanic Current
 Träbert, 2 – 5 Current

Current Waveforms – Muscle Stimulation

For muscle stimulation, the following current waveforms are recommended.
 Biphasic Pulsed Currents (TENS)
o Asymmetrical and Alternating Asymmetrical
o Symmetrical
 Premodulated
 Russian Stimulation
 High Voltage
 Faradic Current
o Faradic Rectangular or Triangular pulsed current
These waveforms are often applied in combination with a surge program, which consists of a sequence of
exercise and rest periods. Two options are available here:
 Reciprocal application, where stimulation alternates between agonists and antagonists. This is
accomplished through asynchronous stimulation over two current channels with an appropriate delay
between the two channels.
 Co-contract application, where two channels operate synchronously to co-contract agonist and
antagonist or different sections of a larger muscle group.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 31

Enraf-Nonius

Current Waveforms – Muscle Stimulation

Combination therapy is available with all current waveforms, but limited to channel 2.

The above mentioned technical specifications are copied from the soon to be released IFU 1498751_46.
The information regarding Dual Channel is copied from the webleaflet 0498731_41 EN

1631901 Sonopuls 190 incl. 5 cm2 ultrasound head

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz
Main unit:
Dimensions : 21 x 19 x 9 cm
Weight : 1152 gr.

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 tot 50 % (23°C contained in original packaging)
: 10 tot 90 % (40°C contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa

Ultrasound parameters
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % :0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100, 48 and 16 Hz ± 1 %
Duty cycle pulsed : 5 – 80 %
Pulse duration at 100 Hz : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) :20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm²
21 CFR 1050.10 : 5 cm²
Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 32

Enraf-Nonius

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² applicator at 3
MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the applicator
surface. This field distribution applies to the radiation emitted into the equivalent of an infinite medium of
distilled, degassed water at 30 ºC and with line voltage variations in the range of ± 10% of the rated value.
The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the Beam Nonuniformity
Ratio (BNR).

The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average
ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the
absence of high and potentially dangerous energy concentrations.

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex I, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance

The above mentioned technical specifications are copied from the IFU 1631750_44.

1631902 Sonopuls 190 incl. 0,8 cm2 ultrasound head

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz
Main unit:
Dimensions : 21 x 19 x 9 cm
Weight : 1137 gr.

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 tot 50 % (23°C contained in original packaging)
: 10 tot 90 % (40°C contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 33

Enraf-Nonius

Ultrasound parameters
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % :0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100, 48 and 16 Hz ± 1 %

Duty cycle pulsed : 5 – 80 %
Pulse duration at 100 Hz : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 0,6 cm²
21 CFR 1050.10 : 0,8 cm²
Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² applicator at 3
MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the applicator
surface. This field distribution applies to the radiation emitted into the equivalent of an infinite medium of
distilled, degassed water at 30 ºC and with line voltage variations in the range of ± 10% of the rated value.
The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the Beam Nonuniformity
Ratio (BNR).
The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average
ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the
absence of high and potentially dangerous energy concentrations.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 34

Enraf-Nonius

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex I, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance

The above mentioned technical specifications are copied from the IFU 1631750_44.

1631903 Sonopuls 190 incl. 5 cm2 and 0,8 cm2 ultrasound head

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz
Main unit:
Dimensions : 29 x 19 x 9 cm
Weight : 1524 gr.

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 tot 50 % (23°C contained in original packaging)
: 10 tot 90 % (40°C contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa

Ultrasound parameters
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)
Peak output power for 5 cm² applicator:
Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % :0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 35

Enraf-Nonius

Pulse frequency : 100, 48 and 16 Hz ± 1 %

Duty cycle pulsed : 5 – 80 %
Pulse duration at 100 Hz : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm²
21 CFR 1050.10 : 5 cm²
Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 0,6 cm²
21 CFR 1050.10 : 0,8 cm²
Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² applicator at 3
MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the applicator
surface. This field distribution applies to the radiation emitted into the equivalent of an infinite medium of
distilled, degassed water at 30 ºC and with line voltage variations in the range of ± 10% of the rated value.
The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the Beam Nonuniformity
Ratio (BNR).
The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average
ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the
absence of high and potentially dangerous energy concentrations.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 36

Enraf-Nonius

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex I, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance

The above mentioned technical specifications are copied from the IFU 1631750_44.

1631904 Sonopuls 190 incl. StatUSTM Pack 100

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz
Main unit:
Dimensions : 22 x 16 x 14 cm
Weight : 1707 gr.

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 tot 50 % (23°C contained in original packaging)
: 10 tot 90 % (40°C contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa

Ultrasound parameters
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 37

Enraf-Nonius

Pulse frequency : 100, 48 and 16 Hz ± 1 %

Duty cycle pulsed : 5 – 80 %
Pulse duration at 100 Hz : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm²
21 CFR 1050.10 : 5 cm²
Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² applicator at 3
MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the applicator
surface. This field distribution applies to the radiation emitted into the equivalent of an infinite medium of
distilled, degassed water at 30 ºC and with line voltage variations in the range of ± 10% of the rated value.
The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the Beam Nonuniformity
Ratio (BNR).
The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average
ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the
absence of high and potentially dangerous energy concentrations.

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex I, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance

The above mentioned technical specifications are copied from the IFU 1631750_44.

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Enraf-Nonius

1629901 StatUSTM Pack 100

Ultrasound parameters
Ultrasound treatment head 5 cm²
Ultrasound frequency:
1 MHz : 0.98 MHz ± 5 %
3 MHz : 3.1 MHz ± 5 %
ERA (Effective Radiation Area):
IEC 60601-2-5 : 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2
Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Technical data
Dimensions : 22 x 12 x 9 cm (b x d x h)
Weight : 930 gr.

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 50 % (23°C contained in original packaging)
10 to 90 % (40°C contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non-condensing
Atmospheric pressure : 500 to 1060 hPa

Technical modifications reserved.

The above mentioned technical specifications are copied from the IFU 1629751_42

1600935 Endomed 684V

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

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Enraf-Nonius

Electrotherapy general
Channels :4
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500 W (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

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Enraf-Nonius

Asymmetrical Alternating
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Symmetrical
Phase Duration : 10 - 1000 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 μs, in steps of 5 μs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 μs, in steps of 5 μs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

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Enraf-Nonius

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 μA - 1 mA

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in
steps of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 μA - 1 mA

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

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Enraf-Nonius

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Vacuum unit (Vacotron)

Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable
Pulsed vacuum via vacuum range : adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for
Australia, Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic

therapy equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and

muscle stimulators.

IEC 60601-2-40 : Particular requirements for the safety of

electromyographs and evoked response equipment.
: This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21

CFR 1050.10, Performance Standard for Ultrasonic
Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21

CFR 898, Performance Standard for electrode lead
wires and patient leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1600915 Endomed 682V

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

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Enraf-Nonius

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Electrotherapy general
Channels :2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500 W (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

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Enraf-Nonius

Asymmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Asymmetrical Alternating
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Asymmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Symmetrical
Phase Duration : 10 - 1000 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 μs, in steps of 5 μs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 μs, in steps of 5 μs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

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Enraf-Nonius

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 μA - 1 Ma

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in
steps of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 μA - 1 mA

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

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Enraf-Nonius

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Vacuum unit (Vacotron)

Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable
Pulsed vacuum via vacuum range : adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for
Australia, Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic

therapy equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and

muscle stimulators.

IEC 60601-2-40 : Particular requirements for the safety of

electromyographs and evoked response equipment.
: This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21

CFR 1050.10, Performance Standard for Ultrasonic
Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21

CFR 898, Performance Standard for electrode lead
wires and patient leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1498920 Endomed 482

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz
Power supply rating : 100 VA

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Enraf-Nonius

Main unit:
Dimensions stand alone : 24 x 32 x 12 cm (w x d x h)
Dimensions on inclination foot : 24 x 30.5 x 18.2 cm (w x d x h)
Dimensions on Vacotron : 24 x 30.5 x 21.6 cm (w x d x h)
Weight : 2 Kg
Weight including optional battery : 3 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa
Available programmable favorites : 1000+

Electrotherapy general
Channels :2
Output characteristics : Constant Current (CC) or Constant Voltage (CV), except for
High Voltage (CV) and Microcurrent (CC).
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.2 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500 (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp up time : 0 - 9 s, in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp down time : 0 - 9 s, in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 10s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 48

Enraf-Nonius

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)

Asymmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 140 mA

Asymmetrical Alternating
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Symmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 140 mA

Burst Symmetrical
Phase Duration : 10 - 400 μs in steps of 5 μs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

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Enraf-Nonius

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burst frequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp up, ramp down : 0,5 seconds
Amplitude : 0 – 500 Volt in steps of 1 Volt

Micro Current
Frequency : 0 – 1000 Hz
Polarity : Positive or Negative
Surge Program : Yes
Amplitude : 10 μA - 1 mA in steps of 10 μA

Micro Current Alternating

Frequency : 0 – 1000 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s, 1 – 20 s in steps
of 1 s.
Ramp up, ramp down : 0 seconds
Amplitude : 10 μA - 1 mA in steps of 10 μA

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 90%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Pulse Frequency : 0.2 – 1 Hz in steps of 0.1 Hz, 1 – 200 in steps of 1 Hz
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

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Enraf-Nonius

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Pulse Frequency : 0.2 – 1 Hz in steps of 0.1 Hz, 1 – 200 in steps of 1 Hz
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular Pulsed Current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 Ma

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy
devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.

The above mentioned technical specifications are copied from the IFU 1498751_45

1416920 Endomed 182

Mains adapter
Type mains adapter : ENB-1530
Mains voltage : 100 - 240 Volt
Frequency : 50/60 Hz.
DC Output : 15 Volt
Max. Output current : 2A

Unit
Medical device classification : IIa (according to Medical Device Directive (93/42/EEC)
Safety class : II* type BF**, according to IEC 60601-1
Patient leakage current : Better than IEC requirement (IEC < 100 μA)
Ditto, first fault condition : Better than IEC requirement (IEC: < 500 μA)
Safety tests : CE-MDD (TÜV Rheinland)
Dimensions : 22 x 20 x 20 cm (w x d x h)
Weight : 1.8 kg.
Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 51
Enraf-Nonius

Environment conditions for transport and Storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environment conditions normal use

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till1060 hPa

Current
Intensity : 0 - 99 mA
Timer : 0 - 60 minutes

2P : 2 pole mid- frequency current :

Carrier wave : 4 kHz
AMF frequency : 5 - 200 Hz
Modulation frequency : 0 - 180 Hz
Modulation program : 1-1, 6-6, 1-30 seconds

4P : Interference classical and isoplanairy

Carrier wave : 4 kHz
AMF frequency : 5 – 200 Hz
Modulation frequency : 0 – 180 Hz
Modulation program : 1-1, 6-6, 1-30 seconds

Bi – asymmetrical biphasic pulsed current (TENS)

Pulse width : 150 μs
Frequency : 1 – 200 Hz
Modulation frequency : 0 – 180 Hz
Modulation program : 1-1, 6-6, 1-30 seconds
Burst frequency : 2 Hz

Safety and Performance standards

Medical class IIa

: This equipment complies with all requirements of the Medical
Device Directive (93/42/EEC).

International safety norm

The unit is confirming the international norm for medical electronic devices IEC 60601-1.

*II : Safety class II (double insulated).

**BF : The equipment has a floating patient circuit.

The Endomed 182 meet the requirements of
IEC 60601-1.

The above mentioned technical specifications are copied from the IFU 1416751_44
Information regarding Medical Class according to Manager Quality A.v.Maurik dd 07-09-2017

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 52

Enraf-Nonius

1498950 Vacotron 460

(only with Sonopuls 492 or Endomed 482, new models)

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz
Power supply rating : 100 VA

Main unit:
Dimensions stand alone : 24 x 32 x 12 cm (w x d x h)
Dimensions on inclination foot : 24 x 30.5 x 18.2 cm (w x d x h)
Dimensions on Vacotron : 24 x 30.5 x 21.6 cm (w x d x h)
Weight : 2 Kg
Weight including optional battery : 3 Kg

Vacotron:
Dimensions : 24 x 28.6 x 9.3 cm (w x d x h)
Weight : 2 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa
Available programmable favorites : 1000+

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 53

Enraf-Nonius

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy
devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.

Technical modifications reserved.

The above mentioned technical specifications are copied from the IFU 1498751_45
Information regarding Medical Class is adjusted, according to Manager Quality A.v.Maurik dd 07-09-2017

1416930 EN-Stim 4

Mains adapter:
Type : ENA-1524
Mains voltage : 100 - 240 Volt ± 10%
Frequency : 50/60 Hz.
DC Output : 15 Volt
Max. Output current : 1.6 A

Pre-programmed protocols : 39
Programmable positions : 100, single and sequential programs

EN-Stim 4 unit:
: This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).

Medical device classification : IIa

Safety tests : according to IEC 60601-1 +A1 +A2 and IEC 60601-2-10
+A1, carried out by TÜV Rheinland Product Safety
GmbH.

Safety class according to IEC 60601-1 : class I type BF

Dimensions : 22 x 20 x 20 cm (w x d x h)
Weight : 1.8 kg.

Environmental conditions for transport and storage

Temperature : -10° to +50° C
Relative humidity : 10 to 100 %
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa

Stimulator Output Parameters

Parameter Asymmetrical Symmetrical
Phase duration 10-200 µs 10-1000 µs
Pulse frequency 1 – 200 Hz (1) 1 – 200 Hz (1)
Frequency modulation 0 – 180 Hz (1) 0 – 180 Hz (1)

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Enraf-Nonius

(1) The sum of the pulse frequency and frequency modulation can never exceed 200 Hz.
(2) To stay below the limits of 50 mA RMS, enforced by IEC 60601-2-10, the amplitude can be limited to
a maximum of 79 mA at some combinations of pulse frequency and phase duration.

The above mentioned technical specifications are copied from the IFU 1416752_42
The pre-programmed protocols and the programmable positions informations are copied from the webleaflets.

1600966 Myomed 632 X (excl. Myocombox)

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Stimulator output parameters

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual
The maximum current amplitude within the specification is achieved up to a load of 500  (CC).
Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC
Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 55
Enraf-Nonius

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

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Enraf-Nonius

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in steps of
1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 Ma

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in steps
of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

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Enraf-Nonius

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA
IG Currents (Impulse Galvanisation) Biphasic
Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

EMG
E.M.G. Channels : 2
Sensitivity : 0,5 µV – 10.000 µV
Raw EMG signal : 1.500 Hz
Sample frequency : 160 Hz
Bandwidth : 5 – 1.500 Hz
Filtering : digital

Pressure : 1 channel via internal sensor

Range : 0 – 360 hPa

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.

IEC 60601-2-40 : Particular requirements for the safety of electromyographs and

evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 58

Enraf-Nonius

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1600968 Myomed 632 UX (excl. Myocombox)

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Ultrasound parameters

Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100 Hz ± 1 % fixed

Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) :20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

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Enraf-Nonius

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2
Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum
Description of ultrasound field
The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² ultrasound
treatment head at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the
ultrasound treatment head surface. This field distribution applies to the radiation emitted into the equivalent
of an infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±
10% of the rated value. The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the
Beam Non-uniformity Ratio (BNR).

The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound
Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the absence of high
and potentially dangerous energy concentrations.

Stimulator output parameters

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 60
Enraf-Nonius

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

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Enraf-Nonius

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in steps of
1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in steps
of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

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Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

EMG
E.M.G. Channels : 2
Sensitivity : 0,5 µV – 10.000 µV
Raw EMG signal : 1.500 Hz
Sample frequency : 160 Hz
Bandwidth : 5 – 1.500 Hz
Filtering : digital

Pressure : 1 channel via internal sensor

Range : 0 – 360 hPa

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Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.

IEC 60601-2-40 : Particular requirements for the safety of electromyographs and

evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1600971 Myomed 632V X (excl. Myocombox)

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

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Stimulator output parameters

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

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Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

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High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in steps of
1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA

Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in steps
of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA
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IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Vacuum unit (Vacotron)

Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable
Pulsed vacuum via vacuum range : adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

EMG
E.M.G. Channels : 2
Sensitivity : 0,5 µV – 10.000 µV
Raw EMG signal : 1.500 Hz
Sample frequency : 160 Hz
Bandwidth : 5 – 1.500 Hz
Filtering : digital

Pressure : 1 channel via internal sensor

Range : 0 – 360 hPa

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.

IEC 60601-2-40 : Particular requirements for the safety of electromyographs and

evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

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1600973 Myomed 632V UX (excl. Myocombox)

Mains voltage : 100 – 240 V ± 10%

Mains frequency : 50 / 60 Hz

Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg

Environmental conditions for transport and storage:

Temperature : -20° to +70° C
Relative humidity : 10 to 90 % (contained in original packaging)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 800 to 1060 hPa

Ultrasound parameters

Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)

Peak output power for 5 cm² applicator:

Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:

Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100 Hz ± 1 % fixed

Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control

Contact control level : 65%

5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

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Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

0.8 cm² Applicator

Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2

Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum

Description of ultrasound field

The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² ultrasound
treatment head at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the
ultrasound treatment head surface. This field distribution applies to the radiation emitted into the equivalent
of an infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±
10% of the rated value. The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and the
Beam Non-uniformity Ratio (BNR).

The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value depends on the
ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10

The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound
Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the absence of high
and potentially dangerous energy concentrations.

Stimulator output parameters

Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual

The maximum current amplitude within the specification is achieved up to a load of 500  (CC).

Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s

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Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC

Dipole Vector Automatic

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC

Dipole Vector Manual

Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Resolution vector : 2.25° per step (160 steps over 360°)
Current mode : CC

Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA

Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA

Burst Asymmetrical Alternating

Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

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Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.

Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.

Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA

Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA

High Voltage (Twin Pulse)

Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)

Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in steps of
1Hz., 100 – 1000 Hz in steps of 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA

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Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0, 1 Hz, 10 -100 Hz in steps
of 1Hz., 100 – 1000 Hz in steps of 10 Hz
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in steps of 1 s.
Ramp-in, ramp out : 0 seconds
Amplitude : 10 µA - 1 mA,

Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude : 0 - 70 mA

MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current

Polarity : Positive or Negative
Amplitude : 0 – 40 mA

Faradic Rectangular Pulsed Current

Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Faradic Triangular Pulsed Current

Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)

Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic

Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic

Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

Vacuum unit (Vacotron)

Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable
Pulsed vacuum via vacuum range : adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

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EMG
E.M.G. Channels : 2
Sensitivity : 0,5 µV – 10.000 µV
Raw EMG signal : 1.500 Hz
Sample frequency : 160 Hz
Bandwidth : 5 – 1.500 Hz
Filtering : digital

Pressure : 1 channel via internal sensor

Range : 0 – 360 hPa

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy

equipment.

IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.

IEC 60601-2-40 : Particular requirements for the safety of electromyographs and

evoked response equipment.

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21 CFR

1050.10, Performance Standard for Ultrasonic Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient leads.

The above mentioned technical specifications are copied from the IFU 1600751_4B

1650900 Endopuls 811

Dimensions : L 350 mm / W 250 mm / H 140 mm

Weight : 2.7 kg
Power supply : 100–240 VAC / 50/60 Hz, 220 VAC / 60 Hz
Fuse : 3,15 AT
Conformity : Protection class I / Application class BF
Frequency range : 1 Hz – 22 Hz, can be adjusted in 1 Hz steps
3 burst modes : 4, 8, 12 shots
Shock energy levels : 60 – 180 in steps of 10 mJ and 185 mJ (at the applicator)
4 selectable fixed settings : at 16 Hz max. 120 mJ
Mode of operation : Intermittent use max. 6000shocks / 15min. break
Accuracy : ± 20%

Shockwave hand-piece: : Ergonomic model with anodized aluminium case and fan cooling

Dimensions : 230 mm in length, 50 mm diameter

Weight : 850 g (with cable)

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Service life : 2,000,000 shocks (minimum)

Applicators exchangeable without any tools
(6 / 15 / 25 mm diameter)

Dimensions (complete with case) : L 580 mm / W 470 mm / H 250 mm

Total weight : 12 kg (total with case)

Environmental conditions
Operational environment : 10 to 25 °C (50 to 77 °F); 700 hPa – 1060 hPa, 20% to
80% rel. humidity, not condensed
Storage / Transport
Short-term : -10 to 55 °C (14 to 131 °F); 700 hPa – 1060 hPa, 20% to
80% rel. humidity, not condensed
Long-term : 0 to 40 °C (32 to 104 °F); 700 hPa – 1060 hPa, 20% to
80% rel. humidity, not condensed

Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical

systems, including Annex 1, national differences for Australia,
Canada and the United States.

Safety class according to IEC 60601-1 : class I type BF

: This equipment complies with all requirements of the Medical

Device Directive (93/42/EEC).

Medical device classification : IIa

The above mentioned technical specifications are copied from the IFU 1650751_40

1422911 EndoLaser 422

Mains voltage: 230 Vac 50-60Hz ±15% 115 Vac 50-60Hz

±15%
Max. Power consumption: 15 VA

Double fuse protection: 250 mA Rit 5 x 20 mm

Plug for Interlock/safety key (contacts normally closed) 6 contact DIN plug

Backlit LCD Display, to visualize and control operating graphic 240 x 128 pixel
parameters:

Programmable treatment time: up to 60 minutes

Diode Laser Wave length for LP025, LP100, CP400 – 905 nm

pulse diode

Diode Laser Wave length for LP500 – continuous laser 808 nm

diode

Laser classification according to EN-60825-1 3B

MPE (Maximum permissible exposure) 5032.06 J . m –2

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Enraf-Nonius

AEL (Accessible emission limit) 77.1 mW (class 3B limit)

Divergence 107 mrad

NOHD (Nominal ocular hazard area) direct light 2.89 metres

NOHD diffused light 0.00 metre

IR radiation sensor for external laserprobe. On front panel

Programmable impulse frequency 10 - 10.000 Hz

Duty Cycle, only available with continuous laser diodes 10 – 9900 Hz

Peak Power Laserprobe LP025 (pulsed laser diode) 25 W – Articlenumber: 1422816

Peak Power Laserprobe LP100 (pulsed laser diode) 100 W – Articlenumber: 1422817
Peak Power Laserprobe LP500 (continuous laser diode) 500 mW – Articlenumber: 1422818
Peak Power Cluster probe LP400 (pulsed laser diodes) 4 x 100 W – Articlenumber: 1422819
Independent output channels 2

Pre-programmed protocols 82

Free programmable positions 50

Plastic desktop container – external dimensions (L x H x D) 29x28x11, 5 cm

Weight of machine body: 3,2 kg

Medical MDD classification IIB

The above mentioned technical specifications are copied from the IFU 1422750_47
Medical MDD classification according to A.v. Maurik, Manager Quality.

1468960 EN-Car U3

Dimensions : 46 x 57 x 110 cm (LxDXH)
Height of worktop adjustable : from 25 to 125 cm
Max weight per tree : 15 kg
Wheel brakes : 2 items (front)
Wheel rotation : 360 degrees
Wheel diameter : 100 mm
Frame column : hollow (for cables and outlets)
Colours : licht grey & dark grey

In the absence of instructions, information obtained from product manager during its time of introduction.

1468950 EN-Car U II

Dimensions : 46 x 57 x 110 cm (LxDXH)
Height of worktop adjustable : from 25 to 125 cm
Max weight per tree : 15 kg
Wheel brakes : 2 items (front)
Wheel rotation : 360 degrees
Wheel diameter : 100 mm
Frame column : hollow (for cables and outlets)
Colours : light grey & lavender
In the absence of instructions, information obtained from product manager during its time of introduction.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 76

Enraf-Nonius

1671901 Eltrac 471

Mains voltage : 100 - 240 V

Mains frequency : 50 / 60 Hz
Maximum power : max. 70 VA
Main fuses : 2 x T6.3AH250V

Dimensions : 30 x 34 x 22 cm (wxdxh)
Weight : 10 kg

Environmental conditions for transport and storage

Temperature : -10° to +70° C
Relative humidity : 10 to 90 % (non condensing)
Atmospheric pressure : 800 to 1060 hPa

Environmental conditions for normal use:

Temperature : 10 to 40 °C
Relative humidity : 10 to 90 % (non condensing)
Atmospheric pressure : 800 to 1060 hPa

Form of therapy : Static, Intermittent, Pro- and Regressive, Cyclic

Traction force : 15 - 900 N / 1.5 - 90 kg / 3.4 - 202 Lbs
Traction force / base force hold time : 1 sec. - 1 hour (1 sec. intervals)
Repeats (intermittent and cyclic) : 1 - 100
Steps hold time (pro- and regressive) : 1 sec.- 5 min. (1 sec. intervals)
Steps (pro- and regressive) : 1 - 25
Speed (change of traction force) : 1 - 50 N/sec. (1 N intervals)
0.1 - 5.0 kg/sec.
0.2 - 11.2 Lbs/sec.
Treatment time : 1 sec. - 150 min.
Programmable favorites : 100+
Clinical protocols : Yes (3)
Sequential programming : Yes (up to 5 forms of therapy)
Safety control for traction force above : 200 N / 20 kg / 45.2 Lbs
Touch screen : 4.3 inch, full colour, capacitive

Safety and performance standards

Medical device classification IIb 

This equipment complies with all essential requirements of the
Medical Device Directive (93/42/EEC)

I Safety class I (IEC 60601-1)

The unit is equipped with a safety earth and must be connected
to a mains plug with earth contact.

Type B
The leakage current and safety earth correspond to
standard IEC 60601 -1.

The above mentioned technical specifications are copied from the IFU 1671751_45

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1442911 EndoPress 442

The Endopress 442 has been designed and manufactured according to current Directives regarding
Electromagnetic compatibility 89/336/CEE with the aim of providing adequate protection from harmful
interferences when installed in homes and health establishments.

Mains voltage : 230 VAC 50-60Hz ±15%

Maximum power consumption : 220 VA
Backlit LCD Display, to visualize and
control operating parameters : graphic 240 x 128 pixel
Pressure adjustment : 0 – 150 mmHg
Programmable treatment time : up to 30 minutes
Output connectors (Parallel) : 2
Pre-programmed protocols : 30
Free programmable positions : 50
Dimensions (W x D x H) : 39x40x93 cm
Weight : Ca.35 Kg

Medical class : IIA

The above mentioned technical specifications are copied from the IFU 1442751_42
Information regarding Medical class received from Manager Quality 07-09-2017

1442912 EndoPress 442

Mains voltage : 115 VAC 50-60Hz ±15%

Maximum power consumption : 220 VA
Backlit LCD Display, to visualize and
control operating parameters : graphic 240 x 128 pixel
Pressure adjustment : 0 – 150 mmHg
Programmable treatment time : up to 30 minutes
Output connectors (Parallel) : 2
Pre-programmed protocols : 30
Free programmable positions : 50
Dimensions (W x D x H) : 39x40x93 cm
Weight : Ca.35 Kg

Medical class : IIA

The above mentioned technical specifications are copied from the IFU 1442751_42
Information regarding Medical class received from Manager Quality 07-09-2017

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 78

Enraf-Nonius

1670901 Curapuls 670

Mains voltage: 100 - 240 Volt ± 10%

Frequency: 50/60 Hz

Max, Power consumption: 400 VA

Patient leakage current: typically, 1 μA

idem single fault condition: typically, 2 μA

Safety class: II Type B, according to IEC 60601-1

Dimension (Length x Width x Height) (Weight)

Main Unit 48 x 56 x 110 cms 22kg

One Electrode Arm - 3kg

Electrode Cable 150cms -
Output Power
Base Frequency: 27.12 MHz
Pulse duration: 65 - 400 µs
Pulse frequency: 26 - 800 Hz
Pulse power: 0 - 200 W
Mean power: 0 - 64 W
Treatment time: 0 - 30 minutes

Environment conditions for Transport and Storage

Environment temperature: –20° till +70° C

Relative humidity: 10 to 90%(non-condensing)
Atmospheric pressure: 500 till 1060 hPa

Environment conditions normal use

Environment temperature: 10° till 40° C

Relative humidity: 10 to 90 % (non-condensing)
Atmospheric pressure: 500 till1060 hPa

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 79

Enraf-Nonius

Safety and performance standards

IEC 60601-1 General requirements for the safety of electrical

medical systems, including Annex I, national
differences for Australia, Canada and the United
States.
Safety class according to Class I
IEC 60601-1
Electrode classified as Type BF
The equipment has a floating patient circuit.
IEC 60601-2-5 Particular requirements for the safety of ultrasonic
therapy equipment.
21 CFR 1050.10 This equipment complies with all requirements of 21
CFR 1050.10, Performance Standard for Ultrasound
Therapy devices.
Medical device classification IIa
This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).

Non-Ionizing radiation

The above mentioned technical specifications are copied from the preliminary version of the IFU 1670750_40P11 dated 23-11-2017

1419942 Curapuls 970

Mains supply : 230V~ 50/60 Hz (art.nr. 1419.942)

240V~ 50/60 Hz (art.nr. 1419.962)
115V~ 50/60 Hz (art.nr. 1419.982)
Mains voltage variation : max. ± 10%
Current consumption : max. 6 A (at 230 V)
Leakage current : typically 350 μA (IEC requirement ≤ 500 μA)
Dimensions : 56 x 43 x 92.5 cm (w x d x h) without arms
Length electrode arms : 93 cm
Weight : ca. 80 kg

Generator frequency : 27.12 MHz, ± 0.6%

Output power : continuous HF max. 400 W */**
pulsed HF max. 1000 W (peak) */**
Pulse duration : ca. 400 μs
Pulse repetition frequency : 15 - 200 Hz adjustable in 10 steps
Timer : 0 - 30 min.; with acoustic signal and automatic switch-off

** Models for Canada and the USA have different specifications.

* Measured with 70 Ohm standard phantom (art.nr. 1462.471).

Environment conditions for transport and storage 
Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa
 

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Enraf-Nonius

Environments conditions for normal use 
Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Safety and performance standards

  :  Medical class IIa 

This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).

International safety standard IEC 60601-1

: Non-ionising radiation

: Safety-class I. The unit must be connected to a grounded

wall socket

: Type BF, including circuplodes.

The leakage current and the ground connection of the
equipment meets the requirements of IEC 60601-I and
IEC 60601-2-3.

The above mentioned technical specifications are copied from the IFU 1419751_47

1435901 Radarmed 650+

Mains voltage : 220-240 Volt

Frequency : 50 / 60 Hz
Current consumption : 1100 VA
Weight : 45 kg (including arm)
Dimensions : 93x39x49 cm (hxwxd including castors)

Microwave therapy

Frequency : 2450 MHz +/- 50 MHz

HF power, continuous : 0 - 250 Watt +/- 20% at 50 Ohm
HF power, pulsed : 0 - 250 Watt +/- 20% with a fixed peak power of 1500 Watt
Operating modes : continuous and pulsed
Clock : 0 - 30 minutes

Environment conditions for transport and storage

Environment temperature : -20° till +70° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 700 till 1060 hPa

Environment conditions for normal use

Environment temperature : 10° till 40° C
Relative humidity : 30 till 75 %
Atmospheric pressure : 700 till 1060 hPa

Marking :

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 81

Enraf-Nonius

Safety and performance standards

Medical class IIa : This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).

International safety standard IEC 60601-1

: Non-ionising radiation

Safety-class I : The unit is equipped with a safety earth and must be connected
to a mains plug with earth contact.

: Type B.

The above mentioned technical specifications are copied from the IFU 1435750_49

1435911 Radarmed 950+

Mains voltage : 220-240 Volt

Frequency : 50 / 60 Hz
Current consumption : 1100 VA
Weight : 45 kg (including arm)
Dimensions : 93x39x49 cm (hxwxd including castors)

Microwave therapy
Frequency : 2450 MHz +/- 50 MHz
HF power, continuous : 0 - 250 Watt +/- 20% at 50 Ohm
HF power, pulsed : 0 - 250 Watt +/- 20% with a fixed peak power of 1500 Watt
Operating modes : continuous and pulsed
Clock : 0 - 30 minutes

Environment conditions for transport and storage

Environment temperature : -20° till +70° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 700 till 1060 hPa

Environment conditions for normal use

Environment temperature : 10° till 40° C
Relative humidity : 30 till 75 %
Atmospheric pressure : 700 till 1060 hPa

Safety and performance standards

Medical class IIa : This equipment complies with all requirements of the `
Medical Device Directive (93/42/EEC).

International safety standard IEC 60601-1

: Non-ionising radiation

Safety-class I : The unit is equipped with a safety earth and must be connected
to a mains plug with earth contact.

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 82

Enraf-Nonius

: Type B.

The above mentioned technical specifications are copied from the IFU 1435751_4A
Note: the Radarmed 950+ is not CE-certified.

3448162 Paraffin-bath

Mains voltage : 230V, 50-60Hz

Power consumption : 2000W
Temperature range : 30 – 90 °C
Overheating safety device : thermal cut-out 110 °C
Internal dimensions : 50 x 30 x 21 cm. (30 L)
External dimensions : 58 x 32 x 50 cm. (30 L)

Environment conditions for transport and storage

Environment temperature : –10° till +50 °C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use

Environment temperature : 10° till 40 °C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Safety and performance standards

: Medical class IIa

This equipment complies with all essential requirements of the
Council Directive 93/42/EEC of the European communities,
concerning medical devices.
 
International safety norm : The unit is confirming the international norm for medical
electronic devices IEC 60601-1

Safety Class I : The unit has a protective earth connection and must be
connected to a wall socket with protective earth.

The above mentioned technical specifications are copied from the IFU 1400005_46

3448163 Paraffin-bath

Mains voltage : 115V, 50-60Hz

Power consumption : 1760W
Temperature range : 30 – 90 °C
Overheating safety device : thermal cut-out 110 °C
Internal dimensions : 50 x 30 x 21 cm. (30 L)
External dimensions : 58 x 32 x 50 cm. (30 L)

Environment conditions for transport and storage

Environment temperature : –10° till +50 °C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use

Environment temperature : 10° till 40 °C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 83

Enraf-Nonius

Safety and performance standards

: Medical class IIa

This equipment complies with all essential requirements of the
Council Directive 93/42/EEC of the European communities,
concerning medical devices.
 
International safety norm : The unit is confirming the international norm for medical
electronic devices IEC 60601-1

Safety Class I : The unit has a protective earth connection and must be
connected to a wall socket with protective earth.

The above mentioned technical specifications are copied from the IFU 1400005_46

3448191 Packheater

Mains voltage : 230 V (suitable for 220-240V)

Power consumption : 1800W
Temperature range : 50°C - 100°C
Safety class : I according to IEC 601
Tank capacityl : 29 liters
Dimensions : height 42 cm, diameter 35 cm
Weight : 7 kg
Saftey approval : This equipment complies with all requirements of the EMC
Directive (89/336/EEC and 92/31/EEC).

The above mentioned technical specifications are copied from the IFU 1400725_43

3448265 Packheater E-1

Power Supply : 115 V~, 220-240 V~

Rated Frequency : 50/60 Hz
Power Consumption : 1000 W
Tank Capacity : 15.44 Liters
Temperature Range : 71°-74°C
Thermal Cut-ut Temp : 82°-85°C
Accuracy : +/- 10%
Heating Up Time : Time to 70°C - 2 Hours
Cool Down Time : Time from 70°C - 1 Hours
Safety Class : Type B
Safety Tests : CMET
Dimensions : 40.64 cm (H) x 33.02 cm (L) x 22.89 cm (W)
Weight : 7.09 kg
Meets Directives : 73/23/EEC, 89/336/EEC
Standard accessories : 4 x Enno Moist 25x30 cm (3448176)

The above mentioned technical specifications are copied from the IFU 1400751_42
The accessories are copied from the webleaflet Packheaters 16-03-2017 - Enraf-Nonius Electro

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Enraf-Nonius

3448264 Packheater E-2

Power Supply : 115 V~, 220-240 V~

Rated Frequency : 50/60 Hz
Power Consumption : 1000 W
Tank Capacity : 43.23 Liters
Temperature Range : 71°-74°C
Thermal Cut-out Temp : 82°-85°C
Accuracy : +/- 10%
Heating Up Time : Time to 70°C - 4 Hours
Cool Down Time : Time from 70°C - 2 Hours
Safety Class : Type B
Safety Tests : CMET
Dimensions : 54.61 cm (H) x 36.83 cm (L) x 31.75 cm (W)
Weight : 13.43 kg
Meets Directives : 73/23/EEC, 89/336/EEC
Standard accessories : 6 x Enno Moist in 3 different sizes

The above mentioned technical specifications are copied from the IFU 1400751_42
The accessories are copied from the webleaflet Packheaters 16-03-2017 - Enraf-Nonius Electro

3448261 Packheater M-2

Power Supply : 115 V~, 220-240 V~

Rated Frequency : 50/60 Hz
Power Consumption : 1000 W
Tank Capacity : 68.81 Liters
Temperature Range : 71° - 74°C
Thermal Cut-out Temp : 82° - 85°C
Accuracy : +/- 10%
Heating Up Time : Time to 70°C - 6 Hours
Cool Down Time : Time from 70°C - 3 Hours
Safety Class : Type B
Safety Tests : CMET
Dimensions : 85.09 cm (H) x 67.31 cm (L) x 39.73 cm (W)
Weight : 37.32 kg
Meets Directives : 73/23/EEC, 89/336/EEC
Standard accessories : 12 x Enno Moist 25x30 cm (3448176)

The above mentioned technical specifications are copied from the IFU 1400751_42
The accessories are copied from the webleaflet Packheaters 16-03-2017 - Enraf-Nonius Electro

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Enraf-Nonius

3448262 Packheater M-4

Power Supply : 115 V~, 220-240 V~

Rated Frequency : 50/60 Hz
Power Consumption : 1500 W
Tank Capacity : 135.76 Liters
Temperature Range : 71° - 74°C
Thermal Cut-Out Temp : 82° - 85°C
Accuracy : +/- 10%
Heating Up Time : Time to 70°C - 8 Hours
Cool Down Time : Time from 70°C - 4 Hours
Safety Class : Type B
Safety Tests : CMET
Dimensions : 85.09 cm (H) x 88.9 cm (L) x 50.16 cm (W)
Weight : 59.712 kg
Meets Directives : 73/23/EEC, 89/336/EEC
Standard accessories : 24 x Enno Moist 25x30 cm (3448176)

The above mentioned technical specifications are copied from the IFU 1400751_42
The accessories are copied from the webleaflet Packheaters 16-03-2017 - Enraf-Nonius Electro

3448260 Packheater SS-2

Power Supply : 115 V~, 220-240 V~

Rated Frequency : 50/60 Hz
Power Consumption : 1000 W
Tank Capacity : 49.32 Liters
Temperature Range : 71° - 74°C
Thermal Cut-out Temp : 82° - 85°C
Accuracy : +/- 10%
Heating Up Time : Time to 70°C - 4 Hours
Cool Down Time : Time from 70°C - 2 Hours
Safety Class : Type B
Safety Tests : CMET
Dimensions : 85.09 cm (H) x 52.07 cm (L) x 39.37 cm (W)
Weight : 29.85 kg
Meets Directives : 73/23/EEC, 89/336/EEC
Standard accessories : 8 x Enno Moist 25x30 cm (3448176)

The above mentioned technical specifications are copied from the IFU 1400751_42
The accessories are copied from the webleaflet Packheaters 16-03-2017 - Enraf-Nonius Electro

3448401 Packheater WB 4-30

Tank capacity : 30 liter

Number of bars (insert grid) : -
Number of packs (25x30 cm) : 5 (not standard supplied)
Gas spring supported lid : -
Power supply : 220-240V / 50/60Hz
Heating capacity : 900 W
Temperature range : 30 – 85 °C
Accuracy (temp. setting) : 5K
Temperature control : thermostatic
Control accuracy : ± 5,0 K
Digital temperature display : -
Thermal cut-out (safety) : 95 °C
Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 86
Enraf-Nonius

External dimensions (lxwxh) : 575x365x370 mm

Internal dimensions (lxwxh) : 500x300x200 mm
Net weight : 12,0 kg
Shipping weight : 15 kg
Cross section of the power cable : 3 x 1 mm²
Device fuses
(IEC 60127-2/4 • DIN VDE 0820) : 6,3x32 5,0 A fast acting
Medical Device Class : Class I

The above mentioned technical specifications are copied from the IFU 1400761_40

3448401 Packheater WB 6-50

Tank capacity : 47 liter

Number of bars (insert grid) : 3
Number of packs (25x30 cm) : 8 (not standard supplied)
Gas spring supported lid : Yes
Power supply : 220-240V / 50/60Hz
Heating capacity : 1500 W
Temperature range : 30 – 85 °C
Accuracy (temp. setting) : 0,1 K
Temperature control : electronic
Control accuracy : ± 2,0 K
Digital temperature display : Yes
Thermal cut-out (safety) : 95 °C
External dimensions (lxwxh) : 675 x 470 x 385 mm
Internal dimensions (lxwxh) : 590 x 400 x 200 mm
Net weight : 23,2 kg
Shipping weight : 25,5 kg
Cross section of the power cable : 3 x 1 mm²
Device fuses
(IEC 60127-2/4 • DIN VDE 0820) : 6,3x32 8,0 A fast acting
Medical Device Class : Class I

The above mentioned technical specifications are copied from the IFU 1400762_40

3448401 Packheater WB 8-90

Tank capacity : 82 liter

Number of bars (insert grid) : 4
Number of packs (25x30 cm) : 12 (not standard supplied)
Gas spring supported lid : Yes
Power supply : 220-240V / 50/60Hz
Heating capacity : 1500 W
Temperature range : 30 – 85 °C
Accuracy (temp. setting) : 0,1 K
Temperature control : electronic
Control accuracy : ± 2,0 K
Digital temperature display : Yes
Thermal cut-out (safety) : 95 °C
External dimensions (lxwxh) : 725 x 470 x 490 mm
Internal dimensions (lxwxh) : 645 x 400 x 320 mm
Net weight : 28,8 kg
Shipping weight : 45 kg
Cross section of the power cable : 3 x 1 mm²
Device fuses
(IEC 60127-2/4 • DIN VDE 0820) : 6,3x32 8,0 A fast acting
Medical Device Class : Class I

The above mentioned technical specifications are copied from the IFU 1400762_40

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3448401 Packheater WB 16-130

Tank capacity : 99 liter

Number of bars (insert grid) : 7
Number of packs (25x30 cm) : 18 (not standard supplied)
Gas spring supported lid : Yes
Power supply : 220-240V / 50/60Hz
Heating capacity : 1500 W
Temperature range : 30 – 85 °C
Accuracy (temp. setting) : 0,1 K
Temperature control : electronic
Control accuracy : ± 2,0 K
Digital temperature display : Yes
Thermal cut-out (safety) : 95 °C
External dimensions (lxwxh) : 775 x 490 x 515 mm
Internal dimensions (lxwxh) : 695 x 420 x 340 mm
Net weight : 30,3 kg
Shipping weight : 50 kg
Cross section of the power cable : 3 x 1 mm²
Device fuses
(IEC 60127-2/4 • DIN VDE 0820) : 6,3x32 8,0 A fast acting
Medical Device Class : Class I

The above mentioned technical specifications are copied from the IFU 1400762_40

3448274 Chilling unit model C-5

Rated Voltage : 220-240V~

Rated Frequency : 50 Hz
Current : 2 A.
Circuit Breaker : 10 A.
Work : 0,14914 kWh
Type of Refrigerant : R-134A
Amount of Refrigerant : C-5, .207L. (7 oz.)
Test Pressures : High, 1.62MPa (235 psi)
Low, 1.03 Mpa (150 psi)
Normal Operating Temperature : -12° C to -6° C (+10° F to +21° F)t

Standard accessories : 6x Colpac 28x36 cm (3448284)

6x Colpac 16x28 cm (3448288)

Safety Class : Type B

m
The above mentioned technical specifications are copied from the IFU 1400752_41

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3441803 Halogen IR-radiator IRS-2

Power supply * : 220-240V / 50/60Hz

(* Power supplied via the support system - optional)
Number of lamps : 2
Heating capacity per lamp : 200 W
Max. heating capacity : 400 W
Lamps individually switchable : No
Timer : Max. 60 min.
Device fuses : 6,3x32 fast acting
5,0 A
IEC 60127-2/4 • DIN VDE 0820
Overall dimensions (LxWxH) : 555 x 365 x 145 mm
Net weight : 11,6 kg
Shipping weight : 13.5 kg
Packing dimensions (LxWxH) : 815 x 500 x 500 mm
Medical Device Class : Class IIa

Photobiological Safety
The photobiological safety of the infrared spot IRS 2 is testified according to the following standard:
DIN EN 62471; VDE 0837-471:2009-03:2009-03: Photobiologische Sicherheit von Lampen und
Lampensystemen (IEC 62471:2006, modifiziert; Deutsche Fassung EN 62471:2008

Safety and performance standards

The Infrared spots IRS 2 comply with the safety requirements of the following
standards, laws and directives:
· German Medical Devices Act
· MDD 93/42/EWG, 2007 – Medical Device Directive
· Classification: Medical Device Class IIa
· DIN EN 60601-1: 2007 – Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
· DIN EN 60601-1-2: 2007 – Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests

The above mentioned technical specifications are copied from the IFU 1400764_40

3441804 Halogen IR-radiator IRS

Power supply * : 220-240V / 50/60Hz

(* Power supplied via the support system - optional)
Number of lamps : 3
Heating capacity per lamp : 200 W
Max. heating capacity : 600 W
Lamps individually switchable : Yes
Timer : Max. 99 min.
Device fuses : 6,3x32 fast acting
5,0 A
IEC 60127-2/4 • DIN VDE 0820
Overall dimensions (LxWxH) : 700 x 395 x 145 mm
Net weight : 12 kg
Shipping weight : 14.5 kg
Packing dimensions (LxWxH) : 815 x 500 x 500 mm
Medical Device Class : Class IIa

Photobiological Safety
The photobiological safety of the infrared spot IRS is testified according to the following standard:
DIN EN 62471; VDE 0837-471:2009-03:2009-03: Photobiologische Sicherheit von Lampen und
Lampensystemen (IEC 62471:2006, modifiziert; Deutsche Fassung EN 62471:2008

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Enraf-Nonius

Safety and performance standards

The Infrared spots IRS comply with the safety requirements of the following
standards, laws and directives:
· German Medical Devices Act
· MDD 93/42/EWG, 2007 – Medical Device Directive
· Classification: Medical Device Class IIa
· DIN EN 60601-1: 2007 – Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
· DIN EN 60601-1-2: 2007 – Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests

The above mentioned technical specifications are copied from the IFU 1400765_40

3441821 Mobile stand SST

Length : 820 mm
Front width : 780 mm
Rear width : 570 mm
Minimum height : 1640 mm
Maximum height : 2040 mm
Height of stand base (front) : 60 mm
Nominal Voltage : 220-240 V
Power frequency : 50/60 Hz
Cross section of the power cable : 3 x 1 mm²
Packing dimensions (L x W x H) : 165 x 29,5 x 16 cm
Net weight : 17,7 kg
Packing - gross weight : 21,5 kg

The above mentioned technical specifications are copied from the webbrochure Mobile stand SST/SSU/SSV & wall arm HWA

3441822 Mobile stand SSU

Length : 800 mm
Front width : 800 mm
Rear width : 800 mm
Minimum height : 1640 mm
Maximum height : 2040 mm
Height of stand base (front) : 65 mm
Nominal Voltage : 220-240 V
Power frequency : 50/60 Hz
Cross section of the power cable : 3 x 1 mm²
Packing dimensions (L x W x H) : 165 x 29,5 x 16 cm
Net weight : 17,8 kg
Packing - gross weight : 21,5 kg

The above mentioned technical specifications are copied from the webbrochure Mobile stand SST/SSU/SSV & wall arm HWA

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Enraf-Nonius

3441823 Mobile stand SSV

Length : 810 mm
Front width : 820 mm
Rear width : 560 mm
Minimum height : 1640 mm
Maximum height : 2040 mm
Height of stand base (front) : 65 mm
Nominal Voltage : 220-240 V
Power frequency : 50/60 Hz
Cross section of the power cable : 3 x 1 mm²
Packing dimensions (L x W x H) : 165 x 29,5 x 16 cm
Net weight : 18,5 kg
Packing - gross weight : 21,5 kg

The above mentioned technical specifications are copied from the webbrochure Mobile stand SST/SSU/SSV & wall arm HWA

3441824 Wall arm HWA

Net weight : 8,5 kg

Shipping weight : 10 kg
Load range : 8-13 kg
Radius of action : 1550 mm
Maximum angle of inclination way up : 35 °
Maximum angle of inclination way down : 55 °
Nominal voltage : 220-240 V
Power frequency : 50/60 Hz
Cross section of the power cable : 3 x 1 mm²

The above mentioned technical specifications are copied from the webbrochure Mobile stand SST/SSU/SSV & wall arm HWA

3446188 Quadriceps Bench

Dimensions : 127 x 70 x 90 cm. (HxWxD)

Weight : 30 kg. (excl. weight discs)
Maximum patient weight : 135 kg.
Angular adjustability of the Range of
Motion limiters : 0° to 360° in steps of 20°
Lever arm adjustment : from 15 to 45 cm.
Angular adjustability of the lever arm : 0° to 360° in steps of 20°
Weight discs : 10 x 0,5 kg
1 x 5 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

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Enraf-Nonius

Medical classification : Class I

This product complies with all essential requirements
of the Council Directive 93/42/EEC of the European
communities, concerning medical devices.

The above mentioned technical specifications are copied from the IFU 1400740_42

1427901 TENSMED S82

Device
Size : 130 X 80 X 20 mm
Weight : 220 g.
Case : in ABS
Protection level : IP 22
Storage and transportation temperature : from -10°C to 45°C
Max. relative humidity : 30% - 75%
The values indicate the limits allowed if the product or its accessories are not in the original package.
Made in PRC.

Charger
Tipo : Switching Power Adaptor
Model : DK7-065-0200-EU
Input : 100-240Vac - 50-60Hz - 0,025 A
Output : 5,8 Vdc - 200 mA
Polarity :
Batteriy pack : Ni-MH AAA 4,8V 800 mAh
Made in PRC.

Use conditions
Temperature : from 0°C to 35°C
Max. relative humidity : From 15% to 93%
Atmospheric pressure : from 700 hPa to 1060 hPa

Technical features of the currents NMES and TENS:

Channels available : channel 1-2
Constant current : Yes
Intensity : 0-100 mA p.p. per channel
Wave form : Rectangular, biphasic, symmetric, compensated
Working frequency : 1-150 Hz
Recovery frequency : 1-150 Hz
Pulse width (single phase : 50-400 µs (total pulse time: 100-800 µs)
Working time : from 1 to 30 seconds
Recovery time : from 0 to 1 minute
Frequency modulation range : continuous variation from 1 to 150 Hz
Min. modulation time : 3 seconds
Pulse width modulation range : continuous variation from 50 to 400 µs
Min. Time : 1 minute
Max. Time : 100 minutes

The above mentioned technical specifications are copied from the soon to be released IFU 1427751_50

1427911 TENSMED S84

Device
Size : 160x99x35.4 mm
Weight : 404 g
Case : in ABS
Protection level : IP 20
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Enraf-Nonius

Storage and transportation temperature : from -10°C to 45°C

Max. relative humidity : 30% - 75%
Medical device classification class : II A
The values indicate the limits allowed, if the product or its accessories are not in the original package.

Conditions of use
Temperature : from 0°C to 35°C
Max. relativity humidity : from 15% to 93%
Atmospheric pressure : from 700 hPa to 1060 hPa

Technical features of the currents NMES and TENS

Channels available : channels 1-2-3-4
Constant current : yes
Intensity : 0-120 mA with 1000 Ohm load
Wave form : rectangular, biphasic, symmetrical, compensated
Working frequency : 1-150 Hz
Recovery frequency : 1-150 Hz
Pulse width (single phase) : 50-450 µs (total pulse width: 100-900 µs)
Working time : from 1 to 30 seconds
Recovery time : from 0 to 1 minute
Frequency mod. range : continuous variation from 1 to 150 Hz
Min. modulation time : 3 seconds
Pulse width modulation range : continuous variation from 50 to 450 µs

Power supply unit

Brand / model : GLOBTEK / GTM4160-2512
PRI : 100-240Vac 50-60Hz Max 0,6A
SEC : 12V 2,08A
Polarity :

Battery : Ni-MH 7,2 V 1,8 Ah

The above mentioned technical specifications are copied from the soon to be released IFU 1427761_50

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Treatment couches
Manumed Technical Specifications
Mains voltage : 120 or 230VAC
Frequency : 50/60 Hz
Duration of continuous operation : short-time operation, 4 minutes’ maximum
Moisture resistance : according IP 44

Safety and performance standards

Medical device classification : I

Safety Class (IEC 60606-1) : II (double insulated)

Type B Applied part

This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).

Max current consumption

height adjustment (cm)
separate arm sections

separate leg sections

Hydraulic high-low

table top size (cm)

Electric high-low

flexion position

lifting capacity
Fixed height
Type

212 Optimal 3-section x 204 x 47 - 97 200 kg

67/57/80
222 Optimal 3-section x 204 x 47 - 100 200 kg 2,0 A
67/57/80
213 Optimal 3-section x x 204 x 47 - 97 200 kg
67/57/80
243 Optimal 3-section x x 204 x 47 - 100 200 kg 2,0 A
67/57/80
214 Optimal 3-section x x 204 x 47 - 97 200 kg
67/57/80
224 Optimal 3-section x x 204 x 47 - 100 200 kg 2,0 A
67/57/80
215 Optimal 3-section x x x 204 x 47 - 97 200 kg
67/57/80
245 Optimal 3-section x x x 204 x 47 - 100 200 kg 2,0 A
67/57/80

311 Optimal 2-section x 201 x 47 - 97 200 kg

67/57/80
312 Optimal 2-section x 201x67/57/80 45 – 95 200 kg

321 Optimal 2-section x 201 x 47 – 100 200 kg 2,0 A

67/57/80
322 Optimal 2-section x 201x67/57/80 45 – 98 200 kg 2,0 A

313 Optimal 2-section x x 201 x 47 - 97 200 kg

67/57/80
323 Optimal 2-section x x 201 x 47 - 100 200 kg 2,0 A
67/57/80

446 Osteo 4-section 3 x x 214 x 51 - 103 200 kg 2,0 A

motors 67/57/80

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Max current consumption

height adjustment (cm)
separate arm sections

separate leg sections

Hydraulic high-low

table top size (cm)

Electric high-low

flexion position

lifting capacity
Fixed height
Type

448 Osteo 6-section 3 x x x 214 x 67/80 51 - 103 200 kg 2,0 A

motors
449 Osteo 7-section 3 x x x x 214 x 67 51 - 103 200 kg 2,0 A
motors

612 Comfort 3-section x 200 x 67/80 46- 96 200 kg

622 Comfort 3-section x 200 x 67/80 46 - 99 200 kg 2,0 A

632 Comfort 3-section x 200 x 67/80 46 - 99 200 kg 2,0 A

613 Comfort 3-section x x 200 x 67 46 - 96 200 kg

623 Comfort 3-section x x 200 x 67 46 - 99 200 kg 2,0 A

511 Exercise 2-section x 203 x 120 44 - 94 200 kg

521 Exercise 2-section x 203 x 120 44 - 97 250 kg 2,0 A

500 Exercise fixed height x 100 x 200 55 135 kg

510 Exercise 1-section x 100/120 x 200 44 - 94 200 kg

520 Exercise 1-section x 100/120 x 200 44 - 97 250 kg 2,0 A

004 Traction fixed height x 195 x 67 83 135 kg

916 Traction 4-section x 203 x 67 45 - 95 200 kg 2,0 A

926 Traction 4-section x 203 x 67 45 - 95 200 kg 2,0 A

Technical modifications reserved!

The above mentioned table and technical informatino is copied from the IFU 1400912_4D, which will be released during 2018.

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Manumed upholstery and foam

Upholstery
Manumed couches : different colours available
Manumed ST : different colours available
ManuXelect : different colours available
Other couches and more information : upon request

Colour frame
Manumed couches : grey (Ral 7035) black (Ral 9005) white (RAL9010)
Check with the local distributor which frame colour is available
for your type Manumed couch.
ManuXelect : grey (RAL 7035)

Foam filling
Information upon request

Manumed environment conditions

Environment conditions for transport and storage
Environment temperature : -10 to +50 °C
Relative humidity : 20 to 90%
Atmospheric pressure : 800 till 1060 hPa

Environment conditions normal use

Environment temperature : 10° till 40° C
Relative humidity : 30 to 70 %
Atmospheric pressure : 700 till1060 hPa

The above mentioned environment conditions are copied from the IFU 1400912_4D

Manumed ST 3-section

Height adjustment : from 48 till 101 cm

Length : ca. 207 cm
Width : ca. 67 cm
Lifting capacity : 150 kg for the electrical model
150 kg for the hydraulic model
Motor speed : 6 mm/sec
Power supply : 230V~ 50/60 Hz
Current consumption : 1,0A
Moisture resistance : according IPX4
Medical device classification : I
Safety class (IEC 60601-1) : II (double insulated)
Upholstery : Type AKV Peri
Fire safety : DIN EN 1021 part 1/2
Free of phthalates
Biological : DIN EN ISO 10993-5, 1999-11
DIN EN ISO 10993-10, 1999-12

The above mentioned technical specifications are copied from the IFU 1560750_42

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Manumed ST 2-section head-section

Height adjustment : from 48 till 101 cm

Length : ca. 207 cm
Width : ca. 67 cm
Lifting capacity : 150 kg for the electrical model
150 kg for the hydraulic model
Motor speed : 6 mm/sec
Power supply : 230V~ 50/60 Hz
Current consumption : 1,0A
Moisture resistance : according IPX4
Medical device classification : I
Safety class (IEC 60601-1) : II (double insulated)
Upholstery : Type AKV Peri
Fire safety : DIN EN 1021 part 1/2
Free of phthalates
Biological : DIN EN ISO 10993-5, 1999-11
DIN EN ISO 10993-10, 1999-12

The above mentioned technical specifications are copied from the IFU 1560750_42

Manumed ST 2-section back-section

Height adjustment : from 48 till 101 cm

Length : ca. 207 cm
Width : ca. 67 cm
Lifting capacity : 150 kg for the electrical model
150 kg for the hydraulic model
Motor speed : 6 mm/sec
Power supply : 230V~ 50/60 Hz
Current consumption : 1,0A
Moisture resistance : according IPX4
Medical device classification : I
Safety class (IEC 60601-1) : II (double insulated)
Upholstery : Type AKV Peri
Fire safety : DIN EN 1021 part 1/2
Free of phthalates
Biological : DIN EN ISO 10993-5, 1999-11
DIN EN ISO 10993-10, 1999-12

The above mentioned technical specifications are copied from the IFU 1560750_42

ManuXelect 2-section back-section

Height adjustment : ca. 48 - 105 cm

Length : ca. 207 cm
Width : ca. 67 cm
Lifting capacity : 150 kg with the standard motor KL95 of 6000N
250 kg with the optional motor SL80 of 8000N
Motor speed : 6 mm/sec for both types
Power supply : 230V~ 50/60 Hz or 115V~ 50/60 Hz
Current consumption : 1,5A for the 6000N motor
2,0A for the 8000N motor
Moisture resistance : according IP 55

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Safety and performance standards

Medical device classification :I
Safety class (IEC 60601-1) : II (double insulated)

Upholstery : Type AKV Peri

Fire safety : DIN EN 1021 part 1/2

Free of phthalates :
Biological : DIN EN ISO 10993-5
DIN EN ISO 10993-10

Climate conditions for transport and storage:

Temperature : -40 to +70 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

Climate conditions for normal use:

Temperature : 10 to 40 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

The above mentioned technical specifications are copied from the IFU 1550750_44

ManuXelect 2-section head-section

Height adjustment : ca. 48 - 105 cm

Length : ca. 207 cm
Width : ca. 67 cm
Lifting capacity : 150 kg with the standard motor KL95 of 6000N
250 kg with the optional motor SL80 of 8000N
Motor speed : 6 mm/sec for both types
Power supply : 230V~ 50/60 Hz or 115V~ 50/60 Hz
Current consumption : 1,5A for the 6000N motor
2,0A for the 8000N motor
Moisture resistance : according IP 55

Safety and performance standards

Medical device classification :I
Safety class (IEC 60601-1) : II (double insulated)

Upholstery : Type AKV Peri

Fire safety : DIN EN 1021 part 1/2

Free of phthalates :
Biological : DIN EN ISO 10993-5
DIN EN ISO 10993-10

Climate conditions for transport and storage:

Temperature : -40 to +70 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

Climate conditions for normal use:

Temperature : 10 to 40 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

The above mentioned technical specifications are copied from the IFU 1550750_44

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ManuXelect 3-section

Height adjustment : ca. 48 - 105 cm

Length : ca. 207 cm
Width : ca. 67 cm
Lifting capacity : 150 kg with the standard motor KL95 of 6000N
250 kg with the optional motor SL80 of 8000N
Motor speed : 6 mm/sec for both types
Power supply : 230V~ 50/60 Hz or 115V~ 50/60 Hz
Current consumption : 1,5A for the 6000N motor
2,0A for the 8000N motor
Moisture resistance : according IP 55

Safety and performance standards

Medical device classification :I
Safety class (IEC 60601-1) : II (double insulated)

Upholstery : Type AKV Peri

Fire safety : DIN EN 1021 part 1/2

Free of phthalates :
Biological : DIN EN ISO 10993-5
DIN EN ISO 10993-10

Climate conditions for transport and storage:

Temperature : -40 to +70 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

Climate conditions for normal use:

Temperature : 10 to 40 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

The above mentioned technical specifications are copied from the IFU 1550750_44

ManuXelect Traction (traction frame standard included)

Height adjustment : ca. 48 - 105 cm

Length : ca. 207 cm (ca. 240 cm inc. traction frame)
Width : ca. 67 cm
Lifting capacity : 150 kg with the standard motor KL95 of 6000N
250 kg with the optional motor SL80 of 8000N
Motor speed : 6 mm/sec for both types
Power supply : 230V~ 50/60 Hz or 115V~ 50/60 Hz
Current consumption : 1,5A for the 6000N motor
2,0A for the 8000N motor
Moisture resistance : according IP 55

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Enraf-Nonius

Safety and performance standards

Medical device classification :I
Safety class (IEC 60601-1) : II (double insulated)

Upholstery : Type AKV Peri

Fire safety : DIN EN 1021 part 1/2

Free of phthalates :
Biological : DIN EN ISO 10993-5
DIN EN ISO 10993-10

Climate conditions for transport and storage:

Temperature : -40 to +70 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

Climate conditions for normal use:

Temperature : 10 to 40 °C
Relative humidity : 10 to 90 %
Atmospheric pressure : 500 to 1060 hPa

The above mentioned technical specifications are copied from the IFU 1550750_44

5500723 Manumed Tilt 1-section (type 723) with leg fixation rail

Dimensions : 202 x 67 cm
Height adjustment : 55 – 106 cm
Tilt adjustment : 0 - 90°
Inclination back section – 2s : 0 - 82°
Lifting capacity : 175 kg
Power supply : 230V~ 50/60 Hz
Current consumption : 3.0 A max.
Duration of continuous operation : duty cycle 10%, max 2 min. continuous in 20 min.
Moisture resistance : according IP 44
Medical device classification :I
Safety class (IEC 60601-1) : II (earth connection, but not suitable for use in in intensive care
environment)

The above mentioned technical specifications are copied from the IFU 1400915_47

5500722 Manumed Tilt 1-section (type 722)

Dimensions : 202 x 67 cm
Height adjustment : 55 – 106 cm
Tilt adjustment : 0 - 90°
Inclination back section – 2s : 0 - 82°
Lifting capacity : 175 kg
Power supply : 230V~ 50/60 Hz
Current consumption : 3.0 A max.
Duration of continuous operation : duty cycle 10%, max 2 min. continuous in 20 min.
Moisture resistance : according IP 44
Medical device classification :I
Safety class (IEC 60601-1) : II (earth connection, but not suitable for use in in intensive care
environment)

The above mentioned technical specifications are copied from the IFU 1400915_47

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5500724 Manumed Tilt 2-section (type 724)

Dimensions : 202 x 67 cm
Height adjustment : 55 – 106 cm
Tilt adjustment : 0 - 90°
Inclination back section – 2s : 0 - 82°
Lifting capacity : 175 kg
Power supply : 230V~ 50/60 Hz
Current consumption : 3.0 A max.
Duration of continuous operation : duty cycle 10%, max 2 min. continuous in 20 min.
Moisture resistance : according IP 44
Medical device classification :I
Safety class (IEC 60601-1) : II (earth connection, but not suitable for use in in intensive care
environment)

The above mentioned technical specifications are copied from the IFU 1400915_47

5500725 Manumed Tilt 2-section (type 725) with leg fixation rails

Dimensions : 202 x 67 cm
Height adjustment : 55 – 106 cm
Tilt adjustment : 0 - 90°
Inclination back section – 2s : 0 - 82°
Lifting capacity : 175 kg
Power supply : 230V~ 50/60 Hz
Current consumption : 3.0 A max.
Duration of continuous operation : duty cycle 10%, max 2 min. continuous in 20 min.
Moisture resistance : according IP 44
Medical device classification :I
Safety class (IEC 60601-1) : II (earth connection, but not suitable for use in in intensive care
environment)

The above mentioned technical specifications are copied from the IFU 1400915_47

3450010 Manumed Basic 2-section / head section (type 001)

Size table top : 195x67 cm (LxW)
Fixed height : 80 cm
Weight capacity : 135 kg
Colour code frame : grey = RAL 7035
Legs : powder coated

The above mentioned technical specifications are copied from the webleaflet Manumed Basic, with reference 16-06-2016- Enraf-Nonius
Couches

3450001 Manumed Basic 2-section / back section (type 002)

Size table top : 195x67 cm (LxW)
Fixed height : 83 cm
Weight capacity : 135 kg
Colour code frame : grey = RAL 7035
Legs : powder coated

The above mentioned technical specifications are copied from the webleaflet Manumed Basic, with reference 16-06-2016- Enraf-Nonius
Couches

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Enraf-Nonius

3450007 Portable Massage Couch with head-section

Size tabletop (lxw) : 210x56 cm

Fixed height : 73 cm
Load capacity : 135 kg
Upholstery : grey
Color frame : aluminum
Weight : 15 kg

The above mentioned technical specifications are copied from the webleaflet Portable Massage Couch, with reference 24-09-2015- Enraf-
Nonius Couches

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Medical Fitness and Rehabilitation

1665901 EN- Motion treadmill

Power supply : 230V

Frequency : 50/60 Hz
Permitted voltage deviation : 10%

Drive : DC-motor, 3.5 Hp

Motor power : 2600 W
Max. current consumption : 10 A

Fuses : 2 x 10 A (T)

Min. – max. speed : 0.4 – 18 km/h (in increments of 0.1 km/h)

Max. speed in Autospeed mode : adjustable up to 18 km/h

Positive angle of inclination : 0% to +15% (in increments of 0.5%)

Negative angle of inclination : 0% to -10% (in increments of 0.5%)

Other training parameters

Time : 1 – 1440 min (in increments of 1 minute)
Distance : 0.1 – 100 km (in increments of 0.1 km = 100 m)
Energy : 1 – 10,000 kcal (in increments of 1 kcal)
Heart rate : 60 to 220 bpm (beats per minute; in increments of 1 bpm)
Readout : current heart rate readout
Heart rate detection : Polar  transmitter and receiver (optional: built-in receiver)

Dimensions : 212 x 86 x 148 cm (L x W x H); height includes console

Effective running surface : 150 x 50 cm

Height of fixed side supports : 76 cm (distance from running surface to bottom of side
supports) 93.5 cm (distance from running surface to top of side
supports)

Height of optional adjustable

side supports : min. 61 cm (distance measured from running surface to bottom
of side supports)

Range : 30 cm (electrically adjustable)

Step-up height : 12.5 cm (‘Standard’ and ‘Plus’ models)

Treadmill weight : 140 kg

Max. permissible weight on

running surface : 235 kg (see figure below)

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Display : LCD/TFT colour display (with backlight)

Training profiles (fixed programmes) : 14

Training profiles (user-defined) : 30

Storage and transport conditions

Temperature : -10° to +50 °C
Humidity : 10 - 90% (without condensation)
Atmospheric pressure : 500 - 1060 hPa

Usage environment:
Temperature : +5° to +30° C
Humidity : 10 - 90% (without condensation)
Atmospheric pressure : 500 - 1060 hPa

The technical specifications are subject to changes.

Safety and performance standards

The EN-Motion treadmill satisfies the requirements of the Medical Devices Directive (MDD 2007/47/EEC).

Medical Class : Class IIa

Electrical safety : IEC 60601-1
IEC 60601-1+A1+A2
IEC 60601-1-2
IEC 60601-1-4+A1

The device has an earth connection and must be connected to an earthed wall socket (on a separate power
group!). The leakage current and earth connection satisfy the requirements of IEC 60601-1.

Safety class according to IEC 60601-1 : class I type B

The above mentioned technical specifications are copied from the IFU 1665751_42

1665902 EN- Motion Plus

Power supply : 230V
Frequency : 50/60 Hz
Permitted voltage deviation : 10%

Drive : DC-motor, 3.5 Hp

Motor power : 2600 W
Max. current consumption : 10 A

Fuses : 2 x 10 A (T)

Min. – max. speed : 0.4 – 18 km/h (in increments of 0.1 km/h)

Max. speed in Autospeed mode : adjustable up to 18 km/h

Positive angle of inclination : 0% to +15% (in increments of 0.5%)

Negative angle of inclination : 0% to -10% (in increments of 0.5%)

Other training parameters

Time : 1 – 1440 min (in increments of 1 minute)
Distance : 0.1 – 100 km (in increments of 0.1 km = 100 m)
Energy : 1 – 10,000 kcal (in increments of 1 kcal)
Heart rate : 60 to 220 bpm (beats per minute; in increments of 1 bpm)
Readout : current heart rate readout
Heart rate detection : Polar  transmitter and receiver (optional: built-in receiver)

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Dimensions : 212 x 86 x 148 cm (L x W x H); height includes console

Effective running surface : 150 x 50 cm

Height of adjustable side supports : max. 108.5 cm (distance measured from running surface to top
of side supports)
Range : 30 cm (electrically adjustable)

Step-up height : 12.5 cm (‘Standard’ and ‘Plus’ models)

Treadmill weight : 155 kg

Max. permissible weight on

running surface : 235 kg (see figure below)

Display : LCD/TFT colour display (with backlight)

Training profiles (fixed programmes) : 14

Training profiles (user-defined) : 30

Storage and transport conditions

Temperature : -10° to +50 °C
Humidity : 10 - 90% (without condensation)
Atmospheric pressure : 500 - 1060 hPa

Usage environment:
Temperature : +5° to +30° C
Humidity : 10 - 90% (without condensation)
Atmospheric pressure : 500 - 1060 hPa

The technical specifications are subject to changes.

Safety and performance standards

The EN-Motion treadmill satisfies the requirements of the Medical Devices Directive (MDD 2007/47/EEC).

Medical Class : Class IIa

Electrical safety : IEC 60601-1
IEC 60601-1+A1+A2
IEC 60601-1-2
IEC 60601-1-4+A1

The device has an earth connection and must be connected to an earthed wall socket (on a separate power
group!). The leakage current and earth connection satisfy the requirements of IEC 60601-1.

Safety class according to IEC 60601-1 : class I type B

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3446257 Parallel Bars

Dimensions (HxWxD) : 66-108 x 90 x 400 cm.

Weight : 67 kg
Height adjustment handrails : from 66 to 108 cm.
Maximal patient load : 135 kg
Material bars : metal

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Medical classification : Class I

This product complies with all essential requirements of the Council Directive 93/42/EEC of the European
communities, concerning medical devices.
 
The above mentioned technical specifications are copied from the IFU 1400741_42

1413922 Bike Reha

Mains voltage : 100 - 240 V
Frequency : 50 / 60 Hz
Permitted voltage variation : +/- 10%
Power consumption : approx. 40VA
Braking principle : process-controlled eddy-current brake
Load : 20-400 W (resolution: 5 W increments) rpm-independently from
35 – 110 rpm
: 6 – 60 Nm (resolution: 0.5 Nm increments) rpm-independently
from 35 – 110 rpm
Accuracy of rpm : rpm, revs +/- 2 min￣¹ : power in Watts, +/- 5% or 3 W (depending on which value
is the larger)
Heart rate measurement accuracy : heart rate measurement with Polar®, +/-2% or 1 beat per
Minutes (depending on which value is the larger)
This definition assumes constant conditions.
Min. adjustable power : 20 W
Medical class : class I
Electrical safety : Class I type B (according to IEC 60601-1)
Dimensions : 118 cm x 115 cm x 55 cm (l x h x w)
Weight : approx. 55 kg
Saddle height (adjustable) : 50 - 110 cm
Steering column height (adjustable) : 75 - 115 cm
Bike Reha crank length : 170 mm
Max. patiënt weight : 150 kg / 330 lbs
Display : LCD with backlighting
Languages : English, Dutch, German, French, Spanish
Heart rate monitoring (optional) : Polar® chest strap and receiver
Exercise modes : constant torque, constant power, constant heart rate
Parameters displayed during training : time, heart rate, speed, distance, work, power and resistance

Operating conditions:
Temperature : 18 - 40 °C
Humidity : 10 - 90%
Air pressure : 500 - 1060 hPa

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Enraf-Nonius

Storage and transport conditions:

Temperature : -20 - 70 °C
Humidity : 10 - 90%
Air pressure : 500 - 1060 hPa

Program capacity
Fixed programs : 12 pre-programmed exercise profiles

Installation of the Bike Reha with chipcard function on the EN-Track software.
You must have at least version 6.5 of the EN-Track software to be able to operate the machine in a
chipcontrolled manner. The patiënt shall receive instructions to stop training when prescribed environmental
conditions are not met.

The above mentioned technical specifications are copied from the IFU 1413760_43

1419922 Bike Reha, incl. adjustable cranks

Mains voltage : 100 - 240 V
Frequency : 50 / 60 Hz
Permitted voltage variation : +/- 10%
Power consumption : approx. 40VA
Braking principle : process-controlled eddy-current brake
Load : 20-400 W (resolution: 5 W increments) rpm-independently from
35 – 110 rpm
: 6 – 60 Nm (resolution: 0.5 Nm increments) rpm-independently
from 35 – 110 rpm
Accuracy of rpm : rpm, revs +/- 2 min￣¹ : power in Watts, +/- 5% or 3 W (depending on which value
is the larger)
Heart rate measurement accuracy : heart rate measurement with Polar®, +/-2% or 1 beat per
Minutes (depending on which value is the larger)
This definition assumes constant conditions.
Min. adjustable power : 20 W
Medical class : class I
Electrical safety : Class I type B (according to IEC 60601-1)
Dimensions : 118 cm x 115 cm x 55 cm (l x h x w)
Weight : approx. 55 kg
Saddle height (adjustable) : 50 - 110 cm
Steering column height (adjustable) : 75 - 115 cm
Bike Reha incl adjustable cranks
Crank length : 80 – 180 mm
Max. patiënt weight : 150 kg / 330 lbs
Display : LCD with backlighting
Languages : English, Dutch, German, French, Spanish
Heart rate monitoring (optional) : Polar® chest strap and receiver
Exercise modes : constant torque, constant power, constant heart rate
Parameters displayed during training : time, heart rate, speed, distance, work, power and resistance

Operating conditions:
Temperature : 18 - 40 °C
Humidity : 10 - 90%
Air pressure : 500 - 1060 hPa

Storage and transport conditions:

Temperature : -20 - 70 °C
Humidity : 10 - 90%
Air pressure : 500 - 1060 hPa

Program capacity
Fixed programs : 12 pre-programmed exercise profiles

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Enraf-Nonius

Installation of the Bike Reha with chipcard function on the EN-Track software.
You must have at least version 6.5 of the EN-Track software to be able to operate the machine in a
chipcontrolled manner. The patiënt shall receive instructions to stop training when prescribed environmental
conditions are not met.

The above mentioned technical specifications are copied from the IFU 1413760_43

1455925 EN-Dynamic Leg Extension

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 100 x 10 N (kgf)

Size : 140 x 90 x 140 cm
Weight : 105 kg
Transport information : 148 x 88 x 161 cm/135 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455928 EN-Dynamic Adduction

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 60 x 10 N (kgf)
Size : 140 x 140 x 140 cm
Weight : 85 kg
Transport information : 148 x 88 x 161 cm/115 kg

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Enraf-Nonius

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455929 EN-Dynamic Abduction

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 60 x 10 N (kgf)
Size : 140 x 140 x 140 cm
Weight : 85 kg
Transport information : 148 x 88 x 161 cm/115 kg
Environment conditions for transport and storage
Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

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Enraf-Nonius

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455931 EN-Dynamic Total Hip

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 36 x 10 N (kgf)
Size : 110 x 115 x 170 cm
Weight : 120 kg
Transport information : 128 x 103 x 161 cm/150 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455932 EN-Dynamic Seated Leg Curl

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 70 x 10 N (kgf)
Size : 140 x 90 x 140 cm
Weight : 105 kg
Transport information : 128 x 103 x 161 cm/135 kg
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Enraf-Nonius

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455933 EN-Dynamic Seated Leg Press

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 200 x 10 N (kgf)

Size : 220 x 90 x 140 cm
Weight : 105 kg
Transport information : 183 x 98 x 161 cm/135 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

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Enraf-Nonius

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455935 EN-Dynamic Squat

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 200 x 10 N (kgf)

Size : 250 x 80 x 150 cm
Weight : 265 kg
Transport information : 280 x 100 x 160 cm/280 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455921 EN-Dynamic Chest Press

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 120 x 10 N (kgf)

Size : 135 x 105 x 140 cm
Weight : 100 kg
Transport information : 158 x 128 x 161 cm/130 kg
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Enraf-Nonius

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455923 EN-Dynamic Pull Down

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 80 x 10 N (kgf)
Size : 140 x 120 x 180 cm
Weight : 105 kg
Transport information : 158 x 128 x 161 cm/135 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

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Enraf-Nonius

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455926 EN-Dynamic Rowing

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 100 x 10 N (kgf)

Size : 120 x 90 x 115 cm
Weight : 100 kg
Transport information : 128 x 103 x 136 cm/130 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455927 EN-Dynamic Shoulder Press

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 60 x 10 N (kgf)
Size : 140 x 120 x 180 cm
Weight : 135 kg
Transport information : 188 x 128 x 161 cm/165 kg
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Enraf-Nonius

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455930 EN-Dynamic Fly

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 65 x 10 N (kgf)
Size : 130 x 120 x 140 cm
Weight : 100 kg
Transport information : 158 x 128 x 161 cm/130 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

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Enraf-Nonius

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455934 EN-Dynamic Triceps Dips

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 100 x 10 N (kgf)

Size : 130 x 72 x 140 cm
Weight : 96 kg
Transport information : 148 x 88 x 161 cm/126 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455922 EN-Dynamic Low Back Trainer

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 80 x 10 N (kgf)
Size : 160 x 90 x 130 cm
Weight : 120 kg
Transport information : 183 x 98 x 161 cm/140 kg

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Enraf-Nonius

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455924 EN-Dynamic Abdominal Trainer

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 80 x 10 N (kgf)
Size : 160 x 90 x 140 cm
Weight : 120 kg
Transport information : 183 x 98 x 161 cm/150 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

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Enraf-Nonius

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1455936 EN-Dynamic Rotator

Standard skai colour : royal blue F6413056 (12 other colours are optional)

Requirements for operation : compressor (3444668)

installation kit (1411800)

Range : 0 - 60 x 10 N (kgf)
Size : 135 x 95 x 108 cm
Weight : 85 kg
Transport information : 153 x 105 x 128 cm/115 kg

Environment conditions for transport and storage

Environment temperature : -10° till +50° C
Relative humidity : 10 till 95 %
Atmospheric pressure : 500 till 1060 hPa

Environments conditions for normal use:

Environment temperature : 10° till 40° C
Relative humidity : 10 till 90 %
Atmospheric pressure : 500 till 1060 hPa

Power supply
Internal power supply with mains cable
Power supply : 90-240V / 50/60Hz / 15VA

Safety and performance standards

This equipment complies with all requirements of the Medical Devices Directive (93/42/EEC).

Medical device classification : Class I

Safety class (IEC 60601-1) (IEC 60601-1)

Internal power supply with mains cable : Class I B

The above mentioned technical specifications are copied from the IFU 1412791_47. Information regarding skai and requirements for
operations are copied from webleaflet EN-Dynamics.

1446901 EN-Free

Adapter : 230V / 12V

Console
Dimensions (L x W x H) : 21 x 18.5 x 6 cm
Weight : 1.2 kg

Storage and transport conditions

Temperature : – 40° to + 70° C
Humidity : 10 - 90 % (without condensation)
Air pressure : 500 - 1060 hPa
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Operating environment
Temperature : 10° to 40° C
Humidity : 10 - 90 % (without condensation)
Air pressure : 500 - 1060 hPa

The above mentioned technical specifications are copied from the IFU 1446750_44

1412996 EN-TreeP Pulley

Safety class : EN 957-1+A1 Class SB

Medical class : Class I
Dimensions : 218 x 39 x 35 cm (HxWxD)
Weight (w. covers) : 60 kg
Height adjustment for rope : 0 - 200 cm.
Load increments : 40 tol 720 N, in steps of 10 N
For 1 cord end : display value divided in 6
For 2 cord ends : display value divided in 3

Requirements for operation : compressor (3444668)

installation kit (1411800)

The above mentioned technical specifications are copied from the IFU 1400755_46
Medical Class information according to information A.v. Maurik, Manager Quality.

3443354 EN-Tree Pulley Explosive 54 kg

Dimensions : 218 x 39 x 35 cm. (HxBxD)

Weight (wo. covers) : 82 kg.
Height adjustment for rope : 0 - 200 cm
Weights : 2 kg until 54 kg.
For 1 cord end : 0,33-1-1,6-2,3-4,3-5-5,6-6,3-7-7,6-8,3-9 kg
For 1 cord end : 0,66-2-3,33-4,66-6-7,3-8,6-10-11,3-12,6-14-15,33-16,66-18 kg

The above mentioned technical specifications are copied from the IFU 1410750_45

3443370 EN-Tree Pulley Explosive MDD 54 kg, with cover

Safety class : EN 957-1+A1 Class SB

medical class MDD version : 93/42/EEC Class I

Dimensions : 218 x 39 x 35 cm. (HxBxD)

Weight (wo. covers) : 82 kg.
Weight (w. covers) : 97 kg.
Height adjustment for rope : 0 - 200 cm
Weights : 2 kg until 54 kg.
For 1 cord end : 0,33-1-1,6-2,3-4,3-5-5,6-6,3-7-7,6-8,3-9 kg
For 1 cord end : 0,66-2-3,33-4,66-6-7,3-8,6-10-11,3-12,6-14-15,33-16,66-18 kg

The above mentioned technical specifications are copied from the IFU 1410750_45

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Enraf-Nonius

3443353 EN-Tree Pulley 24 kg

Dimensions : 218 x 30 x 33 cm. (HxLxW)

Weight (wo. covers) : 47 kg
Height adjustment for rope : 0 - 200 cm.
Weights : 1 kg until 24 kg.
For 1 cord end : 0,25-0,5-0,75-1-2-3-4-5-6-7-8-9-10-11-12 kg
For 2 cord end : 0,5-1-1,5-2-4-6-8-10-12-14-16-18-20-22-24 kg

The above mentioned technical specifications are copied from the IFU 1410750_45

3443369 EN-Tree Pulley MDD 24 kg, with cover

Safety class : EN 957-1+A1 Class SB

medical class MDD version : 93/42/EEC Class I

Dimensions : 218 x 30 x 33 cm. (HxLxW)

Weight (wo. covers) : 47 kg
Weight (w. covers) : 60 kg
Height adjustment for rope : 0 - 200 cm.
Weights : 1 kg until 24 kg.
For 1 cord end : 0,25-0,5-0,75-1-2-3-4-5-6-7-8-9-10-11-12 kg
For 2 cord end : 0,5-1-1,5-2-4-6-8-10-12-14-16-18-20-22-24 kg

The above mentioned technical specifications are copied from the IFU 1410750_45

3443356 EN-Tree Bench

Dimensions (height x width x length) : 48 x 47 x 134 cm

Weight : 25 kg
Maximum load per section in its
lowest position : 135 kg
Angle adjustment : - back section: 0° to 75°
- leg section: 0° and 7°
Colour skai : Pandoria Plus Royal Blue

Medical class : Class I

The above mentioned technical specifications are copied from the IFU 3443358_43. Colour and Medical class information via Trees
Renoult

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3443355 EN-Tree Train

Dimensions (height x width x length) : 82 x 56 x 143 cm

Weight : 37 kg
Angle adjustment : - trunk section: -80° to +75°
- leg section: -25° to +15°
Maximum load per section : 135 kg
Position of the rolls in relation to the end
of the leg section : - parallel to the top 0 to 27 cm
- at a right angle to the top -45 to +24 cm

Safety class : EN957-1-A1

Colour skai : Pandoria Plus Royal Blue
Medical class : Class I

The above mentioned technical specifications are copied from the IFU 3443359_42. Colour and Medical class information via Trees
Renoult.

3443365 EN-TreeM Pulley MDD 24 kg, with cover

Safety class : EN 957-1+A1 Class SB

medical class MDD version : 93/42/EEC Class I (Class I with measuring function ENTreeM)

Electrical safety class

EN-TreeM : IEC60601-1 Classe II type B

Dimensions : 218 x 30 x 33 cm. (HxWxD)

Weight (wo. covers) : 47 kg
Weight (w. covers) : 60 kg
Height adjustment for rope : 0 - 200 cm.
Weights : 1 kg until 24 kg.
For 1 cord end : 0,25-0,5-0,75-1-2-3-4-5-6-7-8-9-10-11-12 kg
For 2 cord end : 0,5-1-1,5-2-4-6-8-10-12-14-16-18-20-22-24 kg

Accuracy : +/- 10%

The above mentioned technical specifications are copied from the IFU 1410750_45

3443367 EN-TreeM Pulley Explosive MDD 54 kg, with cover

Safety class : EN 957-1+A1 Class SB
medical class MDD version : 93/42/EEC Class I (Class I with measuring function ENTreeM)

Electrical safety class

EN-TreeM : IEC60601-1 Classe II type B

For explosive:
Dimensions : 218 x 39 x 35 cm. (HxBxD)
Weight (wo. covers) : 82 kg.
Weight (w. covers) : 97 kg.
Height adjustment for rope : 0 - 200 cm
Weights : 2 kg until 54 kg.
For 1 cord end : 0,33-1-1,6-2,3-4,3-5-5,6-6,3-7-7,6-8,3-9 kg
For 1 cord end : 0,66-2-3,33-4,66-6-7,3-8,6-10-11,3-12,6-14-15,33-16,66-18 kg

Accuracy : +/- 10%

The above mentioned technical specifications are copied from the IFU 1410750_45

Enraf-Nonius Technical Specs Catalogue 27-03-18 Page 121