PICO* 7 Single Use Negative Pressure Wound Therapy System
The PICO* 7 Single Use Negative Pressure Wound Therapy System is indicated for acute and chronic wounds, and closed surgical incisions with low to moderate levels of exudate. This single use system is canister-free with a wear time of up to seven days. Approved for both hospital and home care settings.
• May reduce complications and provide positive outcomes for patients
• Simple, patient-friendly application
• Pocket-size is easy to wear compared with traditional NPWT devices
• High MVTR top film allows one-way transpiration of exudate vapor
• Silicone contact allows fluid to pass and minimizes pain on removal
• Provides even distribution of negative pressure across the dressing
• Fast and easy to apply and can be easily adjusted
• Simple operation means less chance of error
• Simple instructions reduce training time
• Airlock layer maintains open airflow
• Multisite dressing features Soft Port technology designed to reduce the risk of pressure points while supporting easy application and conformability to challenging anatomical areas
• Multisite dressing makes therapy more accessible for wound in awkward areas such as the neck, shoulder, knee or sacrum
PICO* 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low levels of exudate and infectious materials. Examples of appropriate wound types include: chronic; acute; traumatic; subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; closed surgical incisions.
Suitable for use in both a hospital and home care setting.
The use of PICO* 7 is contraindicated in the presence of:
• Patients with malignancy in the wound bed or margins of the wound (except in palliative care to enhance quality of life).
• Previously confirmed and untreated osteomyelitis.
• Non-enteric and unexplored fistulas.
• Necrotic tissue with eschar present.
• Exposed arteries, veins, nerves or organs.
• Anastomotic sites.
• Emergency airway aspiration.
• Pleural, mediastinal or chest tube drainage.
• Surgical suction.
Certain patients are at high risk of bleeding complications which, if uncontrolled, could potentially be fatal. Patients must be closely monitored for bleeding. If sudden or increased bleeding is observed, immediately discontinue therapy, leave dressing in place, take appropriate measures to stop bleeding and seek immediate medical assistance.
The use of anticoagulants does not deem a patient inappropriate for treatment with PICO* 7, however, hemostasis must be achieved before applying the dressing. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of bleeding. During therapy, avoid using hemostatic products that may increase the risk of bleeding, if disrupted. Frequent assessment must be maintained and considered throughout the therapy.
At all times care should be taken to ensure that the pump and tubing does not:
• Lie in a position where it could cause pressure damage to the patient.
• Trail across the floor where it could present a trip hazard or become contaminated.
• Present a risk of strangulation or a tourniquet to patients.
• Rest on or pass over a source of heat.
• Become twisted or trapped under clothing or bandages so that the negative pressure is blocked.
Sharp edges or bone fragments in a wound must be covered or removed prior to using PICO* 7 due to risk of puncturing organs or blood vessels while under negative pressure.
In the event that defibrillation is required, disconnect the pump from the dressing prior to defibrillation. Remove the dressing if it is positioned in a location that will interfere with defibrillation.
MR unsafe. PICO* 7 is not MRI compatible. Do not take PICO* 7 into the MRI suite.
PICO* 7 has not been studied on pediatric patients. Patient size and weight should be considered when prescribing this therapy.
PICO* 7 is unsuitable for use in areas where there is danger of explosion (e.g. hyperbaric oxygen unit).
PICO* 7 is not suitable for use in the presence of flammable anesthetic mixture with oxygen or nitrous oxide.
Precautions should be taken in the following types of patients who are at high risk of bleeding complications:
• Receiving anticoagulant therapy or platelet aggregation inhibitors or actively bleeding.
• Having weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to; anastomoses, infection, trauma or radiation.
• Suffering from difficult wound hemostasis.
• Untreated for malnutrition.
• Noncompliant or combative.
• Suffering from wounds in close proximity to blood vessels or delicate fascia.
PICO* 7 dressings should only be applied by a health care professional. Dressings are not to be removed or changed by the patient.
Where PICO* 7 is used on infected wounds, more frequent dressing changes may be required. Regular monitoring of the wound should be maintained to check for signs of infection.
If deemed clinically appropriate, care should be taken that the application of a circumferential dressing does not compromise circulation.
PICO* 7 does not contain audible alarms. The pump should be carried so that it is accessible and the patient/health care professional can check the status routinely.
Although PICO* 7 can be used under clothing/bedding, it is important that occlusive materials (e.g. film dressings), are not applied over the pad area of the dressing as this will impair the intended evaporation of moisture through its outer layer.
The PICO* 7 dressing should not be covered by rigid immobilization devices or casts which might apply excessive pressure and cause tissue injury at the wound site, especially where the tubing enters the dressing.
Prolonged placement of rigid or opaque materials over the PICO* 7 dressing may prevent the regular inspection and assessment of the wound, and disrupt scheduled or required dressing changes.
Where PICO* 7 is used on patients with fragile skin, a skin protectant such as SKIN-PREP™ should be used on areas of skin where fixation strips are to be applied. Inappropriate use or repeated application of fixation strips may otherwise result in skin stripping.
If reddening or sensitization occurs, discontinue use and contact the treating health care professional.
Do not use PICO* 7 with oil-based products such as petrolatum as it may compromise establishing an effective seal.
The use of negative pressure presents a risk of tissue ingrowth into foam when this is used as a wound filler. When using foam filler with PICO* 7, tissue ingrowth may be reduced by using a wound contact layer or by increasing the frequency of dressing changes.
PICO* 7 may be used in conjunction with surgical drains, provided the dressing is not placed over tubing where it exits the skin. Any surgical drain should be routed under the skin away from the edge of the dressing and function independently of the PICO* 7 Single Use Negative Pressure Wound Therapy System.
Pump must be protected from sources of fluid (e.g. from incontinence or spillages). Discontinue device use if fluid ingress is observed.
When showering, the PICO* 7 pump should be disconnected from the dressing. Ensure the end of the tubing attached to the dressing is facing down so that water does not enter the top of the tube.
Do not take the pump apart.
The dressing should not be used with any other suction pump.
Do not alter or cut tubing configuration or pull on the tubing.
Do not cut the dressing as this may lead to loss of NPWT application.
Always ensure that the dressing is positioned centrally over the wound. The port should be positioned uppermost on intact skin and not extend over the wound so that the risk of fluid collecting around the port and potentially blocking the negative pressure is minimized.
CT scans and x-ray have the potential to interfere with some electronic medical devices. Where possible, move the device out of the x-ray or scanner range. If the device has been taken into the CT scan or x-ray range, check that it is functioning correctly following the procedure.
This device is single use only. Use of any part of this system on more than one patient may result in cross contamination that may lead to infection.
High temperatures and humidity may reduce wear times of dressings.
During transport, there is a potential for radio frequency interference that could affect PICO* 7 performance. If the device malfunctions, replace batteries. If not corrected, contact your caregiver to replace the device. PICO* 7 is not intended for use aboard aircraft; the batteries should be removed during air travel.
The potential for electromagnetic interference in all environments cannot be eliminated. Use caution if PICO* 7 is near electronic equipment such as RFID (Radio Frequency Identification) readers, anti-theft equipment or metal detectors.
Excessive bleeding is a serious risk associated with the application of suction to wounds which may result in death or serious injury. Careful patient selection, in view of the above stated contraindications, warnings and precautions is essential. Carefully monitor the wound and dressing for any evidence of a change in the blood loss status of the patient. Notify the health care professional of any sudden or abrupt changes in the volume or the color of exudate.
5°C-25°C, 10-75% RH
700 to 1060 mbar atmospheric pressure
Dressing size: 4"x8", 4"x12", 4"x16", 6"x6", 6"x8", 6"x12", 8"x8", 10"x10". Multisite small: 6"x8". Multisite large: 8"x10".
|Accommodates large wounds|
|Accommodates small wounds||●|
|Antimicrobial interface available|
|Portable (under 1lb)||●|
|Single-use – 10 days|
|Single-use – 15 days|
|Single-use – 7 days||●|
|Usable on closed wounds||●|
|Usable on open wounds||●|
|Variable pressure setting|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available||●|
PICO* 7 Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of an electric motor driven, twin-diaphragm, vacuum pump connected to a super absorbent, gentle adhesive dressing. Each kit contains a sterile single-use pump, two dressings and secondary fixation strips.
The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place.
When the PICO* 7 Single Use Negative Pressure Wound Therapy System suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing.
The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (seven days) of battery life depending upon leak rate. The batteries can be replaced if required.
The PICO* 7 Single Use Negative Pressure Wound Therapy System pump is designed to stop working after 168 hours (seven days) of use and will not restart after this time, even with new batteries. Negative pressure will not be applied at this point.
Can be worn for up to seven days.
1. Dressings should be changed in line with standard wound management guidelines, typically every three to four days. More frequent dressing changes may be required depending on the level of exudate, condition of the dressing, wound type/size, orientation of the dressing, environmental considerations or other patient considerations (e.g. when PICO* 7 is used on infected wounds). At the health care professional's discretion, a PICO* 7 dressing may be left in place for up to 7 days.
2. Inspect the dressing regularly. If the dressing appears ready for changing (see diagrams A-C), press the orange button and disconnect the dressing from the pump. The fixation strips should be stretched away from the skin and the dressing lifted at one corner and peeled back until it has been fully removed. Apply another dressing as per section 7.2, connect to the pump and press the orange button to reinitiate the therapy.
(A) Dressing properly positioned and is acceptable to be left in place
(B) Dressing requires change – Port may block with fluid
(C) Dressing requires change – Absorbent area is full
3. Based on dressing change frequency, a new PICO* 7 Single Use Negative Pressure Wound Therapy System kit will be required dependent on whichever of the following occurs first - either when both dressings have been used or after seven days when the pump automatically stops functioning (all the lights will turn off at this point).
4. The dressing should be disposed of as clinical waste. The batteries should be removed from the pump; and both batteries and pump disposed of according to local regulations.
5. For additional information on disposal requirements see: www.possiblewithpico.com
The PICO* 7 Single Use Negative Pressure Wound Therapy System consists of a pump and two sterile dressing kits.
Lightweight, portable suction device: Electric motor driven, twin-diaphragm, vacuum pump
Two AA lithium batteries which provide up to 168 hours (seven days) of battery life depending upon leak rate.
For over 150 years, Smith & Nephew has taken a pioneering approach to product design and services, helping to reduce the human and economic costs of wounds.
Advanced Wound Bioactives
(Includes Collagenase SANTYL* Ointment, OASIS® Ultra Tri-Layer Matrix, OASIS® Wound Matrix, PROSHIELD* Foam & Spray Incontinent & Total Body Cleanser, PROSHIELD* Plus Skin Protectant, REGRANEX* (becaplermin) Gel 0.01%)
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