Stryker 30030511-E-EN-Notice-Screeni-V3 Screeni User manual

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1639

Screeni

30030001

Screeni®

User manual

30030511-E

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Table of Contents

1. Important information – read before use .......................................................................................................... 3

1.1. Foreword ............................................................................................................................................................................. 3

1.2. Intended use ........................................................................................................................................................................ 3

1.3. Indications for use ............................................................................................................................................................... 3

1.4. Contraindications ................................................................................................................................................................ 3

1.5. User qualification................................................................................................................................................................. 3

1.6. Warnings and cautions for use ........................................................................................................................... 4

1.7. Instrument compatibility ..................................................................................................................................................... 4

2. Description of the Screeni and accessories ........................................................................................................ 5

2.1. Product description ............................................................................................................................................................. 5

2.2. Inspecting package contents ............................................................................................................................................... 5

2.3. Screeni details ..................................................................................................................................................................... 6

3. Installation and connection .............................................................................................................................. 7

3.1. Precautions prior to use ...................................................................................................................................................... 7

3.2. Installation ........................................................................................................................................................................... 8

3.3. Power connection .............................................................................................................................................................. 11

4. Instructions for using the Screeni .................................................................................................................... 11

4.1. Using the Screeni for an examination ............................................................................................................................... 11

4.2. System shutdown .............................................................................................................................................................. 14

4.3. Examination management ................................................................................................................................................ 14

4.4. Settings management ........................................................................................................................................................ 16

5. Cleaning precautions ...................................................................................................................................... 17

6. Warranty ....................................................................................................................................................... 17

7. Troubleshooting ............................................................................................................................................. 17

8. Maintenance .................................................................................................................................................. 18

8.1. Nature and frequency of maintenance and calibration .................................................................................................... 18

8.2. Certificate of compliance with the specifications ............................................................................................................. 18

9. Transport, storage, use and disposal ............................................................................................................... 18

9.1. Conditions of transport, storage and use .......................................................................................................................... 18

9.2. Waste disposal ................................................................................................................................................................... 18

10. Labels and meaning of symbols ..................................................................................................................... 19

11. Technical information ................................................................................................................................... 20

11.1. Essential performance ..................................................................................................................................................... 21

11.2. Information concerning the electrical protection class ................................................................................................... 21

11.3. Electromagnetic compatibility information ..................................................................................................................... 21

11.4. Applicable standards ....................................................................................................................................................... 24

12. Manufacturer’s contact details ..................................................................................................................... 24

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1. IMPORTANT INFORMATION – READ BEFORE USE

“WARNING” indicates a particularly hazardous situation. Failure to observe the instruction may damage the instrument, cause injury, or even death.

“CAUTION” indicates that use or improper use of the instrument may cause a problem, such as product malfunction, failure or damage.

1.1. Foreword

This user manual contains essential information for the safe and optimal use of the Screeni. The information in this user manual is subject to change at any time, without notice. Make sure that you are using the latest version by logging onto the Axess Vision website https://endovision.tsc-group.com/ or contacting the distributor.

This user manual does not contain any explanations of information concerning endoscopic techniques per se. Carefully read this manual, along with the manuals for all the instruments used, and use them as instructed. Keep all user manuals

in a safe and readily accessible place. Should you have any questions or comments concerning this manual, do not hesitate to contact the distributor.

This manual describes the recommended inspection and preparation procedures prior to use of the equipment, the procedures for its use and the precautions to be followed for cleaning and maintenance after use.

Carefully follow all the instructions given in this user manual. Poor understanding of these instructions could lead to:

 severe injuries to the patient,  severe injuries to the user,  severe injuries to a third party,  equipment damage.

1.2. Intended use

This product was developed by the company Axess Vision and is exclusively reserved for the endoscopic examinations claimed in the manual of the endoscope used (see list of compatible devices).

The Screeni is used for viewing the lungs and airways by means of a single-use endoscope. The Screeni should not be used for any purpose other than that described herein.

1.3. Indications for use

This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex® videobronchoscope.

1.4. Contraindications

The images generated by this device should not be used for diagnostic purposes. Physicians must interpret and support any findings in other ways, based on the patient's clinical data.

1.5. User qualification

The Screeni can be used by an anaesthesia nurse, scrub nurse, or any other person authorised to interact with and prepare the equipment before a medical procedure under the responsibility of the physician in charge of examining the patient.

Where there are official standards and/or regulations relating to user qualification for performing endoscopy, and endoscopic treatment defined by the medical administration or by other official institutions, such as the academic endoscopy society, these must be respected.

Otherwise, this instrument should only be used by a doctor approved by the head of department responsible for accident prevention in the hospital or by the person in charge of the corresponding department (pulmonology department, etc.). The physician must be able to perform the video endoscopy and the planned endoscopic procedure, safely, in accordance with the guidelines set by the academic endoscopy society and considering the risks of complications related to endoscopy and the endoscopic procedure.

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1.6. Warnings and cautions for use

Observe all the warnings and precautions described in this manual. Otherwise, Axess Vision cannot be held liable in case of injury to the patient or user or damage to the device.

The Screeni should only be used with endoscopes marketed by Axess Vision (see § 1.7 "Instrument compatibility").

The use of incompatible instruments may result in injury to the patient and impede the correct operation of the video-endoscopic system.

Any modification of the Screeni by the user is strictly forbidden. Failure to comply with this instruction may result in injury to the patient or the user and/or impede the correct operation of the video-endoscopic system.

If the Screeni malfunctions, see § 7 "Troubleshooting" or contact the distributor.

Do not expose the Screeni to water or moisture or allow prolonged exposure to the sun.

The Screeni power cable should be placed in an area where there is no risk of it being crushed.

If the power cord is damaged or bare, replace it immediately with another of the same type and rating provided by the manufacturer.

If the Screeni is exposed to liquids (in a manner contrary to the cleaning instructions), in the event of a fall, or if the case is damaged, switch off the Screeni and return it to the manufacturer.

Use only the cables and accessories supplied by the manufacturer for the Screeni (list available in § 2 "Description of the Screeni and its accessories").

Avoid touching the electrical contacts of the Screeni.

Do not simultaneously touch the patient and any metal part of the Screeni.

For battery-powered use, the charge must be checked before starting the examination. If the battery is low, connect the Screeni to the mains to perform the exam.

Do not connect the Screeni to the hospital computer network. The Ethernet port is for maintenance purposes only.

US federal law restricts this device for sale only by, or on the order of, a physician.

Do not use sharp or hard objects to press the On/Off button.

1.7. Instrument compatibility

Compatible devices from the Axess Vision range

Broncoflex® Vortex

Reference: 10030001

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Applied part

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Broncoflex® Agile

Reference: 20030001

Applied part

2. DESCRIPTION OF THE SCREENI AND ACCESSORIES

2.1. Product description

The Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display live imaging data captured by sterile disposable endoscopes marketed by Axess Vision.

For more information on the endoscope used, see the user manual of the endoscope (found in its transport box and available on the Axess Vision website https://endovision.tsc-group.com/).

2.2. Inspecting package contents

When unpacking, any defective instrument should be returned in its original box to the local Axess Vision-approved distributor.

When unpacking and handling the fastening system, take care not to pinch your fingers.

Compare the contents of the package with the items shown below. Ensure that all accessories and components shown below are present and in good condition.

Description Illustration

Screeni

Reference: 30030001

Quick mounting bracket

(already attached to the Screeni)

Reference: 30030301 + 30030302

Knurled screw

Reference: 30030303

Medical-grade power supply (FRIWO

FOX30-XM)

Reference: 00030001

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EU adaptor

1 2 3

4 5

10 11

Reference: 00030002

US adaptor

Reference: 00030006

UK Adaptor

Reference: 00030007

AU adaptor

Reference: 00030008

2.3. Screeni details

# Symbol Description Material

Touch screen display. Glass

Bumper for handling the Screeni.

Screeni On/Off button. The button lights up to indicate that the

Screeni is switched on.

Port for connecting the Axess Vision endoscope to the Screeni.

TPE

(thermoplastic

elastomer)

Silicone

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Flexible connector protection tab:

TPE

(thermoplastic

elastomer)

USB port for USB key connection only (selfpowered hard discs must not be connected).

Ethernet port.

7 VESA 75 compatible mounting bracket. Stainless steel

Support feet / packaged endoscope support system when the system is attached to an IV pole (maximum load: 4 endoscopes).

for maintenance purposes only.

Power connector 15V DC - 2A. Under this connector an LED indicates the

charge status of the Screeni:

For use by qualified personnel

 Orange: charging  White: switched on, not charging  Flashing orange: charging error (see § 7

“Troubleshooting”).

Stainless steel

8 Screw knob for fixing to an IV pole and serving as a take-up reel for the power cable.

10 Lever to release the quick-connect system. Stainless steel

Quick-connect system for vertical tube, diameter between 15 and 25.4 mm (such as an IV pole, for example).

Housing.

3. INSTALLATION AND CONNECTION

3.1. Precautions prior to use

 Perform a general inspection of the product:

 No damage (e.g. deformations or cracks) should be visible.  It should be clean and free from cleaning agent or disinfectant residues.  Ensure that no parts are missing and that all parts are properly attached.  Ensure that the cables are neither broken nor damaged.

 Check that the accessories present with the system are those supplied by Axess Vision.  Make sure the battery charge is sufficient before the examination starts. If not, mains operation is required.

ABS (acrylonitrile

butadiene

styrene)

ABS (acrylonitrile

butadiene

styrene)

ABS (acrylonitrile

butadiene

styrene)

If you notice any anomalies, do not use the Screeni and refer to the instructions in § 7 “Troubleshooting”. If this section fails to eliminate the anomaly, please contact the distributor. Any physical damage or other defects may endanger the patient or user and seriously damage the endoscopic system.

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3.2. Installation

The Screeni offers two installation possibilities: on feet, in which case it must be placed on a flat and stable horizontal surface, or fixed to a stable vertical tubular support *.

3.2.1. Assembly and disassembly on vertical tubular support

a) Mounting

1) Unfold the quick-connect bracket. 2) Position the bracket on the vertical tube and tighten the knob until the assembly is immobilised.

Make sure the Screeni is secure, without risk of falling or tipping.

b) Removal

Unscrew the knob while holding the Screeni and place it on a stable horizontal surface.

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3.2.2. Quick removal and mounting of the Screeni leaving the fixing system on the vertical support

a) Mounting

1) Ensure that the quick-connect bracket is

properly installed ("Top" arrow on the side of the bracket facing upwards) and correctly tightened on the IV pole.

2) Present the Screeni at a 45° angle and slot it into the quick-

connect bracket, then rotate it to the right or left until it locks. Check the stability of the assembly and that the lever is locked.

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b) Removal

1) Raise the lever located on the back of the Screeni.

2) Holding the lever in the up position, rotate the Screeni to the right or left and remove it from its quick-connect bracket.

3.2.3. Tilting the Screeni

When the Screeni is in position on its quick-connect bracket, it is possible to adjust its vertical tilt, holding the bumpers:

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3.2.4. VESA mounting

The Screeni can be mounted on a VESA 75x75 mount. To do this, remove the quick-connect bracket as described in § 3.2.2 "Quick removal and mounting of the Screeni leaving the fixing system on the vertical support".

VESA mounting brackets (75x75)

Next, attach the Screeni to the VESA mounting bracket (not supplied) using four M4 x 10 mm screws (not supplied).

Comply with the size of the screws for VESA mounting to avoid any system damage.

3.3. Power connection

See the list of connectors contained in the package, connect the appropriate power adaptor to the power supply according to the geographical area of use of the system. To change the mains adaptor, see the power supply manual supplied in its packaging.

If used for the first time, connect the power cord to the Screeni and connect the power supply to a power socket.

Use only the power cable provided by Axess Vision to power and charge the Screeni (see list of components presented in § 2 "Description of the Screeni and its accessories").

When using a power strip to power the Screeni:

The power connector LED lights up white when the Screeni is fully charged and connected to mains power, and orange if the Screeni is charging on mains power.

 verify that it complies with the IEC 60884-1 standard,  make sure that it is not placed on the floor, to prevent possible ingress of liquids and to avoid mechanical

or electrical damage.

The use of accessories, transducers or cables other than those described and supplied by Axess Vision may result in an increase in electromagnetic emissions or reduce the electromagnetic immunity of the Screeni and cause a malfunction.

4. INSTRUCTIONS FOR USING THE SCREENI

The Screeni comes with built-in software. The version number of the installed software can be accessed by simply clicking the "TSC" button/logo (12) from the home page. For information concerning the latest software features, go to

https://endovision.tsc-group.com/ or contact the distributor.

4.1. Using the Screeni for an examination

If the following battery symbol is displayed , connect the Screeni to the mains immediately before continuing the examination.

A full battery charge takes about 3 hours.

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1) Switch on the Screeni by pressing the "On/Off" button.

When the home interface below is displayed, the system is operational:

# Meaning

11 Battery charge level.

12 Indication of software version.

13 Access the examination manager.

14 Access Screeni settings.

15 Indication of the location of endoscope connection.

2) Check the battery charge level indicator (11)

Logo displayed Battery power indicator

Battery charging

100% - 80%

70% - 50%

40% - 20%

15% - 5%

Battery fault

(See § 7 “Troubleshooting”)

3) Connect the endoscope to the Screeni

Connect the endoscope to the Screeni before using it on the patient. Before each use, ensure that the orientation of the images observed using the endoscope is correct and check

whether the image displayed is live or not.

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The system automatically switches to "live":

# Meaning

16 Start/Stop a video recording of the current examination.

17 Take a photo of the current examination.

Examination name.

Batch number of the endoscope in use.

20 Symbol indicating whether the endoscope has already been used (absent by default).

Last photo taken (pressing the last photo taken provides access to current examination management: see §

4.3 “Examination management”).

22 Adjust "live" image brightness.

23 Edit the examination name.

24 “Live” indicator.

4) Check that a live video image appears on the screen. Point the distal tip of the Broncoflex display device to an object or the palm of your hand and make sure that the "LIVE" indicator appears.

If the symbol is displayed, this indicates that the endoscope has already been connected to a Screeni. The user is responsible for continuing the examination.

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5) To finish the examination, disconnect the endoscope from the Screeni after removing it and moving it away from the patient. The home screen is displayed once more. See the instructions for use of the endoscope used for details concerning its disposal.

Should the endoscope become disconnected during an examination, reconnect it, making sure to hold the connector by its plastic part.

4.2. System shutdown

Disconnect the Broncoflex display device from the Screeni if you have not already done so. If the charge level of the Screeni battery is low, charge it (see § 3.3 "Power connection "). Switch off the Screeni by pressing the On/Off button once. You will be asked to confirm the shutdown request. If no response is

given to the system, shutdown is automatically cancelled. See § 5 "Cleaning precautions" for cleaning the Screeni.

4.3. Examination management

The USB port is for connecting a USB flash drive only.

Do not remove the USB drive while it is copying examination data as this may corrupt the contents of the USB key.

At any moment during the examination, you can return to the "live" view by pressing the "home" or "back" buttons.

To access exam management:

 Press the dedicated button on the home page,  Press the last photo taken from the "live" page.

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# Meaning

25 Export an examination (the button is enabled when a USB key is connected to the system).

26 Delete an examination.

27 Back to the previous screen (back to "live" if an examination is in progress).

28 List of examinations contained in the system.

Scroll through saved records.

Back to the home screen (back to "live" if an examination is in progress).

When a record is selected from the examination list, the following interface is displayed:

# Meaning

31 Rename the examination being viewed.

32 Delete a file.

33 Details of the selected examination.

34 Thumbnail display area.

35 Scroll through files.

36 Selected file viewing area.

From the examination review page, the following actions are possible:

 Review photos and videos made during an examination,  Rename the examination,  Delete the file being viewed,

 Transfer the examination to a USB key connected to the system.

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When replaying a video, a controller appears, allowing you to navigate easily within the video:

# Meaning

37 Video navigation bar.

38 Rewind the video by 1 second (if video paused) or 5 seconds (if video in playback mode).

39 Resume video playback.

40 Pause video playback.

41 Fast forward the video by 1 second (if video paused) or 5 seconds (if video in playback mode).

42 Information on the current position of the video and its total duration.

4.4. Settings management

The settings are only accessible when no examination is in progress, from the home page using dedicated button 14

# Meaning

43 Set time.

44 Password locking of examination manager access.

Set date.

Language selection.

47 System language.

Access administrator settings. This feature can only be used by the manufacturer/distributor and is password-

protected.

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5. CLEANING PRECAUTIONS

The Screeni must be switched off and the power plug must be removed from the socket before starting the cleaning procedure.

Never immerse the Screeni in liquid, never clean the Screeni by autoclave or steam and never pour alcohol directly onto the Screeni.

Do not spray or pour liquid solution directly onto the Screeni.

Disinfect if necessary, in accordance with the hospital’s standards and protocols or applicable local regulations.

Check that no liquid comes into direct contact with any electrical components of the Screeni.

Never use a solution containing a ketone or an abrasive solution.

It is recommended to clear the Screeni regularly, in accordance with the hospital’s standards and protocols or applicable local regulations. The following solutions should be applied by wetting a non-abrasive sterile gauze compress and must be compatible with those recommended below:

 Mild detergent (pH 7 - 9) and water  Isopropyl alcohol and water, 70% by volume

After cleaning, the Screeni should be stored in a clean, dry place, in accordance with the atmospheric conditions detailed in § 9.1 "Conditions of transport, storage and use".

6. WARRANTY

The Screeni has a two-year warranty from the date of purchase. Opening the Screeni will void the legal warranty.

7. TROUBLESHOOTING

Inspection indications and actions are proposed below to resolve most problems encountered. In the event that the following instructions do not correct the problem, return the Screeni to the local authorised Axess Vision distributor for analysis and repair or replacement of the product. To avoid any risk of contamination, it is strictly prohibited to return a contaminated medical device.

Problem Cause(s) Actions

The battery is discharged

The Screeni will not switch

The battery is discharged and

no power supply

Connect the Screeni to the mains with the specific transformer, and check that the system is working again.

Check the connection to the hospital electrical network. If the Screeni is connected to a power strip, check that the

power strip is working properly.

The power connector light

flashes orange

The following battery

symbol is displayed:

No image despite a

connected endoscope

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Battery fault Return the Screeni to the distributor.

Faulty endoscope/Screeni

connection

First check that the endoscope has been detected, making sure that the “live” page is displayed. Disconnect and reconnect the consumable.

Faulty endoscope Connect another endoscope.

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8. MAINTENANCE

8.1. Nature and frequency of maintenance and calibration

No calibration or maintenance is necessary.

If the Screeni malfunctions, see § 7 "Troubleshooting" or contact the distributor.

8.2. Certificate of compliance with the specifications

The manufacturer, Axess Vision, certifies the compliance of its equipment, both in terms of design and manufacturing, with the applicable directives and regulatory standards.

It uses the appropriate components taking into account:

 their technical characteristics and their limitations,  their intended use and the electromagnetic environment.

9. TRANSPORT, STORAGE, USE AND DISPOSAL

9.1. Conditions of transport, storage and use

Transport and storage

conditions

Conditions of use

Protection type

If you do not use the Screeni for several months, perform a full charge and battery strength test before use.

Parameters Minimum Maximum

Temperature -10°C (14°F) +60°C (140°F)

Relative air humidity (no condensation) 10% 90%

Atmospheric pressure 80kPa 109kPa

Temperature + 10°C (50°F) + 40°C (104°F)

Relative air humidity (no condensation) 30% 85%

Altitude and atmospheric pressure ≤ 2000m – 80kPa ~ 109kPa

The Screeni has an IP30 protection rating. It must be stored away from projections of foreign bodies less than 2.5 mm in diameter. It must be stored away from liquid splashes as there is no protection against water drops.

9.2. Waste disposal

In accordance with Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE), Screeni belongs to category 8 of WEEE (medical devices with the exception of all implanted and infected products).

In order to preserve the environment, the Screeni electronic interface unit must not be discarded with household waste, but rather with waste electrical and electronic equipment for a cycle of reuse, recycling or any form of recovery of this electrical and electronic equipment.

If necessary, return the Screeni unit to the distributor for disposal.

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10. LABELS AND MEANING OF SYMBOLS

The meanings of the various symbols and labels are described in the table below:

Symbol Meaning

Manufacturer

Date manufactured

Serial number

15V – 2A Input voltage: 15V DC; sink current: 2A

IP30

Catalogue reference

Class 2 electrical protection device

Read the instructions for use before use

Do not dispose of with normal household waste

Conformity marking as per the European medical devices directive (MDD) 93/42/EEC, accompanied by the identification number of the notified body SGS

Symbol certifying protection against the effects of temporary immersion in water in accordance with IEC 60529. IPN1N2 with

N1 = 3 Protection against 2.5 mm diameter solid foreign objects,

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N2 = 0 No protection from liquids

Indicates that the instructions for use contain important cautionary information, such as warnings and precautions, that cannot, for various reasons, be displayed on the medical device itself

Do not use if package is damaged

Do not expose the box to rain

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Fragile contents

Store in an environment with a relative humidity of between 10 and 90%

Store in an environment with a temperature of between -10 and +60°C

Store in an environment with an atmospheric pressure of between 80 and 109 kPa

E507080

Device to be used on prescription only

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL

HAZARDS ONLY IN ACCORDANCE WITH

"ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)"

"CAN/CSA-C22.2 No. 60601-1:14"

"IEC 60601-2-18:2009"

11. TECHNICAL INFORMATION

ELECTRICAL CHARACTERISTICS

Power requirement 100-240V AC / 50-60Hz / 0.6A

Power supply

Power output 15 VDC / 2A

Type of protection against electrocution

Battery type Lithium-Ion battery (11,25V - 2950mAh or 10,8V – 3350mAh)

Autonomy At least 3 hours (for a new and fully charged battery)

Class 2

MECHANICAL CHARACTERISTICS

Dimensions L: 300 mm x H: 200 mm x D: 110 mm (mounting bracket folded)

Weight 1.8 kg (with mounting bracket)

Mounting interface VESA 75 mm

TOUCH SCREEN

Maximum resolution 1280x800

Display Type 10.1 inch TFT LCD

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Viewing angle

Protection Rating IP30

Horizontal: 170° Vertical: 170°

MISCELLANEOUS CHARACTERISTICS

Exported file formats

Internal storage capacity 16 Gb (can store up to 14 h of video or more than 100,000 photos)

Connections

Photos: .JPG Videos: .AVI (h264 compression)

TECHNICAL CHARACTERISTICS

USB Type A (for USB key connection only)

Endoscope port

DC 15V / 2A input

11.1. Essential performance

The following requirements are verified and validated:

 Viewing of the upper airways and of the bronchial tree,  Correct image orientation in the view observed by the operator,  Guarantee that the image viewed during an endoscopic procedure is a live one rather than a recorded image.

11.2. Information concerning the electrical protection class

The Screeni possesses class 2 protection meeting the following requirements:

 Protection ensured by a set of constructive provisions making power of the device's exposed conductive parts unlikely,  Extra "insulation" added to the main insulation,  Metal parts separated from live parts by main insulation inaccessible to the user,  No possibility of grounding the exposed conductive parts (elimination of contact voltage risks).

11.3. Electromagnetic compatibility information

RF portable communications equipment (including peripherals such as antenna cables and external antennas) should not be used less than 30 cm (12 inches) from any part of the Screeni, including cables specified by Axess Vision. Otherwise, the performance of these devices may be impaired.

Do not use the Screeni in a room exposed to strong electromagnetic radiation (for example near medical treatment equipment using microwaves or short waves, MRI, radio or mobile/cordless phone). In the event of interference, mitigation measures such as reorienting or moving this instrument or isolating the area may be necessary.

It is not recommended to use the Screeni near other devices or to stack it on other devices. If adjacent installation or stacking is necessary, it should then be checked that the Screeni is working correctly.

This medical electric equipment requires specific precautions with respect to electromagnetic compatibility (EMC) and should be installed and used in accordance with the instructions in this manual.

It is very unlikely that this device will cause harmful interference with other nearby devices. However, there is no guarantee that interference will not occur in a particular installation. Loss of performance of this device or other

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devices when they are used simultaneously may cause interference. If this occurs, try to correct the interference by means of the following measures:

 Switch nearby devices on and off in order to determine the source of the interference,  Reorient or move this device or other devices,  Increase the distance between the devices,  Connect the device to a socket on a different power circuit to that of the other devices,  Eliminate or reduce electromagnetic emissions using technical solutions (such as shielding),  Ensure other medical devices in the vicinity comply with IEC 60601-1-2 standards.

Portable and mobile radiocommunications devices (mobile phones, etc.) can affect medical electrical equipment. Please ensure you take the necessary precautions during their operation.

The Screeni is designed to comply with standard IEC 60601-1-2, which contains requirements related to electromagnetic compatibility (EMC) for medical electrical equipment. The emissions and immunity limits specified in this standard are given to provide acceptable protection against the harmful interference encountered in a typical medical environment.

The system complies with the essential performance requirements specified in standards IEC 60601-1 and IEC 60601-2-18. The results of immunity tests demonstrated that the essential performance of the system is not lost when the system is subject to the conditions present in the following tables.

11.3.1. Table 201: Electromagnetic emissions

Comparison of emissions requirements

Emissions tests Compliance Electromagnetic environment – guidance

Conducted emissions

Group 1 / Class A

CISPR 11 / AMD1 Radiated emissions

Group 1 / Class A

CISPR 11 / AMD1 Harmonic emissions

IEC 61000-3-2

Voltage fluctuations and flicker IEC 61000-3-3 / AMD1

Device with motors or switching devices CISPR 14-1

11.3.2. Table 202: Electromagnetic immunity

Comparison of immunity levels – Transient phenomena

Immunity tests IEC 60601 test level Verdict Electromagnetic environment – guidance

PASS

Not applicable

The Screeni uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.

The emissions characteristics of this device enable it to be used in industrial environments and hospital settings (class A defined in CISPR 11). When it is used in a residential environment (for which class B defined in CISPR 11 is normally required), this device may not provide adequate protection for RF communications services. The user may need to implement corrective measures, such as reinstallation or reorientation of the device.

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/bursts IEC 61000-4-4

Surge – AC mains power supply IEC 61000-4-5 AMD1

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 8 kV contact  2, 4, 8, 15 kV air

 2 kV for power supply lines  1 kV for input/output lines

100 kHz PRR

 2 kV common mode 1 kV differential mode 0°, 90°,

180° and 270° phase change

PASS

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

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

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Surge – 12 VDC power supply

𝑑=1,17 .√𝑃

𝑑=2,33 .√𝑃

ISO 7637-2

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 / AMD1

600 V

UT = 0%, 0.5 cycles (0°, 45°, 90°,

135°, 180°, 225°, 270° and 315°)

UT = 0% 1 cycle – UT = 70%

25/30 cycles (0°)

UT = 0% 250/300 cycles

Not

applicable

PASS

Conducted immunity IEC 61000-4-6

Magnetic immunity IEC 61000-4-8

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

Immunity tests IEC 60601 test level Verdict

Radiated RF disturbances IEC 61000-4-3 / AMD1 / AMD2

Nearby fields emitted by wireless RF communications equipment IEC 61000-4-3 / AMD1 / AMD2

Electromagnetic environment – guidance

RF portable communications equipment (including peripherals such as antenna cables and external antennas) should not be used any closer to any part of the Screeni, including cables specified by Axess Vision, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

𝑑 = 1,17 .√𝑃 (𝑓𝑜𝑟 𝑎 𝑓𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦 𝑟𝑎𝑛𝑔𝑖𝑛𝑔 𝑓𝑟𝑜𝑚 150𝑘𝐻𝑧 𝑡𝑜 80𝑀𝐻𝑧) 𝑑 = 1,17 .√𝑃 (𝑓𝑜𝑟 𝑎 𝑓𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦 𝑟𝑎𝑛𝑔𝑖𝑛𝑔 𝑓𝑟𝑜𝑚 80𝑀𝐻𝑧 𝑡𝑜 800𝑀𝐻𝑧) 𝑑 = 2,33 .√𝑃 (𝑓𝑜𝑟 𝑎 𝑓𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦 𝑟𝑎𝑛𝑔𝑖𝑛𝑔 𝑓𝑟𝑜𝑚 800𝑀𝐻𝑧 𝑡𝑜 2,7𝐺𝐻𝑧)

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter’s manufacturer and d is the recommended separation distance in meters (m).

3V (0.15-80MHz) 6V (ISM bands)

30 A/m 50 and 60 Hz

Comparison of immunity levels – Field phenomena at steady state

3 V/m 80 MHz to 2.7GHz

9V/m to 28 V/m 15 specific frequencies

PASS

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

PASS

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended separation distances between portable communication equipment and the Screeni

The Screeni is intended for use in an electromagnetic environment in which radiated radioelectrical disturbances are controlled. The customer or the user of the Screeni can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Screeni, as recommended below, according to the maximum output power of the communications equipment.

Maximum output

power of

transmitter (W)

0.01

0.1 0.37 m 0.37 m 0.74 m 1 1.17 m 1.17 m 2.33 m

10 3.7 m 3.7 m 7.37 m

100 11.70 m 11.70 m 23.30 m

150 kHz to 80 MHz

30030511-E

Separation distance according to frequency of transmitter (m)

80 MHz to 800 MHz

0.12 m 0.12 m 0.23 m

800 MHz to 2.7GHz

Page 24

11.4. Applicable standards

The Screeni meets the following standards:

 Directive 93/42/EEC: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices  60601-1 edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential

performance

 60601-1-2 edition 4: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential

performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

12. MANUFACTURER’S CONTACT DETAILS

Axess Vision Technology Zone de la Liodière 6 rue de la Flottière 37300 Joué-lès-Tours – France

https://endovision.tsc-group.com/

floppy disc, CD-ROM or other) is prohibited without prior written consent from

AXESS VISION TECHNOLOGY

30030511-E

Stryker 30030511-E-EN-Notice-Screeni-V3 Screeni User manual

Specifications and Main Features

Frequently Asked Questions

User Manual