Arthrex AR-400UBC User Manual Download Page 10 | Manualshive

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Universal DrillSaw Battery Charger

User’s Guide

DFU-0256-1 Rev. 0

Page 5 of 35

Catalog number

The product meets

the essential

requirements of

Medical Device

Directive 93/42/EEC

Quantity

Do not use if package

is damaged

Onn/Off Symbol

Protective Earth

1.3

Shipping, Unpacking, and Warranty Information

Carefully unpack and inspect all components for shipping damage.

Any damage could compromise patient safety and should be reported immediately
to Arthrex or any authorized Arthrex distributor. The warranty could be voided if

shipping or first-installation damage is not reported within seven business days of
receiving the device. Refer also to our General Terms of Business.

Please visit Arthrex.com for warranty information

.

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Summary of Contents for AR-400UBC

Page 1: ...ing personnel must read this User s Guide thoroughly prior to using this system and follow all safety warnings cautions and precautions 0086 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA Toll Free 1 800 934 4404 www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 Fax 49 89 909005 280 www arthrex de DFU 0256 1 Revision 0 2016 Arthrex Inc All ri...

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Page 3: ...0UB Batteries 11 2 2 4 4 5 5 AR 400UBC 3 Charging bay for AR 300 and AR 600 Batteries 12 3 3 0 0 Technical Specifications 13 3 1 Charger 13 3 2 Safety EMC and Regulatory Requirements 14 3 3 Electromagnetic Compatibility EMC 15 3 4 Risks due to electromagnetic fields 15 4 4 0 0 Setup 16 4 1 AC Power Safety Considerations 16 4 2 Basic Setup Procedure for the AR 400UBC Charger 17 4 3 Setup Installing...

Page 4: ... 1 11 1 0 0 Repair Policy 30 1 12 2 0 0 End of Life Environmental Directives 31 1 13 3 0 0 Electromagnetic Emissions 32 List of Figures Figure 1 Front Panel of the Charger 8 Figure 2 Rear Panel of the Charger 9 Figure 3 Charging bay for AR 400UB Batteries 11 Figure 4 Charging bay for AR 300 and AR 600 Batteries 12 Figure 5 Install a charging bay 18 Figure 6 Battery Attachment and Removal 19 ...

Page 5: ...al 20 Table 12 Touch Screen Display Elements 21 Table 13 Options Screen Display 22 Table 14 Options Screen Display 23 Table 15 Error Code Screen Display 23 Table 16 Troubleshooting Faults their Causes and Solutions 28 Table 17 Guidance and Manufacturer s Declaration Electromagnetic Emissions 32 Table 18 Guidance and Manufacturer s Statement Electromagnetic Immunity 33 Table 19 Guidance and Manufac...

Page 6: ...mpt to service this system as this may void your warranty There are no user serviceable parts inside Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or other risks If the system malfunctions return it for service immediately 4 Misuse unauthorized assembly and modifications or repairs to the AR 400UBC system or non compliance with these instruc...

Page 7: ...ystem component or any other system accessory 2 Only use replacement power cords that meet medical grade standards according to IEC 60320 1 Subclause 3 21 Detachable Power Supply Cords or electrical standards for the designated country where the AR 400UBC is being used Contact your Arthrex representative for further information 3 This device has passed testing for EMI RFI radiation and susceptibil...

Page 8: ...User s Guide thoroughly before operating the device and save it for future reference For additional information and training contact your local Arthrex representative 2 The AR 400UBC charger incorporates a universal AC input power supply A voltage selection switch is not required 3 AR 400UBC has been designed to accept EMC from other devices within the limitations as described in section 13 0 ...

Page 9: ...This side up Keep dry Temperature limits for storage and transport Electrical hazard dangerous voltages are present Never attempt to repair the equipment Only trained service personnel may remove the cover or obtain access to system components Atmospheric pressure limitation for storage and transport Authorized representative in the European Community Humidity limits for storage and transport Seri...

Page 10: ...ing Unpacking and Warranty Information Carefully unpack and inspect all components for shipping damage Any damage could compromise patient safety and should be reported immediately to Arthrex or any authorized Arthrex distributor The warranty could be voided if shipping or first installation damage is not reported within seven business days of receiving the device Refer also to our General Terms o...

Page 11: ...vides a means for charging status of the battery and status warning caution indicators of batterie health status The AR 400UBC Universal DrillSaw Battery Charger Applied Parts and Accessories AR 400UBC Universal DrillSaw Battery Charger Charging bays Sold separately AR 400UBC U4 Charging Bay for AR 400UB batteries AR 400UBC S4 Charging Bay for AR 400SB batteries AR 400UBC 3 Charging Bayfor AR 300L...

Page 12: ...e W A R N I N G Misuse may damage the AR 400UBC and cause risks and hazards for patients users and third parties W A R N I N G This device is only for use under the supervision of a trained and licensed physician This device should not be used by untrained personnel or used for indications other than those described in this User s Guide ...

Page 13: ...Universal DrillSaw Battery Charger Front View Figure 1 shows the front panel of the AR 400UBC The features are identified in Table 1 below Figure 1 Front Panel of the Charger Table 1 Front Panel of the Charger 1 Charging Bay No 1 2 Charging Bay No 2 3 Charging Bay No 3 4 Charging Bay No 4 5 Touch Screen Display 1 4 5 2 3 ...

Page 14: ...tery Charger Rear View Figure 2 shows the rear panel of the AR 400UBC The features are identified in Table 2 below Figure 2 Rear Panel of the Charger Table 2 Rear Panel of the Charger 6 ON OFF Power Switch 7 Supply main input Plug 8 Supply main output to connect a second charger to an existing charger 9 Hex wrench 8 7 9 6 ...

Page 15: ...attery needs to be replaced x x 02 Battery failed to communicate Recommend retry charging the battery If the fault repeats replace the battery x 03 Charge time out exceeded 120 minutes Make not of the fault and retry charging the battery If the fault repeats replace the battery x x 04 Battery Identification incorrect or Battery severely discharge Battery should not be used Replace the battery x x ...

Page 16: ...eries Figure 3 shows the Charging bay for the AR 400UB Battery Pack The features are identified in Table 4 below Figure 3 Charging bay for AR 400UB Batteries Table 4 Elements of the Charging bay for AR 400UB Batteries 1 Battery contact 2 Alignment tabs for connecting to the charger 3 Alligment arrow for the AR 400 battery pack 1 2 3 ...

Page 17: ...ws the Charging bay for AR 300L and AR 600L Battery Packs The features and symbols are identified in Table 5 below Figure 4 Charging bay for AR 300 and AR 600 Batteries Table 5 Elements of the Charging bay for AR 300L AR 600L Batteries 1 Battery contact 2 Alignment arrow for AR 300L and AR 600L battery packs 3 Alignment tabs for connecting to the charger 1 2 3 ...

Page 18: ...A Class I Mains Fuse 5A Non Replaceable Power 250W Pollution Level 2 Altitude 4 500 m 15 000 ft Overvoltage Category II Table 7 Ambient conditions for operation Temperature 0 to 35 C 32 to 95 F Relative Humidity 0 to 85 relative non condensing Air Pressure 700 hPa to 1020 hPa 21 in Hg to 30 12 in Hg Table 8 Ambient conditions for storage Temperature 20 to 60 C 4 to 140 F Relative Humidity 10 to 85...

Page 19: ...class Class IIa Health Canada Class Class II Safety Certifications Domestic Certificaton ANSI AAMI ES60601 1 2005 C2 A2 Canadian Certification CSA C22 2 No 60601 1 2008 EU Certification EN IEC 60601 1 2005 A1 2012 EMC Certifications EMC Certification IEC 60601 1 2 2007 Safety Certification Marking UL CE Classification MDD93 42 EEC Annex IX Rule 9 Class IIa For all other accessories refer to accomp...

Page 20: ...onnect the device to an outlet on a different circuit than the other device s are connected to 4 Consult the manufacturer or field service technician for the receiving device for guidance 3 4 Risks due to electromagnetic fields The functionality of implantable systems such as cardiac pacemakers and ICD implantable cardioverter defibrillator can be affected by electric magnetic and electromagnetic ...

Page 21: ...country where the AR 400UBC is being used Avoid positioning the unit so that it is difficult to disconnect the coupler or plug from the supply main To prevent electrical shock do not use extension cords or 2 to 3 pronged adaptors The charger has an AC mains switch on the rear panel When the supply main switch is OFF no electrical power is used by the charger Two chargers may be connected via a the...

Page 22: ...e charger Depending on the charge status and type of battery it can take as little as 15 minutes to charge a battery Once the battery is fully charged the green battery symbol will be completely filled The charger then switches to a maintenance charge The battery may be left on the charger until it s needed Leave the device powered on to ensure that the battery is always fully charged If the batte...

Page 23: ... protective bay cap used during shipping 2 Hold the charging bay at a slight angle and insert the 2 alignment tabs on the charging bay with the two openings on the charging port that is exposed when you removed the protective cap Once the tabs are aligned in the provided holes press down gently to engage the electronic plug connection Using the hex wrench secure the charging bay to the charger tur...

Page 24: ...Battery Charger User s Guide DFU 0256 1 Rev 0 Page 19 of 35 4 4 Setup Battery Installation and Removal These instructions describe how to install remove batteries to the charger Figure 6 Battery Attachment and Removal 1 2 ...

Page 25: ...onto a charging bay The black arrows indicate the direction of insertion Note AR 300L batteries are placed on the charger in the same manner as the AR 600L batteries 2 These pictures represent a battery that has been fully engaged on the charging bay Note The Charger should recognize the battery and visually indicate charging via the display screen within a few seconds ...

Page 26: ...mple of the screen layout 2 Example of the orange light that will appear while the battery is charging If you press this icon while it is orange it will give you additional information about the battery only for AR 400UB 3 Example of the green light that will appear when charging is compelte If you press this icon while it is green it will give you additional information about the battery only for...

Page 27: ...The Options Sreen provides access to settings and information screens Figure 8 Options Screen Display Table 13 Options Screen Display 1 Brightness adjustment 2 Model Serial Number Manufacture Date and Firmware Version for each charger 3 Exit Button When pressed the software returns to the Menu screen 1 2 3 ...

Page 28: ... charged only available for AR 400 Batteries 2 Exit Button returns the user to the charging screen 3 State of capacity icon Green means the battery has enough capacity 5 4 Error Code Screen Display The Error Code Screen provides information about the error type Figure 10 Error Code Screen Display Table 155 Error Code Screen Display 1 Displays the error code listed in Table 3 of Section 2 4 3 2 Exi...

Page 29: ...e Main Power switch to the Off position and disconnect the power before cleaning the AR 400UBC charger Always comply with the instructions issued by the manufacturer of the cleaning and or disinfectant regarding concentration exposure times temperature and material compatibility NEVER clean the charging contacts with liquid cleaners If there is dust remove with dry compressed air DO NOT clean the ...

Page 30: ...opathy TSE Agents The agents for transmission of Creutzfeldt Jakob disease are believed to be resistant to normal disinfection and sterilization processes 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 ...

Page 31: ...is important to visually inspect the charger before each use Your authorized Arthrex service department is extremely knowledgeable about the charger and will provide professional service Any services and or repairs carried out by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure and could void the warranty 8 1 Periodic Maintenance The produ...

Page 32: ...r contact the Arthrex Technical Support Hotline at 1 888 420 9393 Monday through Friday from 9 00 AM to 5 00 PM EST or at 49 89 90 90 05 8800 or techsupport arthrex de from 8 00 AM to 5 00 PM CET 9 1 Additional Technical Information Contact your Arthrex representative if you require more comprehensive technical information Other information will be provided upon request by Arthrex Approved Service...

Page 33: ...he charging cup and mating charger connector for signs of bent pins or loose material that could interfere with mating 2 Attempt to reattach the cup to the charger or attempt to reattach the cup in an alternate bay 3 Return to Arthrex for repairs LCD screen image issues or touch screen is not functional 1 Temporary software issue 2 Charger has an internal connection or hardware error 1 Cycle the p...

Page 34: ... touch screen the screen must be physically pressed not just touched 1 Press the screen firmly 2 Cycle the power On Off button and check again 3 Return to Arthrex for repairs If the problems persist clean and disinfect the Universal DrillSaw Battery Charger and send it to Arthrex using the original packaging when possible Please enclose a brief explanation of the malfunction detected along with an...

Page 35: ...Universal DrillSaw Battery Charger User s Guide DFU 0256 1 Rev 0 Page 30 of 35 1 11 1 0 0 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device ...

Page 36: ...bol 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 natura...

Page 37: ...gnetic environment guidance RF emissions CISPR 11 Group 1 The Universal DrillSaw Battery Charger uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference with nearby electronic equipment RF emissions CISPR 11 Class A The Universal DrillSaw Battery Charger is suitable for use in all establishments other than domestic and those di...

Page 38: ...4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Uτ 95 dip in Uτ for 0 5 cycle 40 Uτ 60 dip in Uτ for 5 cycles 70 Uτ 30 dip in Uτ for 25 cycles 5 Uτ 95 dip in Uτ for 5 sec 5 U...

Page 39: ...n distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagne...

Page 40: ... FL 34108 1945 USA www arthrex com Customer Service 1 800 934 4404 Toll Free Technical Support 1 888 420 9393 Monday through Friday 9 00 AM 5 00 PM EST Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 www arthrex de All rights reserved 0086 ...

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