NiMH Battery Packs Instructions for Use

Table of Contents REF 7505-710 Large Battery and REF 6640-710 Small Battery Instruction Manual

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Compatible Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Cleaning and Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Warranty and Repair Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

INDICATIONS FOR USE The MicroAire REF 7505-710 Large Battery Pack and REF 6640-710 Small Battery Pack are intended for use with MicroAire U.L classified Battery Powered Instruments and Chargers. A list of compatible devices is presented below: COMPATIBLE DEVICES FOR REF 7505-710 Product Catalog Number Description REF 6643/REF 6642B* Battery SmartDriver Duo™ REF 7505/REF 7500* Drill/Reamer REF 7506/REF 7600* Oscillating Saw REF 7507/REF 7700* Reciprocating Saw REF 7800 Sternum Saw REF 7500-700 MicroAire Battery Charger COMPATIBLE DEVICES FOR REF 6640-710 Product Catalog Number REF 6643/REF 6642B* REF 7800 REF 7500-700 NOTE:

Description Battery SmartDriver Duo™ Sternum Saw MicroAire Battery Charger

Used to point out the easiest Means of carrying out techniques.

CAUTION: Used to point out special procedures or precautions that must be followed to avoid damaging the systems. WARNING:

Used to indicate that the safety of the patient and hospital personnel could be involved.

ENVIRONMENTAL CONDITIONS

Temperature limits

Operation

Storage and Transportation

>86°F/30°C

0°F/-20°C

32°F/0°C

91% Relative humidity limits

>120°F/49°C 91%

0%

0% 106 kPA

106 kPA

Atmospheric pressure limits 70

70

NOTE: Always follow the current local recommendations and/or regulated governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life. NOTE: Always decontaminate a battery pack expose to infectious material before sending it to a waste treatment facility. WARNING: Use ONLY with U.L. Classified MicroAire Battery Powered Instruments. WARNING: No modification of this equipment is allowed. WARNING: Operating Duty cycle for REF 6643 and REF 750X is 1 minute on, 1 minute off for a maximum of 6 cycles. Operating Duty cycle for REF 7800 is 1 minute on, 2 hours off. CAUTION: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). *NOTE: Instruments REF 6642B, REF 7500, REF 7600, and REF 7000 are compliant to UL 60601-1/IEC 60601-1 2nd edition only. 1

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MARKINGS Symbol

Definition This icon is blue. Follow Instructions for Use. European Conformity Mark with MicroAire’s Notified Body Number Do not immerse Product catalog number Product serial number

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Temperature Limitation European authorized representative Humidity Limitation Atmospheric Pressure Limitation

Waste Electrical and Electronic Equipment (WEEE) European Community Symbol. Batteries contain materials that must be recycled or disposed of properly. Do not dispose of as unsorted municipal waste. ALWAYS follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its usual life. ALWAYS decontaminate a battery pack exposed to infectious material before sending it to a waste treatment facility.

m

Date of manufacture. Y=year, M=month.

YYYY-MM

Manufacturer Prescription

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SET UP NOTE: Clinical personnel should become familiar with the Battery Pack before it is set up for use in any procedure. NOTE:

For best results, the Battery Pack should be fully charged prior to use.

CAUTION:

Prior to and after use, inspect for cracks, loose or missing parts, or other damage. Such defects can affect product performance.

To attach the battery pack to a MicroAire Battery Powered Instrument, refer to the applicable instrument instruction manual: •

To attach the battery pack to a MicroAire REF 7505, REF 7506, or REF 7507 Battery Powered Instrument, refer to IM-7505.

•

To attach the battery pack to the MicroAire REF 6643 SmartDriver Duo™, refer to IM-6643.

•

To attach the battery pack to the MicroAire REF 7800 Sternum Saw, refer to IM-7800.

BATTERY CARE Battery Charging WARNING:

Do not charge in the patient vicinity.

CAUTION:

MicroAire REF 7505-710 Large Battery Packs and REF 6640-710 Small Battery Packs should only be charged using the MicroAire REF 7500-700 MicroAire Battery Charger.

To charge the battery pack, refer to the operating instructions for the MicroAire REF 7500-700 MicroAire Battery Charger in manual IM-7500-700. Battery Replacement Over time and with repeated use, the physical characteristics of the REF 7505-710 and REF 6640-710 Battery Packs may be diminished. Replacement of the battery should be considered if: •

The Battery Pack shows signs of physical damage, including cracks and loose or missing parts.

•

The gold-plated terminals show sign of corrosion and wear.

•

The Battery Pack shows significantly reduced run-time or insufficient power when used with MicroAire instruments.

•

Instruments such as the oscillating saw suddenly start to stall when heavily loaded.

•

The "Charge Failed" light on the 7500-700 charger comes on repeatedly.

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CLEANING AND STERILIZATION Cleaning 1. Wipe external surfaces of the battery with a disinfectant after each procedure and rinse under warm water. 2. Dry with a lint-free cloth. CAUTION:

The REF 7505-710 and REF 6640-710 Battery Packs are NOT IMMERSIBLE.

Sterilization The following sterilization processes have been validated based on AAMI protocols. The exposure times and temperatures are the minimum validated requirements to ensure sterility. Gravity displacement is the preferred method for battery sterilization. Gravity Displacement Steam • •

3 minutes @ 270° F - 279° F (132° C - 137° C), unwrapped No drying time

CAUTION:

A five-minute gravity cycle is acceptable if a pre-programmed autoclave only has one cycle.

Dynamic Air Removal (Pre-vacuum) • •

4 minutes @ 270° F - 279° F (132° C - 137° C), wrapped or unwrapped No drying time

Sterrad® 100 Sterilization •

44 minutes total exposure time

Sterrad® NX Sterilization •

28 minutes full cycle

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WARRANTY MicroAire Surgical Instruments warrants the REF 7505-710 Large Battery Pack and REF 6640-710 Small Battery Pack to be free from defects in material and workmanship in their manufacture for a period of one (1) year from the original 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 of disassembly, alteration or the repair of the product not authorized by the manufacturer, or in the event that the product has not been used in a reasonable manner, and in compliance with the written instructions furnished by the 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. Due to the nature of batteries, extended warranties are not available for the battery pack. REPAIR SERVICE If a problem with your equipment should arise, contact our Customer Service Department at:

USA Outside USA

Telephone 800-722-0822 434-975-8000

Fax 800-438-6309 434-975-4134

Email [email protected] [email protected]

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MicroAire Surgical Instruments, LLC 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 USA Phone: (800) 722-0822 (434) 975-8000 Order Fax: (800) 648-4309 or (434) 975-4131 www.microaire.com

MediMark Europe 11, rue Emile Zola - BP 2332 F-38033 Grenoble Cedex 2 France

©2017 MicroAire Surgical Instruments LLC | IM-PWRBATT Rev. B, Printed in USA