Instructions for Use
244 Pages
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STRYKER SYSTEM G™ Charger, 2-Bay 7310-120-000
Instructions For Use
ENGLISH (EN) ESPAÑOL (ES) ITALIANO (IT) PORTUGUÊS (PT) POLSKI (PL) ΕΛΛΗΝΙΚΑ (EL) TÜRKÇE (TR) РУССКИЙ (RU)
中文 (ZH) 한국어 (KO) 2021-09
7310-120-700 Rev-AC
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EN
7310-120-700 Rev-AC
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Safety Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 For Use With . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Information Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 To Connect the Charger . . . . . . . . . . . . . . . . . . . . . . . . . 10 To Charge a Power Module . . . . . . . . . . . . . . . . . . . . . . .
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To Reset a Circuit Breaker . . . . . . . . . . . . . . . . . . . . . . . . 15 To Disconnect the Charger . . . . . . . . . . . . . . . . . . . . . . . . 15 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Disposal/Recycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Product Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . 20 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . .
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7310-120-700 Rev-AC
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Introduction This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.
Audience This manual is intended for in-service trainers, physicians, nurses, and surgical technologists. Keep and consult this reference manual during the life of the product.
Conventions 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.
Contact Information For additional information, including safety information, in-service training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-269-323-7700 or 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.
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7310-120-700 Rev-AC
Indications For Use The STRYKER SYSTEM G Charger, 2-Bay is a two-station, modular battery charger intended to charge STRYKER SYSTEM G handpiece power modules.
Contraindications None known.
Safety Directives WARNINGS: ▪
Before using this equipment, read and understand the instructions for use. Pay particular attention to safety information.
▪
Only trained and experienced healthcare professionals should use this equipment.
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For Use With This section identifies components intended to be used with the equipment to obtain a safe combination. WARNINGS: ▪
Use only Stryker-approved equipment, unless otherwise specified.
▪
Use of unapproved electrical equipment may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system.
NOTES: ▪
Components are sold separately.
▪
For a complete list of components or ordering information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary. Description STRYKER SYSTEM G Power Module Power Cord, Plug Type E/F Power Cord, Plug Type G Power Cord, Plug Type B Power Cord, Plug Type N Power Cord, Plug Type I Power Cord, Plug Type D Power Cord, Plug Type M
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REF 7309-120-000 0039-308-000 0039-309-000 0039-310-000 0039-311-000 0039-312-000 0039-313-000 0039-314-000
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Features Charger D
C E
F
A
B
A B C D E F
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Information Screen – Provides status information for the power module. Indicator Lights – Provide status information for the power module. Charger Contacts – Interlock with the power module to complete an electric circuit. Power Cord Receptacle – Allows connection of the power cord. Circuit Breakers – Allow recovery from momentary electrical faults. Power Cord – Connects the charger to a facility power receptacle.
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Information Screen A
B
D
E
C A B C D E
F
F
Counter – Indicates the number of charge cycles or the charge level for the power module. Cycles – Indicates that the counter is displaying the number of charge cycles for the power module. Percentage – Indicates that the counter is displaying the charge level for the power module. Charging – Indicates that the power module is charging. Module Health – For power modules with 10 or more charge cycles, indicates the health of the power module after charging: Excellent – The power module is at or near the beginning of its useful life. Good – The power module is in the middle of its useful life. Poor – The power module is at or near the end of its useful life. Replacement is recommended. Replace – Indicates that the power module is at or near the end of its useful life. Replacement is recommended.
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Indicator Lights Light
Definition Charging (Amber) – Indicates that the power module is charging. Ready (Green) – ▪ When no power modules are installed, indicates that the charger is connected to facility power and ready for use. ▪ When a power module is installed, indicates that the power module is fully charged and ready for use. Replace (Amber) – Indicates that the power module is at or near the end of its useful life. Replacement is recommended.
Definitions The symbols located on the equipment and/or labeling are defined in this section and/or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. Symbol
Definition General Warning Sign Caution
DO NOT STERILIZE
Do not sterilize Consult instructions for use Universal Recycling Symbol
1V 1A 1 VA 1 Hz AC REF
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1 Volt 1 Ampere 1 Volt Ampere 1 Hertz Alternating Current Catalog Number
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Instructions WARNINGS: ▪
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 this equipment. Place the equipment into service according to the EMC information contained in this manual.
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Portable and mobile radio frequency (RF) communications equipment can affect the function of this equipment.
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This equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, ALWAYS verify normal operation in the configuration in which it will be used.
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To avoid the risk of electric shock, ALWAYS connect this equipment to a hospital-grade, facility power receptacle with protective earth.
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DO NOT operate the charger using a voltage inconsistent with the rating on the back of the unit.
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DO NOT operate the charger with a damaged power cord or plug.
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DO NOT modify the power cord.
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ALWAYS position the equipment so that the power cord may be easily disconnected as required.
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DO NOT place the charger within the sterile field.
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ALWAYS operate the equipment within the specified environmental condition values: Temperature Limitation
Humidity Limitation
Atmospheric Pressure Limitation
CAUTION: ALWAYS place the power cord where it will not be stepped on, tripped over, or otherwise subjected to damage or stress.
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To Connect the Charger 1. Before operating the equipment, verify the following: ▪ You are using Stryker-approved equipment. ▪ The equipment is not damaged. ▪ The equipment is clean. NOTE: If you experience difficulty during operation, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary. 2. Use the power cord to connect the charger to a hospital-grade, facility power receptacle. Upon connection, the charger will indicate that it is ready for use: ▪ The ready lights will turn on. ▪ “000” will display on both screens.
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To Charge a Power Module NOTES: ▪
Fully charge power modules before first and every use.
▪
The charging sequence may take between 5 and 45 minutes, based on the existing charge level in the power module.
▪
For maximum capacity, store power modules on the battery charger to maintain a full charge.
1. Install a clean, dry power module onto the charger. Make sure the power module is securely snapped into place on the charger contacts.
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2. Upon installation, the charger will communicate with the power module: ▪ The charging light will turn on. ▪ “000” will flash.
3. After 3 seconds, the charging sequence will begin: ▪ The charging light will flash. ▪ The charging symbol will flash. ▪ The charge level for the power module will display.
NOTE: If the power module is damaged or at the end of its useful life, the charger will not charge the power module: ▪ The replace light will turn on. ▪ The replace symbol will display. ▪ The number of charge cycles for the power module will display.
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4. After 60 seconds, the charge level will alternate with the number of charge cycles for the power module.
NOTE: If the power module is in poor health, the charging sequence will include additional information: ▪ The replace light will turn on. ▪ The replace symbol will display.
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5. When the power module is fully charged, the charging sequence will end: ▪ 100% charge level will display. ▪ The charge level will continue to alternate with the number of charge cycles for the power module. ▪ For power modules with 10 or more charge cycles, the module health symbol will indicate the health of the power module. See the Features section.
NOTE: If the power module is in poor health, the end of the charging sequence will include additional information: ▪ The replace light will remain on. ▪ The replace symbol will continue to display.
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To Reset a Circuit Breaker WARNING: DO NOT use the charger if either of the circuit breakers continues to trip and turn off power. Disconnect the power cord from the facility power receptacle and contact Stryker. In the event of a momentary electrical fault, a circuit breaker may trip and turn off power. Push the toggle switch up to reset the circuit breaker and continue operation.
To Disconnect the 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 charger. Disconnect the power cord from the charger and the facility power receptacle.
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Cleaning WARNING: Before cleaning, ALWAYS disconnect the power cord from the facility power receptacle and the charger to reduce the risk of electric shock. CAUTIONS: ▪
DO NOT immerse the charger in liquid.
▪
DO NOT use solvents, lubricants, or other chemicals to clean the charger or charger modules unless otherwise directed.
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DO NOT allow water to collect on top of the charger.
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DO NOT allow water to enter the cooling vents on the back of the charger.
▪
DO NOT sterilize the charger.
1. Disconnect the power cord from the facility power receptacle and the charger. 2. Gently wipe the external surfaces of the charger and power cord with a soft, lint-free cloth moistened with a prepared cleaning solution or non-abrasive, hospital disinfectant and water. 3. Immediately dry the charger with a soft, lint-free cloth or compressed air, < 140 kPa. 4. Inspect the charger and power cord for damage. See the Inspection section.
Inspection WARNINGS: ▪
Perform recommended inspection as indicated in these instructions.
▪
DO NOT use any equipment if damage is apparent or the inspection criteria are not met.
▪
Before inspection, ALWAYS disconnect the power cord from the charger to reduce the risk of electric shock.
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7310-120-700 Rev-AC
Interval Upon initial receipt and before each use
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Activity Inspect the equipment
Criteria No damage or signs of wear No loose or missing components No cuts in the power cord No bent contacts No cracks in the housing
NOTE: If the equipment fails to meet the inspection criteria, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.
Storage and Handling CAUTION: ALWAYS transport and store the equipment within the specified environmental condition values: Temperature Limitation
Humidity Limitation
Atmospheric Pressure Limitation
Service WARNING: DO NOT disassemble, modify, service, or repair this equipment without authorization of the manufacturer. NOTES: ▪
The useful life of this equipment is dependent upon many factors including, but not limited to, the method and duration of each use, and the handling of the equipment between uses.
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Routine and careful inspection of the equipment is the best method for determining the serviceable life span of the equipment.
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Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only.
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For service information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.
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Disposal/Recycle WARNING: ALWAYS 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. In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended, product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling. NOTE: Contact Stryker for the recycling passport for this product.
China RoHS Standard SJ/T 11364 To comply with China RoHS Standard SJ/T 11364, this device has been marked with the environmentally-friendly use period (EFUP) number, measured in years. The device contains at least one of the listed hazardous substances above threshold.
China RoHS Disclosure Report REF 7310-120-000 Hazardous Substances Part Name
Electronic Circuit Boards
Lead (Pb)
Mercury (Hg)
Cadmium (Cd)
Hexavalent Chromium (Cr [VI])
X
O
X
O
Polybrominated Polybrominated biphenyls diphenyl (PBB) ethers (PBDE) O
O
This table is prepared in accordance with the provisions of SJ/T11364. O: Indicates that said hazardous substance contained in all of the homogenous materials for this part is below the limit requirement of GB/T26572. X: Indicates that said hazardous substance contained in at least one of the homogenous materials used for this part is above the limit requirement of GB/T26572.
Material: In accordance with the European REACH regulation and other environmental regulatory requirements, components within the charger contain Lead Cas. No. 7439-92-1. This declaration is made in good faith and is either based on a technical evaluation, supplier data and/or laboratory testing.
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Specifications Model: Catalog Number: Dimensions: Height: Width: Length: Mass: Mode of Operation: Electrical: Input: Output: Circuit Breakers: Ingress Protection (IP): Equipment Type: Ground Type: Means of Isolation from Supply Mains: European Conformity:
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STRYKER SYSTEM G Charger, 2-Bay 7310-120-000 130 mm 245 mm 394 mm 1.6 kg Continuous Operation 100-240 V AC / 135-175 VA (50/60 Hz) 12.6 V (Direct current) / 3 A maximum 1 A maximum IPX0 Class I Protective Earth Ground Disconnect the power cord from the charger and the facility power receptacle.
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Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1 A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint. IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1 Consolidated Reprint. IEC 60601-1-2: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and essential performance – Incorporates Amendment A12: 2014
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