Arthrex 300 User Manual

Instructions for use

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Contents

Arthrex Symbols ....................................................................................................................................................................3

1. Introduction ........................................................................................................................................................................6

2. Electromagnetic compatibility (EMC) ................................................................................................................................8

3. System overview .............................................................................................................................................................14

4. System components ........................................................................................................................................................ 15

5. Safety notes ....................................................................................................................................................................18

6. Description of handpiece drive ........................................................................................................................................ 24

7. Description of charging station – front side ..................................................................................................................... 25

8. Description of charging station – reverse side ................................................................................................................ 26

9. Description of rechargeable battery ................................................................................................................................27

10. Start-up – charging station ............................................................................................................................................ 28

11. Start-up – handpiece drive ............................................................................................................................................29

12. Removing the rechargeable battery .............................................................................................................................. 30

13. Start-up – Assembling / removing the adaptor ............................................................................................................... 31

14. Changing the rotary instruments and saws .................................................................................................................32

15. Cleaning and maintenance ...........................................................................................................................................37

16. Accessories ...................................................................................................................................................................42

17. Service ..........................................................................................................................................................................43

18. Technical Data ...............................................................................................................................................................45

19. Recycling and disposal .................................................................................................................................................47

Authorized service partner ..................................................................................................................................................48

TRAINING CERTIFICATE ...................................................................................................................................................49

Arthrex Symbols

Symbols in the Instructions for use

WARNING!

(Risk of injury)

Thermo washer disinfectable

ATTENTION!

(To prevent damage occurring)

Sterilizable

up to the stated temperature

General explanations,

no risk to persons or objects

Arthrex Symbols

Symbols on the System components

Consult instructions for use

Follow instructions for use

Date of manufacture

Sterilizable up to the stated temperature

Thermo washer disinfectable

Not suitable for intracardiac application –Type B

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) CAN/CSA-C22.2 No. 60601-1 (2008) File No. E365949 and UL 60601-1:1990 / CSA C22.2 NO. 601.1 File No. E365830

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Do not dispose of with domestic waste

CE 0086 from the manufacturer

Connecting plug

Lock open / closed

Manufacturer

REF

rpm

Part number

Serial number

Battery voltage

Alternating current

Energy quantity

Revolutions per minute (rpm = min

-1

)

Arthrex Symbols

Symbols on the System components

This way up

Fragile, handle with care

Temperature limits

Humidity limitation

Keep away from rain

General symbol for

recovery / recyclable

1. Introduction

For your safety and the safety of your patients

These instructions explain to you how to handle your product. However, we must also warn against possible hazardous situations. Your safety, the safety of your team, and of course, the safety of your patients is of paramount importance to us.

It is therefore essential to read the safety notes on pages 18 to 23.

Intended use

The Arthrex 300 system is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging AR-600L and AR-300L rechargeable batteries.

Misuse can damage the Arthrex 300 system and hence cause risks and hazards for patients, users and third parties.

Qualifications of the user

The Arthrex 300 system may only be used by medically trained, experienced, expert staff, and only once these staff have been briefed. The target group we had in mind when developing and designing the Arthrex 300 system was orthopaedic and A&E surgeons and physicians.

Contraindications

• Use by unskilled/untrained personnel

• Disregarding of the intended use

• Non-compliance with the operation mode

• usage of improper accessories

Introduction

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Production according to EU directive

This medical product has been designed and manufactured according to EU Directive 93/42/EEC and is valid for the Arthrex 300 system, consisting of:

• AR-300 Handpiece

• AR-300L Battery Pack, Li-Ion

• AR-300LBH Battery Housing

• AR-300ATK Transfer Kit

• AR-300/600 Charging Station

• AR-300SAG Saw Attachment –

Sagittal

• AR-300SR Saw Attachment – Reciprocating

• AR-300B Burr Attachment 2.35 mm

• AR-300RAO Reamer Attachment – Style AO

• AR-300RJ Reamer Jacobs Chuck 0-4.0 mm

• AR-300CA Offset Adapter

• AR-300DAO-1 Drill Attachment – Style AO

• AR-300DK30 Drill Keyless Chuck 0-3.0 mm

• AR-300DK45 Drill Keyless Chuck 2.0-4.5 mm

• AR-300DJ Drill Jacobs Chuck 0-4.0 mm

• AR-300DAO-2 Drill Attachment – Style AO

• AR-300DJH Drill Jacobs Chuck Hybrid

0-5.0 mm

• AR-300WD16 Wire Driver Attachment

0.6-1.6 mm

• AR-300PD24 Pin Driver Attachment

1.0-2.4 mm

in the condition as delivered by us. This declaration is not valid for unintended external or internal attachments and the like.

Responsibility of the manufacturer

The manufacturer can only accept responsibility for the safety, reliability and performance of the Arthrex 300 system when it is used in compliance with the following directions:

• The Arthrex 300 system must be used in compliance with these Instructions for use.

• The Arthrex 300 system contains no parts which are repairable by the user. Assembly, modifications or repairs

must be carried out only by Arthrex accredited specialists (see page 48).

• Unauthorized opening of the equipment invalidates all claims under warranty and any other claims.

2. Electromagnetic compatibility (EMC)

Notes on electromagnetic compatibility (EMC)

Medical electrical equipment is subject to particular precautions with regards to EMC and must be installed and put into operation in accordance with the EMC notes included.

Arthrex guarantees the compliance of the device with the EMC requirements only when used with original Arthrex accessories and spare parts. The use of other accessories/other spare parts can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference.

The use of cables, power supplies, accessories other than those specified by the manufacturer may result in increased emission and/or decreased immunity.

Cable and accessories Length Reference

AR-600 Li-Ion battery (AR-600L) -

AR-300 Li-Ion battery (AR-300L) -

mains cable (EU) AR-300/600F-EU 3.0 m [9.8 ft] Manufacturer: Feller GmbH [REF 01343700]

alternative mains cable (DK) AR-300/600F-DK 3.0 m [9.8 ft] Manufacturer: Feller GmbH [REF 05901800]

alternative mains cable (UK) AR-300/600F-UK 2.5 m [8.2 ft] Manufacturer: Feller GmbH [REF 03212700]

alternative mains cable (CH) AR-300/600F-CH 2.5 m [8.2 ft] Manufacturer: Feller GmbH [REF 04280600]

alternative mains cable (AUS, NZL) AR-300/600F-AUS 2.5 m [8.2 ft] Manufacturer: Feller GmbH [REF 02909300]

mains cable, hospital grade (USA) AR-300/600F-US

mains cable (BR) AR-300/600F-BR 2.5 m [8.2 ft] Manufacturer: Feller GmbH [REF 05333500]

3.1 m [10.2 ft] Manufacturer: Feller GmbH [REF 02821400]

Manufacturer: Arthrex GmbH Producer: W&H [REF 30131]

Manufacturer: Arthrex GmbH Producer:W&H [REF 30154]

Operate the product in a place with a maximum distance to electrical and magnetic interfering transmitters.

If operation of the product close to other devices or together in a stack is necessary, observe the correct function of the system.

Electromagnetic compatibility (EMC)

Manufacturer’s declaration – Electromagnetic Emission (Table 201, EN 60601-1-2)

The product is suitable for use in a specific electromagnetic environment. The customer and/or the user of the product should assure that it is used in an electromagnetic environment as described below.

Emission test Compliance Electromagnetic Environment Guidance

RF-emission CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Group 1

Class B

complies

The product use RF energy only for its internal function. Therefore, it’s RF emissions are very low and not likely to cause any interference in nearby electronic equipment.

The product is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power

supply network that supplies buildings used for domestic purpose.

Electromagnetic compatibility (EMC)

Manufacturer’s declaration – Electromagnetic Immunity I (Table 202, EN 60601-1-2)

Immunity Test IEC 60601-Level Compliance Level Electromagnetic Environment Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/bursts IEC 61000-4-4 (AR-300/600 only)

Surge IEC 61000-4-5 (AR-300/600 only)

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 (AR-300/600 only)

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Note: UT is the mains (AC) voltage before apply test levels

± 6 kV contact ± 8 kV air

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV differential mode ± 2 kV common mode

<5% UT (<95% dip in UT)

for 0.5 cycle

<40% UT (<60% dip in UT)

for 5 cycles

<70% UT (<30% dip in UT)

for 25 cycles

<5% UT (<95% dip in UT)

for 5 sec

3A/m 3A/m

± 6 kV contact ± 8 kV air

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV differential ± 1 kV differential mode ± 2 kV common mode

<5% UT (<95% dip in UT)

for 0.5 cycle

<40% UT (<60% dip in UT)

for 5 cycles

<70% UT (<30% dip in UT)

for 25 cycles

<5% UT (<95% dip in UT)

for 5 sec

Floor should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %

Mains power quality should be that of a typical commercial and/or hospital environment

Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the product requires continued operation during power mains interruptions, it is recommended that the product be powered from an uninterruptible power supply.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Electromagnetic compatibility (EMC)

Manufacturer’s declaration – Electromagnetic Immunity II (Table 204, EN 60601-1-2)

Immunity Test IEC 60601-Level Compliance Level Electromagnetic Environment Guidance

Conducted RF IEC 61000-4-6

rms

3 V

150 kHz to 80 MHz

(AR-300/600 only)

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

Note 1: At 80 MHz and 800MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,

objects, people and animals.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM

and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to

fixed RF transmitters, an electromagnetic site survey should be considered, if the measured field strength in the location in which the product is used exceeds the applicable RF compliance level above, the product should be observed, additional measures may be necessary, such as reorienting or relocating the product.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d=1.2√P d=1.2√Pfor80MHzto800MHz d=1.2√Pfor800MHzto2.5GHz

where P is the maximum output power rating of the transmitter in Watt (W) according to the transmitter manufacturer and d is the re-commended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey

, should be less than the compliance level b in each frequency range.

Interference may occur in the vicinity of equipment marked with the symbol described lateral.

Electromagnetic compatibility (EMC)

Manufacturer’s declaration – Electromagnetic Immunity III

Immunity Test IEC 601-Level Compliance Level Electromagnetic Environment Guidance

Variations of power frequency and voltage according to IEC 601-1, Clause 10.2.2. a (AR-300/600 only)

Nominal frequency up to

100 Hz: variation of ± 1

Hz of nominal frequency; Variation of ± 10 % of nominal voltage

Nominal frequency up to

100 Hz: variation of ± 1

Hz of nominal frequency; Variation of ± 10 % of nominal voltage

Mains power quality should be that of a typical commercial and/or hospital environment

Electromagnetic compatibility (EMC)

Manufacturer’s declaration – Recommended Separation Distances between portable and mobile HF- communications equipment and the product (Table 206, EN 60601-1-2)

The product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the product – according on output power and frequency of the communications equipment – as recommended in the following table.

Rated maximum output power of transmitter in watts (W)

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is he maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

objects, people and animals.

Separation distance according to the frequency of transmitter in meter (m)

150 kHz to 80 MHz

d=1.2√P

80 MHz to 800 MHz

d=1.2√P

800 MHz to 2.5 GHz

d=2.3√P

HF communication equipment

Do not use any portable and mobile HF communication equipment (e.g. mobile telephones) during operation. These may affect medical electrical equipment.

3. System overview

4. System components CE certification according to notified body displayed on packaging

AR-300

Arthrex 300 Handpiece

AR-300L

Battery Pack, Unsterile,

Li-Ion for AR-300

AR-300LBH

Battery Housing

AR-300ATK

Aseptic Transfer Kit

for AR-300

AR-300 / 600

Charging Station

AR-300 / AR-600 Batteries

• Incl. flex (Europa)

• Incl. flex (USA, CAN, J)

• optional flex (UK, IRL)

• optional flex (AUS, NZ)

• optional flex (CH)

• Incl. flex (BR)

System components CE certification according to notified body displayed on packaging

Saw Attachment -

Sagittal

Drill Attachment -

Style AO

Drill Jacobs Chuck

0-4.0 mm

AR-300SAG

Technical data:

Speed/frequency 0-15,000 cpm

AR-300DAO-1

Technical data:

Speed / frequency 0-2,750 rpm

AR-300DJ

Technical data:

Speed / frequency 0-1,300 rpm

Saw Attachment -

Reciprocating

Drill Keyless Chuck

0-3.0 mm

Drill Attachment -

Style AO

AR-300SR

Technical data:

Speed / frequency 0-15,000 cpm Travel 2.5 mm

AR-300DK30

Technical data:

Speed / frequency 0-2,750 rpm

AR-300DAO-2

Technical data:

Speed / frequency 0-1,300 rpm

AR-300DK45

Technical data:

Speed / frequency 0-2,750 rpm

Drill Keyless Chuck

2.0-4.5 mm

AR-300DJH

Technical data:

Speed / frequency 0-1,300 rpm

Drill Jacobs Chuck

Hybrid 0-5.0 mm

+ 36 hidden pages

Arthrex 300 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual