Integra Padgett Model S and S6 Users Guide Rev EAB March 2020

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Contents Introduction... 2 Features... 2 Optional Accessory... 2 Components-Model S... 3 Components-Model S6... 4 Classifications... 5 Specifications... 5 Warnings... 5 Precautions... 7 Symbol Definitions... 8 Troubleshooting... 9 The Power Supply...12 Maintenance and Servicing...12 How to Use the Electric Slimline Dermatome Models S and S6... 13 Cleaning and Decontamination...15 Preparation for Sterilization... 17 Sterilization...18 Appendix...20 Limited Warranty... 25

1

Introduction The Integra® Padgett® Slimline Dermatome Models S and S6 are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.

Features • Both the Model S and S6 feature a 100 - 250V~ power supply that will adapt to any input voltage. • Power switch is controlled by the thumb and is located on the top of the handpiece. • The dermatome complete kit is provided in a plastic carrying case with the dermatome handpiece, power supply, power supply wall cord, 13’ (3.96 m) handpiece cable, guard plate, width clips, dermatome screwdriver, pin position guide, and dermatome wrench. • Model S includes 2 in. (5.08 cm), 3 in. (7.62 cm) and 4 in. (10.16 cm) width clips. • Model S6 includes 2 in. (5.08 cm), 3 in. (7.62 cm), 4 in. (10.16 cm) 5 in. (12.70 cm) and 6 in. (15.24 cm) width clips. • Models S and S6 are validated for steam (gravity & pre-vacuum), ethylene oxide, and hydrogen peroxide gas plasma (STERRAD®) sterilization.

Optional Accessory • A 25 ft (7.62 m) handpiece cable (part# 353971525) may also be purchased.

Warning: Read this manual thoroughly before using the Integra Padgett Slimline Dermatome Models S and S6.

2

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Components-Model S 1. 2. 3. 4. 5. 6. 7. 8.

1

2 7

3

4 5

6

Handpiece (Applied Part) Power Supply Dermatome Screwdriver Pin Position Guide Dermatome Wrench Power Supply Wall Cord Handpiece Cable Width Clips

8

Components Catalog #

Description

Catalog #

3539700**

Slimline Dermatome Model S Complete Kit (Includes the following components) Model S Handpiece Power Supply Guard Plate (not shown) Width Clip, 2" (5.08 cm) Width Clip, 3" (7.62 cm) Width Clip, 4" (10.16 cm) Handpiece Cable, 13' (3.96m) Dermatome Screwdriver Dermatome Wrench Pin Position Guide Carrying Case, Plastic (not shown)

3539620**

DP0009 DP0007 35392660 35392662 35392663 35392664 353971513 3539257 3539702 3539259 3539240

Description

Power Supply Wall Cord, 120V (US, Canada, & parts of Mexico) 3539235** Power Supply Wall Cord, Continental Europe 3539236** Power Supply Wall Cord, British Style (UK, Hong Kong) 3539237** Power Supply Wall Cord, Italy (Only one Power Supply Wall Cord included in Complete Kit.) Accessories & Components (To Be Ordered Separately): 35392661 Width Clip, 1" (2.54 cm) 353971525 Handpiece Cable, 25' (7.62m) 3539701 Dermatome Hex Nut (1 each) 3539256 Width Clip Screw (set of 2) 3539252 Blades, Sterile, Single Use, Box of 10

All components may be ordered separately. **Please specify country of use when placing your order. The Model S has no user-serviceable parts. The complete unit must be returned to an authorized repair center to obtain repair or maintenance. USE ONLY INTEGRA PADGETT 4-INCH BLADES (3539252). FAILURE TO DO SO MAY CAUSE INJURY. For product ordering information, please call 800-654-2873 (USA) or 609-275-0500 (outside USA). 3

Components-Model S6

1 2

5

3 6

1. 2. 3. 4. 5. 6. 7. 8.

Handpiece (Applied Part) Power Supply Handpiece Cable Power Supply Wall Cord Dermatome Wrench Dermatome Screwdriver Pin Position Guide Width Clips

7 8

4

Components Catalog #

Description

Catalog #

3539900**

Slimline Dermatome Model S6 Complete Kit (Includes the following components) Model S6 Handpiece Power Supply Guard Plate (not shown) Width Clip, 2" (5.08 cm) Width Clip, 3" (7.62 cm) Width Clip, 4" (10.16 cm) Width Clip, 5" (12.7 cm) Width Clip, 6" (15.2 cm) Handpiece Cable, 13' (3.96m) Dermatome Screwdriver Dermatome Wrench Pin Position Guide Carrying Case, Plastic (not shown)

3539620**

DP0010 DP0007 35399100 35399102 35399103 35399104 35399105 35399106 353971513 3539257 3539702 3539259 3539240

Description

Power Supply Wall Cord, 120V (US, Canada, & parts of Mexico) 3539235** Power Supply Wall Cord, Continental Europe 3539236** Power Supply Wall Cord, British Style (UK, Hong Kong) 3539237** Power Supply Wall Cord, Italy (Only one Power Supply Wall Cord included in Complete Kit.) Accessories & Components (To Be Ordered Separately): 35399101 Width Clip, 1" (2.54 cm) 353971525 Handpiece Cable, 25' (7.62m) 3539701 Dermatome Hex Nut (1 each) 3539256 Width Clip Screw (set of 2) 3539602 Blades, Sterile, Single Use, Box of 10

All components may be ordered separately. **Please specify country of use when placing your order. The Model S6 has no user-serviceable parts. The complete unit must be returned to an authorized repair center to obtain repair or maintenance. USE ONLY INTEGRA PADGETT 6-INCH BLADES (3539602). FAILURE TO DO SO MAY CAUSE INJURY. For product ordering information, please call 800-654-2873 (USA) or 609-275-0500 (outside USA). 4

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Classifications In accordance with: 60601-1/IEC 60601-1, Type BF Non-Continuous Operation Duty Cycle for Dermatome Use: 30 seconds on/5 minutes off Explosion hazard. DO NOT use in the presence of flammable anesthetics.

Specifications Maximum Graft Width

S: 4" (10.16 cm)

S6: 6" (15.24 cm)

Input Voltage

100-250Vac

Input Frequency

50 / 60Hz

VA Rating

110 VA

Output Volts

48Vac

Output Current

1A

Operating Temperature

-20 to 30°C. Humidity 10% to 95% non-condensing, 500 to 1080 hPa

Storage and Transport

-40 to 55°C. Humidity 10% to 95% non-condensing, 500 to 1080 hPa

Assembled Weight

S: 2 Lb 5oz. (1.06 kg),

Safety

IEC 60601-1, IEC 60601-1-2

S6: 2Lb 12oz. (1.24 kg)

Conforms to ANSI/AAMI STD ES60601-1 Certified to CAN/CSA STD C22.2 No. 60601-1 Conforms to Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances (RoHS II)

Warnings Danger: Explosion hazard: Do not use in the presence of oxygen, nitrous oxide, or other flammable anesthetics. These instruments are intended only for professional use in hospitals, physical therapy locations, and similar medical facilities where the patient will be under the supervision of trained personnel. To avoid the risk of electrical shock, this equipment must only be connected to supply mains with a protective earth. The power supply contains internally stored energy, and may be a risk for electrical shock even when unplugged.

5

Warnings (continued) To reduce the risk of electrical shock DO NOT remove power supply cover. Do not disassemble the power supply. 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. Do not allow the dermatome to operate and be in contact with the patient for a period exceeding 30 seconds. If multiple grafts are to be taken allow a cool down period of not less than 5 minutes between grafts.

2

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 Blades of the correct size. Use only Integra Padgett part number 3539252 with the Model S dermatome. Use only Integra Padgett part number 3539602 with the Model S6 dermatome. 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. Do not modify this electromechanical equipment in any manner. The dermatome system contains no user-serviceable components. Unauthorized modifications, including the use of replacement components or products servicing not provided by an authorized Integra Padgett Dermatome Repair Center (IPDRC) can result in serious injury to patient and/or operator.

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Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Precautions A thorough, manual cleaning process as detailed in the Cleaning and Sterilization section is recommended for the Electric Slimline Dermatome Models S and S6. 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 autoclave power supply or power supply wall 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. (Refer to EMC Declaration Table in the appendix for more detailed electromagnetic emission and immunity information.) To improve performance and overall safety of the dermatome it is recommended that the dermatome’s power supply wall cord be connected to a Ground Fault Circuit Interrupter (GFCI) receptacle. Both the Model S and S6 incorporate sealing devices used to prevent moisture from entering the handpiece. 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 the Model S and Model S6 handpiece with the Model S and Model S6 power supply and handpiece cable ONLY. Prior to use, visually inspect the dermatome handpiece and handpiece cable for signs of physical damage or wear. Do not use the dermatome if damage is observed. The dermatome handpiece can only be serviced by an Integra Padgett Dermatome Repair Center (refer to Maintenance and Servicing Section). Dermatome handpiece cable damage may include cracks or discoloration of the cable jacket, exposed conductors, or distortion of the cable or connector. If cable damage is observed contact Integra Customer Service immediately to purchase a replacement handpiece cable (part number 353971513) and discard the damaged cable. 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 handpiece 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 as outlined in the Troubleshooting section.

7

Symbol Definitions: SYMBOL

DEFINITION Type BF applied part (ref. IEC 60417-5333) Protective earth ground (ref IEC 60417-5019) Direct Current (ref. IEC 60417-5031)

~

Alternating Current (ref. IEC 60417-5032) ON for part of equipment (ref. IEC 60417-5264) OFF for part of equipment (ref. IEC 60417-5265) Cutting, general (ref. ISO 7000-0538) Refer to instruction manual/booklet (ref. ISO 7010-M002) General Warning Sign (ref. ISO 7010-W001) Caution (ref. ISO 7000-0434A) Warning: electricity (ref. ISO 7010-W012) Warning; Non-ionizing radiation (ref. ISO 7010-W005)

2

Do not re-use (ref. ISO 7000-1051) Caution: Federal (USA) law restrict this device to sale by or on the order of a physician or practitioner.

SN

Serial Number (ref. ISO 7000-2498) Manufacturer (ref. ISO 7000-3082) Temperature limits. Temperature values are shown adjacent to the symbol (Ref. ISO 7000-0632)

8

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Symbol Definitions (continued) Atmospheric pressure limitation. The atmospheric pressure values in hPa units are shown adjacent to the symbol. (Ref. ISO 7000-2621) Humidity limitation. The relative humidity values are shown adjacent to the symbol. (Ref. ISO 7000-2620)

Troubleshooting: The following assessment steps can be used to confirm proper dermatome operation. This assessment is to be performed without the blade and width clip installed. 1. 2. 3.

4.

5.

Visually inspect all dermatome system components for signs of physical damage or wear including loose parts, part distortion, rough edges, and areas of discoloration. Check for proper oscillating pin position with the oscillating pin position guide as outlined below. Check for proper fit of all dermatome cables. Connect dermatome handpiece cable between dermatome handpiece and power supply. Connect power supply wall cord to power supply. All cable connectors are to fit properly to their mating receptacles. Connect power supply wall cord to wall receptacle and turn power supply switch on. The indicator light on the power supply is to illuminate. Confirm voltage is available at the wall receptacle if the indicator light fails to illuminate. Depress thumb switch on dermatome handpiece momentarily. 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 an Integra Padgett Dermatome Service Center for service (see Maintenance and Servicing section). If no issues are observed during this assessment but performance issues are experienced, refer to the following troubleshooting table.

9

PROBLEM

POSSIBLE SOLUTION

Unit fails to run with blade and width clip installed.

• The blade and its mating surfaces of the dermatome are to be free of lint or other foreign objects which may hinder free movement of the blade. • Use only the supplied dermatome screwdriver in order to avoid overtightening the width clip attachment screws. • Check condition of width clip for distortion (especially flatness), and rough edges.

Troubleshooting (continued): PROBLEM

POSSIBLE SOLUTION

Actual graft thickness varies from dermatome thickness guide setting.

• Actual thickness of the graft is highly dependent upon operator technique and the condition of the tissue being harvested. Refer to section “How To Use The Integra Padgett Electric Dermatome” for additional details. • The dermatome mechanism that controls the graft thickness is factory set to provide proper performance and includes components that may wear after repeated usage. To correct such issues the dermatome must be returned to an Integra Padgett Dermatome Repair Center for service. Annual preventative maintenance is strongly recommended.

A variation in graft thickness is observed during the procedure.

• The thumbscrew lock feature on the thickness knob is not sufficiently tightened to hold the knob at the user-selected thickness setting. • The thumbscrew must be loosened prior to positioning the thickness knob pointer. Failure to loosen the thumbscrew can result in physical damage to the dermatome’s cutting head in the thickness knob area. This can significantly diminish the effectiveness of the thumbscrew lock. If such visual damage is observed the unit should be returned to an Integra Padgett Dermatome Repair Center for service.

Unsatisfactory graft quality.

• Using the dermatome wrench, ensure that the two hex nuts fastening the dermatome’s cutting head to its motor housing are securely tightened. • Check oscillating pin position with the pin position guide as outlined below. If the oscillating pin is not properly positioned the blade may “chatter” or “skip” yielding unsatisfactory results.

10

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Troubleshooting (continued): A pin position guide is included with the dermatome complete kit and can be ordered as an accessory (part #3539259). This guide is intended to determine if the oscillating pin, which moves the blade, is properly positioned. If the oscillating pin is not properly positioned, the blade may “chatter” or “skip,” yielding unsatisfactory results. Prior to each use, the dermatome should be checked using the pin position guide to confirm that the dermatome oscillating pin is properly positioned. The pin position 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 guide, the dermatome’s oscillating pin is properly positioned. If the pin lies on the edge or outside the zone, the dermatome should not be used, and should be sent to an Integra Padgett Dermatome Repair Center (IPDRC) for service. The pin position check procedure is important because rough handling, dropping the dermatome, or inadvertently hitting the oscillating pin may cause the oscillating pin not to be properly positioned. Using the Pin Position Guide (3539259)

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 Pin Position 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’s oscillating pin is properly positioned for optimum performance.

11

The Power Supply The green light on the power supply is a “ready” light, indicating that the dermatome is ready for use whenever the light is on. Please note there may be up to a two-second delay when the power switch is first activated before the green light illuminates. The power supply circuitry includes an overcurrent protection feature that will turn the power supply off (green light will darken) in the case of excessive current draw. DO NOT AUTOCLAVE THE POWER SUPPLY OR THE POWER SUPPLY WALL CORD.

Maintenance and Servicing It is strongly recommended that the dermatome be sent to an approved Integra Padgett Dermatome Repair Center (IPDRC) for servicing annually in order to maintain satisfactory performance. The Electric Slimline Dermatome Models S and S6 do not contain any user-serviceable parts. All maintenance and servicing should be done at an approved Integra Padgett Dermatome Repair Center (IPDRC). Failure to use an authorized repair center voids the warranty. Whether returning the dermatome for annual service or should repair service be required it is very important to return the complete dermatome system, including the handpiece, all power cords, power supply, guard plate, all width clips, pin position guide, dermatome screwdriver, and dermatome wrench. A Return Material Authorization (RMA) number is required and may be obtained by contacting Integra Customer Service prior to returning product. The product is required to be properly cleaned and sterilized before it is returned to the repair center with documentation verifying sterilization. Failure to sterilize the product will result in a handling fee. For Domestic Returns - Customer Service 800-654-2873 or 609-275-0500. Fax 609-750-7999 - Ship unit to: Integra Padgett Dermatome Repair Center (IPDRC) 1109 Valley Ridge Drive Grain Valley, MO 64209 USA For International Returns - Customer Service +49 2102 5535 6150. Fax +49 2102 942 4872 - Ship unit to: Integra Gmbh Technical Service and Repair Gewerbepark Ratingen Halskestrasse 9 D-40880 Ratingen, Germany

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Integra® Padgett®

Electric Slimline Dermatome Models S and S6

How to Use the Electric Slimline Dermatome Models S and S6 The Electric Slimline Dermatome Models S and S6 must be sterilized before use. Refer to the Sterilization Section for validated sterilization cycle parameters. The Electric Slimline Dermatome Models S and S6 are equipped with a detachable handpiece cable. The detachable handpiece cable is color-coded. The silver end connects into the handpiece and the black end connects to the power supply. It is not possible to connect the cable to the wrong receptacles as they are keyed differently to accept the correct end of the cable. The design also includes a reverse pin configuration to avoid electric shock. The dots must be lined up for a connection. When you choose to disconnect the cable from the handpiece and power supply, you must grasp the silver cap.

Note: No installation is required for this device. The Dermatome uses an AC power supply which plugs into a standard AC wall outlet. The device contains no battery. See Specifications Section for details.

2 CAUTION: Blades are single use ONLY. DO NOT reuse blades. The on/off switch is located on the top of the handpiece and is operated with the thumb. Push the switch forward for pulse mode. When the switch is released it will return to the off position. The blade should be given a very thin coat of sterile mineral oil on both sides before insertion. Hold the dermatome in both hands as shown in the picture. Place the blade such that the “This Side Up” marker is facing the operator. The blade grommet hole is to be placed over the dermatome’s oscillating pin. Refer to illustration. Place both thumbs over the eccentric screws and push the blade down and forward. The blade will easily fall into place. The blade and dermatome blade bed should be free from particulate or other foreign objects which may hinder free movement of the blade. The blade is removed by lifting up with both index fingers using the slots at each end of the blade.

Larger grommet diameter 13

Side view of blade

How to Use the Electric Slimline Dermatome Models S and S6 (continued) Select the desired width clip. A one inch (2.54 cm) is available by special order. Fasten in place with the Integra supplied dermatome screwdriver as shown. Be sure there is no lint or other foreign object on the width clip that could restrict free movement of the blade. The screws should be sufficiently tightened to prevent screw loosening during dermatome operation. Excessively tightened screws may cause dermatome performance issues or permanent device damage. Only use the Integra supplied dermatome screwdriver to tighten the screws. The desired thickness of the graft is predetermined by the operator and set by using the pointer on the thickness guide scale. Secure the thickness knob pointer position by tightening the knob’s thumbscrew. It is important to ensure that the knob’s thumbscrew has been loosened prior to moving the knob pointer. The actual thickness of the harvested tissue is highly dependent upon the operator technique and the condition of the tissue being harvested. The thickness guide scale provides both inch and millimeter values. Much of the weight of the motor should be carried by the hand that holds the dermatome to maintain a reasonably light pressure between the cutting edge and the patient’s body. The instrument should be held at a 25° - 45° angle. The cut graft automatically folds itself into the “pocket” of the dermatome head. To sever the graft, simply lift the dermatome up and away from the donor site. As per Association of Perioperative Registered Nurses (AORN®), the recommended practice is that the dermatome’s handpiece cable should be secured to the sterile field with a non-perforating device. Friction from the rapid back and forth movement of the blade generates heat which may cause a heat related injury to the patient. Once the dermatome is placed into contact with the patient you must maintain forward movement until the graft is taken. Do not allow the dermatome to remain running for a period exceeding 30 seconds. If multiple grafts are to be taken allow a cool down period of not less than 5 minutes between grafts. 14

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Cleaning and Decontamination A thorough, manual cleaning process is recommended for the Electric Slimline Dermatome Models S and S6. 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. As with any decontamination procedure, personnel should follow accepted guidelines for hand washing, the use of protective attire, etc. as recommended by A.A.M.I. Standards and Recommended Practice, ANSI/AAMI ST79:2010. Note: For all detergents, chemicals and/or materials used throughout device reprocessing, follow the manufacturer's recommendations and facility protocol for proper disposal to minimize environmental impact. CAUTION: During this cleaning / decontamination process, the dermatome is to be partially disassembled by removal of the guard plate from the unit’s cutting head and removal of the cutting head from the handpiece. With these components removed, certain features of the dermatome that are critical to its proper operation are exposed. Therefore, extra care must be exercised when handling the dermatome components in this state to protect them from physical damage. The critical features of the dermatome components include the oscillating pin and drive shaft of the motor housing, the blade nest and leading edge of the cutting head, and the edge of the guide bar. Only remove the components as instructed below. Further disassembly of the instrument is likely to cause permanent damage. The dermatome contains no user-serviceable parts and must be returned to an approved Integra Padgett Dermatome Repair Center for repair and maintenance. Cutting Head Removal (for Models with Removable Head) Only remove the dermatome’s cutting head to perform the cleaning process. Use the dermatome wrench (3539702) provided to disassemble the two hex nuts located on the motor housing’s flange. Tip the motor housing to create sufficient clearance between the motor shaft and the opening in the blade bed of the cutting head so that the motor housing freely slides out of the cutting head. Forcibly removing the motor housing from the cutting head may cause permanent damage. A. Precleaning Remove width clip and width clip screw fasteners. Carefully remove the single-use dermatome blade (CAUTION: Blade is sharp). Dispose of dermatome blade as per your institution’s protocol regarding the handling and disposal of sharps. Remove any apparent debris from dermatome, width clip, and power cord with a lap sponge and sterile water to prevent drying of blood and body fluids. B. Cleaning and Decontamination To prevent the formation of biofilm, cleaning should occur as soon as possible after dermatome use. 1. 15

Maintain Moisture: Immediately after the surgical procedure, place the dermatome

Cleaning and Decontamination (Continued) handpiece, width clip, guard plate, and width clip screws in an instrument container and apply a transport foam or gel product (e.g., Steris Pre-Klenz®) specifically intended to keep soil moist on surgical instruments. Also introduce some of the foam or gel product into the oscillating pin recess of the cutting head. Transport the tray containing the soiled dermatome in an impervious plastic bag or container to the decontamination environment. Keep the outside of the container clean. 2.

Enzymatic Soak: Prepare a neutral pH enzymatic detergent, ASP® Enzol®, as per the manufacturer’s recommendation at ~8mL per Liter (1 oz. per gallon) using lukewarm tap water. Remove the two dermatome hex nuts fastening the dermatome’s cutting head to the motor housing. Immerse only the dermatome’s cutting head, width clips, guard plate, width clip screws, dermatome hex nuts, dermatome screwdriver, dermatome wrench, and pin position guide in the enzymatic solution. Soak for a minimum period of 30 minutes. Do not immerse the dermatome’s motor housing. Immersion of the motor housing can cause permanent damage to its electrical components. CAUTION: Removing the dermatome’s cutting head from the motor housing will result in exposing the oscillating pin and motor drive shaft. The contour of the oscillating pin is factory set to provide proper dermatome performance. Care must be taken in handling the motor housing in this state. Dropping the motor housing or hitting the oscillating pin can cause damage that may adversely affect dermatome performance.

3.

Rinse: After the enzymatic detergent soak period, remove the dermatome’s cutting head, width clips, guard plate, width clip screws, dermatome hex nuts, dermatome screwdriver, dermatome wrench, and pin position guide from the detergent solution and thoroughly rinse the items with lukewarm tap water.

4.

Clean Instruments: Prepare a neutral pH enzymatic detergent, ASP Enzol, as per the manufacturer’s recommendation at ~8mL per Liter (1 oz. per gallon) using lukewarm tap water. Using a small clean soft-bristled brush, remove soil from all surfaces of the dermatome’s cutting head, width clips, guard plate, width clip screws, dermatome hex nuts, dermatome screwdriver, dermatome wrench, and pin position guide while they are submerged in the solution. Take particular care in removing soils from the dermatome’s cutting head features containing crevices and sharp inside corners. Clean the dermatome’s motor housing by wiping with a soft, clean cloth moistened with the detergent solution. Pay special attention to removing soil from the area of the oscillating pin and drive shaft. Clean the handpiece cable by wiping with a soft, clean cloth moistened with the detergent solution.

5.

Rinse: Thoroughly rinse all dermatome components under gently running tap water and wipe with a dry, soft, clean cloth. Do not immerse the dermatome components. Dry all components with a soft dry towel.

6.

Final Rinse: Rinse all dermatome components with softened or deionized water. Softened

16

Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Cleaning and Decontamination (Continued) or deionized water should be used for the final rinse to better remove detergents and other residues from the rinse water. Excessively hard water can spot or stain instruments. Excess chlorine in the rinse water can result in pitting. Dry all components with a soft dry towel. 7.

Visual Inspection: Visually inspect the equipment to make sure there is no visible organic debris or residue from cleaning agent. Repeat process (steps 2-6) if any soil is detected.

Preparation for Sterilization

17

1.

Visual Inspection: Visually inspect the dermatome components for cleanliness and ensure all components are in proper working order. Visually inspect the dermatome handpiece cable for signs of damage that may include cracks or discoloration of the cable jacket, exposed conductors, or distortion of cable or connector. If cable damage is observed, contact Integra Customer Service immediately to purchase a replacement handpiece cable (part number 353971513) and discard the damaged cable. If damage is observed on any other dermatome components, the dermatome unit should be returned immediately to the Integra Padgett Dermatome Repair Center for service. (Refer to Maintenance and Servicing section.)

2.

Assemble the unit by aligning the holes in the motor housing flange with the threaded studs of the cutting head. Note that the thumbswitch on the motor housing is to be positioned on the top of the unit. Tip the motor housing to create sufficient clearance to carefully slide the motor housing drive shaft into the cutting head. Replace and tighten the two dermatome hex nuts using the dermatome wrench. Check that the oscillating pin is properly positioned using the pin position guide as instructed in the Troubleshooting section.

Correct assembly of hex nut

3.

Wrap Dermatome for Sterilization: The guard plate, width clips, and the width clip attachment screws are not to be assembled to the dermatome in preparation for sterilization. Prepare the dermatome handpiece, guard plate, width clips, width clip screws, handpiece cable, dermatome screwdriver, dermatome wrench, and pin position guide for sterilization using a wrapper that is appropriate for the method of sterilization to be used. The oscillating pin side of the dermatome’s cutting head is to face downward to expedite drainage of potential condensate if a steam sterilization method is employed.

4.

Sterilization: Utilize one of the validated methods of sterilization outlined in the sterilization section.

Sterilization The Electric Slimline Dermatome Models S and S6 are provided NON-STERILE and must be sterilized prior to use. The sterilization cycle parameters outlined below have been validated for the Electric Slimline Dermatome Models S and S6. Steam Sterilization: Cycle Conditions

Exposure Temperature

Exposure Time

Dry Time

Wrapped Pre-Vacuum

132°C (270°F)

4 minutes

20 minutes

Wrapped Gravity

132°C (270°F)

15 minutes

20 minutes

Wrapped Pre-Vacuum - UK Cycle

134°C -0/+3°C (274° F - 0/+ 5° F)

3 minutes

15 minutes

Wrapped Pre-Vacuum - French Cycle

134°C -0/+3°C (274° F - 0/+ 5° F)

18 minutes

15 minutes

NOTE: Ensure sufficient cooling time after the sterilization process to allow the dermatome temperature to equilibrate to ambient room temperature. 100% Ethylene Oxide Sterilization: Precondition the chamber to the specified exposure temperature and 55% relative humidity for a minimum of 1 hour. The 100% Ethylene Oxide gas concentration is 725 mg/L. Cycle Conditions

Exposure Temperature

Exposure Time

Aeration Time

Wrapped

37°C (99°F)

8 hours

12 hrs. min at 51-59°C

Wrapped

55°C (131°F)

180 minutes

12 hrs. min at 51-59°C

Note: 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.

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Integra® Padgett®

Electric Slimline Dermatome Models S and S6

Sterilization (Continued) Sterrad Sterilization: Dermatome to be processed on STERRAD® 100S unit (short cycle) which consists of the following steps: Vacuum 1st Injection Stage 1st Diffusion Stage 1st Gas Plasma Stage 2nd Injection Stage 2nd Diffusion Stage 2nd Gas Plasma Stage Vent Total cycle time = ~55 minutes Note: It is the responsibility of the manufacturer and maintainer of the sterilization equipment to ensure no chemicals or contaminated waste leak into the environment. Follow facility guidelines during sterilization. Environmental Responsibility Environmental Compliance: The Integra Padgett Dermatome system, including the hand piece, power supply, disposable blades and accessories, has been designed and manufactured with the goal to minimize environmental impact throughout the device life cycle in accordance with the following standards: - IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. - IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance: Electromagnetic Compatibility. - Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS II). The Dermatomes are constructed of non-hazardous, recyclable materials and/or materials that are compliant with the safety, performance and hazardous materials standards listed above. Device servicing and maintenance should be performed by an approved Integra Padgett Dermatome Repair Center (IPDRC) in accordance with the Maintenance and Servicing section of this manual. End of Life Management: The Dermatome devices have been deemed environmentally non-hazardous and require no special handling and/or treatment during setup, assembly/disassembly and during normal use, and are safe for disposal in landfills. At end of life, device recycling and/or disposal should be performed in compliance with your facility disposal protocol. Waste treatment facilities vary by locality. Contact your local waste treatment facility as necessary for proper policies and procedures regarding device disposal in accordance with your facility disposal protocol.

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