VideoLaringo - 3.5in Display IFU - TCK Med

Anestesia

REF No. 040-070-0035U

PRODUCT KEY

  1. Display
  2. Charging Dock
  3. USB Charging Cable
  4. Power Button
  5. Wall Plug

Intended Use

The ProVu 3.5” Display is a digital display intended to show live images from the ProVu Video Laryngoscope (VL) only, via a micro-USB connection, as an aid to intubation for the hospital use.

Product Description

The ProVu 3.5” Display is a non-sterile, reusable digital display intended to show live images from the ProVu Video Laryngoscope.

 

When connected to the ProVu device, a live video is shown on the display, which can be used to further aid intubation of the patient. The display can be recharged on the charging dock provided or with the ProVu charging cable and, when fully charged, will provide up to 3 hours of continuous use.

 

Flexicare does not recommend the modification of the display. Any attempts to do so, will result in the failure of the display and voids warranty.

Precautions

  • Ensure that you always have easy access to the power cord, plug or adapter to disconnect this display from the power.
  • Inspect the ProVu 3.5″ Display and all accessories for damage prior to each use.
  • Charge the ProVu 3.5″ Display fully before use. For shipping requirements, ProVu 3.5″ Displays are shipped with zero charge.
  • Before charging, ensure that all components are completely dry, including the micro-USB port.
  • If not connected to ProVu VL and left unmoved for more than 5 minutes, the ProVu 3.5″ Display will switch into “sleep mode” and the screen will go blank. This is normal. To reverse this, briefly press the Power Button, a live image should be seen after 2 seconds.

Warnings & Cautions

  • ProVu 3.5” Display and Accessories should only be used by trained medical professionals.
  • Do not use within Magnetic Resonance Imaging (MR/MRI) environments or with other high interference sources.
  • Do not sterilise the display.
  • The use of devices and other accessories which are not approved by Flexicare may place the patient at risk. It is recommended that the ProVu 3.5” Display should only be used with the ProVu Video Laryngoscope and ProVu accessories.
  • Always disconnect from ProVu 3.5” Display from the charging dock before cleaning.
  • Ensure the voltage recommendations of the display wall plug are compatible with power supplies.
  • Do not clean the display or display accessories using any abrasive agents or mineral acids.
  • Do not use sterilants with caustic ingredients, such as surgical scrub solutions, peroxide solutions, bleaches, or povidone-iodine solutions.
  • Inadequate battery levels may result in sudden failure without warning. Check sufficient battery level before use.
  • Do not disassemble display.
  • Do not modify the display.
  • Battery is non-replaceable.
  • There are no user serviceable parts in the device. Any faulty device should be replaced or returned within warranty to the manufacturer.
  • Do not attempt to charge while battery is in use.
  • Do not attempt maintenance of the device during use.
  • Do not submerge.
  • If the display screen does not illuminate from “sleep mode”, it is likely the battery needs to be charged or the device needs to be reset. Follow Troubleshooting steps below for proper steps.

Setting up the Charging Dock

  1. Remove all components from the box.
  2. Connect the USB cable to the charging dock.
  3. Wrap the cable around the device in the dedicated path on the underside of the
    charging dock, leaving enough free cable outside the charging dock, to be able to
    reach the mains power.
  4. Using the plug adaptor provided, plug into mains power source.
  5. The charging dock is now ready to use.

Charging

  1. Connect the ProVu 3.5” Display to the charging dock or directly into the USB cable, if
    not using the charging dock.
  2. Press the Power Button for 3 seconds.
  3. After 3 seconds, an indication of charge is shown on the screen. If this screen does not
    display, check the security of the connections.
  4. When fully charged, the display will provide up 3 hours of continuous use.
  5. For optimal performance, re-charge after every use.

Using with ProVu Accessories

Secure the ProVu 3.5” Display into the Wrist Mount Case or Display Table Stand (each sold separately). Ensure the stand is placed on a clean,
flat, dry surface when in use. To extend distance between display and ProVu VL, use a ProVu Amplifier Cable.

Wrist Mount

Table Stand

Amplifier Cable

Using with ProVu VL

For more detailed instructions on the use of the ProVu VL, refer to the ProVu VL instructions (IP0000- 018) supplied with the handles and
blades.

  1. Use currently accepted medical techniques to choose the correct size of ProVu VL blade.
  2. Securely connect the ProVu VL handle and blade to the ProVu VL 3.5” Display.
  3. Observe the Display screen to verify that a live image is being received from the ProVu VL blade (as shown in fig A & B).
  4. If no image is seen, briefly press the power button, a live image should be seen after 2 seconds.
  5. Observe the display screen to verify that a live image in being received from the ProVu VL blade.
  6. Once a live image is seen, the device is ready to be used.
  7. If neccessary,when space is restricted, the display can be tilted, in order to show optimum view.

After Use

  1. Disconnect the ProVu VL Handle and blade from the ProVu 3.5” Display.
  2. Dispose of all single-use components in accordance with local policies and / or as advised by your local healthcare provider.
  3. Clean and dry the ProVu 3.5” Display referring to the cleaning instructions.
  4. Place the ProVu 3.5” Display onto the charging dock, when not in use.

Software

The ProVu 3.5” Display has several on-screen prompts to assist use.

Software Version

Software version is displayed in the bottom right of the display when connected to power.

Display is Charging

ProVu 3.5” Display battery is charging. Percentage charge is indicated in the circle.

Charged

ProVu 3.5” Display is fully charged.

Charge Display

ProVu 3.5” Display has insufficient battery.
Please charge via USB or charging dock.

Connect to ProVu VL

Connect ProVu 3.5” Display to ProVu VL and/or Amplifier cable to view camera image.

Connected to ProVu VL

ProVu 3.5” Display is connected and camera image is loading.

Disconnect Display

If camera image fails to load, disconnect the ProVu 3.5” Display.

Error 1

Software error or crash. Release power button. Press power button for 3 seconds to power on.

Error 2

Camera error or crash. Replace ProVu VL and/or Amplifier cable.

Battery Indicator

During use, the battery indicator appears on screen to show battery power remaining.
The icon will change to flash on and off when battery charge is less than 20%.

Cleaning

  1. Wear gloves throughout the cleaning procedure.
  2. Clean the ProVu 3.5” Display and reusable accessories after each use, using either:
    -Sani-Cloth Chlor Wipes
    -IPA 70% Wipes
    -Clinell Universal Wipes (2 quaternary ammonium compounds and 1 polymeric biguanide)
  3. Inspect the ProVu 3.5” Display and reusable accessories for contamination. If any is present repeat steps 1 & 2.
  4. Once the ProVu 3.5” Display and reusable accessories are free from contaminates, dry with a clean, dry cloth.
  5. Check display for damage. If display does not function, refer to troubleshooting steps.

Disinfection should be carried out according to local hospital policies and disinfector manufacturer’s instructions.

  1. Ensure that the device to be disinfected is free from any visible contaminants before disinfection.
  2. Wipe all areas of the display for the time period specified by the manufacturer.
  3. Dry with a clean cloth.
  4. Once dry, it is recommended that the display be placed on charge until next use.

Troubleshooting

Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State of the user and/or patient

Warranty Statement

Flexicare Medical Limited warrants that the product purchased meets the labelled specifications of the product and will be free from defects in materials and workmanship that occur within one (1) year from the date of purchase.

 

Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State of the user and/or patient.

 

This warranty does not cover damage caused by:

  • Handling during shipping.
  • Use or maintenance contrary to labeling and instructions, including but not limited to incorrect disassembly, reprocessing and reassembly.
  • Modification or repair by anyone not authorized by Flexicare Medical Limited

Abuse, misuse or accidental damage

If a product covered by this warranty is determined to be defective materials, components, or workmanship, and the warrant claim is made within the warranty period described above, Flexicare Medical Limited will, at its discretion, repair or replace the defective product free of charge. Written authorisation must be obtained from Flexicare Medical Limited to return the product prior to sending it with postage paid to Flexicare Medical Limited’s designated agent.

 

This warranty is in lieu of all other warranties, expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Flexicare Medical Limited’s obligation under this warranty is limited to repair or replacement of products containing a defect. Flexicare Medical Limited is not responsible for any indirect or consequential damages resulting from a product defect covered by the warranty. This warranty shall be governed by and construed in accordance with Flexicare Medical Limited’s Terms and Conditions.

Technical Specifications

Symbols Glossary

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