DrillSaw Mini 300 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.

Table of contents 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-300 Handpiece ... 9

2.5.2

AR-300L Battery Pack, Li-Ion...10

2.5.3

AR-3000LBH 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 – Burr / Drill 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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Table of contents 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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Table of contents 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 Insert a drill / burr bit ... 23 Figure 12 Insert a pin / wire ... 24 Figure 13 Insert drop-in battery to the Battery Housing ... 25

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Table of contents List of Tables Table 1

Handpiece ... 9

Table 2

Battery Pack ... 10

Table 3

Battery Housing... 11

Table 4

Handpiece AR-300 ... 12

Table 5

Ambient conditions for operation ... 12

Table 6

Ambient conditions for storage (in shipping packaging)... 13

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

Insert a burr / drill bit ... 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 Mini 300 System™ ... 40

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DrillSaw Mini 300™ 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 Mini 300 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 Mini 300 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-300 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 Mini 300™ System User’s Guide 11. Misuse, unauthorized assembly and modifications or repairs to the AR-300 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 Mini 300 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 Mini 300™ 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.

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DrillSaw Mini 300™ System User’s Guide 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.

•

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 Mini 300™ 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 Mini 300™ 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 Mini 300™ System User’s Guide

2.0

Product Description and Intended Use 2.1 Product Description The Arthrex DrillSaw Mini 300 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 Mini 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 for small bone orthopedic and sports medicine applications to make osteotomies, drill holes, and drive pins and wires.

2.3 Contraindications The DrillSaw Mini 300 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 Mini 300 System and cause risks and hazards for patients, users and third parties.

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DrillSaw Mini 300™ System User’s Guide

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.

2.4 Set Composition Arthrex DrillSaw Mini 300 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)

•

Elongation handle (optional device)

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DrillSaw Mini 300™ System User’s Guide

2.5 Product Functions 2.5.1

AR-300 Handpiece

The handpiece functions are identified and defined below. Figure 1

Handpiece 3

1

5

6

7

2

4

Table 1 1.

Handpiece Chuck mechanism

2.

Speed regulator

3.

Battery housing

4.

R/S/F Switch

5.

Forward drive (F)

6.

Safe position (S)

7.

Reverse drive (R)

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DrillSaw Mini 300™ System User’s Guide

2.5.2

AR-300L Battery Pack, Li-Ion

The main elements of the AR-300L battery pack are identified and defined below. Figure 2

Battery Pack

2

1 Table 2

Battery Pack 1.

Battery contacts

2.

Handle

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DrillSaw Mini 300™ System User’s Guide

2.5.3

AR-3000LBH Battery Housing

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

Battery Housing

3

2

1

Table 3

Battery Housing

1.

Battery contacts

2.

Battery housing door

3.

Release tab to remove battery housing from handpiece

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DrillSaw Mini 300™ System User’s Guide

3.0

Technical Specifications 3.1 Handpiece Table 4

Handpiece AR-300

Width

94 mm (3.7”)

Height

47 mm (1.85”)

Depth

175 mm (6.889”)

Weight

550 g (1.21 lbs.)

Cannulation

2.4 mm (0.0945”)

Protection

IPX0

Speed

See Section 3.2 Table 7 Attachments

Torque

See Section 3.2 Table 7 Attachments

Applied part type

B

Pollution level

2

Overvoltage category

II

Altitude

Up to 3,000 m [9,842 ft.] above sea level

Duty Cycle*

Operating Type S3 per IEC 60034-1 At 25°C (77°F) Ambient Temperature: 30 sec on / 30 sec off for 5 cycles, then wait 48 minutes

* Following the duty cycle is an important part of maintaining the Arthrex Mini 300

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 Temperature

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Ambient conditions for operation 10° to 40 °C (50° to 104 °F)

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DrillSaw Mini 300™ System User’s Guide Relative Humidity Table 6

15% to 80% (relative), non-condensing

Ambient conditions for storage (in shipping packaging)

Temperature

-40° to +70°C (-40° to +158°F)

Relative Humidity

8% to 80% (relative), non-condensing

3.2 Attachments Table 7

Attachments

Drill Speed

2.750 rpm 1.300 rpm

Drill Torque

24 Ncm (2.12 inch pounds) 45 Ncm ( 3.98 inch pounds)

Reamer Speed

500 rpm

Reamer Torque

1.15 Nm ( 10.17 inch pounds)

Cutting

15,000 cpm

Sterilization

YES

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DrillSaw Mini 300™ System User’s Guide

3.3 Safety, EMC, and Regulatory Requirements Table 8

Safety, EMC, and Regulatory Requirements

Parameter

Parameter Value

System Classification

Safety Certifications

EMC Certifications Safety Certification Marking

CE Classification MDD 93/42/EEC

IEC 60601-1

Class I

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

(protection against electric shock)

UL

Annex IX Rule 9

Class IIa

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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