Manuals+

PICO 7 Single Use Negative Pressure Wound Therapy System User Manual

Healthcare Professional

Overview

The PICO™ 7 Single Use Negative Pressure Wound Therapy System is designed for use by or under the direction of a trained and licensed physician. This manual provides information specific to healthcare professionals. It is crucial to ensure patients and caregivers receive the separate PICO 7 Patient and Caregiver User Manual.

The PICO 7 System comprises a pump and sterile dressing(s) that maintain negative pressure wound therapy at 80 mmHg (nominal) to the wound surface. Exudate is managed through absorption and evaporation. The system is indicated for low to moderately exuding wounds and can be used for up to 7 days.

Key features include:

1. Description

The PICO 7 System consists of a pump and sterile dressing(s). The pump maintains negative pressure wound therapy at 80 mmHg (nominal) to the wound surface. Exudate is managed by the dressing through absorption and evaporation. The dual dressing kit is for up to 7 days on low to moderately exuding wounds, while the single dressing kit is for up to 7 days on low exuding wounds. For moderate exuding wounds, the system is intended for up to 4 days, with additional dressings available separately for 7-day use. Low exuding wounds are defined as up to 0.6g/cm²/24 hours, and moderate exuding wounds up to 1.1g/cm²/24 hours. The PICO System has been demonstrated to aid in reducing the incidence of surgical site infection for up to 7 days. Dressing change frequency may vary based on wound type, size, exudate rate, orientation, and environmental conditions.

2. Indications for Use

The PICO 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from negative pressure wound therapy (NPWT) to promote wound healing by removing low to moderate levels of exudate and infectious materials. It is suitable for both hospital and homecare settings.

Appropriate wound types include:

When used on closed surgical incisions, the PICO 7 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, and post-operative seroma and dehiscence. Note: Safety and effectiveness for Class III (contaminated) and Class IV (dirty/infected) wounds have not been demonstrated. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds. A comprehensive infection management protocol must still be followed.

3. Contraindications

The PICO 7 System is contraindicated for:

The PICO 7 System should not be used for:

4. PICO 7 System with Graduated Compression Therapy

The PICO 7 System may be used with graduated compression therapy for treating venous ulcerations. Refer to section 10.2 for application details.

5. Important Information

⚠️ Pump Placement Warning

The PICO 7 pump contains a MAGNET ?. Keep the pump at least 4 inches (10 cm) away from other medical devices. Failure to maintain appropriate distance may disrupt the operation of nearby medical devices.

For information on electromagnetic immunity and emissions, see Section 15.

6. Warnings

  1. ? Magnet Warning

    The PICO 7 pump contains a MAGNET. Keep it at least 4 inches (10cm) away from medical devices susceptible to magnetic interference, including but not limited to: Implantable Cardioverter-defibrillators (ICD), Pacemakers, Insulin Pumps, Shunt Valves, Neurostimulators, and Cochlear Implants. This warning applies to all users (patients and caregivers) at all times.

  2. Certain patients are at high risk of bleeding complications. Monitor patients closely for bleeding. If sudden or increased bleeding occurs, immediately disconnect the pump, leave the dressing in place, take measures to stop bleeding, and seek immediate medical assistance.

  3. Hemostasis must be achieved before applying the dressing. Patients on anticoagulants or with difficult hemostasis have an increased risk of bleeding. Avoid hemostatic products that may increase bleeding risk if disrupted. Frequent assessment is required.

  4. Ensure the pump, tubing, and connectors do not: cause pressure damage, trail across the floor, present a strangulation or tourniquet risk, rest on a heat source, or become twisted/trapped, blocking therapy.

  5. Sharp edges or bone fragments in a wound must be covered or removed before using the PICO 7 System to prevent puncturing organs or blood vessels.

  6. In the event of defibrillation, remove the dressing if it interferes.

  7. ? MR Unsafe: Remove the PICO 7 pump before entering an MRI suite. The pump presents a projectile hazard.

  8. Safety and effectiveness in pediatric populations (<22 years) have not been evaluated. Consider patient size and weight.

  9. The PICO 7 System is unsuitable for use in areas with explosion danger (e.g., oxygen-rich environments like hyperbaric units).

  10. The PICO 7 System contains small parts that could be a choking hazard for young children. Keep out of reach.

  11. The PICO 7 System is not suitable for use with flammable anesthetic mixtures with oxygen or nitrous oxide.

  12. PICO dressings should only be applied, changed, or removed by a healthcare professional.

  13. Each PICO dressing must be used for one wound only.

  14. Keep the PICO 7 System away from pets and pests.

  15. No modification of this equipment is allowed.

  16. When using with graduated compression therapy, comply with indications and contraindications for both products.

7. Precautions

  1. Take precautions with patients at high risk of bleeding complications, including those receiving anticoagulants, platelet aggregation inhibitors, actively bleeding, having weakened blood vessels, suffering from difficult hemostasis, malnourished, non-compliant, or with wounds near delicate structures.

  2. If pain, redness, odor, sensitization, or a sudden change in wound fluid occurs, contact a healthcare professional.

  3. When used on skin grafts, visually inspect the system regularly to ensure negative pressure is applied and a seal is maintained.

  4. For infected wounds, more frequent dressing changes may be required. Regular monitoring for infection signs is essential. The PICO 7 System does not replace a comprehensive infection management protocol.

  5. Application of circumferential dressings or NPWT on ischemic limbs should not compromise circulation.

  6. The PICO 7 pump has no audible alerts. Carry it where it is accessible for routine status checks.

  7. Avoid applying occlusive materials over the dressing pad area, as this impairs moisture evaporation.

  8. Do not cover the PICO dressing with rigid immobilization devices or casts that could apply excessive pressure or cause tissue injury.

  9. Prolonged placement of rigid or opaque materials may hinder wound inspection and disrupt dressing changes.

  10. For fragile skin, use a skin protectant like NO-STING SKIN-PREP™ where fixation strips are applied to prevent skin stripping.

  11. Do not use oil-based products (e.g., petrolatum) with PICO dressings, as they can compromise the seal.

  12. NPWT carries a risk of tissue ingrowth into foam fillers. Use a non-adherent wound contact layer or increase dressing change frequency to mitigate this.

  13. When used with surgical drains, ensure the dressing is not placed over the drain exit site. Route drains under the skin away from the dressing.

  14. Protect the pump from fluid sources (e.g., incontinence, spillages). Discontinue use if fluid ingress is observed.

  15. When showering, disconnect the pump and place it safely. Ensure the tubing end attached to the dressing faces downwards to prevent water entry.

  16. Do not disassemble the pump.

  17. PICO dressings are for use only with PICO pumps.

  18. Do not alter or cut tubing or pull on the tubing or soft port.

  19. Do not cut the PICO dressing pad, as this can lead to loss of negative pressure application.

  20. Always position the PICO dressing centrally over the wound. The soft port should be on intact skin, positioned uppermost and not over the wound to minimize fluid collection and blockage.

  21. Be cautious if the PICO 7 System is near electronic equipment like RFID readers, anti-theft devices, or metal detectors due to potential electromagnetic interference.

  22. CT scans and X-rays can interfere with electronic medical devices. Move the pump out of range if possible. After exposure, check system function.

  23. The PICO 7 System is single-use only. Using it on multiple patients can cause cross-contamination and infection. Do not use dressings past their expiry date or if the sterile pouch is compromised or the dressing is contaminated.

  24. High temperatures and humidity may reduce dressing wear times.

  25. The system can be used during transport (aircraft, train, boat). Exercise caution with pump positioning near others due to the magnet warning.

  26. Radio frequency interference during transport may affect pump performance. If malfunction occurs, replace batteries. If the issue persists, contact a healthcare professional.

  27. When applying dressings adjacent to each other, ensure borders do not overlap.

  28. This device has not been evaluated for abdominal and thoracic cavities.

  29. Special care may be required for conditions like use near the vagus nerve (bradycardia) or in patients with spinal cord injury (sympathetic nervous system stimulation).

8. Adverse Reactions

Excessive bleeding is a serious risk associated with suction application to wounds, potentially leading to death or serious injury. Careful patient selection based on contraindications, warnings, and precautions is essential. Monitor the wound and dressing for any changes in blood loss status and observe the patient for sudden or abrupt changes in exudate volume or color.

9. Definitions

According to CDC 2020 recommendations, superficial and deep incisional Surgical Site Infections (SSIs) are defined as follows:

Reference: CDC 2020. SSI - Procedure-associated Module 2020. Available from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf [Accessed 04/11/2020].

10. Instructions for Use

10.1. Guidance on Wound Suitability

PICO dressings must fit comfortably within the pad area, with precautions for soft port positioning (on intact skin, not over the wound). PICO Multisite dressings offer enhanced conformability for anatomical areas. Each dressing is for one wound only.

10.2. Application

Application should be performed by a healthcare professional.

  1. Remove excess hair to ensure close approximation of the dressing to the wound. Irrigate with sterile saline and pat dry if necessary.
  2. Peel off the first release handle and place the dressing centrally over the wound. Ensure it lies flat. Position the soft port on intact skin, higher than the wound (depending on patient position), to prevent fluid pooling. Remove remaining handles and smooth the dressing, repositioning if needed.
  3. Once the dressing is in place, remove the pump and batteries from the tray. ⚠️ Warning: Keep the PICO 7 pump at least 4 inches (10 cm) away from other medical devices (See Section 6 Magnet Warning).
  4. Remove the back cover of the pump, insert AA batteries according to the indicated orientation. All four indicators should briefly illuminate. Replace the back cover.
  5. Connect the pump to the dressing tubes by twisting the connectors. The soft tube can connect directly to the pump if long tubing is not needed.
  6. Press the orange button ▶️ to start negative pressure wound therapy. The green 'OK' and orange 'air leak' indicators will flash together, indicating the pump is establishing therapy. This may take up to 65 seconds. If therapy is not established after 65 seconds, only the orange 'air leak' indicator will flash. Refer to Section 16 for troubleshooting.
  7. If using NO-STING SKIN-PREP™, apply to the area surrounding the dressing and allow to dry.
  8. Apply fixation strips around the dressing border, overlapping the clear border by approximately 1cm (2/5 in.). Ensure strips do not cover the white dressing pad. Remove the top carrier. These strips maintain the seal. In awkward areas, apply strips to help achieve a seal before switching on the pump. Ensure tubing is not twisted or trapped. If fixation strips are removed, the dressing must be replaced. Gel patches may be used additionally.

65 secs indicates the time for therapy establishment.

10.3. Use of the PICO 7 System with Graduated Compression Therapy

When using with graduated compression therapy, comply with indications and contraindications for both products. This combination is suitable for treating venous leg ulcerations. Ensure tubing does not contact skin. For compression therapy, the flat soft port tubing should run over the first layer and beneath subsequent layers. Device-related adverse events in a clinical study included maceration, increased ulcer size, blistering, and irritation. Monitor wounds closely and discontinue combination use if maceration or increased wound size is observed.

10.3. Dressing Change

Dressings should only be changed by a healthcare professional.

  1. Dressings are typically changed every 3-4 days, but may be left in place for up to 7 days at the healthcare professional's discretion. The orange dressing full indicator ⚠️ will flash if the dressing is full or the filter is blocked. More frequent changes may be needed for infected wounds or based on exudate level, dressing condition, wound type/size, orientation, environmental factors, or patient considerations. Additional dressings are available separately.
  2. Inspect the PICO dressing regularly. If it appears ready for changing (see diagrams A-C), press the orange button ▶️ and disconnect the pump. Stretch fixation strips away from the skin, lift a corner, and peel the dressing off. Apply a new dressing as per section 10.2, connect the pump, and press the orange button to restart therapy.

Diagrams A-C illustrate dressing status:

  1. Further dressings may be required based on change frequency (see Section 18).
  2. Dispose of the PICO dressing as clinical waste.
  3. The pump has a 7-day lifespan and stops automatically. Remove batteries and dispose of the pump and batteries according to local regulations.
  4. For disposal information, visit www.mypico.com or contact a Smith & Nephew representative.

10.4. Use of PICO Dressings with Fillers

PICO dressings are compatible with standard gauze and foam fillers for NPWT, especially for defect wounds. When using fillers, change the filler and PICO dressing 2-3 times weekly per clinical protocol. Fill gauze loosely to the wound surface; avoid over-packing.

10.5. Use of PICO Dressings with Non-adherent Layers

PICO dressings can be used over non-adherent layers (e.g., for skin grafts). For infected wounds or those 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.

  1. Stop the PICO 7 pump by pressing the orange button ▶️. All indicators will turn off.
  2. Remove the pump from the dressing by untwisting the connectors.
  3. Remove the PICO dressing by stretching fixation strips away from the skin. Lift at one corner and peel back until fully removed.
  4. Dispose of the PICO dressing and fixation strips as clinical waste. Remove batteries from the pump and dispose of both pump and batteries according to local regulations.

11. General Use

11.1. Showering and Bathing

Light showering is permissible. Stop and disconnect the PICO 7 pump (see Section 7), placing it safely away from water. The dressing should not be directly sprayed or submerged. Ensure the tubing end attached to the dressing faces downwards while disconnected to prevent water entry. Reconnect and restart the pump after showering.

11.2. Cleaning

The pump may be wiped clean with a damp cloth using soapy water or a mild disinfectant solution.

11.3. Inserting or Changing Batteries

Remove the pump's back cover, insert AA batteries according to the indicated orientation. All four indicators should briefly illuminate. Replace the cover. Press the orange button ▶️ to restart the pump after changing batteries.

12. Specifications

Parameter Value
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 dressings are compatible with defibrillation. If defibrillation is required, remove the dressing and pump if they interfere. PICO dressings are MRI compatible, but the PICO 7 pump is NOT MRI compatible. The PICO 7 pump and dressings are not compatible with hyperbaric oxygen (HBO).

14. Safety of the PICO 7 System

The PICO 7 System does not have Essential Performance. When used according to instructions, it complies with General Requirements for Safety of Electrical Medical Equipment (IEC 60601-1) and is intended for uncontrolled environments like home use (IEC60601-1-11).

15. Electromagnetic Compatibility of the PICO 7 System

The PICO 7 System has been tested and found to comply with limits for medical devices to IEC 60601-1-2. These limits aim to provide reasonable safety regarding electromagnetic disturbances in typical medical and uncontrolled environments. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used per instructions, it may cause harmful interference to other devices. However, interference is not guaranteed in all installations.

Guidance and Manufacturer's Declaration – Electromagnetic Immunity

The PICO 7 System is intended for use in the electromagnetic environment specified below. The customer or user should ensure 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°, 270° and 315° phases
0% UT (100% dip in UT) for 0.5 cycle
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
d = 0.175 √P (80 MHz to 800 MHz)
d = 0.35 √P (800 MHz to 2.7 GHz)
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		 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 rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: ((()))

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.

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

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.

⚠️ 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.

16. Troubleshooting

The PICO 7 System has visual indicators to alert the user to issues. It does not have audible alerts. The pump should be carried where it is accessible for routine status checks.

Display/Indicator Status Possible Cause Comments/Troubleshooting
All indicators off The pump is in standby. Negative pressure wound therapy is paused. Press the orange button ▶️ to restart negative pressure wound therapy.
The pump has completed its course of 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.
The batteries have depleted. 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.

17. 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.

18. 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.

19. Glossary of Symbols

20. 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

21. 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

Models: 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

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