Pragma VAC® Manually Operated System for Negative Pressure Wound Therapy International Associates Auditing & Certification Limited Address: The Black Church, Saint Mary’s Place, Dublin7, D07 P4AX, Ireland. Indicates the batch code. Printed on the label and packaging. PragmaVAC device: Not applicable - the device has no expiry date when stored as instructed. Wound dressing: Printed on each pouch and on the outer box. Do not use after this date. Note: All wound dressing information, including manufacturer information and expiration date, is shown on the dressing package. All rights reserved. PRAGMATIC INNOVATION INC. PI-IFU-01EN Instructions for Use iMI 9-2020 Barsuda Drive, Mississauga, ON, Canada Rev06 02/2026 121 [email protected] Manually Operated System for Real World Innovation in Healthcare PragmaVAC is a manually operated device for negative-pressure wound therapy (NPWT). It is supplied with specialized dressings (vacuum-assisted wound closure set), which work together with the device as a complete system. The use of PragmaVAC fosters wound healing by enhancing local blood flow while removing exudate and infectious material from the wound bed. These effects collectively accelerate wound closure and reduce the risk of infection when used in accordance with clinical guidelines and the instructions in this manual. WHEN NOT TO USE PRAGMAVAC (CONTRAINDICATIONS) • ACUTE OR SUBACUTE WOUNDS • CHRONIC WOUNDS • DEHISCED WOUNDS • PRESSURE ULCERS • DIABETIC ULCERS • NEUROPATHIC ULCERS • TRAUMATIC WOUNDS • SURGICAL INCISIONS • NECROTIC TISSUE WITH ESCHAR PRESENT • UNTREATED OSTEOMYELITIS • NON-ENTERIC AND UNEXPLORED FISTULAS • EXPOSED VASCULATURE • EXPOSED NERVES • EXPOSED ANASTOMOTIC SITE OF BLOOD VESSELS OR BYPASSES • EXPOSED ORGANS A If you have concerns, speak with your healthcare professional. • The dressing must be attached or removed by the attending physician or upon his recommendation. • Contact your doctor or nurse if you have any questions about the treatment regimen using PragmaVAC. • Do not use the device in damaged packaging, because the device might be broken and not fully functional. Warnings & Important User Information PragmaVAC is a single-patient, multiple-use device. Using it for more than one patient poses a risk of trans-infection between patients. The accompanying wound dressing is sterile and intended for single use only. Do not re-sterilize. The PragmaVAC device is non-sterile. > SUPPLIED DRESSINGS J ONLY The PragmaVAC device can be used with the supplied dressings only. KEEP AWAY FROM CHILDREN/PETS PragmaVAC is a medical device, not a toy. Please keep it out of the reach of children or pets, as they may cause harm and disrupt its effectiveness. ]VAC Device Components and Mechanism The device consists of a suction pump housed inside the enclosure. The pump is connected to the wound through a tube via a one-way valve that allows secretions to pass from the wound to the pump. When the button is pressed manually, the air and excretions in the pump are pushed through another tube to the canister, where excretions are collected. The spring-like nature of the pump causes it to expand, creating suction effect (negative pressure) on the wound bed. When the patient continues treatment at home, the patient or their companion must continue watching the red strip, and press the button once the red strip appears, as needed. If the dressing is air-tight, the red strip should not appear more than once every 3-5 hours. Do not pull the tubes or connections of the device. Use the product in accordance with the instructions included in this manual and the applicable labels. keep Keep the device away from heat or hot surfaces and do not put it in direct fromheat exposure to sunlight. place7 Do not use the device while showering and do not place the device in water. ALLERGIC REACTION In rare instances, the wound dressing may cause an allergic reaction if you are allergic to certain adhesives or silver. The following symptoms indicate an allergic reaction; please contact your doctor if they appear: • Rash, itching, or urticaria; • If you notice shortness of breath, the allergic reaction could be severe, please call an ambulance immediately. PragmaVAC has been tested to work safely with the recommended wound dressing by the manufacturer. Using the PragmaVAC device with different wound dressing products may cause air leakage in the system that may reduce efficacy, or delay healing. PragmaVAC device should not be used for more than 30 days continuously, which is the period sufficient for treating most wounds. Using it for more than that will increase the risk of device malfunctioning. Reporting of Serious Incidents Any serious incident that has occurred in relation to this device should be reported to the manufacturer and your competent authority. Before using the PragmaVAC device, the healthcare provider should apply the wound dressing following "User Instructions" illustrated leaflet supplied with the product. Once PragmaVAC is connected to the wound dressing by the doctor or nurse, they should press the top button several times, until the dressing foam contracts (shrinks) and becomes tight, indicating that there is no air leakage. Typically, the button should remain in the compressed position for a few hours, as long as the wound dressing is securely sealed. While the top button is fully seated inside the enclosure and the red strip is hidden, this indicates that the negative pressure is well established and active. If the red strip appears, this indicates that negative pressure is too weak and has become ineffective. When you see the red strip, press the button several times, with intervals of 10 seconds, until the foam of the wound dressing becomes fully shrunken and tight, indicating that there is no air leakage. ^ The treating doctor should wrap the dressing with a gauze bandage as an extra protective layer to prevent the rupture of wound dressing. Upon activating the device, ensure that the foam dressing shrinks and becomes firm to the touch. If the foam does not shrink, or if it expands quickly to its original size, this may indicate a failure in the seal, tubing, or the device. If the problem cannot be resolved by checking the seal and connections, do not continue therapy. Immediately consult a healthcare professional to replace the device or dressing. On the other hand, if the red strip rises very frequently, e.g. every 30 minutes or less, this means that there is an air leak in the system. In this case, please follow the steps for fixing the air leak as explained in the subsequent section. Ignoring the need to press the button while the red strip remains visible for several hours will make the treatment ineffective and might lead to bacterial proliferation and wound infection. • It is recommended to keep the device in an upright position throughout the day • The amount of fluid must be recorded before emptying the container (e.g. full canister, half canister, etc.) EMPTYING AND CLEANING THE CANISTER Follow these steps to clean the canister when it is full of excretions: Please contact your doctor in the following cases: • If the canister is filled more than four times a day, which is roughly equivalent to one liter of liquid. • If the canister contains blood or bloody liquids in a significant amount. How to Deal with an Air Leak All PragmaVAC devices are rigorously examined during manufacturing to ensure there is no air leakage before they are released to the market. Yet, some external factors can induce an air leak. Severe air leakage can render the treatment ineffective and cause wound infection. IN ORDER TO RESOLVE AN AIR LEAK, FOLLOW THESE STEPS: 1 - Tighten the tube connector between the device and wound. 2 - Press the button several times until the wound dressing foam is fully shrunken. Immediately close the clamp near the device tightly. 3 - If the dressing expands within seconds or minutes, this means the leakage is from the How to Deal with Clogging There is a small likelihood that the device or the tubes to the wound get obstructed (clogged) by a blood clot. Test: If you feel resistance while pressing the button (i.e. the button becomes hard or does not lower at all), it is possible that the device is clogged with clots. SOLUTION FOR TUBE CLOGGING: • Disconnect the device tube to open it and separate the device from the wound dressing. • Examine all tubes visually and try to locate the clot in the tube. If you see it, press on it with your fingers to eject it outside the tube or dissolve it. • Reconnect the tubes and tighten them fully. dressing drapes or the tube connector. Solution: The drapes must be supported with additional layers. After affixing additional drapes, release the tube clamp and repeat step 2. If the problem is resolved, there is no need for any further action. If the problem persists, proceed to step 4. 4 - Disconnect the device and close the inlet connector with a clamp or stopper. If the top button rises up very quickly and the red strip is seen within seconds or minutes, then the cause of the leakage is the device itself. Solution: The physician needs to replace the device with a new one. The defective device should not be used again. OR: If the button does not rise for a long period (more than 3 hours), while the foam is not contracted, this indicates that the device is not in continuity with the wound dressing, due to an obstruction or clogging of the tube. SOLUTION FOR DEVICE CLOGGING: If the clogging persists despite a clear tube, then the clogging is within the device. In this case: • Inject saline solution into the device tube. • Try to press the button several times in order to circulate the saline in the system. Frequently Asked Questions: Q: Can I travel while using the PragmaVAC? A: Call your doctor or nurse before you travel to determine if it is safe to do so. Do not travel unless you have medical approval. You should also fully understand all risks related to your medical condition before traveling. Your doctor will advise you whether you need dressing changes during your travel and should explain where to find a qualified facility/health worker who can change your dressing. If these conditions cannot be met, then travel is not advisable. Q: What is the weight of the device? A: The device weighs approximately 0.5 kg with an empty canister. Q: What steps should be taken while taking a shower? A: The treatment unit should not be taken to the bathroom. Please follow the instructions for disconnecting the treatment unit mentioned above. For extra caution, try to keep the dressing away from water as much as possible. Please be careful not to scrape the edges of the tape while showering. Q: When should the dressing be changed? A: The attending physician or nurse will inform you about the frequency of dressing changes, which is usually once every 3-5 days. Q: Can PragmaVAC be used during radiological procedures? A: PragmaVAC contains metal parts and therefore, MUST NOT be used during magnetic resonance diagnostic procedures. When a radiograph is taken, the shadow of the foam may appear on the film. Thus, A the decision to leave or remove the dressing during radiographic procedures remains with the treating physician. Disposal of Device and Dressing The PragmaVAC device should be disposed of at the end of the treatment and not used for another patient. The wound dressing should be disposed of after each change. Disposing of hospital-generated medical waste is managed by transferring the waste to the agency handling treatment of the infectious waste or by autoclavingand then giving the waste to the biomedical waste management vendor. Storage Conditions Store the Treatment Set in its original packaging in a cool, dry place.