Information for Patient and Caregiver

Introduction

The PICO 7 Single Use Negative Pressure Wound Therapy System is intended for use by or on the direction of a trained and licensed physician in accordance with these instructions for use. Contact a healthcare professional right away if you are unsure as to the correct use of the PICO 7 System.

1. Indications

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 to moderate levels of exudate and infectious materials. PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Venous leg ulcers – the PICO 7 System can be used in combination with graduated compression therapy in the management of venous leg ulcers.
• Flaps and grafts
• Closed surgical incisions

When used on closed surgical incisions, PICO 7 Single Use Negative Pressure Wound Therapy 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 7 System is contraindicated for:

• 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.
• Exposed anastomotic sites

The PICO 7 System should not be used for the purpose of:

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

3. Description

The PICO 7 System is a device that provides suction to a wound to promote wound healing. When the PICO 7 pump is turned on, air is pulled out of the dressing and excess fluid will start to enter the dressing. The PICO 7 System has visual indicators to let you know when there is an issue. The PICO 7 System does not contain any audible alerts. Dressings should be checked frequently (See Does your dressing look full?). Carry the pump so that the status can be checked frequently. If the air leak, dressing full or battery low indicators illuminate, consult the troubleshooting section.

Visual Indicators:

• A: OK (Green)
• B: Air Leak Indicator (Orange)
• D: Dressing Full Indicator (Orange)
• E: Battery Low Indicator (Orange)
• F: Orange Start/Stop Button
• + Soft Port
• Dressing

4. Important Information

Pump Placement Warning

The PICO 7 pump contains a MAGNET. Keep the PICO 7 pump at least 4 inches (10 cm) away from other medical devices at all times. As with all electrical medical equipment, failure to maintain appropriate distance may disrupt the operation of nearby medical devices. See Section 5 Magnet Warning.

5. Warnings

Magnet Warning

The PICO 7 pump contains a MAGNET. As with all electrical medical equipment, failure to maintain appropriate distance may disrupt the operation of nearby medical devices. The PICO 7 pump must be positioned at least 4 inches (10cm) away from other medical devices that could be affected by magnetic interference. These include but are not limited to:

• Implantable Cardioverter-defibrillator (ICD)
• Pacemakers
• Insulin Pumps
• Shunt Valves
• Neurostimulators
• Cochlear Implants

THIS WARNING APPLIES AT ALL TIMES TO ALL USERS. This applies to both Patients and Caregivers. You must keep the PICO 7 pump at least 4 inches (10cm) away from other devices:

• If you have an electronic medical device and are helping take care of somebody else using the PICO 7 System.
• If you are wearing the PICO 7 pump in a public area where you may come in close contact with someone else who has an electronic medical device.

Additional Warnings:

• Do not attempt to change the dressing. Dressings should only be changed by a healthcare professional.
• Excessive bleeding is a serious risk with the application of suction to wounds, which may result in death or serious injury. Carefully monitor your dressing for any excessive bleeding. If sudden or increased bleeding is observed, immediately disconnect the PICO pump but leave the dressing in place and seek immediate medical assistance.
• If defibrillation is required, only remove the dressing if it is positioned in a location that will interfere with defibrillation.
• The PICO 7 System contains small parts which could represent a choking hazard for young children. Keep out of the reach of children.
• The PICO 7 System is unsuitable for use in areas where there is danger of explosion (e.g. hyperbaric oxygen unit).
• MR Unsafe. You must remove the PICO 7 pump from the dressing before entering the MRI suite. Do not bring the PICO 7 pump into the MRI scan room. The device presents a projectile hazard.
• The PICO 7 System is not suitable for use in the presence of flammable anesthetic mixture with oxygen or nitrous oxide.

5. Warnings (continued)

• PICO dressings should only be applied, changed and removed by a healthcare professional.
• At all times care should be taken to ensure that the pump, tubing and connectors do not:
  • Lie in a position where they could cause pressure damage to the patient.
  • Trail across the floor where they could present a trip hazard or become contaminated.
  • Present a risk of strangulation or a tourniquet to the patient.
  • Rest on or pass over a source of heat.
  • Become twisted or trapped under clothing or bandages so that the air-path delivering negative pressure is blocked.

6. Precautions

• Regularly monitor the PICO dressing. If the dressing appears full or there is fluid around the Soft Port contact your healthcare professional right away.
• Do not let the pump get wet. Protect it from the sources of fluid e.g. from incontinence or spillages. Do not use the PICO 7 pump if it is wet or has previously been 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.
• The potential for electromagnetic interference in all environments cannot be eliminated. Use caution if the PICO 7 pump is near electronic equipment such as RFID (Radio Frequency Identification) readers, anti-theft equipment or metal detectors.
• The PICO 7 System is intended for use in both a hospital and homecare setting. The system can also be used in aircraft, train and boat transportation. Special care must be taken regarding pump positioning when in close proximity to other people (see magnet warning).
• During transport there is a potential for radio frequency interference that could affect the PICO 7 pump performance. If the PICO 7 pump malfunctions, replace batteries. If not corrected, contact your healthcare professional right away to replace the system.
• If pain, reddening, odor, sensitization or a sudden change in the volume or color of wound fluid occurs during use, contact a healthcare professional right away.
• If the PICO 7 System is being used on a skin graft, visually inspect the status of the system regularly to ensure that therapy is continually applied and a seal is maintained.
• The PICO 7 System does not contain audible alerts. Carry the PICO 7 pump so it is accessible and can be checked routinely.
• When showering, disconnect the PICO 7 pump from the dressing. Ensure the end of the dressing tubing faces downwards so water does not enter the tube.

7. Technical Information

Storage and Transport Environment

• 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. Activating the PICO 7 pump

1. Press Orange Button to activate pump.
2. The green 'OK' indicator and orange 'leak' indicator will start to flash together.
3. The pump may take up to 65 seconds to establish therapy, during this time you will hear the pump.

If after this time the orange 'leak' indicator continues to flash without the 'OK' indicator, consult the troubleshooting section.

9. How do I know if the PICO 7 pump is working?

Green 'OK' indicator flashes

While the PICO 7 pump is powered on the OK indicator will flash green. The system is functioning correctly and delivering negative pressure. Regularly check the condition of the dressing by referring to Section 12 Does your dressing look full? If dressing looks full or blocked contact a healthcare professional right away.

10. Changing the batteries

If the battery low indicator flashes, the batteries on the PICO 7 pump will require changing. To change the batteries:

1. Remove the back cover from the PICO 7 pump to access the battery compartment.
2. Remove the used batteries and dispose of in accordance with local regulations.
3. Insert new AA batteries in the orientation indicated inside the battery compartment. Following this all four indicators should briefly illuminate.
4. Replace the back cover.
5. Press the orange button to restart therapy.

11. Showering and bathing

Light showering is permissible; however, the PICO 7 pump should be disconnected and placed in a safe location where it will not get wet. Before showering and bathing:

• Press the orange button to stop therapy. Disconnect the pump from the dressings by untwisting the connectors.

While disconnected:

• PICO dressings should not be exposed to a direct spray or submerged in water. Ensure the ends of the tubing attached to the dressing faces down so that water does not enter the tube.

After showering or bathing:

• Reconnect the dressing to the pump by twisting the connectors together. Press the orange button to resume therapy.

12. Does your dressing look full?

Patients and caregivers should not attempt to change or apply dressings. Dressings should only be changed by a healthcare professional.

If your dressing looks similar to this, you should leave the dressing.

It is acceptable to be left in place.

If your dressing looks similar to either or both of these, you must contact your healthcare professional right away.

Dressing is Full.

Soft port may be blocked with fluid.

13. Troubleshooting

14. Glossary of symbols

• OK Pump is functioning properly
• Warning: The PICO 7 pump contains a MAGNET. The PICO 7 pump must be positioned at least 4 inches (10cm) away from other medical devices that could be affected by magnetic interference. As with all electrical medical equipment, failure to maintain appropriate distance may disrupt the operation of nearby medical devices. See Section 5 Magnet Warning.
• Air leak detected
• Dressing full indicator
• Low battery
• Start/pause/resume therapy
• System lasts up to 7 days
• Caution: Federal (USA) law restricts this device to sale by or on order of a physician
• Single Use. Do not reuse.
• Test symbol of TUV Rheinland with approval for INMETRO Brasil
• LOT Lot number
• EU: Not for general waste
• International classification
• Defibrillation-proof type BF applied part
• MR Unsafe - Keep away from magnetic resonance imaging (MRI) equipment
• STERILE EO Product is sterilized by Ethylene Oxide
• Caution
• Do not use if the package is damaged
• Storage temperature
• Manufacturer
• Date of manufacture
• Consult instructions for use
• Keep product out of sunlight
• Keep dry
• Relative humidity limits
• Atmospheric pressure limits
• CE Mark

15. Contact Information

Smith & Nephew Medical Limited, 101 Hessle Road, Hull, HU3 2BN England. *Trade Marks of Smith & Nephew www.smith-nephew.com Smith & Nephew This product may be covered by one or more US patents. See www.smith-nephew.com/patents

UNITED STATES Smith & Nephew, Inc., Smith & Nephew, Inc. 5600 Clearfork Main Street, Suite 600 Fort Worth, TX 76109 Customer Care Center: 1-817-900-4000 Date of issue 04/2022