Turbo 5 (T5) Surgical Helmet System Ref 0400-6xx-000 Instructions for Use Rev J

EN

0400-610-701 Rev-J

Introduction

Description

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, including safety information, or in-service training is required, contact your Stryker sales representative or call Stryker customer service. Trademarks not the property of Stryker Corporation are the property of their respective owners.

In addition to pulling in and circulating fresh air throughout the helmet, these helmets may be equipped with a fiber-optic headlight or a battery-powered headlight.

Compliance Statements The CE marking affixed to the equipment indicates compliance with the following European Community Directives: • Directive 93/42/EEC – Medical Device • Directive 89/686/EEC - Personal Protective Equipment (PPE) This PPE has been EC-type examined by the following notified body: BSI Kitemark House, Maylands Avenue, Hemel Hempstead, HP2 4SQ, UK, BSI 0086 The lenses were developed and tested in accordance with the requirements of BS EN 166: 2002.

Marking Definitions - S1663F CODE

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 T5 Surgical Helmets are surgical devices that pull in and circulate fresh air throughout the helmet to aid user comfort.

Contraindications None known.

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

For Use With Only T4/T5 Power Packs are designed to be used with these helmets. The T4/T5 Charger is used to charge T4/T5 Power Packs.

2

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, 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 T5 Surgical Helmet. Install and place the helmet into service according to the EMC information in this manual. Portable and mobile RF communications equipment can affect the function of the helmet. 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. • Using other electronic accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. • 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

T4 Sweat Bands (non-sterile, 36 per pack)

0400-205-000

T5 Viscoelastic Foam Sweat Bands (nonsterile, 24 per pack)

0400-210-000

T4/T5 Power Pack

0400-650-000

NOTES: • A set of four thin foam comfort pads is included with your helmet to accommodate various head sizes. • For more information or a complete list of accessory information, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

www.stryker.com

0400-610-701 Rev-J

EN

Features H A I B C D

E

J

F

K N

G

M L

A

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

B

Adjustable Strap (removable) – This strap is used to provide a comfortable fit.

C

Sweat Bands (four) – These removable bands provide a comfortable fit.

D

Shield Clip – This clip 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.

F

Hook and Loop Strips (four) – These strips secure the disposable hood or toga lens to the helmet chin bar.

G

Headband – This headband is adjusted to provide a comfortable fit.

H

Variable Flow Control Buttons – Press these buttons to select a fan speed level. There are eight speed levels available. For helmets with a battery-powered headlight, press and hold both buttons simultaneously until the light turns on or off, as desired.

I

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

M

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

N

Adjustable Air Nozzle Tips (two) – These vents channel air to the user’s back. Rotate the vents to direct flow toward or away from the neck for comfort.

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. SYMBOL

DEFINITION Increase Airflow

Decrease Airflow

Variable Flow Control

Variable Flow Control

Shield Clip

Shield Clip

J

Power Cable Plug – This plug is used to connect to the power pack.

Headlight Direction Adjustment

K

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.

General Warning Sign

L

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.

Refer to Instruction Manual/Booklet

Consult Instructions for Use

Direct Current (DC)

www.stryker.com

3

EN

0400-610-701 Rev-J

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. • 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. 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.

To Use a Battery-powered Headlight (continued) 2. Adjust the headlight beam direction with the headlight adjustment handle (figure B). 3. Press and hold both variable flow control buttons simultaneously until the light turns on or off, as desired (figure C).

To Doff a Surgical Helmet 1. Disconnect the power cable plug from the power pack and remove the power pack from your waistband. 2. Loosen the headband knob and remove the helmet from your head. 3. Remove and discard the sweat bands from the helmet. Clean the helmet and cord. See the Cleaning section.

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 the equipment for damage, wear, or missing components.

If damage is apparent, replace the equipment.

1. Apply the four sweat bands inside the helmet as required (figure 1). 2. Loosen the headband adjustment knob (figure 2). 3. Place the helmet on your head. Make sure your face is fully visible and the bottom of the helmet is parallel to the floor (figure 3). NOTE: Make sure the face mask ties are accessible to allow easy removal of the face mask when donning the hood or toga. 4. Turn the headband adjustment knob to secure the helmet for a comfortable fit (figure 4). WARNING: Keep your fingers away from the fan during operation. 5. Push the power cable plug into the power pack until it snaps into place (figure 5). The helmet fan will start automatically and the headlight will illuminate, if included. 6. Hang the power pack from your waistband (figure 6). 7. Press the variable flow control buttons to adjust the fan speed for optimal air flow (figure 7). See the Troubleshooting section if required. 8. Rotate the adjustable air nozzle tips for optimal air flow (figure 8). NOTES: • 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 Helmet with a 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. To Use a Fiber-optic Headlight 1. Connect the ACMI fiber-optic cable plug (male) into any compatible ACMI fiber-optic light source receptacle (figure A). 2. Adjust the headlight beam direction with the headlight adjustment handle (figure B). To Use a Battery-powered Headlight 1. Make sure a power pack is installed. 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. 4

Inspect the power cord and fiberoptic cable for cuts or punctures. Inspect the 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.

Cleaning WARNINGS: • ALWAYS remove the power pack from the helmet before cleaning. • DO NOT immerse any component in liquid. • 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. NOTE: To clean the power pack, see the instructions for use supplied with the charger.

To Clean the Helmet and Cord 1. Remove all the accessories from the helmet. Discard the sweat bands. 2. Wipe the helmet 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.

www.stryker.com

0400-610-701 Rev-J

EN

Instructions Figures

1

5

A

2

6

B

3

7

C

4

8

www.stryker.com

5

EN

0400-610-701 Rev-J

Troubleshooting

Storage and Handling

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 flow 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 fan speed is not adjusted correctly.

Press the variable flow control buttons to increase the fan speed.

The helmet is damaged.

Replace the helmet.

Electrical noise is present.

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

The fan fails to provide enough or any airflow.

Sporadic electrical interference is experienced.

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 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 the equipment 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.

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.

6

www.stryker.com

0400-610-701 Rev-J

EN

Specifications Model:

REF 0400-610-000

REF 0400-635-000

REF 0400-645-000

Description:

T5 Surgical Helmet

T5 Surgical Helmet with Fiber-optic Headlight

T5 Surgical Helmet with Battery-powered Headlight

European Conformity:

Not Applicable

Dimensions: Length: 34.5 cm [13.6 inch]

34.5 cm [13.6 inch]

34.5 cm [13.6 inch]

Width: 22.3 cm [8.78 inch]

22.3 cm [8.78 inch]

22.3 cm [8.78 inch]

Height: 32.5 cm [12.8 inch]

32.5 cm [12.8 inch]

32.5 cm [12.8 inch]

Mass:

0.56 kg [1.2 lb]

0.79 kg [1.7 lb]

0.67 kg [1.5 lb]

Fiber-optic Cable Length:

Not Applicable

3.05 m [10 feet]

Not Applicable

Fan Speed:

2,400 - 4,400 rpm

Input Voltage:

6V

Ingress Protection (IP):

IPX0

Mode of Operation:

Continuous

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 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) 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 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) 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:

www.stryker.com

7

EN

0400-610-701 Rev-J

Specifications Guidance and manufacturer's declaration - electromagnetic emissions The T5 Surgical Helmet (REF 0400-610-000) and the T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) are intended for use in the electromagnetic environment specified below. The customer or the user of the T5 Surgical Helmet (REF 0400-610-000) and the T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The T5 Surgical Helmet (REF 0400-610-000) and T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) 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. The T5 Surgical Helmet (REF 0400-610-000) and T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) are suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

RF emissions

Class A

Harmonic emissions IEC 61000-3-2

Not Applicable

Voltage fluctuations/flicker emissions IEC 61000-3-3

Not Applicable

Guidance and manufacturer's declaration - electromagnetic immunity The T5 Surgical Helmet (REF 0400-610-000) and T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) are intended for use in the electromagnetic environment specified below. The customer or the user of the T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400635-000) should assure that it is used in such an environment. Immunity test

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 T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000), 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

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

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 T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) are used exceeds the applicable RF compliance level above, the T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000). b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. a

8

www.stryker.com

0400-610-701 Rev-J

EN

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic immunity The T5 Surgical Helmet (REF 0400-610-000) and T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) are intended for use in the electromagnetic environment specified below. The customer or the user of the T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400635-000) 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

±6 kV contact ±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

Not Applicable

Not Applicable

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±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 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s

Not Applicable

Not Applicable

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristics 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.

Recommended separation distances between portable and mobile RF communications equipment and the T5 Surgical Helmet (REF 0400-610-000) or the T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) The T5 Surgical Helmet (REF 0400-610-000) and T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the T5 Surgical Helmet (REF 0400-610-000) or T5 Surgical Helmet with Fiber-optic Headlight (REF 0400-635-000) as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

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

80 MHz to 800 MHz

800 MHz to 2.5 GHz

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

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

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.

www.stryker.com

9

EN

0400-610-701 Rev-J

Specifications Guidance and manufacturer's declaration - electromagnetic emissions The T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) are intended for use in the electromagnetic environment specified below. The customer or the user of the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

Class B

Harmonic emissions IEC 61000-3-2

Not Applicable

The T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) are suitable for use in all establishments including domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Not Applicable

Guidance and manufacturer's declaration - electromagnetic immunity The T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) are intended for use in the electromagnetic environment specified below. The customer or the user of the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) should assure that it is used in such an environment. Immunity test

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 T5 Surgical Helmet with Batterypowered Headlight (REF 0400-645-000), 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

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

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 T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) are used exceeds the applicable RF compliance level above, the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000). b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. a

10

www.stryker.com

0400-610-701 Rev-J

EN

Specifications (continued) Guidance and manufacturer's declaration - electromagnetic immunity The T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) are intended for use in the electromagnetic environment specified below. The customer or the user of the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) 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

±6 kV contact ±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

Not Applicable

Not Applicable

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±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 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s

Not Applicable

Not Applicable

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristics 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.

Recommended separation distances between portable and mobile RF communications equipment and the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) The T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the T5 Surgical Helmet with Battery-powered Headlight (REF 0400-645-000) 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

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.

www.stryker.com

11

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 2014-06

0400-610-701 Rev-J

www.stryker.com