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 battery pack only with a MicroAire U.L. classfied 6640-710, 7500-710, or 7500-735 battery.
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CAUTION: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). NOTE: 7800 Battery Sternum Saw has been designed and tested to also operate with the 7025 Direct Power Console (DPC). NOTE: Disconnect sternum guard, battery, and saw blade prior to sterilization.
- MARKINGS - Attention, See instructions for use. This unit is designed for intermittent operation Type BF equipment. European Conformity Mark with MicroAire Notified Body Number 0086 CLASSIFIED BY UNDERWRITERS LABORATORIES, INC. WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2 NO.
- STANDARDS - 7800 Battery Sternum Saw meets the following standards: 2601-1 WITH RESPECT TO ELECTRIC SHOCK, FIRE, MECHANICAL HAZARD ONLY IN ACCORDANCE WITH UL 2601-1 AND CAN/CSA C22.2 No. 601.1 EN 60601-1/IEC 601-1 EN 60601-1-2, DIN EN 60601-1-2 - ENVIRONMENTAL PARAMETERS -...
(Trigger can be turned in either direction to be turned “OFF”) - REF 7800-002 STERNUM GUARD - 7800 Battery Sternum Saw requires the use of the included 7800-002. The guard can be attached to the handpiece in either a superior or inferior position,...
3. Trigger / Safety Lock 7800 Battery Sternum Saw operates at variable speeds and is controlled by depressing the trigger. The instrument is in the OFF position when the trigger is not depressed. As the trigger is depressed fully the speed increases from 0% - 100%.
- ACCESSORY ATTACHMENT - Battery Attachment 7800 Battery Sternum Saw must have a fully charged MicroAire U.L. classfied 6640-710 battery installed before each use. The MicroAire 7500- 710 and 7500-735 batteries may also be used with the 7800 Battery Sternum Saw.
Twist the blade locking collet into the open position by rotating in the direction of the arrows. While holding the blade locking collet in the open position, insert a MicroAire ZR-032M saw blade until it is fully seated. The blade may be inserted in the inferior or superior position.
Always use the Safety Lock when the instrument is not running. WARNING: Check that the battery is fully seated and locked. WARNING: Disconnect battery in the event of continuous running. - BATTERY CHARGING - See the separate operating instructions provided with the MicroAire 7500-700 charger.
DO NOT OIL the handpiece or trigger, as this could damage the instrument. 4. Handpiece does not run when trigger is depressed. a. Make sure you have a fully charged MicroAire U.L. Classified Battery Pack or 7007-000 DPC Power Pack properly seated in the handpiece base.
- INSTRUMENT STERILIZATION INSTRUCTIONS - [see separate Battery Sterilization Instructions on page 17] MicroAire surgical instruments are normally sterilized using steam autoclaves by either gravity discharge, or pre-vacuum 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.
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3. Ethylene Oxide Sterilization. Ethylene is NOT recommended for powered surgical instruments because lengthy aeration time is needed to assure that no ethylene oxide is left in the internal mechanisms or on the surface of the instrument. 4. Peracetic Acid DO NOT process powered surgical instruments in equipment that uses peracetic acid as a liquid sterilant.
Such service should be documented within the bioengineering department. CAUTION: Repairs or alterations to MicroAire products made by anyone other than MicroAire or an Authorized MicroAire Repair Facility will void that product’s warranty, and the customer will be responsible for any costs...
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7800 Battery Sternum Saw should provide years of reliable service. This life- expectancy is based on the proper handling and care of the instrument, including annual maintenance at a MicroAire authorized service center. Any abuse, misuse, or use in other than recommended operating parameters may affect the life of the equipment.
- EXTENDED WARRANTY / SERVICE AGREEMENT - Extended warranties and service agreements are available on MicroAire power equipment. Extended warranties may be purchased while the equipment is covered by the original warranty. If the equipment is out of warranty, it must first be restored, if necessary, to full serviceable condition before being eligible for a service agreement.
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CAUTION: Leaving a battery pack attached to a handpiece when not in use may accelerate battery drain. -BATTERY STERILIZATION INSTRUCTIONS - MicroAire NiMH Battery Packs are normally sterilized by steam, using either a gravity displacement or prevacuum sterilizer. 1. Steam Sterilization Sterilizers vary in design and performance parameters, verify cycle parameters against the written instructions of the sterilizer and container manufacturers.
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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 warranties and/or service agreements are not available on MicroAire batteries.
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- 7025 DIRECT POWER CONSOLE (DPC) - The direct power console is designed for use only with MicroAire battery powered instrumentation. The DPC uses the MicroAire 7007-000 connecting cable- receptacle only. All personnel should become familiar with the power equipment prior to set-up for use in any procedure.
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Guidance and manufacturer’s declaration – electromagnetic emissions The Sternum Saw Handpiece (REF 7800) is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 7800 should assure that it is used in such an environment.
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The MicroAire Battery Instrument System has been tested to IEC 60601-1-2 Class A limits by an accredited test laboratory. The REF 7800 system is suitable for use in all establishments other than domestic and those [(See 5.2.2.1 c) directly connected to the public low-voltage...
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Guidance and manufacturer’s declaration – electromagnetic immunity The Sternum Saw Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 7800 should assure that it is used in such an environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity The Sternum Saw Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 7800 battery system should assure that it is used in such an environment.
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ME Equipment and ME Systems that are not Life-Supporting (see 5.2.2.2) Recommended separation distances between portable and mobile RF communications equipment and the Sternum Saw Battery System (REF 7800). The Sternum Saw Handpiece is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
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