DrillSaw Max 600 System User’s Guide

This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions refer to the "Arthrex U.S. Product Warranty" section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

1.0

General Warnings and Safety Notices - Read This First ... 1

1.1

Important Safety Conventions ... 1

1.2

Symbol Definitions ... 5

1.3

Shipping, Unpacking, and Warranty Information ... 6

2.0

Product Description and Intended Use ... 7

2.1

Product Description ... 7

2.2

Intended Use ... 7

2.3

Contraindications ... 7

2.4

Set Composition ... 8

2.5

Product Functions ... 9

2.5.1

AR-600 Handpiece ... 9

2.5.2

AR-600L Battery Pack, Li-Ion...10

2.5.3

AR-600LBH Battery Housing ...11

3.0

Technical Specifications ... 12

3.1

Handpiece ... 12

3.2

Attachments ... 13

3.3

Safety, EMC, and Regulatory Requirements ... 14

3.4

Electromagnetic Compatibility (EMC)... 14

3.5

Risks due to electromagnetic fields: ... 15

4.0

Setup ... 16

4.1

How to Set Up the Handpiece ... 16

4.2

Setup - Connecting and removing an attachment to the handpiece ... 16

4.3

Setup - Connecting a battery housing to the handpiece... 17

4.4

Setup - Removing the battery housing from the handpiece ... 18

4.5

Setup - Quick Connect of Drilling and Reaming Attachments ... 19

4.6

Setup - Drilling and Reaming Attachments, Keyed Jacobs Chuck ... 20

4.7

Setup - Drilling and Reaming Attachments, Keyless Chuck ... 21

4.8

Setup - Saw Attachment ... 22

4.9

Setup – Sternum Saw Attachments ... 23

4.10 Setup - Wire/Pin Driver Attachment ... 24 4.11 Battery Housing/Battery Pack/Transfer Plate ... 25

5.0

Cleaning and Disinfecting ... 26

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5.1

Battery Pack ... 26

5.2

Detergent Selection... 27

5.3

Preliminary Cleaning ... 27

5.3.1

Handpieces and Battery Housings ...28

5.3.2

Attachments and Transfer Plates ...28

5.4

Automated Cleaning and Thermal Disinfection ... 28

6.0

Sterilization ... 30

6.1

Approved Sterilization ... 30

6.2

Transmissible Spongiform Encephalopathy Agents ... 32

7.0

Maintenance ... 33

7.1

Periodic Maintenance... 33

8.0

Technical Support ... 34

8.1

Additional Technical Information ... 34

9.0

Repair Policy ... 35

10.0 End of Life, Environmental Directives ... 36 10.1 Specific guidelines for the disposal of Li-Ion batteries... 36

11.0 Electromagnetic Emissions ... 37

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Page ii

List of Figures Figure 1

Handpiece ... 9

Figure 2

Battery Pack ... 10

Figure 3

Battery Housing... 11

Figure 4

Connecting and removing an attachment ... 16

Figure 5

Connecting a battery housing ... 17

Figure 6

Removing the battery housing ... 18

Figure 7

Insert a drill bit ... 19

Figure 8

Insert a drill bit into a Jacobs Chuck... 20

Figure 9

Insert a drill bit into a Keyless Chuck ... 21

Figure 10 Insert a sawblade... 22 Figure 11 Connecting the sternum saw Attachment ... 23 Figure 12 Insert a pin / wire ... 24 Figure 13 Insert drop-in battery to the Battery Housing ... 25

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Page iii

List of Tables Table 1

Handpiece ... 9

Table 2

Battery Pack ... 10

Table 3

Battery Housing... 11

Table 4

Handpiece AR-600 ... 12

Table 5

Ambient conditions for operation ... 12

Table 6

Ambient conditions for storage (in shipping packaging)... 12

Table 7

Attachments ... 13

Table 8

Safety, EMC, and Regulatory Requirements ... 14

Table 9

Connecting and removing an attachment ... 16

Table 10

Connecting a battery housing ... 17

Table 11

Removing the battery housing ... 18

Table 12

Insert a drill bit ... 19

Table 13

Insert a drill bit into a Jacobs Chuck... 20

Table 14

Insert a drill bit into a Keyless Chuck ... 21

Table 15

Insert a sawblade ... 22

Table 16

Connecting the sternum guard ... 23

Table 17

Insert a pin / wire ... 24

Table 18

Drop-in battery ... 25

Table 19

Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 37

Table 20

Guidance and Manufacturer's Statement - Electromagnetic Immunity... 38

Table 21

Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ... 39

Table 22

Accessories for DrillSaw Max 600 System™ ... 40

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DrillSaw Max 600™ System User’s Guide

1.0

General Warnings and Safety Notices - Read This First It is imperative that the symbols and conventions listed below be clearly understood. The DrillSaw Max 600 System User’s Guide identifies critical, important, and useful information using these symbols and conventions.

1.1 Important Safety Conventions Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique.

W A R N I N G ! The WARNING! label is the most important safety symbol. It identifies critical information that must be followed precisely to avoid injury or death. 1.

Use this device only for purposes described in the User’s Guide, under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide.

2.

Before using the DrillSaw Max 600 System for the first time, store it at room temperature for 24 hours.

3.

Charge batteries before every use. Follow instructions for charging batteries before use.

4.

The device is intended to apply mechanical force/rotational energy to the patient.

5.

Before each use, check the handpiece and the attachments for damage and/or loose parts. Do not use any part that is damaged.

6.

Prior to each use, fully assemble the system and press the trigger mechanism to ensure proper function. All couplings and mechanical connections need to be fully secured or locked before the actuation of the system.

7.

Never touch the chuck mechanism of the handpiece while the motor is still in motion.

8.

Avoid overheating at the treatment site by following the duty cycle and using sharp cutting and drilling accessories.

9.

No modification of the AR-600 or the accessories is allowed.

10. Unauthorized attempts to open or service this system will void the warranty. Removing the cover may introduce an electric shock hazard by exposing the user to dangerously high voltages or other risks. If the system malfunctions, it should be returned for service immediately.

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DrillSaw Max 600™ System User’s Guide 11. Misuse, unauthorized assembly and modifications or repairs to the AR-600 system, or non-compliance with these instructions relieves Arthrex of all liability for claims under warranty or other claims. 12. Use only Arthrex approved accessories. Other accessories may result in increased emissions or decreased immunity of the system. Contact your Arthrex representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in injury to the patient and/or operating room staff. 13. Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide, oxygen, or endogenous gases. All oxygen connections must be leak free for the duration of the surgical procedure. 14. After autoclaving, the accessory devices are VERY HOT. Handle with care to avoid burns. 15. The equipment is NOT suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anesthetic substances containing oxygen or nitrous oxide. 16. Zone M is defined as a “medical environment” and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle. 17. Zone G, also known as an “enclosed medical gas system”, does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities. 18. Only fit an attachment/accessory when the handpiece is at a complete stop and in safe position. Safe position is annotated by the “S” on the mode switch. 19. Do not interfere with the rotary instruments or saws while they are in motion. 20. Never touch an attachment or press the release mechanism of the collet while the device is in motion. 21. To avoid potential injury, never allow a rotary or saw attachment to make contact with the surrounding soft tissues and vessels. 22. Never use the Arthrex DrillSaw Max 600 System in areas near strong magnetic fields. 23. Do not place the handpiece on the patient. 24. Disconnect the rechargeable battery immediately after using the handpiece. 25. Only use accessories which are in proper working order. Damaged or improperly functioning accessories must be sent in for service. 26. It is recommended to have a backup system available should the need arise.

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DrillSaw Max 600™ System User’s Guide

The PRECAUTION! symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction. 1. DO NOT – under any condition, or for any reason – open the handpiece, any system component, or any other system accessory. 2. This device has passed testing for EMI/RFI radiation and susceptibility, and EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up, and used as instructed by Arthrex. 3. Do not attach accessories to the handpiece unless the handpiece is in the safe mode. 4. Only use batteries approved by Arthrex. 5. Do NOT clean the device with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch or damage the device. 6. The battery packs are NOT to be cleaned and disinfected in a thermo washer disinfector. 7. NEVER place the handpiece or accessories in Cidex or other aldehyde disinfectant solutions. 8. After sterilization in the autoclave, let the accessory device cool down slowly. NEVER use cold water to cool the handpieces. This will damage the electronic components and seals. 9. Liquid on the battery and handpiece contacts may damage the device. Before connecting the battery housing, ensure the receptacles are clean and dry. 10. Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration, exposure times, temperature, and material compatibility. 11. Remove all accessories, including attachments, battery pack, and accessories before sterilizing a handpiece. 12. Caution: Federal law restricts this device to sale by or on the order of a physician. 13. This device is intended to be used by a trained medical professional 14. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. 15. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. •

Surgeons are advised to review the product-specific surgical technique prior to performing any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations. Or, contact your Arthrex representative for an onsite demonstration.

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DrillSaw Max 600™ System User’s Guide •

In CE accepting Countries: Procedures carried out using these devices may be used on the general population.

•

In CE accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks.

•

In CE accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices.

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DrillSaw Max 600™ System User’s Guide

1.2 Symbol Definitions Safety Sign Follow operating instructions

Caution: Federal law restricts this device to sale by or on the order of a physician.

Non sterile

Fragile, handle with care

Caution

This side up

Keep dry

Temperature limits for storage and transport

Electrical Hazard, dangerous voltages are present. Never attempt to repair the equipment. Only trainer service personnel may remove the cover, or obtain access to system components

Atmospheric pressure limitation for storage and transport

Type B Device – Not suitable for intracardiac applications

Humidity limits for storage and transport

Authorized representative in the European Community

Manufacturer

Serial number

Date of manufacture; year and month.

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DrillSaw Max 600™ System User’s Guide

•

Electrical waste

The product meets the essential requirements of Medical Device Directive 93/42/EEC

Catalog number

Do not use if package is damaged

Quantity

RF symbol. Nonionizing electromagnetic radiation

All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary.

1.3 Shipping, Unpacking, and Warranty Information Carefully unpack and inspect all components for shipping damage. Any damage could compromise patient safety and should be reported immediately to Arthrex or an authorized Arthrex distributor. The warranty could be voided if shipping or first-installation damage is not reported within seven business days of receiving the device. Please visit Arthrex.com for warranty information.

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DrillSaw Max 600™ System User’s Guide

2.0

Product Description and Intended Use 2.1 Product Description The Arthrex DrillSaw Max 600 System is a battery powered surgical instrument. The handpiece contains a microprocessor and is powered by a Lithium Ion battery. Activation of the handpiece is achieved by pressing a hand switch. The handpiece utilizes a drop-in style battery that does not go through the sterilization process, which provides longer life from the battery pack. The battery pack is used in conjunction with a sterile battery case that holds the battery and prevents contact with the sterile surgical field.

2.2 Intended Use The DrillSaw Max 600™ 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 trauma interventions, such as osteotomies, large and small bone operations, and joint replacement operations.

2.3 Contraindications The DrillSaw Max 600 System is contraindicated in any non-orthopedic surgery procedure and procedure disregarding the intended use. Specifically: • • • • •

use by unskilled/untrained personnel disregarding the intended use non-compliance with the operation mode usage of improper accessories not for use on spinal or neuro procedures

Only use Arthrex accessories.

W A R N I N G ! Misuse may damage the DrillSaw Max 600 System and cause risks and hazards for patients, users and third parties.

W A R N I N G ! This device is only for use under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide.

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DrillSaw Max 600™ System User’s Guide

2.4 Set Composition Arthrex DrillSaw Max 600 System parts and accessories: •

Handpiece

•

Attachments (See Table 22)

•

Battery pack

•

Battery housing (aseptic battery only)

•

Battery transfer plate (aseptic battery only)

•

Battery Charger (see DFU-0256-XX)

•

Instrument Tray(s)

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DrillSaw Max 600™ System User’s Guide

2.5 Product Functions 2.5.1

AR-600 Handpiece

The handpiece functions are identified and defined below. Figure 1

Handpiece

1 5

4

2

6

3 7

Table 1 1. 2. 3. 4. 5. 6. 7.

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Handpiece Chuck mechanism Speed regulator Battery housing R/S/F Switch Safe position (S) Forward drive (F) Reverse drive (R)

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DrillSaw Max 600™ System User’s Guide

2.5.2

AR-600L Battery Pack, Li-Ion

The main elements of the AR-600L battery pack are identified and defined below. Figure 2

Battery Pack 1

Table 2

2

Battery Pack 1. 2.

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Battery contacts Handle

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DrillSaw Max 600™ System User’s Guide

2.5.3

AR-600LBH Battery Housing

The main elements of the Battery Housing are identified and defined below. Figure 3

Battery Housing

1

3

2

Table 3 1. 2. 3.

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Battery Housing Battery contacts Battery housing door Release tab to remove battery housing from handpiece

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DrillSaw Max 600™ System User’s Guide

3.0

Technical Specifications 3.1 Handpiece Table 4

Handpiece AR-600

Width Height Depth Weight Cannulation Protection Speed Torque Applied part type Pollution level Overvoltage category Altitude Duty Cycle*

74 mm (2.913”) 200 mm (7.874”) 167 mm (6.574”) 950 g (2.09 lbs.) 4.0 mm (0.157”) IPX0 See Section 3.2 Table 7 Attachments See Section 3.2 Table 7 Attachments B 2 II Up to 3,000 m [9,842 ft.] above sea level Operating Type S3 per IEC 60034-1 At 25°C (77°F) Ambient Temperature: 20 sec on / 60 sec off for 6 cycles, then wait 48 minutes

* Following the duty cycle is an important part of maintaining the Arthrex Max 600

Power System. The duty cycle times have been determined under average load, using the Sagittal Saw attachment and at ambient air temperature of 25° C (77° F). Operating the device above of these prescribed parameters can lead to user and patient injury, as well as a shortened life span of the device itself. The recommended environmental operating temperature is 25° C (77° F) or lower. Operating in environments above 25° C (77° F) can shorten the above prescribed duty cycles. The environment temperature, surgical attachment type and time need to be considered by the user, when planning its use in surgical interventions. Additionally, please read the General Warnings and Safety Notices that start on Page 1 of this User’s Guide. Table 5

Ambient conditions for operation

Temperature Relative Humidity Table 6

Ambient conditions for storage (in shipping packaging)

Temperature Relative Humidity

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10° to 40 °C (50° to 104 °F) 15% to 80% (relative), non-condensing

-40° to +70°C (-40° to +158°F) 8% to 80% (relative), non-condensing

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DrillSaw Max 600™ System User’s Guide

3.2 Attachments Table 7

Attachments

Drill Speed Drill Torque Reamer Speed Reamer Torque Cutting Sterilization

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950 rpm 4.5 Nm ( 40 inch pounds) 200 rpm 17 Nm (150 inch pounds) 13,000 cpm YES

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DrillSaw Max 600™ System User’s Guide

3.3 Safety, EMC, and Regulatory Requirements Table 8

Safety, EMC, and Regulatory Requirements

Parameter

Parameter Value

System Classification

IEC 60601-1

Class I (protection against electric shock)

Safety Certifications

EMC Certifications Safety Certification Marking

CE Classification

FDA class

Class I

EU class

Class IIa

Health Canada Class

Class II

Domestic Certification

ANSI/AAMI ES60601-1

Canadian Certification

CSA C22.2 No 60601.1

EU Certification

EN/IEC 60601-1

EMC Certification

EN/IEC 60601-1-2 4th Edition: 2014

UL

Annex IX Rule 9

Class IIa

MDD 93/42/EEC For all other accessories refer to accompanying DFUs for more information. Refer to Section 11.0 Electromagnetic Emissions for further details on EMC certification.

3.4

Electromagnetic Compatibility (EMC) This device has passed testing for EMI/RFI radiation and susceptibility and EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up and used as instructed by Arthrex.

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