Instruction Manual
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Zimmer™ Air Dermatome Instruction Manual INDICATIONS FOR USE The Zimmer Air Dermatome is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
DESCRIPTION The Zimmer Air Dermatome (See Fig. 1, 2) is an air-powered surgical skin grafting instrument. The thickness control adjustment ranges from 0 to .030 in. (0.75 mm) in 0.002 in. (0.050 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 Fig. 19.) Two stainless steel machine screws secure the plates to the underside of the instrument. The plates are easily fastened and removed with the screwdriver provided. 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.
26 oz. (737 g) 8.5 in. (21.6 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.
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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 or one having a probe conforming to BSI 5682 for high pressure medical-grade compressed air. The Zimmer Air Dermatome 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 is in use, the user must be thoroughly familiar with its function, application and instructions for use. WARNING: MANUAL CLEANING ONLY-NO AUTOMATIC WASHING 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 dermatome 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 word SAFE should be visible. Use only Zimmer Dermatome Blades (REF 00-8800-000-10). The Zimmer Dermatome Blade has been specifically designed and engineered for use with the Zimmer Air Dermatome. Other blades may not fit properly in the dermatome and may cause serious injury. Use of non-Zimmer Dermatome Blades can cause the dermatome to take grafts deeper than what the user has selected. Handle the Zimmer Air Dermatome 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. 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 permits removal 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 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 INSTRUCTIONS FOR THE DERMATOME. Failure to follow these instructions may damage the dermatome.
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.
•
Check the action of moving parts to ensure smooth operation throughout the intended range of motion.
•
The Zimmer Air Dermatome 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.
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RECEIVING INSPECTION After receiving the Zimmer Air Dermatome, 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, Zimmer Air Dermatome must be cleaned and sterilized per instructions. (See Cleaning and Sterilization Instructions.)
•
Observe sterile field precautions per hospital protocol.
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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.
•
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.
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Insert the diffuser end of the hose into the quick-disconnect fitting on the regulator.
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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 supplied 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, when not in use.
•
During setup procedure, visually inspect for damage and/or wear. If damage or wear is noted that may compromise the function of the instrument, do not use.
BLADE INSTALLATION (See Fig. 5.) •
Use a new sterile blade for each procedure. Use only Zimmer Dermatome Blades (REF 00-8800-000-10).
•
To install blade: •
Place the throttle in the SAFE 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 position. Only the word SAFE should be visible.
•
Using a screwdriver, loosen width plate screws approximately two turns. Do not remove screws from handpiece. Refer to BLADE REMOVAL section.
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Place a new blade in slot on the handpiece. If replacing a blade, remove the used blade before inserting the new one.
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Mate the drive pin with the hole in the blade. Note: “INSERT WITH THIS SIDE UP” message.
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•
Lubrication of the blade is not necessary because the backing of the blade is a self-lubricating plastic.
•
Choose proper width plate to satisfy cutting requirements. Place width plate over blade and tighten screws. Do not overtighten. Ensure the printing on the width plate is facing out. (See Fig. 5)
CUTTING THE GRAFT •
Skin should be prepared in routine manner.
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It is not necessary to lubricate the skin; however, lubricating the donor site with sterile mineral oil may ease travel of the Zimmer Air Dermatome.
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Set control lever adjustment knob pointer to desired graft thickness. Factory calibrations indicate 0.002 in. (0.050mm). 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. (See Fig. 6.)
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Hold the handpiece on the donor site at a 30° – 45° angle. (See Fig. 8, 9.)
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To activate the dermatome, lift the throttle lever and slide the safety lock back from the SAFE position toward the hose coupling. The word ON should be visible. (See Fig. 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.
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Depress the throttle to start the cut. Guide the unit forward using a slight downward pressure to ensure that the cutting edge remains continuously firmly in contact with the donor site.
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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 position and carefully remove the graft. (See Fig. 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 nonuniform cuts. Lift the handpiece away from the donor site to end the graft. Return the throttle to the SAFE position. (See Fig. 9.)
AFTER THE PROCEDURE Before removing the dermatome from the regulator: •
Close the tank valve, if applicable.
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Turn the regulator knob until the pressure reads zero.
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Activate the dermatome to bleed off the line pressure.
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Turn quick-disconnect coupling to the right, which disengages the Schrader fitting, then remove the hose from the regulator. The end of the hose should be held securely when disengaging the Schrader fitting to prevent possible damage to the diffuser when the hose is disconnected.
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Remove the used blade and dispose of properly in a designated sharps container or per hospital protocol.
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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.
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Return and secure instrument and width plates to instrument case for transport and cleaning.
BLADE REMOVAL •
Loosen the width plate screws. Do not remove the screws.
•
To remove the width plate, hold both sides and lift. Do not lift the width plate from the front as this will cause contact with the blade and possible injury.
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Remove the blade carefully lifting from the side.
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Dispose of used blade in a sharps container or per hospital protocol.
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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 carefully. Should it be inadvertently dropped or damaged, it should be returned for service. Refer to NEED TO ADHERE TO CARE REGIMEN section. Do not lubricate the Zimmer Air Dermatome. Lubrication may cause extensive damage to the motor. Never immerse the dermatome in any solution. Some solutions will corrode the metal and delicate moving parts and also break down the internal lubricants. Never immerse the dermatome in liquid chemical disinfectant. Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must not be used. Saline solution has a corrosive effect on stainless steel and should not be used. Do not process the dermatome handpiece or accessories in an automatic washer. Automatic washing has the potential to destroy the surface protective layer of the device and cause corrosion. Never clean in an ultrasonic cleaner. Ultrasonic cleaning will dislodge oil from the bearings and render the instrument inoperative. Ultrasonic cleaning may affect calibration of the Zimmer Air Dermatome. Never sterilize the regulator or immerse it in any solution. Steam sterilize the Zimmer Air Dermatome and accessories (except regulator). Follow instructions in STERILIZATION RECOMMENDATIONS.
CLEANING AND DISINFECTION PROCESS INSTRUCTIONS FOR THE DERMATOME •
The following instructions and chart detail the cleaning and disinfection process for the Zimmer Air Dermatome.
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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.
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Never let water or detergent enter the handpiece through the hose connection. Permanent damage may result. The hose should be left attached to the handpiece during cleaning. Disconnect before sterilization. (See Fig. 10.)
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Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with a damp cloth. The damp cloth is utilized to assist in the prevention of the un-removed soil drying prior to cleaning and disinfection process. Body fluids and tissue should not be allowed to dry on the instrument prior to cleaning.
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Universal precautions for handling contaminated/biohazardous materials should be observed.
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Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning.
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Follow the Manual Cleaning Instructions found in Chart 1.
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Following the cleaning procedure, visually inspect for damage and/or wear.
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Prepare cleaning agents at the use-dilution and temperature recommended by the manufacturer.
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The thickness control lever should be moved during cleaning to release any debris which may be trapped under the lever or in the notches.
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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.
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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
Apply Neutral pH disinfectant to the device’s surface area per manufacture’s recommendations.
- Neutral pH disinfectant
While Neutral pH 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
Disinfection Application
Manual Disinfection
- Soft bristle brush (Do not utilize metal cleaning brushes)
- Medical quality filtered compressed air
- Spray bottle or other manual applicator (Do not submerge the device)
- Neutral pH 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.
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Final Rinse
Rinse product under Room Temperature Distilled/Filtered Water.
- Room Temperature Distilled/Filtered Water
Minimum of 30 seconds
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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
- Medical quality filtered compressed air
WARNING : - DO NOT SUBMERGE ZIMMER MESHGRAFT OR DERMATOMES IN WATER OR CLEANER. - WHILE RINSING, DO NOT ALLOW WATER OR CLEANER INTO MOTOR COMPARTMENT OR GEAR AREAS, REMOVE ANY WATER/CLEANER IMMEDIATELY IF ENTERED INADVERTENTLY.
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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 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 Autoclave Case (REF 00-8801-003-00) is recommended. (See Fig. 14.)
•
Do not kink the hose when closing the case lid.
•
If the Zimmer Dermatome 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.
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Follow instructions in RECOMMENDED STEAM STERILIZATION PARAMETERS.
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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 2,3 Prevacuum/Pulsating
Vacuum 3,4 Prevacuum/Pulsating
Vacuum 5 Prevacuum/Pulsating Vacuum Gravity/Gravity Displacement
Minimum Temperature 134°C 273°F 132°C 270°F 134°C 273°F 132°C 270°F
6 Minimum Exposure Time 7,8 Wrapped
9 Unwrapped
3 min
3 min
4 min
4 min
18 min
18 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 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: REF:
Blades (10 per box) 00-8800-000-10
Description: REF:
Zimmer Air Dermatome Complete (includes: 00-8801-001-00, 00-8801-003-00) 00-8801-000-00
Description:
Zimmer Air Dermatome Handpiece (includes: 00-8801-002-00, 00-8802-001-00, 00-8802-002-00, 00-8802-003-00, 00-8802-004-00, 00-8803-000-00) 00-8801-001-00
REF: Description: REF:
Hose 00-8801-002-00
Description: REF:
Autoclave Case 00-8801-003-00
Description: REF:
1 in. (2.5 cm) Width Plate 00-8802-001-00
Description: REF:
1.5 in. (3.8 cm) Width Plate 00-8802-015-00
Description: REF:
2 in. (5.1 cm) Width Plate 00-8802-002-00
Description: REF:
3 in. (7.6 cm) Width Plate 00-8802-003-00
Description: REF:
4 in. (10.2 cm) Width Plate 00-8802-004-00
Description: REF:
Screwdriver 00-8803-000-00
Description: REF:
Width Plate Screws (10 per pack) 00-8803-001-10
SERVICE INFORMATION The Zimmer Air Dermatome should be returned to Zimmer Surgical, Dover, OH 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 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.
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.
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WARRANTY INFORMATION (U.S.A. only) Zimmer Surgical warrants that the Zimmer Air Dermatome, along with all parts and accessories, have been tested and inspected, and have left the factory in proper working condition, free from visible defects. Zimmer Surgical warrants to the first consumer purchaser of new Zimmer Air Dermatomes, 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 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 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. Zimmer Air Dermatomes 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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M Revision: 12-10 © 1992, 2010 Zimmer Surgical, Inc. Printed in U.S.A. 06001810406 Printed on Recycled Paper
Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 U.S.A.
U.K. LTD. P Zimmer 9 Lancaster Place
0086
South Marston Park Swindon, Wiltshire SN3 4FP United Kingdom