Arthex AR-8305 User guide

Synergy

User’s Guide

Arthrex GmbH

© 2020 Arthrex, Inc. All rights reserved.

AR-8305

Resection™

The Arthrex Synergy
information for all components of the Arthrex Synergy
console (Model AR-8305), including the accessories. All operating
personnel must read this User’s Guide thoroughly prior to using
this system and follow all safety warnings, cautions, and notes.

Arthrex, Inc.

Naples, FL 34108-1945 USA
Toll Free: 1-[phone]
www.arthrex.com

Erwin-Hielscher-Strasse 9
81249 München, Germany

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User’s Guide provides safety operation

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Tel: [phone]
www.arthrex.de

DFU-0213-8 Revision 0 03/2020

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Table of Content

1.0 GENERAL WARNINGS AND SAFETY NOTICES - READ THIS FIRST ...... 1

Important Symbols and Conventions ................................................................................ 1

Symbol Definitions ............................................................................................................. 4

Shipping, Unpacking, and Warranty Information .............................................................. 6

2.0 PRODUCT DESCRIPTION .................................................................................. 7

Product Description and Intended Use ............................................................................. 7

Product Features ............................................................................................................... 8

AR-8305Console - Front View ................................................................................................. 8

AR-8305 Console - Rear View ................................................................................................. 9

AR-8305 Display Messages ..................................................................................................... 9

Applied Parts and Accessory Features ............................................................................ 13

Standard Footswitch (AR-8310) ............................................................................................ 13

3.0 TECHNICAL SPECIFICATIONS ........................................................................ 14

Console ............................................................................................................................ 14

Standard Footswitch ........................................................................................................ 14

Ambient Conditions for Operation .................................................................................. 14

Ambient Conditions for Storage (in shipping packaging) ................................................ 14

Safety, EMC, and Regulatory Requirements ................................................................... 15

4.0 SETUP.................................................................................................................... 16

How to Set Up the Console .............................................................................................. 16

AC Power Safety Considerations ..................................................................................... 16

Replacing the Fuses ......................................................................................................... 17

Electromagnetic Compatibility ........................................................................................ 17

Basic Setup Procedure for the AR-8305 Console ............................................................ 18

Setting up a Footswitch ................................................................................................... 19

Setting up the Shaver Handpieces ................................................................................... 19

Setting up Other Accessory Handpieces.......................................................................... 19

Shutdown Procedure ....................................................................................................... 19

5.0 OPERATION AND FREQUENTLY USED FUNCTIONS ............................... 20

Main Screen ..................................................................................................................... 20

Settings Menu Main Screen ............................................................................................. 21

Language Selection Screen .............................................................................................. 23

Oscillation Mode Selection Screen .................................................................................. 24

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Footswitch Override Screen ............................................................................................ 25

Reset Defaults Screen ...................................................................................................... 26

Information Screen .......................................................................................................... 27

Buttons ............................................................................................................................ 28

Buttons - Main Screen .......................................................................................................... 28

Speed Test Mode ............................................................................................................. 30

Speed Adjustment ........................................................................................................... 30

Oscillation Mode Adjustment .......................................................................................... 30

Accessory Handpiece Speed Limits and Deltas ............................................................... 31

Drill Speeds ........................................................................................................................... 31

Console Speed Controls ........................................................................................................ 31

Attachment Motor Control .............................................................................................. 32

Definition of Direction .......................................................................................................... 32

Forward, Reverse and Oscillation Modes ............................................................................. 32

Cruise Control ....................................................................................................................... 32

Toggle Function .................................................................................................................... 33

Footswitches .................................................................................................................... 35

Standard Footswitch ............................................................................................................. 35

Gas Pedal Footswitch ........................................................................................................... 35

Multi-Function Footswitches ................................................................................................ 35

Accessory Handpieces ..................................................................................................... 35

6.0 CLEANING AND DISINFECTING ..................................................................... 36

Console AR-8305 .............................................................................................................. 36

Footswitches .................................................................................................................... 36

Accessory Cable ............................................................................................................... 37

Accessory Handpieces ..................................................................................................... 37

7.0 STERILIZATION ................................................................................................. 39

8.0 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS 40

9.0 MAINTENANCE ................................................................................................... 41

Life Expectancy ................................................................................................................ 41

Periodic Maintenance ...................................................................................................... 41

10.0 TECHNICAL SUPPORT ...................................................................................... 42

How to Display the Software Version .............................................................................. 42

Additional Technical Information .................................................................................... 42

11.0 TROUBLESHOOTING ........................................................................................ 43

Troubleshooting Interference with Other Devices .......................................................... 44

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12.0 REPAIR POLICY .................................................................................................. 45

13.0 END OF LIFE, ENVIRONMENTAL DIRECTIVES ......................................... 45

14.0 ELECTROMAGNETIC EMISSIONS .................................................................. 46

List of Figures

Figure 1 Front Panel of Console ........................................................................................................ 8

Figure 2 Rear Panel of Console ......................................................................................................... 9

Figure 3 Standard Footswitch - Description .................................................................................. 13

Figure 4 Main Screen Display - One Tool Attached ..................................................................... 20

Figure 5 Main Screen Display - Two Tools Attached .................................................................. 20

Figure 6 Settings Menu Display - Operation ................................................................................. 21

Figure 7 Language Selection Display - Operation ........................................................................ 23

Figure 8 Oscillation Mode Selection Screen - Operation ............................................................. 24

Figure 9 Footswitch Override Selection Screen - Operation ....................................................... 25

Figure 10 Reset Defaults Screen - Operation ................................................................................... 26

Figure 11 Information Screen - Operation ....................................................................................... 27

Figure 12 Single Handpiece Screen Oscillation Mode Location ................................................... 28

Figure 13 Two Handpiece Buttons - Operation .............................................................................. 29

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List of Tables

Table 1 Front Panel Elements .......................................................................................................... 8

Table 2 Rear Panel Elements ............................................................................................................ 9

Table 3 AR-8305 Display Messages .............................................................................................. 10

Table 4 *TOOL FAILURE* Error Code Definitions .................................................................... 12

Table 5 Elements of the Standard Footswitch ............................................................................. 13

Table 6 AR-8305 Console Specifications ...................................................................................... 14

Table 7 Standard Footswitch Specifications ................................................................................ 14

Table 8 AR-8305 Ambient Conditions for Operation ................................................................. 14

Table 9 AR-8305 Ambient Conditions for Storage ...................................................................... 14

Table 10 Safety, EMC, and Regulatory Requirements ................................................................. 15

Table 11 Main Screen Display Elements ........................................................................................ 20

Table 12 Settings Menu Display - Operation ................................................................................. 22

Table 13 Language Menu Display - Operation ............................................................................. 23

Table 14 Oscillation Mode Display - Operation ............................................................................ 24

Table 15 Footswitch Override Display - Operation ...................................................................... 25

Table 16 Reset Defaults Display - Operation ................................................................................. 26

Table 17 Information Screen Display - Operation ........................................................................ 27

Table 18 Oscillation Mode - Operation .......................................................................................... 28

Table 19 Two Handpiece Buttons - Operation .............................................................................. 29

Table 20 Accessory Handpiece Speed Limits and Delta .............................................................. 31

Table 21 Handpiece Accuracy ......................................................................................................... 31

Table 22 Toggle Function ................................................................................................................. 34

Table 23 Troubleshooting: Faults, their Causes and Solutions ................................................... 43

Table 24 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ................ 46

Table 25 System Cables .................................................................................................................... 46

Table 26 Guidance and Manufacturer's Statement - Electromagnetic Immunity .................... 47

Table 27 Guidance and Manufacturer's Statement – Recommend Separation Distance

between portable and mobile RF communications equipment and the

Model AR-8305 .................................................................................................................. 49

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General Warnings and Safety Notices - Read This First

Synergy Resection User’s Guide

1.0 General Warnings and Safety Notices - Read This First

Important Symbols and Conventions

It is imperative that the symbols and conventions listed below be clearly

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understood. The Synergy
useful information using these symbols and conventions.

Users of this device are encouraged to contact their Arthrex representatives if
they require a more comprehensive surgical technique.

User’s Guide identifies critical, important, and

WARNING!

The WARNING! is the most important safety symbol. It identifies critical
information that must be followed precisely to avoid injury or death.

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

2. This device is intended to be used by a trained medical professional. Use this
device only for purposes described in the User’s Guide, under the supervision
of a trained and licensed physician.

3. No modifications of the console (AR-8305) or accessories are allowed.

4. Use this device only 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.

5. 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
dangerous high voltages or other risks. If the system malfunctions,
return it for service immediately.

6. To avoid the RISK of electric shock, this equipment must only be connected
to a SUPPLY MAIN with protective earth ground.

7. Do not have device in direct contact with patient if high-frequency devices are
in use, or if the patient requires defibrillation.

8. DO NOT stack or place equipment adjacent to the AR-8305 console, if
possible. If such a configuration is necessary, carefully observe the
configuration in question to ensure that electromagnetic interference does not
degrade performance.

9. 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 patient and/or operating room staff
injury.

10. This equipment is NOT suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen rich or nitrous oxide environment.

11. Do not have device in direct contact with patient if high-frequency devices are

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General Warnings and Safety Notices - Read This First

Synergy Resection User’s Guide

in use or if the patient requires defibrillation.

12. After autoclaving, the accessory devices are VERY HOT. Handle with care to
avoid burns.

13. Biohazard waste, such as explanted devices, needles and contaminated
surgical equipment, should be safely disposed of in accordance with the
institutions policy.

14. Serious incidents should be reported to Arthrex, Inc. or an in-country
representative, and to the health authority where the incident occurred.

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 console (AR-

8305) or any other shaver accessory.

2. Only use replacement power cords that meet medical grade standards
according to IEC 60320-1, Detachable Power Supply Cords or electrical
standards for the designated country where the AR-8305 is being used.
Contact your Arthrex representative for further information.

3. Avoid position console so that it is difficult to disconnect coupler or plug from
supply main.

4. Connecting an extension cord to the AR-8305 may result in a reduced level of

safety.

5. Always use fuses with the correct values to avoid allowing overcurrent to
enter the system.

6. An incorrect fuse may increase the risk of electrical shock or fire hazard.

7. This device has passed testing for EMI / RFI radiation and susceptibility and
EMC compatibility. This device may cause interference to other devices in the
near vicinity if not set up and used as Arthrex instructs.

8. Do not attach handpieces or footswitches during the Self Test or the
Programming Modes.

9. Only use footswitches developed by Arthrex specifically for the AR-8305
Synergy

10. Only use shaver handpieces and cables that have been developed by
Arthrex specifically for the Synergy

11. Only use handpieces and cables that have been developed by Arthrex
specifically for the Synergy
the console to prevent accidental separation during use. To avoid damage,
disconnect the footswitch by pulling on the cable connector shell (plug) only.

12. The accessory handpiece cable connects and locks to the console to prevent
accidental separation during use. To avoid damage, disconnect the
footswitch by pulling on the cable connector shell (plug) only.

13. Always comply with the instructions issued by the manufacturer of the

cleaning disinfectant regarding concentration, exposure times,
temperature and material compatibility.

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console.

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console.

. The footswitch cable connects and locks to

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General Warnings and Safety Notices - Read This First

Synergy Resection User’s Guide

14. NEVER clean the console with liquid cleaners. If there is dust, remove it with
dry compressed air.

15. Do NOT clean the device with abrasive cleaning or disinfectant

compounds, solvents, or other materials that could scratch or damage
the device.

16. The footswitch is NOT suitable to be cleaned and disinfected in a
thermo washer disinfector.

17. NEVER allow the console receptacles to have any contact with liquids. If
there is dust or moisture on the receptacles, remove it with dry compressed
air. ONLY dry connectors should be plugged into the console.

18. Refer to the Instructions for Use package insert for detailed shaver handpiece
(DFU-0154-XX) and Adapteur Power System II Accessory Attachments
(DFU- 0149-XX) cleaning and sterilization instructions included with each
handpiece. Additional copies of this insert can be obtained from the Arthrex
website at www.arthrex.com
representative.

19. NEVER place the shaver handpiece in Cidex or other aldehyde disinfectant
solutions.

20. 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.

21. Liquid on the cable connector of the accessory device can damage the
device. Before connecting the cable, ensure the receptacles are clean and
dry.

22. Open the suction control completely to ensure proper circulation, if
applicable.

23. Open the chuck completely to ensure proper circulation, if applicable.

24. Remove all accessories, including shaver blades, drill bits and saw blades
before sterilizing a handpiece.

25. 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.

, or by contacting your local Arthrex

NOTE: This identifies information that can simplify the setup and

operation of this device.

1. Read this User’s Guide thoroughly before operating the device and save it for
future reference.

2. Extension cords must meet local electrical standard. Extension cords are not
recommended to be used with the AR-8305.

3. The AR-8305 console incorporates a universal AC input power supply. A
voltage selection switch is not required.

4. AR-8305 has been designed to accept EMC from other devices within the

limitations as described in section 14.0.

5. The setup for a footswitch is the same for all models. The console detects
which version is attached and allows the appropriate functions.

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General Warnings and Safety Notices - Read This First

Synergy Resection User’s Guide

Caution: Federal Law

of a Physician.

Electrical Hazard,

components.

6. While operating the handpieces, the settings can be changed without risk of
damaging the motor or console.

In EU Only: Procedures carried out using these devices may be used on the general
population.

In EU Only: The clinical benefits associated with the use of these devices outweigh the known
clinical risks.

In the EU Only: There are no unacceptable residual risks or uncertainties associated with the
clinical use of these devices.

Symbol Definitions

All 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

.

Safety Sign

Follow Operating

Instructions

On / Off (push-push)

Precaution of Warning

Dangerous Voltages

attempt to repair the

Personnel may remove

the cover, or obtain

Notice

Keep Dry

are Present. Never

equipment. Only

Trained Service

access to system

Restricts this device to

sale by or on the order

Type BF Equipment

Fragile

This Side Up

Temperature Limits

for Storage and

Transport

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Alternating Current

Pressure Limits for

Storage and Transport

General Warnings and Safety Notices - Read This First

Synergy Resection User’s Guide

WEEE [Waste

of-Life of Product.

Universal Serial Bus

thumb drive]

The product meets the

Directive 93/42/EEC

USB

Fuse

Equipotential

[Equipment Potential]

Electronics and

Electrical Equipment]

Symbol. Regarding

European Union End-

Manufacturer

Handpiece connection

[For use ONLY with

RS-232

Humidity Limits for

Storage and Transport

Protective Earth

Ground [Functional]

RF Symbol. Non-

ionizing

Electromagnetic

Radiation

Date of Manufacture;

year and month.

Foot Pedal connection

Serial Port [Arthrex

Integration]

Catalog number

Serial number

Representative in the

European Community

Quantity

Consult Instructions

for Use

Authorized

essential requirements

of Medical Device

Non Sterile

Do not use if package

is damaged

No user-serviceable

parts inside

Electrical hazard

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General Warnings and Safety Notices - Read This First

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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. Warranty could be voided if shipping or first­installation damage is not reported within 7 business days of receiving the
device. Refer also to our General Terms of Business.

The warranty is not valid if modifications are made to the product or repairs are
completed 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.

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.

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Product Description

Synergy Resection User’s Guide

2.0 Product Description

Product Description and Intended Use

The Arthrex AR-8305 Synergy

Resection

Shaver System is a motorized,
suction/cutting device used for the resection and aspiration of soft tissue,
cartilage and bone during arthroscopic surgical procedures.

The console is microprocessor controlled and features two fully functional
channels that allow optional simultaneous handpiece operation. Both channels
can be operated with a single foot switch or individually when a second foot

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switch is attached to the console. The Synergy

has a maximum speed of
8,000 revolutions per minute providing precise burr control during surgical
procedures.

The Synergy

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console is designed for continuous operation. The handpieces
are individually protected by a resetting thermal fuse. In the event of a motor
overload fault (e.g., excess current) the fuse heats up and the device is
deactivated. When the fault is removed and the fuse cools down (typically about
30 seconds) operation resumes at the pre-failure settings.

The cable and all handpieces can be sterilized, so handpieces can be changed
during the surgical procedure without endangering surgical sterility.

The AR-8305 Synergy

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Console and included Applied Parts and

Accessories:

• AR-8305 Console with power cord

• User’s Guide Optional

Applied Parts

• Footswitch Controlled (FC) Shaver Handpieces

• Handpiece Controlled (HC) Shaver Handpieces

• Drill Handpiece with key for Jacobs chuck

• Sagittal Saw Handpiece with wrench

• Small Joint Shaver

Other Optional Accessories:

• Accessory Handpiece Cable

• Gas Pedal Footswitch

• Corded Multi-Function Footswitch

• Wireless Multi-Function Footswitch

Save the packaging for later transport of the device.

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Product Description

Synergy Resection User’s Guide

1.

On / Off Power Switch

2.

Handpiece Connectors

3.

Synergy Product Logo

4.

Handpiece Symbols

5.

Touch Panel Visual Display

6.

Footswitch Symbols

7.

Footswitch Connectors

8.

Arthrex Logo

9.

Type BF Symbols (Electric Shock Protection)

10.

Power Switch IEC 60417-5010 symbol (On / Off)

WARNING!

Use this device only 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.

Product Features

AR-8305Console - Front View

Figure 1 shows the front panel of the AR-8305 console. Features and symbols are
identified in Table 1 below.

Figure 1 Front Panel of Console

Table 1 Front Panel Elements

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Product Description

Synergy Resection User’s Guide

1. Main power input Plug

2. Equipotential Bonding Pin with Stamped Equipotential Bonding Symbol

3. Address

4. Fan

5. USB port (For use ONLY with thumb drive)

6. Serial ports for Arthrex integration

7. Serial number label

8. Model number label

9. Fuse holder for the Power Entry Module

10. Fuse label

AR-8305 Console - Rear View

Figure 2 shows the rear panel of the console. Features and symbols are identified
in Table 2 below.

Figure 2 Rear Panel of Console

Table 2 Rear Panel Elements

AR-8305 Display Messages

The console's Touch Panel Visual Display (TPVD) [5] provides information about
the status of the AR-8305 settings in real time. A list of informational and error
messages is shown in Table 3 and 4 below. Messages that represent the active
motor states are displayed in green on the TPVD.

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Product Description

Synergy Resection User’s Guide

Message

Explanation

**EEPROM Reset**

Temporarily displayed first time micro-

has faulted and is reset.

**Motor Fault**

Temporarily displayed when motor fault
condition occurs.

**Overload**

Temporarily displayed when motor over­**Self Test Fail**

Console has failed a critical power on test.

*CRUISE NOT ALLOWED*

Temporarily displayed when cruise button

control.

*FS PEDAL STUCK*

Either a footswitch pedal is being pressed or is

console.

*FWD or REV ONLY*

Temporarily displayed for tools that do not
support OSC mode.

*HP BUTTON STUCK*

Either a handpiece button is being pressed or is

console.

*TOGGLE NOT ALLOWED*

Temporarily displayed when toggle button

mode.

*TOOL FAILURE*

as defined in Table 4.)

Critical Tool Failure caused either by a faulty

*Unable to Install*

Handpiece is not recognized.

[CC]1

Speed locked on cruise control.

CC

Cruise control enabled, about to lock.

AGG

Current mode: Aggressive oscillation mode
(stopped).

Communication Error

Internal data communication error.

Critical Error

Critical error, unit will shut down.

DFS

Digital Footswitch Connected.

Drill

Drill connected.

Table 3 AR-8305 Display Messages

controller is programmed, or if internal memory

current condition occurs.

pressed with tool that doesn’t allow cruise

Remove FS, Repower System

Remove HP, Repower System

ERROR, XXX

(Where “XXX” is an error code

stuck while connecting to console.
Communication error results. Remove the
footswitch and repower the system to reset the

stuck while connecting to console.
Communication error results. Remove the
handpiece and repower the system to reset the

pressed with tool that doesn’t allow oscillation

sensor or an over current condition. Remove
and replace tool or repower console to reset.

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Product Description

Synergy Resection User’s Guide

EFF

Current mode: Efficient oscillation mode
(stopped).

FC Shaver

Footswitch Controlling Shaver connected.

Fwd

Current mode: Forward (stopped).

Fwd

Current status: Motor is moving forward.

Gas Pedal Footswitch

Temporarily displayed when gas pedal
GFS

Gas Pedal Footswitch Connected.

HC Shaver

Handpiece Controlling Shaver connected.

No Footswitch

Temporarily displayed when footswitch
disconnected.

Osc1 Current status: Motor is oscillating.

Power Failure

Power supply error.

Rev

Current mode: Reverse (stopped).

Rev1

Current status: Motor is moving in reverse.

Run1

Current status: Motor is running (for saw).

Safe Mode

Excessive HP communication errors have
occurred.

Sag Saw

Sagittal Saw connected.

SFS

Standard Footswitch Connected.

SJ Shaver

Small Joint Shaver connected.

Standard Footswitch

Temporarily displayed when standard
footswitch connected.

STD

Current mode: Standard oscillation mode (stopped).

1

footswitch connected.

1

Displayed in green, denoting an active tool.

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Product Description

Synergy Resection User’s Guide

Message

Explanation

# $ @

Sensor 1 = No Errors Found

Represents Handpiece Sensor Failures

H13

Multiple sensors shorted

H14

Multiple sensors stuck high/low

H15

Invalid Hall sensor states detected

C31

Over current 7.5A during retries

C32

Over current 5.0A during retries

C33

Over 5.0A for 6 seconds

C34

Over 7.0A for 3 seconds

C35

Over 7.5A for 1 second

C36

Over 8.0A for 250ms

C37

Over 8.1A in INT0

C38

Over 8.1A in A/D ISR

C39

Over 8.0A in FWD/REV ramp up

S52

Over restart tries

S54

General system failure

Table 4 *TOOL FAILURE* Error Code Definitions

# = Sensor 3, $ = Sensor 2, @ = Sensor 1

Example: 022
Sensor 3 = Stuck Low
Sensor 2 = No Errors Found

0 = Stuck Low,
1 = Stuck High,
2 = No Errors Found.

S51 Invalid Gear Ratio

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Product Description

Synergy Resection User’s Guide

1.

Cable

2.

Speed Increase button

3.

Toggle button

4.

Forward pedal

5.

Oscillation pedal

6.

Reverse pedal

Applied Parts and Accessory Features

Standard Footswitch (AR-8310)

Figure 3 shows the Standard Footswitch. Features and symbols are identified in
Table 5 below.

Figure 3 Standard Footswitch - Description

Table 5 Elements of the Standard Footswitch

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Technical Specifications

Synergy Resection User’s Guide

Width

40.64cm (16.00 inches)

Height

13.335cm (5.250 inches)

Depth

30.686cm (12.081 inches)

Weight

6.8kg (15 lbs.)

Water protection

IP22

Mains cable

10 A/250 V

Power entry module

IEC 320/C13

Fuse value

6.3 A, 250 V~, 2.0 cm (0.75 inches) Type T

AC input

100-240V~, 50/60Hz, 6.3A

Applied Part Type

BF

Cleaning, disinfecting and
sterilization

Refer to Sections 6.0 Cleaning and
Disinfecting and 7.0 Sterilization

Functions

Reverse, Forward, Oscillation, Speed Increase,
and Toggle

Width

23.6 cm (9.3 inches)

Height

2.5 cm (1.0 inches)

Depth

20.8 cm (8.2 inches)

Weight

2.2 kg (5 lbs.)

Water protection

IP68

Cleaning, disinfecting, and
sterilization

Refer to Sections 6.0 Cleaning and Disinfecting
and Section 7.0 Sterilization

Temperature

10° to 40°C (50° to 104°F)

Relative humidity

30 % to 75 %

Air Pressure

700 hPa to 1060 hPa (21 in. Hg to 31.3 in. Hg)

Temperature

-30° to 70°C (-22° to 158°F)

Relative humidity

10 % to 90 %, non-condensing

Air Pressure

500 hPa to 1060 hPa (15 in. Hg to 31.3 in. Hg)

3.0 Technical Specifications

Console

Table 6 AR-8305 Console Specifications

Standard Footswitch

Table 7 Standard Footswitch Specifications

Ambient Conditions for Operation

Table 8 AR-8305 Ambient Conditions for Operation

Ambient Conditions for Storage (in shipping packaging)

Table 9 AR-8305 Ambient Conditions for Storage

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Technical Specifications

Synergy Resection User’s Guide

Parameter

Parameter Value

FDA Class

Class 1

EU Class

Class IIA

EU Certification

EN 60601-1:2006

EMC Certification

IEC 60601-1-2:2014 Class A
MDD Classification

CE Marking for MDD93/43/EEC
Class IIA

Safety, EMC, and Regulatory Requirements

Table 10 Safety, EMC, and Regulatory Requirements

System

Classification

Health Canada Class Class 2

Domestic Certification UL 60601-1:2003

Safety

Certifications

EMC

Certifications

Safety

Certification

Marking

CE Markings

Canadian Certification CAN/CSA C22.2 No. 60601-1-2008-02

IEC 60601-1 3rd Ed. + AM1 (2012)

CISPR 11 EMC Class Class A

CISPR 11 EMC Group Group 1

MDD Marking Rule 9

For all other accessories refer to accompanying DFUs for more information.

Refer to Section 14.0 Electromagnetic Emissions for further detail on EMC
Certification

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Setup

Synergy Resection User’s Guide

4.0 Setup

How to Set Up the Console

Users are encouraged to contact their Arthrex representative if they require a
more comprehensive surgical technique.

AC Power Safety Considerations

The AR-8305 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 7/7with the
AR-8305. 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, Detachable Power Supply Cords
or electrical standards for the designated country where the AR­8305 is being used. Contact your Arthrex representative for
further information.

Avoid positioning the console so that it is difficult to disconnect
coupler or plug from supply main.

NOTE:

The console is designed to meet power-saving guidelines. The console has an AC
mains switch on the front panel. 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 console displays the name
and model number. If the tests discover a problem, the problem is shown on the
display. Refer to Tables 3 and 4 for a listing of Display Messages.

In the event of an AC power interruption, the console can run continuously
without a fault for up to 10 milliseconds. If an AC power failure lasts for longer
than 10 milliseconds, the system will return to the default settings when AC
power is restored.

Extension cords must meet the local electrical standard. Extension
cords are not recommended to be used with the AR-8305.

Connecting an extension cord to the AR-8305 may result in a
reduced level of safety.

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Setup

Synergy Resection User’s Guide

1. Disconnect the device from the AC mains.

2. Open the fuse tray in the AC inlet, by pulling out on the tabs.

3. Replace the fuses with T6.3AL250v Line Fuses, as noted on the rear panel.

4. Push the fuse holder back into the AC inlet.

5. Ensure that fuse holder is fully seated and that the tabs snap back

WARNING!

To avoid the RISK of electric shock, this equipment must only be connected to a
SUPPLY MAIN with protective earth ground.

WARNING!

Do not have the device in direct contact with patient if high-frequency devices are
in use, or if the patient requires defibrillation.

Replacing the Fuses

The mains fuse is replaced with T6.3AL250v as follows:

Always use fuses with the correct values to avoid allowing

NOTE:

overcurrent to enter the system.

An incorrect fuse may increase the risk of electrical shock or fire
hazard.

The AR-8305 console incorporates a universal AC input power supply.
A voltage selection switch is not required.

Electromagnetic Compatibility

This device has passed testing for EMI / RFI radiation and
susceptibility and EMC compatibility. This device may cause
interference to other devices in the near vicinity, if not set up and
used as Arthrex instructs.

AR-8305 has been designed to accept EMC from other devices within the
limitations as described in section 14.0.

To determine if the AR-8305 is causing interference to other devices,
power OFF the AC main power switch and then ON again.

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Setup

Synergy Resection User’s Guide

Try to correct the interference by following one or more of these measures:

1. Reorient or relocate the receiving device.

2. Increase the separation between devices.

3. Connect the device to an outlet on a different circuit than the other
device(s) are connected.

4. Consult the manufacturer or field service technician for receiving devices
for guidance.

Basic Setup Procedure for the AR-8305 Console

NOTE: Section 5.0, Operation, explains how to use the console.

1. Place the AR-8305 on a flat, dry surface, such as the AR-6481 Arthrex
Arthroscopy pump cart.

2. Connect the receiver end of the power cord for the AR-8305 into the AC
socket and the plug end to the facility AC mains supply.

3. Power ON the console.

4. Allow it to fully initialize.

5. Attach the shaver handpiece.

6. Attach a footswitch, if applicable.

WARNING!

DO NOT stack or place equipment adjacent to the AR-8305 console, if possible.
If such a configuration is necessary, carefully observe the configuration in
question to ensure that the electromagnetic interference does not degrade the
performance.

Do not attach handpieces or footswitches during the Self Test or
the Programming Modes.

WARNING!

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 patient and/or operating room staff injury.

WARNING!

This equipment is NOT suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen rich or nitrous oxide environment.

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Setup

Synergy Resection User’s Guide

Setting up a Footswitch

Only use footswitches developed by Arthrex specifically for the
AR-8305 Synergy

NOTE:

Insert the footswitch connector into the console’s footswitch receptacle. Align the
red dots on the connector and receptacle so they engage easily.

Setup for a footswitch is the same for all models. The console detects
which version is attached and allows the appropriate functions.

Resection

console.

Setting up the Shaver Handpieces

Only use shaver handpieces and cables that have been developed
by Arthrex specifically for the Synergy

Insert the handpiece connector into the console’s handpiece receptacle. Align the
red dots on the connector and receptacle so they engage easily.

Resection

console.

Setting up Other Accessory Handpieces

Only use handpieces and cables that have been developed by
Arthrex specifically for the Synergy

Resection

.

Other accessory handpieces are available with the SynergyResection

accessory cable. Specific instructions for use of a

Insert one end of the accessory cable connector into the cable receptacle of the
accessory handpiece. Align the red dots on the connector and receptacle so they
engage easily.

Connect the other end of the accessory cable to the handpiece receptacle of the
console. Align the red dots on the connector and receptacle so they engage easily.

n accessory are packaged with that handpiece.

and may require an

Shutdown Procedure

The AR-8305 can be safely shut down at any time by powering down the console.

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1. The main screen, divided into two sections when two tools are attached

2. Settings button (on the lower right corner in the single screen mode)

3. Up button

4. Down button

5. Tool name

6. Footswitch, displayed in green if Footswitch Override is disabled

(SFS = Standard Footswitch, GFS – Gas Footswitch)

7. Speed setting

8. Direction or Mode indicator, displayed in green if active

5.0 Operation and Frequently Used Functions

Main Screen

Figure 4 Main Screen Display - One Tool Attached

Figure 5 Main Screen Display - Two Tools Attached

Table 11 Main Screen Display Elements

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

9. Direction and Oscillation buttons

• The main screen is divided horizontally into two sections, one for
each channel, when tools are connected to both channels.

• Each section contains a display area for messages and five buttons.

• The Settings button on the right configures both main screens. It is on
the lower right corner in the single screen mode or between the two
sections’ Up and Down buttons in dual screen mode.

• The tool name is positioned as depicted in the above diagrams.

• Footswitch data is positioned below the tool name.

• The speed setting is displayed in large numeric digits. They are
visible from a distance by the surgeon in the OR.

• Direction or mode indicators are below the speed setting in large
characters. They are visible from a distance by the surgeon in the OR.

• Direction and oscillation buttons.

• Cruise control status is positioned next to the footswitch data.

Settings Menu Main Screen

The Settings Menu provides access to settings and information screens. There
are six buttons described in Table 12 below.

Figure 6 Settings Menu Display - Operation

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1.

Select Language

When the Select Language button is pressed, the

section 5.3 below.

2.

Select Oscillation

When the Select Oscillation Mode button is

Mode screen, section 5.4 below.

3.

Footswitch Override

When the Footswitch Override button is

Override screen, section 5.5 below.

4.

Reset Defaults button

When the Reset Defaults button is pressed, the

settings to the factory defaults, section 5.6 below.

5.

Information button

When the Information button is pressed, the

5.7 below.

6.

Home button

When the Home button is pressed, the software
displays the Main screen, section 5.1 above.

Table 12 Settings Menu Display - Operation

button

Mode button

button

software displays the Language Selection screen,

pressed, the software displays the Oscillation

pressed, the software displays the Footswitch

software displays the Reset Defaults screen
which asks for confirmation before resetting all

software displays the Information screen, section

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1. Select Language radio

buttons

Select the language of choice.

2. Menu button

When pressed, the software stores the

screen.

3. Home button

When pressed, the software stores the

screen.

4. Cancel button

When pressed, the software returns to the
Menu screen without making any changes.

Language Selection Screen

The Language Selection screen displays a list of available languages with radio
buttons. The software supports the following languages: English, German,
French, Italian and Spanish. It also includes three navigation buttons: Menu,
Home and Cancel as described in Table 13 below.

Figure 7 Language Selection Display - Operation

Table 13 Language Menu Display - Operation

selected language and returns to the Menu

selected language and returns to the Main

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1.

Channel 1

The software supports each handpiece channel
with its own oscillation mode.

2.

Channel 2

3.

Oscillation Mode radio
buttons

Select the oscillation mode: Standard, Efficient
or Aggressive.

4.

Menu button

When pressed, the software stores the selected
mode and returns to the Menu screen.

5.

Home button

When pressed, the software stores the selected
mode and returns to the Main screen.

6.

Cancel button

When pressed, the software returns to the Menu
screen without making any changes.

Oscillation Mode Selection Screen

The Oscillation Mode selection screen has radio buttons for available oscillation
modes for each channel. This screen also includes Menu, Home and Cancel
buttons as described in Table 14 below:

Figure 8 Oscillation Mode Selection Screen - Operation

Table 14 Oscillation Mode Display - Operation

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1.

2.

Channel 1

Channel 2

The software displays the current settings for

sets of radio buttons.

3.

Footswitch Override

Each channel has an Enabled and Disabled

Enabled.

4.

Menu button

When pressed, the software stores the selected
mode and returns to the Menu screen.

5.

Home button

When pressed, the software stores the selected
mode and returns to the Main screen.

6.

Cancel button

When pressed, the software returns to the Menu
screen without making any changes.

Footswitch Override Screen

The Footswitch Override screen has radio buttons to select the footswitch
override mode for each channel.

At the End User’s discretion, the default setting can be changed so that the
Shaver Handpiece can be controlled by both the Footswitch and/or the Hand
Controls as described below. If both the Footswitch and the Hand Controls are
enabled and activated simultaneously, the Footswitch control will be dominant.

In the default (enabled) mode, the buttons on the hand-control shaver handpiece
will not function when a footswitch is attached to the console. When disabled,
both buttons on the handpiece and the footswitch will function. This screen also
includes Menu, Home and Cancel buttons as described in Table 15 below:

Figure 9 Footswitch Override Selection Screen - Operation

Table 15 Footswitch Override Display - Operation

radio buttons

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footswitch override for each channel with two

radio button, with the factory default set to

Operation and Frequently Used Functions

Synergy Resection User’s Guide

1.

Prompt to confirm resetting to factory defaults.

2.

Yes to reset to factory defaults.

3.

No to exit without resetting.

Reset Defaults Screen

The Reset Defaults screen prompts the user to confirm resetting to factory
defaults. This screen is displayed when the Reset Defaults button is pressed on
the Settings screen.

Figure 10 Reset Defaults Screen - Operation

The software displays two buttons that allows the user to confirm resetting of
factory defaults as described in Table 16

below.

Table 16 Reset Defaults Display - Operation

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1. Model, Software Versions & Builds for each controller.

2. Menu button

Returns to the menu screen.

3. Home button

Returns to the main screen.

Information Screen

The Information screen displays the Model, Software Versions and Builds for
each controller, along with Menu and Home buttons as described in Table 17
below:

Figure 11 Information Screen - Operation

Table 17 Information Screen Display - Operation

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1. Oscillation Mode

The OSC Mode button is only displayed when

handpiece screen.

Buttons

Most buttons send a message to the controller when activated and/or released.
The Up and Down speed buttons auto repeat when pressure is maintained. The
selected speed is not sent to the controller until the button is released.

Buttons - Main Screen

The Main Screen is displayed in one of two configurations depending on how
many handpieces are connected to the system. A single handpiece screen is
displayed with a single screen while a two handpiece screen has two equally
sized sections, top and bottom. A single handpiece screen has the same content

as a dual handpiece screen section, with the exception of the OSC Mode
button on a single handpiece screen.

Figure 12 Single Handpiece Screen Oscillation Mode Location

Table 18 Oscillation Mode - Operation

button

a single handpiece is installed and the device is
in OSC mode.
When displayed, it can be pressed to toggle
between the different OSC modes.
This button is not displayed on a dual

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1. Channel 1 Reverse

button

When the Reverse button is pressed, the

shaver.

3. Channel 1 Oscillation

When the Oscillation button is pressed, the

Shaver Controller SRS document.

5. Channel 1 Forward

button

When the Forward button is pressed, the

shaver.

7. Channel 1 Up button

When the Up button is pressed, the speed of

the limit is reached.

Figure 13 Two Handpiece Buttons - Operation

Table 19 Two Handpiece Buttons - Operation

button

2. Channel 2 Reverse

button

4. Channel 2 Oscillation

button

button

6. Channel 2 Forward

8. Channel 2 Up button

handpiece motor moves in a counterclockwise
direction when observed from the tip of the

handpiece motor moves in an alternating
clockwise/counterclockwise direction. The
duration of each direction is specified in the

handpiece motor moves in a clockwise
direction when observed from the tip of the

the motor increases.
The increase of the motor speed depends on
the type of handpiece.
When the Up button is initially pressed, during
the first second, the speed changes by one
increment.
If the Up button is still pressed after the initial
second, the speed continues to increase until

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

9. Channel 1 Down

When the Down button is pressed, the speed

until the limit is reached.

11. Settings button

The Settings button is not displayed if

into speed test mode. See Speed Test Mode.

button

10. Channel 2 Down

button

of the motor decreases.
The decrease of the motor speed depends on
the type of the handpiece.
When the Down button is initially pressed,
during the first second, the speed changes by
one increment.
If the Down button is still pressed after the
initial second, the speed continues to decrease

either of the two motors are in motion.
When the motors are not in motion, the
Settings button is displayed between the Up
and Down buttons for both sections in a dual
screen mode, or in the lower right corner in a
single screen mode.
When the Settings button is pressed for 3
seconds, the software switches the controller

Speed Test Mode

The software enters the Speed Test mode when the Menu button is pressed and
held for 3 seconds until a triple beep is sounded.

Speed Adjustment

The Up and Down speed buttons auto-repeat when pressure is maintained. The
selected speed is not sent to the controller until the button is released.

Oscillation Mode Adjustment

The OSC Mode button is only displayed when a single handpiece is installed
and the device is in OSC mode.

When displayed, it can be pressed to toggle between the different OSC modes.
This button is not displayed on a dual handpiece screen.

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

Forward / Reverse Speeds

(RPM)

Oscillation Speeds

(RPM)

Handpiece

Min.

Max.

Speed Delta

Min.

Max.

Speed

Delta

Shaver

500

8000

300

500

3000

250

Drill

100

1400

See Drill Speeds
Section

N/A

N/A

N/A
Sag Saw

18000

18000

N/A

N/A

N/A

N/A

SJ Shaver

500

6200

300

500

3000

250

Handpiece

ACCURACY

All Shavers

±5 % OR ±100 RPM (greater of the two)

Drill

±5 % OR ±20 RPM (greater of the two)

Sag Saw

±6 %

Accessory Handpiece Speed Limits and Deltas

The console supports individual handpiece motor-speed limits, defaults, and
speed increment and decrement “deltas”. These are defined below for the
supported handpieces.

Table 20 Accessory Handpiece Speed Limits and Delta

Drill Speeds

The drill supports only 100, 300, 500, 900, and 1400 (RPM). It does not cycle
through regular increments.

NOTE: While operating handpieces, the settings can be changed without risk

of damaging the motor or console.

WARNING!

Do not have the device in direct contact with patient if high-frequency devices are
in use or if the patient requires defibrillation.

Console Speed Controls

The Speed Increase and Speed Decrease buttons adjust the speed. Each time a
button is pressed, the speed is adjusted as shown in Table 20. The commands are
ignored if multiple buttons are pressed simultaneously.

To make the handpiece speed increase or decrease automatically, press the Speed
Increase or Speed Decrease button for more than 1 second. The values will not
exceed the minimum and maximum values defined for the attachment.

Table 21 Handpiece Accuracy

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

1. Reverse

Counterclockwise (CCW)

2. Forward

Clockwise (CW)

3. Oscillation

CW then CCW

4. Stop

No rotation

Attachment Motor Control

Definition of Direction

The definition of direction as viewed looking from the proximal to the distal (top
of the tip) of the shaver handpiece.

Forward, Reverse and Oscillation Modes

The buttons and pedals for the Reverse, Forward, and Oscillation modes select
which direction the motor rotates. If the Reverse and Forward buttons or pedals
are detected simultaneously then the motor defaults to Oscillation mode. During
Oscillation mode, the motor will rotate forward, then backward. Any other
combination of simultaneous button and pedal activations are ignored by the
device. This operation applies to both the console front-panel buttons and the
supported footswitch pedals.

Cruise Control

Use the Gas Pedal Footswitch to engage the cruise control function. The Gas
Pedal Footswitch is available as an optional system accessory. To operate the
cruise control, you must:

5.13.3.1 Cruise Set

When you select the Cruise Control Button, the Cruise function becomes
ARMED (signaled by a single audible 1 second alarm) but the LOCK IN
period does not start until one of the three pedals is pressed. If a pedal is
not pressed within 15 seconds then the Cruise function becomes
DISARMED (signaled by a single audible 1 second alarm).

If the Cruise button is pressed on an attachment that does not allow cruise
control, an error alarm occurs (3 fast tones), and displays the message
“*CRUISE NOT ALLOWED*”.

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5.13.3.2 Cruise Lock

The LOCK IN period lasts for up to 15 seconds. During the LOCK IN
period the operator adjusts the speed and must hold the pedal steady for
3 seconds in order for the LOCKED state to occur. Steady is defined as
±500 RPM for forward or reverse, and ±400 RPM for oscillation. If the
pedal is held steady, the Shaver Console emits an audible double alarm
(2 brief tones) that indicates the LOCKED state has been entered, and
“*Lock*” is displayed. If the pedal was not held steady within the
15 second LOCK IN period, then the Cruise function becomes
DISARMED (signaled by a single audible 1 second alarm).

5.13.3.3 Remove Foot

The operator can move the same pedal for the next 3 seconds without
leaving the LOCKED state. This is necessary, since the act of taking the
foot off of the pedal moves the pedal position. Once the pedal is fully
released, or after 3 seconds have elapsed, the system again responds to
this pedal and disables the Cruise function.

5.13.3.4 Disable Cruise Lock

If any other footswitch or console panel button is activated while in the
LOCKED state, the Cruise function becomes DISARMED (with the
exception noted in item Remove Foot).

5.13.3.5 Disable Cruise Set

If the Toggle, Cruise Control, or Front Panel buttons are pressed at any
time after the Cruise Control button is selected (i.e. in the ARMED or
LOCKED state) then the Cruise function becomes DISARMED.

Toggle Function

A Toggle switch is available on both the Standard and the Gas Pedal
footswitches. The toggle function is performed by pressing a button on the
footswitch. The toggle function is available when one footswitch and two

Resection

handpieces are connected to the Synergy
allows the operator to control the handpieces in channel 1 and channel 2, without
moving the footswitch connection.

At power on, or at first connection, the footswitch controls the attachment which
is on the same channel as the one the footswitch is connected to. When the user
presses the Toggle switch, a beep indicates the footswitch has been toggled to the
attachment on the opposite channel. The handpiece on the same channel as the
footswitch is controlled by the front panel buttons only.

console. The toggle function

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Operation and Frequently Used Functions

Synergy Resection User’s Guide

Installed

Handpieces

Installed

Footswitches

When the user presses Toggle again, the footswitch returns control to the
handpiece on the same channel as the footswitch. The channel on the opposite
side as the footswitch is controlled by front panel buttons only.

When controlled by the footswitch, the HC shaver is controlled by the
Footswitch Override setting. When not controlled by the footswitch, the
handpiece buttons and control panel are enabled.

If there is a connected attachment for each installed footswitch, and the
attachment supports oscillation mode, the toggle button switches to the next
oscillation mode in this sequence: efficient mode, aggressive mode, standard
mode and then back to efficient mode.

If two footswitches are installed with only one connected attachment, the
footswitch without a connected attachment is inactive.

If the Toggle switch is activated when only one attachment is connected and this
attachment does not support oscillation modes, an error beep sounds and
“TOGGLE NOT ALLOWED” message is temporarily displayed.

Table 22 Toggle Function

0 1 None None

0 2 None None

1 1 Change oscillation mode Single

1 2 Change oscillation mode (footswitch

2 1 Move control to next channel Single

2 2 Change oscillation mode Single

Action Beep type

Single

on installed HP channel)

None (footswitch with no installed HP) None

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Footswitches

The footswitch cable connects and locks to the console to prevent
accidental separation during use. To avoid damage, disconnect
the footswitch by pulling on the cable connector shell (plug) only.

Standard Footswitch

The Speed Increase button adjusts the speed in the positive direction only. Each
time the button is pressed, the speed adjusts as shown in Table 20. When the
device is at maximum speed setting, the user can return to minimum speeds by
pressing the Speed Increase button one more time. The commands are ignored if
multiple buttons are pressed simultaneously.

If the Speed Increase button is continuously pressed for more than 1 second then
the speed auto-increments accordingly. The speed setting will not wrap when
auto-incrementing. Release the Speed Increase button and then press it again to
get the speed setting to cycle to the minimum setting.

Gas Pedal Footswitch

The Forward, Reverse, and Oscillation pedals linearly adjust the speed. When the
pedal is pressed, it returns an analog signal that is converted to a corresponding
RPM between the minimum and maximum speed of the attachment connected to
the footswitch.

Multi-Function Footswitches

Wireless and Corded Multi-Function Footswitches can operate as either a
Standard Footswitch or as a Gas Pedal Footswitch, as described in the preceding
sections. Function selection is made by pressing the button on the Multi-Function
Footswitch labeled “GFS” or “SFS’. These footswitches are available as optional

Resection

accessories. For more information on the Synergy
8315W), please see DFU-0320-XX. For the Synergy

Wireless Footswitch (AR-

Resection

Wireless Footswitch

Quick Start Guide, please see DFU-0323-XX-SUB.

Accessory Handpieces

The accessory handpiece cable connects and locks to the console
to prevent accidental separation during use. To avoid damage,
disconnect the footswitch by pulling on the cable connector shell
(plug) only.

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Cleaning and Disinfecting

Synergy Resection User’s Guide

6.0 Cleaning and Disinfecting

Console AR-8305

The AR-8305 console is provided non-sterile and must not be
sterilized.

The AR-8305 console can be cleaned/disinfected using a cloth and commercially
available surfactants or surface disinfectants only. Use a commercially available
cleaning disinfectant for surfaces. Alkaline agents with a pH value > 8 are to be
avoided Do NOT clean the device with abrasive cleaning or disinfectant
compounds, solvents, or other materials that could scratch or damage the device.
The AR-8305 must not be submersed in any liquid.

Always place the Main Power Switch to “Off (O), position” and disconnect the
power before cleaning the AR-8305 console.

Always comply with the instructions issued by the manufacturer of
the cleaning disinfectant regarding concentration, exposure times,
temperature and material compatibility.

NEVER clean the console with liquid cleaners. If there is dust,
remove it with dry compressed air.

Do NOT clean the device with abrasive cleaning or disinfectant
compounds, solvents, or other materials that could scratch or
damage the device.

Footswitches

The footswitch is provided non-sterile and must not be
sterilized.

To clean and disinfect, unplug the cord from the console and add the protective
cap to the connector. Use a commercially available cleaning disinfectant for
surfaces. Alkaline agents with a pH value > 8 are to be avoided. Clean the
footswitch with an enzymatic cleaner without subsequent acid neutralization.

Rinse the footswitch thoroughly after cleaning.

After cleaning, disinfect the footswitch with a commercially available surface
disinfectant, thoroughly rinse the footswitch under lukewarm water.

Refer to the Multifunction Wireless Footswitch Operator's Manual, LM0659 for
additional cleaning instructions.

Always comply with the instructions issued by the manufacturer of
the cleaning disinfectant regarding concentration, exposure times,
temperature and material compatibility.

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Cleaning and Disinfecting

Synergy Resection User’s Guide

NEVER allow the console receptacles to have any contact with
liquids. If there is dust or moisture on the receptacles, remove it
with dry compressed air. ONLY dry connectors should be plugged
into the console.

Do NOT clean the device with abrasive cleaning or disinfectant
compounds, solvents, or other materials that could scratch or
damage the device.

The footswitch is NOT suitable to be cleaned and disinfected in a
thermo washer disinfector.

Accessory Cable

Clean the cable with an enzymatic cleaner without subsequent acid
neutralization. Use a commercially available cleaning disinfectant for surfaces.
Alkaline agents with a pH value > 8 are to be avoided Do NOT clean the device
with abrasive cleaning or disinfectant compounds, solvents, or other materials
that could scratch or damage the device.

Rinse the cable thoroughly after cleaning.

After cleaning, disinfect the cable with a commercially available surface
disinfectant.

Thoroughly rinse the cable under lukewarm distilled water or preferably
demineralized sterile water. See Section 7.0 for sterilization information.

Refer to the Instructions for Use package insert for detailed Adapteur
Power System II Accessory Attachments (DFU-0149-XX) cleaning and
sterilization instructions included with each cable. Additional copies
of this insert can be obtained from the Arthrex website at
www.Arthrex.com, or by contacting your local Arthrex Representative.

Always comply with the instructions issued by the manufacturer of
the disinfectant.

NEVER allow the console plug pins to have any contact with
liquids. If there is dust or moisture on the receptacles, remove it
with dry compressed air. ONLY dry connectors may be plugged
into the console.

Accessory Handpieces

Refer to the Instructions for Use package insert for detailed shaver
handpiece (DFU-0154-XX, or DFU-0240-XX) and Adapteur Power
System II Accessory Attachments (DFU-0149-XX) cleaning and
sterilization instructions included with each handpiece. Additional
copies of this insert can be obtained from the Arthrex website at
www.Arthrex.com, or by contacting your local Arthrex
Representative.

DFU-0213-8r0_fmt_en-US Page 37 of 50

Cleaning and Disinfecting

Synergy Resection User’s Guide

Remove any accessories in the device. This includes shaver blades, saw blades or
drill bits.

If the handpiece has suction control, make sure it is fully open.

Clean the handpiece with an enzymatic cleaner without subsequent acid
neutralization.

If the handpiece has suction control, clean the connection with a cleaning brush.
Rinse the handpiece thoroughly after cleaning.

Disinfect the handpiece with a commercially available disinfectant.

Thoroughly rinse the handpiece under lukewarm distilled water or preferably
demineralized sterile water.

See Section 7.0 for sterilization information.

Always comply with the instructions issued by the manufacturer of
the disinfectant.

NEVER place the shaver handpiece in Cidex or other aldehyde
disinfectant solutions.

NEVER allow the console plug pins to have any contact with
liquids. Remove dust or moisture with dry compressed air. Only
DRY connectors may be plugged into the console.

DFU-0213-8r0_fmt_en-US Page 38 of 50

Sterilization

Synergy Resection User’s Guide

7.0 Sterilization

Sterilization capabilities, cleaning, disinfecting, handling, and storage of instrumentation
are the responsibility of qualified facility and/or user personnel. Qualified personnel
must still properly clean and disinfect the instruments prior to sterilization.

Refer to the Instructions for Use package insert for detailed Shaver
Handpiece (DFU-0154-XX or DFU-0240-XX) and Adapteur Power
System II Accessory Attachments (DFU-0149-XX) cleaning and
sterilization instructions included with each handpiece. Additional
copies of this insert can be obtained from the Arthrex website at
www.Arthrex.com, or by contacting your local Arthrex
Representative.

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.

Liquid on the cable connector of the accessory device can damage
the device. Before connecting the cable, ensure the receptacles
are clean and dry.

WARNING!

After autoclaving, the accessory devices are VERY HOT. Handle with care to avoid burns.

The following special instructions are to be observed when sterilizing
accessory handpieces.

Open or remove the suction control completely to ensure proper
circulation, if applicable.

Open the chuck completely to ensure proper circulation, if
applicable.

Remove all accessories, including shaver blades, drill bits and saw
blades before sterilizing a handpiece.

DFU-0213-8r0_fmt_en-US Page 39 of 50

Transmissible Spongiform Encephalopathy (TSE) Agents

Synergy Resection User’s Guide

8.0 Transmissible Spongiform Encephalopathy (TSE) Agents

It is outside the scope of this document to describe in detail the precautions that should
be taken for Transmissible Spongiform Encephalopathy (TSE) Agents.

The agents for transmission of Creutzfeldt-Jakob disease are believed to be resistant to
normal processes of disinfection and sterilization. Therefore, the normal processing
methods of decontamination and sterilization as described above may not be
appropriate where CJD transmission is a risk.

In general, the tissues that come into contact with orthopedic surgical instruments are
those of low TSE infectivity. However, take particular precautions when handling
instruments that have been used on known, suspected, or at risk patients.

References:

ANSI/AAMI ST79: Good Hospital Practice: Steam sterilization and sterility assurance.

DFU-0213-8r0_fmt_en-US Page 40 of 50

Maintenance

Synergy Resection User’s Guide

9.0 Maintenance

Regular and proper maintenance of your Synergy
your investment and avoid non-warranty repairs.

Recommended care and handling of the Synergy
day operation, cleaning, and sterilization which are extremely important to ensure safe
and efficient operation. It is important to visually inspect the foot pedal and handpiece,
cable and connectors before each use.

Your authorized Arthrex service department is the most knowledgeable about the
Arthrex Medical Resection Systems and/ foot pedal and handpiece, and will provide
competent and efficient service. Any services and/or repairs done by any unauthorized
repair facility may result in reduced performance of the instruments or instrument
failure.

Resection

System is the best way to protect

Resection

System includes proper day- to-

Life Expectancy

Life expectancy for the console is approximately 5 years under normal use and
standard of care.

Periodic Maintenance

The product should be inspected prior to and after each use to ensure that the
foot pedal, handpiece, cable, strain relief, overmold, or connector contacts are not
damaged or worn. If it becomes necessary to return the foot pedal and / or
handpiece to Arthrex for service, please disinfect the foot pedal and/or sterilize
the handpiece before shipping.

DFU-0213-8r0_fmt_en-US Page 41 of 50

Technical Support

Synergy Resection User’s Guide

10.0 Technical Support

For assistance in using the products identified in this User’s Guide, contact an Arthrex
representative or contact the Arthrex Technical Support Hotline at 1 [phone],
Monday through Friday from 8:00 AM to 8:00 PM EST; at [phone] or

[email protected]

How to Display the Software Version

Technical Support may request the software version of the AR-8305. Follow these
instructions to display the software version.

1. Power On the AC mains power switch [3] on the AR-8305.

2. The software version is displayed on the TPVD during the power-up
sequence.

Additional Technical Information

from 8:00 AM to 5:00 PM CET

Contact your Arthrex representative if require more comprehensive technical
information. Circuit diagrams, component part lists, descriptions, calibration
instructions, or other information will be provided upon request by Arthrex
APPROVED SERVICE PERSONNEL

DFU-0213-8r0_fmt_en-US Page 42 of 50

Troubleshooting

Synergy Resection User’s Guide

Fault

Cause

Solution

Unit does not power on.

1. Not receiving power from the wall

3. Console has an internal power failure.

1. Check the main power plug and wall

3. Send in for repairs.

Handpiece does not

1. Handpiece is not connected to the correct

1. Check the connector is plugged into the

9. Send in for repairs.

Motor runs but shaver

1. Shaver blade/burr incorrectly inserted.

1. Insert the shaver blade so that it engages.

3. Replace the shaver blade/burr.

No suction.

1. Clogged suction connection.

4. Damaged Suction Control.

1. Rinse with a syringe.

4. Send in for repairs.

11.0 Troubleshooting

Refer to Table 23 for device troubleshooting if problems occur after cleaning, transporting or changing operating staff.

Table 23 Troubleshooting: Faults, their Causes and Solutions

work.

blades/burrs do not
work.

receptacle or the power strip.

2. Blown fuses.

channel.

2. Not fully or properly connected or
connector is damaged.

3. Liquid in the receptacle or connector.

4. Connector is damaged.

5. Footswitch is defective.

6. Footswitch is functional.

7. Handpiece is too hot after sterilization.

8. Handpiece over-current is detected.

9. Defective handpiece.

2. Damaged hub.

3. Bent sleeve.

receptacle.

2. Check the fuses.

correct channel receptacle.

2. Check both connectors are plugged in
properly.

3. Dry thoroughly.

4. Replace the cable.

5. Operate the device using the console unit.

6. Replace the handpiece.

7. Allow it to cool down as indicated in the
WARNING in Section 7.0.

8. Allow 30 seconds for the console to reset the
affected channel.

Fully close the locking mechanism.

2. Replace the shaver blade/burr.

DFU-0213-8r0_fmt_en-US Page 43 of 50

2. Clogged shaver blade or burr.

3. Closed Suction Control.

2. Clean with a brush.

3. Open Suction Control.

Troubleshooting

Synergy Resection User’s Guide

Fault

Cause

Solution

System runs with the
control unit but not with
the footswitch.

1. Not fully, properly connected or damaged

3. Defective Footswitch.

1. Check the connector from the footswitch to the

3. Send in for repairs.

Connected handpiece not
shown on display.

1. Not fully or properly connected or

1. Check that both connectors are plugged in

connector.

2. Liquid in receptacle or connector.

connector is damaged.

2. Defective handpiece or connector.

3. Connector is damaged.

4. Defective handpiece.

If the problems persist, disinfect the Synergy

Resection

System and send in to Arthrex using the original packaging. Always send

control unit.

2. Dry thoroughly.

properly.

2. Check the connector with another handpiece.

3. Replace.

4. Send in for repairs.

the corresponding handpiece together with the console, footswitch and cable. Please enclose a brief explanation of the
detected malfunction. Refer to Section 12.0 for more information.

Troubleshooting Interference with Other Devices

Try one or more of the following to correct interference:

• Reorient or relocate the receiving device.

• Increase the distance between devices.

• Connect the device to an outlet on a different circuit than the other device(s).

• Consult the manufacturer or field service technician for the receiving device for assistance.

DFU-0213-8r0_fmt_en-US Page 44 of 50

Electromagnetic Emissions

Synergy Resection User’s Guide

12.0 Repair Policy

Contact Arthrex for a Return Authorization Number and instructions prior to returning
the device.

13.0 End of Life, Environmental Directives

WEEE Directive [2012/19/EU] on Waste Electrical and Electronic
Equipment

The Directive on Waste Electrical and Electronic Equipment obliges manufacturers,
importers, and/or distributors of electronic equipment to provide for recycling of the
electronic equipment at the end of its useful life.

Do not dispose of WEEE in unsorted municipal waste.

The WEEE symbol on the product or its packaging indicates that this product must not
be disposed of with other waste. Instead, it is your responsibility to dispose of your
waste equipment by handing it over to a designated collection point for the recycling of
Waste Electrical and Electronic Equipment. The separate collection and recycling of your
waste equipment at the time of disposal will help conserve natural resources and ensure
that it is recycled in a manner that protects human health and the environment. For
more information about where you can drop off your medical electronic equipment at
the end of its useful life for recycling, please contact Arthrex Customer Service
Department.

DFU-0213-8r0_fmt_en-US Page 45 of 50

Electromagnetic Emissions

Synergy Resection User’s Guide

Emissions test

Complia

nce

Electromagnetic environment – guidance

AR-8305 Synergy

system uses RF energy only for its

not likely to cause any interference in nearby equipment.

RF emissions
CISPR 11

Harmonic

61000-3-2

Voltage

IEC 61000-3-3

Type

Use

Shielded

Ferrite

Maximum Length

Supply Line Power

to the Console

14.0 Electromagnetic Emissions

Table 24 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The AR-8305 Shaver System is intended for use in the electromagnetic environment specified
below. The customer or the user of the AR-8305 Shaver System should assure that it is used in
such an environment.

Resection

RF emissions
CISPR 11

Group1

Class A

internal function. Therefore its RF emissions are very low and

emissions IEC

fluctuations/
flicker emissions

Class A

Complies

Table 25 System Cables

Power Cords

The AR-8305 Synergy

Resection

system is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.

No No 3.048 m

DFU-0213-8r0_fmt_en-US Page 46 of 50

Electromagnetic Emissions

Synergy Resection User’s Guide

Immunity
test

IEC 60601 test
level

Compliance level

Electromagnetic environment ­guidance

Electrostatic

± 8 kV contact

± 8 kV contact

Floors should be wood, concrete or

humidity should be at least 30 %.

Electrical fast

± 2 kV for power

100

± 2 kV for power

Mains power quality should be that of

Surge

± 1 kV line(s) to

earth

± 1 kV line(s) to

earth

Mains power quality should be that of

Voltage dips,

UT= 0%,0.5 cycle

cycles (@0 degrees)

UT= 0%,0.5 cycle

Mains power quality should be that of

Power frequency

30 A/m

30 A/m @

Power frequency magnetic fields

Note: UT is the AC mains voltage prior to application of the test level.

Table 26 Guidance and Manufacturer's Statement - Electromagnetic Immunity

The AR-8305 Synergy

Resection

System is intended for use in the electromagnetic environment
specified below. The customer or the user of the AR-8305 Synergy
that it is used in such an environment.

discharge (ESD)
IEC 61000-4-2

transient/burst
IEC 61000-4-4

IEC 61000-4-5

± 15 kV air

supply lines
± 1 kV for
input/output lines
100khz Cycling
Frequency

line(s)
± 2 kV line(s) to

± 15 kV air

supply lines
± 1 kV for
input/output lines
100khz Cycling
Frequency

line(s)
± 2 kV line(s) to

ceramic tile. If floors are covered with
synthetic material, the relative

a typical commercial or hospital
environment.

a typical commercial or hospital
environment.

Resection

System should ensure

short
interruptions and
voltage variations
on power supply
input lines

(0, 45, 90,135, 180,
225, 270, and 315

U
UT= 70%;25/30

IEC 61000-4-11

UT= 70%;

250/300 cycles

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

T= 0%;1 cycle

(0, 45, 90,135, 180,

0

)

225, 270, and 315

T= 0%;1 cycle

U

T= 70%;25/30

U

cycles (@0 degrees)

T= 70%;

U

250/300 cycles

50 & 60 Hz

a typical commercial or hospital

0

)

environment. If the AR-8305

Resection

Synergy

System requires
continued operation during power
mains interruptions, it is
recommended that the AR-8305

Resection

Synergy

System be powered
from an uninterruptible power
supply.

should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.

DFU-0213-8r0_fmt_en-US Page 47 of 50

Electromagnetic Emissions

Synergy Resection User’s Guide

Immunity
test

IEC 60601 test
level

Compliance level

Electromagnetic environment ­guidance

Portable and mobile RF communications equipment

[ ]

PVd 1/5.3=

P

[ ]

PVd 1/5.3=

P

[ ]

PEd 1/7=

P

reflection from structures, objects and people.

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

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

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80
MHz

3 V/m
80 MHz to 2.7
GHz

3 Vrms

3 V/m

should be used no closer to any part of the Model
AR-8305, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance

= 1.17

=1.17

Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).

Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:

80 MHz to 800 MHz

= 2.33

800 MHz to 2.7 GHz

a should be less than the

b

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the Model AR 8305is used exceeds the applicable RF compliance level
above, the Model AR-8305 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Model AR-8305

DFU-0213-8r0_fmt_en-US Page 48 of 50

Electromagnetic Emissions

Synergy Resection User’s Guide

Separation distance according to frequency of transmitter [m]

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73 1 1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation

absorption and reflection from structures, objects and people.

Table 27 Guidance and Manufacturer's Statement – Recommend Separation Distance

between portable and mobile RF communications equipment and the
Model AR-8305

Recommended separation distances between portable and mobile RF communications
equipment and the ModelAR-8305

Resection

The ModelAR-8305 Synergy
environment in which radiated RF disturbances are controlled. The customer or the user of the
Model AR-8305 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
Model AR-8305 as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum output
power of transmitter [W]

System is intended for use in an electromagnetic

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.7 GHz

d = 1.2 √P

d = 1.2 √P

d = 2.3 √P

distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

Synergy Resection User’s Guide

DFU-0213-8r0_fmt_en-US Page 49 of 50

Synergy Resection User’s Guide

Arthrex, Inc.

1370 Creekside Blvd.
Naples, FL 34108-1945 USA
www.arthrex.com

Customer Service
1-[phone]

Toll-Free Technical Support: 1-[phone],
Monday through Friday, 9:00 AM – 5:00 PM EST.

Arthrex GmbH

Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: [phone]
www.arthrex.de

All rights reserved. Printed in USA

DFU-0213-8r0_fmt_en-US Page 50 of 50