7025 Direct Power Console Instruction Manual Rev A March 2002

- INTRODUCTION This manual has been written to help describe the procedures required to keep the MicroAire Direct Power Console system operating properly. Throughout the manual, the following terms are used to identify tips and precautions that will help avoid accidental injury to patients or personnel, or prevent damage to the system. 1. NOTE: Used to point out the easiest means of carrying out techniques. 2. WARNING: Used to indicate that the safety of the patient and hospital personnel could be involved. 3. CAUTION: Used to point out special procedures or precautions that must be followed to avoid damaging the system / instrument.

- GENERAL WARNINGS WARNING: Risk of fire. Replace fuse with T8A/250V. WARNING: Risk of fire. Replace Direct Power Console pack only with a MicroAire 7007-000 Direct Power Console Pack. WARNING: Use only with MicroAire Instruments that are Classified to U.L. 2601-1. WARNING: Explosion Hazard. Not suitable for use in the presence of flammable anesthetics or oxygen. WARNING: Electric Shock. Do not remove cover. Refer servicing to qualified personnel only.

WARNING: Use care to ensure that there is no electromagnetic interference between this device and other devices in use. NOTE: Continuous Operation with Short-Time Loading (1 Minute).

- MARKINGS EXTERNAL: Model: 7025 Ratings: 14.4VDC 480W

7025 DIRECT POWER CONSOLE

WARNING: Type BF rating may only be maintained if the instrument is not used to bridge between the patient and ground.

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INTERNALLY POWERED EQUIPMENT See instructions for use. This unit is designed for Continuous Duty with ShortC Attention, Time Loading(1 Minute Running, Allow to cool to Room Temperature).

A Type BF equipment. E European Conformity Mark BY UNDERWRITERS LABORATORIES, INC. WITH RESPECT TO U CLASSIFIED ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2 NO. 601-M90 Control Number: 8R91

V Power “ON” W Power “OFF” - SETUP CAUTION: Direct Power Console Pack 7007-000 should not be left in the instrument when not in use.

MICROAIRE INSTRUCTION MANUAL

1. Plug Direct Power Console into wall power source (100-120 volts and 200-230 volts).

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2. Insert Direct Power Console Pack 7007-000 cable into connection on front of Direct Power Console. 3. Insert Direct Power Console Pack into Handpiece. 4. Turn the console “ON” by depressing switch on right front of console. 5. Follow Handpiece instructions for proper use.

- 7025 DIRECT POWER CONSOLE The Direct Power Console is designed for use only with MicroAire Battery Powered Instruments. Only the 7007-000 Direct Power Console Pack can be used with the console. All personnel should become familiar with the power equipment before it is set-up for use in any procedure. Personnel in-serviced should include, but not be limited to, central processing personnel, members of the surgical team, and the bioengineering department. WARNING: Prior to use, system components should be inspected and operated to detect any damage or malfunction. Do not use if damage is apparent.

- CLEANING / DECONTAMINATION FOR 7025 1. External surfaces of the unit should be carefully wiped down with a disinfectant after each procedure.

CAUTION:

Do not autoclave. Do not immerse in liquids to cool. Do not flash sterilize Do not use Ethylene Oxide Sterilization Do not use a washer sterilizer Do not process in equipment using peracetic acid

- CLEANING/STERILIZATION FOR THE 7007-000 DIRECT POWER CONSOLE PACK Cleaning 1. Clean the Direct Power Console Pack and cable thoroughly with warm water, mild detergent, and a soft brush. 2. Rinse the Direct Power Console Pack and cable under running water to remove all traces of detergent solution.

7025 DIRECT POWER CONSOLE

C DO NOT sterilize the Direct Power Console or power cord.

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3. Dry all components with a lint-free towel. Sterilization - Wrapped or unwrapped a. Prevacuum Steam Sterilization: 4 minutes @ 270° - 279°F (132° - 137°C) 8 minutes minimum dry time. b. Gravity Displacement Steam Sterilization: 35 minutes @ 270° - 279°F (132° - 137°C) 8 minutes minimum dry time.

- SHIPPING AND ENVIRONMENTAL PARAMETERS This device has been tested and proven to function after repeated exposure to the following conditions: A) Temperature: 0°F (-17.8°C) through 120°F (48.8°C) B) Humidity: 0% through 91% C) Pressure: 645 mmHg through 795 mm Hg Shipping: The materials and components used in the construction of this device were selected to insure that the device could be shipped by any standard commercial method without special handling conditions.

MICROAIRE INSTRUCTION MANUAL

- TROUBLESHOOTING -

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If the unit fails to operate properly, check the following: 1. The Console is connected to an operational Direct Power Console Pack. 2. The Console is connected to a functional power outlet. 3. The Direct Power Console Pack is properly connected to the correct handpiece. 4. The handpiece is functioning correctly. Warranty, Service And Repair Periodic inspection and factory service is essential to keep precision MicroAire instruments running properly. If repairs are required, they can be accomplished quickly with a minimum of disruption to the hospital’s schedule.

- IN HOSPITAL SERVICE All MicroAire equipment should be inspected and tested periodically in accordance with the facility’s bio-engineering policy. Such service should be documented within the bio-engineering department.

- MICROAIRE REPAIR SERVICE Responsive service comes with every MicroAire product. If a problem arises, contact our Technical Service Department at: Telephone (800) 722-0822 (434) 975-8000

Mail 1641 Edlich Dr. Charlottesville, VA 22911, USA

Fax (434) 975-4126

We may be able to help solve the problem quickly without returning the item to the factory. DO NOT disassemble or attempt to service the equipment. It can only be serviced at the factory. Unauthorized service will void the warranty. To return an item to the factory, follow this procedure: 1. Clean and disinfect equipment before sending for repair. 2. Along with the items sent for repair, enclose a description of the problem encountered, the type of use, the place of use, a contact name, and a telephone number. This information is helpful to our repair technicians. 3. If the instrument is out of warranty, enclose a purchase order number with the instrument. If the instrument is under warranty, include the purchase date. 4. In the United States, ship the merchandise by Express Mail, Federal Express, or UPS Blue Label to prevent shipping delays. From outside the United States, return goods by Federal Express or Air Freight. 5. Return the merchandise prepaid.

7. We will repair and reship the item by 2nd Day Air within the United States and by Federal Express or Air Freight outside the U.S. unless specified otherwise.

- PERIODIC INSPECTION Because of the stressful nature of surgical use, decontamination, and sterilization, we recommend that all equipment be returned to the factory for routine inspection and service at least once a year. There is no charge for service during the warranty period.

- WARRANTY MicroAire Surgical Instruments warrants its 7025 Direct Power Console to be free from defects in material and workmanship in their manufacture for a period of 1 year from the original

7025 DIRECT POWER CONSOLE

6. If an estimate of repair costs is needed before the repair technicians start work, include the name and telephone number of the person to contact.

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purchase date by the end customer. The warranty is limited to the repair or replacement of the product without charge. This warranty is void in the event of abuse, misuse, or use in other than normal surgical environment, or in the event disassembly, alteration, or repair of the product not authorized by the manufacturer, or in the event of that the product has not been used in a reasonable manner and in compliance with the written instructions furnished by Manufacturer. All other expressed or implied warranties of fitness and merchantability are excluded here from, and manufacturer shall have no liability of any kind for incidental or consequential damages. Extended Warranty An extended warranty is available on all MicroAire instruments. If the instrument is out of warranty, it must first be restored, if necessary, to full serviceable condition before being eligible for the extended warranty.

- REFERENCES Association for the Advancement of Medical Instrumentation (AAMI) AAMI Good Hospital Practice: Flash Sterilization-Steam Sterilization of Patient-Care Items for Immediate Use. 1995 Edition. pp. 61-79 AAMI Good Hospital Practices: Steam Sterilization and Sterility Assurance. 1995 Edition. pp. 1-60.

MICROAIRE INSTRUCTION MANUAL

AAMI Good Hospital Practice: Handling and Biological Decontamination of Reusable Medical Devices, 1995 Edition. pp. 393-414.

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Association of Operating Room Nurses (AORN) Association of Operating Room Nurses. “Recommended practices for care of instruments, scopes, and powered surgical instruments.” In Standards & Recommended Practices, Denver, CO: AORN, 1995. pp. 197-204. Association of Operating Room Nurses. “Recommended practices for care sterilization in the practice setting.” In: Standards & Recommended Practices. Denver, CO: AORN, 1995. pp. 267-278. U.S. Centers for Disease Control and Prevention (CDC) Centers for Disease Control. “Recommendations for prevention of HIV transmission in health-care settings.” In: Morbidity and Mortality Weekly Report 36 (August 21, 1987): 1S-12S.

Garner, Julia S., and Martin S. Favero. Guideline for Handwashing and Hospital Environmental Control, 1985. Atlanta: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, 1985. U.S Occupational Safety and Health Administration (OSHA)

7025 DIRECT POWER CONSOLE

Occupational Safety and Health Administration. “Occupational exposure to bloodborne pathogens, final rule.” Federal Register 56 (December 6, 1991): 64004-64182.

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MICROAIRE INSTRUCTION MANUAL

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7025 DIRECT POWER CONSOLE

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ISO 9001

1641 Edlich Drive Charlottesville, VA 22911 U.S.A. (800) 722-0822 (434) 975-8000 Order Fax (800) 648-4309 or (434) 975-4131

©2002, MicroAire Surgical Instruments, Inc. IM-7025 Rev. A Printed in USA 3/02