Integra Padgett SB User manual

Integra®Padge®
Model SB
Slimline Dermatome

1
Contents
Introduction .............................................................................................................................2
Features.....................................................................................................................................2
Optional Features ....................................................................................................................2
Components—Model SB Slimline........................................................................................ 3
Classifications..........................................................................................................................4
Specifications...........................................................................................................................4
Warnings................................................................................................................................... 5
Precautions...............................................................................................................................6
International Symbols.............................................................................................................8
Calibration................................................................................................................................9
The Power Supply.................................................................................................................. 10
How to Use the Model SB Slimline Dermatome................................................................ 11
Maintenance And Servicing..................................................................................................13
Trade-In ...................................................................................................................................13
Cleaning And Decontamination...........................................................................................14
Sterilization .............................................................................................................................17
Limited Warranty ....................................................................................................................18

2
Introduction
The Integra®Padgett®Model SB Slimline Dermatome is intended for use in skin
harvesting from cadavers or animals in registered tissue banks or testing laboratories.
This equipment is intended only for professional use in tissue banks and similar
medical facilities, where it will be used under the supervision of trained personnel.
Features
• Available in 100 - 250V~, power supply will adapt to any input voltage.
• Power switch is controlled by the thumb and is located on the top of the hand
piece.
• The complete dermatome is delivered to you in a sturdy carry case with the
power supply, power supply cord, 13 ft (3.96 m) hand piece cord, guard, 2, 3 and
4 inch (5.08, 7.62 and 10.16 cm) width clips, screwdriver, calibration gauge, and
dermatome wrench.
• The Model SB has multiple methods of sterilization including: Steam, Ethylene
Oxide, Flash Autoclave and Sterrad® or Hydrogen Peroxide Gas Plasma.
Optional Features
• Integra Padgett Universal Dermatome Sterilizing Tray (part #3539-799). Contact
your Integra Padgett representative to purchase the Sterilization Tray.
• A 25 ft (7.62 m) hand piece power cord (part# 3539-715-25) may also be
purchased.
Warning: Read this manual thoroughly before using any parts of the Integra
Padgett Model SB Slimline Dermatome.

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Components—Model SB Slimline
Components
3539-800 Model SB Slimline Dermatome
Complete Unit (Includes the
following unless indicated)
DP-0800 Power supply
DP-0810 Hand piece
3539-258 Calibration guide
3539-257 Screwdriver
3539-702 Dermatome wrench
3539-266-0 Guard Plate
3539-266-2 2” (5.08 cm) width blade clip
3539-266-3 3” (7.62 cm) width blade clip
3539-266-4 4” (10.16 cm) width blade clip
3539-715-13 13’ (3.96 m) Hand piece power cord
3539-240 Dermatome carry case
Catalog # Description
1. Power Supply
2. Hand Piece Cord
3. Hand Piece
4. Blade Clips
5. Calibration Guide
6. Screwdriver
7. Power Supply Wall Cord
2
3
4
5
1
Catalog # Description
Optional Accessories
3539-701 Dermatome hex nuts (2 pcs.)
3539-266-1 1” (2.54 cm) width blade clip
3539-715-25 25’ (7.62 m) Hand piece power cord
3539-252 Box of blades (10 per box)
3539-799 Integra Padgett Universal
Dermatome Sterilizing Tray
The Model SB has no user serviceable parts! The complete unit must be returned to the authorized repair
center to obtain repair or maintenance. Failure to do so voids the warranty.
For product ordering information please call 877-444-1122 or 609-275-0500.
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Catalog # Description
Power Supply Wall Cord
3539-620 120 Volt (US)

4
Classifications
In accordance with: 60601-1/IEC 60601-1, Class I, Type BF
Continuous Operation with Short Term Loading
Explosion hazard. DO NOT use in the presence of flammable anesthetics.
Specifications
Maximum Graft Width SB: 4" (10.16 cm)
Input Voltage 100-250Vac
Input Frequency 50 / 60Hz
Output Volts 48Vac
Output Current 1A
Operating Temperature -20 to 50°C. Humidity 10% to 95% non-condensing
Storage -40 to 55°C. Humidity 10% to 95% non-condensing
Assembled Weight 1 Lb 8oz. (.7 kg)

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Warnings
Danger: Explosion hazard. DO NOT use in the presence of oxygen, nitrous
oxide, or other flammable anesthetics.
This equipment is intended only for professional use in hospital, physical
therapy locations, and similar medical facilities where the patient will be under
the supervision of trained personnel.
To reduce the risk of electrical shock DO NOT remove power supply cover. Refer
maintenance and servicing to the Integra Padgett Dermatome Repair Center.
The movement of the blade generates heat which may cause a heat related
injury to the patient. Maintain forward movement while the dermatome is in
contact with the patient.
The Model SB DOES NOT have an automatic turn off feature. This product may
cause injury to the user if not operated in accordance with this manual. Handle
the Model SB with care.
Do not reuse blades. Blades are designed as single-use, disposable products
and should not be re-sterilized. Re-sterilization and subsequent reuse will dull
the blades and may result in cross-contamination or impaired function of the
product. Sharpness of the blades is not guaranteed with repeated use. Any
blade, once used, should be discarded according to hospital policy.
Use ONLY with Integra Padgett Dermatome Blade part number 3539-252.
It is the sole responsibility of the end-user to validate alternate sterilization
methods and cycles that do not comply with the validated sterilization
methods and cycles specified within this manual. Failure to comply with the
validated sterilization methods may result in ineffective sterilization and
damage to the device.
The dermatome is supplied non-sterile and must be sterilized prior to use.
Validated sterilization cycles are provided in the Sterilization section. The
dermatome blades have been sterilized with a minimum dose of 2.5 Mrads (25
kGy) of gamma irradiation, sterility assurance level of 10-6. Prior to use inspect
the blade packaging for damage which may compromise sterility. If damaged,
or in any way compromised, the dermatome blade must be assumed to be non-
sterile and must not be used.

6
Precautions
A thorough, manual cleaning process as detailed in the Cleaning and
Decontamination section is recommended for the Dermatome Model SB. The
Dermatome motor housing cannot be immersed in liquid cleaners, which would
occur in an automated process. Automated cleaning methods may not be effective
and may result in damage and reduced performance of the device.
DO NOT auto clave power supply or power supply cord which interconnects the
power supply with the wall receptacle. Damage and reduced performance of the
device may result.
EMC Caution: Care should be taken if the equipment is used adjacent to or stacked
with other equipment. If adjacent or stacked use is inevitable, the equipment should
be observed to verify normal operation in the configuration in which it will be used.
The Model SB incorporates sealing devices used to prevent moisture from
entering the hand piece. One or more of these sealing devices can be damaged if
disassembled and reassembled. Refer servicing to an authorized Integra Padgett
Dermatome Repair Center.
Use Model SB hand piece with Model SB power supply and hand piece cord ONLY.
Prior to use visually inspect the dermatome hand piece and its cord for signs of
physical damage or wear. Do not use the dermatome if damage is observed. The
dermatome hand piece can only be serviced by the Integra Padgett Dermatome
Repair Center (refer to Maintenance and Servicing Section, page 13). Dermatome
hand piece cord damage may include cracks or discoloration of the cable jacket,
exposed conductors, or distortion of the cord or connector. If cord damage is
observed contact Integra Padgett Customer Service immediately to purchase a
replacement power cord (part number 3539-715-13) and discard the damaged cord.
Used blades should always be disposed of in proper safety containers.
Unit disposal (if necessary) is to be in compliance with your facilities disposal
protocols.
Avoid rough handling or dropping the dermatome hand piece and dermatome power
supply. If rough handling is suspected or the unit is dropped, it is recommended to
assess the condition of the dermatome system prior to use by the following method.

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1. Visually inspect all dermatome components for signs of physical
damage including loose parts, part distortion, rough edges, and areas of
discoloration.
2. Check the oscillating pin calibration (see Calibration section).
3. Check fit of all dermatome cables. Connect dermatome hand piece cord
between dermatome hand piece and power supply. Connect wall power
cord to power supply. All cable connectors are to fit properly with their
mating receptacles.
4. Connect power supply power cord to wall receptacle and turn power supply
switch on. The indicator light on the power supply is to illuminate.
5. Depress thumb-switch on dermatome hand piece. Dermatome motor is
to run and oscillating pin is to move rapidly from side to side. Note any
unusual motor sounds.
If issues are experienced with any of these system checks, do not use the dermatome
and return the unit to the Integra Padgett Dermatome Service Center for service (see
Maintenance and Servicing section).
Precautions (continued)

8
International Symbols
This symbol represents the international symbol for Type B Medical
Equipment.
This symbol represents the international symbol for Protective Earth
(ground).
This symbol represents the international symbol for Direct Current.
This symbol represents the international symbol for cutting.
This symbol represents the international symbol for
“Caution, consult accompanying documents.”
This symbol represents the international symbol for Alternating
Current.
~
This symbol represents the international symbol for Explosion
Hazard.
This symbol represents the international symbol for Electrical
Shock.
Caution: Federal (USA) law restricts this device to sale by or
on the order of a physician.
Serial number.

9
Calibration
A calibration guide is included with the dermatome and can be ordered as an
accessory (part #3539-259). This guide is intended to determine if the oscillating pin,
which moves the blade, is within specifications. If the oscillating pin is not within
specifications, the blade may “chatter” or “skip,” yielding unsatisfactory results.
Prior to each use, the dermatome should be checked using the calibration guide to
determine if the particular instrument is within calibration specifications.
The calibration guide should be inserted between the oscillating pin and the base
of the blade guide (as shown in the diagram). This can be done from the right. If the
oscillating pin lies anywhere within the zone clearly marked on the calibration guide,
the dermatome is properly calibrated. If the pin lies on the edge or outside the zone,
the dermatome should not be used, and should be sent to the Integra Padgett
Dermatome Repair Center (IPDRC) for recalibration. The calibration procedure is
important because dropping the dermatome or inadvertently hitting the oscillating
pin may knock the instrument out of calibration.
Using the Calibration Guide (3539-259)
1
Hold the Guide in your Right hand with the Integra logo facing up. Lower the LEFT side
of the Guide Slot over the Oscillating Pin and against the top of the Blade Guides.
2
Gently slide the Calibration Guide to the LEFT until the Oscillating Pin touches the
BOTTOM edge of the Guide Slot. If the Oscillating Pin lies anywhere between the
two vertical lines the dermatome is properly calibrated.