Flyte Surgical Helmet Instructions for Use Rev AB March 2020

EN

0408-600-705 Rev-AB

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

Compliance Statements The CE marking affixed to the equipment indicates compliance with the following European Community Regulations: • Medical Device Regulation (EU) 2017/745 • Regulation (EU) 2016/425 - Personal Protective Equipment (PPE) This PPE has been EC-type examined by the following notified body: BSI Group the Netherlands B.B. John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands, BSI 2797 The lenses were developed and tested in accordance with the requirements of BS EN 166: 2002.

Marking Definitions - S1663F CODE

User/Patient Safety WARNINGS: • Before using any component, or any component compatible with this equipment, read and understand the instructions. Pay special 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, operate the equipment and 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. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. • 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 helmet. Install and place the helmet into service according to the EMC information in this manual. Portable and mobile radio frequency (RF) equipment, such as wireless phones, can affect the function of the helmet. 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.

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 surgical helmet. WARNINGS:

DEFINITION

S

Code of Manufacturer, Stryker

166

European Norm Standard - Personal Eye Protection Specification

3

Liquid Droplets

F

Mechanical Strength, Low Energy Impact

Indications For Use The Stryker Flyte Helmets are surgical devices that pull in and circulate fresh air throughout the helmet to aid user comfort.

Contraindications None known.

Limitations of Use

• Use only Stryker-approved components and accessories, including earphones and dictation equipment, unless otherwise specified. • Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the equipment. • DO NOT modify any component or accessory, unless otherwise specified. • DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a single use only. A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. Design features may make cleaning difficult. Reuse may create a serious risk of contamination and may compromise the structural integrity of the single use device resulting in operational failure. Critical product information may be lost if the single use device is re-packaged. Failure to comply may lead to infection or cross-infection and result in patient and/or health care staff injury. The following Stryker-approved accessories are sold separately: DESCRIPTION

REF

Flyte Lithium-Ion Extended Life Power Pack

0408-660-000

• The surgical helmet is not intended to be used as a respiratory protection device. • The materials contained within this device are not known allergens. However, if an allergic reaction occurs, contact a physician.

Flyte Comfort Pads – A set of five disposable pads are installed in the inner helmet to provide additional comfort; eight sets per case

0408-210-000

Flyte Helmet Power Cord

0408-600-300

For Use With

Flyte Helmet Dictation Power Cord – When using a Strykerapproved device such as a dictation recorder or MP3 player, replace the power cord with a dictation power cord.

0408-605-300

SONY Earphone-Right

0400-615-600

SONY Earphone-Left

0400-615-610

PANASONIC Earphone-Right

0400-615-620

PANASONIC Earphone-Left

0400-615-630

WARNINGS:

Rechargeable Flyte Power Pack and the Flyte Power Cord. See Accessories section.

Description In addition to pulling in and circulating fresh air throughout the surgical helmet, each helmet has microphone and speaker capability. Stryker-approved dictation recorders, MP3 players or other compatible communication devices may be connected to the helmet via a communication cord.

2

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.

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0408-600-705 Rev-AB

EN

Features

A

P

B C

D Q E

R

F S

G

H

M N

O

L

T U V

I

J

K

A

Front Flexible Air Duct – This vent channels air to the front of the helmet.

N

Adjustable Air Nozzle Tip – This vent channels air to the user’s back. Rotate the vent to direct flow toward or away from the neck for comfort.

B

Height Adjustment Strap – This strap is adjusted to provide a comfortable fit. Pull to extend or push to retract the length of the strap for fit and comfort.

O

Headband Adjustment Knob – Customize the fit by turning the knob clockwise to tighten and counterclockwise to loosen the headband.

C

Headlight Adjustment Handle – Available on the fiber-optic and batterypowered headlight helmet models only. The handle is used to direct the headlight beam.

P

Fan Intake – The fan pulls in air and circulates the air throughout the helmet.

Q

Fiber-optic Cable – Available on the fiber-optic headlight helmet model only. This cable routes light from the fiber-optic light source to the headlight.

D

Hook – This hook aids in positioning the hood or toga lens on the helmet.

E

Headlight – Available on the fiber-optic and battery-powered headlight helmet models only.

R

Audio Jack – When using a dictation device, use this jack to connect an earphone.

F

Light Shroud – Available on the fiber-optic and battery-powered headlight helmet models only. The shroud prevents glare from the shield and may be trimmed or removed as desired.

S

Power Cable – This built-in cable is compatible with the power cord and holster combination, and the dictation power cord.

G

Microphone Indicator Light – Illuminates green while the microphone is on.

T

H

Power Loss Indicator Light – Flashes on and off red when the power pack has a reduced amount of power remaining.

Power Cord with Holster – This cord is supplied with all helmet models. The holster holds standard and extended life power packs. The holster swivels to hang from your waist band for either left or right handed access.

U

I

Variable Control Buttons – Press these buttons to select a fan speed level. There are six speed levels available. For helmets with a batterypowered headlight, press both buttons simultaneously until the light turns on or off, as desired.

Power Cable Plug – This plug is used to connect to the appropriate power cord. See the Accessories section.

V

ACMI Fiber-optic Cable Plug with Cap – Available on the fiber-optic headlight helmet model only. This plug is used to connect to an ACMI compatible fiber-optic light source.

J

Microphone – A built-in microphone provides voice transmission to compatible devices such as a dictation recorder.

K

Microphone Button – Press this button to toggle the microphone on and off (mute).

L

Attachment Points (two magnets) – These magnets secure the disposable hood or toga lens to the helmet.

M

Comfort Pads – These removable pads provide a comfortable fit.

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

Increase Air Flow

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Decrease Air Flow

Microphone Mute

General Warning Sign

Refer to Instruction Manual/ booklet

Direct Current (DC)

3

EN

0408-600-705 Rev-AB

Instructions WARNINGS: • Perform 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. • This equipment is suitable to use in a professional healthcare facility environment. • ALWAYS wear the surgical helmet with a surgical toga or surgical hood to obtain the required personal protection. • DO NOT cut or puncture the fiber-optic cable. • ALWAYS turn the light source power off before connecting or disconnecting the fiber-optic cable to or from the source. • ALWAYS hold the strain relief near the end of the fiber-optic cable when connecting or disconnecting the cable from the light source. CAUTIONS: • DO NOT scratch the headlight lens. • DO NOT stretch or kink the fiber-optic cable. Failure to comply will damage the cable and reduce the light output permanently. • If using a dictation recorder or MP3 player, ALWAYS make sure the device has standard 3.5 mm port(s). Failure to comply may result in helmet or accessory damage. NOTE: Helmet position will vary from person to person depending on head size and personal comfort preferences.

To Don a Surgical Helmet WARNING: DO NOT connect the power cable plug to the power pack before donning the helmet. NOTE: ALWAYS perform the following steps in sequence. Failure to comply may cause the red power loss indicator to flash. See the Troubleshooting section. 1. Apply the comfort pads inside the helmet as required (figure 1). 2. Connect the helmet power cable to the appropriate power cord (figures 2 and 2a). See the Accessories section. NOTES: • To disconnect the power cord, pull the connector sleeve back before separating the connector plug and receptacle (figure 2). • If using a dictation power cord, connect the pink-band plug into the microphone receptacle and the green-band plug into the speaker receptacle (figure 2a). Only one connector plug may be used based on the recorder or player receptacles available. • If using a dictation recorder or MP3 player, connect a earphone to the helmet audio jack (figure 2b as required). See the Accessories section. 3. Loosen the headband adjustment knob (figure 3). CAUTION: DO NOT pull to extend or push to retract the front flexible air duct. Failure to comply may result in product damage. 4. Put the helmet on your head while extending the height adjustment strap for a comfortable fit (figure 4). 5. Turn the headband knob to secure the helmet (figure 5). NOTES: • Make sure the helmet fits securely on top of your head. • Make sure the face mask ties are accessible to allow easy removal of the face mask when donning the hood or toga. WARNING: Keep your fingers away from the fan during operation. 6. Slide a fully charged power pack into the holster by aligning the grooves on the power pack with the holster. The power pack will snap into place (figure 6). NOTES: • Make sure the indicator lights momentarily flash and the fan turns on automatically. See the Troubleshooting section if required. • If using a helmet with a battery-powered headlight, install an extended life power pack into the holster. 7. Hang the holster from your waistband and swivel the holster to the desired orientation (figure 7). 8. Press the variable control buttons to adjust the fan speed for optimal air flow. See the Troubleshooting section if required (figure 8). 9. Rotate the adjustable air nozzle tip for optimal air flow (figure 9).

4

NOTES: • If using a dictation recorder or MP3 player, see the instructions for use supplied with the device for volume adjustment, then place the earphone in your ear (figure 2b). • You are now ready to scrub for surgery and don a hood or toga. See the instructions for use supplied with the hood or toga. • If the face shield lens begins to fog during use, see the Troubleshooting section.

To Use a Surgical Helmet with a Headlight To Use a Fiber-optic Headlight CAUTIONS: • ALWAYS remove the protective cap from the plug of the ACMI fiber-optic cable before installing the plug into the fiber-optic light source receptacle. • ALWAYS put the protective cap onto the plug of the ACMI fiber-optic cable after use and before storage. NOTES: • If using a fiber-optic headlight, turn the light beam on and off and adjust the brightness at the light source. See the instructions for use supplied with the light source. • A clamp may be used to fasten the fiber-optic cable to the gown to support the weight of the cable. 1. Remove the protective cap on the male plug of the ACMI fiber-optic cable and install the plug into any compatible ACMI fiber-optic light source receptacle (figure A). 2. Adjust the headlight beam direction with the headlight adjustment handle (figure C). To Use a Battery-powered Headlight NOTE: Using the battery-powered headlight will decrease the power pack capacity by half. See the instructions for use supplied with the power pack for capacity values. 1. Make sure a power pack is installed. 2. Press both variable air flow control buttons simultaneously until the light turns on or off, as desired (figure B). 3. Adjust the headlight beam direction with the headlight adjustment handle (figure C).

To Doff a Surgical Helmet 1. Flex the tab back to release the power pack, then lift the power pack from the holster (figure D). 2. Loosen the headband knob and remove the helmet from your head. 3. Remove and discard the comfort pads from the helmet. Clean the helmet and cord. See the Cleaning section. To clean the power pack, see the instructions for use supplied with the Flyte charger.

Inspection and Testing WARNINGS: • Only individuals trained and experienced in the maintenance of reusable medical devices should inspect and test this equipment. • 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. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. INTERVAL

INSPECTION CRITERIA

ACTION

Before Use

Inspect equipment for damage, wear, or missing components.

If damage is apparent, replace the equipment.

Inspect power cord and fiber-optic cable for cuts or punctures. Inspect headlight lens for scratches. Inspect the power pack housing for cracks. Check fan motor for excessive noise. NOTE: If any component must be discarded, see the Disposal/Recycle section.

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0408-600-705 Rev-AB

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Instructions Figures

1

3

2

4

2a

5

2b

6

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5

EN

0408-600-705 Rev-AB

Instructions Figures (continued)

7

A

8

B

9

C

D

6

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0408-600-705 Rev-AB

Cleaning

EN

Troubleshooting

WARNINGS: • ALWAYS remove the power pack, any type power cord, earphone, and comfort pads from the helmet before cleaning. • DO NOT sterilize any component. CAUTIONS: • DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified. • DO NOT allow liquids or moisture into the fan or electrical connections of the helmet. • DO NOT allow debris to enter the helmet fan. NOTES: • The cord may be the power cord or the dictation power cord. • To clean the power pack, see the instructions for use supplied with the Flyte charger.

WARNING: DO NOT service this equipment, unless otherwise specified. If you require service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

ACTION

The face shield lens is fogging.

Not enough airflow is circulating throughout the helmet.

Press the variable control buttons to increase the fan speed if possible.

The power pack requires replacement.

Replace the power pack with a fully charged power pack.

The helmet is damaged.

Replace the helmet.

The power pack requires replacement.

Replace the power pack with a fully charged power pack.

The power cord with holster is damaged.

Replace the power cord with holster.

The helmet is damaged.

Replace the helmet.

The helmet will not allow airflow adjustment.

The helmet is damaged.

Replace the helmet.

Storage and Handling

The fan fails to provide enough or any airflow.

The fan speed is not adjusted correctly.

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.

Press the variable control buttons to increase the fan speed.

The helmet is damaged.

Replace the helmet.

The green microphone indicator flashes rapidly for several seconds.

The power pack may be dislodged or the fan may be experiencing physical interference.

Make sure the power pack is secure in the holster. Remove any fan obstruction.

The red power loss indicator light flashes on and off.

The steps within the To Don a Surgical Helmet section were performed out of sequence.

See the To Don a Surgical Helmet section and perform the steps in sequence.

The power pack requires replacement.

Replace the power pack with a fully charged power pack to prevent the loss of air circulation in the helmet.

Electrical noise is present.

Turn off all the electrical equipment not in use in the room.

To Clean the Surgical Helmet and Cord 1. Remove all the accessories from the helmet. Discard the comfort pads. 2. Wipe the helmet, cord, and power pack holster with a soft cloth dampened with a nonabrasive, hospital disinfectant. 3. Dry the equipment with a lint-free towel or medical-grade compressed air. 4. Clean the headlight lens with lens tissue. See the instructions for use supplied with the lens tissue. 5. See the Storage and Handling section.

Disposal/Recycle WARNING: ALWAYS follow the current local recommendations and/or regulations governing environmental protection and 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.

The indicator lights fail to flash and/or the fan fails to turn on during start up.

Sporadic electrical interference is experienced.

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

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EN

0408-600-705 Rev-AB

Specifications Model:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Description:

Flyte Helmet

Flyte Helmet with Fiber-optic Headlight

Flyte Helmet with Battery-powered Headlight

Not Applicable

European Conformity: Mass:

0.47 kg [16.6 oz]

0.68 kg [24.0 oz]

0.52 kg [18.3 oz]

Fiber-optic Cable Length:

Not Applicable

3.05 m [10 ft]

Not Applicable

Fan Speed:

2,250 - 3,500 rpm

Input Voltage:

6 - 8.4 V

Ingress Protection (IP):

IPX0

Mode of Operation:

Continuous

Product Safety Certification:

CSA International International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation Humidity Limitation Atmospheric Pressure Limitation

8

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0408-600-705 Rev-AB

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Specifications Guidance and manufacturer's declaration - electromagnetic emissions Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment specified below. The customer or the user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment.

Harmonic emissions IEC 61000-3-2

Not Applicable

Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are suitable for use in all establishments other than domestic, and may be used in 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

Not Applicable

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 Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 or shielding the location.

Guidance and manufacturer's declaration - electromagnetic immunity Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment specified below. The customer or the user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

3 V 0.15 MHz – 80 MHz

3 V 0.15 MHz – 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

80% AM at 1 kHz

80% AM at 1 kHz

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

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

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 = 2 W

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

IEC 60601-1-2 3rd Edition: Portable and mobile RF equipment should be used no closer to any part of the Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000, 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 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).

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

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 = 2 W

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

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

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

Radiated RF IEC 61000-4-3

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 Helmet REF 0408-600-000, 0408-635000, or 0408-645-000, 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) 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 Helmet REF 0408-600-000, 0408-635-000, and 0408-645-000 are used exceeds the applicable RF compliance level above, the Flyte Helmet REF 0408-600-000, 0408-635-000, and 0408-645-000 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 Helmet REF 0408-600-000, 0408-635-000, and 0408-645-000. a

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

b

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EN

0408-600-705 Rev-AB

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic immunity Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment specified below. The customer or the user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 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

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 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 at 100 kHz repetition frequency for power supply lines ± 1 kV at 100 kHz repetition frequency for input/output lines

Not Applicable

Not Applicable

Surge IEC 61000-4-5

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

Not Applicable

Not Applicable

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

Not Applicable

Not Applicable

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

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

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

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

NOTE: UT is the a.c. mains voltage prior to application of the test level. IEC 60601-1-2 3rd Edition: Recommended separation distances between portable and mobile RF equipment and the Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF equipment (transmitters) and Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 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

80 MHz to 800 MHz

800 MHz to 2.5 GHz

W

d=1.2√P

d=1.2√P

d=2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.74

1

1.2

1.2

2.3

10

3.8

3.8

7.4

100

12

12

23

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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0408-600-705 Rev-AB

ES

Especificaciones Modelo:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Descripción:

Casco Flyte (Flyte Helmet)

Casco Flyte con luz de fibra óptica (Flyte Helmet with Fiber-optic Headlight)

Casco Flyte con luz alimentada por batería (Flyte Helmet with Battery-powered Headlight)

No aplicable

Conformidad europea: Masa:

0,47 kg

0,68 kg

0,52 kg

Longitud del cable de fibra óptica:

No aplicable

3,05 m

No aplicable

Velocidad del ventilador:

2250 - 3500 rpm

Voltaje de entrada:

6 - 8,4 V

Protección de ingreso (PI):

IPX0

Modo de funcionamiento:

Continuo

Certificación de seguridad del producto:

CSA International

International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) Condiciones ambientales:

Funcionamiento

Almacenamiento y transporte

Límite de temperatura: Límite de humedad: Límite de presión atmosférica:

www.stryker.com

17

DE

0408-600-705 Rev-AB

Technische Daten Modell:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Beschreibung:

Flyte Helm (Flyte Helmet)

Flyte Helm mit Fiberoptik-Stirnlampe (Flyte Helmet with Fiber-optic Headlight)

Flyte Helm mit akkubetriebener Stirnlampe (Flyte Helmet with Battery-powered Headlight)

Nicht zutreffend

CE-Zeichen: Masse:

0,47 kg

0,68 kg

0,52 kg

Länge des Fiberoptik-Kabels:

Nicht zutreffend

3,05 m

Nicht zutreffend

Ventilatorgeschwindigkeit:

2.250 - 3.500 U/min

Eingangsspannung:

6 - 8,4 V

Schutz vor Eindringen (IP):

IPX0

Betriebsart:

Kontinuierlich

Produktsicherheitszertifizierung: CSA International

International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) Umgebungsbedingungen:

Betrieb

Aufbewahrung und Transport

Temperaturbereich:

Feuchtigkeitsbereich:

Luftdruckbereich:

26

www.stryker.com

0408-600-705 Rev-AB

FR

Caractéristiques techniques Modèle :

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Description:

Casque Flyte (Flyte Helmet)

Casque Flyte avec lampe frontale à fibres optiques (Flyte Helmet with Fiber-optic Headlight)

Casque Flyte avec lampe frontale alimentée par batterie (Flyte Helmet with Battery-powered Headlight)

Non applicable

Conformité européenne : Masse :

0,47 kg

0,68 kg

0,52 kg

Longueur du câble à fibres optiques :

Non applicable

3,05 m

Non applicable

Vitesse du ventilateur :

2 250 - 3 500 tr/min

Tension alimentation :

6 - 8,4 V

Indice de protection (IP) :

IPX0

Mode de fonctionnement :

Continu

Certification de la sécurité du produit :

CSA International

International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) Conditions ambiantes :

Fonctionnement

Stockage et transport

Limite de température : Limite d’humidité : Limite de pression atmosphérique :

www.stryker.com

35

IT

0408-600-705 Rev-AB

Caratteristiche tecniche Modello:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Descrizione:

Caschetto Flyte (Flyte Helmet)

Caschetto Flyte con faretto a fibre ottiche (Flyte Helmet with Fiber-optic Headlight)

Caschetto Flyte con faretto alimentato a batteria (Flyte Helmet with Battery-powered Headlight)

Non pertinente

Conformità alle norme europee: Massa:

0,47 kg

0,68 kg

0,52 kg

Lunghezza del cavo a fibre ottiche:

Non pertinente

3,05 m

Non pertinente

Velocità della ventola:

2.250 - 3.500 giri/min

Tensione in ingresso:

6 - 8,4 V

Protezione da infiltrazioni (IP):

IPX0

Modalità operativa:

Continua

Certificazione della sicurezza del prodotto:

CSA International

International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) Condizioni ambientali:

Funzionamento

Conservazione e trasporto

Limite di temperatura:

Limite di umidità: Limite di pressione atmosferica:

44

www.stryker.com

0408-600-705 Rev-AB

NL

Specificaties Model:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Beschrijving:

Flyte-helm (Flyte Helmet)

Flyte-helm met vezeloptische hoofdlamp (Flyte Helmet with Fiberoptic Headlight)

Flyte-helm met batterijgevoede hoofdlamp (Flyte Helmet with Battery-powered Headlight)

Niet van toepassing

Europese conformiteit: Massa:

0,47 kg

0,68 kg

0,52 kg

Lengte van de vezeloptische kabel:

Niet van toepassing

3,05 m

Niet van toepassing

Ventilatorsnelheid:

2.250 - 3.500 rpm

Ingangsspanning:

6 - 8,4 V

IP-code (bescherming tegen binnendringing):

IPX0

Bedrijfsmodus:

Continu

Veiligheidscertificatie van product:

CSA International

International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) Omgevingscondities:

Bedrijf

Opslag en vervoer

Temperatuurlimieten:

Vochtigheidslimieten:

Limieten atmosferische druk:

www.stryker.com

53

SV

0408-600-705 Rev-AB

Specifikationer Modell:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Beskrivning:

Flyte-hjälm (Flyte Helmet)

Flyte-hjälm med fiberoptisk pannlampa (Flyte Helmet with Fiber-optic Headlight)

Flyte-hjälm med batteridriven pannlampa (Flyte Helmet with Battery-powered Headlight)

Ej tillämpligt

Överensstämmelse med europeiska krav: Massa:

0,47 kg

0,68 kg

0,52 kg

Fiberoptiska kabelns längd:

Ej tillämpligt

3,05 m

Ej tillämpligt

Fläkthastighet:

2 250 - 3 500 varv/min

Ingångsspänning:

6 - 8,4 V

Intrångsskydd (IP):

IPX0

Driftssätt:

Kontinuerligt

Certifiering av produktsäkerhet:

CSA International International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)

Omgivningsförhållanden:

Drift

Förvaring och transport

Temperaturbegränsning:

Fuktighetsbegränsning: Begränsning av atmosfärstryck:

62

www.stryker.com

0408-600-705 Rev-AB

DA

Specifikationer Model:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Beskrivelse:

Flyte-hjelm (Flyte Helmet)

Flyte-hjelm med fiberoptisk pandelampe (Flyte Helmet with Fiber-optic Headlight)

Flyte-hjelm med batteridrevet pandelampe (Flyte Helmet with Battery-powered Headlight)

Ikke relevant

CE-mærke: Masse:

0,47 kg

0,68 kg

0,52 kg

Fiberoptikkabel, længde:

Ikke relevant

3,05 m

Ikke relevant

Ventilatorhastighed:

2.250 - 3.500 o/min.

Indgangsspænding:

6 - 8,4 V

Beskyttelse mod indtrængende vand:

IPX0

Driftsform:

Kontinuerlig

Certificering af produktsikkerhed:

CSA International International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)

Miljøforhold:

Drift

Opbevaring og transport

Temperaturbegrænsning:

Fugtbegrænsning: Grænse for atmosfærisk tryk:

www.stryker.com

71

FI

0408-600-705 Rev-AB

Tekniset tiedot Malli:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Kuvaus:

Flyte-kypärä (Flyte Helmet)

Kuituoptisella otsalampulla varustettu Flyte-kypärä (Flyte Helmet with Fiber-optic Headlight)

Akkukäyttöisellä otsalampulla varustettu Flytekypärä (Flyte Helmet with Battery-powered Headlight)

Ei soveltuva

Eurooppalainen vaatimustenmukaisuus: Massa:

0,47 kg

0,68 kg

0,52 kg

Valokaapelin pituus:

Ei soveltuva

3,05 m

Ei soveltuva

Tuulettimen nopeus:

2 250–3 500 kierrosta minuutissa

Tulojännite:

6 – 8,4 V

Nestesuoja:

IPX0

Käyttötapa:

Jatkuva

Tuotteen turvallisuushyväksyntä:

CSA International International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)

Ympäristöolosuhteet:

Käyttö

Säilytys ja kuljetus

Lämpötilarajoite:

Kosteusrajoite:

Ilmanpainerajoitus:

80

www.stryker.com

0408-600-705 Rev-AB

PT

Especificações Modelo:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Descrição:

Capacete Flyte (Flyte Helmet)

Capacete Flyte com lanterna frontal de fibra óptica (Flyte Helmet with Fiber-optic Headlight)

Capacete Flyte com lanterna frontal alimentada por bateria (Flyte Helmet with Battery-powered Headlight)

Não aplicável

Conformidade europeia: Massa:

0,47 kg

0,68 kg

0,52 kg

Comprimento do cabo de fibra óptica:

Não aplicável

3,05 m

Não aplicável

Velocidade da ventoinha:

2.250 - 3.500 rpm

Tensão de entrada:

6 - 8,4 V

Protecção contra entrada (IP):

IPX0

Modo de funcionamento:

Contínuo

Certificação da segurança do produto:

CSA International

International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) Condições ambientais:

Funcionamento

Armazenamento e transporte

Limites de temperatura:

Limites de humidade: Limites de pressão atmosférica:

www.stryker.com

89

NO

0408-600-705 Rev-AB

Spesifikasjoner Modell:

REF 0408-600-000

REF 0408-635-000

REF 0408-645-000

Beskrivelse:

Flyte-hjelm (Flyte Helmet)

Flyte-hjelm med fiberoptisk hodelampe (Flyte Helmet with Fiber-optic Headlight)

Flyte-hjelm med batteridrevet hodelampe (Flyte Helmet with Battery-powered Headlight)

Ikke relevant

Europeisk samsvar: Masse:

0,47 kg

0,68 kg

0,52 kg

Lengde på fiberoptisk kabel:

Ikke relevant

3,05 m

Ikke relevant

Viftehastighet:

2250 – 3500 o/min

Inngangsspenning:

6 – 8,4 V

Tetthetsgrad (IP):

IPX0

Driftsmodus:

Kontinuerlig

Sikkerhetssertifisering for produktet:

CSA International International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012) European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, 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); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)

Miljømessige forhold:

Drift

Oppbevaring og transport

Temperaturbegrensning:

Fuktighetsbegrensning: Atmosfærisk trykkbegrensning:

98

www.stryker.com