Model AR-8305 Arthrex Synergy Resection Users Guide Rev 0 March 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 DFU-0213-8r0_fmt_en-US

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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 DFU-0213-8r0_fmt_en-US

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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 understood. The SynergyResection User’s Guide identifies critical, important, and 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.

W A R N I N G ! 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 DFU-0213-8r0_fmt_en-US

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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 (AR8305) 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 SynergyResection console. 10. Only use shaver handpieces and cables that have been developed by Arthrex specifically for the SynergyResection console. 11. Only use handpieces and cables that have been developed by Arthrex specifically for the SynergyResection. 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. 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. DFU-0213-8r0_fmt_en-US

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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, or by contacting your local Arthrex 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.

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. DFU-0213-8r0_fmt_en-US

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General Warnings and Safety Notices - Read This First Synergy Resection User’s Guide 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

Caution: Federal Law Restricts this device to sale by or on the order of a Physician.

On / Off (push-push)

Type BF Equipment

Precaution of Warning Notice

Fragile

Keep Dry

This Side Up

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.

Temperature Limits for Storage and Transport

Alternating Current

Pressure Limits for Storage and Transport

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General Warnings and Safety Notices - Read This First Synergy Resection User’s Guide

USB

Fuse

Humidity Limits for Storage and Transport

Equipotential [Equipment Potential]

Protective Earth Ground [Functional]

WEEE [Waste Electronics and Electrical Equipment] Symbol. Regarding European Union Endof-Life of Product.

RF Symbol. Nonionizing Electromagnetic Radiation

Manufacturer

Date of Manufacture; year and month.

Handpiece connection

Foot Pedal connection

Universal Serial Bus [For use ONLY with thumb drive]

RS-232

Serial Port [Arthrex Integration]

Catalog number

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

Serial number

Non Sterile

Quantity

Do not use if package is damaged

Consult Instructions for Use

Authorized Representative in the European Community

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No user-serviceable parts inside Electrical hazard

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General Warnings and Safety Notices - Read This First Synergy Resection User’s Guide

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 SynergyResection 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 switch is attached to the console. The SynergyResection has a maximum speed of 8,000 revolutions per minute providing precise burr control during surgical procedures. The SynergyResection 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 SynergyResection 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

W A R N I N G ! 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

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

On / Off Power Switch Handpiece Connectors Synergy Product Logo Handpiece Symbols Touch Panel Visual Display Footswitch Symbols Footswitch Connectors Arthrex Logo Type BF Symbols (Electric Shock Protection) Power Switch IEC 60417-5010 symbol (On / Off)

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Product Description Synergy Resection User’s Guide

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

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

Main power input Plug Equipotential Bonding Pin with Stamped Equipotential Bonding Symbol Address Fan USB port (For use ONLY with thumb drive) Serial ports for Arthrex integration Serial number label Model number label Fuse holder for the Power Entry Module Fuse label

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 Table 3

AR-8305 Display Messages

Message **EEPROM Reset**

**Motor Fault** **Overload** **Self Test Fail** *CRUISE NOT ALLOWED*

*FS PEDAL STUCK* Remove FS, Repower System

*FWD or REV ONLY* *HP BUTTON STUCK* Remove HP, Repower System

*TOGGLE NOT ALLOWED*

*TOOL FAILURE* ERROR, XXX (Where “XXX” is an error code as defined in Table 4.) *Unable to Install* [CC]1 CC AGG Communication Error Critical Error DFS Drill DFU-0213-8r0_fmt_en-US

Explanation Temporarily displayed first time microcontroller is programmed, or if internal memory has faulted and is reset. Temporarily displayed when motor fault condition occurs. Temporarily displayed when motor overcurrent condition occurs. Console has failed a critical power on test. Temporarily displayed when cruise button pressed with tool that doesn’t allow cruise control. Either a footswitch pedal is being pressed or is stuck while connecting to console. Communication error results. Remove the footswitch and repower the system to reset the console. Temporarily displayed for tools that do not support OSC mode. Either a handpiece button is being pressed or is stuck while connecting to console. Communication error results. Remove the handpiece and repower the system to reset the console. Temporarily displayed when toggle button pressed with tool that doesn’t allow oscillation mode. Critical Tool Failure caused either by a faulty sensor or an over current condition. Remove and replace tool or repower console to reset. Handpiece is not recognized. Speed locked on cruise control. Cruise control enabled, about to lock. Current mode: Aggressive oscillation mode (stopped). Internal data communication error. Critical error, unit will shut down. Digital Footswitch Connected. Drill connected. Page 10 of 50

Product Description Synergy Resection User’s Guide EFF FC Shaver Fwd Fwd1 Gas Pedal Footswitch GFS HC Shaver No Footswitch Osc1 Power Failure Rev Rev1 Run1 Safe Mode Sag Saw SFS SJ Shaver Standard Footswitch STD 1

Current mode: Efficient oscillation mode (stopped). Footswitch Controlling Shaver connected. Current mode: Forward (stopped). Current status: Motor is moving forward. Temporarily displayed when gas pedal footswitch connected. Gas Pedal Footswitch Connected. Handpiece Controlling Shaver connected. Temporarily displayed when footswitch disconnected. Current status: Motor is oscillating. Power supply error. Current mode: Reverse (stopped). Current status: Motor is moving in reverse. Current status: Motor is running (for saw). Excessive HP communication errors have occurred. Sagittal Saw connected. Standard Footswitch Connected. Small Joint Shaver connected. Temporarily displayed when standard footswitch connected. Current mode: Standard oscillation mode (stopped).

Displayed in green, denoting an active tool.

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Product Description Synergy Resection User’s Guide Table 4

*TOOL FAILURE* Error Code Definitions

Message # $ @ Example: 022 Sensor 3 = Stuck Low Sensor 2 = No Errors Found Sensor 1 = No Errors Found H13

Explanation Represents Handpiece Sensor Failures # = Sensor 3, $ = Sensor 2, @ = Sensor 1 0 = Stuck Low, 1 = Stuck High, 2 = No Errors Found. 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

S51

Invalid Gear Ratio

S52

Over restart tries

S54

General system failure

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Product Description Synergy Resection User’s Guide

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

1. 2. 3. 4. 5. 6.

Cable Speed Increase button Toggle button Forward pedal Oscillation pedal Reverse pedal

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Technical Specifications Synergy Resection User’s Guide

3.0 Technical Specifications Console Table 6

AR-8305 Console Specifications

Width Height Depth Weight Water protection Mains cable Power entry module Fuse value AC input Applied Part Type Cleaning, disinfecting and sterilization

40.64cm (16.00 inches) 13.335cm (5.250 inches) 30.686cm (12.081 inches) 6.8kg (15 lbs.) IP22 10 A/250 V IEC 320/C13 6.3 A, 250 V~, 2.0 cm (0.75 inches) Type T 100-240V~, 50/60Hz, 6.3A BF Refer to Sections 6.0 Cleaning and Disinfecting and 7.0 Sterilization

Standard Footswitch Table 7

Standard Footswitch Specifications

Functions Width Height Depth Weight Water protection Cleaning, disinfecting, and sterilization

Reverse, Forward, Oscillation, Speed Increase, and Toggle 23.6 cm (9.3 inches) 2.5 cm (1.0 inches) 20.8 cm (8.2 inches) 2.2 kg (5 lbs.) IP68 Refer to Sections 6.0 Cleaning and Disinfecting and Section 7.0 Sterilization

Ambient Conditions for Operation Table 8

AR-8305 Ambient Conditions for Operation

Temperature Relative humidity Air Pressure

10° to 40°C (50° to 104°F) 30 % to 75 % 700 hPa to 1060 hPa (21 in. Hg to 31.3 in. Hg)

Ambient Conditions for Storage (in shipping packaging) Table 9

AR-8305 Ambient Conditions for Storage

Temperature Relative humidity Air Pressure

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-30° to 70°C (-22° to 158°F) 10 % to 90 %, non-condensing 500 hPa to 1060 hPa (15 in. Hg to 31.3 in. Hg)

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