CM2 and GD-113 dermadrive User Manual Ver 11.3

Contents 1

Important Information... 1

2

Safety Instructions... 1 Intended Use... 2 Disposal... 2 Symbols... 3

3

Reprocessing - Sterilisable Equipment... 4

4

Limitations on reprocessing... 4 Safety Instructions... 4 Point of Use (before reprocessing)... 5 Containment and Transportation... 5 Cleaning and Disinfection... 5 Maintenance... 8 Inspection and Function Testing... 8 Packaging... 8 Sterilisation of Handpieces and Accessories... 9 Storage... 9 Point of Use (after reprocessing)... 10 Additional Information... 10 Reprocessing - Non-sterilisable Equipment... 11

5

Limitations on reprocessing... 11 Safety Instructions... 11 Manual Cleaning... 11 Overview... 12

6

Front... 12 Rear... 13 Dermatome... 14 Configuring the Control Box... 15

7

Fitting and Removing the Micro-motor... 15 Fitting and Removing the Pedal... 16 Setting the Maximum Speed... 17 Controlling the Speed... 17 Configuring the Dermatome Head... 18

8

Fitting and Removing the Handle... 18 Fitting a Blade and Sole Plate... 19 Removing a Blade and Sole Plate... 21 Using the Dermatome... 22

9

Fitting and Removing the Dermatome... 22 Adjusting the Graft Thickness... 23 Fitting and Removing a Drive Bush... 24 Technical and Ordering Information... 25

10

Control Box Specifications... 25 Accessories... 25 Sterilisation Accessories... 26 Troubleshooting... 27

11

Further Help... 27 Service and Repair Information... 28 Guarantee and Liability... 28 EMC Guidance... 29

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 General 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: this equipment is not intended for use in an oxygen rich environment or in the presence

of flammable gases 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: 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: only use Stericut or De Soutter Medical approved accessories WARNING: always allow the handpiece to stop before removing from the surgical site

Control Box, Micro-motor & Foot pedal WARNING: this equipment must be only be connected to a supply with a protective earth 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 CAUTION: do not wash the control box, the foot pedal or the micro-motor. Refer to separate

cleaning instructions. CAUTION: do not sterilise the control box or the foot pedal. Refer to separate cleaning instructions. CAUTION: do not immerse any part of this equipment in fluids

Dermatome Head CAUTION: do not immerse any part of this equipment in fluids except as required by an automatic

washer-disinfector cycle 1

Intended Use The equipment described in this user manual is intended for use in surgical procedures to harvest thin slices of skin for grafting.

Disposal All equipment should be recycled or disposed of, in accordance with local regulations.

2

Symbols Symbol

SN 12/00500

Meaning

Symbol

Meaning

Refer to the user manual

Only for use by a physician

Single-use only

Do not immerse

Dispose of in accordance with local regulations

Vacuum steam sterilise

The first two digits indicate the year of manufacture

Type B protection

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Reprocessing - Sterilisable Equipment These reprocessing instructions are suitable for the sterilisable equipment described in this user manual. • GD-1xx - Dermatome Head • Micro-motor (refer to separate cleaning and sterilisation instructions)

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 General 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: 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 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. Control Box, Micro-motor & Foot pedal CAUTION: do not wash the control box, the foot pedal or the micro-motor. Refer to separate

cleaning instructions. CAUTION: do not sterilise the control box or the foot pedal. Refer to separate cleaning instructions. CAUTION: the micro-motor must be inspected and cleaned separately, prior to any further

reprocessing CAUTION: do not autoclave the micro-motor without a sterilisation bag

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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.

Cleaning and Disinfection Cleaning the Micro-motor CAUTION: do not immerse any part of this equipment in fluids CAUTION: the micro-motor must be inspected and cleaned separately, prior to any further

reprocessing 1. Unscrew the front housing of the micro-motor. 2. Clean the micro-motor and the housing, ensuring any fluid and contaminant deposits are removed in accordance with local reprocessing guidelines. NOTE: use a clean cloth dampened with a suitable disinfectant solution 3. Ensure the micro-motor and the front housing are completely dry. 4. Re-assemble the micro-motor. 5. Fit the sterilisation stopper. 6. Wipe the outside case and power cable. NOTE: use a clean cloth dampened with a suitable disinfectant solution

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Manual Cleaning CAUTION: do not wash the control box, the foot pedal or the micro-motor. Refer to separate cleaning instructions.

• 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.

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Automatic Cleaning CAUTION: do not wash the control box, the foot pedal or the micro-motor. Refer to separate cleaning instructions.

• Large contaminant deposits should be removed 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. NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require particular attention during reprocessing 1. Place the dermatome head into a wire basket. i) Remove the sole plate. ii) Set the blade adjuster to a middle position. 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 manufacturer’s 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°C

Endozime AW Triple Plusa

Rinse 1

2:00

> 55°C

-

Rinse 2

2:00

> 55°C

-

Thermal rinse

1:00

90°C

-

Pure water rinse

0:10

66°C

-

Drying

20:00

110°C maximum

-

a. other brands of detergent may be used provided the suitability of the detergent is verified before use.

3. Remove the disinfected equipment from the washer-disinfector to a clean area. 4. Visually inspect each item. Verify that all contaminants have been removed in accordance with local reprocessing guidelines.

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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 CAUTION: do not lubricate the micro-motor

No lubrication is necessary during reprocessing.

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 (such as, drill bits and reamer shells) for damage and wear. NOTE: dispose of worn or damaged cutting accessories appropriately

Packaging CAUTION: ensure the micro-motor is completely dry before sealing inside a sterilisation bag. Failure to do so may damage the micro-motor. CAUTION: ensure the sterilisation plug is fitted to the micro-motor

1. Place the clean, dry, micro-motor and the attached cable inside a porous sterilisation bag. NOTE: the sterilisation bag should conform to DIN 58953 2. Seal the sterilisation bag according to the bag manufacturer’s instructions. 3. Place the sterilisation bag, the dermatome head, and any other sterilisable accessories into the sterilisation tray. NOTE: if wrapping is required, use material suitable for the chosen sterilisation method

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Sterilisation of Handpieces and Accessories Steam Sterilisation CAUTION: do not autoclave the micro-motor without a sterilisation bag CAUTION: do not autoclave the sterilisation bag if it has liquid inside. Doing so may permanently

damage the micro-motor. Exposure Time and Temperature (-0°C / +3°C)

Drying Time b

optional

3-4 minutes at 134°C

30 minutes at maximum 110ºC

unwrapped

3-4 minutes at 134°C

none

wrapped

15 minutes at 134°C

30 minutes at maximum 110ºC

wrapped

50 minutes at 121°C

20 minutes at maximum 110ºC

Cycle

Wrapping

vacuum assisted vacuum assisted (flash)

a

gravity

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 are for a full, wrapped sterilisation case containing 3 handpieces. If different quantities are used, the necessary drying time may vary. CAUTION: allow the micro-motor to dry, at room temperature for at least one hour after sterilisation CAUTION: it is normal for water to condense inside the sterilisation bag after sterilisation. If this

occurs, do not remove the micro-motor from the sterilisation bag for 6 hours to allow the water to drain. STERIS Sterilisation WARNING: STERIS sterilisation is not suitable for the micro-motor

Sterilisation System

Cycle

V-PRO® 1

standard

V-PRO® 1 Plus

lumen

V-PRO® maX

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.

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

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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 CAUTION: allow the micro-motor to cool at room temperature for at least one hour after

autoclaving. Do not use forced air cooling. 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. 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.

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Reprocessing - Non-sterilisable Equipment These reprocessing instructions are suitable for the non-sterilisable equipment described in this user manual. • CM2 - Control Box • Foot pedal

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.

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Overview Front









1)

Speed display

2)

Direction button

3)

Speed adjust buttons

4)

Micro-motor start/stop button

12

Rear







1)

Micro-motor socket

2)

Pedal socket

3)

Power switch

4)

Mains cord



13

Dermatome



 



1)

Handle

2)

Sole plate

3)

Blade

4)

Adjuster clamp screw

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Configuring the Control Box Fitting and Removing the Micro-motor WARNING: ensure the equipment is switched off and the mains supply is disconnected

1. Align the pins in the plug with the pins in the socket. NOTE: the plug will only fit in one orientation 2. Insert the plug. 3. Rotate the plug sleeve clockwise to secure in place. 4. To remove the plug, rotate the plug sleeve anti-clockwise and remove the plug.



 

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Fitting and Removing the Pedal WARNING: ensure the equipment is switched off and the mains supply is disconnected

1. Align the pins in the plug with the pins in the socket. NOTE: the plug will only fit in one orientation 2. Insert the plug. 3. Rotate the plug sleeve clockwise to secure in place. 4. To remove the plug, rotate the plug sleeve anti-clockwise and remove the plug.





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Setting the Maximum Speed 1. To increase the maximum speed, press 2. To decrease the maximum speed, press

. .

NOTE: the maximum speed is displayed on the front of the control box in revolutions per minute

Controlling the Speed The speed of the micro-motor is controlled by progressively pressing the foot pedal. Alternatively, pressing MOTOR will start and stop the micro-motor. NOTE: if the foot pedal is not fitted, the micro-motor will only run at maximum speed Pressing REVERSE will run the micro-motor in the opposite direction. NOTE: the direction has no effect on the oscillating dermatome blade NOTE: when running in reverse, an audible alarm will be emitted by the control box

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