Synthes Universal Battery Charger II Instructions For Use Manual
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Synthes Universal Battery Charger II Instructions For Use Manual

Synthes Universal Battery Charger II Instructions For Use Manual

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Universal Battery
Charger II
Instructions for Use

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Summary of Contents for Synthes Universal Battery Charger II

  • Page 1 Universal Battery Charger II Instructions for Use...

  • Page 3: Table Of Contents

    • Battery Power Line II and Colibri II / SBD II batteries 14 • Trauma Recon System power module Storing Batteries 30% State of Charge Care and Maintenance Cleaning Repair and Technical Service Disposal Troubleshooting Universal Battery Charger II Instructions for Use DePuy Synthes...
  • Page 4 • Power module for Trauma Recon System • Batteries for Colibri/Small Battery Drive • Battery for Colibri II/Small Battery Drive II Explanation of Symbols Used Symbols for Operating the Charger Symbols on the Charger Ordering Information DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 5: General Information

    Introduction Associated device systems with these instructions for use are the Universal Battery Charger II (05.001.204). The Universal Battery Charger II consists of the charger (05.001.204). This charger is also supplied with a ­ c ountry-specific­power­cord­and­four­slot­cover­sets­ (05.001.228). The charger may only be used with the supplied power cord.
  • Page 6 Introduction General Information Indications Intended User There­are­no­device­specific­indications­associated­with­ The Universal Battery Charger II is intended to be used the UBC II device as it is not patient contacting and is by­qualified­health­care­professionals.­ not used during a surgical procedure. Expected Clinical Benefits Contraindications Not applicable.
  • Page 7 Send the device to the DePuy Synthes device for damage and wear (e.g. unrecognizable representative for repairs. markings, missing or removed part numbers, corrosion, etc.). Do not use any component if dam- age is apparent. Universal Battery Charger II Instructions for Use DePuy Synthes...
  • Page 8 The manufacturer does not accept lia- bility for damage resulting from repairs or maintenance carried out by un authorized sites. For a complete warranty statement, please contact DePuy Synthes Customer Service. DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 9: Front View

    8 Fuses: 225 AT/250 V 9 Power cord connection The Slot Covers Set (05.001.228) consists of three plastic elements which can be used to cover the non-used slots of the charger. Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 10: Starting The System

    Precaution: Ensure that the power cord can always be disconnected immediately from mains supply. Fig. 2 Fig. 3 DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 11: Charging The Battery

    1 Battery Power Line and Battery Power Line II batteries (530.620, 530.630) 2 Trauma Recon System Power Module (05.001.202) 3 Colibri / SBD and Colibri II / SBD II batteries (532.003, 532.033, 532.103) Fig. 1 Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 12: Charging The Battery

    If the battery is removed from the charger before the symbol lights up green, it will not be fully charged. DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 13: Temperature Monitoring

    No symbol lights up The battery has not engaged in the charging bay or has not been recognized by the device. Remove the battery and insert again or use another charger bay. Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 14: Checking And Refreshing Batteries

    • Do not remove the battery from the charger bay as long as the symbol is yellow. Wait until the pro- cess has ended and the symbols light up. Only then is the battery status clearly assessed. DePuy Synthes Instructions for Use Universal Battery Charger II...
  • Page 15 • The process is interrupted if there is a power cut or a switch to the emergency power supply and will then have to be restarted. Fig. 4 Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 16: Battery Power Line Ii And Colibri Ii / Sbd Ii Batteries

    • Do not remove the battery from the charger bay as long as the symbol is yellow (fig. 6). Wait until the process has ended and the symbols light up. Only then is the battery status clearly Fig. 6 assessed. DePuy Synthes Instructions for Use Universal Battery Charger II...
  • Page 17 • The process is interrupted if there is a power cut or a switch to the emergency power supply and will then have to be restarted. Fig. 8 Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 18: Trauma Recon System Power Module

    Fig. 10 module lights up. Send in the power module for ser- vicing. A power module can be charged or checked indepen- dently in each charger bay. Fig. 11 DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 19: Storing Batteries

    For further information, refer to the section ‘Disposal’ in this IFU. Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 20: 30% State Of Charge

    • If the battery is removed during the 30% SOC function, then the process needs to be restarted. • Please note that during the SOC function the other charging bays can be used as usual. DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 21: Cleaning

    Avoid contact of the device with fluids. Warning: Make sure that no solution enters the device. Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 22: Repair And Technical Service

    To prevent damage of the charger during shipping use the original packaging to return devices back to DePuy Synthes. If this is not possible, please contact the DePuy Synthes representative. When shipping Synthes batteries in aircraft carrier bays, please follow the instructions in the section 30% State of Charge of this IFU as well as the IFU of the device used.

  • Page 23: Disposal

    Precaution: The UBC II should be disposed of in an environmentally friendly manner and in accor- dance with national regulations. Universal Battery Charger II Instructions for Use DePuy Synthes...
  • Page 24 Check­firmware­version­on­the­ sticker, which is visible on the under- side of the charger and compare with­the­minimum­required­firmware­ listed on page 25. Send the charger to DePuy Synthes re presentative for a software update. DePuy Synthes Instructions for Use Universal Battery Charger II...
  • Page 25 Auto- heat source. matic cooling is on full power. Universal Battery Charger II Instructions for Use DePuy Synthes...
  • Page 26 UBC II was short-fused by metal objects. Replace UBC II. UBC­II­fell­on­the­floor. Please also observe the instructions for use of the corresponding Power Tools. If the recommended solutions do not work, please contact your DePuy Synthes representative. DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 27: Device Specifications

    Mains rated input 250 W Protection class I, EN/IEC 60601-1 Protection type by casing IPX0, EN/IEC 60601-1 Fuses 225 AT/250 V Operating mode Continuous operating mode Sterilization Device must not be sterilized Subject­to­technical­modifications Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 28: Minimum Required Firmware Version Of Ubc Ii

    17.2 (sticker visible on the underside of the charger*) 530.630 (14.8 V, Li-Ion) * The UBC II device features a sticker on the underside SW-Rev. 17.2 which­indicates­the­latest­firmware­version­applicable­ to the device. 2019/10/16 DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 29: Environmental Conditions

    Duration Humidity –29 °C; –20 °F 72 h uncontrolled 38 °C; 100 °F 72 h 85 % 60 °C; 140 °F 30 % *Products have been tested according to ISTA 2A Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 30: Applicable Standards

    Collateral Standard: Electromagnetic disturbances – Requirements and tests: IEC 60601-1-2 (2014) (Ed 4.0), EN 60601-1-2 (2015) Medical electrical equipment – Part 1–6: Collateral Standard: Usability: IEC 60601-1-6 (2010) (Ed. 3.0) + A1 (2013) DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 31: Electromagnetic Compatibility

    Electromagnetic Compatibility Table 1: Emissions Guidelines and manufacturer’s declaration – electromagnetic emissions The­Synthes­Universal­Battery­Charger­II­is­intended­for­use­in­the­electromagnetic­environment­specified­below.­The­ customer or the user of the Synthes Universal Battery Charger II should assure that it is used in such an environment. Emission tests Compliance Electromagnetic environment – guidance...
  • Page 32 Electromagnetic Compatibility Table 2: Immunity (all devices) Guidelines and manufacturer’s declaration – electromagnetic immunity The­Synthes­Universal­Battery­Charger­II­is­intended­for­use­in­the­electromagnetic­environment­specified­below.­ The customer or the user of the Synthes Universal Battery Charger II should assure that it is used in such an envi- ronment. IEC 60601 Compliance Electromagnetic environment –...
  • Page 33 RF compliance level above, the Synthes Universal Battery Charger II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Synthes Universal Battery Charger II.
  • Page 34 Synthes Universal Battery Charger II The Synthes Universal Battery Charger II is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Synthes Universal Battery Charger II can help prevent...

  • Page 35: Permissible Battery Types

    Power module for Trauma Recon System Art. no. 05.001.202 Operating voltage (rated) 25.2 V Battery capacity 1.2 Ah/30.24 Wh Battery Li-Ion Typical charging time <60 min * Phased-out and no longer available. Subject­to­technical­modifications. Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 36: Batteries For Colibri/Small Battery Drive

    Synthes batteries. The battery for the Power Drive (530.200) cannot be charged with the UBC II. Please use the UBC item number 530.600 or 530.601. * Phased-out and not longer available. Subject­to­technical­modifications. DePuy Synthes Instructions for Use Universal Battery Charger II...

  • Page 37: Symbols For Operating The Charger

    Symbol for Battery Power Line and Battery Power Line II batteries (530.620, 530.630) Symbol for Trauma Recon System power module (05.001.202) Symbol for Colibri/SBD and Colibri II/SBD II batteries (532.003, 532.033, 532.103) Universal Battery Charger II Instructions for Use DePuy Synthes...

  • Page 38: Symbols On The Charger

    The device meets the requirements of the Do not use Medical Device Regulation (EU) 2017/745. if package is damaged Reference number Environment-friendly use period according to China RoHS. Lot number Serial number Packaging unit INMETRO­Ord.­350­certified DePuy Synthes Instructions for Use Universal Battery Charger II...
  • Page 39 Power Cord, three-pole (China) 05.001.145 Power Cord, three-pole (Japan) 05.001.146 Power Cord, three-pole (Argentina) 05.001.147 Power Cord, three-pole (Israel) Slot Covers Set 05.001.228 Slot Covers Set, for Universal Battery Charger II Universal Battery Charger II Instructions for Use DePuy Synthes...
  • Page 40 For full user instructions, warnings and precautions please 4436 Oberdorf Switzerland consult the IFU of any additional devices used. All Synthes Tel: +41 61 965 61 11 implant instructions for use as well as other instructions for use are available as PDF files at www.depuysynthes.com/ifu www.jnjmedicaldevices.com...

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