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 ......................
1.3. Indications for use This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex® video-bronchoscope. 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 www.axessvision-tsc.com).
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").
Axess Vision. 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.
Description Material Touch screen display. Glass Bumper for handling the Screeni. (thermoplastic elastomer) Screeni On/Off button. Silicone The button lights up to indicate that the Screeni is switched on. Port for connecting the Axess Vision endoscope to the Screeni. 30030511-C...
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.
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.
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3.2.2. Quick removal and mounting of the Screeni leaving the fixing system on the vertical support a) Mounting Ensure that the quick-connect bracket Present the Screeni at a 45° angle and slot it into the quick- is properly installed ("Top" arrow on connect bracket, then rotate it to the right or left until it side of the bracket...
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b) Removal 1) Raise the lever located on the back of the 2) Holding the lever in the up position, rotate the Screeni. 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: 30030511-C...
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 §...
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When the home interface below is displayed, the system is operational: Meaning Battery charge level. Indication of software version. Access the examination manager. Access Screeni settings. Indication of the location of endoscope connection. 2) Check the battery charge level indicator (11) Logo displayed Battery power indicator Battery charging...
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Meaning Start/Stop a video recording of the current examination. Take a photo of the current examination. Examination name. Batch number of the endoscope in use. 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 §...
4.2. 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.
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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 Rename the examination being viewed.
When replaying a video, a controller appears, allowing you to navigate easily within the video: Meaning Video navigation bar. Rewind the video by 1 second (if video paused) or 5 seconds (if video in playback mode). Resume video playback. Pause video playback. Fast forward the video by 1 second (if video paused) or 5 seconds (if video in playback mode).
5. C LEANING 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.
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.
10. L ABELS 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 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...
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 Device to be used on prescription only 11.
No possibility of grounding the exposed conductive parts (elimination of contact voltage risks). 11.3. Electromagnetic compatibility information 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.
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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, ...
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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.
37300 Joué-lès-Tours – France www.axessvision-tsc.com Copyright @2019 SA AXESS VISION TECHNOLOGY All rights reserved. Any reproduction, even partial, of the page, by any process (electronic, photocopy, printer, magnetic tape, floppy disc, CD-ROM or other) is prohibited without prior written consent from...
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