DrillSaw Highspeed AR-200

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 General Warnings and Safety Notices - Read This First ... 1 1.1

Important Safety Conventions ... 1

1.2

Symbols Definition ... 5

1.3

Shipping, Unpacking, and Warranty Information ... 7

Product Description and Intended Use ... 8 2.1

Product Description ... 8

2.2

Intended Use ... 8

2.3

Contraindications ... 8

2.4

Set Composition ... 9

2.5

Product Features... 10

2.5.1

AR-200C Console: Front View ...10

2.5.2

AR-200C Console: Rear View ...11

2.5.3

AR-200C Console: Main Screen and Iconography ...12

2.5.4

Foot Control Unit (S-N1) ...13

2.5.5

AR-200M, AR-200M-ISO Motors with Cable ...15

2.5.6

AR-200SP Spray Clip ...17

Technical Specifications ... 18 3.1

Console AR-200C ... 18

3.2

Motor AR-200M ... 19

3.3

Motor AR-200M-ISO ... 19

3.4

Foot Control Unit ... 19

3.5

Safety, EMC, and Regulatory Requirements ... 20

Setup ... 21 4.1

How to Set Up the Console ... 21

4.2

AC Power Safety Considerations ... 21

4.3

Replacing the Fuses ... 22

4.4

Electromagnetic Compatibility (EMC)... 22

4.5

Basic Setup Procedure for the AR-200 ... 23

4.6

Motor Detection ... 24

4.7

Connecting and Removing Attachments to the AR-200M Motor ... 25

4.8

Pump Tubing ... 26

4.9

AR-200SP Spray Clip ... 28

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Table of Contents 4.10 AR-200H Handle ... 29 4.11 Screen Navigation Overview ... 30 4.12 General Settings ... 31 4.12.1

Changing the Date ...31

4.12.2

Changing the Time ...32

4.12.3

Changing the Contrast ...32

4.12.4

Changing the Volume ...32

4.12.5

Reset Factory Setting ...33

4.12.6

Exit setting ...33

4.12.7

Factory Settings (P1-P6) ...34

4.13 AR-200 Settings ... 35 4.13.1

Changing the Foot Controller Mode ...35

4.13.2

Show Hardware / Software / Production Date and Serial Number ...35

Operation and Frequently Used Functions ... 36 5.1

Changing the Program ... 37

5.2

Changing the Speed ... 37

5.3

Changing the Torque ... 38

5.4

Changing the Coolant Flow ... 38

5.5

Changing Settings with the Foot Control Unit ... 38

5.6

System Shutdown ... 39

5.7

Backup System ... 39

5.8

Infrequently Used Functions... 39

Cleaning and Disinfecting ... 40 6.1

Console (AR-200C) and Foot Control Unit (S-N1) ... 40

6.2

Motor with Cable (AR-200M, AR-200M-ISO) and Spray Clip (AR-200SP ... 41

6.2.1 6.2.1.1

6.2.2

Detergent Selection ...41 Preliminary Cleaning ... 42

Automated Cleaning and Thermal Disinfection ...42

Sterilization ... 44 7.1 Approved Sterilization - Motor with Cable (AR-200M, AR-200M-ISO) and Spray Clip (AR-200SP) ... 44 7.2

Irrigation pump tubing ... 46

7.3

Transmissible Spongiform Encephalopathy Agents ... 46

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Table of Contents Maintenance ... 47 8.1

Periodic Maintenance... 47

Technical Support... 48 9.1

Additional Technical Information ... 48

Troubleshooting... 49 10.1 Troubleshooting Interference with Other Devices ... 50

Repair Policy ... 51 End of Life, Environmental Directives ... 52 Electromagnetic Emissions... 53

List of Figures Figure 1

Front Panel of Console ... 10

Figure 2

Rear Panel of Console ... 11

Figure 3

Main Screen Overview ... 12

Figure 4

Foot Control Unit (S-N1) ... 13

Figure 5

AR-200M Motor with AR-300 Attachment Coupling ... 15

Figure 6

AR-200M-ISO Motor with ISO Saw Attachment Coupling ... 16

Figure 7

AR-200SP Spray Clip ... 17

Figure 8

Set up the AR-200 ... 23

Figure 9

Connecting and removing an attachment ... 25

Figure 10 Irrigation Pump Tubing Setup ... 26 Figure 11 Connection of AR-200SP Spray Clip to the Motor AR-200M ... 28 Figure 12 Connection of AR-200H handle to the AR-200M motor ... 29 Figure 13 Overview of different screens ... 30

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Table of Contents List of Tables Table 1

Front Panel Elements ... 10

Table 2

Rear Panel Elements ... 11

Table 3

Main Screen Elements ... 12

Table 4

Foot Control Unit Elements (S-N1)... 13

Table 5

AR-200M Motor Elements ... 15

Table 6

AR-200M-ISO Motor Elements... 16

Table 7

AR-200SP Spray Clip Elements ... 17

Table 8

Console (AR-200C) Specifications ... 18

Table 9

Ambient Conditions for Operation ... 18

Table 10

Ambient Conditions for Storage (in shipping packaging) ... 18

Table 11

Motor AR-200M Specifications ... 19

Table 12

Motor AR-200M-ISO Specifications... 19

Table 13

Foot Control Unit (S-N1) Specifications... 19

Table 14

Set up the AR-200 ... 23

Table 15

Connecting and removing an attachment ... 25

Table 16

Irrigation Pump Tubing Configuration ... 26

Table 17

One-Piece Tubing Configuration ... 28

Table 18

AR-200H handle connection to AR-200M motor ... 29

Table 19

Calling Up the Settings Screens ... 30

Table 20

Factory Settings AR-200C ... 34

Table 21

Troubleshooting: Faults, Causes, and Solutions ... 49

Table 22

Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 53

Table 23

System Cables ... 53

Table 24

Guidance and Manufacturer's Statement - Electromagnetic Immunity... 54

Table 25

Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ... 55

Table 26

Attachments for AR-200M motor for DrillSaw Highspeed 200... 56

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DrillSaw Highspeed 200™ User’s Guide

General Warnings and Safety Notices - Read This First It is imperative that the symbols and conventions listed below be clearly understood. The DrillSaw Highspeed 200 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 ! WARNING! is the most important safety symbol. It identifies critical information that must be followed precisely to avoid injury or death. 1. Ensure that you comply with these instructions for use and the instructions pertaining to all instruments used (drills, saws etc.). 2. This device is only for use in normal orthopedic procedures as 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. 3. The device is intended to apply mechanical force / rotational energy to the patient. 4. Check the console, the motor and the foot control with cables for damage and loose parts before each use. Correct any faults or refer to an authorized Arthrex service partner. Do not operate the AR-200 if it is damaged. 5. Before using the AR-200 for the first time, store it at room temperature for 24 hours. 6. Perform a test run before each use. All couplings and mechanical connections need to be fully secured or locked before the actuation of the system. 7. Check the parameter settings every time the device is restarted. 8. Never touch the open chuck mechanism of the motor during operation, or while the motor is still running. 9. Put the attachment onto the motor, only when the motor is at a complete stop. Never touch the rotating instrument when it is still moving. 10. Never touch the pump motor while the pump arm door is open 11. Always ensure adequate cooling and correct operating conditions are observed. 12. Avoid overheating at the treatment site. DFU-0225-6r0_fmt_en-US Page 1 of 58

DrillSaw Highspeed 200™ User’s Guide 13. Never touch the patient and the connection for the foot control simultaneously. 14. The ESD (electrostatic discharge) spring contact on the underside of the foot control must touch the floor during operation. 15. Do not open or attempt to service this system, as this may void your warranty. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or other risks. If the system malfunctions, return it for servicing immediately. 16. Misuse may damage the AR-200 and may cause risks and hazards for patients, users and third parties. 17. Misuse, as well as unauthorized assembly and modifications or repairs to the AR-200 system, or non-compliance with our instructions relieves us of all liability for claims under warranty or other claims. 18. 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. 19. Do not modify the console or any accessory. Failure to comply may result in injury to the patient and/or operating room staff. 20. Do not use improper or damaged accessories. 21. 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. 22. After autoclaving, the accessory devices are VERY HOT. Handle with care to avoid burns. 23. The console, the motors with cable and the footswitch are not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anesthetic substances containing oxygen or nitrous oxide. 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. 24. 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. 25. Never use the Arthrex AR-200 in areas close to strong magnetic fields. 26. Do not place the handpiece drive on the patient.

The PRECAUTION! symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction. DFU-0225-6r0_fmt_en-US Page 2 of 58

DrillSaw Highspeed 200™ User’s Guide 1. Do not disconnect the plug of the motors or foot control unit by pulling on the cable. Remove it by grasping and pulling on the body of the connector. 2. Only use replacement power cords that comply with medical grade standards, IEC 60320-1 Subclause 3.21, Detachable Power Supply Cords or electrical standards for the designated country where the AR-200C is being used. Contact your Arthrex representative for further information. 3. Avoid positioning the console so that it is difficult to disconnect the coupler or plug from the mains power supply. 4. To prevent electrical shock do not use extension cords or two-prong/threeprong adaptors. 5. Always use fuses with the correct values to avoid allowing overcurrent to enter the system. Only use Arthrex original fuses. 6. An incorrect fuse may increase the risk of electrical shock or fire hazard. 7. This device has passed testing for EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up and used as instructed by Arthrex. 8. Do not attach the motor or the foot control unit during the Self Test. 9. NEVER use liquid to clean the accessory device connector contacts. Remove dust regularly using dry compressed air. 10. Liquid on the cable connector of the accessory device can damage the device. Before connecting the cable, ensure the receptacles are clean and dry. 11. Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration, exposure times, temperature, and material compatibility. 12. NEVER allow the console receptacles to have any contact with liquids. If there is dust or moisture on the receptacles, remove using dry compressed air. ONLY dry connectors should be plugged into the console. 13. Do not clean the device with abrasive cleaning agents or disinfectant compounds, solvents, or other materials that could scratch or damage the device. 14. The foot control unit is NOT suitable to be cleaned and disinfected in a thermo washer disinfector. 15. After sterilization in the autoclave, let the accessory device cool down slowly. NEVER use cold water to cool the remote control. This will damage the electronic components and seals. 16. Please note that at low speeds, it is more difficult to determine that the motor is running. 17. The motors must be used in compliance with the operation mode. 18. Please refer to the User’s Guide DFU-0223-XX for more information about the DrillSaw Mini 300™ attachments that can be connected to the AR-200M motor. DFU-0225-6r0_fmt_en-US Page 3 of 58

DrillSaw Highspeed 200™ User’s Guide 19. The third conductor in the power supply cord is only a functional earth. 20. The console is NOT released for automatic cleaning. 21. Before starting operation again: Wait until the motor and cable are completely dry. Moisture in the plug or motor can lead to a malfunction. (short circuit). 22. Position the foot control unit, where it cannot be pushed unintended. 23. Caution: Federal law restricts this device to sale by or on the order of a physician. 24. This device is intended to be used by a trained medical professional 25. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. 26. 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 Highspeed 200™ User’s Guide

1.2 Symbols Definition Safety Sign Follow operating instructions

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

On/Off (push-push)

Fragile, handle with care

Caution / Precaution

This side up

Keep dry

Temperature limits for storage and transport

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

Atmospheric pressure limitation for storage and transport

Alternating current

Humidity limits for storage and transport

Fuse

Foot control unit connection

No user-serviceable parts inside

Electrical waste

Electrical hazard

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DrillSaw Highspeed 200™ User’s Guide

•

Manufacturer

Date of manufacture; year and month.

Non sterile

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

Catalog number

Serial number

Quantity

Authorized representative in the European Community

Do not use if package is damaged

Non-ionizing 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.

[x] Square brackets that enclose a letter, number or lower-case Roman numeral reference a callout on a line drawing. The section for “Product Features” includes line drawings of products associated with the DrillSaw Highspeed 200. Each line drawing has its own callout system to identify important elements of each product.

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DrillSaw Highspeed 200™ User’s Guide

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 any 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. Refer also to our General Terms of Business. All defective products will be repaired or replaced at the discretion of Arthrex at no charge. The warranty does not cover damage caused by unlawful use or improper handling of a product. The warranty is not valid if modifications are made to the product or repairs are carried out outside of Arthrex or an authorized Arthrex distributor. Arthrex will answer any questions referring to the quality, reliability, and/or shelf life of any product identified in this User’s Guide.

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DrillSaw Highspeed 200™ User’s Guide

Product Description and Intended Use 2.1 Product Description The DrillSaw Highspeed 200 is a console driven power tool for orthopedic surgeries. Two different motors can be connected. Only one motor can be used at a time. Both motors can be operated with the foot control unit. The motors will be reused. Different attachments can be connected to resect bone and tissue. A Spray Clip guides fluid to the tip of the drills/burrs. A fluid pump is integrated in the console.

2.2 Intended Use The DrillSaw Highspeed 200 is an electrically-powered system to be used for treatment in orthopedic surgeries, as well as for surgery in the hand and foot, e.g. fracture treatment, drilling holes for plating, cutting bone for corrective osteotomies, and percutaneous surgery. Intended User Profile: The DrillSaw Highspeed 200 is intended for use by suitably qualified and trained medical, technical and specialist staff only. The development and design of the AR-200 is based on the “physician” target group. Patient Population: Whoever needs an orthopedic surgical intervention defined in the intended use demanding the use of a power tool. Conditions of Use: The system is used in an operating room. The motors with connected attachments are intended to be used in the sterile field. The console is located in the operating room, close to the operation field, unsterile and shall stand stable on a non-vibrating surface.

2.3 Contraindications The DrillSaw Highspeed 200 is contraindicated in any non-orthopedic surgery procedure and procedures disregarding the intended use. • • • • •

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

The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator) can be affected by electric, magnetic and electromagnetic fields. Find out if patient and/or user have implanted systems before using the product and consider the application. Weigh the risks and benefits before using. Keep the product away from implanted systems. Make appropriate emergency provisions and take immediate action at any signs of health issues. Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD (implantable cardioverter defibrillator). DFU-0225-6r0_fmt_en-US Page 8 of 58

DrillSaw Highspeed 200™ User’s Guide

W A R N I N G ! Misuse may damage the AR-200 and may 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.

2.4 Set Composition The AR-200 Set includes: • • • • • • • •

AR-200C AR-200M AR-200SP OEM06202400 OEM04005900 OEM06177800 WH013437000-01 WH028214000-01

Console (CE2797) Motor with cable, with AR-300 coupling (CE2797) Spray Clip (CE2797) Foot Control Unit S-N1 with handle (CE0297) Stand (CE2797) Motor support (CE2797) Power Cord with a European Plug (CE2797) Power Cord with a US Plug (CE2797)

The AR-200M-ISO includes: • •

AR-200M-ISO OEM04006800

Motor with cable, for ISO saw attachments (CE2797) Locking Pin (CE2797)

Accessories for AR-200M motor: All attachments that can be used with AR-200M motor are listed in Table 26 Other optional accessories: • • •

OEM06290600 OEM06352200 OEM07149200 OEM01525000

• • • •

OEM04013500* OEM04364100 AR-200H 30264001

•

AR-200 - CLIPS (5 PIECES) AR-200 - FUSE 250V-T1.6AH AR-200 - CLEANING ADAPTER FOR SPRAY CLIP AR-200 – SILICONE TUBING FOR CLEANING ADAPTER, 10 PIECES AR-200 - STERILIZATION CASSETTE (CE) Irrigation Tubing Set (6 pieces) (CE0481) Handle for AR-200M (CE2797) Footswitch for AR-200, wireless

* not for distribution in the U.S. DFU-0225-6r0_fmt_en-US Page 9 of 58

DrillSaw Highspeed 200™ User’s Guide

2.5 Product Features 2.5.1

AR-200C Console: Front View

Figure 1 uses a numeric callout system to identify the main elements of the console’s front panel, which are listed and labeled in Table 1. These callouts are referenced throughout this User’s Guide. Figure 1

Front Panel of Console

Table 1

Front Panel Elements 1. 2. 3. 4. 5. 6. 7.

Shift buttons Operator display PLUS / MINUS buttons Motor connecting socket Pump arm OPEN Pump arm Stand holder

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DrillSaw Highspeed 200™ User’s Guide

2.5.2

AR-200C Console: Rear View

Figure 2 uses a numeric callout system to identify the main elements of the console’s rear panel, which are listed and labeled in Table 2. These callouts are referenced throughout this User’s Guide. Figure 2

Rear Panel of Console

Table 2

Rear Panel Elements

8. 9. 10. 11.

Connecting socket for foot control AC mains power input plug Main power input - Fuse holder (250V – T1,6AH) AC Mains power ON / OFF

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DrillSaw Highspeed 200™ User’s Guide

2.5.3

AR-200C Console: Main Screen and Iconography

The console’s Main Screen (Operator display) [2] provides information about the status of the AR-200 programs, speed, torque and coolant settings in real time. Table 3 describes each message or button, cause and explanation when the AR200 is in the ready state. Figure 3

Main Screen Overview

1

AR-200M

2

15.000

3

6 7 8

4

9

5

10

Table 3 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Main Screen Elements Programs (P1-P6) Speed [rpm] Torque [% Ncm] Coolant [%] Transmission (always 1:1) Motor selected Speed displayed in bars Torque displayed in bars Time / Date Clockwise / counterclockwise rotation

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DrillSaw Highspeed 200™ User’s Guide

2.5.4 Foot Control Unit (S-N1) Figure 4 uses a numeral callout system to identify the main elements on the foot pedal unit, which are listed and labeled in Table 4. These callouts are referenced throughout this User’s Guide. Figure 4

Foot Control Unit (S-N1)

Table 4

Foot Control Unit Elements (S-N1)

12.

13. 14. 15. 16.

Handle for Foot Control Unit: – Attach: (1) Guide the ends of the Handle into the two holes of the Foot Control Unit. (2) Insert the Handle until the stop is reached. - Detach: Pull out the handle until completely removed. Green – Pump on/ off Grey – Start motor (pedal), variable or ON/OFF, factory setting = variable Yellow – Change motor direction, clockwise / counterclockwise rotation Orange – Change program, programs 1 to 6

When counterclockwise rotation is used, the motor panel emits a warning tone before the motor starts (after approximately 1 second).

W A R N I N G ! The ESD (electrostatic discharge) spring contact on the underside of the foot control must touch the floor during operation. DFU-0225-6r0_fmt_en-US Page 13 of 58

DrillSaw Highspeed 200™ User’s Guide

W A R N I N G ! The console, the motors with cable and the footswitch are not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anesthetic substances containing oxygen or nitrous oxide. 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.

W A R N I N G ! 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.

Do not disconnect the plug of the foot pedal unit by pulling on the cable. Remove the foot control plug by grasping and pulling on the body of the connector. Position the foot control unit, where it cannot be unintentionally pushed. Foot control: The foot control is approved for use in zone M (AP). Regular checking of the foot control: - Visual inspection for outside damage - Visually inspect the ESD spring contact on the underside of the foot control (electrostatic discharge) - Clean and inspect the ESD spring contact on the underside of the foot control on a regular basis.

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DrillSaw Highspeed 200™ User’s Guide

2.5.5 AR-200M, AR-200M-ISO Motors with Cable Two different, externally powered motors can be connected to the AR-200C Console AR-200M: Figure 5

AR-200M Motor with AR-300 Attachment Coupling

17

20

19 18

Table 5

AR-200M Motor Elements

17. 18. 19. 20.

Motor chuck mechanism Clip for Irrigation Pump Tubing Motor cable Connector

The AR-200M motor can be connected to all AR-300 attachments, except the AR-300CA Offset Cannulation Adapter. The motors with cable must not be disassembled. The motors with cable must not be lubricated during their lifetime. Please note that at low speeds, it is more difficult to determine that the motor is running. The motors must be used in compliance with the operation mode. Please refer to the User’s Guide DFU-0223-XX for more information about the DrillSaw Mini 300 attachments that can be connected to the AR-200M motor. Never touch the open chuck mechanism of the motor during operation, or while the motor is still running. DFU-0225-6r0_fmt_en-US Page 15 of 58

DrillSaw Highspeed 200™ User’s Guide The maximum rotational speed of the DrillSaw Mini 300 attachments stated in the User’s Guide DFU-0223-XX can only be reached when the AR-200M motor speed is set to 15,000 rpm on the AR-200C console. Rotational energy: Fast deceleration of the bur can cause the selected torque to be overloaded as a result of the rotational energy stored in the drive system.

AR-200M-ISO: Only use ISO saw attachments that are listed in this User’s Guide as official DrillSaw Highspeed 200 accessories. These ISO saw attachments provide their own User’s Guide. Coupling system according to ISO 3964 / DIN 13940 Please refer to the device specific User’s Guide and safety notes for more information about the ISO saw attachments that can be connected to the AR-200M-ISO motor. To prevent the ISO saw attachments from turning during transmission of high torques, the locking pin supplied can be pushed into the designated hole. See Figure 6. Figure 6

AR-200M-ISO Motor with ISO Saw Attachment Coupling

22

23

21

Table 6 21. 22. 23.

AR-200M-ISO Motor Elements ISO Coupling Motor cable Locking Pin

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DrillSaw Highspeed 200™ User’s Guide

2.5.6 AR-200SP Spray Clip Figure 7

AR-200SP Spray Clip

26

24 25

Table 7 24. 25. 26.

AR-200SP Spray Clip Elements Coolant tube Clip mechanism Connection for Irrigation pump tubing

The Spray Clip can be attached to the AR-200M motor with cable, and leads the irrigation fluid to the tip of the connected burr. The Spray Clip is not intended to be used with the motor AR-200M-ISO, since the ISO saw attachments have their own spray rod attached. The irrigation tubing set can be connected on the proximal side [3] of the Spray Clip. The fluid pump can be activated / deactivated on the AR-200C console or with the foot control unit S-N1.

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DrillSaw Highspeed 200™ User’s Guide

Technical Specifications 3.1 Console AR-200C Table 8 Console (AR-200C) Specifications Width 256 mm (10 in.) Height 109 mm (4.3 in.) Depth 305 mm (12 in.) Weight 7.0 kg (15.4 lbs.) Maximum flow rate ≥ 90 mL/minute Power supply 110-130 V / 220-240V, 50/60 Hz, 0.1-1.8A / 0.1-0.9A Allowed voltage +/- 10% fluctuation Mains fuse 2 x 250V – T1.6AH Power: max 180 VA Cleaning Refer to Section 6.0 Cleaning and Disinfecting Sterilization No Pollution level 2 Overvoltage category II Altitude Up to 3000 m [9842 ft.] above sea level Protection IP22 Table 9 Ambient Conditions for Operation Temperature 10° to 40 °C (50° to 104 °F) Relative Humidity 15% to 80% (relative), non-condensing Table 10 Ambient Conditions for Storage (in shipping packaging) Temperature -40° to +70°C (-40° to 158°F) Relative Humidity 8% to 80% (relative), non-condensing Atmospheric Pressure 700 hPa – 1060 hPa In the event of a power failure, or if the AR-200C is switched off, or when switching between programs, the last set of values are saved and re-activated when the device is switched on again. A total system failure does not constitute a critical fault. Simply switch the device off and on again. In the event of interruption/restoration of power, the device may lose settings or functions. In the case of a display failure, the device must be taken out of service and returned to the service center. DFU-0225-6r0_fmt_en-US Page 18 of 58

DrillSaw Highspeed 200™ User’s Guide

3.2 Motor AR-200M Table 11 Motor AR-200M Specifications Diameter 26.3 mm (1.04 in.) Length 96 mm (3.78 in.) Weight 0.42 kg (0.93 lbs.) Speed 300-15,000 rpm Torque 7 Ncm Length in Cable 3.5 m (137.8 in.) Cleaning Refer to Section 6.0 Cleaning and Disinfecting Sterilization Refer to Section 7.0 Sterilization Mode of Operation Non-continuous Applied part type Type BF Operation Mode 30 sec ON, 60 sec OFF (max. 4 repetitions)

3.3 Motor AR-200M-ISO Table 12 Motor AR-200M-ISO Specifications Diameter 23 mm (0.91 in.) Length 112 mm (4.41 in.) Weight 0.38 kg (0.84 lbs.) Speed 300-40,000 rpm Torque 7 Ncm Length in Cable 3.5 m (137.8 in.) Cleaning Refer to Section 6.0 Cleaning and Disinfecting Sterilization Refer to Section 7.0 Sterilization Mode of Operation Non-continuous Applied part type Type BF Operation Mode 30 sec ON, 60 sec OFF (max. 4 repetitions)

3.4 Foot Control Unit Table 13 Foot Control Unit (S-N1) Specifications Width 207 mm (8.15 in.) Height 45 mm (1.77 in.) Depth 198 mm (7.79 in.) Weight 1.15 kg (2.2 lbs.) Cable length 3.5 m (137.8 in.) Cleaning Surface cleaning with mild detergent Sterilization No Protection IPX8, 1 m depth of immersion, 1 hour (water-tight in accordance with IEC 60529)

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DrillSaw Highspeed 200™ User’s Guide

3.5 Safety, EMC, and Regulatory Requirements Parameter System Classification

Parameter Value IEC 60601-1

Class II (protection against electric shock)

FDA class

Class I exempt

EU class

Class IIa

Health Canada Class

Class 2

Domestic Certification

ANSI/AAMI ES60601-1 (2005+C2+A2)

Canadian Certification

CSA C22.2 No 60601.1 (2008)

EU Certification

IEC 60601-1:2005+A1:2012

EMC Certifications

EMC Certification

EN 60601-1-2 :2015-09

Safety Certification Marking

UL

CE Classification MDD 93/42/EEC

Annex IX Rule 9

Safety Certifications

Refer to section 14 for further details on EMC certification.

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Class IIa

DrillSaw Highspeed 200™ User’s Guide

Setup 4.1 How to Set Up the Console Users are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique.

4.2 AC Power Safety Considerations The AR-200C is powered by a medically rated universal AC input switching power supply. This power supply allows users to connect the console to any local AC mains outlet. Please use the appropriate plug and a reliable ground conductor. Arthrex supplies separate power cords for the U.S. and Europe CEE 7/7 with the AR-200. Contact your Arthrex representative if you need a power cord that must meet the electrical standards of another country. Only use replacement power cords that comply with medical grade standards, IEC 60320-1 Subclause 3.21, Detachable Power Supply Cords, or electrical standards for the designated country where the AR-200C is being used. Contact your Arthrex representative for further information. Avoid positioning the console so that it is difficult to disconnect the coupler or plug from the mains supply. To prevent electrical shock do not use extension cords or twoprong/three-prong adaptors. The third conductor in the power supply cord is only a functional earth. If required by local codes, connect the console to the hospital equalization connector with an equipotential cable. Connect the power cord to a wall outlet with the correct voltage. Otherwise, the product may be damaged. The console is designed to meet power-saving guidelines. The console has an AC mains switch on the rear panel [11]. When the AC mains switch is OFF, no electrical power is drawn by the console. When the AC mains switch is ON, the console executes a series of self-diagnostic tests. Upon successful completion of these tests, the operator display [2] shows the Main Display [Figure 3]. If the tests detect a problem, an error message is shown on the display. Refer to the section for Troubleshooting for a complete list of operator display messages. DFU-0225-6r0_fmt_en-US Page 21 of 58

DrillSaw Highspeed 200™ User’s Guide Set up the device so that the power switch is easily accessible. In dangerous situations the device can be disconnected from the power supply using the power switch. The power switch can also be used to safely stop the device. In dangerous situations the device can be disconnected from the power supply by disconnecting the mains-cable. No excessive heat generation within the operation mode. The responsibility for the timely switch off of the motor is the responsibility of the user.

W A R N I N G ! Do not have the device in direct contact with the patient if high-frequency devices are in use, or if the patient requires defibrillation.

4.3 Replacing the Fuses The main fuse is replaced as follows: 1. Disconnect the device from the AC mains power supply. 2. Open the fuse tray in the AC inlet [10] by pinching the tabs and pulling outward. 3. Replace the fuses with 2 x 250V – T1.6AH Line Fuses as noted on the rear panel. 4. Push the fuse holder back into the AC inlet. 5. Ensure that the fuse holder is fully seated and that the tabs snap back. Always use fuses with the correct values to avoid allowing overcurrent to enter the system. Only use Arthrex original fuses. An incorrect fuse may increase the risk of electrical shock or fire hazard. The AR-200C console incorporates a universal AC input power supply. A voltage selection switch is not required.

4.4 Electromagnetic Compatibility (EMC) This device has passed testing for EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up and used as instructed by Arthrex. The AR-200 has been designed to accept EMC from other devices within the limitations as described in section 14.

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DrillSaw Highspeed 200™ User’s Guide To determine if the AR-200 is causing interference with other devices, power the AC mains power switch [11] OFF, and then ON again. Try to correct the interference by following one or more of these measures: 1. 2. 3.

Reorient or relocate the receiving device. Increase the distance between the devices. Connect the device to an outlet on a different circuit than the other device(s) are connected to. Consult the manufacturer or field service technician for the receiving device for guidance.

4.

4.5 Basic Setup Procedure for the AR-200 Place the AR-200C on a flat, dry and stable surface. Figure 8

Set up the AR-200

a

b

c

d

Table 14 a

b c d

Set up the AR-200 Connect the receiver end of the power cord for the AR-200C into the AC mains power socket [9] and connect the plug end into the facility AC mains supply. Additionally, connect the foot control unit cable to the console. Connect one of the motors with cable. Insert the Stand. Note the positioning! (maximum load capacity 1,5 kg / 3.3 lbs.) Attach the motor support and lock it.

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DrillSaw Highspeed 200™ User’s Guide The motor connector plug cannot be properly inserted into the console receptacle if the corresponding red dots are not aligned. The foot control unit connector plug cannot be properly inserted into the console receptacle if the corresponding black triangle of the console is not aligned with the black arrows of the cable plug.

W A R N I N G ! 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.

W A R N I N G ! 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.

W A R N I N G ! Before using the AR-200 for the first time, store it at room temperature for 24 hours.

4.6 Motor Detection The AR-200C detects when a motor with cable has been activated. The Motor Detection feature operates differently, depending on if an AR-200M or an AR-200M-ISO motor is connected to the AR-200C console.

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DrillSaw Highspeed 200™ User’s Guide

4.7 Connecting and Removing Attachments to the AR-200M Motor These instructions describe the procedure for connecting an attachment to the AR-200M motor. Figure 9

Connecting and removing an attachment

a

b

Table 15

a

Connecting and removing an attachment To Insert the attachment: - Step 1: Turn the motor chuck mechanism - Step 2: Push the adaptor into the locking mechanism - Step 3: Loosen the chuck mechanism Note: For insertion only: Steps 1 and 2 can be combined

b

To Remove the attachment: - Turn the motor chuck mechanism - Pull out the adaptor

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DrillSaw Highspeed 200™ User’s Guide

4.8 Pump Tubing These instructions describe the setup of the AR-200 irrigation pump tubing. Figure 10

Irrigation Pump Tubing Setup

Table 16

Irrigation Pump Tubing Configuration

a b, c, d e

Install the bag and spike the bag with the irrigation pump tubing Open the Pump arm door Insert the irrigation pump tubing Close the pump arm door. It is confirmed by physically hearing and feeling the latching mechanism. The surface of the door is flush with the surface of the front panel. Follow the sequences a - e when removing the irrigation tubing

The AR-200 is designed for use with physiological saline solution. Use only suitable irrigation fluids and follow the manufacturer's medical information and instructions. DFU-0225-6r0_fmt_en-US Page 26 of 58

DrillSaw Highspeed 200™ User’s Guide Sterile irrigation pump tubing is supplied with the equipment. These irrigation pump tubing is disposable and must be discarded after each use. Please note the expiration date and the relevant regulations for disposal of irrigation pump tubing. Only use disposable irrigation pump tubing with undamaged packaging/ sealing.

W A R N I N G ! Never touch the pump motor while the pump arm door is open

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