Zimmer Tissue Bank Instruction And Service Manual

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ZIMMER™Tissue Bank
Dermatome
FOR CADAVER USE ONLY
Instruction and Service Manual REF: 8831-001
GENERAL DESCRIPTION
only
, and not for living patients requiring skin grafts.
This instrument is designed for retrieving tissue in thicknesses ranging from 0 to .060 in. (0 to 1.52 mm) in .004 in. (.102 mm) increments. It also allows a choice of either 3 or 4 in. (7.6 and 10.2 cm) skin widths using the two width plates included. Two stainless steel machine screws secure the plates to the underside of the instrument. with the screwdriver provided.
This dermatome is powered by an ironless rotor, low inertia motor, which provides nearly vibration-free power.
The plates are easily fastened and removed
SPECIFICATIONS
It is intended for use on cadavers
STORAGE
The Zimmer Tissue Bank Dermatome has an operating temperature range of 50° to 88°F (10° to 31°C).
The following are environmental conditions for transportation and storage:
A. Ambient temperature
range . . . . . . . . . . . . . . .1°F to 149°F (–17°C to 65°C)
B. Relative humidity range . . . . . . . . . . . . . . .10% to 80%
C. Atmospheric pressure range . . . .500 hPa to 1060 hPa
RECEIVING INSPECTION
After receiving the Zimmer Tissue Bank 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 Orthopaedic Surgical Products sales agreements concerning this unit are F.O.B., Dover, Ohio, U.S.A., and the responsibility of Zimmer Orthopaedic Surgical Products 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.
1. POWER SUPPLY
I. Physical:
Weight: 2.6 lb. (1.18 kg) Dimensions: 9.12 in. (23.2 cm) Length
5.44 in. (13.8 cm) Height
6.69 in. (17.0 cm) Depth
II. Electrical:
Power Requirements: 100-240 V~ (Auto Switching)
150 VA, 50/60 Hz Single Phase
Power Output: 14.5 V , 4.3
A Maximum
2. HANDPIECE
Physical:
I.
Weight: 2.9 lb. (1.31 kg) Dimensions: 9.75 in. (24.8 cm) Length
5.2 in. (13.2 cm) Width
ibration and Shock:
V
Cutting Speed: 5000–6000 Cycles/Minute
II. Electrical:
Power Requirements: 14.5 V , Fully Regulated
Standard Commercial Practice
Maximum
and Isolated, 4.3
A
UL 60601-1 Classification:
Type of protection against electrical shock Class I
Degree of protection against electrical shock: Type BF applied part
Classification according to the degree of IPXO protection against ingress of water:
Mode of operation: 50% Duty Cycle, 10
Maximum operating ambient:
minute maximum ON
°F (31°C)
88
Your Zimmer distributor or local Zimmer representative will 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.
GENERAL PRECAUTIONS
This equipment is for use only by qualified tissue bank personnel. To avoid serious injury to the tissue bank staff when using the Zimmer Tissue Bank Dermatome, the operator must be thoroughly familiar with its function, application, and instructions before use. and blade must be inspected for proper operation before use. If you have any questions, please contact your Zimmer representative.
Ground reliability can only be achieved when the hospital grade power cord is connected to a proper receptacle.
NEVER connect the Zimmer Tissue Bank Dermatome Handpiece to any source other than the Bank Dermatome Power Supply. It has been factory calibrated to provide optimum cutting performance and maximum safety specific medical electrical safety standards.
For continued protection against fire hazard, replace only with the same type and rating of fuse. (Refer to FUSES section.)
Possible explosion hazard exists if this instrument is used in the presence of flammable anesthetics or gases.
NEVER sterilize the power supply. Disconnect the dermatome handpiece from the power supply before sterilization.
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. It is also designed to meet or exceed
The handpiece
Zimmer T
issue
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WARNING AND CAUTION LABELS
See Fig. 3.
SYMBOL DEFINITIONS
See Fig. 4.
OPERATING PRECAUTIONS
The on/off lever must be in the SAFE position before changing blades when the instrument is not in use, or when connecting power to the instrument. Accidental
activation of the instrument during these procedures may injure the tissue bank personnel.
Zimmer TISSUE BANK Dermatome Components (REF 8831)
1. Power Supply (REF 8831-06)
2. Handpiece with cord (REF 8831-01)
3. Screwdriver (REF 8803)
4. Autoclave case (REF 8831-03)
5. Width plate, 3 in. (7.6 cm) (REF 8831-04)
6. Width plate, 4 in. (10.2 cm) (REF 8831-05)
7. Fuse drawer, 5 mm x 20 mm
8. Fuses, 1.25 A (Qty 2) (Installed)
9. Fuses, 1.25 A (Qty 2) (5 mm x 20 mm included)
10. Power Cord
11. Instruction and Service Manual
ZIMMER TISSUE BANK DERMATOME ILLUSTRATIONS
See Fig. 5–7.
BEFORE OPERATION
Connect the Zimmer Tissue Bank Dermatome to its power supply by inserting the connector plug into the connector receptacle. (See Fig. 8.) Disconnect the power supply from the power source before inserting. Remove any kinks or twists from the cord. Align the connector plug to the receptacle by rotating the plug while gently pushing inward. When aligned, push in until the plug clicks into the receptacle.
To remove the connector plug, pull outward on the outer collar portion of the plug to separate the plug from the receptacle.
o replace input fuses, disconnect the power supply from
T the power source. Remove the fuse drawer by lifting up on the tab using a tool and pulling the drawer outward. (See Fig. 9.) Replace the fuse drawer with the correct fuses installed. The correct fuse type is listed in the SERVICE INFORMATION section. The unit is shipped with a 0.25 in. (6.35 mm) x 1.25 in. (31.75 mm) fuse drawer installed. A separate fuse drawer is supplied for 0.197 in. (5 mm) x
0.787 in. (20 mm) fuses.
Before connecting the power supply to a power source, be sure that the switch on the front of the power supply is in
OFF (O) position, and that the safety lock is in the
the SAFE position. Connect to a power source via the "IEC" connector in the rear of the power supply
Turn power on to the power supply by moving the rocker switch on the front of the power supply to the ON (I) position. safety lock to the ON position and briefly depress the on/off lever to ensure that power is being applied to the handpiece, and that the carriage is oscillating. Return the safety lock to the SAFE position.
The rocker switch should illuminate. Move the
To avoid any injury, use extreme caution when handling the blade.
Use extreme caution when handling the dermatome with the blade installed. Before using, always inspect the cord for signs of wear or damage. A worn or damaged cord must be returned for service immediately for continued safety.
Use only Zimmer Tissue Bank Dermatome Blades (REF 8831-000-10). Zimmer Tissue Bank Dermatome Blades have been specifically designed for use with the Zimmer Tissue Bank Dermatome. Other blades will not fit properly in the dermatome and may cause deeper grafts than selected.
OPERATING INSTRUCTIONS
1. Place the power supply in the OFF (O) position. Place the dermatome in the SAFE position by sliding the safety lock on the on/off lever toward the blade end of the instrument to the SAFE position. Only the word SAFE should be visible.
2. Choose the proper width plate to satisfy cutting requirements. Two width plates are supplied: 3 and 4 in. (7.6, and 10.2 cm).
3. Install the blade. (Refer to Blade Placement diagram, (Fig. 7.) Use caution when inserting the blade to avoid nicking it, which may result in an uneven cut. Use a new sterile blade for each procedure.
a. Place the on/off lever in the SAFE position.
b. Using the Zimmer screwdriver (REF 8803), loosen the
width plate screws approximately two turns. DO NOT remove screws from handpiece.
c. Remove width plate and used blade.
d. Place a new blade onto the carriage.
Align the two holes in the blade with the two pins on
e.
the carriage.
f. Place width plate over blade and tighten screws.
4. Control lever adjustment determines graft thickness. (See Fig. 10.) Factory markings indicate 0.004 in. (0.102 mm) divisions. Set control knob pointer to desired thickness.
semi-annual calibration check by an authorized
A Zimmer Orthopaedic Surgical Products service center is recommended to verify continued accuracy
5. To activate the dermatome, place the power supply in the ON (I) position. Lift the on/of back to the ON position. Depress the on/off lever to start the motor. DO NOT run the dermatome without cutting for an extended time, as this needlessly wears the blade.
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f lever and slide the safety lock
.
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CUTTING THE GRAFT
1. Lubricating the donor site with sterile mineral oil or other lubricant may ease the travel of the Zimmer Tissue Bank Dermatome.
2. Hold the handpiece on the donor site at a 30–45 degree angle.
3. Depress the on/of forward using a slight downward pressure to ensure that the cutting edge remains in contact with the donor site.
f lever to start the cut. Guide the unit
Safely dispose of all used blades. Thoroughly scrub the dermatome and width plate(s) with a soft brush and mild detergent. All traces of blood, coagulated material, stains, etc. should be removed.
Rinse all detergent from the dermatome and width plate(s) under a faucet.
Shake the dermatome and width plate free of water and wipe with a clean, lint-free cloth. An alcohol wipe may be used to disinfect the surface of the dermatome before steam sterilization.
DO NOT IMMERSE IN LIQUID.
4. Two methods of graft removal may be used:
a. Method I (see Fig. 11): 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 on/off lever to the SAFE position and
carefully remove the graft.
b. Method II (see Fig. 12): 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 on/off lever to the
5. DO NOT run the Zimmer Tissue Bank Dermatome without cutting for an extended time. Release the on/off lever and return the safety lock to the SAFE position between cuts to remove the graft.
SAFE position.
CLEANING PRECAUTIONS
See Fig. 13–15.
DO NOT LUBRICATE THE ZIMMER TISSUE BANK DERMATOME. The dermatome contains sealed bearings.
No lubrication is necessary.
NEVER IMMERSE THE ZIMMER TISSUE BANK
OME
DERMA
solutions, or rinse water. Some solutions will corrode the metal, delicate moving parts, and seals.
DO NOT process the dermatome handpiece or cord in a washer/sterilizer.
NEVER CLEAN THE DERMATOME IN AN ULTRASONIC CLEANER. Ultrasonic cleaning will dislodge oil from the
internal bearings and render the instrument inoperative.
HANDLE THE ZIMMER TISSUE BANK DERMATOME CAREFULL
be returned to an authorized Zimmer Orthopaedic Surgical Products service center to ensure the integrity of calibration.
NEVER STERILIZE OR IMMERSE THE POWER SUPPLY.
T
in liquid chemical disinfectants, detergent
.
Y
Should it be dropped or damaged, it should
CLEANING INSTRUCTIONS
Clean the power supply with a damp, lint-free cloth using a mild detergent. the surface of the power supply. NEVER IMMERSE the power supply
An alcohol wipe may be used to disinfect
.
Steam sterilize the handpiece, width plates, and screwdriver. Follow the instructions in the STERILIZATION RECOMMENDATIONS section.
Always inspect the handpiece carefully for possible scratches, nicks, or burrs. Inspect the dermatome’ cuts or missing insulation caused by extended use or mishandling. If necessary, return for service to an authorized Zimmer Orthopaedic Surgical Products service center.
Zimmer Tissue Bank Dermatome
s cord for
STERILIZATION RECOMMENDATIONS
Steam sterilization is safe and effective, and is the only recommended method for the dermatome. There are no contraindications for steam sterilizing the Zimmer Tissue Bank Dermatome handpiece.
NEVER sterilize the power supply. Disconnect the dermatome from the power supply before sterilization.
Place cleaned instruments in an instrument tray or fully perforated autoclave case. The Zimmer Tissue Bank Dermatome Autoclave Case (REF 8831-03) is recommended.
DO NOT kink or crimp the dermatome’s cord when closing the case lid.
If the instruments are to be wrapped, two double thicknesses of #140 thread count wrappers, or equivalent, should be utilized. Exposure times are the same for wrapped or unwrapped instruments.
Follow the instructions for prevacuum steam sterilization or gravity air displacement steam sterilization listed below
Prevacuum Steam Sterilization
If your prevacuum steam sterilizer has prefixed cycles, use the "hard goods" cycle. If it does not have a prefixed cycle:
1. Set temperature at 270–272°F (132–133°C).
2. Set exposure time for 4 minutes.
3. Set drying time for 8 minutes minimum.
Gravity
1. Set the temperature and corresponding exposure time as follows:
2. Set the drying time for 8 minutes minimum. DO NOT IMMERSE in liquid to cool. Cool by exposure to room temperature or cover with a cold, sterile towel.
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Air Displacement Steam Sterilization
270–272 250–254°F (121–123°C) 60 minutes
°F (132–133°C) 35 minutes
.
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SERVICE INFORMATION
Caution: Risk of electric shock. Do not remove cover.
Return to an authorized Products service center for servicing. Do not attempt to disassemble the handpiece. It is a factory sealed unit with no user serviceable parts inside. Refer servicing to qualified service personnel.
DO NOT attempt to adjust the power supply. It has been factory calibrated to provide optimum cutting performance and maximum safety. It has been designed to meet or exceed specific medical electrical safety standards.
The Zimmer Tissue Bank Dermatome should be returned to an authorized Zimmer Orthopaedic Surgical Products service center every 6 months for inspection, preventive maintenance, and calibration.
Zimmer Orthopaedic Surgical
FUSES
Input fuses are located in the fuse drawer in the power entry module at the rear of the power supply.
120 V~1.25 A time lag/delay
WARRANTY (U.S.A.)
Zimmer Orthopaedic Surgical Products warrants that the Zimmer Tissue Bank 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 Orthopaedic Surgical Products warrants to the first purchaser of the Zimmer Tissue Bank Dermatome, Width Plates, Screwdriver, and Power Supply 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 Zimmer Tissue Bank Dermatome Blades are warranted to be free from defects in material and workmanship upon delivery. During the warranty period, Zimmer Orthopaedic Surgical Products 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 Orthopaedic Surgical Products. This warranty does not cover damage caused by misuse, abuse, accident, neglect, or any uses 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.
TROUBLESHOOTING GUIDE (TABLE 1)
PROBLEM ACTION
DERMATOME NOT CHECK INPUT FUSES. OPERATING. CHECK POWER CORD POWER LIGHT OFF. CONNECTIONS.
RETURN FOR SERVICE.
DERMATOME NOT CHECK BLADE FIT. OPERATING. CHECK HANDPIECE POWER LIGHT ON. CONNECTION TO
.
POWER SUPPL RETURN FOR SERVICE.
DERMATOME CHECK HANDPIECE OPERATING TOO CONNECTION TO SLOWLY. POWER SUPPLY.
ERRATIC SPEED CHECK HANDPIECE CHANGES. CONNECTION TO
POWER SUPPL
Y
.
Y
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 Orthopaedic Surgical Products nor the Zimmer distributor who sells the 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 T repair may be returned to Zimmer Orthopaedic Surgical Products, 200 West Ohio Avenue, Dover, Ohio, U.S.A.
44622. A purchase order and return goods authorization number must accompany all equipment for repair. The customer will be responsible for all shipping charges. 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.) or 574-267-6131 (outside the U.S.A.).
issue Bank Dermatomes requiring service or
Zimmer Tissue Bank
ACCESSORIES ZIMMER TISSUE BANK DERMATOME
See Fig. 16–23.
For further information contact your representative or the Zimmer Customer Service Department at 800-348-2759 (inside the U.S.A.) or 574-267-6131 (outside the U.S.A.).
Zimmer
sales
WARRANTY (Outside U.S.A.)
Please contact your local warranty information.
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Zimmer representative for
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1
2
A
C
E
D
B
A. Autoclave Case B. Power Supply C. Screwdriver D. Width Plates E. Handpiece
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3 4
WARNING AND
CAUTION LABELS
ARNING
W
TISSUE BANK DERMATOME IS INTENDED FOR
THE USE ON CADAVERS ONLY, AND NOT FOR LIVING PATIENTS REQUIRING SKIN GRAFTS.
SYMBOL
DEFINITIONS
A. Type of Equipment
B. Direct Current
C. Year of Manufacture
D. OFF (Power: Disconnection from the Mains)
E. On (Power: Connection to the Mains)
F. Alternating Current
G. Protective Earth (Ground)
H. Potential Equalizing Conductor (Ground)
I. Zimmer Dermatome Handpiece
J. Attention, Consult Accompanying
Documents
K. Conformity Marking for Underwriters
Laboratories, Inc. UL 60601-1 Standard
5
B
C
A
D
E
Power Supply
A. Front B. Mains Switch C. Connector Receptacle D. Power Entry Module E. Back
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6
8
E
Handpiece
A. On/Off Safety Lock B. On/Of C. Handpiece D. Connector Plug E. Thickness Control Lever
f Lever
B
C
A
D
9
7
A
B
C
D
10
Blade Replacement
A. Screwdriver
idth Plate
B. W C. Blade D. Carriage
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11
METHOD I
A. Handpiece B. Pocket
13
A
B
14
12
METHOD II
A. Handpiece B. Forceps
B
15
A
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16
17
REF 8831 DESCRIPTION: Zimmer Tissue Bank Dermatome Complete (includes 8831-01, 8821-06, 8831-03)
18
REF 8831-01 DESCRIPTION: Handpiece (includes 8831-04, 8831-05, 8803)
19
REF 8831-06 DESCRIPTION: Power Supply
REF 8831-03 DESCRIPTION: Autoclave Case
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20
21
REF 8831-000-10 DESCRIPTION: Zimmer Tissue Bank Dermatome Blades, Sterile (10 per box)
22
REF 8803 DESCRIPTION: Screwdriver
23
REF 8831-04, 8831-05 DESCRIPTION:
idth Plates
W
REF 8803-001-10 DESCRIPTION: Width Plate Screws (10 per pack)
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Revised: 05-05 © 2005 Zimmer, Inc. Printed in U.S.A. 18-10620
Printed on Recycled Paper
Zimmer Orthopaedic Surgical Products 200 West Ohio Avenue P.O. Box 10
, Ohio U.S.A. 44622
Dover
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