Instruction Manual
6 Pages
Preview
Page 1
ENGLISH
Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 USA (800) 830-0970 www.ZimmerBiomet.com
IFUs, Patents & Symbol Glossary http://labeling.zimmerbiomet.com
06001811272 (EN) Rev. C (Dec 2021) © 2016, 2021 Zimmer Surgical, Inc. 2797
Dermatome AN Instruction Manual
Steam Sterilize
Ȯ
I
Do Not Lubricate
BIOMET GSCC B.V. Hazeldonk 6530 4836 LD Breda The Netherlands
Insert Barcode here INDICATIONS FOR USE The Dermatome AN is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
Never use standard compressed air with the Dermatome AN. Standard compressed air directly from a compressor can contain impurities, oils, and moisture that can damage the dermatome.
DESCRIPTION The Dermatome AN (see Figures 1, 2 and 3) is an air-powered surgical skin grafting instrument. The thickness control adjustment ranges from 0, 0.004 in. (0.1 mm) to 0.024 in. (0.6 mm) in 0.002 in. (0.05 mm) increments.
The automatic shut-off valve in the end of the hose (see Figure 4) permits removal and reconnection 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 Dermatome AN above recommended pressures. Excessive pressure may cause internal damage and exert unusual stress on the hose.
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 and 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 (see Figure 21). The plates are easily fastened and removed with the screwdriver provided (see Figure 20).
The user and operating staff must always pay close attention to the CLEANING PRECAUTIONS and CLEANING PROCESS INSTRUCTIONS. Failure to follow these instructions may damage the dermatome.
The dermatome has a self-cooling rotary vane air motor. The motor is powered by waterpumped compressed dry nitrogen (99.97% pure) or by medical-grade compressed air and provides nearly vibration-free power.
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.
SPECIFICATIONS I. Physical Weight: Length: Width: Exhaust:
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 Dermatome AN should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued accuracy.
II.
Operational No-Load speed: Recommended Power Source: Operating Pressure: Consumption:
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 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
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 Dermatome AN, 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 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.
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 gases 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.
Your local Zimmer Biomet 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.
Medical Grade compressed air: Oxygen: 21% ± 0.5% Nitrogen and inert gases: Balance Moisture: 15.0 vpm (max)
Note: Do not attempt to return damaged goods without first securing proper authorization from the delivering carrier. SETUP INSTRUCTIONS • Prior to initial usage, Dermatome AN must be cleaned and sterilized per instructions (see CLEANING PROCESS INSTRUCTIONS and STERILIZATION PROCESS INSTRUCTIONS). • 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 keep it 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, which will allow 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 (I) 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 (690 kPa) 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 (Ȯ) position when the dermatome is not in use. • During setup procedure, visually inspect the dermatome handpiece and hose for damage and/or wear. If damage or wear that may compromise the function of the instrument is noted, do not use.
Note: Use only compatible air hoses conforming to BSI 5682 for high pressure medical-grade compressed air. The Dermatome AN 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 Dermatome AN is in use, the user must be thoroughly familiar with its function, application and instructions for use. Use only Dermatome Blades (REF 88700010). The Dermatome Blade has been specifically designed and engineered for use with the Dermatome AN. Other blades may not fit properly in the dermatome and may cause serious injury. Use of non- Dermatome Blades can cause the dermatome to take grafts deeper than what the user has selected. Blade is Sterile only if package is unopened and undamaged. Blade is sharp. Handle with care. 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 (Ȯ) 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 (Ȯ) position, the safety lock on the throttle should be toward the blade end of the dermatome and only the SAFE (Ȯ) symbol should be visible. Handle the Dermatome AN 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. Page 1/6
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).
CLEANING PROCESS INSTRUCTIONS The following instructions and chart detail the cleaning process for the Dermatome AN and reusable accessories. • 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 or after removal from solution 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 for the Dermatome AN handpiece and width plates, autoclave case, and screwdriver. Follow the Cleaning Instructions found in Chart 2 for the Dermatome Air Hoses. • Prepare cleaning agents at the use-dilution and temperature recommended by the manufacturer. Use of recommended temperatures is important for optimal performance of cleaning agents. • Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid). • Always use fresh volumes of water for rinsing. Do not reuse rinsing water for rinsing or any other purpose. • Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Purified water should be used for final rinsing to eliminate mineral deposits on instruments (e.g. ultra-filter (UF), reverse-osmosis (RO), deionized (DI), or equivalent). • 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 given to joints, mated areas, and cavities of the device during the Pre-Soak step in Chart 1 below. Verify all visible soil has been removed from these areas, especially the drive pin cavity located at the bottom of the device. • Following the cleaning procedure, visually inspect the dermatome handpiece and hose for damage and/or wear. • 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 PROCESS INSTRUCTIONS.
To install the blade: • Place the Dermatome AN handpiece throttle in the SAFE (Ȯ) position. To place the dermatome in the SAFE (Ȯ) position, slide the safety lock on the throttle toward the blade end of the instrument to the SAFE (Ȯ) position. Only the SAFE (Ȯ) symbol should be visible (see Figure 7). • Using the Dermatome Screwdriver (REF 88700500), 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 Figures 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 7E). 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 Figures 7F-H), 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 7I). 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 7H). 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 Dermatome AN. • 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 (Ȯ) position toward the hose coupling. The ON (I) 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 (I) position. • Depress the throttle to start the dermatome. With unit running, 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.
Chart 1 Validated Automated Cleaning Procedure Step
Step Description Removal of width plate(s)
Disassembly
1
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 (Ȯ) 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 (Ȯ) position (see Figure 9).
Accessories - Screwdriver, PN 88700500
Duration N/A
The width plate can be removed by using a screwdriver, and loosening width plate screws approximately two turns. Do not remove screws from handpiece.
The cleaning instructions listed below are intended for the handpiece, width plates, screwdriver, and autoclave case. Each device should undergo each of the steps below individually.
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 Dermatome AN. • 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. Place instruments in a basin of distilled water or in a tray covered with a damp cloth. Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning. • Return and secure instrument, hose, width plates and screwdriver to instrument case for transport and cleaning.
2
Contamination Removal
Handle the Dermatome AN 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. Dermatome AN. Lubrication may cause extensive damage to the motor. 3
Page 2/6
- Soft Bristle Brush - Lukewarm/ Room Temperature (22°C - 40°C) running utility water
Brush each component for a minimum of one minute or until all visible soil is removed.
Careful attention must be given to joints, mated areas, and cavities of the components. Verify all visible soil has been removed from these areas, especially the drive pin cavity located at the bottom of the handpiece.
CLEANING PRECAUTIONS All subsequent cleaning and sterilization steps are facilitated by not allowing blood, tissue debris, or disinfectants to dry on used instruments.
Steam sterilize the Dermatome AN and accessories (except regulator and single use blades) by following instructions in STERILIZATION PROCESS INSTRUCTIONS.
Rinse handpiece, width plates, autoclave case, and screwdriver under running lukewarm/ room temperature (22°C - 40°C) running utility water for a minimum of one minute. Remove gross soil and debris using a soft bristled brush. (Refer to Figures 10 – 13) The thickness control lever of the handpiece should be moved during cleaning to release any debris which may be trapped under the lever or in the notches.
Cleaning Steps
BLADE REMOVAL • Loosen the width plate screw using the Dermatome 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 Figures 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 7J), or remove the blade assembly carefully by lifting up from under the blade assembly using the finger access area (see Figure 7K). • Dispose of used blade in a sharps container or per hospital protocol.
Do not lubricate the
Step Instruction Prior to cleaning, ensure the width plate has been removed from the handpiece and is cleaned separately.
Pre-soak
Place handpiece, width plates, autoclave case, and screwdriver into an immersion container containing water and liquid detergent, ensuring to completely submerge
- Lukewarm/ Room Temperature Tap Water (not to exceed 55°C) - Neutral pH Enzymatic Detergent
Minimum of ten (10) minutes is recommended for pre-soak.
ENGLISH
Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 USA (800) 830-0970 www.ZimmerBiomet.com
IFUs, Patents & Symbol Glossary http://labeling.zimmerbiomet.com
06001811272 (EN) Rev. C (Dec 2021) © 2016, 2021 Zimmer Surgical, Inc. 2797
Dermatome AN Instruction Manual
Steam Sterilize
Ȯ
BIOMET GSCC B.V. Hazeldonk 6530 4836 LD Breda The Netherlands
Do Not Lubricate
I
Insert Barcode here Chart 2 Validated Manual Cleaning Procedure for the Air Hoses
- Appropriately Sized Immersion Container
Step 1 Disassembly
all components. Soak products and remove any remaining visible soil with the assistance of a soft bristle brush.
- Soft Bristle Brush
The thickness control lever of the handpiece should be moved during cleaning to release any debris which may be trapped under the lever or in the notches.
Automated Washer
2
3
Rinse products under cold/room temperature purified water for a minimum of one minute.
- Cold/Room Temperature Purified Water
Place all components (handpiece, width plates, autoclave case, and screwdriver) into a suitable washer/disinfector basket and process through the automated washing cycle.
N/A
Automated Washer Steps
Step Description
Duration
Contamination Removal
Detergent Application
Minimum of 1 minute
Rinse and brush device under lukewarm/room temperature (22°C 40°C) running utility water for a minimum of one (1) minute, removing all visible organic material with the assistance of a soft bristle brush.
- Lukewarm/ Room Temperature Utility Water
Apply neutral pH detergent per the detergent manufacturer's recommendations to the device’s surface area using a spray bottle for a minimum of 30 seconds.
- Neutral pH Enzymatic Detergent
Directly following the detergent application, apply additional detergent solution and utilizing a clean soft bristle brush clean all surfaces, joints, and mated areas of the device for a minimum of one (1) minute. Additional detergent should be applied during this time.
- Clean soft bristle brush
N/A 4
Recommended Automatic Washer Cycle
Step
Accessories Dermatome AN Handpiece
Duration N/A
Disconnect before sterilization.
Manual Cleaning
Cleaning Steps
5
Rinse
Step Instruction Ensure the air hose is attached and subsequently left attached to the handpiece during cleaning.
The cleaning instructions listed below are intended for the air hoses.
Careful attention must be given to joints, mated areas, and cavities of the components. Verify all visible soil has been removed from these areas, especially the drive pin cavity located at the bottom of the handpiece. 4
Step Description Connect Air Hose
Recommended Water Temperature
Recommended Water/ Detergent
Cold
Utility Water
1
Pre-Wash
2:00 – 2:30 minutes
2
Enzyme Wash
1:00 – 3:00 minutes
Heated
Neutral pH Enzymatic Detergent
3
Wash I
2:00 – 4:00 minutes
60-65°C
Neutral pH Enzymatic Detergent
4
Rinse I
15 seconds
Hot Water
Utility Water
5
Final Rinse
30 seconds – 1:00 minute
66-90°C
Critical Water
6
Drying
7 minutes
Chamber Temperature 115°C
Minimum of one (1) minute.
- Soft bristle brush (Do not utilize metal cleaning brushes)
- Spray bottle or other manual applicator
Contact time will vary per product usage; minimum of thirty (30) seconds
(Do not submerge the handpiece or air hose)
- Neutral pH Enzymatic Detergent
Minimum of one (1) minute
Particular attention must be given to crevices, mated surfaces, connectors and other hard-toclean areas.
Note 1: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/disinfector. A washer/disinfector with approved efficacy (e.g. CE mark, FDA approval, and validation according to ISO 15883) should be used.
5
Final Rinse
Rinse the device under lukewarm/room temperature (22°C 40°C) purified water for a minimum of 30 seconds.
Room Temperature Purified Water
Minimum of thirty (30) seconds
6
Final Drying
Dry the device utilizing a dry nonshedding wipe. Medical quality filtered air may be utilized if available.
- Non-shedding wipe
Until product is visually dry
Visually inspect the device for cleanliness.
N/A
VI*
Note 2: Follow AAMI TIR34 definitions of Utility Water and Critical Water.
7
*Visual Inspection
- Medical quality filtered compressed air N/A
WARNING: - DO NOT SUBMERGE AIR HOSES IN WATER OR CLEANER. STERILIZATION PRECAUTIONS Steam sterilization is safe and effective and is the only recommended method for the Dermatome AN and reusable accessories. There are no contraindications for sterilizing the Dermatome AN and accessories. Ethylene oxide sterilization is not recommended because reliable outgassing times are difficult to determine for lubricated powered instruments. Page 3/6
STERILIZATION PROCESS INSTRUCTIONS The following instructions detail the steam sterilization process for the Dermatome AN and reusable accessories.
•
Note: The Dermatome Blades (REF 88700010) are terminally-sterilized, single-use devices, and therefore are not reuseable and should be safely disposed of after use.
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.
• • • •
• •
If necessary, dry the instruments utilizing a dry non-shedding wipe. Medical quality filtered air may be utilized if available. Ensure depth gauge control lever is on 0.000 in (0.000 mm). Do not kink the hose when closing the case lid. If the Autoclave Case is used, the case is to be double wrapped with medical grade steam sterilization. Sterilization wraps must be free of detergent residues. The package should be prepared using the AAMI double wrap or equivalent method. 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. Follow instructions in RECOMMENDED STEAM STERILIZATION PARAMETERS. Do not immerse in liquid to cool. Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79.
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 Dermatome AN and 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 the Dermatome AN, 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. 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.
VALIDATED STEAM STERILIZATION PARAMETERS
Cycle Type 1 Prevacuum/
Pulsating Vacuum 2 Prevacuum/
Pulsating Vacuum 3 Prevacuum/
Pulsating Vacuum 1. 2. 3.
4. 5.
6. 7.
Minimum Temperature
Minimum Exposure Time
6 Minimum
7 Minimum
Dry Time
Cool Time
30 minutes
30 minutes
4 Wrapped
134°C 273°F
3 min
132°C 270°F
4 min
134°C 273°F
18 min
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.
•
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 Biomet distributor who sells the Dermatome AN 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
Dermatome AN requiring service or repair may be returned to the following address:
Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 U.S.A.
Minimum validated steam sterilization time required to achieve a 10-6 sterility assurance level (SAL). Minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level (SAL). Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. This cycle is not effective for the inactivation of prions. Instruments used in suspected or confirmed prion (e.g., TSE/CJD) cases must not be reused and shall be discarded. Medical grade steam sterilization compatible wrap that is FDA cleared and compliant to ISO 11607-1. Immediate use (Flash) steam sterilization by exposure at 132°C/270°F or 134°C/273°F should only be used as an emergency procedure. Instruments must be cleaned with accessories removed. Drying times vary according to load size and should be increased for larger loads. Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79.
For further information concerning warranties and repairs, contact your Zimmer Biomet sales representative or the Zimmer Biomet Customer Service Department at 800-348-2759 (inside the U.S.A.). WARRANTY (Outside U.S.A.) Please contact your local Zimmer Biomet representative for warranty information. REPORTING PROBLEMS The user and/or patient should report any suspected serious incident related to the device by informing the manufacturer and the competent authority of the member state in which the serious incident has occurred.
1
2
3
4
Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly. STORAGE CONDITIONS The system should be stored under normal warehouse conditions. ACCESSORIES (see Figures 15 – 21) For use with the following models: N/A
Part Number 88710100
Description Dermatome AN Handpiece (includes width plates, screwdriver and manual)
88700010
Dermatome Blades (10 per box)
8871
88700300
Autoclave Case
8871
8870N100
Width Plate, Neutral, 1 in.
8871
8870N150
Width Plate, Neutral, 1.5 in. (available separately)
8871
8870N200
Width Plate, Neutral, 2 in.
8871
8870N300
Width Plate, Neutral, 3 in.
8871
8870N400
Width Plate, Neutral, 4 in.
8871
88700500
Screwdriver
8871
88701805
Width Plate Screws (5 per pack)
8871
00-8801-002-00
Dermatome Hose, Schrader 10 ft (3m)
8871
00-8851-002-02
Dermatome Hose, Draeger 10 ft (3m)
8871
00-8851-002-03
Dermatome Hose, Synthes (AO) 10 ft (3m)
8871
00-8851-002-04
Dermatome Hose, Heyer 10 ft (3m)
8871
00-8851-002-05
Dermatome Hose, AGA 10 ft (3m)
8871
00-8851-002-06
Dermatome Hose, UK, MA-7 Schrader 10 ft (3m)
8871
00-8851-002-07
Dermatome Hose, DIN 10 ft (3m)
8871
00-8801-105-41
O-rings
8871 and 8801
A. B. C. D. E. F. G.
SERVICE INFORMATION The Dermatome AN 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 Dermatome AN should be returned with the hose every 12 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, Page 4/6
Throttle Throttle Safety Lock 360° Swivel Quick Disconnect Thickness Control Lever Width Plate Finger Indents
ENGLISH
Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 USA (800) 830-0970 www.ZimmerBiomet.com
IFUs, Patents & Symbol Glossary http://labeling.zimmerbiomet.com
06001811272 (EN) Rev. C (Dec 2021) © 2016, 2021 Zimmer Surgical, Inc. 2797
Dermatome AN Instruction Manual
Steam Sterilize
Ȯ
BIOMET GSCC B.V. Hazeldonk 6530 4836 LD Breda The Netherlands
Do Not Lubricate
I
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5
A. B. C. D. E. F. G. H. I.
Width Plate Screwdriver Blade Drive Pin Hole Thickness Control Lever Drive Pin Handpiece Thickness Control Lever Pointer Finger Indents
7B
6
7H
7I
7
7J
7K
A. B.
Safe On A. A. B.
7A 8
9
7C
METHOD I A. Pocket B. Handpiece
7D
7E
A. B. C. D.
Blade Cover Drive Pin Blade Key Notch
10
A. B.
7G
A.
METHOD II A. Handpiece B. Forceps
11
12
Blade Blade Cover
13 7F
Finger Indents
Blade Blade Cover
Locking Mechanism
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14
15
16
A. B. C. D.
Blade Blade Cover Blade Key Drive Pin Hole
17
18
18A
19
20
21
Note: Screw should not be removed from dermatome.
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