deSoutter Medical AB-70 Series User manual

User Manual
International
English
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BC-700
AB-70x
SB-70x

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Contents
1 Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use - Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Intended Use - Battery Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
General Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
User Interface Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3 Reprocessing - Sterilisable Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Limitations on reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Point of Use (after reprocessing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4 Reprocessing - Non-sterilisable Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Limitations on reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Touch-screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6 Configuring the Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Fitting and Removing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Fitting and Removing Charger Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Viewing Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Adjusting the Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Adjusting the Display Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Setting the Display Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
7 Using the Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Charging Sterile Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Charging the AB-701 or AB-702 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Charging the AB-600 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Charging the AB-450 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Healthcheck Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Selecting a Healthcheck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
8 Using Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Using Aseptic Housings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Lithium Battery Capacity Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Battery Shelf-life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
9 Technical and Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Battery Charger Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Battery Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Sterilisation Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Further Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Service and Repair Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Guarantee and Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
11 EMC Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

1
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: 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: ensure theasepticbatteryloadinginstructionsare followedclosely.Failuretodosowill
increase the likelihood of cross-contamination.
WARNING: this equipment must be only be connected to a supply with a protective earth
WARNING: ensure the voltage rating of the electrical supply corresponds with the voltage rating
stated on the equipment label
WARNING: ensure that correctly rated fuses are fitted before use
WARNING: this equipment is not intended for use in the vicinity of the patient
WARNING: this equipment is not intended for use in an oxygen rich environment or in the presence
of flammable gases
WARNING: do not expose this equipment to rain or use near water
WARNING: do not attempt to dismantle or modify this equipment, except as directed in this user
manual
CAUTION: ensure this equipment is regularly serviced. Refer to the service and repair information
section of this user manual.
CAUTION: only clean and sterilise 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: ensure the fan vent is not obstructed
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

2
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.
NOTE: if electro-magnetic interference occurs, causing undesirable operation, increase the
distance between the interfering devices and if possible, connect the items of equipment to
separate power outlets
NOTE: this equipment must be disposed of in accordance with local regulations. For more
information, refer to the disposal section of this user manual.
Intended Use - Battery Charger
The battery charger described in this user manual is intended for charging De Soutter Medical
batteries, outside the patient environment.
Intended Use - Battery Systems
The battery systems described in this user manual are intended for use in surgical procedures to
provide power to De Soutter Medical power instruments.
Disposal
WARNING: do not dispose of batteries by throwing them into a fire or immersing them in water
WARNING: SB-703 and SB-704 batteries contain lithium-ion cells and are subject to transportation
restrictions
NOTE: the BC-700 battery charger contains a primary lithium battery
All equipment should be recycled or disposed of, in accordance with local regulations.

3
Symbols
General Symbols
Symbol Meaning Symbol Meaning
Refer to the user manual Only for use by a physician
Refer to the user manual Do not immerse
Dispose of in accordance
with local regulations Suitable for recycling
Vacuum steam sterilise Refer to the accompanying
warning
Single-use only Fuse
Direct current Alternating current
Input Output
Off On
SN 12/00500 The first two digits indicate
the year of manufacture
a

4
User Interface Symbols
Symbol Meaning Symbol Meaning
Settings Product Information
Set Contrast Set Brightness
Set Language Set Healthcheck
Decrease Increase
Down Up
Factory Settings Back
Empty Charging (animated)
Healthcheck (animated) Battery good
Light use only Charging error or replace
battery
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5
Reprocessing - Sterilisable Equipment
These reprocessing instructions are suitable for the sterilisable equipment described in this user
manual.
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.
CAUTION: following a wet cleaning process, ensure that this equipment is dried immediately
CAUTION: correctinternaldryingofsterilisableequipmentcanonlybe achievedbyusinga 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 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
Detergents and Rinse Aids
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 and PPSU
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)
Remove excess soil with a disposable cloth or other suitable wipe.
Containment and Transportation
It is important that this equipment is reprocessed immediately after use. In order to minimise
contamination risks, the handling, collection and transportation of soiled equipment should be
strictly controlled.

6
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.
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).
NOTE: avoid fluid ingress
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.
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.

7
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 a wire basket.
i) Set chucks and blade clamps to a middle position.
ii) Ensure that sterile batteries are inverted (that is, contacts facing down).
iii) Ensure that aseptic battery housings are empty and open, with the open side facing
down.
iv)Fit washing spacers and end caps as required.
v) Ensure that all items are separated.
NOTE: the placement of items in automatic washer-disinfector baskets can be a critical
factorin achievingeffective cleaning. Thebaskettype andthepositionof the itemswithin
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:
Cycle Stage
Minimum Recirculation
Time (min:secs) Temperature Detergent
Pre-wash 5:00 < 35°C -
Enzyme wash 5:00 55 - 65°C Endozime AW Triple
Plus a
a. other brands of detergent may be used provided the suitability of the detergent is verified before use.
Rinse 1 2:00 55 - 65°C -
Rinse 2 2:00 55 - 65°C -
Thermal rinse 1:00 90°C -
Pure water rinse 0:10 66°C -
Drying (not suitable
for batteries) 20:00 110°C maximum -

8
3. Remove the disinfected equipment from the washer-disinfector and place the equipment
in a clean area.
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.
Where the use of an automatic washer-disinfector is not possible, the equipment should be wiped
with a suitable disinfectant.
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 troubleshootingsection of this
user manual
2. Inspect reusable cutting accessories (such as, drill bits and reamer shells) for damage
and wear.
NOTE: dispose of worn or damaged 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

9
Sterilisation of Handpieces and Accessories
Steam Sterilisation
CAUTION: these sterilisation instructions are not suitable for sterilisable batteries
CAUTION: ensure that aseptic battery housings are open, with the open side facing down
Sterilisation of Sterilisable Batteries
Steam 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.
Cycle Wrapping a
a. for reasons of non-repeatability during transport and storage, processes involving unwrapped equipment
cannot be validated beyond the sterilisation procedure.
Exposure Time and
Temperature
(-0°C / +3°C) Drying Time b
b. the drying times specified are for a full, wrapped sterilisation case containing 3 handpieces. If different
quantities are used, the necessary drying time may vary.
vacuum assisted optional 3-4 minutes at 134°C 30 minutes at
maximum 110ºC
vacuum assisted
(flash) unwrapped 3-4 minutes at 134°C none
gravity
wrapped 15 minutes at 134°C 30 minutes at
maximum 110ºC
wrapped 50 minutes at 121°C 20 minutes at
maximum 110ºC
Model Cycle Wrapping a
a. For reasons of non-repeatability during transport and storage, processes involving unwrapped
equipment cannot be validated beyond the sterilisation procedure.
Exposure Time and
Temperature
(-0°C / +3°C)
Drying Time
(maximum 110ºC)
SB-450
vacuum
assisted optional 3-4 minutes maximum at 134°C
3 minutes
maximum
SB-600
SB-701
SB-702
SB-703 12 minutes
maximum
SB-704
AB-450
not suitable for sterilisation
AB-600
AB-701
AB-702

10
STERRAD® Sterilisation
Sterrad NX Advanced cycle, wrapped.
STERIS Sterilisation
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.
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 CFPP 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.
Sterilisation System Cycle
V-PRO® 1 standard
V-PRO® 1 Plus lumen
V-PRO® maX lumen

11
Reprocessing - Non-sterilisable Equipment
These reprocessing instructions are suitable for the non-sterilisable equipment described in this
user manual.
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: ensure the equipment is disconnected from all power sources before cleaning
WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment
CAUTION: do not immerse any part of this equipment in fluids
CAUTION: do not clean this equipment in an automatic washer-disinfector
CAUTION: do not clean any part of this equipment in an ultrasonic cleaner
Manual Cleaning
NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require
particular attention during reprocessing
1. Remove any attachments and accessories.
2. Using a soft brush, clean the fan grill and air vents to remove any dust or debris.
3. Wipe the surfaces of the equipment with a clean, soft cloth, dampened with a mild pH
balanced detergent or alcohol.
NOTE: avoid fluid ingress
4. Wipe the surfaces of the equipment with a clean, soft cloth, dampened with distilled or
sterilised water.
5. Dry the equipment with a clean, soft, dry cloth.

12
Overview
Front
1) Bay 1
2) Bay 2
3) Bay 3
4) Bay 4
5) Charger module
6) Touch-screen
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VHOHFWDED\

13
Rear
1) Mains inlet
2) Fuse drawer
3) Power switch (mains isolation)
4) Fan grill
5) Hex tool
6) Ratings label
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14
Touch-screen
1) Bay status indicator
2) Bay number
3) Status bar
4) Button
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15
Configuring the Battery Charger
Fitting and Removing Fuses
WARNING: ensure the equipment is switched off, the mains supply is disconnected and any
batteries are removed
1. Open the fuse drawer, located underneath the mains inlet.
2. Insert or remove the fuses.
NOTE: ensure the fuses are correctly rated for the mains supply in use
3. Close the fuse drawer fully.
Supply Voltage Fuse Rating
100 - 230V T6.3 A
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16
Fitting and Removing Charger Modules
WARNING: ensure the equipment is switched off, the mains supply is disconnected and any
batteries are removed
1. Unscrew the charger module retaining screw using the hex tool.
2. Lift and slide the charger module away from the battery charger.
3. Insert the new charger module, aligning the slot at the rear of bay with the flange on the
module.
4. Screw-in the charger module retaining screw using the hex tool.
NOTE: ensure the hex tool is returned to the storage slot after use
NOTE: ensure the charger module is securely attached
NOTE: this procedure applies to all charger modules
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