Stryker SYSTEM G 7310-120-000 User manual
2 www.stryker.com
EN 7310-120-700 Rev-AA
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. . . . . . . . . . . . . . . . . . . . . . . .11
To Reset a Circuit Breaker . . . . . . . . . . . . . . . . . . . . . . . . 15
To Disconnect the Charger . . . . . . . . . . . . . . . . . . . . . . . .15
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Disposal/Recycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Product Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . 20
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . .21
7310-120-700 Rev-AA EN
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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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EN 7310-120-700 Rev-AA
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 REF
STRYKER SYSTEM G Power Module 7309-120-000
Power Cord, Plug Type E/F 0039-308-000
Power Cord, Plug Type G 0039-309-000
Power Cord, Plug Type B 0039-310-000
Power Cord, Plug Type N 0039-311-000
Power Cord, Plug Type I 0039-312-000
Power Cord, Plug Type D 0039-313-000
Power Cord, Plug Type M 0039-314-000
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EN 7310-120-700 Rev-AA
Features
Charger
C
E
A
D
F
B
A Information Screen – Provides status information for the power
module.
B Indicator Lights – Provide status information for the power module.
C Charger Contacts – Interlock with the power module to complete an
electric circuit.
D Power Cord Receptacle – Allows connection of the power cord.
E Circuit Breakers – Allow recovery from momentary electrical faults.
F Power Cord – Connects the charger to a facility power receptacle.
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Information Screen
C F
B D
E
A
A Counter – Indicates the number of charge cycles or the charge
level for the power module.
B Cycles – Indicates that the counter is displaying the number of
charge cycles for the power module.
CPercentage – Indicates that the counter is displaying the charge
level for the power module.
D Charging – Indicates that the power module is charging.
E 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.
F Replace – Indicates that the power module is at or near the end of
its useful life. Replacement is recommended.
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EN 7310-120-700 Rev-AA
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
1 V 1 Volt
1 A 1 Ampere
1 VA 1 Volt Ampere
1 Hz 1 Hertz
AC Alternating Current
REF 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.
▪ Portable and mobile radio frequency (RF) communications equipment can
affect the function of this equipment.
▪ 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.
▪ To avoid the risk of electric shock, ALWAYS connect this equipment to a
hospital-grade, facility power receptacle with protective earth.
▪ DO NOT operate the charger using a voltage inconsistent with the rating on
the back of the unit.
▪ DO NOT operate the charger with a damaged power cord or plug.
▪ 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 charger within the sterile field.
▪ 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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EN 7310-120-700 Rev-AA
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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EN 7310-120-700 Rev-AA
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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EN 7310-120-700 Rev-AA
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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EN 7310-120-700 Rev-AA
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.
▪ DO NOT allow water to collect on top of the charger.
▪ 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.
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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.
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 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
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EN 7310-120-700 Rev-AA
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.
▪ Routine and careful inspection of the equipment is the best method for
determining the serviceable life span of the equipment.
▪ Maintenance documentation for this equipment is available upon request to
Stryker-authorized service personnel only.
▪ 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.
Disposal/Recycle
Per Directive 2012/19/EU, product must be collected separately. Do not
dispose of as unsorted municipal waste. Contact local distributor for
disposal information.
Contains no hazardous substances, per China RoHS standard.
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Specifications
Model: STRYKER SYSTEM G Charger, 2-Bay
Catalog
Number: 7310-120-000
Dimensions:
Height: 130 mm
Width: 245 mm
Length: 394 mm
Mass: 1.6 kg
Mode of
Operation: Continuous Operation
Electrical:
Input: 100-240 V AC / 135-175 VA (50/60 Hz)
Output: 12.6 V (Direct current) / 3 A maximum
Circuit
Breakers: 1 A maximum
Ingress
Protection (IP): IPX0
Equipment
Type: Class I
Ground Type: Protective Earth Ground
Means of
Isolation from
Supply Mains:
Disconnect the power cord from the charger and the facility
power receptacle.
European
Conformity:
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EN 7310-120-700 Rev-AA
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: 2010: EMC (Version 3.0) – Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests
– Edition 3.0
IEC 62133: 2012/12/06 Edition: 2.0: Secondary Cells and Batteries Containing
Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable
Sealed Secondary Cells and for Batteries Made from Them for use in Portable
Applications, Corrigendum 1:2013
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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