Information for Patients and Caregivers

System Overview

The PICO™ 14 Single Use Negative Pressure Wound Therapy System is designed to promote wound healing by removing low to moderate levels of exudate and infectious materials. It is suitable for use in both hospital and homecare settings. The system features a quiet pump (below 35dB), high air leak tolerance, and a dressing with a silicone adhesive that is showerproof. The system can last up to 14 days.

Key Features:

• Quiet Pump (below 35dB)
• Up to 14 Days System Life
• High Air Leak Tolerance
• Dressing Full Indicator
• Airlock™ Layer for maintaining negative pressure
• Exudate Evaporation (low to moderate)
• Silicone Adhesive Dressing (showerproof)

The PICO™ 14 System is intended for use by or under the direction of a trained and licensed physician. Contact a healthcare professional if you are unsure about its use.

1. Indications

The PICO 14 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 to moderate levels of exudate and infectious materials. It is suitable for use in both hospital and homecare settings. Appropriate wound types include:

• Chronic wounds
• Acute wounds
• Traumatic wounds
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure ulcers)
• Venous leg ulcers (can be used with graduated compression therapy)
• Flaps and grafts
• Closed surgical incisions

When used on closed surgical incisions, the PICO 14 System is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high-risk patients in Class I and II wounds
• Post-operative Seroma
• Dehiscence

2. Contraindications

The PICO 14 System is contraindicated for:

• Patients with malignancy in the wound bed or margins (except in palliative care).
• Previously confirmed and untreated osteomyelitis.
• Non-enteric and unexplored fistulas.
• Necrotic tissue with eschar present.
• Exposed arteries, veins, nerves, or organs.
• Exposed anastomotic sites.

The PICO 14 System should not be used for:

• Emergency airway aspiration.
• Pleural, mediastinal, or chest tube drainage.
• Surgical suction.

3. Description

The PICO 14 System is a device that provides suction to a wound to promote healing. When the pump is activated, air is drawn from the dressing, and excess fluid enters the dressing. The system features visual indicators for issues, but no audible alerts. Dressings should be checked frequently. If air leak, dressing full, or battery low indicators illuminate, consult the troubleshooting section.

System Components:

• A - OK Indicator: Green light indicates proper function.
• B - Air Leak Indicator: Orange light indicates an air leak.
• C - Dressing Full Indicator: Orange light indicates the dressing is full.
• D - Battery Low Indicator: Orange light indicates low battery.
• E - Orange Start/Stop Button: Used to start, pause, or resume therapy.
• F - Soft Port: Connects the pump to the dressing.
• G - Dressing: The wound dressing applied to the patient.

4. Important Information

Pump Placement Warning

The PICO 14 pump contains a MAGNET. Keep the PICO 14 pump at least 4 inches (10 cm) away from other medical devices at all times. Failure to maintain appropriate distance may disrupt the operation of nearby medical devices.

Refer to Section 5 for the Magnet Warning.

5. Warnings

Magnet Warning

The PICO 14 pump contains a MAGNET. It must be positioned at least 4 inches (10 cm) away from other medical devices that could be affected by magnetic interference. This applies to all users (patients and caregivers).

Examples of affected devices include, but are not limited to:

• Implantable Cardioverter-defibrillators (ICDs)
• Pacemakers
• Insulin Pumps
• Shunt Valves
• Neurostimulators
• Cochlear Implants

General Warnings:

• Do not attempt to change the dressing; this should only be done by a healthcare professional.
• Excessive bleeding is a serious risk. Monitor the dressing for bleeding. If sudden or increased bleeding occurs, disconnect the pump immediately, leave the dressing in place, and seek immediate medical assistance.
• If defibrillation is required, remove the dressing only if it interferes with the procedure.
• The PICO 14 System contains small parts that may be a choking hazard for young children. Keep out of reach of children.
• The system is unsuitable for use in areas with explosion danger (e.g., oxygen-rich environments like hyperbaric units).
• MR Unsafe: Remove the PICO 14 pump before entering an MRI suite. Do not bring the pump into the MRI scan room due to projectile hazard.
• The system is not suitable for use with flammable anesthetic mixtures.
• PICO dressings should only be applied, changed, and removed by a healthcare professional.
• Ensure the pump, tubing, and connectors do not:
• Cause pressure damage to the patient.
• Trail across the floor, creating a trip hazard or contamination risk.
• Present a risk of strangulation or tourniquet.
• Rest on or pass over a heat source.
• Become twisted or trapped, blocking the air path.
• Keep the system away from pets, pests, and other animals.
• Do not attempt to dismantle or modify the system.

6. Precautions

• Regularly monitor the PICO dressing. If it appears full or fluid is around the Soft Port, contact your healthcare professional.
• Do not let the pump get wet. Protect it from fluids. Do not use if wet.
• Do not take the pump apart.
• Do not cut the tubing between the pump and dressing. Avoid pulling on the tubing or soft port.
• Use caution if the pump is near electronic equipment like RFID readers, anti-theft devices, or metal detectors due to potential electromagnetic interference.
• The system can be used in aircraft, trains, and boats. Exercise special care with pump positioning near other people (refer to magnet warning).
• If the pump malfunctions during transport, replace batteries. If the issue persists, contact a healthcare professional.
• If pain, reddening, odor, sensitization, or a sudden change in wound fluid occurs, contact your healthcare professional.
• When using on a skin graft, regularly inspect the system to ensure therapy is applied and a seal is maintained.
• The PICO 14 System does not have audible alerts. Carry the pump where it is accessible for routine checks.
• When showering, disconnect the pump from the dressing. Place the pump safely away from water. Ensure the dressing tube end faces downwards to prevent water entry. Reconnect and restart the pump after showering.

7. Technical Information

Storage and Transport Conditions

• Temperature: 41°F - 77°F (–13°F to +41°F allowable for up to 7 days)
• Relative Humidity: 10-75%
• Atmospheric Pressure: 700 to 1060 mbar

Operating Conditions

• Temperature: 41°F - 104°F
• Relative Humidity: 10-95%
• Atmospheric Pressure: 700 to 1060 mbar

Pump Information

• Ingress Protection Rating: IP22
• Battery Type: 2 x AA 1.5V (LR6 / FR6)

8. How do I know if the PICO 14 pump is working?

Indicator Status: Green 'OK' indicator flashes.

Description: While the PICO 14 pump is powered on, the OK indicator will flash green, signifying the system is functioning correctly. Regularly check the dressing condition. If the dressing appears full or blocked, contact a healthcare professional.

9. How do I know if the PICO 14 pump is pumping down?

Indicator Status: Green 'OK' and Orange 'Leak' indicators flash.

Description: The pump is working to achieve therapy but has not reached the intended pressure. This may take up to 100 seconds depending on wound size. Check the dressing condition. If the dressing is not full or blocked, no action is required. If it appears full or blocked, contact a healthcare professional.

10. Changing the Batteries

If the battery low indicator flashes, the batteries need changing.

1. Remove the back cover of the PICO 14 pump to access the battery compartment.
2. Remove used batteries and dispose of them according to local regulations.
3. Insert new AA batteries, observing the correct orientation inside the compartment.
4. Replace the back cover. All four indicators should illuminate for 3 seconds upon completion.

11. Showering and Bathing

Light showering is permissible. Disconnect the PICO 14 pump and place it in a safe location away from water. Untwist the connectors to disconnect the pump from the dressing. The PICO dressing should not be exposed to direct spray or submerged. Ensure the dressing tube end faces downwards to prevent water entry. After showering, reconnect the pump and restart it using the orange button.

12. Does Your Dressing Look Full?

Patients and caregivers should not attempt to change or apply dressings; this must be done by a healthcare professional.

If your dressing looks similar to this: [Image description: Dressing appears normal, not full.]
You should leave the dressing in place.

If your dressing looks similar to either or both of these: [Image description: Dressing appears full, or soft port may be blocked with fluid.]
You must contact your healthcare professional right away.

13. Troubleshooting

14. Glossary of Symbols

• ✔ Follow instructions for use: Indicates adherence to usage guidelines.
• OK Pump is functioning properly: Green indicator light.
• Warning: The PICO 14 pump contains a MAGNET: Keep at least 4 inches (10 cm) away from medical devices susceptible to magnetic interference.
• Air leak detected: Orange indicator light.
• Dressing change needed: Indicates dressing requires attention.
• Low battery: Orange indicator light.
• Start/pause/resume therapy: Orange button.
• System lasts 14 days: Indicates system duration.
• Pump lasts 14 days: Indicates pump duration.
• Caution: Federal (USA) law restricts this device to sale by or on order of a physician: Regulatory notice.
• ② Single Use. Do not reuse: Indicates the device is disposable.
• LOT Lot number: Batch identification.
• EU: Not for general waste: Disposal guidance.
• International classification: Symbol for international standards.
• Defibrillation-proof type BF applied part: Safety standard for electrical equipment.
• MR Unsafe ⚠️: Keep away from magnetic resonance imaging (MRI) equipment.
• STERILE EO: Product is sterilised by Ethylene Oxide: Sterilization method.
• Non-Sterile: Indicates product is not sterile.
• Caution: Do not use if the package is damaged: Safety instruction.
• Storage temperature: Symbol for temperature range.
• Manufacturer: Symbol for manufacturer identification.
• Date of manufacture: Symbol for production date.
• Consult instructions for use: Symbol indicating need to read manual.
• Keep product out of sunlight: Storage instruction.
• Keep dry: Storage instruction.
• Relative humidity limits: Symbol for humidity range.
• Atmospheric pressure limits: Symbol for pressure range.
• CE Mark: European conformity mark.
• It is acceptable to be left in place: Indicates dressing can remain.
• Dressing is full: Indicator status.
• Soft port may be blocked with fluid: Potential issue with the soft port.

15. Contact Information

Smith & Nephew Medical Limited
101 Hessle Road, Hull, HU3 2BN England

UNITED STATES
Smith & Nephew, Inc.
5600 Clearfork Main Street, Suite 600 Fort Worth, TX 76109
Customer care center: 1-817-900-4000

Website: www.smith-nephew.com

Trade Marks of Smith & Nephew. This product may be covered by one or more US patents. See www.smith-nephew.com/patents.

Date of issue: 04/2022

For information on electromagnetic immunity and emissions, contact your Smith & Nephew representative.