Instructions for Use
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T7™ Surgical Helmet Instructions For Use T7 Surgical Helmet 0416-600-000
T7 Surgical Helmet with LED Headlight 0416-610-000
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Table of Contents Important Information ...2 Using this Manual...2 Contact Information ...2 User Profile...2 Patient Profile ...2 Safety Directives ...2 Indications For Use ...2 Contraindications ...2 Limitations of Use...2 Product Overview ...3 For Use With...3 System Description ...3 Definitions ...4 Features...5 Using Your Product ...6 To Don the Helmet ...6 To Doff the Helmet ...8 To Clean ...9 References...10 Troubleshooting ...10 Disposal/Recycle ...10 Specifications ...11 Electromagnetic Compatibility ...11 Compliance Statements...13
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Important Information Using this Manual This manual is the most comprehensive source of information for the safe, effective, and compliant use and/ or maintenance of your product. This product is intended for use by trained and experienced healthcare professionals only. Read and understand this manual before using the product or any component compatible with the product. Contact Stryker for training as needed. This manual is a permanent part of the product. Keep this manual for future reference. The following signal words may be used throughout this manual: W A R N I N G - Highlights a safety-related issue. Always comply with this information to prevent patient and/or healthcare staff injury. C A U T I O N - Highlights a product reliability issue. Always comply with this information to prevent product damage. N o t e - Supplements and/or clarifies procedural information.
component of an overall personal protective barrier between the patient and healthcare provider. The Stryker T7 Personal Protective Equipment (PPE) system is intended to be used with a patient population including both male and females of all ages, with general medical conditions.
Safety Directives WARNING • Healthcare professionals should be thoroughly familiar with the instructions for use and the operation of this product prior to use. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this product and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. • Take special precautions regarding electromagnetic compatibility (EMC) when using this product. Install and/or put this product into service per the EMC information contained in this manual. Portable and mobile radio frequency (RF) equipment can affect the function of this product.
Contact Information Indications For Use Stryker Representative 1-269-323-7700, 1-800-253-3210
The Stryker T7 Surgical Helmet is a surgical device that pulls in and circulates fresh air throughout the helmet to aid user comfort.
Contraindications None known.
www.stryker.com
Limitations of Use N o t e - 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.
User Profile The Stryker T7 Surgical Helmet is intended to be worn by healthcare and operating room personnel such as surgeons, scrub technicians, scrub nurses, and surgical assistants.
Patient Profile The T7 Surgical Helmet is not intended to act on or come into direct contact with a patient, but to act as a
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WARNING • The T7 PPE is NOT intended to be used as a respiratory protection system. • The materials contained in this device are NOT known allergens. However, if an allergic reaction occurs, contact a physician. • The T7 Surgical Helmet is limited to professional use within a professional healthcare environment, including near high frequency (HF) surgical equipment and accessories. See the Electromagnetic Compatibility (page 11) section. • The T7 Surgical Helmet contains magnets located on the chinbar. If you have a pacemaker, implantable cardioverter–defibrillator (ICD), or other implantable device, please consult with your physician before using this helmet.
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Product Overview For Use With WARNING • Use only Stryker-approved electronic components and accessories. Failure to comply may result in degraded performance, increased electromagnetic emissions, or decreased electromagnetic immunity of the system. See the Electromagnetic Compatibility (page 11) section. • Use only Stryker-approved components and accessories, unless otherwise specified.
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Note • The Stryker T7 Surgical Helmet is a component of the Stryker Personal Protection System, and is intended to be used in combination with, and worn under a T7 Hood or Toga. • Contact Stryker for a complete list of accessories. System Components
REF
T7 Comfort Pads
0416-210-000
T7 Power Cord (and holster)
0416-600-500
Flyte Lithium-ion Extended Life Power Pack (rechargeable)
0408-660-000
Flyte Charger, 120 V
0408-655-000
Flyte Charger, 230 V
0408-655-001
Flyte Charger, 100 V
0408-655-002
The Stryker T7 PPE system includes a surgical helmet with a power pack, a disposable surgical gown (toga or hood), and a power pack (battery). The system is intended to be used in a healthcare facility, specifically an operating room (OR) environment. The power pack is recharged using a power pack charger.
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Figure 1 – T7 Personal Protective Equipment System Overview
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A i r I n t a k e - The fan speed is adjustable and pulls fresh air in and circulates the air within the helmet and surgical gown.
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S u r g i c a l H e l m e t - The surgical helmet acts as a physical support structure and aircirculator when used with a disposable surgical gown (toga or hood). The surgical helmet is supplied non-sterile and is a reusable device.
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S u r g i c a l G o w n ( T o g a o r H o o d ) - The disposable surgical gown protects the wearer and patient from infectious material transfer. See the For Use With (page 3) section.
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C O 2 E x h a u s t - The fan reduces CO2 buildup within the surgical helmet and disposable surgical gown. Variable control buttons are used to adjust and control the fan speed and resulting airflow.
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P o w e r P a c k C h a r g e r - The power pack (battery) charger is used to recharge eight power packs simultaneously. See the For Use With (page 3) section.
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P o w e r S o u r c e - The power pack (battery) provides electrical energy to the helmet’s fan and headlight. The power pack holster (holds power pack) with cord and plug is connected to the helmet. See the For Use With (page 3) section.
System Description
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Definitions
Product Symbols
N o t e - 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 product.
Directional Arrows (head strap adjustment knobs) Headlight ON/OFF Control (if headlight is present); Airflow INCREASE/DECREASE Control (chinbar)
Labeling Symbols CSA Group certification mark for United States and Canada. These products were tested and meet medical electrical equipment certification requirements, including compliance with applicable 60601 series standards. For additional information, contact Stryker. See the Contact Information (page 2) section. Product Symbols Increase Air Flow (chinbar button) Decrease Air Flow (chinbar button)
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Pause Control (chinbar button)
Product Indicators Low Battery Power (amber) - Illuminates when power pack electrical energy is less than 20%. Pause Control (green) - After the power pack is connected, one green blink indicates the helmet is operational. Continuous green blinking indicates the helmet is in a paused state.
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Features B
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Figure 2 – Surgical Helmet and Power Pack Holster A
F a n - The fan pulls in and circulates fresh air throughout the helmet and surgical gown or hood to aid in cooling and comfort.
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P a u s e C o n t r o l I n d i c a t o r - The green indicator blinks once to confirm helmet functionality and continuously blinks to confirm a paused state. The fan and headlight (if present) may be temporarily turned off in a paused state.
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H e a d l i g h t A d j u s t m e n t H a n d l e - The handle (if present) is used to direct the headlight beam to the surgical site.
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L o w B a t t e r y P o w e r I n d i c a t o r - The amber indicator will illuminate when the power pack has reached a low energy level.
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H o o k - The hook is used to attach the toga or hood face shield.
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P a u s e C o n t r o l B u t t o n - The button allows the wearer to temporarily stop the fan and headlight (if present).
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H e a d l i g h t - The headlight (if present) is used to illuminate the surgical site for better visibility.
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D e c r e a s e A i r F l o w B u t t o n - The button allows the wearer to decrease the fan speed and air flow.
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L i g h t S h r o u d - The light shroud (if present) prevents glare from the face shield.
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I n c r e a s e A i r F l o w B u t t o n - The button allows the wearer to increase the fan speed and air flow.
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F a c e S h i e l d A t t a c h m e n t P o i n t s ( 2 ) - The magnetic attachment points are used to attach the face shield.
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P o w e r P a c k H o l s t e r - The power pack holster with cord and plug is used to connect a power pack to the helmet.
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F r o n t a n d B a c k ( c o m f o r t ) P a d s ( 2 ) - The pads provide a comfortable fit for the head and may be replaced.
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H e i g h t H e a d S t r a p A d j u s t m e n t K n o b - The knob is used to adjust the size of the height head strap for comfort and fit.
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H e i g h t H e a d S t r a p - The adjustable height head strap provides a comfortable fit for the head.
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C r o w n H e a d S t r a p A d j u s t m e n t K n o b - The knob is used to adjust the size of the crown head strap for comfort and fit.
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C r o w n H e a d S t r a p - The adjustable crown head strap provides a comfortable fit for the head.
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P o w e r P l u g R e c e p t a c l e - The receptacle is used to connect the power pack holster with cord and plug.
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Using Your Product To Don the Helmet WARNING • Upon initial receipt and before each use, always clean the surgical helmet. See the To Clean (page 9) section. • Always wear a surgical toga or hood when using the T7 surgical helmet to obtain the required personal protection. See the For Use With (page 3) section. • Always inspect the product and all system components for damage upon initial receipt and before each use. Do not use the product if damage is apparent. • Do not use this product in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide. • Do not service or repair this equipment during a procedure with a patient. • Do not look at the headlight during operation. The retinal blue light from the headlight is classified as a (low) risk group 1 hazard per IEC 62471. Retinal bluelight emission evaluated at a distance of 200mm has a maximum acceptable retinal exposure duration of 4 minutes. Failure to comply may result in discomfort or harm to the eye.
Figure 3 – Install Pads into Helmet 2. Install the power cord plug into the helmet power cord receptacle. (Figure 4).
CAUTION • Always operate, store, and transport the equipment within the specified environmental limitations. • Always keep your fingers away from the helmet’s (fan) air intake during operation. Note • The T7 surgical helmet is intended to be donned outside the sterile field. • Do not scratch the headlight lens if present on the surgical helmet. • The position of the surgical helmet will vary from person to person depending on head size and personal comfort preferences. • Make sure the surgical helmet fits securely on top of your head.
Figure 4 – Install Power Cord Plug into Helmet 3. Install a fully charged power back into the power cord holster. (Figure 5). The power pack will snap into place. See the For Use With (page 3) section.
1. Install the front and back comfort pads inside the helmet (Figure 3). See the For Use With (page 3) section.
Figure 5 – Install Power Pack into Holster N o t e - The pause control indicator briefly blinks once. The fan and headlight (if present) turns on. See the Troubleshooting (page 10) section, if necessary.
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4. Put the helmet on top of your head (Figure 6). N o t e - The head straps may be adjusted using the adjustment knobs after putting the helmet on your head.
Figure 8 – Secure Power Pack Holster Figure 6 – Don Helmet 5. Turn the outer adjustment knob to adjust the size of the head height strap appropriately. Turn the inner adjustment knob to adjust the size of the head crown strap appropriately (Figure 7).
7. Push and release the increase or decrease airflow buttons for the desired airflow (Figure 9). See the Troubleshooting (page 10) section if airflow is not present or cannot be adjusted properly. N o t e - If you push and hold the increase or decrease airflow button for a few seconds, the airflow will be set to maximum or minimum respectively.
Figure 9 – Adjust Fan Speed 8. Push both airflow buttons simultaneously to toggle the headlight (if present) on or off, as desired (Figure 10).
Figure 7 – Adjust Size of Helmet Head Straps 6. Using the holster clip, secure the power pack holster to your waistband (Figure 8). N o t e - The power pack holster may also be put into a pocket.
Figure 10 – Turn Headlight On or Off 9. Use the headlight adjustment handle (if present) to direct the headlight beam as desired (Figure 11).
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3. Remove the power pack from the holster by flexing the holster tab back to release the power pack. Lift the power pack from the holster (Figure 13).
Figure 11 – Adjust Headlight Beam Note • Use the pause control button to temporarily turn off the fan (and headlight if present) before donning a surgical toga or hood. • When correctly donned, the face shield (aligned with helmet’s magnetic attachment points) will automatically turn on the fan (and headlight if present). 10. Push the pause control button to turn off the fan (and headlight if present) as desired (Figure 12).
Figure 13 – Remove Power Pack from Holster 4. Remove the helmet from your head. 5. Disconnect the power cord plug from the helmet power cord receptacle (Figure 14).
Figure 12 – Pause Control 11. Scrub in for surgery per hospital protocol. 12. Don a surgical toga or hood as required. See the instructions for use supplied with the equipment. See the For Use With (page 3) section.
To Doff the Helmet 1. Remove the surgical gown (toga or hood). See the instructions for use supplied with the equipment. Dispose of the surgical gown per hospital protocol.
Figure 14 – Remove Power Cord Plug from Helmet 6. Remove the front and back pads from inside the helmet. Discard the pads per hospital protocol. 7. Clean the helmet, power cord, and power pack. See theTo Clean (page 9) section.
2. Remove the power pack holster from your waistband or pocket.
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To Clean W A R N I N G - Always remove the power pack, power pack holster, and (comfort) pads from the helmet before cleaning. CAUTION • Do not sterilize the surgical helmet. • Do not use solvents, lubricants, or other chemicals, unless otherwise specified. • Do not immerse the product in liquid. Do not allow liquids or moisture to enter any electrical connection. • Do not allow debris to enter the helmet fan.
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N o t e - To clean the power pack, see the instructions for use supplied with the power pack charger. See the For Use With (page 3) section. 1. Wipe all external surfaces of the helmet and power pack holster (with cord) with a soft cloth dampened with a nonabrasive, hospital cleaning agent. Clean surfaces until all visible soil is removed. 2. Dry the equipment with a lint-free towel or medicalgrade compressed air. 3. Clean the headlight lens with lens tissue. See the instructions for use supplied with the lens tissue. 4. Install new comfort pads inside the helmet. See the For Use With (page 3) section.
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References Troubleshooting W A R N I N G - Do not disassemble, modify, service, or repair this product without authorization of the manufacturer. Contact Stryker for service. N o t e - Maintenance documentation for this product is available upon request to Stryker-authorized service personnel only. Observation
Possible Cause
Corrective Action
The face shield is fogging.
Not enough airflow is circulating throughout the helmet.
Use the variable control buttons to adjust the fan speed and air flow.
The power pack is not fully charged.
Replace the power pack with a fully charged power pack.
The toga or hood white filter material is not directly over the helmet fan air intake.
Align the white filter material over the helmet fan air intake.
The helmet is damaged.
Replace the helmet.
The power pack is not fully charged.
Replace the power pack with a fully charged power pack.
The power cord with power pack holster is damaged
Replace the power cord with power pack holster. See the For Use With (page 3) section.
The helmet is damaged.
Replace the helmet.
The variable control buttons fail to adjust airflow.
The helmet is damaged.
Replace the helmet.
The fan provides little or no airflow.
The fan speed is not adjusted correctly.
Use the variable control buttons to adjust the fan speed and air flow.
The helmet is damaged.
Replace the helmet.
The power pack is not fully charged.
Replace the power pack with a fully charged power pack.
The green pause control indicator fails to blink and/or the fan fails to turn on after connection to the power pack.
The amber low battery indicator illuminates.
Disposal/Recycle W A R N I N G - Always follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the product at the end of its useful life. In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended, the product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Make sure equipment is decontaminated before recycling. N o t e - Contact Stryker for the recycling passport for this product.
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Specifications Specifications Model:
REF 0416-600-000
REF 0416-610-000
Description:
T7 Surgical Helmet
T7 Surgical Helmet with LED Headlight
Mass (weight):
0.45 kg [15.9 oz]
0.52 kg [18.3 oz]
Material:
In accordance with the European REACH regulation and other environmental regulatory requirements, printed circuit board assemblies (PCBAs) contain Diborontrioxide CAS No. 1303-86-2, Lead CAS No. 7439-92-1 and Lead-monoxide CAS No. 1317-36-8. This declaration is made in good faith and is either based on a technical evaluation, supplier data and/or laboratory testing.
Fan Speed:
1200 – 2400 rpm
Internally Powered (input voltage):
6 – 8.4 V
Ingress Protection (IP):
IPX0
Mode of Operation:
Continuous
C A U T I O N - Always operate, store, and transport the product within the specified environmental limitations. Environmental Limitations
Operation
Temperature:
Storage and Transportation
40 °C 10 °C
Relative Humidity: Atmospheric Pressure:
Electromagnetic Compatibility W A R N I N G - Avoid stacking or locating equipment near the T7 Surgical Helmet. If such a configuration is necessary, verify normal operation of both the T7 Surgical Helmet and the equipment during use. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The T7 Surgical Helmet REF 0416-600-000 and 0416-610-000 is intended for use in the electromagnetic environment specified below. The customer or the user of the T7 Surgical Helmet REF 0416-600-000 and 0416-610-000 should assure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
Group 1
The T7 Surgical Helmet REF 0416-600-000 and 0416-610-000 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.
Class B
The T7 Surgical Helmet REF 0416-600-000 and 0416-610-000 is equipment suitable for use in locations in residential environments and in establishments directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.
CISPR 11 RF emissions CISPR 11
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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The T7 Surgical Helmet REF 0416-600-000 and 0416-610-000 is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment. Immunity Test
IEC 60601 Test Level
Compliance Level
± 8 kV contact
± 8 kV contact
± 15 kV air
± 15kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 10%.
30 A/m at 50 and 60 Hz
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.
3 Vrms 150 kHz to 80 MHz outside ISM bands 80% AM at 1 kHz
3 Vrms 150 kHz to 80 MHz outside ISM bands 80% AM at 1 kHz
6 Vrms 150 kHz to 80 MHz in ISM bands 80% AM at 1 kHz
6 Vrms 150 kHz to 80 MHz in ISM bands 80% AM at 1 kHz
Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8
Conducted RF IEC 61000-4-6
3 V/m
3 V/m
80 MHz to 2.7 GHz
80 MHz to 2.7 GHz
80% AM at 1 kHz
80% AM at 1 kHz
Radiated RF IEC 61000-4-3
Electromagnetic Environment - Guidance
W A R N I N G - 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 T7 Surgical Helmet 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)
Electromagnetic Disturbances created by HF Surgical Equipment IEC 60601-2-2
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HF surgical equipment and HF surgical accessories in monopolar and bipolar configurations, adjusted to the following surgical modes and output powers: •
Various cutting modes, maximum output power of 300 Watts
•
Various coagulation modes, maximum output power of 120 Watts
Healthcare and operating room personnel who wear T7 Surgical Helmets are known to also simultaneously operate, or are near those operating HF surgical equipment and accessories. Therefore, the T7 Surgical Helmets are evaluated per Annex BB of the IEC 60601-2-2 standard, and are determined suitable for use near HF surgical equipment and accessories. However, when using the T7 Surgical Helmets near HF surgical equipment and accessories, due to the wide variety of factors impacting the resulting electromagnetic disturbances, the T7 Surgical Helmets should be observed to verify normal operation. If degradation of performance is observed, users may need to relocate or re-orient the T7 Surgical Helmets.
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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity N o t e - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a 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 T7 Surgical Helmet is used exceeds the applicable RF compliance level above, the T7 Surgical Helmet should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the T7 Surgical Helmet. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Compliance Statements Regulatory Compliance European Regulations
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Regulation EU 2017/745– Medical Device
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Regulation EU 2016/425 - Personal Protective Equipment (PPE)
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Casque chirurgical T7™ Mode d’emploi Casque chirurgical T7 0416-600-000
Casque chirurgical T7 avec lampe frontale LED 0416-610-000
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Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: t h e S t r y k e r l o g o . All other trademarks are trademarks of their respective owners or holders.
Manufactured For: Stryker Instruments 1941 Stryker Way, Portage, Michigan 49002 USA
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