International

̿ English

User Manual

V-MBU-470
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Contents
1 Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use and Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3 Reprocessing - Sterilisable Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Limitations on reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Point of Use (before reprocessing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Containment and Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Inspection and Function Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Sterilisation of Handpieces and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Sterilisation of Sterilisable Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Point of Use (after reprocessing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5 Configuring a Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Selecting the Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Controlling the Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6 Using Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Fitting an Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Removing an Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Fitting a Bur Guard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Removing a Bur Guard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Using a Wire or Pin Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7 Using Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Fitting and Removing a Rotary Cutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Fitting and Removing a Small Reciprocating Blade . . . . . . . . . . . . . . . . . . . . . . . 20
Fitting a Sagittal Blade (Knob-release) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Removing a Sagittal Blade (Knob-release) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Fitting and Removing a Sagittal Blade (Manual-release) . . . . . . . . . . . . . . . . . . . 23
Fitting and Removing a Bur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Fitting a Wire or Pin (V-WU-470 & V-PU-470) . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Fitting a Wire or Pin (V-WU-471) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Fitting a Wire or Pin Guard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Powering the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
8 Technical and Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Handpiece Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Power Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Sterilisation Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
9 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Further Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Service and Repair Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Guarantee and Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
10 EMC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
EM Compliance (emissions) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
EM Compliance (immunity) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Important Information
Save this user manual. This user manual contains important safety and operating instructions for
this equipment.
Throughout this user manual, the words WARNING, CAUTION and NOTE are used to highlight
important information.
WARNING: WARNING information identifies conditions or practices that could result in injury
CAUTION: CAUTION information identifies conditions or practices that could result in damage to
the equipment or system
NOTE: NOTE information is provided to clarify or supplement procedural information

Safety Instructions
WARNING: do not attempt to use this equipment until this user manual and all cautionary markings
have been studied and understood
WARNING: this equipment should only be used by personnel with appropriate training
WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment
WARNING: always allow the handpiece to stop before removing from the surgical site
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
WARNING: never reuse items marked for single-use . Risks associated with reuse include:
• cross contamination between patients
• bone necrosis due to extra heat generation
• inaccurate cutting.
WARNING: cutting accessories can get hot during use. Saline solution can be used to cool the
cutting site.
WARNING: when using dedicated saws or saw attachments, follow local recommendations for the
avoidance of possible hand-arm vibration damage and long-term hearing damage. (Under certain
circumstances, hand-arm vibration levels exceeding 5ms-2 can be produced and maximum sound
levels can exceed 80dB(A). However, when the equipment is used for the purposes intended this
poses no threat to long-term health.)
WARNING: this equipment is not intended for use in an oxygen rich environment or in the presence
of flammable gases
CAUTION: this equipment must only be used in accordance with the EMC guidelines described in
this user manual. Use of accessories other than those approved by De Soutter Medical may result
in increased interference or emissions.
CAUTION: ensure this equipment is regularly serviced. Refer to the service and repair information
section of this user manual.
CAUTION: only reprocess this equipment as directed in this user manual
CAUTION: do not immerse any part of this equipment in fluids except as required by an automatic
washer-disinfector cycle
CAUTION: only use Stericut or De Soutter Medical approved accessories
CAUTION: always remove batteries when the handpiece is left unused for an extended period of
time

1
Intended Use and Benefits
The equipment described in this user manual is intended for use by a professional surgeon, in a
surgical procedure. The equipment is intended to efficiently drill, ream, bur or cut bone and hard
tissue. The equipment is also intended to drive wires and pins into bone.
There are no known contraindications.

Disposal
WARNING: do not dispose of batteries by throwing them into a fire or immersing them in water
WARNING: lithium batteries are subject to transportation restrictions
WARNING: faulty or suspect lithium batteries must not be returned by air transport. They should be
recycled or disposed of in accordance with local regulations.
All equipment should be recycled or disposed of, in accordance with local regulations.

2
Symbols

Symbol Meaning Symbol Meaning

Refer to the user manual Only for use by a physician

Single-use only Do not immerse

Refer to the user manual Dispose of in accordance

%65:
$:$-& for the duty cycle with local regulations

Drive in the direction

Suitable for recycling
indicated

Normal mode Screwing mode

Attachment locked Attachment unlocked

Pull and/or turn in the

Type BF protection
direction shown to unlock

Temperature limits to Pressure limits to which

which the equipment can the equipment can be
be exposed exposed
Humidity limits to which
Transport - keep away
the equipment can be
from rain
exposed

Transport - fragile, handle

Transport - this way up
with care

The first two digits (YY)

SN YY/000000 indicate the year of Manufacturer
manufacture

Do not use if packaging is

0' Medical Device
damaged or opened

EC authorised
(& 5(3 representative

3
Reprocessing - Sterilisable Equipment
These reprocessing instructions are suitable for the sterilisable equipment described in this user
manual.
• All Handpieces
• All Attachments
• SB-xxx - Sterile Battery
• AS-xxx - Aseptic Shield
• V-AH-xxx - Aseptic Housing

Limitations on reprocessing
Repeated processing as specified in these instructions has minimal effect on this equipment.
Equipment end-of-life is normally determined by wear or damage during use.

Safety Instructions
WARNING: never reuse items marked for single-use . Risks associated with reuse include:
• cross contamination between patients
• bone necrosis due to extra heat generation
• inaccurate cutting.
WARNING: do not clean any part of this equipment with pressurised air

CAUTION: following a wet cleaning process, ensure that this equipment is dried immediately
CAUTION: correct internal drying of sterilisable equipment can only be achieved by using a vacuum
steam autoclave with the vacuum assisted drying period activated
CAUTION: do not immerse any part of this equipment in fluids except as required by an automatic
washer-disinfector cycle
CAUTION: do not exceed temperatures of 140°C
CAUTION: do not clean any part of this equipment in an ultrasonic cleaner
CAUTION: do not use saline water to rinse the equipment
CAUTION: do not wash or sterilise aseptic batteries, power supplies or battery chargers. Refer to
separate reprocessing instructions.
CAUTION: ensure that aseptic battery housings are reprocessed in the open position
NOTE: ensure that attachments and handpieces with collet mechanisms are fully open when
reprocessing
NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require
particular attention during reprocessing
NOTE: STERIS processes will affect the appearance of equipment with coloured anodizing. The
discolouration caused by the processes will not affect the performance of the product.

4
Detergents and Rinse Aids for use on Batteries
WARNING: the choice of detergent or rinse aid, and the manner in which they are used, is critical
to sustaining the reliability of the equipment. Failure to follow the instructions given in this user
manual may cause premature failure of the equipment and may compromise patient safety.
CAUTION: ensure the detergent or rinse aid manufacturer’s guidelines and process parameters
(such as, dilution and temperature) are followed
CAUTION: ensure the detergent or rinse aid used is suitable for use on anodised aluminium and
the following plastics: PEEK, PPSU and PAEK
CAUTION:ensure a pH-neutral enzymatic detergent is used for cleaning batteries. Failure to do so
may adversely affect the battery.
Detergents and Rinse Aids for use on all Other Equipment
WARNING: the choice of detergent or rinse aid, and the manner in which they are used, is critical
to sustaining the reliability of the equipment. Failure to follow the instructions given in this user
manual may cause premature failure of the equipment and may compromise patient safety.
CAUTION: ensure the detergent or rinse aid manufacturer’s guidelines and process parameters
(such as, dilution and temperature) are followed
CAUTION: ensure the detergent or rinse aid used is suitable for use on anodised aluminium and
the following plastics: PEEK, PPSU and PAEK
CAUTION: never use detergents with a pH value greater than 11.0
NOTE: the use of pH-neutral enzymatic detergents is highly recommended

Point of Use (before reprocessing)

WARNING: do not allow the soil to dry on the equipment
WARNING: ensure the equipment is reprocessed as soon as practically possible after use
CAUTION: do not use saline water to rinse the equipment
CAUTION: only use pH neutral substances prior to reprocessing
Excess soil may be removed with a suitable wipe, or rinsed away with deionised or distilled
running water after use (maximum 35°C).
CAUTION: do not immerse any part of the equipment

Containment and Transportation

It is important that this equipment is reprocessed as soon as practically possible after use. In order
to minimise contamination risks, the handling, collection and transportation of soiled equipment
should be strictly controlled.

5
Cleaning and Disinfection
Manual Cleaning
• Remove all attachments and accessories and wash them separately.
• Dispose of single-use accessories in accordance with local guidelines.

Manual cleaning should only be carried out where an automatic washer-disinfector is not
available, or in order to remove large contaminant deposits. Manual cleaning should be conducted
in a dedicated area, by trained personnel who are wearing protective clothing, for example:
gloves, a waterproof apron, and goggles or a visor.
CAUTION: do not use saline water to rinse the equipment
NOTE: the use of dedicated sinks with temperature controlled water, ideally deionised or distilled,
is recommended
NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require
particular attention during reprocessing
1. Wash off excess soil with running water (maximum 35°C).
CAUTION: do not immerse any part of the equipment
2. Prepare a solution of detergent according to the detergent manufacturer’s instructions.
3. Remove all visible traces of contaminant, using suitable nylon brushes to scrub the
equipment thoroughly.
CAUTION: when using brushes, extra care must be taken to avoid damaging the equipment
i) Manually open and close chucks and blade clamps.
ii) Ensure any trapped contaminants are removed by flushing through cannulations
and other surfaces which are hard to reach.
4. Rinse off all traces of the detergent with deionised or distilled running water (45 - 65°C).
5. Shake off any excess water and dry the surfaces with a lint-free cloth.
6. Visually inspect each item. Verify that all contaminants have been removed in
accordance with local reprocessing guidelines.

6
Automatic Cleaning
• Remove large contaminant deposits by manual cleaning.
• Remove all attachments and accessories and wash them separately.
• Dispose of single-use accessories in accordance with local guidelines.

An automatic washer-disinfector, capable of meeting the relevant national and international

cleaning and disinfection standards (such as, ISO 15883 or HTM 2030), should be used.
CAUTION: the drying cycle should not be used with batteries. The drying cycle will adversely affect
the performance and life of the battery.
NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require
particular attention during reprocessing
1. Place the handpieces, attachments and accessories into an insert tray and/or a wire
basket.
i) Set chucks and blade clamps to a middle position.
ii) Fit washing spacers and end caps as required.
iii) Ensure that all items are separated.
NOTE: the placement of items in automatic washer-disinfector baskets can be a critical
factor in achieving effective cleaning. The basket type and the position of the items within
the basket should be managed by suitably trained personnel and be in accordance with
the washer-disinfector instructions.
2. Follow the washer-disinfector manufacturer’s loading instructions and select the
appropriate cycle. The cycle should include the following:

Minimum Recirculation
Cycle Stage Time (min:secs) Temperature Detergent

Pre-wash 5:00 < 35°C -

Enzyme wash 5:00 55 - 65°C Neutral Enzymatic

Triple Enzyme
Detergent

Rinse 1 2:00 55 - 65°C -

Rinse 2 2:00 55 - 65°C -

Thermal rinse 5:00 90°C -

Pure water rinse 1:00 60°C -

Drying (not suitable 20:00 110°C maximum -

for batteries)

7
 3. Remove the disinfected equipment from the washer-disinfector and place the equipment
in a clean area.
CAUTION: ensure the equipment has been sufficiently dried. Check cannulations, blind holes
and recesses for moisture.
4. Remove any washing spacers and end caps, if fitted.
5. Visually inspect each item. Verify that all contaminants have been removed in
accordance with local reprocessing guidelines.
Disinfection
Thermal disinfection is recommended and included in the automatic cleaning process.

Maintenance
Lubricate collets and chucks using a suitable surgical instrument oil.

Inspection and Function Testing

WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment
WARNING: never reuse items marked for single-use . Risks associated with reuse include:
• cross contamination between patients
• bone necrosis due to extra heat generation
• inaccurate cutting.
1. Ensure the equipment is in good working order.
i) Note any unusual sounds, vibrations or operating speeds.
NOTE: if operating difficulties are experienced, refer to the troubleshooting section of this
user manual
2. Inspect reusable cutting accessories for damage and wear.
NOTE: dispose of worn or damaged and single-use cutting accessories appropriately

Packaging
Place the disinfected equipment into a sterilisation container.
NOTE: if wrapping is required, use a material suitable for the chosen sterilisation method

8
Sterilisation of Handpieces and Accessories
CAUTION: these sterilisation instructions are not suitable for sterilisable batteries
CAUTION: ensure that aseptic battery housings are open, with the open side facing down
Steam Sterilisation Using a Wire Sterilisation Case

Exposure Time and Minimum Drying

Cycle a Temperature
Wrapping
(-0°C / +3°C) Time b

30 minutes at
vacuum assisted wrapped 3-4 minutes at 134°C
maximum 110ºC
vacuum assisted
unwrapped 3-4 minutes at 134°C none
(flash)
30 minutes at
wrapped 15 minutes at 134°C
maximum 110ºC
gravity
60 minutes at
wrapped 50 minutes at 121°C
maximum 110ºC
a. for reasons of non-repeatability during transport and storage, processes involving unwrapped equipment
cannot be validated beyond the sterilisation procedure.
b. the drying times specified for the wrapped cycles are based on using 2 layers of 56gsm Crepe paper
wrap. If different wrapping is used, the necessary drying time may vary.
Steam Sterilisation Using a Filtered Sterilisation Case
CAUTION: filtered sterilisation cases are not suitable for gravity steam sterilisation

Exposure Time and

Cycle Minimum Drying Time
Temperature (-0°C / +3°C)
vacuum assisted 3-4 minutes at 134°C 30 minutes at maximum 110ºC
vacuum assisted (flash) 3-4 minutes at 134°C none
STERIS Sterilisation

Sterilisation System Cycle

V-PRO® 1 standard
V-PRO® 1 Plus lumen
V-PRO® maX lumen
V-PRO® 60 lumen
NOTE: STERIS processes will affect the appearance of equipment with coloured anodizing. The
discolouration caused by the processes will not affect the performance of the product.

9
Sterilisation of Sterilisable Batteries
Steam Sterilisation
CAUTION: aseptic batteries (AB-xxx) are not suitable for sterilisation
CAUTION: high temperature can affect the performance and life of a battery. The specified drying
times should not be exceeded.
CAUTION: ensure that sterile batteries are fitted to the holder in the sterilisation container. The
contacts should be facing downwards to allow any liquid to drain away freely.

Exposure Time and Drying Time

Model Cycle Wrapping a Temperature (maximum 110ºC)
(-0°C / +3°C) b

SB-703 vacuum 3-4 minutes 12 minutes

wrapped
SB-704 assisted maximum at 134°C maximum
vacuum
3-4 minutes
SB-xxx assisted unwrapped none
maximum at 134°C
(flash)
a. For reasons of non-repeatability during transport and storage, processes involving unwrapped
equipment cannot be validated beyond the sterilisation procedure.
b. the drying times specified for the wrapped cycles are based on using 2 layers of 56gsm Crepe paper
wrap. If different wrapping is used, the necessary drying time may vary.
STERRAD® Sterilisation
CAUTION: insert trays are not suitable for use with the STERRAD® sterilisation process
NOTE: STERRAD® sterilisation is only suitable for SB-703 & SB-704 batteries
NOTE: prior to reprocessing any medical device in a STERRAD® System, refer to the STERRAD®
System User’s Guide for general reprocessing instructions, and proper cleaning, drying and
packaging information
NOTE: batteries must be packaged in an approved container and wrap

Sterilisation System Cycle

STERRAD® 100S short or long a
STERRAD® NX standard or advanced
STERRAD® 100NX standard
a. the STERRAD® 100S long cycle is only available outside the U.S.
STERIS Sterilisation

Sterilisation System Cycle

V-PRO® 1 standard
V-PRO® 1 Plus lumen
V-PRO® maX lumen
V-PRO® 60 lumen
NOTE: STERIS processes will affect the appearance of equipment with coloured anodizing. The
discolouration caused by the processes will not affect the performance of the product.

10
Storage
To preserve sterility, wrap the sterilised equipment with a suitable material, capable of presenting
a barrier to micro-organisms and particulate contamination.

Point of Use (after reprocessing)

CAUTION: do not operate this equipment while it is still warm from reprocessing
CAUTION: this equipment should not be placed in a refrigerator or similar
Following sterilisation, allow this equipment to cool to room temperature before being used.

Additional Information
Manual cleaning has been validated in accordance with AAMI TIR30.
Automated cleaning has been validated, in accordance with HTM 2030 and AAMI TIR30, using
an automated washer-disinfector.
Vacuum and gravity steam sterilisation have been validated in accordance with HTM 2010, AAMI
TIR12, ANSI/AAMI ST79, ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2.
Sterrad sterilisation has been validated in accordance with ANSI/AAMI/ISO 14937.
Steris sterilisation has been validated in accordance with AAMI TIR12.
The reprocessing instructions provided in this user manual are compatible with the requirements
of HTM 01-01.
The reprocessing instructions provided in this user manual have been validated by De Soutter
Medical as being capable of preparing a device for reuse. It remains the responsibility of the
reprocessor to ensure that the reprocessing as actually performed, using equipment, materials
and personnel in the reprocessing facility, achieves the desired result.This normally requires
validation and routine monitoring of the process.
Likewise, any deviation by the reprocessor from the instructions provided in this user manual,
should be properly evaluated for effectiveness and potential adverse consequences.

11
Overview

1) Release ring
2) Trigger
3) Mode selector

12
Configuring a Handpiece
Selecting the Mode
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
Slide the mode selector to choose the required mode.

V-MBU-470

  

  

Normal mode SAFE Screwing mode

(high-speed) (low-speed)
1: Reverse 1: Locked 1: Reverse
2: Forward 2: Locked 2: Forward
Both: Oscillating Both: Locked Both: Tapping
WARNING: tapping mode should be used with care. To minimise the risk of damage, tapping and
screwing in delicate materials should be performed with hand tools instead.

Controlling the Speed

The speed of the handpiece is controlled by progressively pressing the trigger.
Oscillating and Tapping
Oscillating and tapping modes are utilised by pressing both triggers together. The speed of the
handpiece is determined by the trigger which is pressed the least.
NOTE: release both triggers to return to using independent trigger control
CAUTION: ensure the triggers are only pressed independently when using a saw attachment

13
Using Attachments
Fitting an Attachment
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories

NOTE: all attachments are fitted in the same way

14
Removing an Attachment
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Holding both the attachment and the handpiece, rotate the release ring clockwise.
2. Remove the attachment.

NOTE: all attachments are removed in the same way

15
Fitting a Bur Guard
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Place the bur guard onto the attachment.
2. Rotate the bur guard clockwise to lock it in place.

NOTE: this procedure applies to the V-BU-472

16
Removing a Bur Guard
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Rotate the bur guard anti-clockwise to unlock.
2. Pull the bur guard away from the handpiece

NOTE: this procedure applies to the V-BU-472

17
Using a Wire or Pin Driver
CAUTION: if the wire is to be removed from the surgical site, ensure the wire is wiped clean before
inserting into the attachment
WARNING: if the wire or pin protrudes from the rear of the tool, a wire guard must be fitted
CAUTION: do not use bent wires
1. With the wire (or pin) fitted, pull the lever to grip the wire.
NOTE: if the wire driver features a manual adjuster, the bite point of the lever can be
moved by tightening or loosening the adjuster as required
2. While holding the lever, use the trigger to control the rotation of the wire.

18
Using Accessories
Fitting and Removing a Rotary Cutter
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
To secure or release the accessory, adjust the chuck according to the chuck type.
Chuck Type Adjustment Instructions
Keyed Use the chuck key
Keyless Rotate the chuck ring
Quick Release • Pull the chuck sleeve back.
• When inserting an accessory, release the chuck sleeve and ensure
the accessory is clamped in place.
NOTE: to prevent loosening of the chuck, only use keyless chucks in a clockwise
direction with a smooth and moderate feed rate

19
Fitting and Removing a Small Reciprocating Blade
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Rotate the blade clamp anti-clockwise using the wrench.
2. Insert or remove the blade.
3. Tighten the blade clamp by rotating the wrench clockwise.
NOTE: ensure the inserted blade is securely clamped in place

NOTE: this procedure applies to the V-CU-470

20
Fitting a Sagittal Blade (Knob-release)
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. With the blade clamp in the open position, insert the blade.
2. Push the blade clamp down.
3. Tighten the blade clamp.
NOTE: ensure the inserted blade is securely clamped in place

NOTE: this procedure applies to the V-NU-470

21
Removing a Sagittal Blade (Knob-release)
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Pull the blade clamp down and unscrew, anti-clockwise.
2. Lift and remove the blade.

NOTE: this procedure applies to the V-NU-470

22
Fitting and Removing a Sagittal Blade (Manual-release)
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Using the blade clamp tool, rotate the blade clamp anti-clockwise.
2. Insert or remove the blade.
3. Using the blade clamp tool, rotate the blade clamp clockwise to secure the blade.
NOTE: ensure the inserted blade is securely clamped in place

 

NOTE: this procedure applies to the V-SU-470

23
Fitting and Removing a Bur
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
CAUTION: never run the handpiece with the locking sleeve in the unlocked position.
CAUTION: when using a bur attachment, always use a bur guard
1. Rotate the locking sleeve clockwise to the unlocked position.
2. Fit or remove the bur.
NOTE: ensure that the bur does not protrude more than 25mm from the end of the bur
guard
3. Rotate the locking sleeve anti-clockwise to the locked position.
NOTE: when removing a bur, leave the locking sleeve in the unlocked position




NOTE: this procedure applies to the V-BU-472

24
Fitting a Wire or Pin (V-WU-470 & V-PU-470)
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
CAUTION: if the wire is to be removed from the surgical site, ensure the wire is wiped clean before
inserting into the attachment
WARNING: do not grip the lever while adjusting the wire position
WARNING: if the wire or pin protrudes from the rear of the tool, a wire guard must be fitted
CAUTION: do not use bent wires
CAUTION: ensure at least 8mm (5/16 inch) of the wire remains protruding from the surgical site if
the wire is to be removed
Insert the wire (or pin) into the front of the wire driver until the wire is in the required
position.
NOTE: the wire/pin driver will automatically adjust to accommodate the wire being used

25
Fitting a Wire or Pin (V-WU-471)
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
CAUTION: if the wire is to be removed from the surgical site, ensure the wire is wiped clean before
inserting into the attachment
WARNING: do not grip the lever while adjusting the wire position
WARNING: if the wire or pin protrudes from the rear of the tool, a wire guard must be fitted
CAUTION: do not use bent wires
1. Open the adjuster fully by rotating it anti-clockwise.
2. Insert the wire (or pin) into the front of the wire driver until the wire is in the required
position.
3. Tighten the adjuster according to size of the wire being used, by rotating the adjuster
clockwise.




26
Fitting a Wire or Pin Guard
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
CAUTION: do not use bent wires
1. Slide the wire guard over the end of the wire at the rear of the handpiece.
2. Push the wire guard firmly into the handpiece until it snaps into place.
3. To remove, pull the wire guard away from the handpiece.





27
Powering the Handpiece
WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece
configuration, and before fitting or removing attachments and accessories
1. Slide the battery onto the base of the handpiece until it clicks into place.
2. Press the release catch and slide the battery away from the handpiece.

NOTE: this procedure applies to all power options

28
Technical and Ordering Information
Handpiece Specifications

Model V-MBU-470
Part no. 1292444

0 - 1350 rpm
Speed
0 - 270 rpm
Cannulation Diameter 4.2 mm

Protection Type
Type BF protection
Enclosure Protection IP69
Intermittent - 2 minutes on / 8 minutes off, 4 times with a 2
Mode of Operation
hour cooling period
Environmental Conditions

Environment Operating Storage and Transport

 
Temperature (°C)
 

 
Relative humidity (%)
 
 
Atmospheric pressure (kPa)
 

Attachments
Drill Attachments

Model Description Capacity Cannulation (mm) Part No.

V-DU-470 0.5 - 4.0 mm (5/32 inch) 4.1 18780
Keyed
V-DU-470 0.5 - 7.4 mm (1/4 inch) 4.2 18770
V-DU-470 AO Synthes - 2.5 18800
V-DU-470 Hudson/Zimmer - 4.2 18790
Rotary Chuck Accessories

Description Part No.

Key for 0.5 - 4.0 mm keyed chuck 8780
Key for 0.5 - 7.4 mm keyed chuck 30062
De Soutter Medical offer a range of chuck adaptors to suit this equipment. For more details or for
ordering information, please refer to the sales brochure or contact your De Soutter Medical
representative.

29
Reamer Attachments
All reamer attachments have a speed range of 0 - 350 rpm.
Model Description Capacity Cannulation (mm) Part No.
V-RU-470 Keyed 0.5 - 7.4 mm 4.2 18820
V-RU-470 AO Synthes - 4.2 18830
V-RU-470 Hudson/Zimmer - 4.2 18840
Other Attachments

Model Description Speed Blade / Capacity Part No.

De Soutter
V-BU-472 High-speed bur 0 - 27,000 rpm 19480
Medical R-Series
Manual-release sagittal De Soutter
V-SU-470 0 - 22,000 cpm 18870
saw Medical S85
Quick-release sagittal De Soutter
V-NU-470 0 - 20,500 cpm 18880
saw Medical S88-1xx
De Soutter
V-CU-470 Small reciprocating saw 0 - 8000 cpm 18890
Medical S92
V-WU-470 Wire/Pin driver 0 - 1350 rpm 0.6 - 1.8 mm 18900
V-WU-471 Wire/Pin driver 0 - 1350 rpm 0.7 - 4.0 mm 18910
V-PU-470 Pin driver 0 - 1350 rpm 1.8 - 3.2 mm 18920
Attachment Accessories

Description Part No.

Hex tool for V-SU-470 9590
Wrench for V-CU-470 9940
Bur guard - standard 19490
Bur guard - long 19500
Bur guard - extra long 19510
Wire/pin guard 9570
Cleaning brush for wire/pin drivers 8120

30
Power Accessories
Battery Systems
Small batteries are recommended for light use applications and for when a larger battery is not
practical.
Medium batteries are recommended for applications where low weight or small size are important.
Large batteries are recommended for applications where long duration or high power are
important.
NiMH Battery System
Model Description Voltage Capacity Part No.
AB-701 Medium aseptic battery 10.8 V 1950 mAh 15340
V-AH-701 Medium aseptic housing - - 18340
AS-701 Medium aseptic shield - - 15890

Model Description Voltage Capacity Part No.

AB-702 Large aseptic battery 14.4 V 1950 mAh 15350
V-AH-702 Large aseptic housing - - 18350
AS-702 Large aseptic shield - - 15900
Lithium Battery System
Model Description Voltage Capacity Part No.
2000 mAh
AB-703 Small aseptic lithium battery 10.95 V 17910
(21.9 Wh)
Small aseptic lithium battery
V-AH-703 - - 18850
housing
Small aseptic lithium battery
AS-703 - - 18100
shield
Model Description Voltage Capacity Part No.
2000 mAh
AB-704 Large aseptic lithium battery 14.6 V 17920
(29.2 Wh)
Large sterile lithium battery
V-AH-704 - - 18860
housing
Large sterile lithium battery
AS-704 - - 18110
shield

Model Description Voltage Capacity Part No.

1100 mAh
SB-703 Small sterile lithium battery 13.2 V 17210
(14.5 Wh)
2500 mAh (33
SB-704 Large sterile lithium battery 13.2 V 17220
Wh)

31
Battery Charger
The BC-700 can be used, with various interchangeable charging adaptors, to charge a range of
De Soutter Medical batteries.
Alternatively, a dedicated single station charger is available for use with the 700 Series batteries.
Model Battery Type Bays Part No.
BC-700 All De Soutter Medical orthopaedic 4 Various
batteries
BC-705 AB-701, AB-702 1 17980
BC-706 SB-703, SB-704 1 17990
BC-707 AB-703 1 18000
BC-708 AB-704 1 18010
For more details or for ordering information, please refer to the sales brochure or contact your De
Soutter Medical representative.

Sterilisation Accessories
De Soutter Medical offer a range of sterilisation accessories to suit this equipment: including wire
baskets, sterilisation cases and a variety of insert options.
For more details or for ordering information, please refer to the sales brochure or contact your De
Soutter Medical representative.

32
Troubleshooting

Problem Cause Action

Handpiece does not Battery is discharged Charge the battery
run Battery is expended Replace the battery
Power supply fuses have tripped Replace the fuses
Handpiece runs Battery is discharged Charge the battery
slowly or judders Small battery is being used Use a larger battery
Both triggers are pressed when Ensure only one trigger is
using a saw attachment pressed
Motor runs but the Attachment is not securely fitted Refit the attachment
cutting accessory Cutting accessory is not securely Refit the cutting accessory
does not move fitted
Handpiece cuts out Handpiece temperature protection Release the trigger and allow the
during use has activated handpiece to cool
Ensure the recommended duty
cycle is being followed
Ensure the cutting accessory is
sharp
Battery overload protection has Release the trigger. The
activated protection will reset within 2
seconds
Use a larger battery
Charge the battery
Handpiece stall protection has Release the trigger. The
activated protection will reset within 2
seconds
Ensure the cutting accessory is
sharp
Handpiece becomes Handpiece is being loaded too Ensure the recommended duty
unusually hot during heavily cycle is being followed
use Ensure the cutting accessory is
sharp
Battery becomes Handpiece is being loaded too Use a larger battery
unusually hot during heavily Ensure the recommended duty
use cycle is being followed
Ensure the cutting accessory is
sharp
Attachment will not fit Debris on the handpiece or the Clean the handpiece or the
into the handpiece attachment attachment
Cutting accessory will Debris on the handpiece or the Clean the handpiece or the
not fit into the attachment attachment
attachment or
handpiece

33
Further Help
If the problem cannot be resolved, or for any other queries, contact your De Soutter Medical
representative.

Service and Repair Information

All equipment should be periodically checked and cleaned. To minimise the risks associated with
loss of performance, annual servicing is recommended for normal use. Due to the specialist
techniques used in the manufacture and maintenance of De Soutter Medical equipment, user
servicing is not possible.
Returning Equipment for Repair

For service and repair please contact your nearest De Soutter Medical authorised service centre.
WARNING: lithium batteries are subject to transportation restrictions
WARNING: faulty or suspect lithium batteries must not be returned by air transport. They should be
recycled or disposed of in accordance with local regulations.
1. Reprocess the equipment in accordance with this user manual.
2. Record the serial number of the equipment being returned and a brief statement
describing the reason for returning the equipment.
3. Enclose the purchase order number for the equipment if warranty is being claimed. It
would be helpful to include a contact name.
4. Pack the equipment securely.
NOTE: all equipment returned for repair must be accompanied by a declaration of contamination
status

Guarantee and Liability

De Soutter Medical guarantees all equipment to be free from defects in material and workmanship
for one year from the date of purchase. The following exceptions apply:
• Sterile packed consumables are guaranteed for single-use only.
• New batteries are guaranteed for a period of six months from the invoice date.
• Non-sterile consumables are guaranteed for their normal expected working life.
De Soutter Medical is not liable by warranty or otherwise in the case of any of the following:
• abuse, misuse or use in a non-surgical environment
• disassembly, alteration or unauthorised repair
• use of the product in an unreasonable manner or, a manner which is not in full compliance
with these written instructions or with the equipment’s intended use.
In the unlikely event that a serious, adverse event occurs in relation to using this equipment,
details of the event should be reported to De Soutter Medical. The competent authority of the EU
Member State should also be notified, as appropriate.

34
EMC Information
General Information
The equipment described in this user manual is intended for use in hospitals, except near areas where the potential for EM
disturbances is high (such as, near HF Surgical equipment or near the shielded room of an MRI system).
CAUTION: the use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
CAUTION: the use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and
result in improper operation
CAUTION: portable RF communications equipment (including peripherals such as antenna cables and external antennas) should
not be used closer than 30 cm (12 inches) to any part of this equipment, including cables specified by the manufacturer. Otherwise,
the performance of this equipment could degrade.
WARNING: the emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class
A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.

EM Compliance (emissions)
This equipment complies with the tests and levels described.
Test Standard Compliance Level
RF Emissions CISPR 11 Group 1, Class A
Harmonic Emissions IEC 61000-3-2 Class A
Voltage fluctuations & flicker emissions IEC 61000-3-3 Complies

EM Compliance (immunity)
This equipment complies with the tests and levels described.
Test Test Standard Compliance Level
Conducted RF Immunity IEC 61000-4-6 3 Vrms, from 150 kHz to 80 MHz
6 Vrms, in ISM bands between 150 kHz and
80 MHz
Radiated RF Immunity IEC 61000-4-3 3 V/m, from 80 MHz to 2.7 GHz
Electrostatic Discharge (ESD) IEC 61000-4-2 ± 8 kV contact
± 15 kV air
Electrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines
± 1 kV for input/output lines
Surge IEC 61000-4-5 ± 2 kV line(s) to earth
± 1 kV line(s) to line(s)

Voltage dipsa IEC 61000-4-11 0 % UT for 0.5 cycle

0 % UT for 1 cycle

70% UT for 25/30 cycle

Interruptions IEC 61000-4-11 0 % UT for 250/300 cycle

Rated power frequency magnetic fields IEC 61000-4-8 30 A/m, 50 or 60 Hz

Proximity fields from RF wireless communications IEC 60601-1-2 Complies with the requirements of IEC
equipment 60601-1-2

a. UT is the a.c. mains level prior to application of the test voltage

35
 United Kingdom
De Soutter Medical Limited
Halton Brook Business Park
Weston Road
Aston Clinton
Aylesbury
Bucks, HP22 5WF
+44 (0) 1296 634 000
+44 (0) 1296 634 033
info@de-soutter.com
http://www.de-soutter.com

Australia France
De Soutter Medical Australia Pty Ltd De Soutter Medical France
2/12-14 Apollo Drive 1252 Avenue Parc des Expositions
Hallam 33260 La Teste de Buch
Victoria 3803 +33 (0) 5 56 54 89 36
+61 (0) 3 9702 4441 +33 (0) 9 70 61 37 60
+61 (0) 3 9702 4484 france@de-soutter.com
australia@de-soutter.com
Italia
België \ Belgique De Soutter Medical Italy
De Soutter Medical Belgium Località Fornace SNC
Bessemerstraat 14 27022 Casorate Primo - PV
3620 Lanaken +39 (0) 2 9009 4098
+32 (0) 89/47 15 37 +39 (0) 2 9009 2673
+32 (0) 89/70 12 19 italy@de-soutter.com
belgium@de-soutter.com
United States of America
Deutschland De Soutter Medical USA Inc
De Soutter Medical Germany 224 Rolling Hill Road, Suite 12A
Bahnhofstraße 4 Mooresville, NC 28117
66625 Nohfelden +1 (704) 655 9040
+49 (0) 68 52-99 12 46 +1 (704) 987 2035
+49 (0) 68 52-99 12 47 usa@de-soutter.com
deutschland@de-soutter.com

Österreich (& 5(3 Nederland

De Soutter Medical Austria De Soutter Medical Netherlands
Zweigniederlassung Österreich Gelderlandhaven 2X
Dietrichsteingasse 10 3433 PG Nieuwegein
A-3400 Klosterneuburg +31 (0) 85 0491480
+43 (0) 676 96 71 770 +31 (0) 85 0491489
+43 (0) 2243 21 656 nederland@de-soutter.com
austria@de-soutter.com


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