Stryker

Flyte Charger Instructions for Use Rev AB July 2019

Instructions for Use

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File Name: Stryker - 0408-655-700 Rev AB - Flyte Charger Instructions for Use Rev AB July 2019 - 2019-07.pdf

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Flyte® Charger 0408-655-000 0408-655-001 0408-655-002

Instructions For Use

ENGLISH (EN)

2019-07

0408-655-700 Rev-AB

www.stryker.com

0408-655-700 Rev-AB

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. 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. Trademarks not the property of Stryker Corporation are the property of their respective owners.

See the instructions for use supplied with the Stryker Flyte Helmet.

Contraindications See the instructions for use supplied with the Stryker Flyte Helmet.

Intended Use The Stryker Flyte Charger is intended to charge up to eight Stryker Flyte Power Packs simultaneously.

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

REF

Flyte Lithium-Ion Extended Life Power Pack

0408-660-000

Flyte Lithium-Ion Power Pack

0408-650-000

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0408-655-700 Rev-AB

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 Flyte charger. Install and place the charger into service according to the EMC information in this manual. Portable and mobile radio frequency (RF) equipment can affect the function of the charger. See the Specifications section. • DO NOT stack or place equipment adjacent to the product. If such a configuration is necessary, observe the configuration to ensure that electromagnetic interference does not degrade performance. • DO NOT use the product in a magnetic resonance imaging (MRI) environment. Using the product in an MRI environment could affect the function of the system.

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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

Flyte Lithium-Ion Extended Life Power Pack

0408-660-000

Flyte Charger Module

0408-655-300

T4 Charger Module

0400-655-003

T4 Power Pack

0400-650-000

(Power) Source Cord

0277-702-019

European (Power) Source Cord

0590-100-002

NOTE: For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

0408-655-700 Rev-AB

Features

D A B

Module Indicator Light Bars - These light bars indicate the amount of energy remaining in the power pack. The more bars, the better the ability of the power pack to provide energy. An individual bar within the light bar array will flash as the power pack charges.

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

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.

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

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).

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0408-655-700 Rev-AB

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

DEFINITION

INDICATOR LIGHT COLOR

STATUS

CHARGE

Amber

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

READY

Green

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

REPLACE

Amber

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

POWER

Green

The green POWER 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)

Module Indicator Light Bars LIGHT BARS

POWER PACK ENERGY

1 Amber light

0-39%

2 Amber lights

40-59%

3 Amber lights

60-79%

4 Green lights

80-99%

5 Green lights

100%

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0408-655-700 Rev-AB

Instructions WARNINGS: • ALWAYS perform the recommended inspection and testing as indicated in the Inspection and Testing section. • This equipment is suitable to use in a professional healthcare facility environment. • 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 Flyte 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. Flyte charger modules used to charge Flyte power packs may be replaced with T4 charger modules to accommodate T4 power packs. See the Accessories section. NOTES: • Charging time for the Flyte Extended Life Power Packs is approximately eight hours. Actual charging time depends on the remaining energy in the power pack before charging. • 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 Flyte 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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0408-655-700 Rev-AB

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 Before use

INSPECTION CRITERIA

ACTION

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.

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 immerse any component in liquid, including the power pack. • DO NOT sterilize any component, including the power pack. • DO NOT use disinfectants with a pH level higher than 7.5 on the power pack. See the 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.

Cleaning (continued)

0408-655-700 Rev-AB

Disposal/Recycle

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. • ALWAYS dry the power pack before installation into the charger. Failure to comply may result in damage to the power pack and charger.

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. To comply with European Community Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU, this device 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. [charger]

To Clean the Charger and Modules 1. Disconnect the charger power cord from the 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 comply with European Community Batteries Directive 2006/66/EC, this device has been designed for safe removal of the batteries at the end-of-life by a waste treatment facility. Infected units should be decontaminated before they are sent for recycling. If it is not possible to decontaminate the unit for recycling, the hospital should not attempt to remove the batteries from waste equipment. Continued disposal of small amounts of portable batteries to landfill and incineration is allowed under Directive 2006/66/EC and Member State regulations.

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 non-abrasive, hospital disinfectant. 3. Dry the power pack with a lint-free towel or medical-grade compressed air. 4. See the Storage and Handling section.

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.

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

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

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0408-655-700 Rev-AB

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

ACTION

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. See the instructions for use supplied with charger module.

The power pack is damaged.

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

The amber REPLACE indicator light flashes while the module indicator light bars are illuminated.

Intermittent facility power has been supplied to the charger.

Remove and reinstall the power pack(s). If this condition persists, contact Stryker.

The amber CHARGE indicator or the module light indicators do not illuminate when the power pack is installed.

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.

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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0408-655-700 Rev-AB

Specifications NOTE: The Canadian Standards Association (CSA) certification mark only applies to the following charger models: REF 0408-655-000 (120 VAC) and REF 0408-655-001 (230 VAC). Model:

REF 0408-655-000 Flyte Charger

Electrical: Input: 120 V

, 50-60 Hz, 1.7 A

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

REF 0408-655-001 Flyte Charger

Electrical: Input: 230 V

, 50-60 Hz, 0.9 A

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

REF 0408-655-002 Flyte Charger

Electrical: Input: 100 V

, 50-60Hz, 1.9 A

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

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

Dimensions:

146 mm [5.75 inch] height 248 mm [9.75 inch] width 381 mm [15.0 inch] length

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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0408-655-700 Rev-AB

Product Safety Certification:

CSA International

Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:08, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety 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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0408-655-700 Rev-AB

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic emissions The Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) is intended for use in the electromagnetic environment specified below. The customer or the user of the Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) 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 Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) 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, provided the following warning is heeded:

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

WARNING: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. Mitigation measures may be necessary, such as reorienting or relocating the Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) or shielding the location.

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0408-655-700 Rev-AB

Guidance and manufacturer's declaration - electromagnetic immunity The Flyte Charger (REF 0408-655-000 and 0408-655-002) is intended for use in the electromagnetic environment specified below. The customer or the user of the Flyte Charger (REF 0408-655-000 and 0408-655-002) 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 differential mode ±2 kV common mode

±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 characteristic 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 Flyte Charger (REF 0408-655-000 and 0408-655-002) requires continued operation during power mains interruptions, it is recommended that the Flyte Charger (REF 0408-655-000 and 0408655-002) 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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0408-655-700 Rev-AB

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic immunity The Flyte Charger (REF 0408-655-001) is intended for use in the electromagnetic environment specified below. The customer or the user of the Flyte Charger (REF 0408-655-001) should assure that it is used in such an environment. NOTE: The values provided in the table below have changed due to 60601-1-2 4th Edition requirements. Immunity test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance level

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

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 2 kV at 100 kHz repetition frequency for power supply lines

± 1 kV at 100 kHz repetition frequency for input/output lines

± 0.5 kV, ± 1 kV line(s) to line(s)

± 0.5 kV, ± 1 kV, ± 2 kV line(s) to earth

Voltage dips, short interruptions and voltage variations on power supply input lines

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

IEC 61000-4-11

0% UT (100% dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% UT (>100% dip in UT) for 1 cycle at 0°

70% UT (30% dip in UT) for 25 and 30 cycles at 0°

<5% UT (>95% dip in UT) for 5 seconds

0% UT (100% dip in UT) for 250/300 cycles

3 A/m, 30 A/m at 50 and 60 Hz

IEC 61000-4-2

Electrical fast transient/ burst IEC 61000-4-4

Surge IEC 61000-4-5

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

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

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Flyte Charger (REF 0408-655-001) requires continued operation during power mains interruptions, it is recommended that the Flyte Charger (REF 0408655-001) be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic 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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0408-655-700 Rev-AB

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF equipment should be used no closer to any part of the Flyte Charger (REF 0408-655-000 and 0408-655-002), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2√P

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

d=1.2√P 80 MHz to 800 MHz Radiated RF IEC 61000-4-3

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 Flyte Charger (REF 0408-655-000 and 0408-655-002) is used exceeds the applicable RF compliance level above, the Flyte Charger (REF 0408-655-000 and 0408-655-002) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Flyte Charger (REF 0408-655-000 and 0408-655002). a

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

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0408-655-700 Rev-AB

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Conducted RF

3 V 0.15 MHz – 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

80% AM at 1 kHz

IEC 60601-1-2 3rd Edition: Portable and mobile RF equipment should be used no closer to any part of the Flyte Charger (REF 0408-655-001), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

b 3 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz

27 V/m 385 MHz, pulse modulation 18 Hz, Maximum power = 1.8 W

28 V/m 450 MHz, FM ± 5 kHz deviation, 1 kHz sine, Maximum power =2W

9 V/m 710, 745, 780, 5240, 5500, 5785 MHz, pulse modulation 217 Hz, Maximum power = 0.2 W

28 V/m 810, 870, 930 MHz, pulse modulation 18 Hz, Maximum power =2W

28 V/m 1720, 1845, 1970, 2450 MHz, pulse modulation 217 Hz, Maximum power = 2 W

IEC 61000-4-6

Radiated RF IEC 61000-4-3

Recommended separation distance d=1.2√P 150 KHz to 80 MHz 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). IEC 60601-1-2 4th Edition: WARNING: Portable RF equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Flyte Charger (REF 0408-655-001), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 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)

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0408-655-700 Rev-AB

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 Flyte Charger (REF 0408-655-001) is used exceeds the applicable RF compliance level above, the Flyte Charger (REF 0408-655-001) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Flyte Charger (REF 0408-655-001). a

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

IEC 60601-1-2 3rd Edition:

Recommended separation distances between portable and mobile RF equipment and the Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) The Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655-002) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF equipment (transmitters) and the Flyte Charger (REF 0408-655-000, 0408-655-001, and 0408-655002) as recommended below, according to the maximum output power of the equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d=1.2√P

80 MHz to 800 MHz d=1.2√P

800 MHz to 2.5 GHz d=2.3√P

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 JA/ZH/KO SV/DA/FI/PT/NO PL/EL

0408-655-713 0408-655-720 0408-655-730 0408-655-750

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210

2019-07

0408-655-700 Rev-AB

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