Zimmer Electric Dermatome Instructions for Use

UL 60601-1 Classification: Type of protection against electric shock:

Class I

Degree of protection against electric shock:

Type BF applied part

Classification according to the degree of protection against ingress of water:

IPX0

Typical mode of operation:

20 sec ON, 80 sec OFF, 4 cycles

Storage conditions:

-40 to +85°C

Environmental conditions during operation:

Max operating ambient: 88°F (31°C) Relative humidity: 30% to 60% Altitude: ≤ 2000 m – Not intended for high altitude environments NOTE: There are no special requirements for transport or storage. Transport or store in an environment that limits exposure to dust, moisture and temperature extremes.

Applied parts:

Blades Hand Piece (Width plate, Machined head)

The user of this device should be aware that precautions should be taken in regards to EMC. The device should be installed and used according to the EMC information provided in the instructions for use. See EMC Guidance Tables included with this manual. Cables Mains power cord

Maximum length 120 inches (305 cm)

WARNING: use of a mains power cord with a length other than those specified may result in increased emissions and decreased immunity.

Emissions / Immunity:

The Zimmer Electric Dermatome complies with EMC criteria set forth in EN 60601-1-2.

POWER SOURCE

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. To replace input fuses, disconnect the power supply from the power source. Remove the fuse drawer by lifting up on the tab using a tool and pulling the drawer outward. (See Fig. 6) Replace the fuse drawer with the correct fuses installed.

FUSES

Input fuses are located in the fuse drawer in the power entry module at the rear of the power supply. 250 V ~ 1.25 A time lag/delay.

WARNINGS AND PRECAUTIONS

To avoid serious injury to the patient and operating staff while the Zimmer Electric Dermatome is in use, the user must be thoroughly familiar with its function, application, and instructions for use. WARNING: MANUAL CLEANING ONLY – NO AUTOMATIC WASHING 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 dermatome blade side up when not in use. The throttle must be in the SAFE (Ȯ) position before changing blades, when connecting power to the instrument, 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 position, the safety lock on the throttle should be toward the blade end of the dermatome and only the word SAFE should be visible.

Handle the Zimmer Electric Dermatome carefully. Should it be inadvertently dropped or damaged, it should be returned for service. DO NOT use. Use only Zimmer Dermatome Blades (REF 00-8800-000-10). The Zimmer Dermatome Blade has been specifically designed and engineered for use with the Zimmer Electric Dermatome. Other blades may not fit properly in the dermatome and may cause serious injury. Use of non-Zimmer Dermatome Blades can cause the dermatome to take grafts deeper than what the user has selected. Never connect the Zimmer Electric Dermatome Handpiece to any source other than the Zimmer Electric Dermatome Power Supply. It has been factory calibrated to provide optimum cutting performance and maximum safety. It is also designed to meet or exceed specific medical electrical safety standards. Ground reliability can only be achieved when the power cord is connected to a receptacle marked “HOSPITAL GRADE.” Use only the power cord marked “HOSPITAL GRADE” supplied or one that complies with all local and electrical requirements but does not exceed 10 feet (3.05 meters). 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 gasses. Never sterilize the power supply. Disconnect the dermatome handpiece from the power supply before sterilization. The user and operating staff must always pay close attention to the CLEANING PRECAUTIONS and CLEANING INSTRUCTIONS FOR THE DERMATOME. Failure to follow these instructions may damage the dermatome. WARNING: The Zimmer Electric Dermatome is suitable for use in Professional Heathcare Facility Environments except for near active HF SURGICAL EQUIPMENT and the RF shielded room of a ME SYSTEM for magnetic resonance imaging. WARNING: Use of the Zimmer Electric Dermatome adjacent to or stacked with other equipment should be avoided because it could result in improper operation. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas)

should be used no closer than 30 cm (12 inches) to any part of the Zimmer Electric Dermatome. Otherwise, degradation of the performance of this equipment could result.

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.

•

Inspect the dermatome’s cord for cuts or missing insulation caused by extended use or mishandling.

•

Check the action of moving parts to ensure smooth operation throughout the intended range of motion.

•

The Zimmer Electric Dermatome should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued accuracy. 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 Zimmer Electric 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 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. Your local Zimmer 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. Note: DO NOT attempt to return damaged goods without first securing proper authorization from the delivering carrier.

SETUP INSTRUCTIONS •

Prior to initial usage, Zimmer Electric Dermatome must be cleaned and sterilized per instructions. (See CLEANING AND STERILIZATION INSTRUCTIONS)

•

Observe sterile field precautions per hospital protocol.

•

Connect the Zimmer Electric Dermatome to the power supply by inserting the connector plug into the connector receptacle. (See Fig. 7.) 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.

•

Before connecting the power supply to a power source, be sure that the switch on the front of the power supply is in the OFF (O) position and that the safety lock on the Zimmer Electric Dermatome is in the SAFE position. Connect to a power source via the “IEC” connector in the rear of the power supply. Turn power on by moving the rocker switch on the front of the power supply to the ON (I) position. The rocker switch should illuminate. Activate the dermatome by completely depressing the throttle lever with the safety lock in the ON position. Return the safety lock to the SAFE position, when not in use.

•

•

During set-up procedure, visually inspect for damage and/or wear. If damage or wear is noted that may compromise the function of the instrument, do not use.

BLADE INSTALLATION (See Fig. 5.) •

Use a new sterile blade for each procedure. Use only Zimmer Dermatome Blades (REF 00-8800-000-10).

•

To install blade: •

Place the throttle in the SAFE position. To place the dermatome in the SAFE position, slide the safety lock on the throttle toward the blade end of the instrument to the SAFE position. Only the word SAFE should be visible.

•

Using a screwdriver, loosen width plate screws approximately two turns. DO NOT remove screws from handpiece.

•

Place a new blade in slot on the handpiece. If replacing a blade, remove the used blade before inserting a new one. Refer to BLADE REMOVAL section.

•

Mate the drive pin with the hole in the blade. Note: “INSERT WITH THIS SIDE UP” message.

•

Lubrication of the blade is not necessary because the backing of the blade is a self-lubricating plastic.

•

Choose proper width plate to satisfy cutting requirements. Place width plate over blade and tighten screws. DO NOT overtighten. Ensure the printing on the width plate is facing out. (See Fig. 5.)

CUTTING THE GRAFT •

Skin should be prepared in routine manner.

•

It is not necessary to lubricate the skin; however, lubricating the donor site with a small amount of sterile mineral oil may ease travel of the Zimmer Electric Dermatome.

•

Set control lever adjustment knob pointer to desired graft thickness. Factory calibrations indicate 0.002 in. (0.050 mm). 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. (See Fig. 8.)

•

Hold the handpiece on the donor site at a 30° – 45° angle. (See Fig. 10.)

•

To activate the dermatome, place the power supply in the ON (I) position. Lift the throttle lever and slide the safety lock back from the SAFE position toward the hose coupling. The word ON should be visible. 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 position.

•

Depress the throttle to start the cut. Guide the unit forward using a slight downward pressure to ensure that the cutting edge remains continuously firmly in contact with the donor site.

•

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 position and carefully remove the graft. (See Fig. 9.) 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 nonuniform cuts. Lift the handpiece away from the donor site to end the graft. Return the throttle to the SAFE position. (See Fig. 10.)

DO NOT run the Zimmer Electric 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.

AFTER THE PROCEDURE •

Unplug from wall receptacle.

•

To remove the Zimmer Electric Dermatome connector plug from the power supply, pull outward on the outer sleeve of the plug to separate the plug from the receptacle.

•

Remove the used blade and dispose of properly in designated sharps container or per hospital protocol.

•

Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with a damp cloth. Body fluids and tissue should not be allowed to dry on instruments prior to cleaning.

•

Return and secure instrument and width plates to instrument case for transport and cleaning.

BLADE REMOVAL •

Loosen the width plate screws. DO NOT remove the screws.

•

To remove the width plate, hold both sides and lift. DO NOT lift the width plate from the front as this will cause contact with the blade and possible injury.

•

Remove the blade carefully lifting from the side.

•

Dispose of used blade in a sharps container or per hospital protocol.

CLEANING PRECAUTIONS

All subsequent cleaning and sterilization steps are facilitated by not allowing blood, tissue debris, or disinfectants to dry on used instruments. Handle the Zimmer Electric Dermatome carefully. Should it be inadvertently dropped or damaged, it should be returned for service. Refer to NEED TO ADHERE TO CARE REGIMEN section. DO NOT lubricate the Zimmer Electric Dermatome. Lubrication may cause extensive damage to the motor. Never immerse the dermatome in any solution. Some solutions will corrode the metal and delicate moving parts and also break down the internal lubricants. Never immerse the dermatome in liquid chemical disinfectant. Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must not be used. Saline solution has a corrosive effect on stainless steel and should not be used. DO NOT process the dermatome handpiece or accessories in an automatic washer. Automatic washing has the potential to destroy the surface protective layer of the device and cause corrosion. Never clean in an ultrasonic cleaner. Ultrasonic cleaning will dislodge oil from the bearings and render the instrument inoperative. Ultrasonic cleaning may affect calibration of the Zimmer Electric Dermatome. Never sterilize the power supply or immerse it in any solution. Steam sterilize the Zimmer Electric Dermatome and accessories (except power supply). Follow instructions in STERILIZATION RECOMMENDATIONS.

CLEANING INSTRUCTIONS FOR THE POWER SUPPLY •

Ensure the power supply has been fully disconnected from the power source.

•

Clean the power supply with a damp, lint-free cloth using a pH neutral detergent.

•

An alcohol wipe may be used to clean the surface of the power supply.

•

Never immerse the power supply.

CLEANING PROCESS INSTRUCTIONS FOR THE DERMATOME The following instructions and chart detail the cleaning process for the Zimmer Electric Dermatome. •

Ensure the Zimmer Electric Dermatome has been fully disconnected from the power supply.

•

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.

•

Never let water or detergent enter the handpiece. Permanent damage may result. (See Fig. 12.)

•

Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with a damp cloth. The damp cloth is utilized to assist in the prevention of the un-removed soil drying prior to cleaning and disinfection process.

•

Universal precautions for handling contaminated/biohazardous materials should be observed.

•

Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning.

•

Dermatome cord may be wiped down and/or manually cleaned with isopropyl alcohol or silicon rubber compatible cleaner. Do not submerge the hose in liquids or automatic wash.

•

Prepare cleaning agents at the use-dilution and temperature recommended by the manufacturer.

•

Prior to cleaning, remove width plate from device and clean separately.

•

Follow the Manual Cleaning Instructions found in Chart 1 Validated Manual Cleaning Procedure, for the Dermatome handpiece and width plates.

•

Following the cleaning procedure, visually inspect for damage and/or wear.

•

The thickness control lever should be moved during cleaning to release any debris which may be trapped under the lever or in the notches.

•

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 section.

•

Steam sterilize only. Follow instructions in STERILIZATION RECOMMENDATIONS.

Cleaning Steps

Chart 1 Validated Manual Cleaning Procedure Step

Step Description

Step Instruction

Accessories

Duration

1

Contamination Removal

Rinse and brush product under lukewarm/room temperature running utility water for a minimum of three (3) minutes, removing any visible organic material with assistance of a soft bristle brush.

- lukewarm/room temperature tap water

Minimum of three (3) minutes.

- Soft bristle brush (DO NOT utilize metal cleaning brushes)

2

DetergentApplication Apply neutral pH - Neutral pH detergent per the detergent detergent - Spray bottle or other manufacturer's manual applicator recommendations to the device’s surface area. Allow the detergent to (DO NOT submerge remain on the device for the device) a minimum of 3 minutes. Additional detergent may be applied during this time.

Contact time will vary per product usage; minimum of three (3) minutes.

3

Manual Cleaning

Minimum of three (3) minutes.

Following the three (3) minute detergent application, clean all contact surfaces, joints, mated areas utilizing a clean soft bristle brush for a minimum of three (3) minutes using neutral pH detergent.

- Clean soft bristle brush - Neutral pH detergent

4

Final Rinse

Rinse product under - Room temperature room temperature distilled/filtered distilled/filtered water for water a minimum of three (3) minutes.

Minimum of three (3) minutes.

5

Final Drying

Dry the device utilizing a - Non-shedding wipe dry non-shedding wipe. - Medical quality Medical quality filtered filtered compressed air may be utilized if air available.

Until product is visibly dry

WARNING : - DO NOT SUBMERGE ZIMMER DERMATOMES IN WATER OR CLEANER. - WHILE RINSING, DO NOT ALLOW WATER OR CLEANER INTO MOTOR COMPARTMENT OR GEAR AREAS. REMOVE ANY WATER/CLEANER IMMEDIATELY IF ENTERED INADVERTENTLY.

STERILIZATION RECOMMENDATIONS

Steam sterilization is safe and effective, and is the only recommended method for the dermatome. There are no contraindications for sterilizing the Zimmer Electric Dermatome and accessories. Ethylene oxide sterilization is not recommended because reliable outgassing times are difficult to determine for lubricated powered instruments. 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 Dermatome Autoclave Case (REF 00-8801-003-00) is recommended. (See Fig. 17.)

•

DO NOT kink or crimp the dermatome’s cord when closing the case lid.

•

If the Zimmer Dermatome Autoclave Case is used, the instruments are to be wrapped, two double thicknesses of #140 thread count wrappers, or equivalent. If sterilization wraps are used, they must be free of detergent residues. 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. Exposure times are the same for wrapped or unwrapped instruments.

•

Follow instructions in RECOMMENDED STEAM STERILIZATION PARAMETERS.

•

DO NOT immerse in liquid to cool. Cool by exposure to room temperature or cover with a cold, sterile towel.

RECOMMENDED STEAM STERILIZATION PARAMETERS Cycle Type

Minimum Temperature

6 Minimum Exposure Time 7,8 Wrapped

9 Unwrapped

1,3 Prevacuum/Pulsating

134°C 273°F

3 min

3 min

2,3 Prevacuum/Pulsating

Vacuum

132°C 270°F

4 min

4 min

3,4 Prevacuum/Pulsating Vacuum

134°C 273°F

18 min

18 min

5 Prevacuum/Pulsating

132°C 270°F

8 min

8 min

Vacuum

Vacuum

Gravity/Gravity Displacement

3,10 Minimum Dry

Time

8 minutes

Not recommended due to excessively long sterilization cycles which are not practical.

1. Minimum validated steam sterilization time required to achieve a 10-6 sterility assurance level (SAL). 2. Minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level. 3. Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. 4. Disinfection /steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. 5. For Universal Instrument Cases without defined load configurations. 6. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable. 7. Medical grade steam sterilization compatible wrap equivalent to four thicknesses of 140-thread-count muslin. 8. Rigid sterilization container that complies with ANSI/AAMI ST77. 9. Flash (unwrapped) sterilization by exposure at 132°C/270°F should only be used as an emergency procedure. Instruments must be cleaned and disassembled. 10. Drying times vary according to load size and should be increased for larger loads. Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly. Flash sterilization (10-minute exposure in a gravity displacement sterilizer in an open tray at 270°F [132°C]) is not recommended for the Zimmer Electric Dermatome as this method may not provide sterility throughout the instrument.

ACCESSORIES (See Fig. 15–21.) Description: REF:

Blades (10 per box) 00-8800-000-10

Description:

Zimmer Electric Dermatome Complete (includes: 00-8821-001-00, 00-8801-003-00, 00-8821-006-00) 00-8821-000-00

REF: Description: REF: Description: REF:

Zimmer Electric Dermatome Handpiece (includes: 00-8802-001-00, 00-8802-002-00, 00-8802-003-00, 00-8802-004-00, 00-8803-000-00) 00-8821-001-00 Power Supply (includes: Fuse drawer, 5 mm x 20 mm; Fuses, 1.25 A (QTY 2) Fuses, 800 mA (QTY 2); Power Cord) 00-8821-006-00

Description: REF:

Autoclave Case 00-8801-003-00

Description: REF:

1 in. (2.5 cm) Width Plate 00-8802-001-00

Description: REF:

1.5 in. (3.8cm) Width Plate 00-8802-015-00

Description: REF:

2 in. (5.1 cm) Width Plate 00-8802-002-00

Description: REF:

3 in. (7.6 cm) Width Plate 00-8802-003-00

Description: REF:

4 in. (10.2 cm) Width Plate 00-8802-004-00

Description: REF:

Screwdriver 00-8803-000-00

Description: REF:

Width Plate Screws (10 per pack) 00-8803-001-10

TROUBLESHOOTING GUIDE PROBLEM

ACTION

Dermatome not operating. Power light off.

Check input fuses. Check power cord connections. Return for service.

Dermatome not operating. Power light on.

Check blade fit. Check handpiece connection to power supply. Return for service.

Dermatome operating too slowly.

Check dermatome for damage. Check blade for damage. Return for service.

Erratic speed changes.

Check handpiece connection to power supply. Return for service.

SERVICE INFORMATION

Caution: Risk of electric shock. DO NOT remove cover. The Zimmer Electric Dermatome should be returned to Zimmer Surgical, Dover, OH 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. 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 Electric Dermatome should be returned 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, 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. 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. A purchase order must accompany all equipment for repair. The customer will be responsible for all shipping charges.

WARRANTY (U.S.A. only)

Zimmer Surgical warrants that the Zimmer Electric 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 Surgical warrants to the first consumer purchaser of new Zimmer Electric 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. Zimmer 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. 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 distributor who sells the Zimmer Electric 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 Electric Dermatomes requiring service or repair may be returned to: Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 U.S.A. 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.).

WARRANTY (Outside U.S.A.)

Please contact your local Zimmer representative for warranty information.

Zimmer Electric Dermatome EMC Guidance and Declaration EN 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic emissions The Zimmer Electric Dermatome is intended for use in the electromagnetic environments specified below. The customer or the user of the Zimmer Electric Dermatome should assure that it is used in such an environment. The Zimmer Electric Dermatomes should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Zimmer Electric Dermatomes should be observed to verify they are functioning normally. The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment. Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions EN 61000-3-2 Voltage fluctuations/ Flicker emissions EN 61000-3-3

Compliance

Electromagnetic environment - guidance

Group 1

The Zimmer Electric Dermatome uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A Class A

Complies

The Zimmer Electric Dermatome is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Zimmer Electric Dermatome EMC Guidance and Declaration EN 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic immunity The Zimmer Electric Dermatome is intended for use in the electromagnetic environments specified below. The customer or the user of the Zimmer Electric Dermatome should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Electrostatic ± 2, ± 4, ± 8 kV contact discharge (ESD)

Compliance level

Electromagnetic environment – guidance

± 2, ± 4, ± 8 kV contact

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30%.

± 2, ± 4, ± 15 kV air

EN 61000-4-2

± 2, ± 4, ± 15 kV air

Electrical fast transient/burst

± 2 kV for power supply lines

± 2 kV for power supply lines (240 Vac 50 Hz)

± 1 kV for input/output lines

N/A

± 1 kV line(s) to line(s)

± 1 kV line(s) to line(s) (240 Vac 50 Hz)

± 2 kV line(s) to earth

± 2 kV line(s) to earth (240 Vac 50 Hz)

Voltage dips, short interruptions and voltage variations on power supply input lines

100% drop, 0.5 periods, 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°

100% drop, 0.5 periods, 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° (100 Vac 60Hz / 240 Vac 50 Hz)

100% dip, 1 period

100% dip, 1 period (100 Vac 60Hz / 240 Vac 50 Hz)

EN 61000-4-11

30% dip, 25/30 periods

30% dip, 25/30 periods (100 Vac 60Hz / 240 Vac 50 Hz)

Voltage Interruptions (all input current)

Voltage Interruptions (all input current) (100 Vac 60Hz / 240 Vac 50 Hz)

EN 61000-4-4 Surge EN 61000-4-5

Power frequency (50/60 Hz) 30 A/m magnetic field EN 61000-4-8

30 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Zimmer Electric Dermatome requires continued operation during power mains interruptions, it is recommended that the Zimmer Electric Dermatome be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Zimmer Electric Dermatome EMC Guidance and Declaration EN 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic immunity The Zimmer Electric Dermatome is intended for use in the electromagnetic environments specified below. The customer or the user of the Zimmer Electric Dermatome should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Zimmer Electric Dermatome, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter, as it can affect medical electrical equipment.

Conducted RF EN 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

Recommended separation distance d = 1.2 √P d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P

800 MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Radiated RF EN 61000-4-3

3 V/m 80 MHz to 2.7 GHz

3 V/m

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance levels in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Zimmer Electric Dermatome is used exceeds the application RF compliance levels above, the Zimmer Electric Dermatome should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Zimmer Electric Dermatome.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Zimmer Electric Dermatome EMC Guidance and Declaration EN 60601-1-2 Recommended separation distances between portable and mobile RF communication equipment and the Zimmer Electric Dermatome The Zimmer Electric Dermatome is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Zimmer Electric Dermatome can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Zimmer Electric Dermatome as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.7 GHz

d = 1.2√P

d = 1.2√P

d = 2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

1

2

A. Autoclave Case B. Power Supply C. Screwdriver D. Width Plates E. Handpiece

WARNING AND CAUTION LABELS FOR CONTINUED PROTECTION AGAINST FIRE HAZARD REPLACE ONLY WITH THE SAME TYPE AND RATING OF FUSE: 250 V~: T 1.25 AH

3

A. B. C. D. E.

Front Mains Switch Connector Receptacle Power Entry Module Back

4

5

A. On/Off Safety Lock B. On/Off Lever C. Handpiece D. Connector Plug E. Thickness Control Lever

A. Screwdriver B. Width Plate C. Blade D. Drive Pin Hole E. Drive Pin

SYMBOLOGY

I Zimmer Dermatome Handpiece

MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) and CAN/CSA-C22.2 No. 60601-1 (2014) 2R52

MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)

Revision: F (February 2021) © 2014, 2021 Zimmer Surgical, Inc. 06001811224 (EN)