ACCULAN- Dermatom GA643 Instructions for Use Aug 2002

ACCULAN dermatome GA 643

Legend

Contents

1 ACCULAN dermatome 2 Rotational speed control button 3 Safety catch 4 Cover release button 5 Cover 6 Sterile funnel 7 Rechargeable battery 8 Dermatome blade 9 Clamp lever 10 Blade cover 11 Sliding surface 12 Sliding surface 13 Flaps 14 Pusher dog 15 Blade guide peg 16 Surface 17 Scale ring 18 Setting lever 19 Lock of the setting lever 20 Roll pin 21 Guide slots 22 Flap rod 23 Flap noses 24 Nut

1. 2. 2.1 2.2 2.3 2.4 3. 4. 4.1 4.2 4.3 4.4 5. 5.1 5.2 5.3 5.4 6. 7. 8. 9. 10. 11.

Symbols on the product

Ø Prior to use, check for proper condition and functioning of the product. Ø In order to avoid damaging the device through improper assembly/operation and mitigating the manufacturer’s liability: – Use the product only according to these instructions for use. – Follow the safety instructions and maintenance advisories. – Only combine AESCULAP products with each other. Ø Products and accessories may be operated and used only by qualified or trained and experienced personnel. Ø Keep the instructions for use accessible to all operating room staff. Ø Observe the instructions for use of the ACCULAN battery charger and of the rechargeable battery. Ø Adhere to applicable norms.

Attention, see instructions for use

Type B application component

Recyclable product

Rotational speed control

Safe handling... 9 Product description... 10 System components... 10 Necessary components for the use... 10 Intended use... 10 Mode of operation... 10 Preparation... 10 Working with the device... 10 System set-up... 10 Attaching the accessories... 11 Function check... 11 Operation... 12 Care and handling... 12 Disposable products... 12 Cleaning and disinfecting... 12 Care and checking for damage... 13 Sterilization method and parameters... 13 Maintenance... 13 Recognizing and remedying errors... 14 Technical Service... 15 Accessories and spare parts... 15 Technical specifications... 15 Disposal... 15

1. Safe handling

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ACCULAN dermatome GA 643 2. Product description

4. Working with the device

2.1 System components

4.1 System set-up

Designation

Art. no.

ACCULAN dermatome

GA 643

Cover

GA 624

Sterile funnel

GA 625

Rechargeable battery

GA 646

Storage tray

GB 509 R

WARNING

Risk of infection and contamination! The device is delivered in an unsterile condition. Ø Do not sterilize the rechargeable battery. Ø Sterilize the device before use.

Inserting the rechargeable battery

2.2 Necessary components for the use

7 Designation

Art. no.

ACCULAN dermatome

GA 643

Cover

GA 624

Sterile funnel

GA 625

Dermatome blades

GB 228 R

ACCULAN battery charger

GA 627 M

Rechargeable battery

GA 646

Changing funnel

GA 644

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2.3 Intended use The ACCULAN dermatome is used in dermatology/traumatology for obtaining skin grafts.

2.4 Mode of operation In the ACCULAN dermatome, the rotational speed of the motor is converted, through an eccentric-tappet drive, directly and with minimum loss into back-and-forth movement of the dermatome blade.

3. Preparation Non-compliance with these rules will result in complete exclusion of AESCULAP liability. Ø Prior to use, inspect the ACCULAN dermatome and its accessories for visible damage. Ø Use ACCULAN dermatomes and accessories only if they are in perfect condition.

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Fig. 1 Ø Hold the ACCULAN dermatome 1 in a way that the battery compartment is at the top. Ø Set the sterile funnel 6 in place. Ø Have the unsterile rechargeable battery 7 inserted by another person, through the sterile funnel 6 into the battery compartment (note the coding). Ø Remove the sterile funnel 6 and put it down in an unsterile room. Ø Insert the sterile cover 5, making certain that it clicks into place.

ACCULAN dermatome GA 643

Removing the rechargeable battery

Securing the ACCULAN dermatome

Ø If the rechargeable battery needs to be changed during operation, carry out the battery change in sterile conditions only, using the changing funnel GA 644 for the removal and re-insertion of batteries, see instructions for use GA 644. Ø The rechargeable battery 7 always has to be taken out after operation and before processing. Ø Push down both release buttons 4 on the cover 5 simultaneously. Ø Remove the cover 5. Ø Prior to battery removal, make sure that the rotational speed control button 2 is in the front position (rest position). The ACCULAN dermatome will be damaged through knocking it against hard surfaces! Ø Only tap the ACCULAN dermatome on the palm CAUTION of your hand.

In order to avoid that the ACCULAN dermatome is unintentionally turned on during a change of blades, the rotational speed control button 2 can be secured with a safety catch. During normal operation, the safety catch remains in the ON position. Ø Rotate the safety catch 3 to the OFF position. The button is locked and the ACCULAN dermatome cannot be turned on. Ø To deactivate the safety catch 3 turn it back to the ON position.

Ø Tap the ACCULAN dermatome 1 on the palm of your hand until the rechargeable battery 7 comes loose, and remove the battery.

Fig. 2

Inserting a dermatome blade Disassembling the flap rod of the ACCULAN dermatome For disinfecting and cleaning, the head of the ACCULAN dermatome has to be disassembled. Ø Disassemble the flap rod 22 and the flaps 13: – Loosen the nut 24 by turning it clockwise (left-handed thread). – Turn the nut 24 back to the end of the visible surface. – Push the flap rod 22 sideways by approx. 4 mm and twist it until it can be removed. – Remove the flap rod 22. Ø Slide off the flaps 13 from the flap rod 22.

Assembling the flap rod of the ACCULAN dermatome Ø Before assembling the flaps 13, lightly spray all components with Sterilit M. Ø Position the flaps 13 on the flap rod 22 against the edge of the rear surface, taking note of the symbol on the face of the thread. Ø Screw the nut 24 counterclockwise onto the thread of the flap rod 22 (left-handed thread). Ø Turn the nut 24 up to the edge of the visible surface. Ø Insert and twist the complete flap rod 22 in its guide slots 21 on the side surfaces. Ø Push the flap rod 22 sideways as far as it goes, so that the cross pin of the flap rod comes to lie in the guide slot 21. Ø Tighten the nut 24 counterclockwise.

4.2 Attaching the accessories

WARNING

WARNING

Ø Push both clamp levers 9 in the direction of the arrows. The blade cover 10 is now unlocked. Ø Open the blade cover 10 in the direction of the arrows. Ø Insert the dermatome blade 8 in the pusher dog 14 and the blade guide peg 15. Ø Close the blade cover 10. Ø Tighten both clamp levers 9 until the roll pin 20 snaps into the notch of the clamp lever 9.

Removing the dermatome blade Ø Release both clamp levers 9. Ø Open the blade cover 10. Ø Remove the dermatome blade 8 from the pusher dog 14 and the blade guide peg 15.

4.3 Function check Always perform a test run before using the ACCULAN dermatome: Ø Make certain that a rechargeable battery has been installed. Ø Use only devices that are in perfect condition. Ø Operate the ACCULAN dermatome for a short while, at a blade stroke number of approx. 6 300–6 800 strokes/min. Ø Note the instructions in chapter ”Care and checking for damage”. Note Each intraoperative battery change has to be followed by a function check!

Risk of infection or contamination if surgical gloves are damaged! Ø Avoid contact with the cutting edge when inserting the dermatome blade. Risk of injury and material damage through unintentionally putting the ACCULAN dermatome into operation while inserting the blade! Ø Before inserting the blade, activate the safety catch.

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ACCULAN dermatome GA 643 4.4 Operation

5. Care and handling

Adjusting the cutting thickness Note Consider the skin condition (e.g. with regard to the age of the patient)! Ø Note the instructions in chapter ”Recognizing and remedying errors”. Ø Adjust the cutting thickness with the setting lever 18. The lock 19 of the setting lever prevents any unintentional change to the setting of the cutting thickness. Ø Read the cutting thickness on the scale ring 17 (scale gradations 1/10 mm).

5.1 Disposable products

CAUTION

Possible damage or destruction of disposable products through reprocessing! These products are intended for single use only! Ø Do not prepare these products for reuse.

Designation

Art. no.

Dermatom blades

GB 228 R

Adjusting the cutting width

CAUTION

Risk of injury through improper opening of the flaps. Risk of cuts by the dermatome blade. Ø Always use the flap noses for turning up the flaps.

Ø Turn up the number of flaps 13 according to the desired cutting width, until they click into place (1 flap width = 8 mm). Note The width of the skin graft cut out will be 2 mm less than the cutting width set by means of the flaps.

Using the ACCULAN dermatome Note The low beep sound just before the ACCULAN dermatome starts up is a regular design feature of the device. Ø Press the rotational speed control button 2 for the continuous adjustment of the rotational speed.

Taking skin grafts Before using the ACCULAN dermatome for the first time, the user should carry out some test cuts on a specimen in order to make himself familiar with the device. Ø Stretch flabby skin. Ø With the cutting surface lying upon the skin being cut, push the ACCULAN dermatome 1 forward in an even movement, applying gentle pressure and making certain that the ACCULAN dermatome 1 does not cant. Ø If the graft is extremely thin, use tweezers to lay the detached graft up on the surface 16 from time to time. Ø Turn off the motor and pull the freshly cut graft out of the device. - or Lower the handle and cut off the graft with the dermatome.

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5.2 Cleaning and disinfecting

CAUTION

Damage to the ACCULAN dermatome by penetrating fluids! Ø Do not submerge the device in any fluid. Ø Do not use pressurized air on the device. Ø Allow any fluid that has penetrated the device to drain out immediately.

Ø Open the clamp lever 9 and remove the dermatome blade 8. Ø Take out the flap rod 22 of the ACCULAN dermatome, see Disassembling the flap rod of the ACCULAN dermatome.

Manual cleaning and disinfecting Ø Wipe off the device with a clean, lint-free cloth that has been soaked in cleaning and disinfectant solution. - or In order to avoid formation of sticky or encrusted residues, spray the components with a disinfectant spray. Ø Wipe off the component surfaces with a clean, lint-free cloth. Ø Follow the disinfectant manufacturer's instructions.

ACCULAN dermatome GA 643

Mechanical cleaning and disinfecting

CAUTION

Improper mechanical cleaning will damage the ACCULAN dermatome! Ø Clean the ACCULAN dermatome in a suitable storage tray only. Ø Use a suitable cleaning and disinfecting cycle for mechanical cleaning. Ø Do not use alkaline cleaning agents.

Ø Perform mechanical cleaning immediately after the operation. Ø Place storage tray GB 509 R in a suitable wire basket (e.g. JF 214 R). Ø Position the ACCULAN dermatome properly in storage tray GB 509 R immediately after the operation. Ø To avoid abrupt changes in temperature, use a single-chamber washer disinfector. Ø Select a cleaning and disinfecting cycle according to the following criteria: – Neutral cleaner – Cleaning temperature ≤ 50 °C – Final rinse with simultaneous thermal disinfection in demineralized water. Example: Miele Vario TD process. Ø Follow the instructions for use of the AESCULAP ECCOS storage system TA 009 721.

5.4 Sterilization method and parameters The ACCULAN dermatome can be sterilized in the storage tray.

CAUTION

Damage to the rechargeable battery and its integrated electronic components due to sterilization! Ø Remove the rechargeable battery from the device prior to sterilization. Ø Do not heat the rechargeable battery to a temperature higher than 65 °C. Ø Do not sterilize the rechargeable battery.

Ø Sterilize the ACCULAN dermatome immediately after cleaning it. Ø Remove the rechargeable battery 7 from the device, see Removing the rechargeable battery. Ø Prior to sterilization, lightly spray the sliding surfaces 11 and 12 with Sterilit M. Ø Rest the ACCULAN dermatome 1, the cover 5 of the battery compartment and the sterile funnel 6 in a suitable wire basket (e.g. JF 214 R). Ø Sterilize using steam sterilization, taking note of the following: The sterilization must be carried out following a validated steam sterilization procedure (e.g. in a sterilizer according to EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993 and validated according to EN 554/ISO 13683). In case of application of the fractionated vacuum procedure the sterilization has to be done using the 134 °C/2 bar program with a minimal holding time of 5 minutes.

5.3 Care and checking for damage Ø Each time the device is processed and a function check is carried out, check for: – damage, atypical sounds when the device is operated, or excessive vibration or heating-up – damage to the battery compartment seal – damaged or missing silicone seal on the cover Ø If any irregularities are found, do not make further use of the device. Ø Prior to an extended period of non-use, always store the device cleaned and dried according to the instructions.

6. Maintenance To ensure reliable operation, the manufacturer recommends that maintenance be performed after 300 reprocessing cycles, at least once per year. Ø For service, maintenance and repairs, please contact the AESCULAP/B. Braun representative in your country, see Technical Service.

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ACCULAN dermatome GA 643 7. Recognizing and remedying errors

Error

Cause

Finding

Remedy

The motor does not run

Corrosion on motor connectors after infrequent and brief usage

No beep sound when the rotational speed control button is pressed

Have device repaired by the manufacturer

Rechargeable battery defective Motor bearing defective

Test battery charger and replace rechargeable battery if necessary

Beep sounds when rotational speed control button pressed

Have device repaired by the manufacturer

Rechargeable battery nearly or completely discharged

Faint running noise

Charge battery

Rechargeable battery defective

Faint or no running noise

Replace the rechargeable battery

Friction between sliding surface and blade

Faint running noise

Spray the sliding surfaces lightly with Sterilit M

Loud noise

Gearing worn

Loud noise/heating-up

Have device repaired by the manufacturer

Blade does not move

Defective gearing

Motor runs without gearing engaged

Have device repaired by the manufacturer

Lack of cutting performance

Blunted blade

Cutting edge worn

Insert a new blade

Insufficient drive power; motor runs too slowly

See above (error: motor runs too slowly)

See above (error: motor runs too slowly)

Skin graft shows perforations after removal

Components of the dermatome head are damaged

Scratches, grooves, or dents on the dermatome head

Have device repaired by the manufacturer

Varying graft thickness (over the width of the graft)

Dermatome is out of adjustment (damage after knock or drop)

Light slit at the blade is not parallel

Have device repaired by the manufacturer

Varying graft thickness (over the length of the graft)

Dermatome is out of adjustment (damage after knock or drop)

Dents

Have device repaired by the manufacturer

Varying pressure and operating angle during the removal of the skin

Uneven bleeding from the skin

Perform test cuts to determine the graft thickness

Gear or gear bearing defective Motor runs too slowly

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ACCULAN dermatome GA 643

8. Technical Service

10. Technical specifications

For service, maintenance or repairs contact your AESCULAP/B. Braun representative. All guarantees and warranty rights as well as licenses will be void if modifications on the device are performed.

DC voltage

9.6 V

Rated capacity of rechargeable battery

0.5 Ah

Service addresses

Rated current

2A

AESCULAP Technischer Service Am Aesculap-Platz 78532 Tuttlingen/Germany Phone: +49 (7461) 95 27 00 Fax: +49 (7461) 16 28 87 E-mail: [email protected] Other service addresses can be obtained from the address indicated above.

Max. mechanical output

45 W

9. Accessories and spare parts

Designation

Art. no.

ACCULAN dermatome

GA 643

Cover

GA 624

Sterile funnel

GA 625

Dermatom blades (pack of 10)

GB 228 R

ACCULAN battery charger

GA 627 M

Rechargeable battery

GA 646

Changing funnel

GA 644

Storage tray (for GA 624)

GB 504 R

Storage tray (for GA 643)

GB 509 R

Storage tray (for GA 644)

GB 506 R

Max. motor torque

20 Ncm

Rotational speed of motor

0–8 000 1/min

Dimensions (L x W x H)

285 mm x 115 mm x 50 mm

Weight incl. rechargeable battery

1 480 g

Type as per IEC 601

B

Blade travel

3.1 mm

Blade stroke number

6 300–6 800 strokes/min

Cutting width

max. 78 mm, adjustable with 10 flaps of a width of 8 mm each

Cutting thickness

0.2 mm to 1.2 mm, Scale gradations of 1/10 mm

Electromagnetic tolerance

IEC 601-1-2

Norms applied

IEC 601-1

11. Disposal The NiCd cells of the rechargeable battery contain heavy metals and must not be disposed of with regular waste. Ø The NiCd cells should be disposed of and recycled in an environmentally acceptable manner. The remainder of the device is comprised of aluminum, stainless steel and copper. Ø The device may be recycled with other recyclable metals.

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