MicroAire 7800 Manuel utilisateur

REF 7800 Battery Sternum Saw

Instructions for Use

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TABLE OF CONTENTS

Model REF 7800 Battery Sternum Saw

REF 7800-002 Sternum Guard & Accessories

Instruction Manual

Intended Use and Introduction ................................................................3

General Warnings.......................................................................................3-4

Markings........................................................................................................5-6

List of Compatible Accessories..................................................................7

Environmental Parameters .........................................................................7

Technical Data and Handpiece Safety Mechanisms......................7-8

Handpiece Features...................................................................................8-9

System Setup, Assembly, and Operation........................................ 9-10

Troubleshooting .......................................................................................... 10

Instrument Cleaning Instructions ......................................................... 11

Sterilization Parameters ................................................................. 11

Warranty, Service and Repair .................................................................. 12

Battery Information.................................................................................... 13

Electromagnetic Compatibility ........................................................14-15

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APPLICABLE PARTS

REF 7800

INTENDED USE

Multi-purpose, modular, powered instrument system intended for use in general, orthopedic, plastic and

trauma surgery.

INTRODUCTION

This manual has been written to help describe the procedures required to keep the MicroAire REF 7800 Battery

Sternum Saw 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.

NOTE: Used to point out the easiest means of carrying out techniques.

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

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

system/instruments.

GENERAL WARNINGS

WARNING: The REF 7800 Battery Sternum Saw must never be used without the REF 7800-002 sternum guard

securely in place and properly oriented with the MicroAire REF ZR-032M or ZR-033M sternum saw

blade.

WARNING: Replace battery pack only with a MicroAire REF 6640-710, REF 7505-710, or REF 7500-620 battery.

WARNING: Explosion Hazard. Not suitable for use in the presence of flammable anesthetics or oxygen.

WARNING: Electric Shock. Do not remove cover, return to factory for servicing.

WARNING: Medical electrical equipment may be aected by electromagnetic interference. It should be installed

and used in accordance with the electromagnetic compatibility information provided herein.

WARNING: Portable and mobile RF communications equipment can aect medical electrical equipment.

WARNING: Prior to use, system components should be inspected and operated to detect any damage or

malfunction. Do not use if damage is apparent.

WARNING: Always point the handpiece away from the patient and surgical team when testing.

WARNING: If the handpiece will not securely hold the saw blade or sternum guard, discontinue use and return

the instrument to the factory for service.

WARNING: Check Safety Lock and Trigger before operating the handpiece. If the trigger should stick in the

depressed “ON” position, do not use the handpiece. Immediately remove the battery. Return the

instrument to the factory for service. 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.

WARNING: No modication of this equipment is allowed.

WARNING: Operating Duty Cycle is 1 minute on, 2 hours off.

WARNING: Irrigation must be applied to the cutting accessory when cutting bone in order to keep bone

temperature within safe limits. Cutting without irrigation may cause unsafe temperatures leading to

bone necrosis.

WARNING: Use of the REF 7800 Sternum Saw adjacent to or stacked with other equipment should be avoided be

cause it could result in improper operation. If such use is necessary, the REF 7800 Sternum Saw and

the adjacent equipment should be observed to verify that they are operating normally.

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WARNING: Portable RF communications equipment should be used no closer than 30 cm (12 inches) away

from any part of the REF 7800 Sternum Saw. Otherwise degradation of the performance of the

REF 7800 could result.

WARNING: Use of Battery Packs other than those specied in the List of Compatible Accessories could result in

increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and

result in improper operation.

WARNING: REF 7800 Sternum Saw has been tested for use in the vicinity of High Frequency Electrosurgical /

Electro coagulation equipment. Use of such equipment in close proximity to the REF 7800 Sternum

Saw may cause unintended interruptions or unintended motion of durations up to 1 second. Place

the Instrument on a safe surface when not in use. Do not place powered Instruments on the patient

when not in use. Avoid entwining HF surgical cables with powered instruments.

WARNING: The following items should be periodically inspected for signs of damage and repaired or replaced as

needed to ensure continued safety with regard to electromagnetic disturbances over the life of the

system:

• Check that the Battery Connection base, the rear end cap and the front of the instrument

remain securely connected to the main instrument body.

• Check for damage to the battery pack housings.

CAUTION: Do not run the handpiece without the saw blade.

CAUTION: Disconnect battery from handpiece before loading or unloading the saw blade.

CAUTION: Leaving a battery pack attached to a handpiece when not in use may accelerate battery drain.

CAUTION: Make sure the tip of the sternum saw blade is inside the foot of the sternum guard and does not

strike any part of the sternum guard. Improper alignment of the sternum guard with the saw blade

can cause damage to the sternum saw or saw blade.

CAUTION: If the handpiece will not hold the saw blade or sternum guard securely, discontinue use and return to

the factory for service.

CAUTION: Check Safety Lock and Trigger before operating the handpiece. If the trigger should stick in the

depressed “ON” position, do not use the handpiece. Immediately remove the battery. Return the

instrument to the factory for service. Always use the Safety Lock when the instrument is not running.

CAUTION: Check that the battery is fully seated and locked.

CAUTION: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician (or properly licensed

practitioner).

CAUTION: Disconnect sternum guard, battery, and saw blade prior to sterilization. Batteries must be sterilized

separate from the handpiece and sternum guard.

CAUTION: DO NOT run instruments while warm. Cool by exposure to room temperature.

CAUTION: DO NOT immerse in liquid to cool.

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 related to returning the product to working condition

NOTE: Disconnect sternum guard, battery, and saw blade prior to sterilization. Batteries must be

sterilized separately.

NOTE: The REF 7800 Sternum Saw is suitable for use in hospitals and surgery centers. These systems should

not be used near Magnetic Resonance Imaging equipment.

NOTE: The emissions characteristics of this product 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 be required to take mitigation measures, such as relocating or re-orienting

the equipment.

NOTE: Mailing address is located on back cover.

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MARKINGS

Name Ref#

(ISO

7000)2Symbol Description Use Standard

Refer to Instruction

Manual / Booklet

ISO-7010

M002

• Indicates a MANDATORY action for the user to consult the

Instructions For Use (IFU).

• Symbol must be blue, as shown.

IEC 60601-1:20051

Consult

Instructions For

Use (IFU)

1641

Indicates the need for the user to consult the Instructions For Use

(IFU). Not required in conjunction with the Caution

symbol, if applicable.

ISO 15223-1:20121

Caution 0434A /

0434B CIndicates the need for the user to consult the Instructions For Use

(IFU) for important cautionary information such as warnings and

precautions that cannot, for a variety of reasons, be presented on

the device itself.

ISO 15223-1:20121

UL symbol N/A

E494242

MEDICAL-GENERAL MEDICAL EQUIPMENT AS TO ELECTRIC SHOCK,

FIRE, AND MECHANICAL HAZARDS ONLY. IN ACCORDANCE WITH

ANSI/AAMI ES 60601-1 (2005) + A1 (2012) + CAN/CSA C22.2 No.

60601-1 (2014) | Control Number: E494242

Type B Applied

Part 5840 BIndicates a medical device complying with the specied

requirements of IEC 60601-1 to provide protection against electric

shock, particularly regarding allowable patient leakage current and

patient auxiliary current.

IEC 60601-1:20051

Locked 5569 To identify on a control that a function is locked or to show the

locked status. IEC 60878:20151

Unlocked 5570 To identify on a control that a function is not locked or to show the

unlocked status. IEC 60878:20151

Do Not Expose to

Stray Magnetic

Fields

N/A Indicates a medical device that is not to be exposed to stray

magnetic elds. N/A

Authorized

Representative

in the European

Community

N/A

Indicates the authorized representative in the European

Community. This symbol shall be accompanied by the name and

address of the authorized representative, adjacent to the symbol.

ISO 15223-1:20121

Serial # 2498

• Indicates the manufacturer’s serial number so that a specic

medical device can be identied.

• Per EN980:2008, the SN symbol may be used without

surrounding box.

ISO 15223-1:20121

Lot / Batch Code 2492 Indicates the manufacturer’s batch code so that the batch or lot

can be identied. ISO 15223-1:20121

REF (Catalog #) 2493

• Indicates the manufacturer’s catalog number so that the medical

device can be identied.

• Per EN980:2008, the REF symbol may be used without

surrounding box.

ISO 15223-1:20121

Sterile 2499

Indicates a medical device that has been subjected to a

sterilization process. Use of the Sterile symbol requires a use-by date

(see Use-By Date symbol).

ISO 15223-1:20121

Sterilized using

Irradiation

(gamma)

2502 [Indicates a medical device that has been sterilized using irradiation

(gamma). Use of the Sterile symbol requires a use-by date

(see Use-By Date symbol).

ISO 15223-1:20121

Non-Sterile 2609

• Indicates a medical device that has not been subjected to a

sterilization process. This symbol should only be used to

distinguish between identical or similar medical devices sold

in both sterile and non-sterile conditions.

• Also indicates a medical device that is provided non-sterile

but must be sterilized prior to use.

ISO 15223-1:20121

Temperature

Limitation 0632 >Indicates the temperature limits to whichthe medical device can be

safely exposed. The upper and lower limits to temperature shall be

indicated adjacent to the upper and lower horizontal lines.

ISO 15223-1:20121

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Use-By Date 2607 t

Indicates the date after which the medical device is not to be used.

This symbol shall be accompanied by a date to indicate that the

medical device should not be used after the end of the month

shown. The date is expressed as YYYY-MM (e.g. 2015-11) or

YYYY-MM-DD (e.g. 2015-11-29).

ISO 15223-1:20121

Do Not Reuse 1501 2Indicates a medical device that is not to be resterilized. ISO 15223-1:20121

Do Not Use if

Package is

Damaged

2606 wIndicates a medical device that should not be used if the package

has been damaged or opened. This symbol may also mean

“Do not use if the product sterile barrier system or its packaging is

compromised”.

ISO 15223-1:20121

Sternum Saw

Guard Alignment

Arrow

N/A Indicates alignment of Sternum Saw Guard. N/A

Humidity

Limitation 2620

Indicates the range of humidity to which the medical device can be

safely exposed. The humidity limitations shall be indicated

adjacent to the upper and lower horizontal lines.

ISO 15223-1:20121

Atmospheric

Pressure

Limitation

2621

Indicates the range of atmospheric pressure to which the medical

device can be safely exposed. The atmospheric pressure

limitations shall be indicated adjacent to the upper and lower

horizontal lines.

ISO 15223-1:20121

Do Not Immerse in

any Liquid 5995 Indicates a medical device that is not to be immersed in any liquid. IEC 60335-2-15

Do Not Lubricate N/A Indicates a medical device that is not to be lubricated. N/A

Date of

Manufacture 2497

• Indicates the date when the medical device was

manufactured. The date is expressed as YYYY-MM (e.g. 2015-11)

or YYYY-MM-DD (e.g. 2015-11-29).

• If the symbol is lled (see Manufacturer symbol), both

the date of manufacture and the name/address of the

manufacturer may be combined in one symbol.

ISO 15223-1:20121

Manufacturer 3082

• Indicates the medical device manufacturer. This symbol shall be

accompanied by the name and address of the manufacturer. The

date of manufacture may be combined with this symbol.

• When using MicroAire as the manufacturer, use the MicroAire

LLC symbol.

ISO 15223-1:20121

CE Mark with NB N/A

2797

Indicates the European Conformity Mark with Notied Body

Number. 2797 is the BSI-NL-registered Notied Body.

Council Directive

93/42/EEC

Prescription N/A Caution: Federal Law (U.S.A.) restricts this device to sale by or on

the order of a physician (or properly licensed practitioner).

FDA Title 21,

Chapter 1,

Subchapter H,

Part 801.15(F)

Dispose of per

WEEE Directive

2012/19/EU

N/A

Indicates a medical device that is not to be disposed of as

unsorted municipal waste. Medical device is to be disposed of per

WEEE Directive 2012/19/EU.

Council Directive

2012/19/EU

Dispose of per

WEEE Directive

2012/19/EU

N/A

Indicates a medical device that is not to be disposed of as

unsorted municipal waste. Medical device is to be disposed of per

WEEE Directive 2012/19/EU. This symbol is used in place of the

above symbol if the product entered the market after 13 August,

2005.

Council Directive

2012/19/EU

(Symbol: European

Standard EN 50419)

Packaging is

Recyclable 1135 Indicates that the marked item or its material is part of a recovery

or recycling process. IEC 60878:2015

1 ISO 15223-1:2012 – “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements”

2 ISO 7000/IEC 60417 – “Graphical symbols for use on equipment – Registered symbols”

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LIST OF COMPATIBLE ACCESSORIES

Part Number Description IFU Type B Applied Parts

REF ZR-032M Sternum Saw Blade IM-7800 Yes

REF 7800-002 Sternum Saw Guard IM-7800 Yes

REF 6640-710 NiMH Battery Pack IM-PWRBATT No

REF 7505-710 Large NiMH Battery Pack IM-PWRBATT No

REF ZR-033M Aggressive Saw Blade IM-7800 Yes

REF 7500-700 NiMH Battery Charger IM-7500-700 No

REF 7500-615 Aseptic Battery Housing IM-ASEPBATT No

REF 7500-620 Aseptic NiMH Battery Pack IM-ASEPBATT No

REF 7500-625 Charging Adapter IM-ASEPBATT No

REF 7500-630 Aseptic Transfer Shield IM-ASEPBATT No

WARNING: Use of Battery Packs other than those specied in the List of Compatible Accessories could result in

increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and

result in improper operation.

ENVIRONMENTAL PARAMETERS (REF 7800, REF 7800-002)

OPERATING CONDITIONS

This device has been tested and proven to operate within the following conditions:

Temperature Humidity Atmospheric

59° F/15° C

80.6° F/27° C

>20%

60%

70 kPA

106 kPA

SHIPPING & STORAGE CONDITIONS

This device has been tested and proven to operate after repeated exposure to the following conditions:

Temperature Humidity Atmospheric

-0.4° F/-18° C

120° F/49° C

>0%

91%

70 kPA

106 kPA

Shipping: The materials and components used in the construction of this device were selected to ensure that the

device could be shipped by any standard commercial method without special handling conditions.

TECHNICAL DATA  SPECIFICATIONS

Operating Speed: 12,000 CPM (nominal)

Cutting Stroke: 0.117 in. (3.0 mm)

REF 7800 Handpiece Weight

(without battery pack) :

2.65 lb. (1211 g)

REF 6640-710 Battery Weight: 0.95 lb. (431 g)

Battery Voltage: 14.4 volts

Duty Cycle: 1 minute on, 2 hours off.

Rating: 14.4 VDC 225W

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HANDPIECE SAFETY MECHANISMS

Trigger in Upright - “ON” Position

Trigger in “OFF” Position

(Trigger can be turned in either direction

to be turned “OFF”)

REF 7800002 STERNUM GUARD

The REF 7800 Battery Sternum Saw requires the use of the included REF 7800-002. The guard can be attached to the

handpiece in either a superior or inferior position, depending on the position at which the blade was loaded.

INSTRUMENT COMPONENTS

Features & Descriptions

1. Blade Locking Collet

Insert the REF ZR-032M or ZR-033M Sternum Saw

Blade into the blade locking collet by turning the

collet in the direction indicated by the arrow, and then

inserting the blade.

2. Sternum Guard Lock / Release Button

Depress this button to lock or release the

REF 7800-002 Sternum Guard from the handpiece.

3. Trigger / Safety Lock

The REF 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

the speed increases from 0% - 100%. The trigger

also serves as the safety lock for the handpiece (see

previous page). After loading the saw blade and

attaching the sternum guard and battery, fully depress

the trigger and release one time before use.

4. Battery Release Button

Depress this button to remove a battery/power pack

from the handpiece. This button does not need to be

depressed to load a battery/power pack.

ACCESSORY ATTACHMENT

Battery Attachment

The REF 7800 Battery Sternum Saw must have a fully

charged MicroAire REF 6640-710 battery installed before

each use. The MicroAire REF 7505-710 and REF 7500-620

batteries may also be used with the REF 7800 Battery

Sternum Saw. To attach the battery to the handpiece,

place the battery under the base of the instrument with

the longer side facing the rear of the instrument. Firmly

push the battery into the base of the handpiece until the

battery latch clicks into place.

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Sternum Guard Attachment

WARNING: DO NOT USE The REF 7800 Battery Sternum

Saw without the REF 7800-002 sternum

guard securely in place and properly

oriented with the MicroAire REF ZR-032M or

ZR-033M sternum saw blade.

INSTRUMENT SETUP

CAUTION: Disconnect battery from handpiece before loading or unloading the saw blade.

CAUTION: Battery pack should not be left attached to the handpiece when not in use. This could result in

accelerated battery drain.

To insert the REF ZR-032M or ZR-033M saw blade into the sternum saw handpiece:

1. Make sure the handpiece trigger is set to the “OFF” position and the safety is “ON” by turning the trigger to

one side.

2. If installed, remove the sternum guard from the handpiece by depressing the release button located on the

underside of the sternum guard collet.

3. Twist the blade locking collet into the open position by rotating in the direction of the arrows.

4. While holding the blade locking collet in the open position, insert a MicroAire REF ZR-032M or REF ZR-033M

saw blade until it is fully seated. The blade may be inserted in the inferior or superior position.

5. Release the blade locking collet; it should automatically spring back into the lock position.

To install the REF 7800-002 Sternum Guard on the sternum saw:

1. Make sure the handpiece trigger is set to the “OFF” position and the safety is “ON” by turning the trigger to

one side.

2. Make sure that the MicroAire REF ZR-032M or REF ZR-033M sternum saw blade is securely installed.

3. Push the sternum guard into the blade/guard collet, over the installed saw blade. The sternum guard may

be inserted more easily by depressing the sternum guard lock button as the sternum guard is installed on

the handpiece. Make sure that the sternum guard is aligned with the saw blade teeth facing away from the

sternum guard. The sternum guard must be completely locked into place prior to use. Use the alignment

arrows to make sure the sternum guard is properly aligned with the handpiece.

CAUTION: Make sure the tip of the sternum saw blade is inside the foot of the sternum guard and does not strike

any part of the sternum guard. Improper alignment of the sternum guard with the saw blade can cause

damage to the sternum saw or saw blade.

Test run the assembled handpiece for a few seconds to make sure that the blade and sternum guard are properly

aligned and secure.

1. Move the safety lock to the “OFF” position by turning the trigger back into the vertical position.

2. Run the handpiece by fully depressing the trigger.

WARNING: Always point the handpiece away from the patient and surgical team when testing.

WARNING: If the handpiece will not securely hold the saw blade or sternum guard, discontinue use and return

the instrument to the factory for service.

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WARNING: Check Safety Lock and Trigger before operating the handpiece. If the trigger should stick in the

depressed “ON” position, do not use the handpiece. Immediately remove the battery. Return the

instrument to the factory for service. 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.

TROUBLESHOOTING

1. Blade will not load into collet:

a. Make sure that the blade is the MicroAire REF ZR-032M or REF ZR-033M.

b. Mare sure the blade locking collet is fully turned in the direction indicated by the arrow on the collet.

c. Attempt to load a different REF ZR-032M or REF ZR-033M blade into the collet. If the second blade cannot be

loaded into the collet, return the handpiece for service.

2. Sternum Guard will not lock into handpiece:

a. Make sure that the sternum guard is the MicroAire REF 7800-002.

b. Make sure the arrows on the handpiece and guard are aligned properly, and the Guard Lock/Release Button is

depressed when attempting to insert the sternum guard.

c. Attempt to load a different REF 7800-002 sternum guard into the collet. If the second guard cannot be loaded

into the collet, return the handpiece for service.

3. Trigger cannot be depressed:

a. Make sure the trigger is turned to the upright “ON” position (refer to page 6).

b. Make sure the instrument was properly cleaned and sterilized.

c. If trigger cannot be depressed, return to factory for service.

d. 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 Battery Pack properly seated in the handpiece base.

b. Try a different, fully charged battery pack in the handpiece. If the handpiece still does not operate when the

trigger is depressed, return the handpiece for service.

5. Battery does not seat properly in handpiece:

a. Make sure you are using an approved MicroAire battery/power pack (part numbers listed on page 5).

b. Make sure the longer side of the battery pack is facing the rear of the instrument as shown on page 6.

c. Attempt to insert another battery pack. If second battery pack will seat properly, return the first battery for

inspection. If the second battery pack does not seat properly, return the handpiece and batteries for service.

d. Make sure the connector pins in the handpiece battery receptacle are not bent. If the pins are bent, return the

handpiece for service. DO NOT attempt to bend the pins back into place.

6. Handpiece runs slowly:

a. Make sure you have a fully charged MicroAire Battery Pack properly seated in the handpiece base.

b. Try a different, fully charged battery pack in the handpiece. If the handpiece still runs slowly when the trigger is

depressed, return the handpiece for service.

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