smith nephew PICO 7 Single Use Negative Pressure Wound Therapy System User Manual

: June 11, 2024
: smith nephew

Healthcare Professional User Manual
PICO™ 7
Single Use Negative Pressure
Wound Therapy System
User Manual smith nephew PICO 7 Single Use Negative Pressure Wound Therapy
System

PICO 7 Single Use Negative Pressure Wound Therapy System

Pump noise level is below 35dB| System lasts up to 7 days| Pump has high tolerance to air leaks

Dressing full indicator| Airlock layer helps maintain negative pressure across the dressing| 80% of exudate managed through evaporation

Indicated for low to moderate exuding wounds| Silicone gel adhesive dressing| Dressing is showerproof

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. This user manual contains information specific for use by a healthcare professional and is not appropriate for use by patients and caregivers.
Information for patients and caregivers is provided in the form of a separate user manual provided with the PICO 7 kit. ENSURE THAT THE PICO 7 PATIENT AND CAREGIVER USER MANUAL IS HANDED TO THE PATIENT OR CAREGIVER. Care should be taken to ensure that patients and caregivers understand all warnings and precautions, especially those relating to pump placement, as the PICO 7 pump contains a magnet.

Description

The PICO 7 System consists of a pump and sterile dressing(s). The PICO 7 pump maintains negative pressure wound therapy at 80 mmHg (nominal) to the wound surface. Exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film. The PICO 7 dual dressing kit is intended to be used for up to 7 days on low to moderately exuding wounds. The PICO 7 single-dressing kit is intended to be used for up to 7 days on low exuding wounds. For moderate exuding wounds the system is intended to be used of up to 4 days. For 7 days use on moderate exuding wounds additional dressings will be required (available for purchase separately). Low exuding wounds are considered to be up to 0.6g of liquid exudate/cm 2 of wound area/24 hours. Moderate exuding wounds are considered to be up to 1.1g of liquid exudate/cm 2 of wound area/24 hours. 1g of exudate is approximately equal to 1ml of exudate. The PICO System is demonstrated to be effective for up to 7 days for aiding in reducing the incidence of surgical site infection. The frequency of dressing changes can be affected by multiple factors such as wound type, wound size, rate or volume of exudate, orientation or environmental conditions. Additional dressings are available to purchase separately, as required.

Indications for use

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
Iridescence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds – the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol

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.

PICO 7 System with graduated compression therapy

The PICO 7 System with graduated compression therapy may be used to treat venous ulcerations. For more information including application see section 10.2.

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 6 Magnet Warning
For more information on electromagnetic immunity and electromagnetic emissions see Section 15 Electromagnetic compatibility of the PICO 7 System.

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 the patient is wearing the PICO 7 pump in a public area where they may come in close contact with someone else who has an electronic medical device.
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 disconnect pump, leave dressing in place, take appropriate measures to stop bleeding and seek immediate medical assistance.
Hemostasis must be achieved before applying the dressing, although the use of anticoagulants does not deem a patient inappropriate for treatment with the PICO 7 System. 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 throughout the therapy.
At all times care should be taken to ensure that the pump, tubing and connectors do 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 therapy is blocked.
Sharp edges or bone fragments in a wound must be covered or removed prior to using the PICO 7
System due to risk of puncturing organs or blood vessels while under negative pressure wound therapy.
In the event that defibrillation is required, remove the dressing if it is positioned in a location that will interfere with defibrillation.
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.
Safety and effectiveness in pediatric population (<22 years old) has not been evaluated. Patient size and weight should be considered when prescribing this therapy to this population.
The PICO 7 System is unsuitable for use in areas where there is danger of explosion (e.g. oxygen rich environments such as hyperbaric oxygen unit).
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 not suitable for use in the presence of flammable anesthetic mixture with oxygen or nitrous oxide.
PICO dressings should only be applied, changed or removed by a healthcare professional.
Each PICO dressing (including Multisite) must be used to dress one wound only.
Keep the PICO 7 System away from pets, pests and other animals that could damage the PICO 7 System.
No modification of this equipment is allowed.
When using the PICO 7 System with graduated compression therapy you must comply with indications and contraindications for both products.

Precautions

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.
• Non-compliant or combative.
• Suffering from wounds in close proximity to blood vessels or delicate fascia.
If pain, reddening, odor, sensitization or a sudden change in the volume or color of wound fluid occurs during use, contact your healthcare professional.
Where the PICO 7 System is used to bolster skin grafts, it is important to visually inspect the system regularly, especially in the first week of treatment to ensure that negative pressure wound therapy is continually applied and a seal is maintained.
Where PICO dressings are 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. The use of the PICO 7 System does not preclude the need to continue to develop and follow a comprehensive infection management protocol.
If deemed clinically appropriate, care should be taken that the application of a circumferential dressing or the use of negative pressure wound therapy on ischemic limbs does not compromise circulation.
The PICO 7 pump does not contain audible alerts. The pump should be carried so that it is accessible and the patient/healthcare professional can check the status routinely.
Although PICO dressings 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 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 dressing may prevent the regular inspection and assessment of the wound, and disrupt scheduled or required dressing changes.
Where PICO dressings are used on patients with fragile skin, a skin protectant such as NOSTING 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.
Do not use PICO dressings with oil-based products such as petrolatum as it may compromise establishing an effective seal.
The use of negative pressure wound therapy presents a risk of tissue ingrowth into foam when this is used as a wound filler. When using foam filler with the PICO 7 System, tissue ingrowth may be reduced by using a non-adherent wound contact layer or by increasing the frequency of dressing changes.
The PICO 7 System 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 System.
The pump must be protected from sources of fluid e.g. from incontinence or spillages. Discontinue use of the PICO 7 pump if fluid ingress is observed.
When showering the PICO 7 pump should be disconnected from the dressing. Whilst disconnected, ensure the end of the tubing attached to the dressing is facing down so that water does not enter the tube.
Do not take the pump apart.
The PICO dressing should only be used with PICO pumps.
Do not alter or cut tubing configuration or pull on the tubing or soft port.
Do not cut the PICO dressing pad as this may lead to loss of negative pressure wound therapy application.
Always ensure that the PICO dressing is positioned centrally over the wound. The soft port should be positioned uppermost on intact skin and not extend over the wound so that the risk of fluid collecting around the soft port and potentially blocking the therapy is minimised.
The potential for electromagnetic interference in all environments cannot be eliminated. Use caution if the PICO 7 System is near electronic equipment such as RFID (Radio Frequency Identification) readers, anti-theft equipment or metal detectors.
CT scans and x-ray have the potential to interfere with some electronic medical devices. Where possible, move the pump out of the x-ray or scanner range. If the pump has been taken into the CT scan or x-ray range, check that the system is functioning correctly following the procedure.
The PICO 7 System 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. Dressings should not be applied if they have passed their expiry date or been stored outside of their sterile pouch. Dressings must not be used if they have become contaminated.
High temperatures and humidity may reduce wear times of PICO dressings.
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 to replace the system.
When applying dressings next to one another, ensure the dressing borders do not overlap.
This device has not been evaluated for abdominal and thoracic cavity.
The following statements describe conditions that may require special care for the safe and effective use of the PICO 7 System:
• use near vagus nerve (bradycardia)
• patient with spinal cord injury (stimulation of sympathetic nervous system)

Adverse reactions

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. Monitor the patient for signs of any sudden or abrupt changes in the volume or the color of exudate.

Definitions

According to the latest recommendations (CDC 2020), superficial and deep incisional SSIs are defined as follows:

A superficial incisional SSI involves only skin and subcutaneous tissue of the incision and occurs within 30 days after any National Healthcare Safety Network (NHSN) operative procedure.
A deep incisional SSI involves deep soft tissues of the incision (for example, fascial and muscle layers) and occurs within 30 or 90 days after the NHSN operative procedure. Reference: CDC 2020. SSI – Procedure-associated Module 2020. Available from:
https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf. [Accessed 04/11/2020].

Instructions for use

10.1. Guidance on wound suitability
PICO dressings must only be used on wounds which fit comfortably within the area of the pad, observing precautions on soft port positioning (on intact skin and not extending over the wound). PICO Multisite dressings are designed to enhance conformability when dressing awkward anatomical areas. PICO dressings (including Multisite) must be used to dress one wound only. As a guide:
Depth – Wounds greater than 0.5cm (¼ in.) in depth are likely to require a foam or gauze negative pressure wound therapy filler to ensure adequate treatment of all the wound surface. Wounds treated with the PICO 7 System should generally be no more than 4.5cm (1 ¾ in.) in depth and must not contain exposed arteries, veins, nerves or organs (see section 3 – Contraindications).
Exudate – the PICO 7 System is intended for use on wounds where the level of exudate is low (up to 0.6g of liquid exudate/cm 2 of wound area/24 hours) to moderate (up to 1.1g of liquid exudate/ cm 2 of wound area/24 hours). 1g of exudate is approximately equal to 1ml of exudate. When used on a moderately exuding wound, the size of the wound should generally be no more than 25% of the dressing pad area.
10.2. Application
The dressing should only be applied by a healthcare professional.

Remove any excess hair to ensure close approximation of the dressing to the wound. If necessary, irrigate the wound with sterile saline and pat the wound dry.
Using a clean technique, peel off the first release handle and place the dressing centrally over the wound to reduce the chance of wound fluid coming into contact with the soft port. Ensure the dressing lies flat to the wound and the surrounding skin. The port should be applied with the soft port positioned higher than the wound (depending on the patient’s primary position) placed on intact skin and not extending over the wound to prevent fluid pooling around the soft port and blocking the therapy. Remove the other remaining handle(s) and smooth the dressing around the wound to prevent creasing. Reposition if required to ensure border is not creased.
Once the dressing is in place, remove the pump and the batteries from the tray. 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. (See Section 6 Magnet Warning).
Remove the back cover from the PICO 7 pump to access the battery compartment. Insert AA batteries in the orientation indicated inside the battery compartment. Following this all four indicators should briefly illuminate. Replace the back cover.
Join the pump to the dressing tubes by twisting together the connectors. The soft tube can be directly connected to the pump if long tubing is not required.
Press the orange button to start the application of negative pressure wound therapy. The green OK indicator and orange air leak indicator will start to flash together (indicates pump working to establish therapy). Depending on the size of the wound, the pump should take up to 65 seconds to establish therapy. If after 65 seconds the system has not established therapy, just the orange air leak indicator will flash. To troubleshoot refer to section 16.
If using NO-STING SKIN-PREP prior to application of the fixation strips (see section 7. Precautions), wipe the area surrounding the dressing and allow skin to dry.
Apply the fixation strips all the way around the dressing border. Ensure the fixation strips only overlap clear dressing border and do not cover the white dressing pad. Remove top carrier on the strip after each one has been applied. These strips maintain the seal over the wear time of the dressing. In awkward areas, it may be useful to apply the strips to help achieve a seal prior to switching on the pump. Place each strip so that it overlaps the dressing border by approximately 1cm (2/5 in.). Ensure tubing is not twisted or trapped between clothing. Please note that if at any time the fixation strips are removed, the dressing should also be replaced. If desired, gel patches may be applied in addition to the fixation strips to help achieve or maintain a seal.

10.3. Use of the PICO 7 System with graduated compression therapy
When using the PICO 7 System with graduated compression therapy you must comply with indications and contraindications for both products.
The PICO 7 System can be used with compression for the treatment of venous leg ulcerations.
Ensure all tubing including flat soft port tubing is not in contact with skin. When using compression therapy ensure the flat soft port tubing runs over the top of the first layer and beneath subsequent layers.
In a clinical study using the PICO Single Use Negative Pressure Wound Therapy System with compression therapy in venous leg ulcers, device-related adverse events included maceration, increase in ulcer size, blistering, and irritation. Care should be taken when combining these therapies, consider more frequent wound monitoring. Please discontinue combination use if maceration or increase in wound size is observed.
10.3. Dressing change
Dressings should only be changed by a healthcare professional.

Dressings should only be changed in line with standard wound management guidelines, typically every 3-4 days. At the healthcare professional’s discretion a PICO dressing may be left in place for up to 7 days. The orange dressing full indicator on the pump will flash if it detects a full dressing or blocked filter. 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 the PICO 7 System is used on infected wounds. Additional dressings for the PICO 7 System are available for purchase separately.
Inspect the PICO 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 10.2. Application, 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
Based on dressing change frequency, further dressings may be required, see Section 18 – System Variants.
The PICO dressing should be disposed of as clinical waste.
The pump life ends and it automatically stops functioning at 7 days (all the indicators will turn off at this point). The batteries should be removed from the pump; and both batteries and pump disposed of according to local regulations.
For additional information on disposal requirements see: www.mypico.com or speak to your Smith & Nephew representative.

10.4. Use of PICO dressings with fillers
PICO dressings are compatible with standard gauze and foam fillers used in traditional negative pressure wound therapy where this is clinically appropriate – for example on a defect wound. When a filler is used, the filler and the PICO dressing should be changed 2 to 3 times a week, according to local clinical protocol and manufacturer’s instructions. Gauze should loosely fill to the surface of the wound. Avoid over packing.
10.5. Use of PICO dressings with non-adherent layers
PICO dressings may be used over the top of a non-adherent layer if required, for example over a skin graft. On infected wounds or wounds at risk of infection, ACTICOAT™ Flex Antimicrobial Barrier Dressings may be used under PICO dressings.
10.6. To remove a dressing
Dressings should only be removed by a healthcare professional.

Stop the PICO 7 pump by pressing the orange button – All indicators will turn off.
Remove the pump from the dressing by untwisting the connectors.
Remove the PICO dressing by stretching the fixation strips away from the skin. Lift the dressing at one corner and peel back until it has been fully removed.
The PICO dressing and fixation strips should be disposed of as clinical waste in accordance with local protocol. The batteries should be removed from the pump; and both batteries and pump disposed of according to local regulations.

General use

11.1. Showering and bathing
Light showering is permissible; however, the PICO 7 pump should be stopped and disconnected (see section 7. Precautions) and placed in a safe location where it will not get wet. The PICO dressingshould not be exposed to a direct spray or submerged in water. While disconnected, ensure the endof the tubing attached to the dressing is facing down so that water does not enter the tube. After showering and bathing the PICO 7 pump should be reconnected to the dressing and restarted by pressing the orange button.
11.2. Cleaning
Adherence to clinical directives concerning hygiene is of prime importance. The pump may be wiped clean with a damp cloth using soapy water or a weak disinfectant solution.
11.3. Inserting or Changing Batteries
Remove the back cover from the PICO 7 pump to access the battery compartment. Insert AA batteries in the orientation indicated inside the battery compartment. Following this all four indicators should briefly illuminate. Replace the rear cover. After changing the batteries, press the orange button to restart the pump.

Specifications

Pump Dimensions	65 x 78.5 x 21mm (2.6 x 3.2 x 0.9in)
Weight	<108g
Operating Time	7 Days
Battery Type	2 x AA 1.5V (LR6/FR6)
Power	(Battery) 3V DC
Ingress Protection	IP22
Maximum Vacuum	100 mmHg
Mode of Operation	Continuous
Patient Protection	Defibrillation-proof type BF
Short Term Storage/ Transport Conditions	-13°F to +41°F allowable for up to 7

days
Storage/Transport Conditions| 41°F – 77°F, 10 – 75% relative humidity, 700 to 1060 mbar atmospheric pressure
Operating Environment| 41°F – 104°F, 10 – 95% relative humidity, 700 to 1060 mbar atmospheric pressure
Compliance| Conforms to AAMI STD ES60601-1, IEC60601-1-6 & IEC60601-1-11
Certified to CSA STD C22.2 # 60601-1

13. PICO 7 System compatibility with other procedures
The PICO 7 pump and PICO dressings are compatible with defibrillation. If in the event that defibrillation is required, remove the dressing and pump if it is positioned in a location that will interfere with defibrillation.
PICO dressings are MRI compatible, however, the PICO 7 pump is not MRI compatible. The PICO 7 pump and PICO dressings are not compatible with hyperbaric oxygen (HBO).

Safety of the PICO 7 System

The PICO 7 System does not have Essential Performance. When used in accordance with the manufacturer’s instructions, the PICO 7 System complies with the General Requirements for Safety of Electrical Medical Equipment (IEC 60601-1). The PICO 7 System is intended for uncontrolled environments e.g. home use (IEC60601-1-11).

Electromagnetic compatibility of the PICO 7 System

The PICO 7 System has been tested and found to comply with the limits for medical devices to IEC 60601-1-2. These limits and test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the PICO 7 System is used in a typical medical installation and uncontrolled environment like home use. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation.
Guidance and manufacturer’s declaration – electromagnetic immunity
The PICO 7 System is intended for use in the electromagnetic environment specified below. The customer or the user of the PICO 7 System should assure that it is used in such an environment.

Immunity test

| IEC 60601 test level| Compliance level|

Electromagnetic environment – guidelines

---|---|---|---
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±2 kV, ±4 kV, ±6 kV, ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air| Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| ±2 kV For power supply lines| PICO 7 is a battery powered device.| Not applicable
Surge IEC 61000-4-5| ±0.5 kV, ±1 kV Line-to-line| PICO 7 is a battery powered device.| Not applicable
Voltage dips, short Interruptions and voltage variations on power supply input lines IEC 61000-4-11| At 0°, 45°, 90°, 135°, 180°, 225°0, 270° and 315° phases 0% UT (100% dip in UT) for 0.5 cycle At 0° single phase 0% UT (100% dip in UT) for 1 cycle 70% UT (30% dip in UT) for 25/30 cycles 0% UT (100% dip in UT) for 250 cycles 0% UT (100% dip in UT) for 300 cycles| PICO 7 is a battery powered device.| Not applicable
Power frequency 50/60Hz) magnetic field

IEC 61000-4-8

| 30 A/m 50 or 60 Hz| 30 A/m 50 or 60 Hz
100 A/m 50 or 60 Hz
150 A/m 50 or 60 Hz
200 A/m 50 or 60 Hz| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial, hospital or home healthcare environments
Conducted RF IEC 61000-4-6| 3 Vrms 150 kHz to 80 MHz
6 Vrms 150 kHz to 80 MHz
In ISM and amateur radio bands| PICO 7 is a battery powered device.| Portable and mobile communications equipment should be separated from the device by no less than distances calculated/listed below: Recommended separation distance: d = 0.58 √P
Radiated RF IEC 61000-4-3| 10 V/m 80 MHz to 2.7 GHz
IEC 60601-1-2:2014 Table 9| 10 V/m 80 MHz to 2.7 GHz
IEC 60601-1-2:2014 Table 9| d = 0.175 √P (80 MHz to 800 MHz)
d = 0.35 √P (800 MHz to 2.7 GHz)

NOTE 1: At 80 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PICO 7 is used exceeds the applicable RF compliance level above, the PICO 7 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b . Interference may occur in the vicinity of equipment marked with the following symbol:
Guidance and manufacturer’s declaration – electromagnetic emissions the PICO 7 System
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emissions test

| Compliance|

Electromagnetic environment – guidelines

---|---|---
RF emissions CISPR 11| Group 1| The PICO 7 System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The PICO 7 System is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not Applicable
Voltage fluctuations/ flicker emissions

IEC 61000-3-3

| Not Applicable

WARNING: The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. Do not use cables and accessories other than those specified or sold by Smith & Nephew as it may result in increased electromagnetic emissions or decreased electromagnetic immunity of the PICO 7 System. Portable and mobile RF communication devices (mobile telephones) can affect the PICO 7 System.
Recommended separation distances between portable and mobile RF communications equipment and the device
The PICO 7 System is intended for use in an electromagnetic environment in which radiated RF disturbances are uncontrolled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PICO 7 System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Rated maximum output power of transmitter (W)

| Separation distance according to frequency of transmitter (m):
---|---
150 kHz to 80 MHz d = 0.58√P| 80 MHz to 800 MHz d = 0.175√P|

800 MHz to 2.7 GHz d = 0.35√P

0.01| Not applicable| 0.02| 0.03
0.1| Not applicable| 0.05| 0.1
1.0| Not applicable| 0.2| 0.3
10| Not applicable| 0.5| 1.1
100| Not applicable| 1.7| 3.5

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Troubleshooting

The PICO 7 System has visual indicators to let the user know when there is an issue. The PICO 7 System does not contain audible alerts. The pump should be carried so that it is accessible and the patient/ healthcare professional can check the status routinely in case there is a fault or in case of damage.

Display/Indicator status| Possible cause| Comments/troubleshooting
---|---|---
All indicators off| The pump is in standby.
The pump has completed its course of negative pressure
wound therapy.The batteries have depleted.| Negative pressure wound therapy is paused. Press the orange button
to restart negative pressure wound therapy. Pressing the orange button will not restart negative pressure wound therapy. Healthcare professional to apply new pump and dressing if further negative pressure wound therapy is required. If the pump has not yet completed its course of negative pressure wound therapy, replace the batteries.
Green ‘OK’ and orange ‘leak’ indicators flash| The pump is working to achieve negative pressure
wound therapy but has not reached the intended
pressure.| Wait up to 65 seconds. Assess whether negative pressure wound therapy has been established.
Green ‘OK’ indicator flashes| System is functioning properly. No issues.| The pump may be heard running occasionally as it maintains the negative pressure. This is normal.
Green ‘OK’ and orange ‘battery low’ indicators flash| System is functioning properly but the batteries are low.| Replace the batteries and press the orange button to restart therapy.
Orange ‘leak’ indicator flashes| A high air leak has been detected. Therapy is not being applied. (Note: the pump will automatically try to restart therapy after 1 hour).| Smooth down the dressing and strips to remove any creases. Press the orange button to restart therapy. If the air leak remains, the orange ‘leak’ indicator will flash again after approximately 60 seconds. Ensure that the tube connectors have been twisted together securely.
Orange ‘leak’ and orange ‘battery low’ indicators flash| A high air leak has been detected and the batteries are low. Therapy is not being applied. (Note: the pump will
automatically try to restart therapy after 1 hour).| Resolve the air leak according to instructions above. Also replace the
batteries and press the orange button to restart therapy.
Orange ‘dressing full’ indicator flashes| Dressing is saturated or filter is blocked. Therapy is not
being applied. (Note: the pump will automatically try to
restart therapy after 1 hour).| Healthcare professional to replace the dressing with a new one and press the orange button to restart therapy.
Orange ‘dressing full’ and orange ‘battery low’ indicators flash| Dressing is saturated or filter is blocked and the batteries
are low. Therapy is not being applied. (Note: the pump will automatically try to restart therapy after 1 hour).| Healthcare professional to replace the dressing with a new one. Also replace the batteries and press the orange button to restart therapy.
All indicators solidly
illuminated| A pump error has been detected. The pump can no longer apply therapy.| Healthcare professional to apply a new pump and dressing.

Cautions

This user manual is not intended as a guarantee or warranty. It is intended only as a guide. For medical questions please consult a physician.
The product must be used in accordance with this user manual and all applicable labeling.

System variants

Dressing Size| Single Dressing **Kits*| Dual Dressing Kits****|

Fluid Management **Pack*****

---|---|---|---
10cm x 20cm / 3.9in. x 7.9in.| 66022012| 66022002| 66022022
10cm x 30cm / 3.9in. x 11.8in.| 66022013| 66022003| 66022023
10cm x 40cm / 3.9in. x 15.7in.| 66022014| 66022004| 66022024
15cm x 15cm / 5.9in. x 5.9in.| 66022015| 66022005| 66022025
15cm x 20cm / 5.9in. x 7.9in.| 66022016| 66022006| 66022026
15cm x 30cm / 5.9in. x 11.8in.| 66022017| 66022007| 66022027
20cm x 20cm / 7.9in. x 7.9in.| 66022018| 66022008| 66022028
25cm x 25cm / 9.8in. x 9.8in.| 66022019| 66022009| 66022029
Multisite 15cm x 20cm / 5.9in. x 7.9in.| 66022010| 66022000| 66022020
Multisite 20cm x 25cm / 7.9in. x 9.8in.| 66022011| 66022001| 66022021

Single dressing kit comprising of 1 dressing, 1 pump and clip, secondary fixation strips. Low exuding wounds – up to 7 day system. Additional dressings are required for moderately exuding wounds (available separately).
** Dual dressing kit comprising 2 dressings, 1 pump and clip, secondary fixation strips. Low to moderately exuding wounds – up to 7 day system.
*** 5 x individually packaged sterile dressings, secondary fixation strips.
The pump may be carried in the patient’s pocket or using the included clip.

Glossary of symbols

| Follow instructions for use
---|---
| 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 6 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 number
| CE Mark
| EU: Not for general waste
| International classification
| Defibrillation-proof type BF applied part
| MR Unsafe – Keep away from magnetic resonance imaging (MRI) equipment
| Product is sterilised 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

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

Clinical Summary

As per the Indications for use, PICO™ Family devices can be used for different wound types, including closed surgical incisions. To assess the benefit of PICO in being able to reduce certain surgical site complications, a systematic literature review was performed.
A summary of the clinical data used in this review is available at https://ifu.smith-nephew.com

Documents / Resources

| smith nephew PICO 7 Single Use Negative Pressure Wound Therapy System [pdf] User Manual
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7, Single Use Negative Pressure Wound Therapy System, Negative Pressure Wound Therapy System, Pressure Wound Therapy, Wound Therapy
---|---