Arthrex Highspeed 200 User manual

DrillSaw Highspeed 200™
User’s Guide
The Arthrex DrillSaw Highspeed 200™ User’s Guide provides
safety operation information for all components of the
Arthrex DrillSaw Highspeed 200, including accessories. All
operating personnel must read this User’s Guide thoroughly
prior to using this system and follow all safety warnings,
cautions, and precautions.
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-[phone]
www.arthrex.com
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: [phone]
www.arthrex.de
DFU-0225-2
Revision 0
September, 2018
© 2016 Arthrex, Inc. All rights reserved
AR-200

This page intentionally left blank

Table of Contents
DFU-0225-2 Rev. 0 Page i
1.0 General Warnings and Safety Notices - Read This First.....................1
1.1 Important Safety Conventions............................................................................1
1.2 Symbols Definition .............................................................................................4
1.3 Shipping, Unpacking, and Warranty Information................................................6
2
2. .0 0Product 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 Features..............................................................................................10
2
2. .5 5. .1 1AR-200C Console: Front View.............................................................................10
2
2. .5 5. .2 2AR-200C Console: Rear View..............................................................................11
2
2. .5 5. .3 3AR-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
3
3. .0 0Technical 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
4
4. .0 0Setup................................................................................................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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DFU-0225-2 Rev. 0 Page ii
4.10 AR-200H Handle..............................................................................................29
4.11 Screen Navigation Overview............................................................................30
4.12 General Settings ..............................................................................................31
4
4. .1 12 2. .1 1Changing the Date...............................................................................................31
4
4. .1 12 2. .2 2Changing the Time ..............................................................................................32
4
4. .1 12 2. .3 3Changing the Contrast.........................................................................................32
4
4. .1 12 2. .4 4Changing the Volume ..........................................................................................32
4
4. .1 12 2. .5 5Reset Factory Setting ..........................................................................................33
4
4. .1 12 2. .6 6Exit setting...........................................................................................................33
4
4. .1 12 2. .7 7Factory 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
5
5. .0 0Operation 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
6
6. .0 0Cleaning and Disinfecting.................................................................40
6.1 Preliminary Cleaning........................................................................................40
6.2 Console (AR-200C)..........................................................................................40
6.3 Motor with Cable (AR-200M, AR-200M-ISO) and Spray Clip (AR-200SP)....41
6.4 Foot Control Unit (S-N1) ..................................................................................43
7
7. .0 0Sterilization.......................................................................................44
7.1 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
8
8. .0 0Maintenance.....................................................................................47
8.1 Periodic Maintenance.......................................................................................47

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DFU-0225-2 Rev. 0 Page iii
9Technical Support.............................................................................48
9.1 Additional Technical Information......................................................................48
10 Troubleshooting................................................................................49
10.1 Troubleshooting Interference with Other Devices ............................................50
11 Repair Policy....................................................................................51
12 Warranty...........................................................................................52
13 End of Life, Environmental Directives...............................................53
14 Electromagnetic Emissions...............................................................54
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
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 of Contents
DFU-0225-2 Rev. 0 Page iv
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.................... 54
Table 23 System Cables....................................................................................................................... 54
Table 24 Guidance and Manufacturer's Statement - Electromagnetic Immunity....................... 55
Table 25 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ...........56
Table 26 Attachments for AR-200M motor for DrillSaw Highspeed 200........................................57

DrillSaw Highspeed 200™ User’s Guide
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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 Highspeed 200User’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.
WARNING!
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.
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.
13. Never touch the patient and the connection for the foot control
simultaneously.

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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 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.
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.

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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/three-
prong 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.
19. The third conductor in the power supply cord is only a functional earth.
20. The console is NOT released for automatic cleaning.

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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.
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

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Electrical waste
No user-serviceable
parts inside
Electrical hazard
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
[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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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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2
2. .0 0 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. 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).

DrillSaw Highspeed 200™ User’s Guide
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WARNING!
Misuse may damage the AR-200 and may cause risks and hazards for patients,
users and third parties.
WARNING!
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 Console (CE0086)
•AR-200M Motor with cable , with AR-300 coupling (CE0086)
•AR-200SP Spray Clip (CE0086)
•OEM06202400 Foot Control Unit S-N1 with handle (CE0297)
•OEM04364100 Irrigation Tubing Set (3 pieces) (CE0481)
•OEM04005900 Stand (CE0086)
•OEM06177800 Motor support (CE0086)
•WH013437000-01 Power Cord with a European Plug (CE0086)
•WH028214000-01 Power Cord with a US Plug (CE0086)
The AR-200M-ISO includes:
•AR-200M-ISO Motor with cable, for ISO saw attachments (CE0086)
•OEM04006800 Locking Pin (CE0086)
Accessories for AR-200M-ISO motor:
•10100801 AR-200 - ISO SAW S-8R RECIPROCATING (CE0297)
•10100802 AR-200 - ISO SAW S-8O OSCILLATING (CE0297)
•10100803 AR-200 - ISO SAW S-8S SAGITTAL (CE0297)
•OEM04725700 AR-200 - SAWBLADE F/ISO SAW R-30 (CE0123)
•OEM04725900 AR-200 - SAWBLADE F/ISO SAW R-20 (CE0123)
•OEM04726000 AR-200 - SAWBLADE F/ISO SAW R-15 (CE0123)
•OEM04726100 AR-200 - SAWBLADE F/ISO SAW S-10 (CE0123)
•OEM04726200 AR-200 - SAWBLADE F/ISO SAW S-6 (CE0123)
•OEM04800400 AR-200 - SAWBLADE F/ISO SAW O-15 (CE0123)
•OEM04800500 AR-200 - SAWBLADE F/ISO SAW O (CE0123)

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Accessories for AR-200M motor:
All attachments that can be used with AR-200M motor are listed in Table 26
Other optional accessories:
•OEM06290600 AR-200 - CLIPS (5 PIECES)
•OEM06352200 AR-200 - FUSE 250V-T1.6AH
•OEM07149200 AR-200 - CLEANING ADAPTER FOR SPRAY CLIP
•OEM01525000 AR-200 – SILICONE TUBING FOR CLEANING
ADAPTER, 10 PIECES
•OEM04013500 AR-200 - STERILIZATION CASSETTE (CE)
•OEM043641006 Irrigation Tubing Set (6 pieces) (CE0481)

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2.5 Product Features
2
2. .5 5. .1 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.
Shift buttons
2.
Operator display
3.
PLUS / MINUS buttons
4.
Motor connecting socket
5.
Pump arm OPEN
6.
Pump arm
7.
Stand holder

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2
2. .5 5. .2 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 2Rear Panel of Console
Table 2 Rear Panel Elements
8.
Connecting socket for foot control
9.
AC mains power input plug
10.
Main power input - Fuse holder (250V – T1,6AH)
11.
AC Mains power ON / OFF

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2
2. .5 5. .3 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 AR-
200 is in the ready state.
Figure 3 Main Screen Overview
Table 3 Main Screen Elements
1.
Programs (P1-P6)
2.
Speed [rpm]
3.
Torque [% Ncm]
4.
Coolant [%]
5.
Transmission (always 1:1)
6.
Motor selected
7.
Speed displayed in bars
8.
Torque displayed in bars
9.
Time / Date
10.
Clockwise / counterclockwise rotation
1
2
3
4
5
6
7
8
9
10
AR-200M
15.000

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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.
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.
13.
Green – Pump on/ off
14.
Grey – Start motor (pedal), variable or ON/OFF,
factory setting = variable
15.
Yellow – Change motor direction, clockwise / counterclockwise
rotation
16.
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).
WARNING!
The ESD (electrostatic discharge) spring contact on the underside of the foot
control must touch the floor during operation.

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WARNING!
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.
WARNING!
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.