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Universal Battery Charger II. For Trauma Recon System, Small

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1. Immunity test standard IEC 60601 test level Compliance level Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms V1 10 Vrms d 0 35 VP 150 kHz to 80 MHz 150 kHz to 80 MHz 150 kHz to 80 MHz Radiated RF IEC 61000 4 3 3 V m E1 10 V m d 0 35 VP 80 MHz to 800 MHz 80 MHz to 800 MHz 80 MHz to 800 MHz Radiated RF IEC 61000 4 3 3 V m E2 7 V m d VP 800 MHz to 2 5 GHz 800 MHz to 2 7 GHz 800 MHz to 2 7 GHz 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 should be less than the compliance level in each frequency range o Interference may occur in the vicinity of equipment marked with the following symbol Notes At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile 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 f
2. If LEDs do not follow this sequence refer to the troubleshooting section page 14 Figure 1 A Figure 2 Figure 3 g protectii risk replace same rating 6 Synthes Universal Battery Charger II User s Manual Insert the power module battery into one of the appropriate charging bays The yellow LED should remain illuminated indicating that the battery is charging Figure 4 When the green LED illuminates the power module battery is fully charged Figure 5 Note The power modules batteries can be removed during the charging process however they may not be fully charged and operational time may be shorter Important Always leave the charger switched on when a power module battery is inserted in a charging bay The battery cells of the power module do not discharge if not used however it is still good practice to check if it is fully charged prior to use by pressing the information button and reading the battery charge status display Never attempt to insert more than one power module or battery in the same charging bay If LEDs do not follow this sequence refer to the troubleshooting section page 14 Figure 4 Figure 5 Synthes 7 Operating Instructions continued Temperature monitoring The battery and the charger heat up during the charging process Therefore the ventilation holes should not be covered If the temperature is too high the yellow battery
3. cm 10 cm 0 1 7 8 cm 7 8 cm 35cm 1 35cm 35 cm 1m 10 78 cm 78 cm 3 5m 100 3 5m 3 5m 10m For transmitters rated at a maximum output power not listed above the recommended separation 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 Notes At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Synthes 21 Explanation of Symbols The following symbols are for operating the Universal Battery Charger Il i QC gt Battery is charged The charger has switched to maintenance charge and checks that the battery is always fully charged and ready to use Illuminated display the battery is partially charged The charging process is not completed Flashing display the battery is too hot see page 8 The battery is damaged and has to be replaced see page 8 or the charging bay is damaged see page 8 Button to perform diagnostic test for power module see page 9 or to refresh or test batteries see page 10 Illuminated display the diagnostic test for power modules see page 9 or refresh test cycles for batteries see page 10 is in process F
4. out repairs themselves Note The manufacturer shall assume no responsibility for damage resulting from unauthorized repair Synthes 13 Troubleshooting Problem Possible Causes Remedy ON OFF display does not illuminate Charger is switched off Turn charger power switch on Power cord is not plugged in Connect power cord to charger plug into wall outlet and switch on Power supply is interrupted e g damaged fuse Check power supply Replace fuse if necessary Charger is damaged Send to Synthes Service Department ON OFF display flashes Charger is damaged Send to Synthes Service Department Power module battery is inserted and charge display status does not illuminate Power module battery is not fully inserted Ensure the power module battery is inserted properly Contacts in the charging bay are dirty Carefully clean contacts with soft brush Power module battery was not recognized by the charger Remove power module battery and reinsert in an open charging bay Power module battery is damaged Replace power module battery Charging bay is damaged Send to Synthes Service Department Red caution display A illuminates when no power module battery is inserted Charging bay is damaged Send to Synthes Service Department Yellow battery display Gai flashes when charging Power module battery is too
5. 09 J8895 B
6. ONOT STERILIZE Battery for Battery Power Line Part number 530 620 Operating voltage 14 4V Battery capacity 2 Ah Battery type NiMH Typical charging time lt 80 min Power Module for Trauma Recon System Part number 05 001 202 Operating voltage 25 2 V Battery capacity 1 2 Ah Battery type Li lon Typical charging time lt 60 min Subject to technical modifications Synthes Operating Instructions Connect the electrical cord to the charger and plug the cord into a grounded 110 120 VAC outlet ija Turn on the charger by pressing the on the power switch Figure 1 The ON OFF display light on the front of the charger will illuminate Figure 2 Note If the red caution display light for a single charging bay illuminates before the power module battery is inserted this charging bay is damaged Figure 3 The power modules batteries can still be charged in the other charging bays but it is recommended that the device be sent to the Synthes Service Department for repair Important Do not operate the charger in the direct vicinity of radiators or other heat emitting devices as these can affect the device Place the charger on a hard non slip stable base Ensure that the ventilation holes in the base of the device are not covered by towels or other objects Do not expose the device to direct sunlight or moisture Do not cover the side ventilation holes on the device
7. Universal Battery Charger Il For Trauma Recon System Small Battery Drive and Battery Power Line User s Manual SYNTHES Instruments and implants approved by the AO Foundation Table of Contents Introduction Universal Battery Charger II 2 Specifications 4 Instructions Operating Instructions 6 Power Module Diagnostic Test 9 Small Battery Drive and Battery Power Line 10 Batteries Diagnostic Test Storing Batteries and Power Modules 12 Product Information Care and Maintenance 13 Troubleshooting 14 Technical Data 16 Explanation of Symbols 22 Ordering Information 24 Synthes Universal Battery Charger II Application The Universal Battery Charger Il accepts the following Synthes batteries power modules to be charged refreshed and or tested Small Battery Drive 12 V Battery 14 4 V Battery Battery Power Line Battery Trauma Recon System Power Module Safety precautions The charger may only be used with the supplied power cord Place the charger on a hard non slip stable base Ensure that the ventilation holes in the base of the device are not covered by towels or other objects Do not cover the side ventilation holes on the device Do not expose the device to direct sunlight or moisture Ensure that liquids cannot seep into the device Do not operate the charger in the direct vicinity of radiators or other heat emitting devices as thes
8. e can affect the device The device may only be used for the authorized Synthes eae K 7 batteries power modules f Please refer to page 18 for information on the electromag netic compatibility ra i i E 2 5m Important Do not open device Risk of fatal injury due to electric shock Do not use the device in the sterile area of the operating room The device may not come into direct or indirect contact with the patient see Figure 1 for required clearances a eere Do not wash the device in a washer disinfector The device f l may not be sterilized Please refer to page 13 for information on care and maintenance i 1 5m Do not operate the device in potentially explosive areas Figure 1 2 Synthes Universal Battery Charger II User s Manual Storage and transport All batteries power modules should be removed when transporting the charger Use the original packaging for shipping and transport If this is no longer available please contact your local Synthes sales consultant The same environmental conditions apply for transport as for storage see page 12 Warranty The warranty for the device is null and void if the device has not been used properly or the guarantee seal has been broken The manufacturer does not accept liability for damage resulting from repairs or maintenance carried out by unauthorized sites Synthes 3 Specifications Unive
9. es 70 U 25 cycles lt 5 U for 5s lt 5 U 0 5 cycle 40 U 5 cycles 70 U 25 cycles lt 5 U for 5s Electrical power quality should be that of a typical commercial or hospital environment If the user of the Synthes Universal Battery Charger Il requires continued operation during electrical power interruptions it is recommended that the Synthes Universal Battery Charger Il is powered from a UPS Note U is the AC voltage prior to application of the test level Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Synthes 19 Tech nica l Data continued Table 4 Immunity not life supporting devices Guidelines and manufacturer s declaration electromagnetic immunity The Synthes Universal Battery Charger Il is intended for use in the electromagnetic environment specified below The customer or the user of the Synthes Universal Battery Charger Il should ensure that it is used in such an environment Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Synthes Universal Battery Charger Il including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter
10. etics mixture with air or oxygen or with nitrous oxide Applicable Standards The device meets the following standards UL 60601 1 1st Edition IEC 60601 1 2nd Edition CSA C22 2 601 1 REA Universal Battery Charger II c Us IEC 60601 1 2 IEC 60601 1 4 With respect to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 Synthes 17 Technical Data continued Electromagnetic compatibility Accompanying Documents in Accordance with EN IEC 60601 1 2 Clause 5 2 2 Table 1 Emissions Guidelines and manufacturer s declaration electromagnetic emissions The Synthes Universal Battery Charger Il is intended for use in the electromagnetic environment specified below The customer or the user of the Synthes Universal Battery Charger Il should assure that it is used in such an environment Emission tests Compliance Electromagnetic environment guidance RF emissions Group 1 The Synthes Universal Battery Charger II CISPR 11 uses RF energy only for its internal function Therefore its RF emission is very low and it is not likely to cause any interference in nearby electronic equipment RF emissions Class B The Synthes Universal Battery Charger II CISPR 11 is suitable for use in all establishments excluding domestic establishments and eels Ce those directly connected to the public ee low voltage power supply network that Voltage fluctuations f
11. ger Once charged they can be stored outside the charger without any noticeable charge difference Note Do not use batteries power modules that are not fully charged A partial charge may not be sufficient for the intended use Unusable or damaged batteries power modules should not be used 12 Synthes Universal Battery Charger II User s Manual Care and Maintenance Cleaning The device must be unplugged before it is cleaned Occa sionally wipe down the device with a dry cloth If it is very dirty the device can be cleaned with a slightly damp cloth Dry well Do not use solvents Whenever the charger is cleaned ensure it is working properly and is not damaged Maintenance of the device is not required If there are any damages please send the device to the Synthes Service Department Important Danger of electric shock Unplug before cleaning Do not wash the device in a washer disinfector Do not sterilize the device Make sure that no solution enters the device If necessary clean the contacts in the charging bays using extreme care Repairs and technical service The device should be sent to the Synthes Service Department for repair if the charger is damaged the charger malfunctions the ON OFF display does not illuminate when the device is switched on the ON OFF display flashes when the device is switched on Users or third parties should not carry
12. hot Leave power module battery inserted in charging bay Charger automatically restarts the charging process once the battery has cooled 14 Synthes Universal Battery Charger Il User s Manual Problem Possible Causes Remedy Arrow display does not Button was released too soon illuminate when exclamation Press button and hold for at least 2 seconds button is pressed Charging bay is damaged Send to Synthes Service Department Charger has an error Switch off charger wait 5 seconds and switch charger on If the ON OFF display flashes send to Synthes Service Department Power module battery is impossible Power module battery is being inserted to insert into wrong slot in charging bay Insert power module battery into correct slot in charging bay Contacts in charging bay are bent Send to Synthes Service Department Charger is noisy Vents on sides back or base are covered Position charger so that vents are exposed Charger positioned next to heat source Position charger away from heat source Power module battery performance Insufficient battery status is low Refresh battery see page 10 Only possible with Small Battery Drive and Battery Power Line batteries Expected battery life is reached Test power module battery see pages 9 and 10 If the red display A illuminates replace battery or send power module to Synthes Service Department f
13. ield strength in the location in which the Synthes Universal Battery Charger Il is used exceeds the applicable 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 reorienting or relocating the Synthes Universal Battery Charger Il Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 20 Synthes Universal Battery Charger II User s Manual Table 6 Recommended separation distances not life supporting devices Recommended separation distances between portable and mobile RF communications equipment and the Synthes Universal Battery Charger Il The Synthes Universal Battery Charger Il 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 Il can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Synthes Universal Battery Charger Il as recommended below according to the maximum output power of the communication equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 7 GHz W d 0 35 VP d 0 35 VP d P 0 01 3 5 cm 3 5
14. lashing display the connected Trauma Recon System power module requires the diagnostic test to be performed see page 9 22 Synthes Universal Battery Charger II User s Manual Symbol for Battery Power Line Battery Symbol for Trauma Recon System Power Module Caution Read the provided instructions for use before operating the device Date of manufacture Symbol for Small Battery Drive Battery oi The device fulfills the UL requirements for USA c UL us and Canada Compliance The device meets the following standards UL 60601 1 IEC 60601 1 ol com Synthes 23 Ordering Information Battery Charger 05 001 204 Universal Battery Charger II Batteries 05 001 202 Power Module for Trauma Recon System 530 620 Battery for Battery Power Line 532 003 Small Battery Drive 12 V Battery 532 033 Small Battery Drive 14 4 V Battery Also Available 05 001 140 Medical Grade Power Cord 24 Synthes Universal Battery Charger II User s Manual SYNTHES 2009 Synthes Inc or its affiliates All rights reserved Synthes USA Synthes Canada Ltd 1302 Wrights Lane East 2566 Meadowpine Boulevard West Chester PA 19380 Mississauga Ontario L5N 6P9 Telephone 610 719 5000 Telephone 905 567 0440 To order 800 523 0322 To order 800 668 1119 Fax 610 251 9056 Fax 905 567 3185 www synthes com Synthes is a trademark of Synthes Inc or its affiliates Printed in U S A 8
15. licker emissions Complies supplies buildings used for domestic IEC 61000 3 3 purposes 18 Synthes Universal Battery Charger II User s Manual Table 2 Immunity all devices Guidelines and manufacturer s declaration electromagnetic immunity The Synthes Universal Battery Charger Il is intended for use in the electromagnetic environment specified below The customer or the user of the Synthes Universal Battery Charger Il should assure that it is used in such an environment Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If the flooring is a synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for signal lines 2kV for power supply lines 2kV for signal lines Electrical power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line 2 kV line to earth Electrical power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 lt 5 U 0 5 cycle 40 U 5 cycl
16. ng cycles Figure 1 Note Please choose a convenient time for the diagnostic test as it can take up to 4 hours to complete If the diagnos tic test is not initiated within the next 3 charging cycles the device will carry out the diagnostic test automatically The charger will indicate the need for a diagnostic test when 50 charging cycles have been completed since the last diagnostic test To perform the diagnostic test 1 Insert the power module in an open charging bay 2 Press the exclamation mark button on the charger display for that charging bay and hold for at least 2 seconds The yellow arrow light will turn off then illuminate while the diagnostic test is in process Diagnosis Green battery symbol illuminates Figure 2 Power module has been tested charged and is ready to use Red caution symbol illuminates Figure 3 Power module has been checked is not charged and cannot be used The red service indicator wrench on the power module will also illuminate Send power module to the Synthes Service Department Notes If the power module is inserted in the charger the service indicator will remain illuminated If the power module is removed from the charger the service indicator turns off after a few seconds to save the battery Power modules can be charged or undergo diagnostic tests independently in each charging bay Important Only press the exclamation mark to initiate the diagnostic test This
17. or battery replacement Battery is not ready for use Charge power module battery until green display am illuminates Drive unit or attachment is compromised i e due to insufficient maintenance Send drive unit or power module to Synthes Service Department for repair If the suggested solutions are unsuccessful please contact the Synthes Service Department at 1 800 288 6698 Synthes recommends an annual preventive maintenance service by qualified Synthes personnel Synthes 15 Technical Data Device specifications Dimensions L X W x H 310 mm X 220 mm X 175 mm Weight 4 8 kg Operating voltage 100 VAC 240 VAC 50 Hz 60 Hz Operating current 0 8 2 8 A AC Power input rating 250 W Protection class EN 60601 1 paragraph 5 1 Protection type by casing IP XO EN 60601 1 paragraph 5 3 Protection degree Type B EN 60601 1 paragraph 5 2 Fuse 2 x5 AT slow blow Operating mode Continuous Sterilization Device cannot be sterilized Subject to technical modifications 16 Synthes Universal Battery Charger II User s Manual Environmental conditions Operation Transportation and storage Temperature 40 C 50 C 10 C 20 C Relative humidity 90 90 d 6 30 4 10 4 Atmospheric pressure 1060 hPA 1060 hPA 500 hPA 500 hPA Important The device is not suitable for use in the presence of a flammable anesth
18. rsal Battery Charger Il 05 001 204 The Universal Battery Charger Il includes four independent charging bays Each charging bay has three slots for the following batteries power module Battery Power Line Battery Trauma Recon System Power Module Small Battery Drive Battery Note The maximum charging time depending on the charge status and type of battery power module is 15 to 80 minutes 1 Battery Power Line Battery 530 620 2 Trauma Recon System Power Module 05 001 202 3 Small Battery Drive Battery 532 003 or 532 033 Complies with standards UL 60601 1 1st Edition IEC 60601 1 2nd Edition wii Universal Battery Charger II With respect to electrical shock fire and c US mechanical hazards only in accordance 10PB with UL 60601 1 CAN CSA C22 2 No 601 1 IEC 60601 1 2 IEC 60601 1 4 Front view A W N kod 1 Charging bays 4 2 Symbols for battery power module type 3 ON OFF display 4 Control display for each charging bay 5 Ventilation holes Rear view foe 6 Ventilation holes 7 Power switch 8 Fuses 25 AT 9 Power cord connection 4 Synthes Universal Battery Charger II User s Manual Compatible power module batteries Batteries for Small Battery Drive Part numbers 532 003 532 033 Operating voltage 12 V 532 003 14 4 V 532 033 Battery capacity 0 5 Ah Battery type NiCd Typical charging time lt 60 min D
19. symbol will flash Figure 1 To protect the battery the device stops charging until the battery has cooled down If this occurs do not remove the battery from the charger until the yellow battery symbol stays illuminated The charging time will be longer in this case Charging new batteries or batteries not recently used New Small Battery Drive or Battery Power Line batteries that have not been used for longer than 6 weeks and that have not been stored in an activated charger may require 3 to 5 charging cycles to reach their full capacity When in doubt the charger can be used to check the battery status and to refresh the battery see page 10 Errors during charging The following errors may occur when charging a battery Yellow display light flashes Figure 1 The battery is too hot and must cool down before the charging process can automatically resume The battery can be left in the charger Red display light illuminates Figure 2 The battery is damaged and must be replaced No display light 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 charging bay Figure 1 Figure 2 flashing 8 Synthes Universal Battery Charger II User s Manual Power Module Diagnostic Test The flashing yellow arrow on the charger display indicates that it is time for the power module to undergo a diagnostic test within the next 3 chargi
20. tery has been checked is not charged and cannot be used The battery must be replaced Important The diagnostic test takes up to 10 hours and should only be carried out if there is enough time to do so Note Batteries can be charged or undergo diagnostic tests independently in each charging bay Important To recharge batteries normally do not press the exclamation mark button Checking the battery status and refreshing the battery have an impact on the battery If this is carried out frequently the lifespan of the battery may be affected Do not remove the battery from the charging bay while the yellow display is illuminated Wait until the diagnostic process has ended and the green or red display illuminates Only then is the battery status clearly assessed If the diagnostic process is interrupted such as a power outage or a switch to the hospital s emergency power system the diagnostic process must be restarted Figure 3 Figure 4 Synthes 11 Storing Batteries and Power Modules Immediately recharge batteries and the power module after each use Small Battery Drive or Battery Power Line batteries that are not used should always be stored in a Synthes Universal Battery Charger II that is plugged in and turned on maintenance charge This guarantees that the batteries are always fully charged It is not necessary to store Trauma Recon System power modules in the char
21. test should only be initiated when the yellow arrow flashes Figure 1 Figure 2 Figure 3 flashing Synthes 9 Small Battery Drive and Battery Power Line Batteries Diagnostic Test The Small Battery Drive and Battery Power Line batteries can be tested for remaining capacity or if they have not been used for some time can be refreshed with the Universal Battery Charger Il The following can affect battery performance new unused battery battery not used for long period of time old battery Important The diagnostic test takes up to 10 hours and should only be carried out if there is enough time to do so After the battery is inserted the yellow battery symbol illuminates To refresh and check the battery press the button with the exclamation mark on the charger display of the charging bay for at least 2 seconds Figure 1 until the yellow arrow illuminates Figure 2 The device then carries out the diagnostic test The yellow arrow remains illuminated throughout the diagnostic process Figure 1 Figure 2 10 Synthes Universal Battery Charger II User s Manual Diagnosis Green battery symbol illuminates Figure 3 Battery has been tested charged and is ready to use Small Battery Drive battery is charged with at least 80 capacity remaining and Battery Power Line battery is charged with at least 70 capacity remaining Red caution symbol illuminates Figure 4 Bat

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