Genadyne UNO+ User Manual
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Genadyne UNO+ User Manual

Negative pressure wound therapy
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UNO+
Negative Pressure Wound Therapy
DMR-07-091 Rev F
Page 1 of 25

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Summary of Contents for Genadyne UNO+

  • Page 1 UNO+ Negative Pressure Wound Therapy DMR-07-091 Rev F Page 1 of 25...

  • Page 2: Table Of Contents

    Contents Description ......................................... 3 Indications for Use ......................................4 Contraindications ......................................4 WARNINGS ........................................4 Precautions ........................................6 User ............................................ 7 Instructions for Use ......................................7 Maintenance ........................................18 Cleaning ........................................... 18 Returning the Device ..............................19 Disposing of the Device and Canisters ................................19 Electromagnetic Compatibility ..........................

  • Page 3: Description

    WARNING: Keep body parts away from the device if the device gets hot during charging. Description The Genadyne UNO+ Negative Pressure Wound Therapy (NPWT) (Ref # UP-S01) is a multi-patient use, rechargeable negative pressure wound therapy unit, designed for moderate to low severity wounds. The UNO+ NPWT features an interface panel which provides 5 alerts for the user, selectable therapy modes (Continuous Mode and Variable Mode) and multi-pressure options (4 0 m m H g , 6 0 m m H g , 8 0mmHg, 100mmHg or 125mmHg).

  • Page 4: Indications For Use

    If active bleeding develops suddenly or in large amounts during wound therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop the Genadyne UNO+ NPWT, leave dressing in place, take measures to stop the bleeding assistance.
  • Page 5 Infected blood vessels are at risk of complications, including bleeding which, if uncontrolled, could be potentially fatal. Extreme caution should be used when Genadyne UNO+ NPWT is applied in close proximity to infected or potentially infected blood vessels. (NOTE: Refer to Protect Vessels and Organs section...

  • Page 6: Precautions

    If significant bleeding develops, immediately discontinue the use of the Genadyne UNO+ NPWT system, take measures to stop the bleeding and do not remove the foam dressing until the treating physician or surgeon is consulted.

  • Page 7: User

    The Genadyne UNO+ NPWT is intended to be operated by qualified clinical caregivers in acute or extended settings. In-service and training programs for use of the Genadyne UNO+ NPWT are available. Patients are not expected to apply or change Genadyne Genadyne Foam Dressings or adjust therapy settings.
  • Page 8 3. Cut foam to appropriate size of the wound. Place the foam on/into the wound. Avoid cutting the foam over the wound. Do not over pack. Cover the foam with Transparent Film. Peel layers 1, 2 and 3. Remove the handlers. 5.
  • Page 9 6. Attach the canister to the back of the machine. Slide in the canister and make sure it clicks to confirm the canister is secure and tightly held. 7. Connect the port tubing to the canister tubing. Ensure all clamps are unclamped at this time. 8.
  • Page 10 3. Prior beginning therapy, clamp the port tubing of one of the wounds. Note: this is an important step to achieve the desired therapy 4. Turn on the pump to begin negative pressure therapy in the wound without port clamped. Finished dressing should be firm to the touch.
  • Page 11 3. Punch a small hole (with a diameter of 2.5mm) in the center of film over the foam. 4. Apply the port tubing on top of the GENADYNE XLR8 Bridge Foam Dressing hole. 5. Apply the GENADYNE XLR8 Bridge Foam Dressing on top of the hole.
  • Page 12 Device is in Variable Mode 10. Select therapy pressure of 40 mmHg, 60mmHg, 80mmHg, 100mmHg or 125 mmHg by pressing mmHg button. The green LED light next to the button will indicate the selected pressure: Device is on 125mmHg Device is on 40mmHg 11.
  • Page 13 d. Dressing Removal NOTE: If dressing is lifted to observe wound, do not re-adhere the same dressing. A new dressing must be applied. 1. Turn therapy unit off by pressing the power button. 2. Gently remove the XLR8 film. Do not peel vertically. 3.
  • Page 14 Leak When the UNO+ NPWT device detects a significant leak, a visual and an audible alert will activate. Leakage icon When the UNO+ NPWT device detects a small leak (check dressing alert), the LED on the leak alert icon will be flashing, and the audible alert will beep every 1-minute interval and will clear itself when the leak is corrected.
  • Page 15 Confirms with the Waste Electrical and Electronic Directive (2002/96/EC). At the end of useful life: dispose of all waste according to local requirements, or contact your local Genadyne subsidiary or agent for advice. This product is designated for separate collection at an appropriate collection point. Do not dispose of in normal waste stream.
  • Page 16 2. Connect the USB cable into the charger head. Make sure you have connected the USB cable all the way in as shown in the image below: 3. Connect the USB charger to a nearby outlet. 4. Plug the USB cable into the lower part of the Genadyne UNO+ NPWT unit (slot below the power button). DMR-07-091 Rev F Page 16 of 25...
  • Page 17 The UNO+ NPWT is fully operational while charging. WARNING: It is unsafe to use any other USB charger and USB cable other than the ones provided in the Genadyne UNO+ NPWT Kit. This could potentially lead to product malfunctioning and will negate the product warranty.

  • Page 18: Maintenance

    Cleaning Adherence to facility directives concerning hygiene is of prime importance. Only use a low level, diluted form of disinfectant or cleaning agent when cleaning the Genadyne UNO+ NPWT unit. Use a damp cloth to clean the pump. Do not use solvents or abrasives.

  • Page 19: Returning The Device

    Disposing of the Device and Canisters Device The device contains li-ion batteries. Do not dispose of this device by placing it in the trash. Return the device to Genadyne or your distributor/caregiver or use local procedures for proper disposal. Canisters All used canisters have to be disposed of according to local protocols.
  • Page 20 Directive (2002/96/EC). At the end of useful life; dispose of all waste according to local requirements, or contact your local Genadyne subsidiary or agent for advice. This product is designated for separate collection at an appropriate collection point. Do not dispose of in normal waste stream.

  • Page 21: Electromagnetic Compatibility

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Genadyne UNO+ NPWT is intended for use in the electromagnetic environment specified below. The customer or the user of the Genadyne UNO+ NPWT should assure that it is used in such an environment.
  • Page 22 The Genadyne UNO+ NPWT is intended for use in the electromagnetic environment specified below. The customer or the user of the Genadyne UNO+ NPWT should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Environment –...
  • Page 23 Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The Genadyne UNO+ NPWT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Genadyne UNO+ NPWT can help prevent...

  • Page 24: Specifications

    Specifications Service Life 2 years 4 3/8 ” x 3 ” x 1 5/8” Maximum Dimensions Weight 0.49 lbs (220g) Operating/Running Time ~ 40 hours of usage time per charge ~15 hours with pump ON all the time Battery Type 3.6V, 1700mAh, Rechargeable Lithium Ion Batteries Power Adaptor/Charger...

  • Page 25: Contact Information

    Contact Information Genadyne Biotechnologies, Inc. 16 Midland Avenue Hicksville, NY 11801 Toll Free +1.800.208.2025 Tel. +1.516.487.8787 Fax +1.516.487.7878 www.genadyne.com Obelis S.A. EU Representative Bd. General Wahis 53 BELGIUM +32 (0) 2.732.59.54 (Tel) +32 (0) 2.732.60.03 (Fax) www.obelis.net Distributed by DMR-07-091 Rev F...

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