The Smith & Nephew PICO 7 is a single-use Negative Pressure Wound Therapy (NPWT) system designed to promote wound healing through continuous or intermittent suction.
1.1 Overview of the PICO 7 System
The PICO 7 System is a single-use Negative Pressure Wound Therapy (NPWT) device designed for up to 7 days of use. It includes a compact pump, absorbent dressing, and accessories. The system uses visual indicators for status updates and does not include audible alerts. It is portable, lightweight, and designed for wounds with low to moderate exudate, promoting healing through consistent negative pressure. The system also features AIRLOCK Technology for reliable therapy delivery.
1;2 Importance of Following Instructions
Adhering to the PICO 7 instructions is crucial for safe and effective use. Proper application and operation ensure optimal wound healing, minimize complications, and maintain system performance. Deviating from guidelines may lead to reduced efficacy or safety risks. Always consult the user manual and follow healthcare professional advice to comply with FDA clearance and manufacturer recommendations. This ensures compliance with safety standards and warranty terms.
Key Features of the PICO 7 System
The PICO 7 System features a portable, single-use design with advanced NPWT technology, visual indicators for system status, and AIRLOCK Technology for consistent therapy delivery.
2.1 Portable and Single-Use Design
The PICO 7 System is lightweight and portable, designed for single-use, making it easy to transport and use without the need for maintenance or sterilization. Its compact design ensures patient mobility, while the single-use feature eliminates cross-contamination risks and simplifies disposal. This design enhances convenience for both healthcare professionals and patients, ensuring uninterrupted therapy during daily activities.
2.2 Advanced Negative Pressure Wound Therapy (NPWT)
The PICO 7 System employs advanced NPWT to promote wound healing by applying controlled negative pressure. This therapy helps draw out excess fluid, reducing swelling and promoting a moist environment conducive to healing. The system’s AIRLOCK Technology ensures consistent pressure delivery, enhancing blood flow and reducing bacterial load. Its intuitive design makes it easy to apply and monitor, providing effective therapy for various wound types with minimal user intervention required.
2.3 Visual Indicators for System Status
The PICO 7 System features visual indicators, such as LED lights, to provide real-time feedback on its operational status. These indicators show power status, battery life, and therapy progression. They also alert users to potential issues, such as low battery, dressing leakage, or system malfunctions. The clear visual cues enable users to monitor the system effectively and take prompt action if needed, ensuring optimal therapy delivery and patient care.
2.4 AIRLOCK Technology for Consistent Therapy
The PICO 7 System incorporates AIRLOCK Technology, ensuring consistent negative pressure wound therapy (NPWT) delivery. This innovative feature minimizes interruptions and maintains therapeutic pressure, reducing the risk of leakage. AIRLOCK Technology enhances wound healing by providing a stable environment, promoting tissue repair and fluid management. It is designed to operate seamlessly, offering reliable performance for up to 7 days of continuous therapy.
Preparing for Use
Before using PICO 7, unpack and inspect the system, install batteries, and prepare the wound site according to the instructions. Ensure the pump and dressing are ready for application.
3.1 Unpacking and Inspection
Begin by carefully unpacking the PICO 7 system and inspecting all components for damage or expiration. Ensure the pump, dressings, and accessories are included and undamaged; Check the expiration dates on the packaging and components. Verify the integrity of the dressings and ensure no parts are missing or compromised. Consult the instructions for a detailed list of components and inspection criteria to ensure safe and effective use.
3.2 Battery Installation
Insert two AA lithium batteries into the PICO 7 pump, ensuring they are aligned correctly. Avoid mixing old and new batteries or using different types. Securely close the battery compartment. The pump will not operate without properly installed batteries. Ensure the batteries are fresh for optimal performance. Refer to the instructions for detailed guidance on battery installation and maintenance to guarantee reliable operation of the PICO 7 system during therapy.
3.3 Preparing the Wound Site
Clean the wound with sterile saline solution to remove debris and bacteria. Pat dry the surrounding skin thoroughly. Ensure the area around the wound is free from lotions, oils, or other substances that may interfere with dressing adhesion. Debridement may be necessary to remove dead tissue, promoting healing. Always follow healthcare provider instructions for wound preparation to ensure proper dressing application and optimal therapy outcomes with the PICO 7 system.
Applying the PICO 7 System
Peel the dressing, place it over the wound, and smooth out air pockets. Connect the pump, ensuring a secure seal. Check for visual indicators confirming proper application.
4.1 Dressing Application Steps
Begin by preparing the wound site, ensuring it is clean and free of debris. Peel the backing from the dressing, carefully placing it over the wound. Smooth out any air pockets using gentle pressure. Secure the edges firmly to ensure a proper seal. Connect the pump to the dressing, following the manufacturer’s instructions. Check for the green indicator to confirm the system is functioning correctly. Replace the dressing as directed, typically every 7 days.
4.2 Securing the Dressing
To ensure a proper seal, smooth the dressing over the wound site, removing any air pockets. Use the provided frame to secure the dressing firmly, ensuring edges are tightly sealed. Check for the green indicator on the pump to confirm the system is functioning correctly. Avoid creases or folds in the dressing, as this may compromise suction. Regularly inspect the dressing for any signs of leakage or detachment.
4.3 Connecting the Pump
Align the connector on the pump with the port on the dressing and click it securely into place. Ensure the connection is snug to avoid leakage. Once connected, the pump will automatically detect the dressing and begin operation. Check for the green indicator light to confirm proper connection. If the pump does not activate, gently press the connector again to ensure a secure fit. Proper connection is essential for effective therapy.
Operating the PICO 7 System
Turn on the pump, monitor the system, and adjust settings if necessary. The pump operates quietly, providing consistent negative pressure for wound healing.
5.1 Turning On the Pump
To activate the PICO 7 pump, press and hold the power button until it beeps and the green indicator flashes, signaling proper operation. The pump will run intermittently to maintain consistent negative pressure, with occasional audible sounds during cycling. Ensure the system is placed on a stable surface and kept at least 4 inches away from other medical devices to avoid magnetic interference. Always follow the instructions for use to ensure safe and effective therapy.
5.2 Monitoring the System
Monitor the PICO 7 system by checking the visual indicators regularly. A steady green light confirms normal operation, while a flashing red light indicates an issue such as low battery or dressing leakage. Ensure the dressing remains intact and free from leaks. If alarms sound or lights flash, refer to the troubleshooting section in the instructions for use. Regular checks help maintain consistent therapy and optimal wound healing outcomes. Always follow the manufacturer’s guidelines for monitoring and addressing system status changes.
5.3 Adjusting Settings (If Applicable)
The PICO 7 system typically operates in a preset mode, requiring no additional setting adjustments. However, ensure the device is turned on using the ON/OFF button and confirm operation with the visual indicators. The system is designed for up to 7 days of use, with two AA batteries providing power. No further adjustments are needed for standard operation, as the device is pre-configured for optimal wound therapy delivery. Always refer to the instructions for specific guidance.
Safety Precautions
Keep the PICO 7 System away from pets and pests to prevent damage. No modifications are allowed. Maintain a 4-inch distance from other medical devices due to the magnet. Always comply with indications and contraindications when using with other therapies.
6.1 General Safety Guidelines
Always follow the manufacturer’s instructions to ensure safe use. Keep the PICO 7 System away from pets and pests to prevent damage. Maintain a minimum distance of 4 inches from other medical devices due to the magnet in the pump. Avoid exposing the system to extreme temperatures or moisture. Do not modify the equipment, as this may compromise its functionality and safety. Ensure proper disposal of used components. Always follow environmental regulations and guidelines provided in the IFU. If unsure about any aspect, consult a healthcare professional.
6.2 Handling the Pump and Dressing
Handle the PICO 7 pump and dressing with care to avoid damage. Ensure the pump is not exposed to extreme temperatures or moisture. Avoid touching electrical components with wet hands. Secure the dressing firmly to maintain proper suction. Regularly inspect the dressing for signs of wear or leakage. Store the system in a clean, dry environment when not in use. Follow all handling instructions provided in the IFU to ensure optimal performance and safety.
6.3 Environmental and Disposal Considerations
Dispose of the PICO 7 system and its components in accordance with local regulations for medical devices. Keep the pump away from pets and pests to prevent damage. Do not modify the equipment. Properly recycle batteries, separating them from other waste. Ensure the system is stored in a clean, dry environment when not in use. Follow all environmental guidelines provided in the IFU to minimize ecological impact.
Troubleshooting Common Issues
This section helps identify and resolve common issues with the PICO 7 system, such as no power, alarms, or dressing leakage, ensuring optimal therapy continuation.
7.1 No Power or Pump Not Turning On
Troubleshoot power issues by checking the battery installation and ensuring the power button is pressed firmly. Verify all connections are secure and not damaged. If the pump doesn’t activate, check for blockages in the tubing or dressings. The system may flash visual indicators to signal errors. Ensure it’s away from other medical devices to avoid interference. If unresolved, consult the manual or contact Smith & Nephew customer support for assistance.
7.2 Alarm or Warning Lights
If the PICO 7 system displays alarm or warning lights, refer to the user manual for specific indicator meanings. Flashing lights may signal low battery, blockage, or dressing issues. Check connections and ensure the dressing is properly sealed. If alarms persist, restart the device or replace the dressing. Consult the manual for troubleshooting steps or contact Smith & Nephew support for further assistance.
7.3 Dressing Leakage or Loss of Suction
If the PICO 7 system experiences dressing leakage or loss of suction, inspect the dressing for proper adhesion and ensure the wound site is clean and dry. Check for blockages or kinks in the tubing. Verify that the dressing is securely sealed and free from damage. If issues persist, restart the system or replace the dressing, following the manufacturer’s guidelines. Consult the user manual for detailed troubleshooting steps.
Indications and Contraindications
The PICO 7 is indicated for wounds with low to moderate fluid, including surgical incisions, ulcers, and burns. It is contraindicated for untreated osteomyelitis or exposed blood vessels.
8.1 Approved Uses for PICO 7
The PICO 7 System is FDA-cleared for use on wounds with low to moderate fluid levels, including chronic wounds, diabetic ulcers, venous leg ulcers, and closed surgical incisions. It is designed to promote healing by applying negative pressure to remove excess fluid and improve tissue perfusion. The system is intended for single-use and is suitable for patients requiring continuous or intermittent therapy, making it a versatile option for various wound care needs.
8.2 Conditions Where PICO 7 Should Not Be Used
The PICO 7 System is contraindicated for use on wounds with necrotic tissue (without physician guidance), exposed blood vessels, or untreated osteomyelitis. It should not be used on wounds with active bleeding, malignant tissue, or in cases where negative pressure is not advised. Additionally, it is not recommended for use onpatients with sensitivity to the dressing materials or in situations where consistent negative pressure cannot be maintained due to wound location or patient mobility.
Regulatory Approvals and Compliance
The PICO 7 System has received FDA clearance and CE marking, ensuring compliance with international standards for medical device safety and efficacy in wound therapy.
9.1 FDA Clearance and Compliance
The PICO 7 System has received FDA clearance, ensuring it meets rigorous U.S. regulatory standards for safety and effectiveness in wound therapy. This clearance confirms the device’s adherence to FDA guidelines, allowing healthcare providers to use it with confidence. Compliance with FDA requirements underscores the system’s reliability and efficacy in promoting wound healing through advanced NPWT technology.
9.2 CE Mark and European Standards
The PICO 7 System holds the CE Mark, confirming compliance with European Union medical device regulations. This certification ensures the system meets strict EU standards for safety, performance, and quality. The CE Mark allows the PICO 7 to be marketed across European countries, providing healthcare professionals with a reliable, compliant solution for wound therapy that aligns with European regulatory requirements.
Customer Support and Service
Smith & Nephew offers dedicated customer support for PICO 7, including a toll-free hotline and email assistance, ensuring prompt help for any inquiries or technical issues.
10.1 Contact Information for Assistance
For assistance with the PICO 7 system, contact Smith & Nephew customer support at 08000 157 573 (UK) or 1-800-876-7765 (US). Email inquiries can be directed to customer.service@smith-nephew.com. Additional support, including technical help and warranty inquiries, is available through their official website or by contacting local distributors. Representatives are available Monday through Friday during business hours to address any questions or concerns.
10.2 Warranty and Repair Options
The PICO 7 system is covered by a limited warranty for manufacturing defects. For warranty claims or repairs, contact Smith & Nephew customer service at 08000 157 573 (UK) or 1-800-876-7765 (US). Repairs are typically processed within 5-7 business days. Unauthorized modifications or misuse may void the warranty. For details, refer to the Instructions for Use or visit the Smith & Nephew website for comprehensive support options.
Clinical Evidence and Studies
Clinical evidence supports the efficacy of the PICO 7 system in promoting wound healing, reducing fluid, and enhancing closure rates (Hudson et al., 2015). Demonstrated in benchtop testing.
11.1 Efficacy in Wound Healing
Clinical studies demonstrate the PICO 7 system’s effectiveness in wound healing, reducing fluid accumulation, and promoting faster closure rates. Its advanced technology enhances tissue perfusion and reduces bacterial load, supporting improved patient outcomes. Designed for up to 7 days of use, PICO 7 has proven efficacy in managing various wound types, including diabetic ulcers and surgical incisions, safely and effectively.
11.2 Comparative Studies with Other NPWT Systems
Comparative studies highlight PICO 7’s superior portability and single-use convenience compared to traditional NPWT systems. Its AIRLOCK Technology ensures consistent therapy delivery, outperforming other systems in maintaining negative pressure. Benchtop testing demonstrates PICO 7’s reliability and efficacy, making it a preferred choice for wound care. These studies underscore its advantages in clinical settings, enhancing patient outcomes and operational efficiency.
Patient and Caregiver Testimonials
Patients and caregivers praise the PICO 7 for its portability, ease of use, and effectiveness in promoting wound healing. Real-world experiences highlight improved recovery and convenience.
12.1 Real-World Experiences with PICO 7
Patients and caregivers share positive experiences with PICO 7, highlighting its portability, ease of use, and effectiveness in wound healing. Many report reduced healing time and minimal disruption to daily life. The system’s lightweight design and silent operation are particularly praised, making it ideal for home use. Testimonials emphasize how PICO 7 has improved recovery outcomes and simplified wound care management, fostering confidence in its reliability and performance.
12.2 Feedback on Ease of Use
Users consistently praise the PICO 7 for its intuitive design and straightforward operation. The system’s visual indicators and quiet functionality make it user-friendly, even for those without medical training. Patients and caregivers appreciate its lightweight, portable nature, allowing for seamless integration into daily life. The ease of use enhances overall user experience, making PICO 7 a practical choice for wound care management at home or on the go.
The Smith & Nephew PICO 7 provides a portable, easy-to-use solution for effective wound healing, combining advanced NPWT with user-friendly design for optimal therapy outcomes.
13.1 Summary of Key Benefits
The Smith & Nephew PICO 7 offers a portable, single-use NPWT system designed for up to 7 days of use. Its advanced features, including AIRLOCK Technology, ensure consistent therapy and promote wound healing. The system is user-friendly, with visual indicators for easy monitoring. Its compact design enhances patient mobility, making it ideal for both home and clinical settings. PICO 7 supports efficient fluid management and reduces the need for frequent dressing changes, benefiting both patients and healthcare providers.
13.2 Final Tips for Optimal Use
For optimal use of the PICO 7, ensure proper wound preparation and secure dressing application. Monitor the system regularly for any leaks or alarms. Keep the pump away from other medical devices to avoid interference. Follow the recommended therapy duration and settings. Clean and store the system as instructed after use. Always dispose of the system responsibly. Adhere to these guidelines for safe and effective wound healing outcomes.