Universal Battery Charger Instructions for Use Oct 2011

EN

Introduction This Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. If additional information or in-service training is required, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

Indications For Use The Stryker Universal Battery Charger (battery charger) is a four-station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger and battery packs are specifically designed to work together so that the battery charger’s information screen will provide specific battery pack information.

Contraindications

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User/Patient Safety WARNINGS: • Before using any system component, or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • Only trained and experienced healthcare professionals should use this equipment. • Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent. See the Periodic Maintenance section for inspection criteria. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide. • Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. Place this equipment into service according to the EMC information contained in this manual. Portable and mobile radio frequency (RF) communications equipment can affect the function of this equipment. • ALWAYS use the appropriate battery charger to charge battery packs. • DO NOT operate the battery charger using a voltage inconsistent with the rating on the back of the unit. • DO NOT operate the battery charger with a damaged power cord or plug.

None known.

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Accessories WARNINGS: • Use only Stryker-approved system components and accessories, unless otherwise specified. DO NOT modify any system component or accessory. • Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. • DO NOT use any battery charger accessory that is not recommended or sold by Stryker. Failure to comply may result in fire, electric shock, or injury.

CAUTION: ALWAYS select and install the appropriate charger module for the specific battery pack used. NOTES: • Four System 6 Modules (REF 6110-625000) are supplied with the Universal Battery Charger. Alternative charger modules may be installed to accommodate specific types of battery packs as required. • For a complete list of accessories, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

The following Stryker-approved accessories are sold separately: CHARGER MODULE

REF

FOR USE WITH BATTERY PACK REF

Charger Module*

6110-412-000

4112-000-000

System 5 Module

6110-415-000

4115-000-000

Charger Module

6110-422-000

4212-000-000 4215-000-000

Non-Sterile Battery Charger Module

6110-426-000

4126-110-000 4222-110-000

System 6 Module

6110-625-000

6126-110-000 6212-000-000 6215-000-000 7212-000-000 7215-000-000

*This charger module is not design integrated. The battery charger will not display charge cycle count information for this charger module.

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Features Battery Charger

A F

G

B H

I

C J

D E

A

Battery Pack – A variety of battery packs are sold separately.

F

Power Cord Receptacle – Accepts the power cord.

B

Charger Module – An interchangeable component designed to accept a specific type of battery pack. A variety of charger modules are sold separately.

G

Power Cord – Connects the battery charger to a hospital-grade, facility power receptacle

H

Isolated Diagnostics Port – An Ethernet receptacle used to export device usage data from the battery charger to Stryker via the Internet, if desired.

I

Ethernet Cable (not supplied) – Connects the isolated diagnostics port to a facility Ethernet receptacle

J

MAC ID Label – Shows the Media Access Control Identifier (MAC Address) for the battery charger.

C

Indicator Lights – Provide status information for each charger module.

D

Information Screen – Provides status information and error messages for the battery charger, charger modules, and battery packs.

E

4

Input Buttons – Allow the user to interact with the battery charger. The information screen displays appropriate input button labels during the battery pack charging sequence.

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Information Screen

Indicator Lights

A

B

C

D A

E

State-of-Health Area – Indicates charging or conditioning activity, and the state-of-health of the battery pack.

B

Counter Area – Displays numeric information based on the state of the battery charger, charger modules, and/ or battery packs.

C

Message Area – Displays status information and requests user action.

D

Symbol Area – Displays symbols based on the state of the battery charger, charger modules, and/or battery packs.

E

Input Button Label Area – Displays appropriate input button labels during the battery pack charging sequence.

INDICATION

STATUS

GREEN (Steady State)

The battery pack is fully charged.

AMBER (Steady State)

The battery charger is either charging or discharging the battery pack.

AMBER (Slow Blinking)

The battery pack is at or near the end of its useful life.

AMBER (Fast Blinking)

The battery charger or charger module failed diagnostic testing.

Definitions The symbols located on the equipment and/ or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL

DEFINITION REPLACE – The battery pack failed the state-of-health test. Ethernet

MAC ID

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Media Access Control Identifier

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Instructions To Connect the Battery Charger WARNINGS: • To avoid the risk of electric shock, ALWAYS connect this equipment to a hospital-grade, facility power receptacle with protective earth. • DO NOT modify the power cord. • ALWAYS position the equipment so that the power cord may be easily disconnected as required. • DO NOT place the battery charger within the sterile field. CAUTION: ALWAYS place the power cord where it will not be stepped on, tripped over, or otherwise subjected to damage or stress. 1. Use the power cord to connect the battery charger to a hospital-grade, facility power receptacle (figure 1). The power-up sequence will begin: • A diagnostic test will be performed to ensure the battery charger and each installed charger module is operational • The battery charger software and hardware revision numbers will appear (figures 2 and 3) • The charger module revision number will appear for each installed charger module (figure 4). NOTE: If an ERROR message appears during the power-up sequence, note the error code that appears in the counter area (figure 5). See the Troubleshooting section. 2. If desired, use an Ethernet cable (not supplied) to connect the isolated diagnostics port to a facility Ethernet receptacle. NOTES: • Confirm with a facility IT representative that the Ethernet receptacle has access to the Internet. • See the Network Requirements in the Specifications section. • For more information, contact your Stryker sales representative.

Figure 1 – Battery Charger Connections

Figure 2 – Software Revision Number

Figure 3 – Hardware Revision Number

Figure 4 – Charger Module Revision Number

Figure 5 – Error Code

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To Charge a Battery Pack CAUTION: When battery packs require postsurgical sterilization, ALWAYS allow the battery packs to cool for one hour before charging. Excess heat buildup from sterilization and charging will damage the battery packs. NOTES: • To ensure maximum operating time, always charge battery packs before sterilization, even if the battery packs have not been used. • The charging sequence may take between 5 and 120 minutes, based on the type of battery pack and the existing level of charge in the battery pack. 1. Install a clean, dry battery pack into a compatible charger module with a NO BATTERY message screen (figure 6). The information screen will momentarily display the battery pack part number (figure 7) and the charging sequence will begin. During the charging sequence, a CHARGING message will appear and the number of illuminated state-of-health bars will increase from left to right (figure 8). After the battery pack is fully charged, a stateof-health test will be performed (figure 9): • Five to eight bars will illuminate in the state-of-health area. More illuminated bars indicates a better ability of the battery pack to store energy. • The counter area will update the charge cycle count (for design integrated components only). • A READY message will appear. NOTE: If the battery pack fails the state-of-health test, a REPLACE message and symbol will appear (figure 10). See the Troubleshooting section.

Figure 6 – No Battery Message

Figure 7 – Battery Pack Part Number

Figure 8 – Charging Message and Bars

Figure 9 – Ready Message with State-ofHealth Bars and Charge Cycle Count

2. Store the battery pack on the battery charger to maintain a full charge before sterilization.

Figure 10 – Replace Message and Symbol

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To Condition a Battery Pack NOTES: • During the conditioning sequence, the battery charger provides a controlled discharge of the battery pack. • Lithium-ion and other specific types of battery packs do not require conditioning. When a battery pack that does not require conditioning is installed in the battery charger, conditioning is not an available option. • Conditioning and recharging may take up to 1.5 hours or longer, based on the type of battery pack and the health of the battery pack. • You may press the END button to interrupt the conditioning sequence at any time. If conditioning is interrupted, the battery charger will automatically enter a charging sequence. 1. From the READY, CHARGING, or REPLACE message screen, press the MORE button. The CONDITION? message screen will appear (figure 11). 2. Press the OK button to initiate battery pack conditioning. A CONDITIONING message will appear and the conditioning sequence will begin. During the conditioning sequence, a CONDITIONING message will appear and the number of illuminated state-of-health bars will decrease from right to left (figure 12). After the battery pack is fully conditioned, the battery charger will automatically enter a charging sequence. NOTE: If a CONDITION ERROR message appears during the conditioning sequence (figure 13), see the Troubleshooting section.

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Figure 11 – Condition? Message

Figure 12 – Conditioning Message and Bars

Figure 13 – Condition Error Message

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To Access Over Temperature Information NOTES: • Specific types of battery packs allow you to access information about battery pack exposure to over temperature conditions. • The information screen will return to its origin after displaying an over temperature message screen for five seconds. 1. From the READY, CHARGING, REPLACE, or CONDITIONING message screen, press the MORE button. The CONDITION? message screen will appear. NOTE: From the CONDITIONING screen, the # (number) of OVER TEMP screen will appear directly. 2. Press the MORE button again to access the # of OVER TEMP message screen. The counter will display the number of times the battery pack has been exposed to an over temperature condition (figure 14). 3. Press the MORE button again to access the TIME OVER TEMP message screen. The counter will display how much time, in minutes, the battery pack has been exposed to over temperature conditions (figure 15).

Figure 14 – Total Number of Over Temperature Events

Figure 15 – Total Time Exposed to Over Temperature Conditions

To Disconnect the Battery Charger CAUTION: To reduce the risk of damage to the power cord, ALWAYS pull the power cord plug, not the power cord when disconnecting the battery charger. Disconnect the battery charger from the facility power receptacle and Ethernet receptacle, as required.

To Replace a Charger Module See the instructions for use supplied with the replacement charger module.

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Cleaning To Clean the Battery Charger and Charger Modules WARNING: Before cleaning, ALWAYS disconnect the power cord from the facility power receptacle and the battery charger to reduce the risk of electric shock. CAUTIONS: • DO NOT immerse the battery charger or charger modules in liquid. • DO NOT use solvents, lubricants, or other chemicals to clean the battery charger or charger modules unless otherwise directed. • DO NOT allow water to collect in the charger modules or on top of the battery charger. • DO NOT allow water to enter the cooling vents on the back of the battery charger. • DO NOT sterilize the battery charger or charger modules. 1. Disconnect the power cord from the facility power receptacle and the battery charger. 2. Disconnect the Ethernet cable, if used, from the isolated diagnostics port. 3. Gently wipe the external surfaces of the battery charger and power cord with a soft, lint-free cloth moistened with a prepared cleaning solution or non-abrasive, hospital disinfectant and water. 4. Immediately dry the battery charger with a soft, lint-free cloth or compressed air, < 140 kPA [< 20 psi]. 5. Inspect the battery charger and power cord for damage. See the Periodic Maintenance section for inspection criteria.

Inspection and Testing WARNINGS: • Only individuals trained and experienced in the maintenance of reusable medical devices should inspect and test this equipment. • Before attempting any inspection and testing, ALWAYS disconnect the power cord from the battery charger to reduce the risk of electric shock. • Perform recommended inspection and testing as indicated in these instructions. • DO NOT use any equipment if damage is apparent. • DO NOT use any system component if the inspection criteria are not met. • DO NOT disassemble or service this equipment. Failure to comply may result in electric shock or fire. NOTES: • If the equipment fails to meet the inspection and testing criteria, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. • Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only. INTERVAL

ACTIVITY

CRITERIA

Upon initial receipt and before each use

Inspect the equipment

No damage or signs of wear No loose or missing components No cuts in the power cord No bent pins or contacts

To Clean the Battery Pack See the instructions for use supplied with the battery pack.

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No cracks in the housing

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Storage and Handling To ensure the longevity, performance, and safety of this equipment, use the original packaging materials when storing or transporting this equipment.

Disposal/Recycle Follow the current local recommendations and/ or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life.

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Troubleshooting WARNING: DO NOT disassemble or service this equipment. Failure to comply may result in electric shock or fire. NOTE: If you require service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

COMPONENT

CAUSE

ACTION

Indicator lights do not illuminate.

Battery charger

No power to battery charger.

Reseat the cord connections on back of the battery charger and the facility power receptacle.

Battery charger is damaged.

Return the battery charger for repair.

Charger module is not properly connected.

Reseat the charger module connectors. See the instructions for use supplied with the charger module.

Charger module is damaged.

Replace the charger module.

Battery pack

Battery pack is not fully seated in charger module.

Reseat the battery pack.

Battery pack/ Charger module

Contacts are dirty or corroded.

Clean the contacts.

REPLACE appears in the message area of the information screen.

Battery pack

Battery pack capacity is reduced.

Condition the battery pack.

Battery pack has exceeded its operational life.

Replace the battery pack.

Battery pack does not fit into charger module.

Charger module

Charger module is intended for different battery pack.

Install the proper charger module. See the instructions for use supplied with the charger module.

Charger module is loose.

Charger module

Screw is not secure.

Tighten the screw.

NO MODULE appears in the message area of the information screen.

NO BATTERY appears in the message area of the information screen.

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Charger module

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Troubleshooting (continued) PROBLEM

COMPONENT

CAUSE

ACTION

Battery pack becomes unusually hot during use or while charging.

Charger module

Battery pack is intended for different charger module.

Install the battery pack in the correct charger module.

Battery pack

Internal problem.

Check battery pack status in the battery charger; replace the battery pack if indicated.

Battery charger

Internal problem.

Return the battery charger for repair.

Information screen does not display battery pack stateof-health information.

Battery charger

The battery charger will display the battery pack state-of-health at the end of the charge cycle.

Wait until the charge cycle is complete.

Information screen does not display charge cycle count information.

Battery pack

Battery pack is not a Stryker-approved battery pack.

Use Stryker battery packs only.

Battery pack/ Charger module

Battery pack (REF 4112000-000) is not a design integrated component.

No action required.

Battery pack

Lithium-ion and other specific types of battery packs do not require conditioning.

No action required.

Amber indicator light flashes Battery pack/ continuously. charger module

Battery pack and/or battery charger contacts may be dirty.

Clean the contacts.

NO MODULE appears in the message area of the information screen.

Charger module is disconnected from battery charger.

Connect the charger module to the battery charger.

Charger module is failing to communicate with the battery charger.

Replace the charger module.

The CONDITION? message screen does not display; battery pack conditioning is not an available option.

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Charger module

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Troubleshooting (continued) ERROR code 007 appears in the counter area of the information screen.

Battery pack

Charger module

Battery charger

Battery pack contact is corroded.

Clean the battery pack contact.

Battery pack contact is damaged.

Replace the battery pack.

Battery pack ID is not present.

Replace the battery pack.

Battery pack has lost smart communication function.

Replace the battery pack.

Battery pack was repaired by an unauthorized provider and is not programmed.

Replace the battery pack.

Battery pack is not a Stryker-approved battery pack.

Use Stryker battery packs only.

Charger module contact is corroded.

Clean the charger module contact.

Charger module contact is damaged.

Replace the charger module.

Battery charger contact is corroded.

Clean the battery charger contact.

Battery charger contact is damaged.

Return the battery charger for repair.

CONDITION ERROR appears in the message area of the information screen.

Battery charger

Battery charger component is malfunctioning.

Return battery charger for repair.

Sporadic electrical interference is experienced.

Battery charger

Electrical noise is present.

Turn off all electrical equipment not in use. Relocate electrical equipment; increase spatial distance. Install electrical equipment into different facility power receptacles.

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Specifications NOTES: • Specifications are approximate and may vary from unit to unit or as a result of power supply fluctuations. • Store the equipment within the specified environmental condition values throughout its useful life. Model:

Universal Battery Charger (REF 7110-120-000)

Size:

130 mm [5.125 inch] height 257 mm [10.125 inch] width 394 mm [15.5 inch] length

Weight:

5.2 kg [11.5 lb]

Cord:

2 m [78.7 inch] length, fitted with NEMA 5-15 hospital-grade plug, or 2.5 m [98.4 inch] length, fitted with CEE 7/7 plug

Mode of Operation:

Continuous Operation

Electrical: Input:

100-120 VAC, 3.0 A, 50-60 Hz 230 VAC, 1.5 A, 50-60 Hz

Output:

Open Circuit 22 V

Enclosure Protection:

IPX0 Ordinary Equipment

Equipment Type:

Class I

Ground Type: Product Safety Certification:

Protective Earth Ground

CSA International International Electrotechnical Commission IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirements for Safety - Second Edition Amendment 1 (1991); Amendment 2 (1995); Corrigendum 1 (1995) Canadian Standards Association CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety Underwriters Laboratories UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety - First Edition Revisions through and including April 26, 2006

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Specifications (continued) Network Requirements: Purpose of the Connection:

Device Usage Data

Required Network Characteristics:

Standard TCP/IP over Ethernet (IEEE 802.3 10/100 Mbs)

Required Network Configuration:

DHCP server or Static IP, Mask and Gateway provided by site IT admin; Access to the Internet

Technical Specifications of the Connection:

Standard TCP/IP over Ethernet (IEEE 802.3 10/100 Mbs), utilized industry standard https (port 443) web services communication to the Stryker Servers.

Intended Information Flow:

Device Usage Data

Hazardous Situations Resulting from a Failure of the Network:

None known.

Environmental Conditions:

Operation

Storage and Transportation

Temperature:

Relative Humidity:

Atmospheric Pressure:

Guidance and manufacturer’s declaration - electromagnetic emissions The Universal Battery Charger (REF 7110-120-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal Battery Charger (REF 7110120-000) should assure that it is used in such an environment.

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Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The Universal Battery Charger (REF 7110-120-000) uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The Universal Battery Charger (REF 7110-120-000) is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

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Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic immunity The Universal Battery Charger (REF 7110-120-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal Battery Charger (REF 7110120-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Universal Battery Charger (REF 7110-120000), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.67√P

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

d=1.67√P 80 MHz to 800 MHz d=2.33√P 800 MHz to 2.5 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) Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800MHz the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic immunity The Universal Battery Charger (REF 7110-120-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal Battery Charger (REF 7110120-000) should assure that it is used in such an environment. Electromagnetic environment - guidance

Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±2, 4, 6 kV contact

±8 kV air

±2, 4, 8 kV air

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

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% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 seconds

95% Reduction (10 ms)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Universal Battery Charger (REF 7110-120-000) requires continued operation during power mains interruptions, it is recommended that the Universal Battery Charger (REF 7110-120000) be powered from an uninterruptible power supply or a battery.

3 A/m

3 A/m at 50 Hz CRT 1 A/m

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

60% Reduction (100 ms) 30% Reduction (500 ms) 95% Reduction (5 sec)

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

NOTE: UT is the alternating current mains voltage prior to application of the test level.

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Specifications (continued) Recommended separation distances between portable and mobile RF communications equipment and the Universal Battery Charger (REF 7110-120-000) The Universal Battery Charger (REF 7110-120-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Universal Battery Charger (REF 7110-120-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Universal Battery Charger (REF 7110-120-000) as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

,

,

800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74 2.33

1

1.17

1.17

10

3.70

3.70

7.37

100

11.70

11.70

23.30

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. NOTE 1: At 80 MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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ES/DE/FR/IT/NL JA/ZH/KO SV/DA/FI/PT/NO PL/EL

7110-120-710 7110-120-720 7110-120-730 7110-120-750

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210

Stryker France ZAC Satolas Green Pusignan Av. de Satolas Green 69881 MEYZIEU Cedex France 2011-10

7110-120-700 Rev-A

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