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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 2: Table Of Contents

    Small Battery Drive II (SBD II) Batteries • Trauma Recon System Power Module and UNIUM™ Power Unit 30% State of Charge Care and Maintenance Cleaning and Disinfection Repair and Technical Service Disposal of Waste Universal Battery Charger II • Instruction for Use...
  • Page 3 • Battery for Colibri II/Small Battery Drive II • Power Module for Trauma Recon System • UNIUM™ Power Unit Explanation of Symbols Used Symbols for Operating the Charger General Symbols Ordering Information ■ Notes ▲ Precautions ▲ WARNINGS Instruction for Use • Universal Battery Charger II...

  • Page 4: General Information

    Refer to section ‘Ordering Information’ for specific devices in scope. The Universal Battery Charger II (UBC II), allows the following Batteries, Power Module and Power Unit to be automatically charged and manually checked, as shown in the table below.
  • Page 5 Synthes manufactures surgical instruments in tended Use the original packaging for shipping and transport as to prepare the site and aid in implantation of Synthes damage may occur otherwise. implants. The adverse events/side effects are based upon If the original packaging materials are no longer available, the implant devices rather than the instru ments.
  • Page 6 Ampere Protective Earth L  W  H Length  Width  Height Milliampere Neutral Minute µA Microampere Phase Hour mΩ Milliohm Normal condition °C Degrees Celsius Ampere hour Single fault condition Universal Battery Charger II • Instruction for Use...

  • Page 7: Description Of The Device

    UNIUM™ Power Unit (05.001.602) to be charged. The adapter is not delivered with the UBC II and needs to be ordered separately. Instruction for Use • Universal Battery Charger II...

  • Page 8: Starting The Charger

    Ensure that the ventilation holes in the base and side of the device are not covered by towels or other objects. ▲ Precaution: Ensure that the power cord can always be disconnected immediately from main supply. Fig. 2 Fig. 3 Universal Battery Charger II • Instruction for Use...

  • Page 9: Charging Batteries, Power Module And Unium™ Power Unit

    UNIUM™ Power Unit (05.001.602) connected to it. When UNIUM™ Power Unit (05.001.602) inserting the adapter care must be taken to correctly orientate it so that the DePuy Synthes logo is next to the UNIUM™ Adapter for control symbols on the charger. UBC II (05.001.604) Furthermore, the Power Unit illustration on the adapter shows which way round the Power Unit is to be inserted.

  • Page 10: Charging Procedure

    Leave the device switched on to ensure that they are always fully charged. If they are removed from the charger before the symbol lights up green, they will not be fully charged. Universal Battery Charger II • Instruction for Use...

  • Page 11: Temperature Monitoring

    The battery, power module or power unit (using the adapter) has not engaged in the charging bay or has not been recognized by the device. Remove it and insert again or use another charger bay. Instruction for Use • Universal Battery Charger II...

  • Page 12: Checking Function

    The process is interrupted if there is a power outage or • a switch to an internal power generator and will then have to be restarted. Fig. 4 Universal Battery Charger II • Instruction for Use...

  • Page 13: Trauma Recon System Power Module And Unium™ Power Unit

    Module or Power Unit status clearly assessed. The process is interrupted if there is a power outage or • a switch to an internal power generator and will then have to be restarted. Instruction for Use • Universal Battery Charger II...

  • Page 14: 30% State Of Charge

    UNIUM Power Unit (05.001.602) are not affected by this regulation as they are not classified as a Li-Ion battery. They are covered by UN 3481 PI 967 (Li-Ion Battery Contained in Equipment). Universal Battery Charger II • Instruction for Use...

  • Page 15: Care And Maintenance

    Make sure that no solution enters the device. • Do not sterilize, wash, rinse, drop or apply force to the • UBC II and UNIUM™ Adapter for UBC II. This will destroy them with possible secondary damage. Instruction for Use • Universal Battery Charger II...

  • Page 16: Repair And Technical Service

    Care and Maintenance Repair and Technical Service The device should be sent to the DePuy Synthes Service Center for repair if it is faulty or malfunctions. The same applies if the ON/OFF blue LED does not light up or flashes when the device is switched on.

  • Page 17: Disposal Of Waste

    ▲ Precaution: The UBC II and UNIUM™ Adapter for UBC II should be disposed of in an environmentally friendly manner and in accordance with national and local regulations. Instruction for Use • Universal Battery Charger II...

  • Page 18: Troubleshooting

    21. Send the charger to DePuy Synthes Re presentative for a firmware update. Universal Battery Charger II • Instruction for Use...
  • Page 19 Charger makes loud noises. or base are covered and/or the ensure that the device is not next to a device is next to a heat source. heat source. Automatic cooling is on full power. Instruction for Use • Universal Battery Charger II...
  • Page 20 UBC II. missing or have been removed. 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. Universal Battery Charger II • Instruction for Use...

  • Page 21: Technical Data

    Device Specifications and Materials Performance Characteristics of the Device Synthes has established the performance and safety of the UBC II. It represents a state of the art medical device and performs as intended when used according to the Instructions for Use and associated labeling.

  • Page 22: Minimum Required Firmware Version Of Ubc Ii

    Module and UNIUM™ Power Unit can be recognized and charged by UBC II, the correct Firmware version is required. The table below outlines the requirements for each device type. If required, send the charger to a DePuy Synthes Service Center for a firmware update. Device/feature...

  • Page 23: Environmental Conditions

    –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 or ISTA 3A. Instruction for Use • Universal Battery Charger II...

  • Page 24: 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) Universal Battery Charger II • Instruction for Use...

  • Page 25: Electromagnetic Compatibility

    Guidelines and manufacturer’s declaration – electromagnetic emissions The Universal Battery Charger II is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal Battery Charger II should assure that it is used in such an environment. Emission tests Compliance Electromagnetic environment –...
  • Page 26 Guidelines and manufacturer’s declaration – electromagnetic immunity The Universal Battery Charger II is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal Battery Charger II should assure that it is used in such an envi ronment. Immunity test Compliance Electromagnetic environment –...
  • Page 27 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro- magnetic site survey should be considered. If the measured field strength in the location in which the Universal Battery Charger II is used exceeds the applicable RF compliance level above, the Universal Battery Charger II should be observed to verify normal operation.
  • Page 28 Universal Battery Charger II The Universal Battery Charger II is intended for use in the electromagnetic environment in which radiated RF distur- bances are controlled. The customer or the user of the Universal Battery Charger II can help prevent electromagnetic...

  • Page 29: Electrical Safety Check Of The Ubc Ii

    N interrupted be below 10 mA AC. Measurement 4 Reverse polarity of P and N The Earth Leakage Current SFC must (single fault condition SFC) N interrupted be below 10 mA AC. Instruction for Use • Universal Battery Charger II...

  • Page 30: Touch Current

    Following the measurements, a functional test must be performed to prove that the device is functioning properly. Connecting point for the protec- tive earth measurement on the bottom plate of UBC II Universal Battery Charger II • Instruction for Use...

  • Page 31: Compatibility

    Typical charging time < 60 min UNIUM™ Power Unit Art. no. 05.001.602 Operating voltage (rated) 10.8 V Battery capacity 2.0 Ah/21.6Wh Battery Li-Ion Typical charging time < 60 min Subject to technical modifications. Instruction for Use • Universal Battery Charger II...

  • Page 32: Explanation Of Symbols Used

    Module (05.001.202) and UNIUM™ Adapter for UBC II (05.01.604) Symbol for Colibri II/SBD II battery (532.103) The symbol on the UNIUM™ Adapter for UBC II shows how the UNIUM™ Power Unit is to be inserted. Universal Battery Charger II • Instruction for Use...

  • Page 33: General Symbols

    Made in (Ref. 5140 IEC TR 60878): Interference may occur in the vicinity of equipment marked with Quantity, indicates the number of pieces in the following symbol (IEC 60601-1-2, clause 5.1.1) the package Instruction for Use • Universal Battery Charger II...

  • Page 34: Ordering Information

    05.001.144 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 • Instruction for Use...
  • Page 35 Not all products are currently available in all markets. Data available on request. Please contact your DePuy Synthes Representative for more information. All DePuy Synthes Implant Instructions for Use as well as general Instructions for Use are available as PDF files at www.e-ifu.com The trademarks used herein are trademarks of DePuy Synthes.