MicroAire Series 7000 Large Power Battery System Instruction Manual

TABLE OF CONTENTS

Series 7000 Large-Power Battery System REF 7505, REF 7506, REF 7507

Instruction Manual

Intended Use and Introduction ...3 General Warnings...3-5 Markings...6-8 List of Compatible Accessories...8 Environmental Parameters...9 REF 7505 Drill Reamer Handpiece... 9-11 REF 7506 Oscillating Saw Handpice...12-14 REF 7505 Reciprocating Saw Handpiece...15-17 Series 7000 Battery Instructions...17-18 Drive Couplers...18-23 Instrument Cleaning and Sterilization Instructions...23-26 Warranty, Service and Repair... 27 Troubleshooting...26-28 Electromagnetic Compatibility...29-30

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APPLICABLE PARTS

REF 7505, REF 7506, REF 7507

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 Series 7000 Battery Large Power System with Handpiece Models: REF 7505, REF 7506, and REF 7507 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: WARNING: WARNING:

Risk of fire. Replace battery pack only with a MicroAire Battery Pack (REF 7505-710, REF 7500-620). Explosion Hazard. Not suitable for use in the presence of flammable anesthetics or oxygen. Electric Shock. Do not remove cover. Refer servicing to qualified personnel only.

WARNING:

Medical electrical equipment may be affected by electromagnetic interference. It should be installed and used in accordance with the electromagnetic compatibility information provided herein.

WARNING: WARNING:

Portable and mobile RF communications equipment can affect medical electrical equipment. Prior to use, all system components (handpiece, couplers, and batteries) should be inspected to detect any damage or malfunction. DO NOT use any component if damage is apparent. Prior to use, all system component manuals should be reviewed for important warnings and instructions for use. Eye protection must be worn when operating any power equipment. Dislodged burs, blades, or bone fragments can result in eye injury, blindness, or contamination of the eye from patient tissue or body fluids.

WARNING: WARNING:

WARNING: WARNING:

No modification of this equipment is allowed. Operating Duty cycle is 1 minute on, 1 minute off for a maximum of 6 cycles.

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:

Risk of fire. Replace battery pack only with a MicroAire Battery Pack (REF 7505-710, REF 7500-620).

WARNING:

To prevent inadvertent running of the handpiece while loading a drive coupler or surgical accessory, do not attach the battery pack until the coupler and surgical accessory have been loaded for use.

WARNING: WARNING:

Any power instrument is subject to overheating, especially in the nose section. Compliance with the listed duty cycle will reduce this risk. Excessive heat is the most likely cause of patient injury. Any power instrument is subject to become hot. Do not use excessive force or pry on the saw blade when in use. Doing so may cause the blade to bend or break, causing potential injury.

WARNING:

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WARNING: WARNING: WARNING: WARNING: WARNING: WARNING: WARNING: WARNING: WARNING:

Use of the Series 7000 Instruments adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the Series 7000 Instrument and the adjacent equipment should be observed to verify that they are operating normally. Portable RF communications equipment should be used no closer than 30 cm (12 inches) away from any part of Series 7000 Instruments. Otherwise degradation of the performance of the Series 7000 instruments could result. Use of Battery Packs other than those specified in the List of Compatible Accessories could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The Series 7000 instruments have been tested for use in the vicinity of High Frequency Electrosurgical / Electrocoagulation equipment. Use of such equipment in close proximity to the Series 7000 instruments 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. If any corrosion or debris is detected in/on the instrument, it must be considered contaminated. Replace the instrument immediately or remove it from the surgical field and reprocess. If the instrument looks damaged or shows signs of excessive wear, return for service. Large reciprocating saw blades are longer in length and can whip when the handpiece is operated below the maximum speed. Personnel should be alert. Blade whip can increase the chance of blade fracture and user/patient injury. Use of Battery Packs other than those specified in the List of Compatible Accessories could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Universal precautions for handling contaminated materials should be observed at all times. Some flexible IM reamers can bind in the medullary canal if inadvertently run in reverse. Pay close attention to the direction of the drill reamer before actuating during reaming with a flexible reamer.

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:

Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

CAUTION: Battery pack should not be left in the instrument when not in use because this will accelerate battery drain. CAUTION:

The REF 6640-710 battery pack is not compatible with Series 7000 Large Battery Instruments. Attempting to force a REF 6640-710 into a Series 7000 Large Battery Instrument may result in damage to both instrument and battery.

CAUTION:

Allow the blade to do the cutting when operating the saw. Applying too much pressure may bend the blade and reduce the cutting quality.

CAUTION:

To prevent damage to the instrument, the oscillating saw head must be firmly locked into place before use. The tapered neck of the oscillating saw head must be seated flush with the handpiece body to ensure that it is properly locked in position.

CAUTION:

Exceeding recommended steam sterilization exposure times or temperatures for the battery may reduce battery life and/or performance.

CAUTION: DO NOT lubricate or oil the handpieces. Lubrication may damage the internal motor mechanism. Also take special precautions to avoid the use of cleaners that contain lubrication. CAUTION: DO NOT immerse the handpiece in any fluid. IM-7505 Rev J 2021-05

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CAUTION: DO NOT utilize cleaning solutions that are not mild pH unless they are approved for use with Anodized Aluminum and Surgical Instruments. CAUTION: DO NOT utilize cleaning agents with chlorine or chloride as the active ingredient is corrosive to stainless steel. CAUTION:

DO NOT use an ultrasonic cleaner. Ultrasonic cleaning can damage the bearings in the handpiece, potentially resulting in overheating or failure of the handpiece.

CAUTION: Dried blood, saline, and other deposits inside the handpiece are a major cause of equipment malfunctio. Proper cleaning and inspection prior to sterilization will avoid delays during the surgical procedure. CAUTION:

NOTE:

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. All personnel should become familiar with the power equipment before it is set-up for use in any procedure. Personnel trained should include, but not be limited to, central processing personnel, members of the surgical team, and the bioengineering department.

NOTE:

Sterile instrument packages should be examined closely prior to opening to ensure that there has been no loss of package integrity.

NOTE:

Do not use instruments when they are still warm. They need to cool down to room temperature.

NOTE:

Do not soak instruments to cool them down nor wrap cold towels around them.

NOTE:

Mailing address is located on back cover.

NOTE:

The Series 7000 battery system has no essential performance.

NOTE:

The REF 7100-006 will not accept MicroAire twist drill numbers REF 8053-020, REF 8053-024, REF 8053-032, REF 8053-036, REF 8053-115, and REF 8053-119.

NOTE: If concerns are noted that may compromise the function of the device, please contact your MicroAire representative. NOTE: Where there is a concern about TSE/vCJD contamination, the World Health Organization recommends processing through a pre-vacuum steam sterilization cycle for 18 minutes at 134 °C (273 °F). (WHO/ CDS/CSR/2000.3, “WHO Infection Control Guidelines for TSE,” March 1999). NOTE: Washer/Disinfectors should comply with the requirements of ISO 15883 (in preparation). They should be properly installed and be regularly tested in accordance with ISO 15883. NOTE:

The Series 7000 Battery Instruments are 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.

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MARKINGS Name

Ref#

(ISO 7000)2

Description

Use Standard

• Indicates a MANDATORY action for the user to consult the Instructions For Use (IFU). • Symbol must be blue, as shown.

IEC 60601-1:20051

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

0434A / 0434B

Indicates 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

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

UL

Indicates a medical device complying with the specified 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

Refer to Instruction Manual / Booklet

ISO-7010 M002

Consult Instructions For Use (IFU) Caution

UL symbol

Symbol

C

N/A E494242

Type B Applied Part

5840

B

Forward Direction

N/A

F

Indicates rotation will be counterclockwise when viewed from the front of the instrument.

N/A

Reverse Direction

N/A

R

Indicates rotation will be clockwise when viewed from the front of the instrument.

N/A

Locked

5569

Unlocked

5570

“ON” Position

N/A

Indicates “ON” position (both triggers functional).

N/A

“OFF” Position (Safety)

N/A

Indicates “OFF” position (both triggers will not function when depressed).

N/A

Do Not Expose to Stray Magnetic Fields

N/A

Indicates a medical device that is not to be exposed to stray magnetic fields.

N/A

Slow Speed

N/A

Indicates speed set to slow.

N/A

Fast Speed

N/A

Indicates speed set to fast.

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 specific medical device can be identified. • 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 identified.

ISO 15223-1:20121

2493

• Indicates the manufacturer’s catalog number so that the medical device can be identified. • Per EN980:2008, the REF symbol may be used without surrounding box.

ISO 15223-1:20121

REF (Catalog #)

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 

p pp

To identify on a control that a function is locked or to show the locked status.

IEC 60878:20151

To identify on a control that a function is not locked or to show the unlocked status.

IEC 60878:20151

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Humidity Limitation

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.

2620

• Non-Sterile

2609 •

Sterile

2499

Do Not Reuse

1501

Do Not Use if Package is Damaged

2606

Temperature Limitation

0632

2 w >

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

ISO 15223-1:20121

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

Indicates a medical device that is not to be resterilized.

ISO 15223-1:20121

Indicates 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

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

ISO 15223-1:20121

IEC 60335-2-15

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.

Do Not Immerse in any Liquid

5995

Indicates a medical device that is not to be immersed in any liquid.

Do Not Lubricate

N/A

Indicates a medical device that is not to be lubricated.

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 filled (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

Indicates the European Conformity Mark with Notified Body Number. 2797 is the BSI-NL-registered Notified Body.

Council Directive 93/42/EEC FDA Title 21, Chapter 1, Subchapter H, Part 801.15(F)

Date of Manufacture

2797

N/A

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).

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



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Use-By Date

1 2

2607

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).

t

ISO 15223-1:20121

ISO 15223-1:2012 – “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements” ISO 7000/IEC 60417 – “Graphical symbols for use on equipment – Registered symbols”

LIST OF COMPATIBLE ACCESSORIES Part Number

Description

Type B Applied Parts

REF 7505-045

Wire/Pin Driver Coupler (used only with REF 7505 Drill/Reamer)

Accepts wires and pins from 1.6mm to 2.8mm

REF 7505-050

Pin Driver Coupler (Used only with REF 7505 Drill/Reamer)

Accepts wires and pins from 3.2mm to 4.0mm

REF 7505-040

Sterilization Case and Washer Tray

N/A

REF 7500-700

Universal Battery Charger

N/A

REF 7505-710

Large NIMH Battery Pack

N/A

REF 7500-615

Aseptic Battery Housing

N/A

REF 7500-620

Aseptic NIMH Battery Pack

N/A

REF 7500-625

Charging Adapter

N/A

REF 7500-630

Aseptic Trasnfer Shield

N/A

REF 7100-003

Jacobs®-Style Couper 1/4" (with Key) REF 4100-030 Key Included

N/A

REF 7100-004

Keyless Coupler 1/4"

N/A

REF 7100-005

Keyless Coupler 1/8"

N/A

REF 7100-006

Synthes® Quick Connect Coupler

N/A

REF 7100-051

Zimmer® (Hudson® Modified Trinkle) Coupler

N/A

REF 7100-058

Hudson® Coupler

N/A

REF 7100-002

Trinkle Coupler

N/A

REF 7100-001

Zimmer® Reamer Coupler (Hudson® Modified Trinkle)

N/A

REF 7100-008

Hudson® Reamer Coupler

N/A

REF 7100-010

Jacobs®-Style Couper 1/4" (REF 4100-030 Key Included)

N/A

REF 7100-011

Harris/Aesculap® Reamer Coupler

N/A

REF 7100-111

Synthes® Reamer Coupler

N/A

REF 7100-112

Synthes® Non-reversing Reamer Coupler

N/A

Accepted Cutting and Drilling Accessories

WARNING:

REF ZO11-XXX-XXX, REF ZO18-XXX-XXX, REF ZO25-XXX-XXX, REF ZO-7XXXX, REF ZO-XXX, REF ZO-7XXX, REF ZR-XXX, REF 8054-XXX, REF 8054-XXXNS

Use of Battery Packs other than those specified in the List of Compatible Accessories could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

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ENVIRONMENTAL PARAMETERS OPERATING CONDITIONS This device has been tested and proven to operate within the following conditions:

>

59° F/15° C

106 kPA

60%

80.6° F/27° C

70 kPA

20%

Temperature

Humidity

Atmospheric

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

>

-0.4° F/-18° C

106 kPA

91%

120° F/49° C

70 kPA

0%

Temperature

Humidity

Atmospheric

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.

REF 7505 DRILL REAMER HANDPIECE

1

2

4

3

Features and Descriptions 1. Coupler Locking Ring – The coupler locking ring locks and releases a drive coupler on the REF 7505 Drill Reamer. The Coupler Locking Ring must be pulled back completely to fully insert or remove a drive coupler into the REF 7505 drill reamer. 2. Trigger / Safety Lock – The MicroAire REF 7505 Drill Reamer handpiece 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 slowly from 0% - 100%. The trigger also serves as the safety lock for the handpiece by rotating clockwise or counterclockwise.

3. Forward/Reverse Control Switch– The drill reamer will operate in forward and reverse; clockwise and counterclockwise rotation. To select the forward direction, move the control switch to the “F” position. To select the reverse direction, move the control switch to the “R” position. 4. Battery Release Button – Depress this button to remove a battery pack from the handpiece. The button does not need to be depressed to load a battery pack.

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Handpiece Safety Mechanisms:

Trigger in “OFF” position Trigger in upright – “ON” position

(Trigger can be turned in either clockwise or counterclockwise from the upright “ON” position to be turned “OFF”.)

Technical Data – Specifications* High Torque Output: Reaming Coupler

0 – 250 rpm, 0-150 in/lbs (16.9 N-m)

High Speed Output: Drilling/Pinning Coupler

0 – 750 rpm, 0 – 50 in/lbs. (5.6 N-m)

Cannulation:

5.0 mm (.200”)

Handpiece Weight: Without Battery

2.38 lb. (1080 g)

Battery Weight: REF 7505-710

1.59 lb. (721 g)

Battery Voltage:

14.4 volts

Battery Chemistry:

Nickel Metal Hydride (NiMH)

Duty Cycle:

1 minute on, 1 minute off, 6 cycles maximum

Rating: * Values are typical and may vary.

14.4 VDC 225W

REF 7505 Drill Reamer Handpiece Technical Description

The MicroAire REF 7505 Drill Reamer is a single-trigger, two-speed, multi-purpose (drill, ream, pin drive) handpiece with a selection of quick-connect Drive Couplers. The couplers automatically key to the correct drive speed (250 rpm or 750 rpm). The individual drive couplers are designed to accept standard orthopaedic instrument fittings including Jacobs®-style, Zimmer®-style (Also referred to as Hudson®-style Modified Trinkle), Hudson®-style, Aesculap®-style, Synthes®-style, and Trinkle®-style. Adjustable wire and pin driver couplers allow for easy insertion of smooth or threaded wires and pins from 1.6 mm ­– 4.0mm (.062” ­– 5/32”). All personnel should become familiar with the power equipment before it is set-up for use in any surgical procedure. Personnel who should attend an in-service instruction includes, but is not limited to, central processing personnel, members of the surgical team, and the bio-engineering departments.

Drill Reamer Setup: CAUTION: Battery pack should not be left in the instrument when not in use because this will accelerate battery drain. WARNING:

To prevent inadvertent running of the handpiece while loading a drive coupler or surgical accessory, do not attach the battery pack until the coupler and surgical accessory have been loaded for use.

1. Inspect the handpiece and couplers for damage, corrosion, or signs of excessive wear. WARNING:

If any corrosion or debris is detected in/on the instrument, it must be considered contaminated. Replace the instrument immediately or remove it from the surgical field and reprocess. If the instrument looks damaged or shows signs of excessive wear, returned for service.

2. Make sure the handpiece trigger is set to the “OFF” position. 3. Check all surgical accessories. Make sure that reamers, drills, pins, etc. are not dull or bent, and that they lock correctly into the handpiece. IM-7505 Rev J 2021-05

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4. Attach a large power Drive Coupler (REF 7100/7505-XXX series) to the front of the drill reamer handpiece. To connect a Drive Coupler to the REF 7505 Drill Reamer Handpiece, pull back on the coupler locking ring and insert the drive coupler with a slight twisting motion as the coupler locks into position. Release the coupler locking ring to lock the coupler in place before use. The coupler locking ring must release completely and sit flush with the base of the drive coupler. 5. Insert the surgical accessory (drill, reamer, pin, etc.) into the drive coupler, checking for a secure and proper fit. Use blue and red color coding for easy coupler selection: Red banded couplers provide the high torque and slower speed for reaming. Blue banded couplers provide less torque and higher speed for drilling and pin driving. Remember, “red is for reaming.” a. When the trigger is in the “OFF” position, make sure the motor cannot be activated. b. When the trigger is in the “ON” position, make sure that it it allows activation of the motor. c. Make sure that the trigger does not stick in the fully depressed position. If it has any tendency to stick, clean and sterilize the handpiece. If the handpiece still does not meet the requirements above, return the handpiece for service. 6. Attach a fully charged MicroAire Battery Pack (REF 7505-710, REF 7500-620) to handpiece. To attach the battery/power pack 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/power pack into the base of the handpiece until the battery latch clicks into place. Before use, check to make sure the battery pack is locked securely on the handpiece by giving the battery a firm tug. The battery pack should remain securely attached to the handpiece. If the battery/power pack is lose or not secure, reinstall or replace with another battery/power pack. CAUTION: The REF 6640-710 battery pack is not compatible with Series 7000 Large Battery Instruments. Attempting to force a REF 6640-710 into a Series 7000 Large Battery Instrument may result in damage to both instrument and battery. 7. Choose designated drive direction on base of handpiece. To select the forward direction, move the control switch to the “F” position. To select the reverse direction, move the control switch to the “R” position. 8. With the surgical accessory inserted, test run the instrument in the sterile field with three ten-second bursts, checking for any indications of irregular noise, excessive heat or vibration. Irregular grinding noises may indicate incomplete drive coupler connection, impending failure, or overheating of the handpiece. If any irregular grinding noises are present, check for proper setup or return the instrument for service. 9. Check for excessive heat. WARNING:

Any power instrument is subject to overheating, especially in the nose section. Compliance with the listed duty cycle will reduce this risk.

To check for overheating, test run the handpiece for approximately 30 seconds. Periodically monitor the temperature of the nose section. The temperature should not rise above 115° F (46° C) and should not become uncomfortable to touch with gloved fingers. If the instrument temperature exceeds 115° F (46° C) , return for service. The following conditions may cause overheating or total failure of the instrument: · Blood deposits, saline, and bone fragments may enter the forward section of the handpiece during operation. Saline causes corrosion, and blood produces restrictive deposits. · Repeated sterilization removes grease from the bearings, and leaves mineral deposits on moving parts Regular maintenance is recommended to replace lubrication, bearings, seals, and O-rings. · The force of high torque and high speed commonly encountered in many surgical procedures produces wear on bearings and gear train mechanisms. 10. Drill Reamer is ready for use. 11 of 32

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REF 7506 OSCILLATING SAW HANDPIECE 1

2

3

5

4

Features and Description 1. Oscillating Saw Blade Mount – The oscillating saw blade mount securely locks MicroAire ZO -series large bone oscillating saw blades into the REF 7506 Oscillating Saw. The blade mount may be pulled forward and rotated into eight (8) possible cutting angles. 2. Load/Unload Latch – This latch locks the oscillating saw blade into the blade mount. Lifting the latch opens the blade mount for insertion and removal of saw blades. 3. Trigger/Safety Lock – The MicroAire REF 7506 Oscillating Saw handpiece 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 slowly from 0% - 100%. The trigger also serves as the safety lock for the handpiece by rotating clockwise or counterclockwise.

4. Oscillating Saw Speed Switch – The MicroAire REF 7506 Oscillating Saw has a two-speed control switch that allows for two maximum speed settings. Placing the switch in the  position (fast) operates the handpiece at high speeds. Moving the switch to the  position (slow) allows the handpiece to operate at high torque and reduces the maximum speed by 20%. 5. Battery Release Button – Depress this button to remove a battery pack from the handpiece. The button does not need to be depressed to load a battery pack.

Handpiece Safety Mechanisms:

Trigger in “OFF” position (Trigger can be turned in either the clockwise or counterclockwise direction from the upright “ON” position to be turned “OFF”.)

Trigger in upright – “ON” position

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Technical Data – Specifications* Oscillating Saw Speed:

0 – 15,000 cpm,

 Setting:

0 – 15,000 cpm maximum

 Setting:

0 – 12,000 cpm maximum

Blade Cutting Arc:

4°

Handpiece Weight: Without Battery

2.63 lb. (1196 g)

Battery Weight: REF 7505-710

1.59 lb. (721 g)

Battery Voltage:

14.4 volts

Battery Chemistry:

Nickel Metal Hydride (NiMH)

Duty Cycle:

1 minute on, 1 minute off, 6 cycles maximum

Rating: * Values are typical and may vary

14.4 VDC 225 W

REF 7506 Oscillating Saw Handpiece Technical Description

The MicroAire REF 7506 Oscillating Saw is a single-trigger, variable speed, multi-purpose handpiece designed for total joint arthroplasty. The saw’s heavy-duty high-speed oscillating mechanism is designed to drive the extra-long and wide saw blades required for total knee osteotomies. The oscillating saw may also be used in total hip arthroplasty, trauma, and revision sternotomies. All personnel should become familiar with the power equipment before it is set-up for use in any surgical procedure. Personnel who should attend an in-service instruction includes, but is not limited to, central processing personnel, members of the surgical team, and the bio-engineering departments.

Oscillating Saw Setup: CAUTION: Battery pack should not be left in the instrument when not in use because this will accelerate battery drain. WARNING:

To prevent inadvertent running of the handpiece while loading a saw blade, do not attach the battery pack until the saw blade has been securely locked into place and is ready for use.

1. Inspect the handpiece for damage, corrosion, or signs of excessive wear. WARNING:

If any corrosion or debris is detected in/on the instrument, it must be considered contaminated. Replace the instrument immediately or remove it from the surgical field and reprocess. If the instrument looks damaged or shows signs of excessive wear, return for service.

2. Make sure the handpiece trigger is set to the “OFF” position. 3. Check all surgical accessories. Make sure that saw blades are not dull or bent, and that they lock correctly into the handpiece. 4. To load a saw blade, use ONLY MicroAire “ZO” series large oscillating saw blades. Release the Load/Unload Latch by pulling down and away from the cutting head. The blade mount is spring loaded and will open to reveal blade alignment pins. Insert the blade so it sits flat against the back of the blade mount, and the blade hub is seated over the alignment pins. Hold the saw blade securely in place and push up and back on the latch to lock the blade into place. To remove a saw blade from the saw, release the Load/Unload Latch and remove saw blade. a. When the trigger is in the “OFF” position, make sure the motor cannot be activated. b. When the trigger is in the “ON” position, make sure that it allows activation of the motor. c. Make sure that the trigger does not stick in the fully depressed position. If it has any tendency to stick, clean and sterilize the handpiece. If the handpiece still does not meet the above requirements, return the handpiece for service. 13 of 32

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5. Attach a fully charged MicroAire Battery Pack (REF 7505-710, REF 7500-620) to handpiece. To attach the battery/ power pack 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/power pack into the base of the handpiece until the battery latch clicks into place. Before use, check to make sure the battery pack is locked securely on the handpiece by giving the battery a firm tug. The battery pack should remain securely attached to the handpiece. If the battery/power pack is lose or not secure, reinstall or replace with another battery/power pack. CAUTION:

The REF 6640-710 battery pack is not compatible with Series 7000 Large Battery Instruments. Attempting to force a REF 6640-710 into a Series 7000 Large Battery Instrument may result in damage to both instrument and battery.

6. Choose designated speed control option on base of handpiece. To select the standard (high-speed)  setting, move the control switch to the  position. To select the slow (reduced speed)  setting, move the control switch to the  position. 7. The oscillating saw head may be positioned in eight (8) possible cutting angle positions. (45° increments). To rotate the oscillating saw head, pull the head forward and away from the handpiece body and rotate in either direction to the desired cutting angle. CAUTION:

To prevent damage to the instrument, the oscillating saw head must be firmly locked into place before use. The tapered neck of the oscillating saw head must be seated flush with the handpiece body to ensure that it is properly locked in position.

8. With the saw blade securely locked in place, test run the instrument in the sterile field with three ten-second bursts, checking for any indications of irregular noise, or excessive heat or vibration. If any irregular grinding noises are present, check for proper setup or return the instrument for service. 9. Check for excessive heat. WARNING:

Excessive heat is the most likely cause of patient injury. Any power instrument is subject to become hot.

To check for overheating, test run the handpiece for approximately 30 seconds. Periodically monitor the temperature of the nose section. The temperature should not rise above 115° F (46° C) and should not become uncomfortable to touch with gloved fingers. If the instrument temperature exceeds 115° F (46° C), please return for service. The following conditions may cause overheating or total failure of the instrument: · Blood deposits, saline, and bone fragments may enter the forward section of the handpiece during operation. Saline causes corrosion, and blood produces restrictive deposits. · Repeated sterilization removes grease from the bearings, and leaves mineral deposits on moving parts Regular maintenance is recommended to replace lubrication, bearings, seals, and O-rings. · The force of high-torque and high-speed commonly encountered in many surgical procedures produces wear on bearings and gear train mechanisms. WARNING:

Do not use excessive force or pry on the saw blade when in use. Doing so may cause the blade to bend or break, causing potential injury.

CAUTION:

Allow the blade to do the cutting when operating the saw. Applying too much pressure may bend the blade and reduce the cutting quality.

10. Oscillating saw is ready for use.

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REF 7507 RECIPROCATING SAW HANDPIECE

1

2

3

4

Features and Descriptions 1. Blade Mount – Grippers that hold and align reciprocating saw blades in the reciprocating saw. The blade mount with blade may be oriented in any 360° position. 2. Blade Locking Collar – The locking collar rotates to securely lock the saw blade in the saw.

3. Trigger/Safety Lock – Saw handpiece 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 slowly from 0% - 100%. The trigger also serves as the safety lock for the handpiece by rotating clockwise or counterclockwise. 4. Battery Release Button – Depress this button to remove a battery pack from the handpiece. The button does not need to be depressed to load a battery pack.

Handpiece Safety Mechanisms:

Trigger in “OFF” position Trigger in upright – “ON” position

(Trigger can be turned in either the clockwise or counterclockwise direction from the upright “ON” position to be turned “OFF”.)

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Technical Data – Specifications* Reciprocating Saw Speed:

0 – 15,000 cpm

Blade Cutting Stroke:

3.2 mm (.125”)

Handpiece Weight: Without Battery

2.59 lbs. (1175 g)

Battery Weight: REF 7505-710

1.59 lbs. (721 g)

Battery Voltage:

14.4 volts

Battery Chemistry: Duty Cycle:

Nickel Metal Hydride (NiMH) 1 minute on, 1 minute off, 6 cycles maximum

Rating: * Values are typical and may vary.

14.4 VDC 225W

REF 7507 Reciprocating Saw Handpiece Technical Description

The MicroAire REF 7507 Reciprocating Saw handpiece is a single-trigger, variable speed, multi-purpose handpiece designed for linear bone cutting in total joint arthroplasy and other large-bone orthopaedic procedures. All personnel should become familiar with the power equipment before it is setup for use in any surgical procedure. Personnel who should attend an in-service instruction includes, but is not limited to, central processing personnel, members of the surgical team, and the bio-engineering departments.

Reciprocating Saw Setup: CAUTION: Battery pack should not be left in the instrument when not in use because this will accelerate battery drain. WARNING:

To prevent inadvertent running of the handpiece while loading a drive coupler or surgical accessory, do not attach the battery pack until the coupler and surgical accessory have been loaded for use.

1. Inspect the handpiece for damage, corrosion, or signs of excessive wear. WARNING:

If any corrosion or debris is detected in/on the instrument, it must be considered contaminated. Replace the instrument immediately or remove it from the surgical field and reprocess. If the instrument looks damaged or shows signs of excessive wear, return for service.

2. Make sure the handpiece trigger is set to the “OFF” position. 3. Check all surgical accessories. Make sure that saw blades are not dull or bent, and that they lock correctly into the handpiece. 4. To load a saw blade, use MicroAire “ZR” series large reciprocating saw blades. Rotate the locking collar in the counterclockwise direction to open the blade mount. Insert the saw blade between the blade mount grippers and push the blade back into the saw hub until it stops and is fully seated. Tighten the blade by rotating the blade locking collar in the clockwise direction until it is hand tight. Hold the blade in place while tightening the blade locking collar to prevent the saw blade from rotating. To remove the saw blade, follow the above steps in reverse. a. When the trigger is in the “OFF” position, make sure the motor cannot be activated. b. When the trigger is in the “ON” position, make sure that it allows activation of the motor. c. Make sure that the trigger does not stick in the fully depressed position. If it has any tendency to stick, clean and sterilize the handpiece. If the handpiece still does not meet the requirements above, return the handpiece for service.

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5. Attach a fully charged MicroAire Battery Pack (REF 7505-710, REF 7500-620) to handpiece. To attach the battery/ power pack 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/power pack into the base of the handpiece until the battery latch clicks into place. Before use, check to make sure the battery pack is locked securely on the handpiece by giving the battery a firm tug. The battery pack should remain securely attached to the handpiece. If the battery/power pack is lose or not secure, reinstall or replace with another battery/power pack. CAUTION:

The REF 6640-710 battery pack is not compatible with Series 7000 Large Battery Instruments. Attempting to force a REF 6640-710 into a Series 7000 Large Battery Instrument may result in damage to both instrument and battery.

6. With the saw blade securely locked in place, test run the instrument in the sterile field with three ten-second bursts, checking for any indications of irregular noise, or excessive heat or vibration. Irregular grinding noises may indicate impending failure or over heating of the handpiece. If any irregular grinding noises are present, check for proper setup or return the instrument for service. 7. Check for excessive heat. WARNING:

Excessive heat is the most likely cause of patient injury. Any power instrument is subject to become hot.

To check for overheating, test run the handpiece for approximately 30 seconds. Periodically monitor the temperature of the nose section. The temperature should not rise above 115° F (46° C) and should not become uncomfortable to touch with gloved fingers. If the instrument temperature exceeds 115° F (46° C), please return for service. The following conditions may cause overheating or total failure of the instrument: · Blood deposits, saline, and bone fragments may enter the forward section of the handpiece during operation. Saline causes corrosion, and blood produces restrictive deposits. · Repeated sterilization removes grease from the bearings, and leaves mineral deposits on moving parts. Regular maintenance is recommended to replace lubrication, bearings, seals, and o-rings. · The force of high torque and high speed commonly encountered in many surgical procedures produces wear on bearings and gear train mechanisms. WARNING:

Large reciprocating saw blades are longer in length and can whip when the handpiece is operated below the maximum speed. Personnel should be alert. Blade whip can increase the chance of blade fracture and user/patient injury.

WARNING:

Do not use excessive force or pry on the saw blade when in use. Doing so may cause the blade to bend or break, causing potential injury.

CAUTION:

Allow the blade to do the cutting when operating the saw. Applying too much pressure may bend the blade and reduce the cutting quality.

8.

Reciprocating saw is ready for use.

SERIES 7000 BATTERY INSTRUCTIONS Battery Charging See separate operating instructions provided with the MicroAire UL Classified Battery Charger (REF 7500-700).

Battery Installation

The Series 7000 Battery Large Power System must have a fully charged MicroAire battery pack (REF 7505-710 or Aseptic Battery installed before each use). 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. Before use, check to make sure the battery pack is locked securely on the handpiece by giving the battery a firm tug. The battery pack should remain securely attached to the handpiece. If the battery pack is lose or not secure, reinstall or replace with another battery. 17 of 32

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Aseptic Battery

The MicroAire Series 7000 battery instruments have been designed to operate using the MicroAire Aseptic Battery System. The Aseptic Battery uses a non-sterile battery pack REF 7500620 that is placed in a sterilized REF 7500-615 housing with locking door and removes the need to steam sterilize battery packs. The Aseptic Battery System has been designed for use with all MicroAire battery operated instruments. The Aseptic Battery provides comparable power, but will have reduced run times compared to a REF 7505-710 Battery Pack. See separate instructions provided with the REF 7500-6XX Aseptic Battery System.

DRIVE COUPLERS (For use with REF 7505 Drill Reamer Handpiece) The MicroAire Series 7000 REF 7505 Drill Reamer handpiece operates using a selection of quick-connect drive couplers. The couplers automatically key to the correct drive speed (250 rpm or 750 rpm). The individual drive couplers are designed to accept standard orthopaedic instrument fittings including Jacobs ®-style, Zimmer ®-style (Also referred to as Hudson®-style Modified Trinkle), Hudson®-style, Aesculap®-style, Synthes®-style, and Trinkle®-style. Adjustable wire and pin driver couplers allow for easy insertion of smooth or threaded wires and pins from 1.6 mm – 4.0mm (.062” – 5/32”).

How to connect drive couplers and wire/pin drivers:

Attach a large-bone Drive Coupler (REF 7100/7505-XXX series) to the front of the drill reamer handpiece. To connect a Drive Coupler to the REF 7505 Drill Reamer Handpiece, pull back on the coupler locking ring and insert the drive coupler with a slight twisting motion as the coupler locks into position. Release the coupler locking ring to lock the coupler in place before use. The coupler locking ring must release completely and set flush with the base of the drive coupler.

Drill/Screwdriver Drive Couplers (750 rpm) Blue Band REF 7100-002 Trinkle Drive Coupler – 750 rpm (nominal)

The Trinkle drive coupler accepts standard Trinkle shank twist drills and screw driver bits. To insert a Trinkle accessory into the REF 7100-002 Trinkle drive coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Pull back on the drive coupler locking collar located on the nose end of the coupler. 3. Insert the Trinkle accessory, making sure that it seats and locks properly into the drive coupler. 4. Release the locking collar. 5. Being careful of sharp drill flutes, pull on the accessory to make sure it does not slip loose. REF 7100-003 ¼” Jacobs® Drill Coupler (6.35 mm) – 750 rpm (nominal) Requires REF 4100-030 ¼” Jacobs® Key (included)

The Jacobs® drill coupler accepts MicroAire 8051 and 8054 series Jacobs®-style twist drills with diameters between 1.0 mm (.039”) and 6.5 mm (.25”) and smooth shank reamers. To insert a twist drill into the REF 7100-003 ¼” Jacobs® drill coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Using the ¼” Jacobs® key (REF 4100-030), open the check to the desired size. 3. Insert the twist drill, making sure it seats properly in the coupler. 4. Tighten the Jacobs® chuck using the same Jacobs® key (REF 4100-030). 5. Being careful of sharp drill flutes, pull on the drill bit to make sure it does not disengage. IM-7505 Rev J 2021-05

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REF 7100-004 ¼” Keyless Drill Coupler (6.35 mm) – 750 rpm (nominal)

This keyless drill coupler accepts MicroAire 8051 and 8054 series Jacobs®-style twist drills with diameters between 1.0 mm (0.39”) and 6.5mm (.25”) and smooth shank reamers. Applications requiring high torque are not recommended while running in reverse with the keyless drive couplers, because the twist drill may become loose. To insert a twist drill into the REF 7100-004 ¼” keyless drill coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Open the ¼” keyless drive coupler to desired size by firmly holding the middle adjustment ring and twisting the nose of the coupler counterclockwise. 3. Insert the twist drill, making sure it seats properly in the coupler. 4. Tighten the keyless coupler by firmly holding the middle adjustment ring and twisting the nose of the coupler clockwise until it is finger tight and the twist drill is secure. 5. Being careful of sharp drill flutes, pull on the drill bit to make sure it does not disengage. REF 7100-005 1/8” Keyless Drill Coupler (3.2mm) – 750 rpm (nominal)

This keyless drill coupler accepts MicroAire 8051 and 8054 series Jacobs® style twist drills with diameters between 1.0 mm (0.39”) and 3.2 mm (1/8”) and smooth shank reamers. Applications requiring high torque are not recommended while running in reverse with the keyless drive couplers, because the twist drill may become loose. To insert a twist drill into the REF 7100-005 1/8” keyless drill coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Open the 1/8” keyless drive coupler to desired size by firmly holding the middle adjustment ring and twisting the nose of the coupler counterclockwise. 3. Insert the twist drill, making sure it seats properly in the coupler. 4. Tighten the keyless coupler by firmly holding the middle adjustment ring and twisting the nose of the coupler clockwise until it is finger tight and the twist drill is secure. 5. Being careful of sharp drill flutes, pull on the drill bit to make sure it does not disengage. REF 7100-006 Synthes®-Style Quick-Connect Drill Coupler – 750 rpm (nominal)

The Synthes®-style drill coupler accepts MicroAire 8053-type twist drills and taps and other accessories with the Synthes®-style drill fitting. NOTE:

The REF 7100-006 will not accept MicroAire twist drill numbers REF 8053-020, REF 8053-024, REF 8053-032, REF 8053-036, REF 8053-115, and REF 8053-119.

To insert a twist drill into the REF 7100-006 Synthes®-style Quick-Connect Drill Coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Pull back on the locking collar located on the front of the coupler (knurled section). 3. Insert the twist drill, making sure it seats fully in the coupler. 4. Release the locking collar on the coupler. 5. Being careful of sharp drill flutes, pull on the drill bit to make sure it does not disengage. 19 of 32

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REF 7100-051 Zimmer®-Style Drill Coupler – 750 rpm (nominal) (Also referred to as Hudson® Modified Trinkle)

The REF 7100-051 Zimmer®-style Drill coupler is designed to accept standard Zimmer®-style (Hudson®-style modified Trinkle) quick-connect drill/reamer attachments. The 750 rpm high-speed drive coupler does not provide the high torque often required for reaming in total hip arthroplasty and is more appropriate for low torque reaming/drilling (total knee arthroplasty). To insert a reamer or quick-connect adapter into the REF 7100-051 Zimmer®-style Drill Coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Pull back on the locking collar located on the front of the coupler. 3. Insert the reamer/ drill making sure it seats fully in the coupler. 4. Release the locking collar on the coupler. 5. Being careful of sharp reamers or drill flutes, pull on the accessory to make sure it does not disengage. REF 7100-058 Hudson®-style Drill Coupler – 750 rpm (nominal)

The REF 7100-058 Hudson®-style Drill coupler is designed to accept standard Hudson®-style quick-connect drill/ reamer attachments. The 750 rpm high speed drive coupler does not provide the high torque often required for reaming in total hip arthroplasty and is more appropriate for low torque reaming/drilling (total knee arthroplasty). To insert a reamer or quick-connect adapter into the REF 7100-058 Hudson® -style Drill Coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Pull back on the locking collar located on the front of the coupler. 3. Insert the reamer/ drill making sure it seats fully in the coupler. 4. Release the locking collar on the coupler. 5. Being careful of sharp reamers or drill flutes, pull on the accessory to make sure it does not disengage.

Reaming Drive Couplers (250 rpm) Red Band REF 7100-001 Zimmer®-style Reamer Coupler – 250 rpm (nominal) (Also referred to as Hudson®-style Modified Trinkle)

The REF 7100-001 Zimmer®-style Reamer Coupler (Hudson®-style Modified Trinkle) is designed to accept standard Zimmer®-style quick-connect reamer attachments. The 250 rpm drive coupler has been designed to provide the high torque required for reaming in total hip arthroplasty. To insert a reamer into the REF 7100-001 Zimmer®-style Reamer Coupler: 1. Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece. 2. Pull back on the locking collar located on the front of the coupler. 3. Insert the reamer making sure it seats fully in the coupler. 4. Release the locking collar on the coupler. 5. Being careful of sharp reamers or drill flutes, pull on the accessory to make sure it does not disengage. IM-7505 Rev J 2021-05

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