Universal Battery Charger II Instructions for Use Oct 2017

Table of Contents

Introduction

General Information

3

• Intended use

3

• Compatibility 

3

• Abbreviations3 • Safety precautions

4

• Scope of delivery

5

• Storage and transport

5

• Warranty5

Description of the Controls

Operating the Device

• Front view

6

• Rear view

6

Starting the System

7

Charging the Battery

8

• Charger bay

8

• Charging the battery

9

• Temperature monitoring

10

• Charging new batteries or batteries not recently used 10 • Errors during charging

10

Checking and Refreshing Batteries

11

• Battery Power Line and Colibri/SBD batteries

11

• Battery Power Line II and Colibri II / SBD II batteries 13 • Trauma Recon System power module

15

Storing Batteries

16

Slot Covers Set 

17

Universal Battery Charger II Instructions for Use

DePuy Synthes

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Table of Contents

Care and Maintenance

Cleaning18 Repair and Technical Service

19

Disposal20

Troubleshooting21

Technical Data

Explanation of Symbols Used

Device Specifications

24

Minimum required Firmware version of UBC II

25

Environmental Conditions

26

Applicable Standards

27

Electromagnetic Compatibility

28

Permissible Battery Types

32

• Battery for Battery Power Line 

32

• Battery for Battery Power Line II

32

• Power module for Trauma Recon System 

32

• Batteries for Colibri/Small Battery Drive 

33

• Battery for Colibri II/Small Battery Drive II

33

Symbols for Operating the Charger

34

Symbols on the Charger 

35

Ordering Information36

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Introduction General Information

Intended use The Universal Battery Charger II (05.001.204), referred to henceforth as the charger or device, allows the following Synthes batteries to be automatically charged and manually checked: System

Handpieces

Battery/Power Module

Battery Power Line

530.605 530.610 530.615 530.705 530.710 530.715

530.620 (14.4 V, NiMH)

Trauma Recon System

05.001.201 05.001.240

05.001.202 (25.2 V, Li-Ion)

Colibri/Small Battery Drive

532.001 532.010 532.101 532.110

532.003 (12 V, NiCd) 532.033 (14.4 V, NiCd) 532.103 (14.4 V, Li-Ion)

Battery Power Line II

Colibri II/Small Battery Drive II

530.630 (14.8 V, Li-Ion)

If required, Battery Power Line battery (530.620) and Colibri/Small Battery Drive batteries (532.003, 532.033) can also be refreshed with the charger (see page 11). Compatibility The Colibri/Small Battery Drive batteries (532.003, 532.033) can be used with Colibri II/Small Battery Drive II handpiece (532.101, 532.110). The Colibri II/Small Battery Drive II battery (532.103) can be used with the Colibri/Small Battery Drive handpiece (532.001, 532.010).

Abbreviations Please note the below mentioned items are abbreviated throughout the document as follows: Items

Abbreviation

Colibri/Small Battery Drive

Colibri/SBD

Colibri II/Small Battery Drive II

Colibri II/SBD II

Power Module for Trauma Recon System

Power Module

Universal Battery Charger II

UBC II

The Battery Power Line battery (530.620) can be used with the Battery Power Line II handpieces (530.705, 530.710, 530.715). The Battery Power Line II battery (530.630) can be used with the Battery Power Line handpieces (530.605, 530.610, 530.615). Precaution: 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.

Universal Battery Charger II Instructions for Use

DePuy Synthes

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Introduction General Information

Safety precautions The device may only be used with the supplied power cord. The device may only be operated on an even, dry surface that is sufficiently strong to hold its weight. Avoid contact with fluids. The device is designed to be operated and stored in closed rooms. Ensure that the device is not operated in the direct vicinity of radiators or other heat emitting ­devices (please ­refer to page 26 for details on environmental conditions). Please observe the information on the electromagnetic ­compatibility, see page 28. The device may only be used for the authorized Synthes ­batteries. Before operating the device, visually inspect the device for damage and wear. If it is not in perfect working order, contact the Synthes ­representative. Do not use a damaged or faulty device.

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Precautions: • Only use the Synthes Universal Battery Charger II (05.001.204) to charge the batteries. Using a charger that does not originate from Synthes can damage the battery. • Do not open ­device. Risk of fatal injury due to electric shock! • As the charger is not a sterile product, it must not be used in the sterile area of the operating room. However, the device may be used in the non-sterile part of the operating room. • The device must not come into direct or indirect contact with the patient. • The use of HF (= high frequency) equipment for ­tissue coagulation can cause electromagnetic interferences – in this case cables should be separated as far as possible. • Do not wash the device in a washer/disinfector. The device must not be sterilized. Please see page 18 for information on cleaning and maintenance. • Do not operate the device in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous ­oxide. • Do not expose the device to direct sunlight or moisture. • The charging station should always be turned on when a battery is in the charging bay. This ensures availability and prevents discharge.

Storage and transport All batteries / power modules should be removed for transporting the charger. Use the original packaging for shipping and transport. If this is no longer available, please contact the Synthes represen­tative. The same environmental conditions apply for transport as for storage, see page 26. Warranty The warranty for the device is null and void if the device has not been used properly or the guarantee seal has been damaged. The manufacturer does not accept lia­ bility for damage resulting from repairs or maintenance carried out by un­authorized sites. For a complete ­warranty statement, please contact Synthes Customer Service.

Scope of delivery The Universal Battery Charger II consists of the charger (05.001.204), the supplied, country-specific power cord and four slot covers sets (05.001.228). The device may only be used with the supplied power cord.

Universal Battery Charger II Instructions for Use

DePuy Synthes

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Description of the Controls

Front view 1 Charger bays (24) 2 Symbols for battery type 3 ON/OFF blue LED 4 Control symbols for each charging bay 5 Ventilation holes

1 2 3 4

5

Rear view 6 Ventilation holes 7 Power switch 8 Fuses: 225 AT/250 V 9 Power cord connection 6

7 8 9

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Operating the Device

Starting the System

Before starting for the first time, ensure that the power switch is set to . The device can only be connected to the power supply using the supplied power cord. Set the power switch to I to turn the device on (fig. 1). The ON/ OFF b ­ lue LED on the front of the device shows that it is working ­properly (fig. 2). If the blue LED flashes, the ­device must be sent in for control. If the symbol for a single charger bay is red (fig. 3) ­before the battery is inserted, this charger bay is faulty. In this case, batteries can still be charged in the other charger bays, but it is recommended that the device be sent to the local Synthes representative for ­repairs. Precautions: • Place the device on a non-slip, stable base. Ensure that the ventilation holes in the base of the device are not covered by towels or other objects. • Ensure that the power cord can always be disconnected immediately from mains supply. • Do not operate the device in the direct vicinity of radiators or other heat emitting devices, as these can affect the ­device. • Do not expose the device to direct sunlight or moisture. • Do not cover the side ventilation holes on the ­device. • Only connect to a power supply with grounding, a rated voltage between 100 V and 240 V and a ­network ­f requency range of 50 or 60 Hz.

Fig. 1

Fig. 2

Fig. 3

Universal Battery Charger II Instructions for Use

DePuy Synthes

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Operating the Device

Charging the Battery

Charger bay The device is fitted with four independent charger bays. Each of these has three slots for the following batteries (fig. 1):

1

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)

2

3

Fig. 1

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Charging the battery Place the battery to be charged in the proper direction into the corresponding slot of an empty charger bay. Only one battery can be charged in each charger bay at a time. All charger bays can, however, be used simultaneously with any combination of battery types. Once the battery types have been identified the charging process starts automatically and the symbol is yellow ­ (fig. 2). Depending on the charge status and type of battery, it can take from about 15 minutes to around 60 minutes to charge.

Fig. 2

Once the battery is fully charged, the symbol is green and the charger switches to maintenance charge (fig. 3). The battery can be left in the charger. Leave the device switched on to ensure that the battery is always fully charged. If the battery is removed from the charger before the symbol lights up green, it will not be fully charged. Precautions: • Insert the battery into the correct slot. • Ensure that the battery is fitted correctly and is identified by the device (symbol is yellow). • If the symbol does not light up after the battery is inserted, remove the battery and insert again or insert into another charger bay. • Do not insert any objects other than batteries into the charger, as the contacts may otherwise be damaged.

Fig. 3

Universal Battery Charger II Instructions for Use

DePuy Synthes

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Operating the Device Charging the Battery

Temperature monitoring The battery and the charger heat up during the charging process. The ventilation holes should therefore not be ­covered.

flashing

If the battery temperature is too high, the symbol starts flashing (fig. 4). To protect the battery, the device stops charging until the battery has cooled down. Do not remove the battery from the charger if this occurs ­until the symbol stops flashing and stays yellow. The charging time will be longer in this case. Charging new batteries or batteries not recently used Battery Power Line battery (530.620) or Colibri/SBD batteries (532.003, 532.033) that have not been used for a long period of time and that have not been stored in an activated charger do not reach their maximum performance for several charging and discharging cycles. The charger can be used to check the battery status and to refresh the battery (see page 11).

Fig. 4

Errors during charging The following errors may occur while charging a battery: Symbol flashes (fig. 4) The battery is too hot and has to cool down before the charging process can be automatically resumed. The ­battery should be left in the charger until the battery symbol lights up green. Otherwise, it is not ensured that the battery is fully charged.

Fig. 5

Symbol is red (fig. 5) The battery is faulty and has to be replaced. 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. Precautions: • Do not charge mechanically damaged batteries in the charger. • Only charge batteries authorized for the device (see page 32). • Only use fully charged batteries to avoid delays during ­surgery.

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Operating the Device

Checking and Refreshing Batteries

Battery Power Line and Colibri/SBD batteries The charger enables Battery Power Line battery (530.620) and Colibri/SBD batteries (532.003, 532.033) to be refreshed and checked. It will be indicated if the battery performance is sufficient or if the battery needs to be replaced. The following factors will affect the battery performance: • Unused, new battery • Battery not used for a longer period

Fig. 1

In these cases a battery will only reach its maximum performance after several charging and discharging ­c ycles. The check and refresh function ensures that the battery regains its maximum performance again. • Old battery The battery performance declines with age and usage. With the check function it can be seen if the battery ­performance is sufficient. In some cases, batteries that are too old can no longer be refreshed. When required, the check and refresh function is started manually, as outlined below.

Fig. 2

After the battery is inserted, the symbol lights up ­yellow. To refresh and check the battery, press the button with the exclamation mark for at least 2 seconds (fig. 1) until the symbol lights up yellow (fig. 2). The device then carries out the process. The symbol is ­yellow throughout this time.

Universal Battery Charger II

Instructions for Use

DePuy Synthes

11

Operating the Device Checking and Refreshing Batteries

Completion of the process is indicated as follows: • Symbol is green (fig. 3): Battery has been successfully refreshed, checked and charged. • Symbol is red (fig. 4): Either the battery is faulty or performance is insufficient. The battery must be disposed of. The entire process (refreshing and checking battery status) takes around 10 hours and should only be carried out if there is enough time to do so. A battery can be charged, checked or ­refreshed independently in each charger bay. Precautions: • 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 ­f requently the lifespan of the battery can be affected. • Do not remove the battery from the charger bay as long as the symbol is yellow (fig. 2 on previous page). Wait until the process has ended and the symbols or light up. Only then is the battery status clearly assessed. • 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.

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Fig. 3

Fig. 4

DePuy Synthes Universal Battery Charger II Instructions for Use

Battery Power Line II and Colibri II / SBD II batteries The charger enables Battery Power Line II and Colibri II / SBD II batteries (530.630, 532.103) to be checked. It will be indicated if the battery performance is ­sufficient or if the ­battery needs to be replaced. Due to the very low self-discharging rate of Lithiumbased batteries a refresh function is not required. When required, the check function is started manually, as outlined below. After the battery is inserted, the symbol lights up ­yellow. To check the battery, press the button with the ­exclamation mark for at least 2 seconds (fig. 5) until the symbol lights up yellow (fig. 6). The device then ­carries out the process. The symbol is yellow throughout this time.

Fig. 5

Fig. 6

Universal Battery Charger II Instructions for Use

DePuy Synthes

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Operating the Device Checking and Refreshing Batteries

Completion of the process is indicated as follows: • Symbol is green (fig. 7): Battery has been successfully checked and charged. • Symbol is red (fig. 8): Either the battery is faulty or performance is insufficient. The battery must be disposed of. The entire process (checking battery status) takes around 3 hours and should only be carried out if there is enough time to do so. A battery can be charged or checked independently in each charger bay. Precautions: • To recharge batteries normally, do not press the exclamation mark button . • Checking the battery status has an impact on the battery. If this is carried out frequently the lifespan of the battery can be affected. • Do not remove the battery from the charger bay as long as the symbol is yellow (fig. 6 on previous page). Wait until the process has ended and the symbols or light up. Only then is the battery status clearly assessed. • 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.

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Fig. 7

Fig. 8

DePuy Synthes Universal Battery Charger II Instructions for Use

Trauma Recon System power module To ensure that the Trauma Recon System (05.001.201, 05.001.240) can operate safely and reliably, the Trauma ­Recon System power module (05.001.202) has to be checked at periodical intervals. It will be indicated if the power module performance is sufficient or if the power module needs to be replaced. flashing

The charger will indicate the necessity, but the user can choose a convenient time to check the power module, as this can take around 4 hours. When it needs to be checked, the symbol flashes (fig. 9). The check needs to be carried out within the next 3 charging cycles. This is done by pressing the ex­ clamation mark button for at least 2 seconds (fig. 10). The symbol light goes out and the symbol stops flashing and stays yellow (fig. 11). If the check is not ­carried out within the next 3 charging ­c ycles, the device carries out the check automatically. Completion of the process is indicated as follows: • Symbol is green (fig. 7 on previous page): power module has been checked, charged and is ready to use. • Symbol is red (fig. 8 on previous page): power ­module has been checked, is not charged and cannot be used; the red service indicator lamp on the power module lights up. Send in the power module for ser­ vicing.

Fig. 9

flashing

Fig. 10

A power module can be charged or checked indepen­ dently in each charger bay. Precautions: • If the check is not carried out within the next 3 charging cycles, the charger starts this process ­automatically. The symbol is yellow (fig. 11). • It takes around 4 hours to check the power ­module. Fig. 11

Universal Battery Charger II

Instructions for Use

DePuy Synthes

11

Operating the Device

Storing Batteries

Immediately recharge batteries and the power module after each use. Any Colibri/SBD batteries (532.003, 532.033) or Battery Power Line battery (530.620) that are not used should ­always be stored in the activated charger (maintenance charge). This guarantees that the batteries are always fully charged and ready to use. It is not necessary to store Trauma Recon System power module (05.001.202), Battery Power Line II battery (530.630) and Colibri II/SBD II battery (532.103) in the charger. Once charged they can be stored outside the charger without any noticeable charge difference due to a very low self-discharging rate of Lithium-based batteries. Precautions: • Do not use batteries/power modules that are not fully charged. A partial charge may not be sufficient for the ­intended use. • Unusable or faulty batteries/power modules should not be used. They should be disposed of (see section “Disposal” on page 20).

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Operating the Device

Slot Covers Set

The Slot Covers Set (05.001.228) consists of three plastic elements which were developed to cover the non-used slots of the charger (fig. 1). A Slot Cover helps to insert a battery or power module much easier into the Universal Battery Charger II because it covers the unused slots of the charger (fig. 2). Therefore, it prevents to insert the appropriate battery or power module into the wrong slot.

Fig. 1

Fig. 2

Universal Battery Charger II

Instructions for Use

DePuy Synthes

17

Care and Maintenance Cleaning

The device must be unplugged before it is cleaned. To clean the charger, wipe it off with a clean, soft and lintfree cloth dampened with deionized water and dry prior to reprocessing. Then wipe the charger with a new, clean, soft and lintfree cloth dampened with a minimum of 70% ­alcoholbased disinfectant for thirty (30) seconds. A dis­in­fectant that is VAH listed, EPA registered or locally r­ ecognized is recommended. This step has to be repeated two (2) ­additional times using a new, clean, soft and lint-free cloth dampened with a minimum 70% ­alco­hol-based disinfectant each time. Follow the ­instructions provided by the manufacturer. Whenever it is cleaned, the device should be checked to ­ensure it is working properly and is not damaged. Maintenance of the device is not required. If there are any faults, please send the device to a ­Synthes representative (see next section). Precautions: • Danger of electric shock! Unplug before cleaning and disinfection. • Provide sufficient ventilation. • Do not wash the device in a washer/disinfector. • Please follow the safety instructions given by the manual of the disinfectant manufacturer. • Device must not be sterilized. • Make sure that no solution enters the device. • If necessary, clean the contacts in the charger bays using utmost care.

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DePuy Synthes Universal Battery Charger II

Instructions for Use

Care and Maintenance

Repair and Technical Service

The device should be sent to the Synthes representative 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. To prevent damage during shipping use the original packaging to return devices back to Synthes. If this is not possible, please contact the Synthes representative. Users or third parties should not carry out repairs themselves. Precaution: The manufacturer shall assume no ­responsibility for damage resulting from unauthorized repair.

Universal Battery Charger II

Instructions for Use

DePuy Synthes

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