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Zimmer Biomet

Zimmer Electric Dermatome Instructions for Use

Revision Not Listed

Zimmer Skin Systems

184 Pages

ENGLISH Zimmer® Air Dermatome II Instruction Manual INDICATIONS FOR USE The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities... DESCRIPTION The Zimmer Air Dermatome II (see figures 1, 2 , 3) is an air-powered surgical skin grafting instrument... he thickness control adjustment ranges from 0, 0... 4 in... 0... mm) to ... 4 in... 0... mm) in 0... 2 in... 0...  mm) increments... ndividual graft widths of 1 in... 1... in... 2 in... 3 in... nd 4 in... 2... cm, 3... cm, 5... cm, 7... cm, 10... cm) are obtained with five width plates (see figure 19)... ne stainless steel machine screw secures the plates to the underside of the instrument (figure 21)... he plates are easily fastened and removed with the screwdriver provided (figure 20)... he dermatome has a self-cooling rotary vane air motor... he motor is powered by water-pumped compressed dry nitrogen (99... % pure) or by medical-grade compressed air and provides nearly vibration-free power... SPECIFICATIONS I... Physical Weight: Length: Width: Exhaust:  II... 28 oz... 794 g) 8...  in... 22...  cm) 5...  in... 13...  cm) Detachable hose with exhaust 10 feet (3...  m) from surgical site  Operational No-Load speed: Recommended Power Source: Operating Pressure: Consumption:  4,500-6,500 cycles/minute Water-pumped compressed dry nitrogen (99... % pure)... here nitrogen is not available, medical-grade compressed air may be used... 00 PSI (690 kPa) running 8 CFM maximum  POWER SOURCE Nitrogen (preferred) or medical-grade compressed air: Compressed dry nitrogen is the preferred power source... here nitrogen is not available, medical-grade compressed air can be used... hese gasses should meet the following specifications to ensure optimum safety for both patient and instrument:  Nitrogen: Nitrogen content: Quality assurance:  99... % pure, dry nitrogen To obtain the quality of gas needed, “water-pumped dry nitrogen or liquid nitrogen, pumped dry” should be specified... 1   Medical Grade compressed air: Oxygen: Nitrogen and inert gasses: Moisture:  21% ± 0...  Balance 15... vpm (max)  Note: Use only the supplied air hose conforming to BSI 5682 for high pressure medical-grade compressed air... he Zimmer Air Dermatome II should be operated at 100 PSI (690 kPa) for maximum operating efficiency and should be monitored with the operating pressure gauge of the regulator... hen using the recommended hose, pressure must be set with the instrument running to avoid excessively low operating pressures... WARNINGS AND PRECAUTIONS To avoid serious injury to the patient and operating staff while the Zimmer Air Dermatome II is in use, the user must be thoroughly familiar with its function, application and instructions for use... se only Zimmer Dermatome II Blades (REF 00-8851-000-10)... he Zimmer Dermatome II Blade has been specifically designed and engineered for use with the Zimmer Air Dermatome II... ther blades may not fit properly in the dermatome and may cause serious injury... se of non-Zimmer Dermatome II Blades can cause the dermatome to take grafts deeper than what the user has selected... arning! Blade is sharp... andle with care... lade is Sterile only if package is unopened and undamaged... o avoid injury, use extreme caution when handling the blade or when handling the dermatome with the blade installed... se caution when inserting blade to avoid nicking it, which may result in an uneven cut... o avoid blade damage, place the dermatome with blade side up when not in use... he throttle must be in the SAFE position before changing blades or hoses, or when the instrument is not in use... ccidental activation of the instrument during these procedures may injure the patient or operating staff... o ensure that the instrument is in the SAFE position, the safety lock on the throttle should be toward the blade end of the dermatome and only the SAFE symbol (O•) should be visible... andle the Zimmer Air Dermatome II carefully... hould it be inadvertently dropped or damaged, it should be returned for service... o not use... o not use a worn or damaged hose... nder pressure, a severed or broken hose can whip out of control... e sure the hose is securely fastened to the instrument so that the hose will not fall against a hard surface and become damaged... ever use standard compressed air with the Zimmer Air Dermatome II... tandard compressed air directly from a compressor can contain impurities, oils, and moisture that can damage the dermatome... he automatic shut-off valve in the end of the hose, (see figure 4), permits removal and re-connection of the hose under pressure... se care to prevent dirt or debris from entering the end of the handpiece when the handpiece and hose are separated... ever operate the Zimmer Air Dermatome II above recommended pressures... xcessive pressure may cause internal damage and exert unusual stress on the hose... he user and operating staff must always pay close attention to the CLEANING PRECAUTIONS and CLEANING AND DISINFECTION PROCESS INSTRUCTIONS FOR THE DERMATOME II... ailure to follow these instructions may damage the dermatome... euse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury... ossible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents... IMPORTANCE OF THE NEED TO ADHERE TO A CARE REGIMEN The handpiece and accessories must be inspected prior to each use...   Visually inspect for damage and/or wear... •  Always inspect the handpiece carefully for possible scratches, nicks, or burrs caused by extended use or mishandling... 2
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Page 1

ENGLISH

Zimmer® Air Dermatome II

Instruction Manual

INDICATIONS FOR USE

The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width

capabilities.

DESCRIPTION

The Zimmer Air Dermatome II (see figures 1, 2 , 3) is an air-powered surgical skin grafting instrument. The thickness

control adjustment ranges from 0, 0.004 in. (0.1 mm) to .024 in. (0.6 mm) in 0.002 in. (0.05 mm) increments.

Individual graft widths of 1 in., 1.5 in., 2 in., 3 in. and 4 in. (2.5 cm, 3.8 cm, 5.1 cm, 7.6 cm, 10.2 cm) are obtained with

five width plates (see figure 19). One stainless steel machine screw secures the plates to the underside of the

instrument (figure 21). The plates are easily fastened and removed with the screwdriver provided (figure 20).

The dermatome has a self-cooling rotary vane air motor. The motor is powered by water-pumped compressed dry

nitrogen (99.97% pure) or by medical-grade compressed air and provides nearly vibration-free power.

SPECIFICATIONS

I.

Physical

Weight:

Length:

Width:

Exhaust:

II.

28 oz. (794 g)

8.92 in. (22.66 cm)

5.18 in. (13.16 cm)

Detachable hose with exhaust 10 feet (3.05 m) from surgical site

Operational

No-Load speed:

Recommended Power Source:

Operating Pressure:

Consumption:

4,500-6,500 cycles/minute

Water-pumped compressed dry nitrogen (99.97% pure). Where

nitrogen is not available, medical-grade compressed air may be used.

100 PSI (690 kPa) running

8 CFM maximum

POWER SOURCE

Nitrogen (preferred) or medical-grade compressed air:

Compressed dry nitrogen is the preferred power source. Where nitrogen is not available, medical-grade compressed air

can be used. These gasses should meet the following specifications to ensure optimum safety for both patient and

instrument:

Nitrogen:

Nitrogen content:

Quality assurance:

99.97% pure, dry nitrogen

To obtain the quality of gas needed, “water-pumped dry nitrogen or

liquid nitrogen, pumped dry” should be specified.

1

Page 2

Medical Grade compressed air:

Oxygen:

Nitrogen and inert gasses:

Moisture:

21% ± 0.5%

Balance

15.0 vpm (max)

Note: Use only the supplied air hose conforming to BSI 5682 for high pressure medical-grade compressed air.

The Zimmer Air Dermatome II should be operated at 100 PSI (690 kPa) for maximum operating efficiency and should be

monitored with the operating pressure gauge of the regulator. When using the recommended hose, pressure must be

set with the instrument running to avoid excessively low operating pressures.

WARNINGS AND PRECAUTIONS

To avoid serious injury to the patient and operating staff while the Zimmer Air Dermatome II is in use, the user must be

thoroughly familiar with its function, application and instructions for use.

Use only Zimmer Dermatome II Blades (REF 00-8851-000-10). The Zimmer Dermatome II Blade has been specifically

designed and engineered for use with the Zimmer Air Dermatome II. Other blades may not fit properly in the dermatome

and may cause serious injury. Use of non-Zimmer Dermatome II Blades can cause the dermatome to take grafts deeper

than what the user has selected.

Warning! Blade is sharp. Handle with care.

Blade is Sterile only if package is unopened and undamaged.

To avoid injury, use extreme caution when handling the blade or when handling the dermatome with the blade installed.

Use caution when inserting blade to avoid nicking it, which may result in an uneven cut. To avoid blade damage, place

the dermatome with blade side up when not in use.

The throttle must be in the SAFE position before changing blades or hoses, or when the instrument is not in use.

Accidental activation of the instrument during these procedures may injure the patient or operating staff. To ensure that

the instrument is in the SAFE position, the safety lock on the throttle should be toward the blade end of the dermatome

and only the SAFE symbol (O•) should be visible.

Handle the Zimmer Air Dermatome II carefully. Should it be inadvertently dropped or damaged, it should be returned for

service. Do not use.

Do not use a worn or damaged hose. Under pressure, a severed or broken hose can whip out of control.

Be sure the hose is securely fastened to the instrument so that the hose will not fall against a hard surface and become

damaged.

Never use standard compressed air with the Zimmer Air Dermatome II. Standard compressed air directly from a

compressor can contain impurities, oils, and moisture that can damage the dermatome.

The automatic shut-off valve in the end of the hose, (see figure 4), permits removal and re-connection of the hose under

pressure. Use care to prevent dirt or debris from entering the end of the handpiece when the handpiece and hose are

separated.

Never operate the Zimmer Air Dermatome II above recommended pressures. Excessive pressure may cause internal

damage and exert unusual stress on the hose.

The user and operating staff must always pay close attention to the CLEANING PRECAUTIONS and CLEANING AND

DISINFECTION PROCESS INSTRUCTIONS FOR THE DERMATOME II. Failure to follow these instructions may

damage the dermatome.

Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient

or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical

failure and transmission of infectious agents.

IMPORTANCE OF THE NEED TO ADHERE TO A CARE REGIMEN

The handpiece and accessories must be inspected prior to each use.

•

Visually inspect for damage and/or wear.

•

Always inspect the handpiece carefully for possible scratches, nicks, or burrs caused by extended use or

mishandling.

2

Page 3

•

Check the action of moving parts to ensure smooth operation throughout the intended range of motion.

•

The Zimmer Air Dermatome II should be returned every 12 months and the hose every 6 months for

inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to

verify continued accuracy.

Note: If damage or wear is noted that may compromise the function of the instrument, do not use. Refer to RETURN

AUTHORIZATION AND REPLACEMENT INFORMATION section.

RECEIVING INSPECTION

After receiving the Zimmer Air Dermatome II, examine the unit for external signs of damage. Retain all packing material

until the contents have been verified and an initial operational check has been performed. If the device has been

damaged, forward an immediate request to the delivering carrier to perform an inspection and prepare a “Concealed

Damage” report. The terms of all Zimmer Surgical sales agreements concerning this unit are F.O.B., Dover, Ohio,

U.S.A., and the responsibility of the Zimmer Surgical ends with delivery to the first carrier. Thereafter, the shipment

becomes the property of the customer. Any claims for loss, damage, or non-delivery must be made against the

delivering carrier within 10 days of shipment.

Your local Zimmer sales representative may assist you in determining the cost of replacement or repair so that a proper

claim may be filed with the delivering carrier.

Note: Do not attempt to return damaged goods without first securing proper authorization from the delivering carrier.

SETUP INSTRUCTIONS

•

Prior to initial usage, the Zimmer Air Dermatome II must be cleaned and sterilized per instructions. (See

CLEANING AND DISINFECTION PROCESS INSTRUCTIONS FOR THE DERMATOME II and STERILIZATION

RECOMMENDATIONS.)

•

Observe sterile field precautions per hospital protocol.

•

Connect the handpiece to the hose by grasping both the swivel on the end of the handpiece and the hose firmly.

Push together and twist the hose to the right so that the pins are in the indentations (see figure 4).

•

When using a pressurized tank, the tank should be thoroughly wiped off with disinfectant and draped prior to

placement in the operating room. Always have the tank securely fastened to the wall, a stable cart or some other

stationary device to prevent falling and away from sources of heat.

•

Prior to setup in the operating room, open the tank valve very slowly and allow only enough gas to escape to

blow out any debris that may have accumulated in the valve. Stay clear of the opening, behind the tank, during

this procedure. Return the valve to the closed position. Install the regulator.

•

Once the regulator is securely installed, be certain the regulator is in the full OFF position. The tank valve may

then be opened slowly until it is fully open. This will allow for the gas to pressurize the regulator.

•

Never start a procedure if the pressure gauge indicates that there is less than 500 PSI (3450 kPa) in the tank.

Never allow the tank pressure to fall below 200 PSI (1380 kPa) or correct output pressure will not be maintained.

•

Insert the diffuser end of the hose into the quick-disconnect fitting on the regulator.

•

Activate the dermatome by completely depressing the throttle lever with the safety lock in the ON ( |-- ) position.

Pressure is established by gradually turning the regulator control knob. Always establish the designated pressure

using the pressure gauge with the instrument running. Recommended pressure is 100 PSI running, using a

recommended hose. When using an extension hose, increase the pressure at the source 1 PSI per foot

(22.6 kPa/m) of extension hose. For example, if a 10 foot (3.05 meter) extension hose is added to the standard

hose, indicated pressure at the source should be 110 PSI (759kPa) when the dermatome is running. Return the

safety lock to the SAFE position (O•), when not in use.

•

During setup procedure, visually inspect for damage and/or wear. If damage or wear that may compromise

the function of the instrument is noted, do not use.

3

Page 4

BLADE INSTALLATION (See Figure 7)

Lubrication of the blade is not necessary. Use a new, sterile blade for each procedure. (Additional blades may be

required for extensive procedures.)

To install the blade:

•

Place the the Zimmer Dermatome II handpiece throttle in the SAFE (O•) position. To place the dermatome

in the SAFE position, slide the safety lock on the throttle toward the blade end of the instrument to the

SAFE (O•) position. Only the SAFE symbol (O•) should be visible (see figure 7).

•

Using the Zimmer Dermatome II screwdriver (REF 00-8851-205-00), loosen the handpiece width plate

screw. Do not remove the screw from the handpiece. If a width plate is already attached, remove by

holding both sides and sliding/lifting forward and up (see figure 7A-C). Do not lift from the front as this will

cause contact with the blade and possible injury.

•

If replacing a blade, remove the used blade before inserting a new one. Refer to BLADE REMOVAL

section.

•

Place entire blade/cover assembly (see figure 7D) onto the handpiece such that the blade key fits into the

notch of the handpiece, and the handpiece drive pin mates with the hole in the blade (see figure 7E).

Place your finger on the blade assembly (white portion). While holding the blade assembly, lift one end of

the blade cover (blue portion) and remove blade cover from blade assembly (see figure 7F). Retain blade

cover for blade removal after use.

•

With the printing on the width plate facing out, place the width plate flat on the face of the dermatome

head. Carefully slide back toward the screw (see figure 7G-I) , until the width plate hole is located under

the mounting screw. Do not grasp the front of the width plate as this will cause contact with the blade and

possible injury. Using the screwdriver, gently tighten the mounting screw. Do not over-tighten screw (see

Figure 7J).

•

NOTE: Choose the proper width plate to satisfy cutting requirements

•

Caution: Be sure the width plate is securely under the outside width plate holders, (see figure 7I). Failure

to properly install/secure the width plate may result in a patient injury.

CUTTING THE GRAFT

•

Skin should be prepared in routine manner.

•

It is not necessary to lubricate the skin; however, lubricating the donor site may ease travel of the Zimmer Air

Dermatome II.

•

Set control lever adjustment knob pointer to desired graft thickness (see figure 6). Do not insert any instrument

between the blade and the control lever as this may damage or knick the blade causing a poor cut. Further, it

may compromise the calibration of the instrument.

•

To activate the dermatome, lift the throttle lever and slide the safety lock back from the SAFE (O•) position toward

the hose coupling. The ON symbol ( |-- ) should be visible. (See figure 7). For optimum results, it is recommended

that the dermatome operate at full speed. To ensure that full speed is achieved, completely depress the throttle

control with the safety lock in the ON ( |-- ) position.

•

Depress the throttle to start the dermatome. Apply the handpiece on the donor site at a 30° – 45° angle (see

figure 8). Guide the unit forward using a slight downward pressure to ensure that the cutting edge remains

continuously and firmly in contact with the donor site.

•

Two methods of graft removal from the instrument may be used:

• Method I

Allow the cut graft to accumulate in the pocket of the handpiece. Lift the handpiece away from the donor

site to end the graft. Return the throttle to the SAFE (O•) position and carefully remove the graft. (See

figure 8.)

• Method II

Use tissue forceps to gently lift the graft as it emerges from the pocket area. Do not stretch or pull the graft

as this causes irregular edges and non-uniform cuts. Lift the handpiece away from the donor site to end

the graft. Return the throttle to the SAFE (O•) position. (See figure 9.)

4

Page 5

AFTER THE PROCEDURE

Before removing the dermatome from the regulator:

•

Close the tank valve, if applicable.

•

Turn the regulator knob until the pressure reads zero.

•

Activate the dermatome to bleed off the line pressure.

•

Remove the hose from the Zimmer Air Dermatome II.

•

Remove the hose from the regulator. The end of the hose should be held securely when disengaging the fitting to

prevent possible damage to the diffuser when the hose is disconnected.

•

Remove the used blade (see BLADE REMOVAL section) and dispose of properly in a designated sharps

container or per hospital protocol.

•

Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with a damp cloth. Body

fluids and tissue should not be allowed to dry on instruments prior to cleaning.

•

Return and secure instrument, hose, width plates and screwdriver to instrument case for transport and cleaning.

BLADE REMOVAL

•

Loosen the width plate screw using the Dermatome II screwdriver. Do not remove the screw from the device.

•

To remove the width plate, hold both sides of the width plate and slide/lift forward and up (see figure 7A-C). Do

not lift from the front as this will cause contact with the blade and possible injury.

•

Replace the blade cover over one end of the blade assembly and snap it down onto other end of the blade

assembly (preferred, see figure 7K), or remove the blade assembly carefully by lifting up from under the blade

assembly using the finger access area (see figure 7L).

•

Dispose of used blade in a sharps container or per hospital protocol.

CLEANING PRECAUTIONS

All subsequent cleaning and sterilization steps are facilitated by not allowing blood, tissue debris, or disinfectants to dry

on used instruments.

Handle the Zimmer Air Dermatome II carefully. Should it be inadvertently dropped or damaged, it should be returned for

service.

Refer to IMPORTANCE OF THE NEED TO ADHERE TO A CARE REGIMEN section.

Do not lubricate the Zimmer Air Dermatome II. Lubrication may cause extensive damage to the motor.

Steam sterilize the Zimmer Air Dermatome II and accessories (except regulator). Follow instructions in STERILIZATION

RECOMMENDATIONS.

5

Page 6

CLEANING AND DISINFECTION PROCESS INSTRUCTIONS FOR

THE DERMATOME II (SEE FIGURES 10-13)

The following instructions and chart detail the cleaning and disinfection process for the Zimmer Air Dermatome II.

•

Use caution when handling the dermatome to determine that the used blade has been removed. If not,

safely dispose of all used blades in accordance with hospital policy for contaminated waste and sharps.

•

Universal precautions for handling contaminated/biohazardous materials should be observed.

•

Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to

cleaning.

•

Prior to cleaning, remove width plate from device and clean separately.

•

Follow the Cleaning Instructions found in Chart 1 or Chart 2 for the Dermatome II handpiece and width

plate.

•

Zimmer Air hose may be wiped down and/or manually cleaned with isopropyl alcohol or silicon rubber

compatible cleaner. Do not submerge the hose in liquids or automatic wash.

•

Following the cleaning procedure, visually inspect for damage and/or wear.

•

Prepare cleaning agents at the use-dilution and temperature recommended by the manufacturer.

•

The thickness control lever should be moved during cleaning to release any debris which may be trapped

under the lever or in the notches.

•

Careful attention must be made to joints, mated areas, and cavities while cleaning the device. Verify all

visible soil has been removed from these areas, especially the drive pin cavity located at the bottom of the

device.

•

Check the action of moving parts to ensure smooth operation throughout the intended range of motion.

Note: If damage or wear is noted that may compromise the function of the instrument, do not use. Refer to RETURN

AUTHORIZATION AND REPLACEMENT INFORMATION section.

•

Steam sterilize only. Follow instructions in STERILIZATION RECOMMENDATIONS.

6

Page 7

Cleaning Steps

Chart 1 Validated Manual Cleaning and Disinfection Procedure

Step

Step

Description

Step Instruction

Accessories

Duration

1

Contamination

Removal

Rinse product under Cold/

Room Temperature

running tap water

removing any visible

organic material with

assistance of a soft bristle

brush

- Cold/Room

Temperature Tap

Water

Until all visible soil is

removed

Dry the device utilizing a

dry non-shedding wipe.

Medical quality filtered air

may be utilized if available

- Non- shedding wipe

Disinfection

Application

Apply disinfectant to the

device's surface area per

manufacturer's

recommendations

- Disinfectant

Manual

Disinfection

While disinfectant is on the

device surface clean all

contact surfaces, joints,

mated areas utilizing a

clean soft bristle brush

- Clean Soft bristle

brush

2

Disinfection Steps

3

4

Drying

- Soft bristle brush

(Do not utilize metal

cleaning brushes)

- Medical quality

filtered compressed

air

- Spray bottle or other

manual applicator

- Disinfectant

Until product is

visually dry

Contact time will vary

per product usage;

minimum of one (1)

minute is

recommended

Manual cleaning time

duration is complete

when the device's

surface, joints, &

crevices have been

manually cleaned

5

Final Rinse

Rinse product under Room

Temperature Distilled/

Filtered Water

- Room Temperature

Distilled/Filtered

Water

Minimum of

30 seconds

6

Final Drying

Dry the device utilizing a

dry non-shedding wipe.

Medical quality filtered air

may be utilized if available

- Non- shedding wipe

Until product is

visually dry

7

- Medical quality

filtered compressed

air

Page 8

Chart 2 Validated Automated Cleaning and Disinfection Procedure

Step

Step Description

Step Instruction

Accessories

Duration

1

Gross Soil

Contamination

Removal

Rinse product under

Cold/Room

Temperature running

tap water removing any

visible organic material

with assistance of a

soft bristle brush

- Cold/Room Temperature

Tap Water

Until all visible soil is

removed

Place device into

Immersion Container

containing water and

liquid cleaner

- Tap water at

manufacturer’s

recommended

temperature

2

Pre-soak

(Optional)

- Soft bristle brush

(Do not utilize metal

cleaning brushes)

Cleaning Steps

- Disinfectant/cleanera

Contact time will

very per product

usage; minimum of

fifteen (15) minutes

is recommended

- Appropriate Immersion

Container

3

4

5

Pre-soak

Rinse

Drying

Automated

Washer

Rinse product under

Cold/Room

Temperature running

tap water with

assistance of a soft

bristle brush

- Cold/Room Temperature

Tap Water

Dry the device utilizing

a dry non-shedding

wipe. Medical quality

filtered air may be

utilized if available

- Non-shedding wipe

Place entire

disassembled device

into the automated

washer

- Automated Washer

Minimum of

30 seconds

- Disinfectant/cleaner

- Soft bristle brush

- Medical quality filtered

compressed air

- Disassembled Device

- Washer Cleaning

Solution

Until product is

visually dry

Minimum total cycle

time: 34 minutes

when including all

steps below

- Washer Neutralizing

Solutionb (If Applicable)

Disinfection Steps

Recommended Automatic Washer Cycle

Step

Minimum Time

Recommended Temperature

Pre-Wash

3:00 minutes

Water Temperature 65°C

Cleaning I-

3:00 minutes

Water Temperature 85°C

Cleaning IIb- Or

Neutralizing

1:00 minutes

Water Temperature 10°C

Rinse I

1:00 minutes

Water Temperature 10°C

Rinse II(Final)

1:00 minutes

Water Temperature 80°C

Thermal

Disinfection &

Drying

25:00 minutes

Chamber Temperature 110°C

8

Page 9

a: Pre-soak cleaner solution may be surfactant or protease/enzymatic based cleaning solution compatible with

aluminum

b: Neutralizing solution should be appropriate for the utilized cleaning solution, based upon the manufacturers’

recommendation. Certain cleaning solutions do not require a neutralization post-application of the cleaner. If

Neutralization is not required, initiate a second cleaning application.

9

Page 10

STERILIZATION RECOMMENDATIONS

Steam sterilization is safe and effective and is the only recommended method for the dermatome. There are no

contraindications for sterilizing the Zimmer Air Dermatome II and accessories.

Ethylene oxide sterilization is not recommended because reliable outgassing times are difficult to determine for

lubricated powered instruments.

•

Place cleaned instruments in an instrument tray or fully perforated autoclave case. The Zimmer Dermatome II

Autoclave Case (REF 00-8851-003-00) is recommended. (See Fig. 14.)

•

Insure depth gauge control lever is on 0.002 in (0.05 mm).

•

Do not kink the hose when closing the case lid.

•

If the Zimmer Dermatome II Autoclave Case is used, the instruments are to be wrapped, two double thicknesses

of #140 thread count wrappers, or equivalent. If sterilization wraps are used, they must be free of detergent

residues. Foam sheets should not be reused. They may have trapped impurities from the steam supply, and

subsequently may form deposits on the instruments. Textiles that have been scorched by overheating also

may form deposits on instruments. Exposure times are the same for wrapped or unwrapped instruments.

•

Follow instructions in RECOMMENDED STEAM STERILIZATION PARAMETERS.

•

Do not immerse in liquid to cool. Cool by exposure to room temperature or cover with a cold, sterile towel.

RECOMMENDED STEAM STERILIZATION PARAMETERS

Cycle Type

1,3

Prevacuum/ Pulsating

Vacuum

Prevacuum/Pulsating

Vacuum

3,4 Prevacuum/Pulsating

Vacuum

5 Prevacuum/Pulsating

Vacuum

2,3

Gravity/Gravity

Displacement

Minimum

Temperature

134°C

273°F

132°C

270°F

134°C

273°F

132°C

270°F

7,8

6 Minimum Exposure Time

9 Unwrapped

Wrapped

3 min

3 min

4 min

4 min

18 min

8 min

8 min

8 min

3,10

Minimum Dry

Time

8 minutes

Not recommended due to excessively long sterilization cycles which are not practical.

1. Minimum validated steam sterilization time required to achieve a 10-6 sterility assurance level (SAL).

2. Minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level.

3. Local or national specifications should be followed where steam sterilization requirements are stricter or more

conservative than those listed in this table.

4. Disinfection /steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing

instruments where there is concern regarding TSE/CJD contamination.

5. For universal Instrument Cases without defined load configurations.

6. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable.

7. Medical grade steam sterilization compatible wrap equivalent to four thicknesses of 140-thread-count muslin.

8. Rigid sterilization container that complies with ANSI/AAMI ST46.

9. Flash (unwrapped) sterilization by exposure at 132°C/270°F should only be used as an emergency

procedure. Instruments must be cleaned and disassembled.

10. Drying times vary according to load size and should be increased for larger loads.

Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed

explicitly.

Flash sterilization (10-minute exposure in a gravity displacement sterilizer in an open tray at 270° F [132° C]) is not

recommended for the Zimmer Air Dermatome II as this method may not provide sterility throughout the instrument.

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STORAGE CONDITIONS

The system should be stored under normal warehouse conditions.

ACCESSORIES (See Fig. 15–21.)

Description:

Zimmer Dermatome II Blades (10 per box)

REF: 00-8851-000-10

Description:

Zimmer Air Dermatome II Complete (includes: 00-8851-001-00, 00-8801-002-00,

00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00,

00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-00

Description:

Zimmer Air Dermatome II Complete (Draeger) (includes: 00-8851-001-01,

00-8851-002-02, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00,

00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-02

Description:

Zimmer Air Dermatome II Complete (Synthes) (includes: 00-8851-001-01,

00-8851-002-03, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00,

00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-03

Description:

Zimmer Air Dermatome II Complete (Heyer) (includes: 00-8851-001-01,

00-8851-002-04, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00,

00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-04

Description:

Zimmer Air Dermatome II Complete (AGA) (includes: 00-8851-001-01,

00-8851-002-05, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00,

00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-05

Description:

Zimmer Air Dermatome II Complete (UK Shrader) (includes: 00-8851-001-01,

00-8851-002-06, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00,

00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

Description:

Zimmer Air Dermatome II Complete (DIN) (includes: 00-8851-001-01,

00-8851-002-07, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00,

00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

Description:

Zimmer Air Dermatome II Handpiece (includes: 00-8851-001-00, 00-8801-00200, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-00

Description:

Zimmer Air Dermatome II Handpiece (Draeger) (includes: 00-8851-001-01,

00-8851-002-02, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-001-02

Description:

Zimmer Air Dermatome II Handpiece (Synthes) (includes: 00-8851-001-01,

00-8851-002-03, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-001-03

Description:

Zimmer Air Dermatome II Handpiece (Heyer) (includes: 00-8851-001-01,

00-8851-002-04, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-001-04

Description:

Zimmer Air Dermatome II Handpiece (AGA) (includes: 00-8851-001-01,

00-8851-002-05, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-001-05

REF: 00-8851-000-06

REF: 00-8851-000-07

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Description:

Zimmer Air Dermatome II Handpiece (UK Schrader) (includes: 00-8851-001-01,

00-8851-002-06, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-001-06

Description:

Zimmer Air Dermatome II Handpiece (DIN) (includes: 00-8851-001-01, 00-8851002-07, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-07

Description:

Zimmer Air Dermatome II Hose, 10 ft (3m)

REF: 00-8801-002-00

Description:

Zimmer Air Dermatome II Hose,: Draeger, 3m

REF: 00-8851-002-02

Description:

Zimmer Air Dermatome II Hose: Synthes (AO), 3m

REF: 00-8851-002-03

Description:

Zimmer Air Dermatome II Hose: Heyer, 3m

REF: 00-8851-002-04

Description:

Zimmer Air Dermatome II Hose: AGA, 3m

REF: 00-8851-002-05

Description:

Zimmer Air Dermatome II Hose: UK MA-7 Schrader, 3m

REF: 00-8851-002-06

Description:

Zimmer Air Dermatome II Hose: DIN, 3m

REF: 00-8851-002-07

Description:

Zimmer Dermatome II Autoclave Case

REF: 00-8851-003-00

Description:

Zimmer Dermatome II Width Plate, 1 in.

REF: 00-8851-201-00

Description:

Zimmer Dermatome II Width Plate, 1.5 in.

REF: 00-8851-215-00

Description:

Zimmer Dermatome II Width Plate, 2 in.

REF: 00-8851-202-00

Description:

Zimmer Dermatome II Width Plate, 3 in.

REF: 00-8851-203-00

Zimmer Dermatome II Width Plate, 4 in.

REF: 00-8851-204-00

Description:

Description:

Zimmer Dermatome II Screwdriver

REF: 00-8851-205-00

Description:

Width Plate Screws

REF: 00-8851-006-00 (5 per pack)

Description:

Dermatome O-rings

REF: 00-8800-105-41

SERVICE INFORMATION

The Zimmer Air Dermatome II should be returned to Zimmer Surgical, Dover, OH or an authorized repair center

(outside the U.S.A.) for servicing. NOTE: Zimmer cannot be held liable for any instrument malfunction resulting

from repairs or service performed by an unauthorized service center. Do not attempt to disassemble the

handpiece. It is a factory sealed unit with no user serviceable parts inside.

The Zimmer Air Dermatome II should be returned every 12 months and the hose every 6 months for inspection

and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued

accuracy.

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RETURN AUTHORIZATION AND REPLACEMENT INFORMATION

When it is necessary to return the instrument for inspection and preventive maintenance or repair; within the U.S.A. call

1-800-830-0970 to receive a Return Goods Authorization (RGA) number. Outside the U.S.A., please contact your local

Zimmer representative.

The instrument must be properly packaged when sent in for repair. If the original packaging is no longer available,

proper packaging can be requested when the Return Goods Authorization (RGA) number is received.

A purchase order must accompany all equipment for repair. The customer will be responsible for all shipping charges.

WARRANTY INFORMATION (U.S.A. only)

Zimmer Surgical warrants that the Zimmer Air Dermatome II, along with all parts and accessories, have has been tested

and inspected, and have has left the factory in proper working condition, free from visible defects.

Zimmer Surgical warrants to the first consumer purchaser of the new Zimmer Air Dermatome II, width plates and

screwdrivers, that these products and accessories will, under normal and reasonable use, be free from defects in

material and workmanship for one (1) year after the date of shipment from the factory. The warranty period for hoses is

six (6) months. Zimmer Dermatome II Blades are warranted to be free from defects in material and workmanship upon

delivery. During the warranty period, Zimmer Surgical shall repair (or at its sole option replace) the defective product or

part without cost to the purchaser. Defective parts replaced under this warranty shall become the property of Zimmer

Surgical. This warranty does not cover damage caused by misuse, abuse, accident, neglect, or any use not prescribed

in this manual. If the unit becomes defective because of misuse or abnormal conditions of operation, repairs will be

billed at our current rate.

ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, IMPLIED

WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN TIME TO

THE PERIOD OF THE WARRANTY GRANTED HEREBY. SOME STATES DO NOT ALLOW LIMITATIONS ON THE

DURATION OF AN IMPLIED WARRANTY, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.

Neither Zimmer Surgical nor the Zimmer distributor who sells the Zimmer Air Dermatome II is responsible for indirect,

incidental, or consequential damages. Some states do not allow the exclusion of incidental or consequential damages,

so the above limitations or exclusions may not apply to you.

A Zimmer Air Dermatome II requiring service or repair may be returned to:

Zimmer Surgical, Inc.

200 West Ohio Avenue

Dover, Ohio 44622 U.S.A.

For further information concerning warranties and repairs, contact your Zimmer sales representative or the Zimmer

Customer Service Department at 800-348-2759 (inside the U.S.A.).

WARRANTY (Outside U.S.A.)

Please contact your local Zimmer representative for warranty information.

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DANSK

Zimmer® Luftdermatom II

Instruktionsmanual

INDIKATIONER FOR BRUG

Zimmer Luftdermatom II er et hudtransplantationsinstrument, som er beregnet til at yde variable transplantattykkelser og

breddemuligheder.

BESKRIVELSE

Zimmer Luftdermatom II (se figurerne 1, 2 , 3) er et luftdrevet, kirurgisk hudtransplantationsinstrument.

Tykkelseskontroljusteringsmulighederne går fra 0, 0,1 mm til 0,6 mm i trin på 0,05 mm.

Individuelle transplantatbredder på 2,5 cm, 3,8 cm, 5,1 cm, 7,6 cm, 10,2 cm opnås med fem breddeplader. (Se figur 19.)

En maskinskrue i rustfrit stål fastholder pladerne til instrumentets underside (figur 21). Pladerne kan let fastgøres og

fjernes med den medfølgende skruetrækker (figur 20).

Dermatomet har en selvkølende, roterende vingeluftmotor. Motoren drives af vandpumpet, tør nitrogen (renhedsgrad

99,97 %), eller af komprimeret luft i medicinsk kvalitet, og yder næsten vibrationsfri kraft.

SPECIFIKATIONER

I.

II.

Fysisk

Vægt:

794 g

Længde:

22,66 cm

Bredde:

13,16 cm

Udstødning:

Aftagelig slange med udstødning 3,05 m fra operationsstedet

Hastighed, ubelastet:

4.500-6.500 sekvenser/minut

Anbefalet energiforsyning:

Vandpumpet, komprimeret tør nitrogen (renhedsgrad 99,97 %). Hvis

nitrogen ikke er til rådighed kan der anvendes komprimeret luft i

medicinsk kvalitet.

Drift

Driftstryk:

690 kPa i drift

Forbrug:

Maksimalt 8 CFM

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ENERGIFORSYNING

Nitrogen (foretrukket), eller komprimeret luft i medicinsk kvalitet:

Komprimeret, tør nitrogen er den foretrukne energiforsyning. Hvis nitrogen ikke er til rådighed, kan der anvendes

komprimeret luft i medicinsk kvalitet. Disse gasarter skal efterleve de følgende specifikationer for at sikre den optimale

sikkerhed for både patient og instrument:

Nitrogen:

Nitrogenindhold:

99,97 % renhedsgrad tør nitrogen

Kvalitetssikring:

For at opnå den nødvendige gaskvalitet skal der specificeres,

“vandpumpet, tør nitrogen, eller flydende nitrogen, pumpet tørt”.

Komprimeret luft i medicinsk kvalitet:

Oxygen:

21 % ± 0,5 %

Nitrogen og inaktive luftarter:

Balance

Fugtighed:

15,0 vpm (maksimalt)

Bemærk: Anvend kun den medfølgende luftslange, der er i overensstemmelse med BSI 5682 for højtrykskomprimeret

luft i medicinsk kvalitet.

Zimmer Luftdermatom II skal anvendes ved 690 kPa for maksimal anvendelseseffektivitet, og skal overvåges med

regulatorens driftstrykmåler. Når den anbefalede slange anvendes skal trykket indstilles med instrumentet i drift for at

undgå uforholdsmæssigt lave driftstryk.

ADVARSLER OG FORHOLDSREGLER

For at undgå alvorlig skade på patient og operationspersonale, mens Zimmer Luftdermatom II er i brug, skal brugeren

være fuldstændig bekendt med dens funktion, applikation og instruktionsmanual.

Brug kun Zimmer Dermatom II blade (REF 00-8851-000-10). Zimmer Dermatom II bladet er særligt skabt og fremstillet

til brug med Zimmer Luftdermatom II. Andre blade sidder muligvis ikke korrekt i dermatomet, og kan medføre alvorlig

skade. Brug af andre blade end Zimmer Dermatom II blade kan medføre, at dermatomet tager transplantater dybere,

end brugeren har valgt.

Advarsel! Bladet er skarpt Skal håndteres forsigtigt.

Bladet er kun sterilt, hvis pakken er uåbnet og ubeskadiget.

For at undgå skade skal den yderste forsigtighed udvises, når bladet håndteres, eller når dermatomet håndteres med

bladet isat.

Vær forsigtig, når bladet isættes, for at undgå at lave hakker i det, hvilket kan medføre, at bladet skærer ujævnt. For at

undgå skade på bladet placeres dermatomet med bladsiden opad, når det ikke er i brug.

Regulatorhåndtaget skal stå i positionen SIKKER, før der skiftes blade eller slanger, eller når instrumentet ikke er i brug.

Utilsigtet aktivering af instrumentet under disse procedurer kan skade patienten eller operationspersonalet. For at sikre,

at instrumentet er i positionen SIKKER, skal sikkerhedslåsen på Regulatorhåndtaget vende mod dermatomets bladende,

og kun symbolet SIKKER (O•) må være synligt.

Vær forsigtig i håndteringen af Zimmer Luftdermatom II. Tabes eller beskadiges den ved et uheld, skal den returneres til

service. Må ikke anvendes.

Brug ikke en slidt eller beskadiget slange. En slange, der er gået løs eller i stykker, kan svinge ud af kontrol under tryk.

Kontroller, at slangen er sikkert fastgjort til instrumentet, sådan at slangen ikke falder imod en hård overflade og bliver

beskadiget.

Brug aldrig almindelig, komprimeret luft med Zimmer Luftdermatom II. Almindelig, komprimeret luft, direkte fra en

kompressor, kan indeholde urenheder, olier og fugt, som kan beskadige dermatomet.

Den automatiske stopventil ved slangens ende (se figur 4) tillader, at slangen fjernes og genpåsættes under tryk. Vær

omhyggelig med at forhindre snavs eller skidt i at komme ind i håndstykkets ende, når håndstykke og slange er adskilt.

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Brug aldrig Zimmer Luftdermatom II ved højere tryk end det anbefalede. For højt tryk kan medføre intern skade, og

udøve usædvanligt tryk på slangen.

Brugeren og operationspersonalet skal altid nøje følge FORHOLDSREGLER VED RENGØRING og ANVISNING TIL

RENGØRING OG DESINFEKTION AF DERMATOM II. Hvis disse anvisninger ikke følges, kan dermatomet tage skade.

Genbrug af en engangsenhed, som har været i kontakt med blod, knogle, væv, eller andre kropsvæsker, kan medføre

skader på patient eller bruger. Mulige risici ved genbrug af engangsudstyr inkluderer, men er ikke begrænset til,

mekanisk svigt og overførsel af smitstoffer.

VIGTIGHEDEN AF BEHOVET FOR OMHU

Håndstykket og tilbehøret skal kontrolleres før hver brug.

•

kontroller visuelt for skader og/eller slid.

•

Kontroller altid håndstykket omhyggeligt for mulige skrammer, hak eller rifter, skabt ved for langvarig brug

eller fejlhåndtering.

•

Kontroller de bevægelige dele for at sikre gnidningsfri brug gennem hele det beregnede

bevægelsesspektrum.

•

Zimmer Luftdermatom II skal returneres hver 12 måned, og slangen hver 6 måned til kontrol og

forebyggende vedligeholdelse. Årlige kalibreringskontroller på fabrikken anbefales kraftigt for at bekræfte

fortsat præcision.

Bemærk: Hvis skade eller slid, som kan kompromittere instrumentets funktion, bemærkes, må det ikke anvendes. Se

afsnittet RETURNERINGSGODKENDELSE OG INFORMATION OM UDSKIFTNING.

KONTROL VED MODTAGELSE

Ved modtagelsen af Zimmer Luftdermatom II, skal du kontrollere denne for ydre tegn på beskadigelse. Gem al

emballagematerialet, indtil indholdet er kontrolleret og der er udført et første driftstjek. Hvis der er skade på enheden,

skal du straks sende en anmodning til forsendelsesfirmaet om at iværksætte en undersøgelse og udfærdige en rapport

om beskadigelse af indholdet. Leveringsbetingelserne i alle Zimmer Surgical salgskontrakter for salg af denne enhed er

fob Dover, Ohio, USA, og Zimmer Surgical's ansvar ophører, når varen er leveret til den første fragtfører. Derefter

overgår ejerskabet til kunden. Ethvert krav i anledning af tab, skade eller manglende levering skal gøres gældende over

for forsendelsesselskabet inden for 10 dage efter afsendelsen.

Din lokale Zimmer salgsrepræsentant kan hjælpe dig med at afgøre prisen for udskiftning eller reparation, så at et

korrekt krav kan udfyldes til forsendelsesselskabet.

Bemærk: Forsøg ikke at returnere beskadigede produkter uden først at have skaffet den korrekte godkendelse fra

forsendelsesselskabet.

INSTALLATIONSANVISNING

•

Inden første ibrugtagning skal Zimmer Luftdermatom II rengøres og steriliseres i henhold til anvisning. (Se

ANVISNING TIL RENGØRING OG DESINFEKTION AF DERMATOM II og STERILISATIONSANBEFALINGER.)

•

Overhold forholdsreglerne i hospitalets protokol angående sterile områder.

•

Forbind håndstykket til slangen ved at tage godt fat i både drejetappen på enden af håndstykket og slangen. Pres

dem sammen, og drej slangen mod højre, således at stifterne er i fordybningerne (se figur 4).

•

Når der bruges en tryktank skal tanken væres grundigt aftørret med desinfektionsmiddel og tildækket inden

placeringen i operationsstuen. Tanken skal altid være godt fastgjort til væggen, en stabil vogn eller en anden

stationær enhed, for at forhindre den i at falde ned, og væk fra varmekilder.

•

Før installationen i operationsstuen åbnes tankens ventil ganske langsomt, således at der kun slippes gas nok ud

til at blæse snavs, der måtte have samlet sig i ventilen, ud. Stå væk fra åbningen, bag ved tanken, under denne

proces. Sæt ventilen tilbage i lukket position. Installer regulatoren.

•

Når regulatoren er korrekt installeret kontrolleres det, at regulatoren står i helt slukket tilstand. Tankens ventil kan

så langsomt åbnes, indtil den er helt åben. Dette vil tillade gassen at sætte regulatoren under tryk.

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•

Påbegynd aldrig en procedure, hvis trykmåleren viser, at der er mindre end 3450 kPa i tanken. Lad aldrig trykket i

tanken falde til under 1380 kPa, ellers vil det korrekte output-tryk ikke vedligeholdes.

•

Sæt slangens fordelingsenhedsende ind i regulatorens lynkoblingspakning.

•

Aktivér dermatomet ved at trykke regulatorhåndtaget helt ned med sikkerhedslåsen i positionen TÆNDT ( |-- ).

Trykket etableres ved gradvis at dreje på regulatorstyringsknappen. Det fastsatte tryk skal altid etableres ved

brug af trykmåleren med instrumentet tændt. Det anbefalede tryk er 100 PSI i tændt tilstand ved brug af en

anbefalet slange. Hvis der anvendes en forlængerslange, skal trykket ved kilden øges med 1 PSI pr. fod (22,6

kPa/m) forlængerslange. Hvis der for eksempel tilføjes en 10 fod (3,05 m) forlængerslange til standardslangen,

skal det angivne tryk ved kilden være 110 PSI (759 kPa), når dermatomet er tændt. Sæt sikkerhedslåsen tilbage i

positionen SIKKER (O•), når det ikke er i brug.

•

Under installationsproceduren kontrolleres visuelt for skader og/eller slid. Hvis der ses skade eller slid, som kan

kompromittere instrumentets funktion, må dette ikke anvendes.

MONTERING AF BLADET (Se figur 7)

Det er ikke nødvendigt at smøre bladet. Brug et nyt, sterilt blad til hvert indgreb. (Der kan være brug for flere

blade ved omfattende indgreb).

Montering af bladet:

•

Sæt Zimmer dermatom II's gashåndtag i positionen SIKKER (O•). Dermatomet sættes i positionen SIKKER ved

at skubbe sikkerhedslåsen på regulatorhåndtaget mod instrumentets bladende til positionen SIKKER (O•). Kun

symbolet SIKKER (O•) må være synligt (se figur 7).

•

Ved brug af Zimmer dermatom II-skruetrækkeren (REF 00-8851-205-00), løsnes håndstykkets breddepladeskrue.

Skruen må ikke fjernes fra håndstykket. Hvis der allerede sidder en breddeplade på det, fjernes den ved at holde

i begge sider og skubbe/løfte fremad og opad (se figur 7A-C). Der må ikke løftes fra forsiden, da det vil medføre

kontakt med bladet og mulig tilskadekomst.

•

Hvis bladet skal udskiftes, fjernes det brugte blad, inden der isættes et nyt. Se afsnittet FJERNELSE AF BLADET.

•

Sæt hele blad/dæksel-enheden (se figur 7D) på håndstykket, så bladnøglen passer i indhakket på håndstykket og

håndstykkets drevpind går ind i hullet i bladet (se figur 7E). Sæt din finger på bladenheden (den hvide del). Hold

bladenheden, og løft samtidig den ene ende af bladdækslet (den blå del), og tag bladdækslet af bladenheden (se

figur 7F). Gem bladdækslet til fjernelse af bladet efter brug.

•

Med trykket på breddepladen vendende udad anbringes breddepladen fladt på forsiden af dermatomhovedet (se

figur 6). Skub forsigtigt bagud mod skruen (se figur 7G-I, indtil hullet i breddepladen er under monteringsskruen.

Grib ikke fat i breddepladens forende, da det vil bevirke kontakt med bladet og mulig tilskadekomst. Stram

forsigtigt monteringsskruen ved hjælp af skruetrækkeren. Skruen må ikke strammes for meget (se figur 7J).

•

BEMÆRK: Vælg den rigtige breddeplade, så skærekravene opfyldes.

•

Forsigtig: Kontroller, at breddepladen ligger sikkert under de ydre breddepladeholdere (se figur 7I). Hvis

breddepladen ikke monteres/sikres korrekt, kan dette medføre patientskade.

SÅDAN SKÆRES TRANSPLANTATET

•

Huden skal forberedes på rutinemæssig vis.

•

Det er ikke nødvendigt at smøre huden, men det kan dog gøre bevægelsen med Zimmer Luftdermatom II lettere

på donorstedet, hvis dette er smurt.

•

Indstil knappen på håndtaget til kontrol af tykkelse til den ønskede transplantattykkelse (se figur 6). Der må ikke

indsættes noget instrument mellem bladet og håndtaget til kontrol af tykkelse, da dette kan beskadige eller give

et hak i bladet, hvilket medfører ringe skæring. Det kan desuden kompromittere instrumentets kalibrering.

•

For at aktivere dermatomet løftes regulatorhåndtaget, og sikkerhedslåsen føres tilbage fra SIKKER (O•)

positionen mod slangekoblingen. Symbolet for TÆNDT ( |-- ) skal være synligt. (Se figur 7.) For det bedste

resultat anbefales det, at dermatomet kører ved højeste hastighed. For at sikre, at højeste hastighed opnås

trykkes der helt ned på regulatorhåndtaget, mens sikkerhedslåsen er i TÆNDT ( |-- ) positionen.

•

Tryk ned på regulatorhåndtaget for at starte dermatomet. Sæt håndstykket på donorstedet i en vinkel på

30° – 45° (se figur 8). Før enheden fremad med et let, nedadgående tryk for at sikre, at skæret forbliver i

vedvarende og fast kontakt med donorstedet.

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•

Der kan anvendes to metoder til at fjerne transplantatet fra instrumentet:

• Metode I

Lad det afskårne transplantat akkumuleres i håndstykkets lomme. Løft håndstykket væk fra donorstedet for

at afslutte transplantatet. Før regulatorhåndtaget tilbage til positionen SIKKER (O•), og flyt forsigtigt

transplantatet (se figur 8).

• Metode II

Brug en vævstang til forsigtigt at løfte transplantatet, efterhånden som det kommer frem af lommeområdet.

Transplantatet må ikke strækkes eller trækkes i, idet dette fører til ujævne kanter og uensartede skæringer.

Løft håndstykket væk fra donorstedet for at afsluttet transplantatet. Før regulatorhåndtaget tilbage til

positionen SIKKER (O•) (se figur 9).

EFTER PROCEDUREN

Før dermatomet fjernes fra regulatoren:

•

Luk tankens ventil, hvis relevant.

•

Drej på regulatorknappen, indtil trykket aflæses som nul.

•

Aktiver dermatomet for at tømme linjetrykket.

•

Fjern slangen fra Zimmer Luftdermatom II.

•

Fjern så slangen fra regulatoren. Slangens ende skal fastholdes godt, når frakobles, for at forebygge mulig skade

på fordelingsenheden, når slangen frakobles.

•

Fjern brugte blade (se afsnittet FJERNELSE AF BLADET), og bortskaf på korrekt vis, i beholdere til skarpe og

spidse genstande, eller i overensstemmelse med hospitalets protokol.

•

Fjern overskydende kropsvæske og væv med en engangs-, ikke-fnuggende serviet, og dæk området til med en

fugtig klud. Kropsvæsker og væv må ikke tørre på instrumenterne, inden de rengøres.

•

Instrument, slange, breddeplader og skruetrækker lægges tilbage og sikres i instrumentkassen for transport og

rengøring.

FJERNELSE AF BLADET

•

Løsn breddepladens skrue ved hjælp af Dermatom II skruetrækkeren. Skruen må ikke fjernes fra enheden.

•

Breddepladen fjernes ved at holde i begge sider af breddepladen og skubbe/løfte fremad og opad (se figur 7A-C).

Der må ikke løftes fra forenden, da det vil bevirke kontakt med bladet og mulig tilskadekomst.

•

Placer igen bladdækslet over den ene ende af bladenheden, og klik det ned på den anden ende af bladenheden

(helst, se figur 7K), eller fjern forsigtigt bladenheden ved at løfte opad fra under bladenheden ved brug af

fingeradgangsområdet (se figur 7L).

•

Bortskaf brugte blade i en beholder til skarpe og spidse genstande, eller i overensstemmelse med hospitalets

protokol.

FORHOLDSREGLER VED RENGØRING

Alle efterfølgende rengørings- og sterilisationstrin faciliteres ved ikke at tillade blod, vævsrester, eller desinfektionsmidler

at tørre på brugte instrumenter.

Vær forsigtig i håndteringen af Zimmer Luftdermatom II. Tabes eller beskadiges den ved et uheld, skal den returneres til

service.

18

Page 19

SE afsnittet VIGTIGHEDEN AF BEHOVET FOR OMHU.

Zimmer Luftdermatom II må ikke smøres. Smøring kan føre til alvorlig skade på motoren.

Zimmer Luftdermatom II og tilbehør (undtagen regulatoren) dampsteriliseres. Følg instruktionerne i

STERILSATIONSANBEFALINGER.

ANVISNING TIL RENGØRING OG DESINFEKTION AF DERMATOM II

(SE FIGURERNE 10-13)

I følgende anvisninger og tabel gives detaljerede forklaringer om rengøring og desinfektion af Zimmer Luftdermatom II.

•

Vær forsigtig, når du håndterer dermatomet for at kontrollere, at det brugte blad er blevet fjernet. Hvis ikke,

skal alle brugte blade bortskaffes i overensstemmelse med hospitalets politik vedrørende kontamineret

affald og skarpe og spidse genstande.

•

De universelle forholdsregler vedrørende håndtering af kontaminerede/biofarlige materialer skal efterleves.

•

Instrumenter skal rengøres inden 30 minutter efter brug for at minimere potentialet for tørring før rengøring.

•

Breddepladen fjernes før rengøring, og rengøres separat.

•

Følg de rengøringsanvisninger, der findes i skema 1 eller skema 2, for håndstykket og breddepladen til

dermatom II.

•

Zimmer luftslange kan aftørres og/eller rengøres manuelt med isopropylalkohol eller et rengøringsmiddel,

der er kompatibelt med silikonegummi. Slangen må ikke nedsænkes i væske eller vaskes automatisk.

•

Følg rengøringsproceduren; tjek visuelt for beskadigelse og/eller slitage.

•

Klargør rengøringsmidlerne ved den brugsopløsning og temperatur, som producenten anbefaler.

•

Håndtaget til kontrol af tykkelse skal flyttes under rengøring for at frigøre snavs, der kan sidde fast under

håndtaget, eller i indhakkene.

•

Der skal udvises omhu omkring led, forbundne områder og fordybninger, når enheden rengøres. Bekræft,

at alt synligt snavs er fjernet fra disse områder, især drevpindsfordybningen, som findes i bunden af

enheden.

•

Kontroller de bevægelige dele for at sikre gnidningsfri brug gennem hele det beregnede

bevægelsesspektrum.

Bemærk: Hvis skade eller slid, som kan kompromittere instrumentets funktion, bemærkes, må det ikke anvendes. Se

afsnittet RETURNERINGSGODKENDELSE OG INFORMATION OM UDSKIFTNING.

•

Kun dampsterilisation. Følg instruktionerne I STERILSATIONSANBEFALINGER.

19

Page 20

Rengøringstrin

Tabel 1 Valideret manuel rengørings- og desinfektionsprocedure

Trin

Beskrivelse af trin

Trinanvisning

Tilbehør

Varighed

1

Fjernelse af

kontaminering

Skyl produktet under

rindende vandhanevand,

koldt eller ved

stuetemperatur, for at

fjerne evt. synligt organisk

materiale, og brug dertil en

blød børste

- Koldt/stuetemperatur

vand fra hanen

Indtil alt synligt snavs

er fjernet

Tør instrumentet med en

tør, ikke-fnuggende serviet.

Filtreret luft af medicinsk

kvalitet kan anvendes, hvis

det haves

- Ikke- fnuggende klud

Påføring af desinfektionsmiddel

Kom desinfektionsmiddel

på instrumentets

overflader ifølge

producentens anbefalinger

- Desinfektionsmiddel

Manuel

desinfektion

Mens desinfektionsmidlet

er på instrumentets

overflader, rengøres alle

kontaktflader, led og

forbundne områder med

en ren, blød børste

- Ren, blød børste

5

Slutskylning

Skyl produktet under

destilleret/filtreret vand ved

stuetemperatur

- Destilleret/filtreret

vand ved

stuetemperatur

Mindst 30 sekunder

6

Endelig tørring

Tør instrumentet med en

tør, ikke-fnuggende serviet.

Filtreret luft af medicinsk

kvalitet kan anvendes, hvis

det haves

- Ikke- fnuggende klud

Indtil produktet ses at

være tørt

2

3

Desinfektionstrin

4

Tørring

20

- Blød børste

(brug ikke

rengøringsbørster

af metal)

- Filtreret, komprimeret

luft af medicinsk

kvalitet

- Sprayflaske eller

anden manuel

påføringsanordning

- Desinfektionsmiddel

- Filtreret, komprimeret

luft af medicinsk

kvalitet

Indtil produktet ses at

være tørt

Kontakttiden varierer

alt efter produktets

brug; mindst et (1)

minut anbefales

Den manuelle

rengøring er

gennemført, når

instrumentets

overflade, led &

sprækker er blevet

manuelt rengjort

Page 21

Tabel 2 Valideret, automatisk rengørings- og

desinfektionsprocedure

Trin

Beskrivelse af trin

Trinanvisning

Tilbehør

Varighed

1

Fjernelse af

kontaminering

med meget snavs

Skyl produktet under

rindende

vandhanevand, koldt

eller ved

stuetemperatur, for at

fjerne evt. synligt

organisk materiale, og

brug dertil en blød

børste

- Koldt/stuetemperatur

vand fra hanen

Indtil alt synligt

snavs er fjernet

2

Præ-iblødsætning

(Valgfrit)

Nedsænk instrumentet

i en beholder indeholdende vand og flydende rengøringsmiddel

- Blød børste

(Brug ikke

rengøringsbørster af

metal)

- Vandhanevand ved den

temperatur, som

producenten anbefaler

- Desinfektionsmiddel/

rengøringsmiddela

Kontakttiden varierer

alt efter produktets

brug; mindst

femten

(15) minutter

anbefales

Rengøringstrin

- Egnet nedsænkningsbeholder

3

4

5

Præ-iblødsætning

Skyl

Tørring

Automatisk

vaskemaskine

Skyl produktet under

rindende vandhanevand, koldt eller ved

stuetemperatur, med

hjælp fra en blød børste

- Koldt/stuetemperatur

vand fra hanen

Tør instrumentet med

en tør, ikke-fnuggende

serviet. Filtreret luft af

medicinsk kvalitet kan

anvendes, hvis det

haves

- Ikke-fnuggende serviet

Skil instrumentet ad,

og læg alle delene i

opvaskemaskinen

- Automatisk

vaskemaskine

- Desinfektionsmiddel/

rengøringsmiddel

- Blød børste

- Filtreret, komprimeret luft

af medicinsk kvalitet

- Adskilt enhed

- Vaskemaskine

rengøringsopløsning

- Vaskemaskine

neutraliserende

opløsningb (hvis

relevant)

21

Mindst

30 sekunder

Indtil produktet ses

at være tørt

Minimum

sekvenstid: 34

minutter, når alle

nedenstående trin

gennemføres

Page 22

Desinfektionstrin

Anbefalet automatisk vaskemaskinesekvens

Trin

Minimumstid

Anbefalet temperatur

Forvask

3:00 minutter

Vandtemperatur 65 °C

Rengøring I-

3:00 minutter

Vandtemperatur 85 °C

Rengøring IIb eller

neutraliserende

1:00 minut

Vandtemperatur 10 °C

Skylning I

1:00 minut

Vandtemperatur 10 °C

Skylning II(sidste)

1:00 minut

Vandtemperatur 80 °C

Varmedesinfektion

og tørring

25:00 minutter

Kammertemperatur 110 °C

a: Rengøringsopløsning til præ-iblødsætning kan være en tensid eller protease/enzymatisk baseret

rengøringsopløsning, kompatibel med aluminium

b: Neutraliserende opløsning skal være passende til den anvendte rengøringsopløsning, baseret på producentens

anbefaling. Visse rengøringsopløsninger kræver ikke en neutraliserende efterpåføring af rengøringsmidlet. Hvis

neutralisering ikke er påkrævet påbegyndes den anden rengøringsapplikation.

22

Page 23

STERILISATIONSANBEFALINGER

Dampsterilisation er sikkert og effektivt, og er den eneste, anbefalede metode til dermatomet. Der er ingen

kontraindikationer over for sterilisation af Zimmer Luftdermatom II og dets tilbehør.

Sterilisation med ethylenoxid anbefales ikke, fordi pålidelige afgasningstider er svære at fastslå for smurte, kraftdrevne

instrumenter.

•

Anbring de rengjorte instrumenter i en instrumentbakke eller en fuldt perforeret autoklavekasse. Zimmer

Dermatom II autoklavekasse (REF 00-8851-003-00) anbefales. (Se fig. 14.)

•

Vær sikker på, at målerkontrolhåndtaget står på 0,05 mm.

•

Slangen må ikke knækkes, når kassens låg lukkes.

•

Hvis Zimmer Dermatom II autoklavekassen er brugt skal instrumenterne pakkes ind i to omslag af dobbelt

tykkelse, af nummer 140 trådantal, eller tilsvarende. Hvis der anvendes sterilisationsomslag skal de være fri for

vaskemiddelrester. Skumpuder må ikke genbruges. De kan indeholde opfangede urenheder fra dampforsyningen,

og kan derfra skabe aflejringer i instrumenterne. Tekstiler, som er blevet afsvedne på grund af overophedning kan

også skabe aflejringer på instrumenter. Eksponeringstiden er den samme for instrumenter i omslag som for

instrumenter uden.

•

Følg instruktionerne i ANBEFALEDE DAMPSTERILISATIONSPARAMETRE.

•

Må ikke nedsænkes i kold væske til afkøling. Nedkøles ved eksponering mod stuetemperatur, eller dækkes med

et koldt, sterilt klæde.

ANBEFALEDE DAMPSTERILISATIONSPARAMETRE

Sekvenstype

1,3

Præ-vakuum/ pulserende

vakuum

Præ-vakuum/pulserende

vakuum

3,4 Præ-vakuum/pulserende

vakuum

5 Præ-vakuum/pulserende

vakuum

2,3

Autoklavering i klasse N

Minimumstemperatur

7,8

6 Minimum eksponeringstid

9 Uden omslag

Med omslag

134 °C

3 minutter

3 minutter

132 °C

4 minutter

4 minutter

134 °C

18 minutter

8 minutter

132 °C

8 minutter

8 minutter

3,10

Minimum

tørretid

8 minutter

Anbefales ikke på grund af yderst lange sterilisationssekvenser, hvilket ikke er

praktisk.

1. Minimum valideret dampsterilisationstid, der kræves for at opnå 10-6 sterilitetssikkerhedsniveau (SAL).

2. Minimum valideret dampsterilisationstemperatur, der kræves for at opnå 10-6 sterilitetssikkerhedsniveau.

3. Lokale eller nationale specifikationer skal følges, hvor kravene til dampsterilisation er strengere eller mere

konservative end de, der er opregnet i denne tabel.

4. Desinfektion / dampsterilisationsparametre, anbefalet af Verdenssundhedsorganisationen (WHO) for genbrug af

instrumenter, hvor der er bekymringer vedrørende TSE/CJD kontaminering.

5. For universelle instrumentkasser, uden defineret lastkonfigurationer.

6. AAMI/AORN dampsterilisationssekvenser med længere varighed end de opregnede er også acceptable.

7. Dampsterilisationskompatible omslag, svarende til fire tykkelser af 140 trådantal musselin og i medicinsk kvalitet.

8. Stiv sterilisationsbeholder, som er i overensstemmelse med ANSI/AAMI ST46.

9. Flash-sterilisering (uden omslag) ved eksponering for 132 °C bør kun anvendes som nødsfaldsprocedure.

Instrumenter skal rengøres og skilles ad.

10. Tørretiden varierer efter ladningens størrelse, og skal forlænges for større ladninger.

Bemærk: Sterilisationsapparatets producents brugsvejledning og lastkonfiguration skal følges meget nøje.

Flash sterilisation (10 minutters eksponering i en autoklave, klasse N, i en åben bakke ved 132° C) anbefales ikke for

Zimmer Luftdermatom II, idet denne metode muligvis ikke yder sterilitet gennem hele instrumentet.

23

Page 24

OPBEVARINGSFORHOLD

Systemet skal opbevares under forhold, der er almindelige for lagerbygninger.

TILBEHØR (Se fig. 15-21.)

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Zimmer Dermatom II blade (10 pr. kasse)

REF: 00-8851-000-10

Zimmer Luftdermatom II, komplet (indeholder: 00-8851-001-00, 00-8801-002-00,

00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-000-00

Zimmer Luftdermatom II, komplet (Draeger) (indeholder: 00-8851-001-01, 00-8851002-02, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00,

00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-02

Zimmer Luftdermatom II, komplet (Synthes) (indeholder: 00-8851-001-01, 00-8851002-03, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00,

00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-03

Zimmer Luftdermatom II, komplet (Heyer) (indeholder: 00-8851-001-01, 00-8851-00204, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-000-04

Zimmer Luftdermatom II, komplet (AGA) (indeholder: 00-8851-001-01, 00-8851-00205, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-000-05

Zimmer Luftdermatom II, komplet (Shrader) (indeholder: 00-8851-001-01, 00-8851002-06, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00,

00-8851-204-00, 00-8851-205-00)

REF: 00-8851-000-06

Zimmer Luftdermatom II, komplet (DIN) (indeholder: 00-8851-001-01, 00-8851-00207, 00-8851-003-00, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851204-00, 00-8851-205-00)

REF: 00-8851-000-07

Zimmer Luftdermatom II håndstykke (indeholder: 00-8851-001-00, 00-8801-002-00,

00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00, 00-8851-205-00)

REF: 00-8851-001-00

Zimmer Luftdermatom II håndstykke (Draeger) (indeholder: 00-8851-001-01, 00-8851002-02, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-02

Zimmer Luftdermatom II håndstykke (Synthes) (indeholder: 00-8851-001-01, 00-8851002-03, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-03

Zimmer Luftdermatom II håndstykke (Heyer) (indeholder: 00-8851-001-01, 00-8851002-04, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-04

24

Page 25

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse::

Beskrivelse::

Beskrivelse::

Beskrivelse::

Beskrivelse::

Beskrivelse::

Beskrivelse::

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Beskrivelse:

Zimmer Luftdermatom II håndstykke (AGA) (indeholder: 00-8851-001-01, 00-8851002-05, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-05

Zimmer Luftdermatom II håndstykke (UK Schrader) (indeholder: 00-8851-001-01,

00-8851-002-06, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-06

Zimmer Luftdermatom II håndstykke (DIN) (indeholder: 00-8851-001-01, 00-8851002-07, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00,

00-8851-205-00)

REF: 00-8851-001-07

Zimmer luftdermatom-II-slange, 10 ft (3 m)

REF: 00-8801-002-00

Zimmer luftdermatom-II-slange: Draeger, 3 m

REF: 00-8851-002-02

Zimmer luftdermatom-II-slange: Synthes (AO), 3 m

REF: 00-8851-002-03

Zimmer luftdermatom-II-slange: Heyer, 3 m

REF: 00-8851-002-04

Zimmer luftdermatom-II-slange: AGA, 3 m

REF: 00-8851-002-05

Zimmer luftdermatom-II-slange: UK MA-7 Schrader, 3 m

REF: 00-8851-002-06

Zimmer luftdermatom-II-slange: DIN, 3 m

REF: 00-8851-002-07

Zimmer Dermatom II autoklavekasse

REF: 00-8851-003-00

Zimmer Dermatom II breddeplade, 2,5 cm.

REF: 00-8851-201-00

Zimmer Dermatom II breddeplade, 3,8 cm.

REF: 00-8851-215-00

Zimmer Dermatom II breddeplade, 5,1 cm.

REF: 00-8851-202-00

Zimmer Dermatom II breddeplade, 7,6 cm.

REF: 00-8851-203-00

Zimmer Dermatom II breddeplade, 10,2 cm.

REF: 00-8851-204-00

Zimmer Dermatom II skruetrækker

REF: 00-8851-205-00

Breddepladeskruer

REF: 00-8851-006-00 (5 pr. pakke)

Dermatom O-ringe

REF: 00-8800-105-41

SERVICE INFORMATION

Zimmer Luftdermatom II skal returneres til Zimmer Surgical, Dover, OH, eller et autoriseret reparationscenter

(uden for U.S.A.) til service. BEMÆRK: Zimmer er ikke ansvarlig for nogen instrumentfejl, som opstår grundet

vedligeholdelse udført af et ikke autoriseret servicecenter. Forsøg ikke at skille håndstykket ad. Det er en

25

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