The Zimmer Tissue Bank Dermatome is an electrically
powered instrument designed specifically for tissue
retrieval procedures.
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 ofIPXO
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.
- 1 -
. It is also designed to meet or exceed
The handpiece
Zimmer T
issue
Page 2
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
.
Page 3
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. DONOT 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.
-3-
Air Displacement Steam Sterilization
270–272
250–254°F (121–123°C) 60 minutes
°F (132–133°C) 35 minutes
.
Page 4
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)
PROBLEMACTION
DERMATOME NOTCHECK INPUT FUSES.
OPERATING.CHECK POWER CORD
POWER LIGHT OFF.CONNECTIONS.
RETURN FOR SERVICE.
DERMATOME NOTCHECK BLADE FIT.
OPERATING.CHECK HANDPIECE
POWER LIGHT ON.CONNECTION TO
.
POWER SUPPL
RETURN FOR SERVICE.
DERMATOMECHECK HANDPIECE
OPERATING TOOCONNECTION TO
SLOWLY.POWER SUPPLY.
ERRATIC SPEEDCHECK 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.
- 4 -
Zimmer representative for
Page 5
1
2
A
C
E
D
B
A. Autoclave Case
B. Power Supply
C. Screwdriver
D. Width Plates
E. Handpiece
- 5 -
Page 6
34
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
- 6 -
Page 7
6
8
E
Handpiece
A. On/Off Safety Lock
B. On/Of
C. Handpiece
D. Connector Plug
E. Thickness Control Lever