Introduction
VivereX™ system is a medical therapeutic device which apply controlled negative pressure to the wound bed. VivereX™ system includes a non-sterile single use battery powered device and should be used with a sterile NPWT dressing set. VivereX™ is equipped with necessary safety visual indicators and performs Negative Pressure Wound Therapy (NPWT) by a continuous mode. VivereX™ device is intended to be used for ten days for one patient, which means no risk for cross contamination. Applying negative pressure results in transferring wound exudate to the NPWT dressing. The NPWT dressing contains of Several layers and is designed to manage the wound exudate in two different mechanisms, by which VivereX™ system increases dramatically the dressing life time:
- The absorbent layer of the dressing absorbs some of the secretion.
- The dressing allows evaporation of the rest of the wound secretion.
What does VivereX™ do?
VivereX™ provides suction known as Negative pressure wound therapy (NPWT) which draws out excess fluid from a wound and protects the incision or wound.
How does VivereX™ work?
VivereX™ consists of an NPWT pump connected to an absorbent gentle adhesive dressing.
The dressing is applied to the wound bed and extra adhesive strips are placed over the outside edge to help hold the dressing in place. When the pump is turned on, air is pulled out of the dressing and excess fluid from the wound will start to enter the dressing. The dressing helps to prevent bacteria from entering the wound. It may also improve blood flow to the wound which will help it to heal.
INSTRUCTION TO USE VIVEREX™ DEVICE:
- Insert two AA batteries into the battery compartment on the back side of the VivereX™ device, in the correct orientation. Alkaline batteries are recommended. Do not use rechargeable battery, the device will not work. All indicators flash twice indicating the device is ready to use. Secure the battery compartment cover.
- Twist luer connectors together to connect the dressing tube to VivereX™ device.
- Use extension tube if a longer distance between dressing and the device is required.
- Ensure the tube is free from kinks and not blocking the flow between the dressing and VivereX™ device.
- Press the power button on the front of the VivereX™ device to start the device. The green indicator starts to flash, indicating that the device is on.
- The device can be heard functioning while contraction of the dressing confirms the start of NPWT.
- The leak indicator flashes if the dressing is not sealed (refer to section 20 for troubleshooting in the user manual). VivereX™ will turn off if the leak is not adequately solved within 30 seconds.
- Keep VivereX™ in a place close to the patient, where the patient can easily monitor the status of LED indicators e.g. using the belt holder to hang the device on their pocket, outer garments, or belt.
- VivereX™ will automatically stop functioning ten days after start date. Note: The dressing should be removed as soon as possible or VivereX™ should be replaced with a new one.
- To turn off the device, press the power button for 3 seconds.
- If you require any assistance in setting up, using or maintaining the VivereX™ system, or if any unexpected alerts or fault are encountered, please contact Sunmedic.
WILL IT BE PAINFUL?
The first time the VivereX™ pump is turned on, you may feel a slight pulling or drawing sensation.
If you experience any pain, please speak to your nurse or doctor for advice.
Taking shower with VivereX™ dressing:
Press the power button for 3 seconds to put the device in «Off» mode and disconnect VivereX™ and keep the device in a safe place. The end of the dressing’s tube should be facing down, to prevent water entering the tube and should not be submerged in water or sprayed. After showering reconnect the device using the luer lock and press power button to turn the device to «On» mode. Ensure that the green indicator flashes, the dressing is contracted and no yellow indicator is active.
Will the dressing changes hurt?
Some people may experience slight discomfort during dressing changes, specifically during cleaning of the wound, depending on the type and position of the wound. If you feel any discomfort, please contact your healthcare giver.
Can you move around while on the therapy?
Patients using VivereX™ can move around but this will depend on recommendations provided by your healthcare giver.
When you are asleep
Make sure that the VivereX™ pump is placed somewhere safe and cannot be pulled off a table or cabinet onto the floor during sleep.
WHEN TO CHANGE THE DRESSING?
A common wear time for a silicone dressing is three to seven days. This period of time reduces in case of wound infection or excessive wound secretion. The dressing should be changed in accordance with following guidelines:
- When the «change dressing» indicator is turned «On».
- When the wound exudate has reached or is close to the suction port as in (b) and (c).
- When there is repeated sign of leak which has been difficult to solve.
Dressing properly positioned and is accept- able to be left in place (a)
HOW DO I KNOW IF THE VIVEREX™ SYSTEM IS WORKING?
While the VivereX™ pump is working correctly a green light located at the left top of the device will flash continuously. The dressing should have a slightly wrinkled appearance and feel firm to the touch.
WHAT HAPPENS IF THE VIVEREX™ VISUAL INDICATORS STARTS FLASHING?
The VivereX™ system has a visual indicator for “Low Battery” and “Leak”. These issues are easily solved, for example:
“Leak indicator is flashing” – A significant leak exits. NPWT is not established.
The unit will be turn off after 30s. if NPWT has not been established due to air leak, press the power button to start the unit.
Check dressing’s border and smooth out if any creasing is observed and check and secure tube-unit connectors.
Press power button to restart the unit.
“Normal function and Battery indicator flash”
The unit is functioning normal but the battery power is too low. Replace batteries during one day or as soon as possible.
“BATTERY INDICATOR ALONE FLASHES”
Replace the batteries within few hours, preferably immediately. Press power button to restart the therapy.
When will I need a new pump?
The pump is designed to stop working after ten days after initially started. After this time, it will stop and will not restart even with new batteries. Negative pressure therapy is not being applied at this point so healthcare giver will need to apply a new VivereX™ therapy system if needed. The pump will look like this when it has come to the end of its life.
Call your healthcare giver immediately if:
You notice a change in the colour or amount of the fluid in the dressing, for example:
- If it changes from clear to cloudy or bright red.
- You see the dressing fill rapidly with blood.
- Your wound looks more red than usual or has a foul smell.
- The skin around your wound looks reddened or irritated.
- The dressing feels or appears loose.
- You experience pain.
- The yellow indicator is flashing.
FAQ
What is NPWT?
Negative Pressure Wound Therapy also called vacuum therapy for the treatment of wounds was described by Argenta and Morykwas in 1997. The system contains a wound dressing connected to a pump that continuously or intermittently applies negative pressure to the surface of a wound. The mechanism of action of this method is reducing swollen and increasing blood flow at the wound bed. The indication for NPWT has been expanded to the treatment of many wound types, including orthopedic trauma, acute and chronic wound, skin grafts, close surgical incision, pressure ulcers, venous leg ulcers, diabetic foot ulcers, burns, surgical infections, and management of other major surgical wounds.
What is the VivereX® System?
VivereX® system consists of an NPWT pump connected to an absorbent adhesive dressing that is applied to the wound. The pump is programmed to produce a predefined level of negative pressure on the wound surface. The dressing is a multilayers with adhesive silicone border which allows the wound exudate to pass through from the wound. It secures the dressing in place too and reduces pain on removal. The dressing helps to prevent bacteria from entering the wound. It may also improve blood flow to the wound which will help it to heal.
How do I know that VivereX® is functioning normally?
VivereX® demonstrates its normal or abnormal function in its status window. The status window has 4 led indicators. The normal function is demonstrated when green therapy sign flashes. How often the dressing has to be changed? VivereX® is equipped with an advanced function to warn the need of dressing change. However, the dressings may be left in place for up to 7 days. Your doctor or nurse will inform you when the dressings should be changed.
Is the treatment with VivereX® system painful?
The source of pain in many patients is the acute cyclic pain secondary to the disruption of the granulation tissue induced by dressing removal. VivereX® dressing is in contact with the wound surface by its gentle adhesive silicone layer which makes it almost pain-free on removal. Few patients have reported mild pain or uncomfortable feeling a few minutes after the pump has been turned on. If the doctor gave you a prescription medicine for pain, take it as prescribed.
Can I take shower when VivereX® system is on?
You can shower or wash with the dressing in place. The dressing is water-resistant, but you should avoid exposing the dressing to direst water jet or submerge it in water may cause it to fall off. To take shower consider carefully the following instructions: Press the power button for three sec to put the device in Off mode. Disconnect VivereX® and keep the device in a safe place. The end of the dressing’s tube should be facing down, to prevent water from entering the tube. The dressing should not be directly submerged in water or spayed. After showering reconnect the device as described in section D. Press power button to turn the device in «On» mode. Ensure that the green therapy LED flashes, the dressing is contracted and no LED alarm is active.
How do I notice if battery power is low?
The turned on both green therapy LED and red battery LED to indicate a low battery power and the batteries should be replaced with a new one within 24 hours. If the only red battery LED flashes the battery power is too low, and a normal therapy is not established. The batteries should be replaced immediately. Refer to instruction video for replacing batteries.
How long does my wound need to be treated with VivereX®?
The treatment time depends on the size and type of wound you have. Your doctor will give you information about how often the dressing should be change and approximate treatment time. Be sure to go to all appointments, and call your doctor or nurse call line if you The wound starts bleeding.
When Should I call my health care professionals?
When the bandage comes off. Cover the area with a sterile bandage until you can see your doctor. When All LED indicators are turned on When the umber leak or dressing change LED indicator is flashing When the machine makes more often noise or gets loud. This may mean the seal is broken. When you have signs of infection, such as: Swelling, or warmth, or redness around the wound , or increased pain, or observing pus, or in case of fever.
Important issues that patients should be aware of:
- Keep the device in a position that allows good visibility of the four LED indicators.
- Observe routinely tubing to ensure the tubes are free from kinks and not blocking the flow between the dressing and the device.
- Keep the device free from dust, drop down, out of reach of children and pets.
- Do not spray or submerge on water.
- The device may be wiped clean with mild disinfectant solution or soapy water. Avoid spilling liquid on the device as liquids can cause malfunction of VivereX® and possible hazard to patient.
- Contact your healthcare professional if you observe any evidence of damage or sign of malfunction the of VivereX® system.
Understanding the way VivereX® communicates with you
Why all LED indicators are turned Off?