Stryker

Turbo 4 (T4) Battery Chargers Instruction for Use Rev F May 2013

Instruction for Use

16 Pages

Turbo 4 (T4) Battery Chargers 0400-655-000 0400-655-001 0400-655-002 Instructions For Use 2013-05 0400-655-706 Rev-F www.stryker.com

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Turbo 4 (T4) Battery Chargers 0400-655-000 0400-655-001 0400-655-002

Instructions For Use

2013-05

0400-655-706 Rev-F

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0400-655-706 Rev-F

Introduction

Indications For Use

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, biomedical equipment technicians, and central supply/sterile processing 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. For additional information, including safety information, or in-service training, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. Trademarks not the property of Stryker Corporation are the property of their respective owners.

See the instructions for use supplied with the Stryker T4/T5 Helmets.

Contraindications See the instructions for use supplied with the Stryker T4/T5 Helmets.

Intended Use The Stryker T4 Battery Charger is intended to charge up to eight Stryker T4 Power Packs simultaneously. See the For Use With section.

For Use With WARNING: ALWAYS use the Stryker T4 Battery Charger to charge T4 Power Packs only, unless otherwise specified. Charging other power packs may cause the power pack to explode. DESCRIPTION

REF

T4 Power Pack

0400-650-000

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0400-655-706 Rev-F

User/Patient Safety WARNINGS: • Before using any component, or any component compatible with this equipment, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the components prior to use. • Only trained and experienced healthcare professionals should use this equipment. • Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See the Inspection and Testing 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 like the T4 Battery Charger. Install and place the charger into service according to the EMC information in this manual. Portable and mobile RF communications equipment can affect the function of the charger. See the Specifications section.

Accessories This section describes components that may be ordered to replace original equipment that is damaged, worn, or must be replaced. This section may also contain optional components used with the equipment. WARNINGS: • Use only Stryker-approved components and accessories, unless otherwise specified. Failure to comply may result in fire, electric shock, or injury. • Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. • DO NOT modify any component or accessory, including the ground of the charger power cord. The following Stryker-approved accessories are sold separately: DESCRIPTION

REF

T4 Power Pack

0400-650-000

T4 Charger Module

0400-655-003

(Power) Source Cord

0277-702-019

European (Power) Source Cord

0590-100-002

Flyte Software Upgrade Kit

0408-655-200

Flyte Charger Module

0408-655-300

Flyte Lithium-Ion Extended Life Power Pack

0408-660-200

NOTES: • The Flyte Software Upgrade Kit is only compatible with T4 Battery Chargers that have a serial number of 07113XXXXX or higher. • For a complete list of accessory information, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

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0400-655-706 Rev-F

Features

Power Connection - To connect or disconnect the charger to/from facility power, insert or remove the power cord connector to/from the power cord receptacle (appliance inlet).

Indicator Lights - These lights indicate the status of the power pack in the corresponding charger module: CHARGE, READY, and REPLACE. The amber REPLACE light also provides information about the corresponding module.

Charger Modules - Each module provides a pocket into which a T4 power pack may be installed. Eight power packs may be charged simultaneously.

Power Source Cord - To connect the charger to facility power, always use the appropriate power source cord. See the Accessories section.

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0400-655-706 Rev-F

Definitions Symbols and Related Indicator Lights 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

Power

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DEFINITION

INDICATOR LIGHT COLOR

STATUS

CHARGE

Amber

The amber CHARGE indicator light illuminates while the power pack is charging.

READY

Green

The green READY indicator light illuminates when the power pack is fully charged and ready to use.

REPLACE

Amber

The amber REPLACE indicator light illuminates if a module is empty, if a power pack has exceeded its operational life or if a power pack is damaged. Replace the power pack as required.

Amber Flashing

The amber REPLACE indicator light flashes if the corresponding charger module is not functioning properly. - See the Troubleshooting section.

Green

The green POWER indicator light illuminates to indicate the charger is connected to the facility power and is energized.

General Warning Sign

Refer to Instruction Manual/ Booklet

Consult Instructions for Use

Alternating Current (AC)

Direct Current (DC)

Protective Earth (ground)

POWER

0400-655-706 Rev-F

Instructions WARNINGS: • ALWAYS perform the recommended inspection and testing as indicated in the Inspection and Testing section. • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. • ALWAYS operate the equipment at the specified nominal voltage. See the Specifications section. • To avoid the risk of electric shock, ALWAYS connect this equipment to a hospital-grade, facility power receptacle with protective earth. • ALWAYS position the equipment so that the power cord may be easily disconnected as required. • ALWAYS place the power cord away from personnel traffic areas to eliminate a trip hazard and cord damage. • DO NOT touch the power pack receptacle terminals of the charger module with a metal object.

To Set Up the Charger 1. Position the charger so that the power cord may be easily connected and disconnected as required. 2. Install the plug of the power cord into the power cord receptacle on the charger. 3. Install the other end of the power cord into a hospital-grade facility power receptacle with protective earth. NOTE: During power initiation, all the indicator lights will illuminate briefly. The power indicator will stay illuminated. See the Symbols and Related Indicator Lights section for details.

To Charge the T4 Power Packs WARNINGS: • ALWAYS make sure the power packs are dry BEFORE charging. • DO NOT charge a power pack that gives off an odor, generates heat, becomes discolored, or leaks. • DO NOT touch the charger’s voltage output terminals and the patient simultaneously. Failure to comply may result in electric shock. CAUTION: Make sure the correct charger module is installed for the appropriate power pack. T4 charger modules used to charge T4 power packs may be replaced with Flyte charger modules to accommodate Flyte power packs. A software upgrade may be required. See the Accessories section. NOTES: • Charging time for the T4 Power Packs is approximately four hours. Actual charging time depends on the remaining energy in the power pack. • If the power packs will be stored for an extended period, it is recommended that they remain in the charger to stay fully charged. 1. Insert a clean, dry power pack into a charger module. Make sure the power pack is properly seated in the module. NOTE: The amber CHARGE indicator light will illuminate during charging and remain illuminated. The green READY indicator light will illuminate when the power pack is fully charged. See the Symbols and Related Indicator Lights section for details. 2. Once charged, keep the power packs in the charger so the power packs remain fully charged and ready for use.

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0400-655-706 Rev-F

Instructions (continued) To Shut Down the Charger CAUTION: To reduce the risk of damage to the power cord, ALWAYS grasp and pull the (mains) connector and plug when disconnecting the power cord from the charger and facility power. 1. Remove power cord plug from the hospitalgrade facility power receptacle. 2. Remove the power cord (mains) connector from the power cord receptacle (appliance inlet) on the charger. NOTE: If the charger is disconnected from facility power, remove the power packs from the modules to prevent discharge.

Inspection and Testing WARNINGS: • Only individuals trained and experienced in the maintenance of reusable medical devices should inspect this equipment. • Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. • DO NOT disassemble or service this equipment, unless otherwise specified. Failure to comply may result in electric shock or fire. NOTES: • For service, 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.

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INTERVAL

INSPECTION CRITERIA

ACTION

Before use

Check equipment for damage, wear, or missing components.

If damage is apparent, replace the equipment.

Check power cord for cuts or bent pins. Check power cord receptacle or charger module for bent pins or bent contacts. Check charger housing and power pack housing for cracks. A cracked power pack housing has the potential to leak electrolytes and cause chemical burns. NOTE: If any component must be discarded, see the Disposal/Recycle section.

0400-655-706 Rev-F

Cleaning WARNINGS: • Before cleaning the charger, ALWAYS disconnect the charger from facility power to reduce the risk of electric shock. • Before cleaning the power pack, ALWAYS remove the power pack from the helmet power pack holster or charger module. • DO NOT use disinfectants with a pH level higher than 7.5 on the power pack. See the Material Safety Data Sheet of the disinfectant to verify the pH range. Failure to comply may cause the power pack housing material to crack and leak. CAUTIONS: • DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified. • DO NOT allow liquids or moisture into any electrical connections, including the power cord receptacle. • DO NOT allow water to collect in the charger modules or on top of the charger. • DO NOT immerse any component in liquid, including the power pack. • DO NOT sterilize any component, including the power pack. • ALWAYS dry the power pack before installation into the charger. Failure to comply may result in damage to the power pack and charger.

To Clean the Charger and Modules

Storage and Handling CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. See the Specifications section. To ensure the longevity, performance and safety of this equipment, use of the original packaging material is recommended when storing or transporting this equipment.

Disposal/Recycle WARNINGS: • 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. • ALWAYS decontaminate equipment exposed to infectious material before sending it to a waste treatment facility. Per Directive 2002/96/EC, product must be collected separately. DO NOT dispose of as unsorted municipal waste. Contact local distributor for disposal information. [charger]

Per Directive 2006/66/EC, collect and recycle batteries/ battery packs according to EU Member State regulations. The rechargeable power pack contains Nickel Metal Hydride material.

1. Disconnect the power cord from the charger power cord receptacle and facility power. 2. Wipe the surfaces of the charger and modules with a soft cloth dampened with a nonabrasive, hospital disinfectant and immediately dry. 3. See the Storage and Handling section.

To Clean the Power Pack 1. Remove the power pack from the helmet power pack holster. 2. Wipe the surfaces of the power pack with a soft cloth dampened with a nonabrasive, hospital disinfectant. 3. Dry the power pack with a lint-free towel or medical-grade compressed air. 4. See the Storage and Handling section.

Years of environmentally-friendly use, per China RoHS standard. [charger]

Years of environmentally-friendly use, per China RoHS standard. [power pack]

To comply with Batteries Directive 2006/66/EC, the power pack has been designed to be recycled at the end-of-life by the end user as a complete unit. No disassembly is required.

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0400-655-706 Rev-F

Troubleshooting WARNING: DO NOT disassemble or service this equipment, unless otherwise specified. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

SOLUTION

The indicator lights do not illuminate.

No power is applied to the charger.

Make sure the power cord connections between the charger and facility power are secure.

The charger is damaged.

Return the charger to Stryker.

The charger module is not properly connected.

Make sure the charger module connection is secure.

The charger module is damaged.

Replace the charger module. See the Accessories section.

The power pack is damaged.

Replace the power pack. See the For Use With section.

The charger module is damaged.

Replace the charger module. See the Accessories section.

The charger module is loose.

The charger module screws are not secure.

Tighten the charger module screws.

The power pack becomes unusually hot during use or while charging.

The power pack is damaged.

Replace the power pack. See the For Use With section.

The charger is not functioning properly.

Return the charger to Stryker.

Electrical noise is present.

Turn off all electrical equipment not in use.

The amber REPLACE indicator light flashes.

The amber CHARGE indicator light does not illuminate when the power pack is installed.

Sporadic electrical interference is experienced.

Relocate electrical equipment; increase spatial distance. Plug electrical equipment into different electrical outlets. NOTE: If any component must be discarded, see the Disposal/Recycle section.

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0400-655-706 Rev-F

Specifications NOTE: The Canadian Standards Association (CSA) certification mark only applies to the following charger models: REF 0400-655-000 (120 VAC) and REF 0400-655-001 (230 VAC). Model:

REF 0400-655-000 T4 Battery Charger

Electrical: Input: 120 V

, 50-60 Hz, 1.7 A

Terminal Nominal Open Circuit 20 VDC Voltage: Power Cord: 2 m long, fitted with NEMA 5-15 hospital grade plug (USA) Model:

REF 0400-655-001 T4 Battery Charger

Electrical: Input: 230 V

, 50-60 Hz, 0.9 A

Terminal Nominal Open Circuit 20 VDC Voltage: Power Cord: 2.5 m long, fitted with CEE 7/7 Schucko plug (Europe) European Conformity: Model:

REF 0400-655-002 T4 Battery Charger

Electrical: Input: 100 V

, 50-60Hz, 1.9 A

Terminal Nominal Open Circuit 20 VDC Voltage: Power Cord: 2 m long, fitted with NEMA 5-15 hospital grade plug (Japan) Ground Type: Protective Earth Means of Disconnection from Supply Mains:

Disconnect the power cord connector from the power cord receptacle (appliance inlet).

Dimensions: Height: 146 mm [5.75 inches] Width: 248 mm [9.75 inches] Length: 381 mm [15.0 inches] Mass:

5.5 kg [12.1 lb]

Ingress Protection (IP):

IPX0

Equipment Classification:

Class I Medical Electrical (ME) Equipment

Mode of Operation:

Continuous

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0400-655-706 Rev-F

Specifications (continued) Product Safety Certification:

CSA International

Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety CAN/CSA-C22.2 No. 60601-1:08, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009); Amendment 2 (2010) Underwriters Laboratories (UL) UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety - First Edition; Revisions through and including April 26, 2006 International Electrotechnical Commission (IEC) IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Corrigendum 1 (2006); Corrigendum 2 (2007) IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirements for Safety - Second Edition; Amendment 1 (1991); Amendment 2 (1995); Corrigendum 1 (1995) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); CENELEC Corrigendum (2010); CENELEC Amendment A11 (2011) Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure Limitation:

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0400-655-706 Rev-F

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic emissions The T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) is intended for use in the electromagnetic environment specified below. The customer or the user of the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) 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 B

Harmonic emissions IEC 61000-3-2

Class A

The T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) is suitable for use in all establishments, including 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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0400-655-706 Rev-F

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic immunity The T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) is intended for use in the electromagnetic environment specified below. The customer or the user of the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±2, 4, 6 kV contact ±2, 4, 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with 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 input/output lines

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

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

±0.5, 1 kV differential mode ±0.5, 1 & 2 kV common mode

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

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

3 A/m

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

Power frequency magnetic fields should be at levels characteristics of a typical location in 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)

60% Reduction (100 ms)

30% Reduction (500 ms)

95% Reduction (5 sec)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the T4 Battery Charger (REF 0400-655-000, 0400655-001, and 0400-655002) requires continued operation during power mains interruptions, it is recommended that the T4 Battery Charger (REF 0400-655-000, 0400655-001, and 0400-655002) be powered from an uninterruptible power supply or a battery.

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

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0400-655-706 Rev-F

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 T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400655-002), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

d=1.2√P d=1.2√P 80 MHz to 800 MHz d=2.3√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). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

(Non-ionizing electromagnetic radiation) NOTE 1: At 80 MHz and 800 MHz 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. 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 field strength in the location in which the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) is used exceeds the applicable RF compliance level above, the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002). a

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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0400-655-706 Rev-F

Specifications (continued) Recommended separation distances between portable and mobile RF communications equipment and the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) The T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the T4 Battery Charger (REF 0400-655-000, 0400-655-001, and 0400-655-002) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the T4 Battery Charger (REF 0400-655-000, 0400655-001, and 0400-655-002) as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

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

80 MHz to 800 MHz

800 MHz to 2.5 GHz

1.2√p

2.3√p

W 0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

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 800 MHz, 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/SV/DA/FI/PT/NO/PL/EL 0400-655-712 JA/ZH/KO 0400-655-720

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

2013-05

0400-655-706 Rev-F

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