Rehab Series
Rehab Series
Standard Accessories:
NUPOWERCABLE Nu-Tek Power Cable
User Manual
NUELECRUB6090 Rubber Electrodes - 60 x 90mm (Pair)
NUELECRUB70110 Rubber Electrodes - 70 x 110mm (Pair)
NUSPOENV70100 Envelope Sponges - 70 x 100mm (Pair)
NUSPOENV80120 Envelope Sponges - 80 x 120mm (Pair)
ACF35050 AllCare Electrodes - 50 x 50mm Square (x4)
- Self Adhesive
ACF35090 AllCare Electrodes - 50 x 90mm Rectangle (x4)
- Self Adhesive
NUSTRAP751200 Nu-Tek Straps - 75 x 1200mm
NUSTRAP75600 Nu-Tek Straps - 75 x 600mm
NULEADSTIMGY Nu-Tek Stim Leads - Grey
NULEADSTIMBU Nu-Tek Stim Leads - Blue
Optional Accessories:
Optional
Nu-Tek Trolley NUTROLLEY Nu-Tek Trolley
NUBATTERY Nu-Tek Battery Pack
Code: Description:
NUSTIM Nu-Tek® Stim Rehab2 - MT2200
The Warehouse Beck Bank West, Pinchbeck, Spalding, Lincolnshire, PE11 3QN Phone: 01775 640972 Email: sales@physiosupplies.co.uk
Rehab – Series
USER MANUAL
0197
www.nutekmedical.com
Rehab-Series
Declaration of conformity:
Shenzhen Dongdixin Technology Co.,LTD.declares that the ComboRehab-Series,
StimRehab-Series and UltraRehab-Series complies with following normative documents:
IEC60601-1,IEC60601-1-2,IEC60601-2-10,IEC60601-2-5,ISO7010
IEC61689,ISO14971,ISO10993-1,ISO10993-5,ISO10993-10
1. Foreword
This manual has been written for the users of the Rehab-Series include ComboRehab-
Series, StimRehab- Series and UltraRehab-Series. It contains general information on the
operation, precautionary practices,and maintenance information. In order to maximize its
use, efficiency,and the life of the system, please read this manual thoroughly and become
familiar with the controls, as well as the accessories before operating the system.
This device is designed to only be used by or under the supervision of persons using the
medical device in the course of their work and in the framework of a professional healthcare
activity, who understand the benefits and limitations of electrotherapy and ultrasound
therapy.
U.S.A. Federal Law restricts these devices to sale by, or on the orderof, a physician or
licensed practitioner. This device should be used only under the continued supervision of a
physician or licensed practitioner.
Specifications put forth in this manual were in effect at the time of publication. However,
owing to manufacturer her policy of continual improvement, changes to these specifications
may be made at any time without obligation on the part of manufacturer.
2. Product Description
The Rehab-Series is a family of products for physical therapy, the Rehab-Series offers the
practitioner a wide range of treatment options. The devices share an identical control panel
equipped with a full colour touch panel means treatment setup has never been easier. A few
simple key presses are all you need to quickstart a treatment. The User Interface intuitively
groups and displays all the options for a modality setup on the large touch screen to ensure
that treatment parameters can easily be selected and adjusted. The devices are mains pow-
ered and can optionally be equipped with a battery for mains independent operation. The
family comprises the products described below.
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Rehab-Series
StimRehab
The StimRehab is equipped with two or four completely identical electrotherapy channels.
The electrotherapy channels can be used in combination (linked) or totally independent. A
comprehensive set of current waveforms is available, targeting both pain management and
muscle stimulation applications.
Protocols can run on linked or independent channels. With independent channels two or
four different protocols can be performed simultaneously.
UltraRehab
The UltraRehab is an ultrasound therapy device. The device provides two positions for
attachment of an ultrasound applicator. Depending on the device configuration ordered,
the UltraRehab comes with an applicator with a large contact area, an applicator with a
small contact area or with both applicators. The applicators can operate in continuous or
pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz. The lower frequency (1 MHz)
penetrates deeper than a higher frequency (3 MHz), thus the practitioner can decide which
frequency to use according to the condition and depth to be treated. Contact control sus-
pends the application of ultrasonic energy when acoustical contact with the treatment area
becomes insufficient. The applicators are suitable for subaqual treatments.
ComboRehab
The ComboRehab is a combination device, combining the functions of the StimRehab and
the UltraRehab in a single device. With the ComboRehab the simultaneous application of
ultrasound and electrotherapy (combination therapy) is also possible. The remaining elec-
trotherapy channel can then be used independently.
VAM200
Electrotherapy can be applied through standard or vacuum electrodes. With vacuum elec-
trodes the VAM200 generates the vacuum through which the vacuum electrodes are
attached to the patient. The device is placed beneath the StimRehab or ComboRehab, from
which its power is derived and through which it is also operated.
MTM200
The MTM200 is a two channel electrotherapy module intended to upgrade the StimRehab
and ComboRehab to Four Channel Electrotherapy or Combination Therapy Systems. This
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Rehab-Series
EMG200
The EMG200 is designed for use with the StimRehab and the ComboRehab. With EMG
electrodes the EMG200 generates the sEMG (Surface Electromyography) , ETS (Surface
Electromyography with Triggered Stimulation) through which the EMG electrodes are
attached to the patient.
BTM200
The BTM200 Battery Module is designed for use with the Rehab-Series systems to create a
battery powered Therapy System. No additional Software is required for the Module as the
System automatically recognizes its presence and activates all necessary software inherent
in the System.
CT2200
Mainframe
ComboRehab² (two channels electrotherapy,
CT2200
ultrasound and combo)
CT2201
two channels electrotherapy, Mainframe
ComboRehab² Vac
ultrasound and combo+vacuum CT2200
module
CT2202
two channels electrotherapy, Mainframe
ComboRehab² Bio
ultrasound and combo+EMG
CT2200
module
CT2203
two channels electrotherapy, Mainframe
ComboRehab² Plus
ultrasound and combo+battery
CT2200
module
5
Rehab-Series
CT2204
two channels electrotherapy, Mainframe
ComboRehab² VB
ultrasound and combo+vacuum CT2200
module +EMG module
CT2205
two channels electrotherapy, Mainframe
ComboRehab² Vac
Plus ultrasound andcombo+vacuum CT2200
module+ battery module
CT2206
ComboRehab² Bio two channels electrotherapy, Mainframe
Plus ultrasound and combo+battery CT2200
module + EMG module
Mainframe
CT2400
CT2400
ComboRehab4 four channels electrotherapy,
CT2200
ultrasound and combo
+MTM200
CT2401 Mainframe
4 four channels electrotherapy, CT2400
ComboRehab Vac
ultrasound and combo+vacuum CT2200
module +MTM200
CT2402 Mainframe
four channels electrotherapy, CT2400
ComboRehab4 Bio
ultrasound and combo+EMG CT2200
module +MTM200
CT2403 Mainframe
four channels electrotherapy, CT2400
ComboRehab4 Plus
ultrasound and combo+battery CT2200
module +MTM200
MT2000 Mainframe
StimRehab²
two channels electrotherapy MT2200
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Rehab-Series
MT2201
Mainframe
Stim Rehab² Vac two channels electrotherapy
MT2200
+vacuum module
MT2202
Mainframe
two channels electrotherapy
Stim Rehab² Bio
MT2200
+EMG module
MT2203
Mainframe
Stim Rehab² Plus two channels electrotherapy
MT2200
+battery module
MT2204
two channels electrotherapy Mainframe
Stim Rehab² VB
+vacuum module+EMG MT2200
module
MT2205
MT2206
Mainframe
MT2400
MT2400
Stim Rehab4 four channels electrotherapy
MT2200
+MTM200
MT2401 Mainframe
four channels MT2400
Stim Rehab4 Vac
electrotherapy +vacuum module MT2200
+MTM200
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Rehab-Series
MT2402 Mainframe
four channels MT2400
Stim Rehab4 Bio
electrotherapy +EMG module MT2200
+MTM200
MT2403 Mainframe
four channels MT2400
Stim Rehab4 Plus
electrotherapy +battery module MT2200
+MTM200
UT2200 Mainframe
UltraRehab
two channels ultrasound UT2200
UT2201
UltraRehab Plus two channels ultrasound Mainframe
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8
Rehab-Series
3. Precautionary Instructions
In this section general Warnings and Precautions are listed, that you should be aware of
when using the Rehab-Series. See also chapter 4.1 for Warnings and Precautions that are
application specific.
WARNING:
Federal law (USA only) restricts this device to sale by, or on the order of, a physician
or licensed practitioner. This device should be used only under the continued supervi-
sion of a physician or licensed practitioner.
Make certain that the unit is electrically grounded by connecting only to a grounded
electrical service receptacle conforming to the applicable national and local electrical
codes.
Do not operate the unit in an environment of short-wave or micro-wave diathermy.
The device is designed for indoor use only.It is prohibited to use the device in a loca-
tion where explosion or water intrusion risk are present and in dusty or humid
environment.It is prohibited to use the device in spaces where flammable anaesthetics
oxidizing gases(O2,N2O) and other flammable gases or vapors are present.
This device should be kept out of the reach of children.
Place the device out of direct sunlight and strong electromagnetic fields of surrounding
devices(diathermy,X-rays,mobile phones and other radio-frequence equipment) to
prevent unwanted interference.If unwanted interference occurs,place the device farther
from the source of interference or contact the Nu-Tek authoried service.
Before administering any treatment to a patient you should become acquainted with
the operating procedures for each mode of treatment available, as well as the indica-
tions, contraindications, warnings and precautions. Consult other resources for addi-
tional information regarding the application of electrotherapy and Ultrasound.
No modification of this equipment is allowed! Do not try to open or remove the
protective covers or disassembly the device for any reason.There is a danger of electric
shock and serious injury.All service actions must be done by an authorized Nu-Tek
service only;otherwise Nu-Tek bear no responsibility for further operation of the
device.
Never use the accessories connector and other connectors to plug in anything else
except transducers and cables sold by the manufacturer as replacement parts for inter-
nal components.There is a serious risk of electric shock and serious damage to the
device
This device is not designed to be use in an MRI Environment and should be removed
prior to MRI exposure.
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Rehab-Series
CAUTION:
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Rehab-Series
The device is designed to only be used by or under the supervision of persons using
the medical device in the course of their work and in the framework of a professional
healthcare activity, who understand the benefits and limitations of electrotherapy and
ultrasound therapy. I.e.“professional users”.
4. Intended Use
Do not use this device on patients whose pain syndromes are undiagnosed.
Do not use this device on patients who have a cardiac pacemaker, implanted defibril-
lator, or other implanted metallic or electronic device, because this may cause electric
shock, burns, electrical interference, or death.
Do not use this device on patients whose pain syndromes are undiagnosed.
Do not apply stimulation over the patient’s neck because this could cause severe
muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse
effects on heart rhythm or blood pressure;
Do not apply stimulation across the patient’s chest, because the introduction of electri-
cal current into the chest may cause rhythm disturbances to the patient’s heart, which
could be lethal;
11
Rehab-Series
Do not apply stimulation over open woundsor rashes, or over swollen, red, infected,
or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);
Do not apply stimulation over, or in proximity to, cancerous lesions;
Do not apply stimulation in the presence of electronic monitoring equipment (e.g.,
cardiac monitors, ECG alarms), which may notoperate properly when the electrical
stimulation device is in use;
Do not apply stimulation when the patient is in the bath or shower;
Do not apply stimulation while the patient is sleeping;
Do not apply stimulation while the patient is driving, operating machinery, or during
any activity in which electrical stimulation can put the patient at risk of injury.
Consult with the patient’s physician beforeusing this device, because the device may
cause lethal rhythm disturbances to the heart in susceptible individuals;
Apply stimulation only to normal,intact, clean, healthy skin.
See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
12
Rehab-Series
Add:
Patients may experience skin irritation and burns beneath the stimulation electrodes
applied to the skin;
Patients may experience headache and other painful sensations during or following
the application of electrical stimulation near the eyes and to the head and face;
Patients should stop using the device and should consult with their physicians if they
experience adverse reactions from the device.
For pain management the following current waveforms are recommended 4.1.3.1, 4.1.3.2,
4.1.3.3, 4.1.3.5, 4.1.3.6, 4.1.3.7, 4.1.3.9, 4.1.3.10.
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Rehab-Series
Do not use this device on patients who have a cardiac pacemaker, implanted defibril-
lator, or other implanted metallic or electronic device, because this may cause electric
shock, burns, electrical interference, or death.
If you are in the care of a physician, consult with your physician before using this
device;
Do not apply stimulation over your neck because this could cause severe muscle
spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on
heart rhythm or blood pressure;
Do not apply stimulation across your chest because the introduction of electrical cur-
rent into the chest may cause rhythm disturbances to your heart, which could be lethal;
Do not apply stimulation over painful areas. If you have painful areas, you should con-
sult with your physician before using this device;
Do not apply stimulation over open woundsor rashes, or over swollen, red, infected,
or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);
Do not apply stimulation over, or in proximity to, cancerous lesions;
Do not apply stimulation in the presence of electronic monitoring equipment (e.g.,
cardiac monitors, ECG alarms), which may notoperate properly when the electrical
stimulation device is in use;
Do not apply stimulation whenin the bath or shower;
Do not apply stimulation while sleeping;
Do not apply stimulation while driving, operating machinery, or during any activity in
which electrical stimulation canput you at risk of injury;
Do not use the device on children, if it has not been evaluated for pediatric use;
Consult with your physician before using this device, because the device may cause
lethal rhythm disturbances to the heart in susceptible individuals;
Apply stimulation only to normal,intact, clean, healthy skin.
See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
14
Rehab-Series
Since the effects of stimulation of the brain are unknown, stimulation should not be
applied across your head, and electrodes should not be placed on opposite sides of
your head;
The safety of electrical stimulation during pregnancy has not been established;
You may experience skin irritation or hypersensitivity due to the electrical stimulation
or electrical conductive medium (gel);
If you have suspected or diagnosed heart disease, you should follow precautions
recommended by your physician;
If you have suspected or diagnosed epilepsy, you should follow precautions recom-
mended by your physician.
Use caution if you have a tendency to bleed internally, such as following an injury or
fracture;
Consult with your physician prior to using the device after a recent surgical procedure,
because stimulation may disrupt the healing process;
Use caution if stimulation is applied over the menstruating or pregnant uterus;
Use caution if stimulation is applied over areas of skin that lack normal sensation;
Keep this device out of the reach of children;
Use this device only with the leads, electrodes, and accessories recommended by the
manufacturer.
Some patients may experience skin irritation or hypersensitivity due to electrical stimu-
lation or electrical conductive medium. The irritation can usually be reduced by using
an alternative conductive medium, or alternate electrode placement.
See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
You may experience skin irritation and burns beneath the stimulation electrodes
applied to your skin;
You may experience headache and other painful sensations during or following the
application of electrical stimulation near your eyes and toyour head and face;
You should stop using the device and should consult with your physician if you experi-
ence adverse reactions from the device.
For muscle stimulation the following current waveforms are recommended 4.1.3.2,
4.1.3.3, 4.1.3.4, 4.1.3.8, 4.1.3.10
15
Rehab-Series
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:
Remark:
16
Rehab-Series
Parameters:
Carrier frequency: Carrier frequency is the base frequency of the alternating current.
Beat Frequency: The frequency at which the amplitude is modulated. This is the effective
therapeutic frequency.
Vector-Auto: Vector-Auto is a form of amplitude modulation and is a percentage of the
interferential amplitude (intensity) and will decrease from its maximum level over 6 seconds.
Vector-Manual Vector-Manual is a form of amplitude modulation. When Vector-Manual
set to a different Angle, the output intensities of two channels are different. The rhythmical
varying of the current amplitude of each channel produces the perceived movement of the
interferential field by the patient.
Premodulated Current is a medium frequency waveform. Current comes out of one channel
(two electrodes). The current intensity is modulated: it increases and decreases at a regular
frequency (the Amplitude Modulation Frequency).
Parameters:
Carrier frequency: Carrier frequency is the base frequency of the alternating current.
Beat Frequency: The frequency at which the amplitude is modulated. This is the effective
therapeutic frequency.
Cycle Time: refers to the time that the current is On and Off (in seconds). Example: for a
Cycle Time of 10/50, the current will be flowing for 10 seconds and resting for 50 seconds.
Ramp Time: the time that the current will take to increase to the set intensity level. Ramps
occur at the beginning and ending of a timed On cycle.
The Asymmetrical Biphasic and the Symmetrical Biphasic waveform are often used in TENS
(Transcutaneous Electrical Nerve Stimulation) applications. The TENS has a short pulse
duration. It is capable of strong stimulation of the nerve fibers in the skin as well as of muscle
tissue. Because of its short pulse, the patient typically tolerates the current well, even at rela-
tively high intensities. The Alternating Rectangular waveform is an interrupted biphasic
current with a rectangular pulse shape. This waveform is commonly used as a pain manage-
ment application.
17
Rehab-Series
Parameters:
Phase Duration: expressed in µs, is the elapsed time from the beginning to the end of the
initial pulse phase.
Frequency: In a pulsed current the Frequency refers to the number of pulses that occur in a
one second period of time and is denoted as in Hz or Pulses Per Second (pps).
Frequency Modulation: expressed in Hz, defines a variable frequency range that is summed
to the Pulse frequency i.e when the Pulse frequency is set to 80 Hz and the Frequency modu-
lation is set to 40 Hz, the final frequency will vary from 80 – 120 Hz.
Amplitude Modulation: Rhythmical fluctuation of the intensity to prevent accommodation.
Burst Frequency: expressed in Hz or bps, defines the repetition rate of bursts of pulses. A
Burst (an interrupted train) is a finite series of pulses that are delivered at a specific
frequency and are separated by interburst intervals.
Russian Current is a rectangle waveform, delivered in bursts or series of pulses. This method
was claimed by its author (Kots) to produce maximal muscle strengthening effects without
significant discomfort to the patient.
Parameters:
Carrier Frequency: Carrier frequency is the base frequency of the alternating current.
Frequency: In a pulsed current the Frequency refers to the number of pulses that occur in a
one second period of time and is denoted as in Hz or Pulses Per Second (pps).
Duty: The percentage of the total treatment time that the current is actually flowing.
Cycle Time: refers to the time that the current is On and Off (in seconds). Example: for a
Cycle Time of 10/50, the current will be flowing for 10 seconds and resting for 50 seconds.
Ramp: The time that the current will take to increase to the set intensity level. Ramps occur
at the beginning and ending of a timed On cycle.
The High Volt waveform has a very brief pulse duration characterized by 2 distinct peaks
delivered at high voltage. The waveform is monophasic (current flows in one direction
only).The high voltage causes a decreased skin resistance making the current comfortable
and easy to tolerate. The very short pulse duration followed by a very long interpulse interval
eliminates the formation of any appreciable chemical or thermal effects in the tissue.
18
Rehab-Series
The High Volt waveform is frequently used to increase local blood circulation and relax
muscles in spasm.
Frequency: In a pulsed current the Frequency refers to the number of pulses that occur in a
one second period of time and is denoted as in Hz or Pulses Per Second (pps).
Polarity: This refers to the polarity (+/-) of the red lead wire; connect the lead wire to the
active electrode.
Cycle Time: refers to the time that the current is On and Off (in seconds). Example: for a
Cycle Time of 10/50, the current will be flowing for 10 seconds and resting for 50 seconds.
Ramp: The time that the current will take to increase to the set intensity level. Ramps occur
at the beginning and ending of a timed On cycle.
Microcurrent is a monophasic waveform of very low intensity. The literature reports benefi-
cial effects of this waveform in the treatment of wounds. The physiological working mecha-
nism of this effect is as yet not clearly understood. It is thought to stimulate tissue healing by
stimulating the 'current of injury', a current which naturally occurs in healing tissue.
Parameters:
Frequency: In a pulsed current the Frequency refers to the number of pulses that occur in a
one second period of time and is denoted as in Hz or Pulses Per Second (pps).
Polarity: This refers to the polarity (+/-) of the red lead wire; connect the lead wire to the
active electrode.
4.1.3.7 Trabert
Parameters:
Polarity: This refers to the polarity (+/-) of the red lead wire; connect the lead wire to the
active electrode.
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Rehab-Series
The Diadynamic waveforms are rectified alternating currents. The alternating current is
modified (rectified) to allow the current to flow in one direction only.
4.1.3.9 NMS
NMS is a symmetrical biphasic waveform with a 120 µsec interphase interval (NMS Burst is
a symmetrical biphasic waveform delivered in a burst format). Because the pulse is relatively
short, the waveform has a low skin load, making it suitable for applications requiring high
intensities, such as in muscle strengthening protocols.
Frequency: In a pulsed current the Frequency refers to the number of pulses that occur in a
one second period of time and is denoted as in Hz or Pulses Per Second (pps).
Phase Duration: expressed in µs, is the elapsed time from the beginning to the end of the
initial pulse phase.
Cycle Time: refers to the time that the current is On and Off (in seconds). Example: for a
Cycle Time of 10/50, the current will be flowing for 10 seconds and resting for 50 seconds.
Ramp: The time that the current will take to increase to the set intensity level. Ramps occur
at the beginning and ending of a timed On cycle.
Galvanic Current is a direct current flowing in one direction only. The current can be con-
tinuous or interrupted.
Parameters:
Polarity: This refers to the polarity (+/-) of the red lead wire; connect the lead wire to the
active electrode.
20
Rehab-Series
Polarity: This refers to the polarity (+/-) of the red lead wire; connect the lead wire to the
active electrode.
Cycle Time: refers to the time that the current is On and Off (in seconds). Example: for a
Cycle Time of 10/50, the current will be flowing for 10 seconds and resting for 50 seconds.
Ramp: The time that the current will take to increase to the set intensity level. Ramps occur
at the beginning and ending of a timed On cycle.
f Carrier frequency
fb Beat frequency
Premod
1/f
f Carrier frequency
CH1: fb Beat frequency
CH2:
Beat:
IFC-4P
f Beat frequency
100mA max.
1/f
Russian
21
Rehab-Series
t Phase duration
f Pulse frequency
200mA max.
1/f
Asymmetrical
t Phase duration
200mA max. f Pulse frequency
1/f
Alternating
t Phase duration
200mA max.
f Pulse frequency
t
1/f
Symmetrical
f Burst frequency
200mA max.
1/f
Burst Asymmetrical
200mA max. f Burst frequency
1/f
Burst Symmetrical
22
Rehab-Series
f Burst frequency
200mA max.
1/f
Burst Alternating
fp Phase duration:
80mA max. 2 ms
ti Phase interval:
tp ti 5 ms
Träbert, 2 – 5 Current
tp Phase duration
80mA max. f Pulse frequency
tp
1/f
tp Phase duration
80mA max.
f Pulse frequency
tp
1/f
NMS
t
t Phase duration
200mA max. f Pulse frequency
100ms
1/f NMS
23
Rehab-Series
f Burst frequency
200mA max.
1/f
NMS Burst
Galvanic Current
f Carrier frequency
- 8 kHz fixed
80mA max.
80mA max.
Galvanic Continuous
t Peak interval
500V max. - 100 µs fixed
f Pulse frequency
1/f
High Voltage
f Frequency
1000uA max.
1/f
Micro Current
24
Rehab-Series
Diadynamic Current
70mA max. MF
70mA max. DF
70mA max. LP
70mA max.
CP
1s 1s 1s
70mA max. CPid
1s 1s 1s
Modulation program
Ramp Up Ramp Dowm
Reset Time
Surge program parameters
25
Rehab-Series
Frequence Modulation
1/Frequency 1/Freq. Mod.+Frequency
TENS
IPC-4P/Premod
Beat High Beat Low
Channel Mode
CH1:
CH2:
10s 10s
Co-Cont Both(ON:10/OFF:10)
CH1:
CH2:
26
Rehab-Series
Ultrasound is indicated for conditions that benefit from the application of deep heat: relief
of pain, muscle spasms and joint contractures. The objective of therapeutic ultrasound in the
treatment of selected medical conditions associated with the chronic and sub chronic condi-
tions of bursitis/ capsulitis, epicondylitis, ligament sprains, tendinitis, scar tissue healing and
muscle strain, is to reduce pain.
27
Rehab-Series
Precaution should be taken when using therapeutic ultrasound on patients with hem-
orrhagic diatheses.
Ultrasound treatment presents a potential safety hazard in patients whose pain
response has been decreased because of disease, previous surgery, ionizing radiation
therapy, chemotherapy, general or regional anaesthesia. It may cause burns. Do not
use on insensitive areas or in the presence of poor circulation.
Large thermal doses may result in regions of thermal aseptic necrosis which may not
be apparent on inspection of the skin.
See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
Use of ultrasound in treating areas above the shoulders may pose relevant hazards.
While it is recognized that certain specific conditions involving the eyes can and have
been treated by specialists qualified by training, knowledge and experience to admin-
ister such treatments, such application carries with it recognized hazards of applying
heat to the eyes.
Treatment of the facial sinus exposes the eyes to the same hazards.
Treatment of the thyroid, as well as lymph nodes in the neck, may expose the patient
to as yet undetermined effects, in as much as the safety of such treatments has not yet
been established.
Ultrasound Frequency: expressed in MHz, is the frequency of the ultrasound waves. The
ultrasound frequency determines the penetration depth, which has the largest value at 1
MHz. The ultrasound frequency can be set at 1 MHz or 3 MHz.
Duty Cycle: expressed in %, defines the ratio of the pulse duration to the pulse repetition
time. Ultrasound can be applied in pulsed or in continuous mode. When the Duty Cycle is
set to 100%, the apparatus operates in continuous mode.
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Rehab-Series
Effective Radiation Area (ERA): expressed in cm², defines the cross-sectional area of the
ultrasound beam (See technical specifications for details). The Effective Radiation Area is
fixed and defined by the size of the ultrasound applicator.
Ultrasound Power: is the ultrasound output expressed in Watt. The ultrasound output
display can be toggled between Watt and Watt/cm². In pulsed mode the power during the
pulse is displayed. The time averaged power can be obtained by multiplying this value with
the Duty Cycle.
Ultrasound Amplitude: expressed in Watt/cm², is the quotient of Ultrasound Power and
Effective Radiation Area. The ultrasound output display can be toggled between Watt and
Watt/cm². In pulsed mode the Amplitude during the pulse is displayed. The time-averaged
Amplitude can be obtained by multiplying this value by the Duty Cycle.
29
Rehab-Series
This makes Myofeedback especially suitable as a measuring instrument for charting our
locomotive operations.
4.4.1 Parameters
Indications
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'\VSKDJLD
30
Rehab-Series
Contraindications
Because Biofeedback therapy does not “do” anything to the body, few contraindications
exist. Biofeedback therapy is not recommended for persons with severe psychosis, depres-
sion, or obsessional neurosis, nor for debilitated patients or those with psychopathic person-
alities. However, because resulting functional improvements can require strenuous physical
effort, individuals interested in Biofeedback may need to be aerobically fit.
Biofeedback is dangerous for diabetics and others with endocrine disorders, as it can
change the need for insulin and other medications. Please check with the doctor to see
whether this is an appropriate treatment for you.
5 Package Contents
Device model:
The package contents depend on the device model ordered. The following models are avail-
able:
5.1 CT2200
Standard Accessories:
31
Rehab-Series
5.2 MT2200
Standard Accessories:
32
Rehab-Series
5.3 UT2200
Standard Accessories:
5.4 MTM200
Standard Accessories:
33
Rehab-Series
5.5 BTM200
Standard Accessories:
5.6 VAM200
Standard Accessories:
5.7 EMG200
Standard Accessories:
34
Rehab-Series
6 Installation
6.1 Installation of functional modules
Remove the Rehab2 series device and any additional items ordered from the carton
and inspect for damage that may have occurred during shipment.
the device on a desk or Cart200. Ensure that there is sufficient air flow below the
device (do not place the device on a table-cover).
Remove the functional module and any additional items ordered from the carton and
inspect for damage that may have occurred during shipment.
Place the functional module on a desk or Cart200. Ensure that there is sufficient air
flow below the device (do not place the device on a table-cover).
Remove the Rehab2 series device and any additional items ordered from the carton
and inspect for damage that may have occurred during shipment.
Place the main device on top of the functional module.
Carefully lift the main device at the front and insert flat cable into connector.
6.1.3 Rehab series with two modules
Remove the bottom functional module and any additional items ordered from the
carton and inspect for damage that may have occurred during shipment.
Place the bottom functional module on a desk or Cart200. Ensure that there is suffi-
cient air flow below the device (do not place the device on a table-cover) and the white
gap on front panel is upward.
Remove the top functional module and any additional items ordered from the carton
and inspect for damage that may have occurred during shipment.
Place the top functional module on top of the bottom functional module and ensure
the white gap on front panel is downward.
Carefully lift the top functional module at the front and insert flat cable into connector.
Place the main device on top of functional modules.
Carefully lift the main device at the front and insert flat cable into connector.
35
Rehab-Series
Insert the mains cable into socket and connect it to a wall socket.
CAUTION:
Do not place the device in a location where the power cord could be tripped over or
pulled out during treatment.
Do not attempt to use the device if it is not properly grounded. Make certain that the
device is electrically grounded by connecting it only to a grounded electrical service
receptacle conformable with the applicable national and local electrical codes regard-
ing medical environments.
Set power line switch On(1).
Power LED indicator is lit green indicating that the device is connected to the mains
supply.
The device will initialize and perform a self test. This may take a while.
At the end of the self test the device enters the Home menu and is ready for use.
Leave power line switch in the Off position (0) and turn on the device on using push
button.
Power LED indicator is lit orange, indicating that the device is operating from the bat-
tery.
The charge status of the battery is indicated in the right hand top corner of the display.
When you have finished treatments turn off the device using push button
With the power line switch On (1), the battery is automatically charged, independent
of the state of the on/off push button. We recommend to use the apparatus from the
powerline whenever possible. This will increase the service life of the battery.
36
Rehab-Series
7 Application Information
7.1 Electrotheraphy
CAUTION:
Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and
is therefore not permitted.
To prevent infection, electrodes and sponge pads should not be used on broken skin.
Prior to initial use thoroughly rinse the sponge pads in warm tap water to remove the
impregnating agent.
Before application saturate the sponge pads with tap water. In areas with soft tap water
use a saline solution instead. This will improve electrical conduction.
The supplied sponge pads have three layers. With AC currents, apply one sponge layer
between the skin and the electrode for minimum resistance.
With DC currents, apply two sponge layers between the skin and the electrode. Two
layers provide more absorbing capacity for electrolysis by-products.
Fix the electrode/sponge pad assembly to the patient using the supplied fixation straps.
Depending on the electrode size, use two or three wraps to maximize the contact
surface. See the illustrations below.
Use the stimulator in the Constant Current (CC) mode. This will maintain the set current
amplitude, even when the impedance of the sponge pads increases during treatment
caused by water evaporation.
Keep the sponge pads well moistened during treatment, especially with DC currents. If
the current display starts blinking, it is an indication of poor electrical contact.
After use clean the sponge pads as described in the User Maintenance instructions.
37
Rehab-Series
7.1.3Vacuum electrodes
There is a choice of large and small electrodes. The areas of the electrodes correspond to
those of the 4 x 6cm and 6 x 8cm flexible rubber electrodes. The vacuum electrodes are
sufficiently flexible to ensure optimum contact with the skin, but rigid enough to prevent any
changes in the contour of the part being treated, allowing full advantage to be taken of the
massage effect of the pulsed vacuum.
After use clean the sponge pads as described in the User Maintenance instructions.
Self-adhesive electrodes have higher series impedance than flexible rubber electrodes. This
can cause the stimulator to terminate treatment at higher current amplitudes. When this
occurs it is recommended to continue the treatment with flexible rubber electrodes, com-
bined with properly moistened sponge pads.
Self-adhesive electrodes are not recommended for use with currents that contain a DC com-
ponent.
CAUTION:
Electrolysis occurs under the electrodes when current types with a DC component are
applied. Because the largest concentration of electrolytic by-products caused by ion migra-
tion occur under the electrodes, we recommend the use of the supplied sponges to keep the
effects to a minimum. Make sure that the sponges are kept well moistened and place the
thick side of the sponge between the flexible rubber electrode and the patient.
38
Rehab-Series
To find the maximum recommended current amplitude in mA for the Interferential, Premodu-
lated and Russian Stimulation current waveforms, multiply the electrode surface in cm² by
two. For all other current waveforms the stimulator output current can never exceed 50 mA
r.m.s. This implies that with an electrode surface of 25 cm² the current density can never
exceed 2 mA r.m.s. / cm². As a rule of thumb for smaller electrodes, such as the 3.2mm self
adhesives, the maximum current setting available on the stimulator for a given current wave-
form should proportionally be reduced.
For a precise calculation of the r.m.s. value of a pulsed current waveform the following
IRUPXODFDQEHXVHG,506 ,SHDN¥ 3KDVHGXUDWLRQ>V@ SXOVHIUHTXHQF\>+]@
For symmetrical TENS currents, the Phase duration should be multiplied by 2. The value of
the peak current Ipeak can be taken from the current display.
Electrodes should be placed with care, ensuring good electrical contact over the entire elec-
trode surface.
Constant Current (CC) output characteristics may cause unpleasant connection and discon-
nection reactions if the electrodes are not securely placed or lose contact with the skin. Make
sure the current amplitude is set to 0 mA when you apply or remove the electrodes. Use the
Constant Voltage (CV) output mode with dynamic electrode applications.
7.2 Ultrasound
The ultrasound applicator has a contact control function that suspends treatment when the
acoustical contact with the body drops below a certain level (see paragraph 10.1). The indi-
cator light on the applicator is turned on to signal this situation, the ultrasound Amplitude
display will start blinking and the treatment timer will stop counting down. During this situa-
tion the applicator emits a small amount of energy to sense restoration of acoustical contact.
You may experience this when the applicator only partially contacts the body. When contact
restoration is sensed the treatment is resumed at the set Amplitude.
The contact control function does not work at Amplitudes below 0.2 Watt/cm².
39
Rehab-Series
To ensure efficient transfer of energy, a contact medium is required between the ultrasound
applicator and the body. Air causes virtually total reflection of the ultrasound energy. The
best medium for the transfer of ultrasound energy is a gel.
The gel should be applied to the part of the body to be treated and then spread out
with the ultrasound applicator.
Never apply the gel to the ultrasound applicator. The applicator will register this as
acoustical contact and may emit ultrasound energy, which could damage the applica-
tor.
If the body surface is very irregular, making it difficult to obtain good contact between the
ultrasound applicator and the body, or if direct contact must be avoided (e.g. due to pain),
the affected area may be treated under water (subaqual method). The water should be
degassed (by previous boiling) in order to prevent air bubbles arising on the ultrasound
applicator and the body.
Check the patient for contra-indications. See section 4.2.2 for details.
Test the warmth sensibility of the treatment area.
To optimize ultrasound transmission, clean the skin of the treatment area with soap or
a 70% alcohol solution.
Strong hair growth has to be shaved.
The ultrasound applicator has to be moved constantly, also with the semi-static
method. During treatment the displayed ultrasound Amplitude can vary around the set
value, caused by fluctuations in acoustical coupling.
Ask the patient regularly for his/her findings. If necessary the treatment will have to be
adapted. The Amplitude can be reduced or the continuous mode can be changed to
pulsed mode or vice versa.
When there are signs that the ultrasound transmission is bad, add more contact gel or
spread it with the applicator.
40
Rehab-Series
CAUTION:
The ultrasound applicator is a precision instrument. Great care has been taken during
the development and in production to obtain the best possible beam characteristics.
Rough treatment (jarring or dropping) can adversely affect these characteristics, and
must therefore be avoided.
Clean the skin of the patient and the ultrasound applicator with a towel or tissue. Clean
the applicator with a 70% alcohol solution.
Check for the effects that can be expected (for example pain, circulation and mobility).
Ask the patient to inform the therapist of any reactions.
7.3 Vacuum
Vacuum electrodes make good contact with the skin, which means that effective use is made
of the whole electrode area. The massage effect resulting from the pulsed vacuum ensures
a good blood flow through the skin under the electrodes. This reduces the resistance of the
skin and increases he effectiveness of the stimulation current.
f using the EMG or ETS phase,connect the EMG reference lead to a surface skin electrode
and place it appropriately on the body, making sure the skin is free from grease and dirt;
repeat the above procedure with the other two skin electrodes. If using a probe, place the
single surface skin electrode on the thigh area and then insert the probe.
Always use Reference wire (REF) for the precise EMG measurement!
Place reference electrode anywhere on your skin.When using with Vaginal probe, you can
place the reference electrode on your thigh.
41
Rehab-Series
7.4.2 Probes
NOTE:
AC4001(24.5x97mm) NT1041(26.5x97mm)
AC4000(29.5x97mm) NT1011(14x132mm)
42
Rehab-Series
8 Operating Instructions
8.1 Operator Controls
8 11
7 10
12
1
9
3
13 14 15 16
43
Rehab-Series
44
Rehab-Series
CAUTION:
Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and
is therefore not permitted. For combined applications only use CARETALK type BF
equipment. The very low leakage current of this type of equipment ensures absolute
safe therapy.
The ultrasound applicator is a precision instrument. Great care has been taken during
the development and in production to obtain the best possible beam characteristics.
Rough treatment (jarring or dropping) can adversely affect these characteristics, and
must therefore be avoided.
CAUTION:
&RQQHFWLRQV>@>@>@>@>@>@>@>@>@>@>@DUHLQWHQGHGIRUWKH
connection of type BF applied parts complying with the leakage current requirements
of IEC 60601-1.
8.2 Symbol
Complies with the European Medical Device Directive (93/42/EEC) and amended
0197
by directive 2007/47/EC requirements. Notified body TÜV Rheinland (CE0197)
45
Rehab-Series
The display is organized as a spreadsheet of 3 sheets, one for each channel. The channels
refer to the patient connector groups accessible at the front of the unit. A sheet can be
selected by touching its tab. The tab shows important information, such as the output ampli-
tude and the remaining treatment time. This information is continuously visible, also when
the sheet is not selected.
46
Rehab-Series
A selected sheet gives an overview of the parameters belonging to that channel. A param-
eter can be selected by touching it, which causes its sheet to be lit and the strip lamp in the
bottom of the screen bar is to be illuminated. The parameter can now be adjusted with the
FHQWUDOFRQWUROOHU>@7KHSDUDPHWHUFDQEHFORVHGE\WRXFKLQJDQRWKHUSDUDPHWHU
To adjust the output amplitude of a channel, touch the tab of the selected channel again. Its
colour will change into orange. The output amplitude can now be adjusted with the central
FRQWUROOHU>@
For some applications, such as interferential therapy and combination therapy, two adjacent
channels can be linked. Linked channels are indicated by a combined tab. The tab halves
show the output amplitude of each channel, while the parameters on the remainder of the
sheet apply to both channels.
When you turn on the unit, you will first enter the Home menu. In the Home menu none of
the channels are selected. The Home menu provides a structured access to all therapies
available within the unit, with appropriate parameter defaults. Just select a menu item by
touching the button to navigate to the next screen. You can navigate back to the previous
screen by touching the back arrow at the top of the screen. Anywhere in the navigation, you
can jump back to the Home menu, by touching the home button .
8.3.3 Sign
47
Rehab-Series
A Output Indicator Standard electrodes
Channel 2
Remaining treatment time. When a sequential protocol has been loaded, the value
C
indicates the total remaining treatment time of the sequential protocol.
D Output value
E Unit of Output value: mA, V
48
Rehab-Series
8.3.4 Navigation
8.2.4.1 Electrotherapy
Home
49
Rehab-Series
Therapy information
50
Rehab-Series
Channel Selection
51
Rehab-Series
Electrotherapy
“Manual Operation”
Select
from the list a current waveform
6FUROOWRWKHQH[WSDJHZLWKWKHFHQWUDOFRQWUROOHU>@
or select the current waveform by touching the button.
52
Rehab-Series
Channel Selection
Parameter screen
53
Rehab-Series
7RSDXVHWKHWUHDWPHQWWRXFKWKHSDXVH
button in the navigation bar.
7RFRQWLQXHWKHWUHDWPHQWWRXFKWKHUXQ
button in the navigation bar.
7R6WRSWKHWUHDWPHQWWRXFKWKH6723
button in the navigation bar.
8.2.4.2 Ultrasound Therapy
54
Rehab-Series
Therapy information
8VHWKHFHQWUDOFRQWUROOHU>@WRVFUROOWKURXJK
the pages, in most cases the first page is text
followed by one or more illustrations.
55
Rehab-Series
56
Rehab-Series
6HOHFWWKHXOWUDVRXQGEXWWRQWRDGMXVWWKH
ultrasound parameters.
7RXFKWKHHOHFWURWKHUDS\EXWWRQWRUHWXUQWR
the previous screen.
7RXFKWKHXOWUDVRXQGUHDGRXWDQGDGMXVW
WKHLQWHQVLW\ZLWKWKHFHQWUDOFRQWUROOHU>@
7RXFKWKHFXUUHQWUHDGRXWFKDQQHOWR
adjust the current intensity. (electrode and
treatment head need to be in contact with
the patient).
57
Rehab-Series
8.2.4.4 Vacuum
7RXFKWKHEXWWRQDQGDGMXVWWKHSUHVVXUH
XVLQJWKHFHQWUDOFRQWUROOHU>@7KHYDFXXP
cups are automatically selected when the pump
starts to run.
7RXFKWKHEXWWRQDQGVHOHFWWKHGHVLUHG
PDVVDJHUK\WKPXVLQJWKHFHQWUDOFRQWUROOHU>@
You can choose between Continuous,
Pulsed mode 1 s and Pulsed mode 2 s.
58
Rehab-Series
8.2.4.5 MTM200
8.2.4.6 EMG200
59
Rehab-Series
60
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Channel Selection
61
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Enter the name of your favorite using the keyboard.
Touch to store your favorite under the name
just entered.
Notes:
Once saved, favorites can be retrieved from the
Electrotherapy, Ultrasound Therapy and Combination
Therapy menus.
4-polar treatments are automatically saved and
loaded as a dual channel treatment.
Vacuum settings are not saved.
62
Rehab-Series
63
Rehab-Series
To adjust the output current, touch the tab of the selected channel. Its colour will change to
RUDQJHDIWHUZKLFKWKHFXUUHQWDPSOLWXGHFDQEHVHWZLWKWKHFHQWUDOFRQWUROOHU>@
The current amplitude can only be adjusted when the clock has been set.
With 4 polar interferential current waveforms the current amplitude operates on both chan-
nels simultaneously. In this case a balance facility is available for the classical interferential
current waveform (see paragraph 4.1.3 for details).
The unity of the displayed current amplitude depends on the previously selected current
waveform and can be expressed in mA, µA or V.
A treatment is started by adjusting the current amplitude, unless a surge program has been
selected. To start a surge program, touch the Start/Continue button in the navigation bar.
Depending on the selected current waveform, the electrotherapy channels can be used in the
Constant Current or Constant Voltage mode. It is advised to use the CV mode with dynamic
electrode applications. In CV mode the output current depends on the electrical contact with
the patient and can therefore vary. You can change the CC/CV setting in the parameter
menu.
When DC currents are used, the red connection is the positive connection and the black one
the negative connection.
Manually changing the polarity during a treatment will result in a current decaying to 0,
followed by a current with the opposite polarity, rising to a value equal to 80% of the previ-
ous value
64
Rehab-Series
Switch off the device and disconnect it from the power supply.The apparatus can be
cleaned with a damp cloth. Use lukewarm water and a non-abrasive liquid household
cleaner (no abrasive, no alcohol content solution). If a more sterile cleaning is needed,
use a cloth moistened with an antimicrobial cleaner.
CAUTION:
Do not submerse the apparatus in liquids. Should the unit accidentally become sub-
mersed, contact the dealer or Authorized Service center immediately .Do not attempt to
use a system that has been wet inside until inspected and tested by a Service Technician
Certified by Authorized Service center . Do not allow liquids to enter the ventilation
holes.
Use a soft and dry cotton cloth or micro fiber tissue to clean the panel. To remove
fingerprints or grease, use a non-abrasive glass cleaning agent. Apply a small amount
of the cleaning agent to a soft cotton cloth and then carefully clean the panel.
CAUTION:
Apply the protective backing to the tacky side of the electrode. Place the electrode
on the side of the protective backing that is labeled with the word on.
It may be helpful to improve repeated application by spreading a few drops of
cold water over the adhesive and turn the surface up to air dry . Over Saturation
with water will reduce the adhesive properties.
Between uses, store the electrodes in the reusable bag in a cool dry place.
65
Rehab-Series
CAUTION:
Periodically wipe the lead wires clean with a cloth dampened in a mild soap solution, and
then gently wipe them dry . Use of rubbing alcohol on the lead wires will damage the insula-
tion and dramatically shorten their life.
To prevent corrosion,clean and dry the contact surface immediately after use.Make sure that
no ultrasound gel remains on the applicator.We further recommend cleaning the applicator
and cable daily,using lukewarm water.The applicator can be disinfected using a cloth moist-
ened with a 70% alcohol solution.Check the applicator and cable regularly for damage.
The vacuum electrodes and sponges should be cleaned with lukewarm water. In the case of
persistent dirt, and for disinfection, a 70% alcohol solution may be used.
Sponges should be replaced regularly. It is recommended to keep sponges and a spare elec-
trode in stock.
Calcium scale can be deposited on the metal surfaces of the electrodes. This has an insulat-
ing effect. In order to maintain optimum conductivity, these surfaces should be regularly
cleaned and polished.
Clean the vacuum cable with a damp cloth. Use lukewarm water and a non-abrasive house-
hold cleaning agent. Do not use an alcohol solution. Check the cable regularly for damages
and/or bad electrical contact. We advise, keeping a spare vacuum cable in stock.
66
Rehab-Series
Carefully clean the probe after use.Wash the probe gently in mild soapy water,rinse and
make sure the probe is completely dry before returning to storage in the plastic bag.
Content
error code reason System processing
Tooltip Voice
Output pause
Ultrasound applicar is system recover
001 without load
N/A Prompt tone
output when
detecting load.
Parameters remain
003 Parameters is sett lower limit N/A Prompt tone in lower limit
67
Rehab-Series
Content
System
error code reason
processing
Tooltip Voice
68
Rehab-Series
Battery level is Low Battery level too Low Warning The operation
113
tone is invalid
69
Rehab-Series
9.3 Maintenance
On request a service manual can be made available containing: spare part list, descriptions,
calibration instructions and other information which will assist the user’s qualified technical
personnel to repair those parts of the equipment which are designated by the manufacturer
as repairable.
CAUTION:
Electrical safety of the device relies on a properly earthed electrical connection via the
power cord. It is therefore necessary to have this connection checked annually.
To ensure continued compliance with the 21 CFR 1050.10 standard, this unit should
be adjusted and safety tested once each year. Procedures laid down in the service
manual should be followed. This may be carried out by your supplier, or by another
agency, authorized by the manufacturer. It is also recommended that a service history
record is maintained. In some countries this is even obligatory.
Use of controls or adjustments or performance of procedures other than those speci-
fied herein may result in hazardous exposure to ultrasonic energy.
70
Rehab-Series
WARNING:
This unit operates with high voltages. No attempt should be made to disassemble the
unit.Maintenance and repair should be carried out by authorized personnel only. The
manufacturer will not be held responsible for the results of maintenance or repairs by
unauthorized persons.
9.4 Troubleshooting
Electrodes 1. Replace.
1. Dried out or contaminated 2. Electrodes must be a minimum of 2
Displays fail inches apart.
2. Placement
to light up
Lead wires Old/worn/damaged Lead wires Old/worn/damaged
71
Rehab-Series
Electrode active area size is Replace electrodes with ones that have
too small an active area no less than 25.0cm .
72
Rehab-Series
10. Specifications
10.1 Ultrasound parameters
Output Power
'XW\IDFWRUIRUFP²........................................................................0.5W-10.0W
'XW\IDFWRUIRUFP²........................................................................0.5W-15.0W
'XW\IDFWRUIRUFP²..........................................................................0.1W-2.0W
'XW\IDFWRUIRUFP²..........................................................................0.1W-2.0W
Output accuracy........................................± 20% (for any level above 10% of maximum)
'XW\IDFWRU:FPò
'XW\IDFWRU:FPò
Treatment timer.............................................................................0 - 30 min ± 0.1 min
5 cm² Applicator
1cm² Applicator
73
Rehab-Series
Premodulated Current is a medium frequency waveform. Current comes out of one channel
(two electrodes). The current intensity is modulated: it increases and decreases at a regular
frequency (the Amplitude Modulation Frequency).
74
Rehab-Series
The Asymmetrical Biphasic and the Symmetrical Biphasic waveform are often used in TENS
(Transcutaneous Electrical Nerve Stimulation) applications. The TENS has a short pulse
duration. It is capable of strong stimulation of the nerve fibers in the skin as well as of muscle
tissue. Because of its short pulse, the patient typically tolerates the current well, even at rela-
tively high intensities. The Alternating Rectangular waveform is an interrupted biphasic
current with a rectangular pulse shape. This waveform is commonly used as a pain manage-
ment application.
75
Rehab-Series
76
Rehab-Series
10.2.4 Russian
Russian Current is a rectangle waveform, delivered in bursts or series of pulses. This method
was claimed by its author (Kots) to produce maximal muscle strengthening effects without
significant discomfort to the patient.
Carrier Freq....................................................................................................2-10KHz
Burst Frequency.........................................................................20-100Hz,stepping 5Hz
Duty cycle.................................................................................10%-50%,stepping 10%
Intensity....................................CC:0-200mA,stepping 0.5mA;CV:0-200V,stepping 0.5V
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp.........................................................................0/0,1/1, 2/2,5/5,8/8,custom:0-9
10.2.5 Microcurrent
Microcurrent is a monophasic waveform of very low intensity. The literature reports benefi-
cial effects of this waveform in the treatment of wounds. The physiological working mecha-
nism of this effect is as yet not clearly understood. It is thought to stimulate tissue healing by
stimulating the 'current of injury', a current which naturally occurs in healing tissue.
Frequency....................................................................0.1-1000Hz,stepping 0.1Hz/1Hz
Polarity................................................................................................Positive,negative
Intensity..............................................................................CC:0-1000uA,stepping 5uA
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp..........................................................................0/0,1/1,2/2,5/5,8/8,custom:0-9
10.2.6 Faradic
10.2.6.1 Trabert
Polarity................................................................................................Positive,negative
77
Rehab-Series
Phase Duration.....................................................................................Positive,negative
Phase Duration.......................................................................................................2ms
Interval..................................................................................................................5ms
Intensity.........................................CC:0-70mA,stepping 0.5mA;CV:0-70V,stepping 0.5V
Treatment Time.........................................................................................1-60 minutes
10.2.6.2 Rectanglar
Frequency..................................................................0.2Hz-200Hz.stepping 0.1Hz/1Hz
Polarity................................................................................................Positive,negative
P.Dur......................................................................20-10000us,steping 100us/1000us
Intensity.........................................CC:0-80mA,stepping 0.5mA;CV:0-80V,stepping 0.5V
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp.........................................................................0/0,1/1, 2/2,5/5,8/8,custom:0-9
10.2.6.3 Triangular
Frequency..................................................................0.2Hz-200Hz.stepping 0.1Hz/1Hz
Polarity................................................................................................Positive,negative
P.Dur......................................................................20-10000us,steping 100us/1000us
Intensity.........................................CC:0-80mA,stepping 0.5mA;CV:0-80V,stepping 0.5V
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp.........................................................................0/0,1/1, 2/2,5/5,8/8,custom:0-9
10.2.7 Diadynamic
The Diadynamic waveforms are rectified alternating currents. The alternating current is
modified (rectified) to allow the current to flow in one direction only.
Mode...............................................................................................MF,dF,LP,CP,CP.id
Polarity................................................................................................Positive,negative
Intensity........................................CC:0-70mA,stepping 0.5mA; CV:0-70V,stepping 0.5V
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
78
Rehab-Series
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp.........................................................................0/0,1/1, 2/2,5/5,8/8,custom:0-9
The High Voltage Pulsed Current (HVPC) has a very brief pulse duration characterized by two
distinct peaks delivered at high voltage. The waveform is monophasic (current flows in one
direction only). The high voltage causes a decreased skin resistance making the current
comfortable and easy to tolerate.
Frequency...................................................................................1-120Hz,stepping 1Hz
Polarity................................................................................................Positive,negative
P.Dur.................................................................................................................100us
Intensity.....................................................................................CV:0-500V,stepping 5V
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp.........................................................................0/0,1/1, 2/2,5/5,8/8,custom:0-9
10.2.9 NMS
10.2.9.1NMS
Mode...................................................................................................NMS,NMS Burst
Frequency...................................................................................1-250Hz,stepping 1Hz
P.Dur....................................................................................20us-1000us,stepping 5us
Intensity.....................................CC:0-200mA,stepping 0.5mA;CV:0-200V,stepping 0.5V
Channel mode....................Single channel Mode,Reciprocal Mode,Co-Contraction Mode
Treatment Time.........................................................................................1-60 minutes
Cycle Time........................................continues,10/10,10/20,10/30,10/50,custom:0-60
Ramp.........................................................................0/0,1/1, 2/2,5/5,8/8,custom:0-9
10.2.10 Galvanic
10.2.10.1 Continuous
Polarity................................................................................................Positive,negative
Intensity................................................CC:0-80mA,stepping 5uA;CV:0-80V,stepping 5V
79
Rehab-Series
10.2.10.2 Interrupted
Frequency.....................................................................................................8KHz fixed
Polarity................................................................................................Positive,negative
Duty cycle......................................................................................................90% fixed
Intensity................................................CC:0-80mA,stepping 5uA;CV:0-80V,stepping 5V
For security, the device has some some limited for electrotherapy.The maximum intensity has
a relationship with the frequency and pulse duration following below table:
For security, the device has some some limited for electrotherapy.The maximum intensity has
a relationship with the frequency and pulse duration following below table:
80
Rehab-Series
IEC 60601-1
General requirements for the safety of electrical medical systems, including Annex 1,
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.
0197
This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).
21 CFR 1050.10
This equipment complies with all requirements of 21 CFR1050.10, 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.
Portable and mobile RF communication systems (e.g. mobile phones) may interfere with
medical electrical Rehab-series.
81
Rehab-Series
The Rehab-series should only be operated with the original mains cable specified in the list
of contents delivered.
Operating the device with any other mains cable can lead to increased emissions or reduced
interference immunity of the device.
RF emissions according to CISPR 11 ClassA The Rehab-series device is suitable for use
in all establishments other than domestic
Harmonic emissions according to and those directly connected to the public
Class A
IEC 61000-3-2 low-voltage power supply network that
supplies buildings used for domestic
purposes.
Voltage fluctuation emissions and
Conforms
flicker according to IEC 61000-3-3
The device should not be used when placed immediately next to or stacked on top of other
devices. If operation is necessary when immediately next to or stacked on top of other
devices, the device should be monitored to ensure it is operating as intended in this arrange-
ment.
82
Rehab-Series
The REHAB SERIES device is intended for use in the electromagnetic environment specified
below. The customer or the user of the REHAB SERIES device should assure that it is used
in such an environment.
IEC 60601 Compliance Electromagnetic
Immunity test
test level level environment - Guidance
Floors should be wood,
Electrostatic concrete or ceramic tile.
discharge (ESD) to ± 6 kV contact ± 6 kV contact If floors are covered with
IEC 61000-4-2 ± 8 kV air ± 8 kV air synthetic material, the
relative humidity should
be at least 30%.
± 2 kV for Mains power quality should
Electrical fast ± 2 kV
power supply lines be that of a typical
transient / burst to for power supply lines
± 1 kV for commercial or hospital
IEC 61000-4-4 not applicable
input /output lines environment.
± 1 kV ± 1 kV Mains power quality should
Surge differential mode differential mode be that of a typical
IEC 6100-4-5 ± 2 kV ± 2 kV commercial or hospital
common mode common mode environment.
Mains power quality should
<5% UT <5% UT
be that of a typical
(>95% dip in UT for (>95% dip in UT for
Voltage dips, short commercial or hospital
0.5 cycle) 40% UT 0.5 cycle) 40% UT
interruptions and environment. If the use
(60% dip in UT for (60% dip in UT for 5
voltage variations of the REHAB SERIES
5 cycles) 70% UT cycles) 70% UT
on power supply device requires continued
(30% dip in UT for (30% dip in UT for 25
input lines operation during mains
25 cycles) <5% UT cycles) <5% UT
IEC 61000-4-11 power interruptions,
(>95% dip in UT for (>95% dip in UT for 5
it is recommended to
5 seconds) seconds)
install a battery.
Power frequency magnetic
Power frequency fields should be at levels
(50/60 Hz) characteristic of a typical
3 A/m 3 A/m
magnetic field to location in a typical
IEC 61000-4-8 commerical or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.
83
Rehab-Series
The main features of the REHAB SERIES devices are as follows: interference-free delivery of
shockwaves, interference-free control of all functions. Uninterrupted operation is not
required with the use intended.
The REHAB SERIES device is intended for operation in the electromagnetic environment
specified below. The customer or user of the REHAB SERIES should ensure that it is used
in such an environment.
Interference Electromagnetic
IEC 60601-test level Compliance level environment-guidelines
immunity tests
Portable and mobile radio should
not be used any closer to the REHAB
SERIES devices, including cables,
than the recommended separation
distance calculated from the equa-
tion applicable to the transmission
Conducted frequency.
RF disturbance Recommended separation distance:
variables G ¥3
according G ¥3IRU0+]WR0+]
to IEC 3 Veffective value 3 Veffective value G ¥3IRU0+]WR*+]
61000-4-6 150 kHz to 80MHz 150 kHz to 80 MHz Where P is the rated power of the
Radiated RF 3 V/m 3 V/m transmitter in Watts (W) according to
disturbance 80 MHz to 2.5GHz 80 MHz to 2.5 GHz the transmitter manufacturer and d is
variables the recommended separation
according distance in meters (m).
to IEC According to an investigation in
61000-4-3 situa, the field strength of stationary
radio transmitters should be less
than the compliance level at all
frequencies.
Interference may occur in the vicinity
of REHAB SERIES devices which is
marked with the following symbol:
84
Rehab-Series
NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
NOTE 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Theoretically, it is not possible to exactly predict the field strengths of fixed transmitters such
as base stations for radio telephones and land mobile radios, amateur radio stations, AM
and FM radio and TV broadcasting. To determine the electromagnetic environment in rela-
tion to the fixed transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location where the REHAB SERIES device is to be used exceeds
the above compliance levels, the REHAB SERIES device should be monitored in order to
ensure that it is functioning as intended. If unusual features are noticed, additional measures
may be necessary such as re-orienting or relocating the REHAB SERIES device.
Above the frequency range from 150 kHz to 80 MHz the field strength should be less than
3 V/m.
85
Rehab-Series
100 12 3.5 7
For transmitters rated at a maximum output which is not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to
the respective column, whereby P is the maximum rated output of the transmitter in Watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
86
Rehab-Series
Model numbers:
11.1 CT2200
Standard Accessories:
Optional Accessories:
87
Rehab-Series
11.2 MT2200
Standard Accessories:
11.3 UT2200
Standard Accessories:
88
Rehab-Series
11.4 MTM200
Standard Accessories
11.5 BTM200
Standard Accessories:
11.6 VAM200
Standard Accessories:
89
Rehab-Series
11.7 EMG200
Standard Accessories
Optional Accessories:
11.8 Cart:
www.nutekmedical.com
90