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Acelity KCI V.A.C. SIMPLICITY User Manual

For patients and clinicas
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V.A.C. SIMPLICITY™
THERAPY SYSTEM
User Manual
For Patients and Clinicians

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Summary of Contents for Acelity KCI V.A.C. SIMPLICITY

  • Page 1 V.A.C. SIMPLICITY™ THERAPY SYSTEM User Manual For Patients and Clinicians...
  • Page 4 DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY KCI HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE KCI PRODUCT(S) DESCRIBED IN THIS PUBLICATION. ANY WRITTEN WARRANTY OFFERED BY KCI SHALL BE EXPRESSLY SET FORTH IN THIS PUBLICATION OR INCLUDED WITH THE PRODUCT.
  • Page 5 V.A.C. SIMPLICITY™ THERAPY SYSTEM For Patient Use...

  • Page 6: Table Of Contents

    Patient Table of Contents Important Safety Information Accompanies This Device ........ 7 WARNING: Warnings: Important Information for Users ....................8 Introduction ................................9 V.A.C. SIMPLICITY™ Therapy Unit ......................10 Control Panel ..............................10 Control Buttons .............................. 11 Battery/Power Icons ............................. 11 Alarm Icons ..............................11 Battery Charging Instructions ...........................

  • Page 7: Warning: Important Safety Information Accompanies This Device

    WARNING: Important Safety Information Accompanies This Device This manual includes important warnings for your safety. Before using the V.A.C. SIMPLICITY™ Therapy System: • Review this manual with your doctor or nurse. • Review the quick reference guide. This guide is kept in the pocket on the therapy unit carrying case.

  • Page 8: Warnings: Important Information For Users

    Warnings: Important Information for Users The V.A.C. SIMPLICITY™ Therapy Unit is a medical device, not a toy. Keep away from children, pets and pests as they can damage the dressing and therapy unit and affect performance. Keep the therapy unit free of dust and lint as they can also damage the dressing and therapy unit and affect performance.

  • Page 9: Introduction

    Introduction The V.A.C. SIMPLICITY™ Therapy System is a prescription medical device. Please read and follow all the instructions in this user manual so the product can perform properly while in use. This manual will show you: • How to start and stop therapy. •...

  • Page 10: V.a.c. Simplicity™ Therapy Unit

    V.A.C. SIMPLICITY™ Therapy Unit Canister KCI Authorized Maintenance Access Only Power Connection Battery Charging Light Control Panel Control Panel Power and Therapy On/Off Button with LED AC Power LED Blockage LED Battery Level LED Leak LED Audio Pause Button with LED...

  • Page 11: Control Buttons

    Control Buttons Power and Therapy On/Off Press and hold the Power and Therapy On/Off button for three seconds to turn the unit on and start therapy. The LED will be solid green. Press and hold Power and Therapy On/Off button for three seconds to turn the unit off and stop therapy.

  • Page 12: Battery Charging Instructions

    Battery Charging Instructions The V.A.C. SIMPLICITY™ Therapy Unit contains a rechargeable battery. This battery is charged using the power supply and cord that come with the unit. The battery is not user accessible or serviceable. To avoid damage to the therapy unit, use only the power supply and cord that come with the unit.
  • Page 13 To charge the battery: 1. Plug the power cord into the power supply. 2. Plug the power cord into an AC wall outlet. 3. Plug the charging cord into the therapy unit as shown. 4. Keep the unit plugged in whenever possible to maximize battery life. The plug icon appears on the touch screen when the unit is plugged in.

  • Page 14: Battery Charging Light

    Battery Charging Light The battery charging light will glow amber while unit is charging. The light will change to green when the unit is fully charged. Battery Level The battery level is shown on the bottom left of the control panel (see page 10 or page 13).

  • Page 15: Canister

    Canister Silicone Seals Canister Latch Release Canister Latch Canister Guide Tubing Canister Canister Tubing Bumpers Clamp Canister Tubing Connector The canister latch guide on the therapy unit may have sharp edges. Do not handle the therapy unit by the canister latch guide. Always apply the canister straight on and straight off the therapy unit.
  • Page 16 Canister Changes (cont.) 1. Press and hold the Power and Therapy On/Off button for three seconds to turn the unit off and stop therapy. 2. Slide both tubing clamps toward the tubing connector. 3. Tightly close both tubing clamps to avoid spilling tubing contents Fig.
  • Page 17 Canister Changes (cont.) 6. To install a new canister: • Slide the canister over the canister latch guide. • Do not twist or turn the canister as it is being installed. • Press the canister firmly onto the therapy unit. When the canister is properly installed, it cannot be removed by gently Fig.

  • Page 18: Carrying Case

    Carrying Case Access Flap with Hook and Loop Fastener Storage Pocket for the V.A.C. SIMPLICITY™ Therapy System Quick Reference Guide and the V.A.C. Therapy System ® Safety Information Sheet Buckles (shown connected) (may be available on some cases) Belt Loop Tubing (may be available on Storage...

  • Page 19: Carrying Case Options

    Carrying Case Options Use the adjustable strap to wear the carrying case across your chest. You can also wear the carrying case on your belt. Make sure the case buckles are securely snapped together (if equipped). Do not wrap the carrying case strap, power cord or dressing tubing around neck.

  • Page 20: Therapy Unit Disconnect

    Therapy Unit Disconnect You can disconnect the therapy unit from the dressing tubing for short amounts of time for such activities as bathing. Do not take the therapy unit into the shower or tub. For more information see the Frequently Asked Questions on page 30. WARNING: If the therapy unit will be off for more than two hours, call your doctor or nurse right away.

  • Page 21: Alerts And Alarms

    Alerts and Alarms When the therapy unit detects certain conditions, it will activate an alert or an alarm. Low Priority Alert • Requires patient or caregiver attention. • Indicated by a single audible tone and a solid yellow LED. Medium Priority Alarm •...

  • Page 22: Battery Critical Alarm (Medium Priority)

    Battery Critical Alarm (Medium Priority) This alarm appears about one hour before the battery power runs out. It is indicated by a repeating audible tone and one flashing yellow LED. Audio Pause Press and release to silence the audible tone for two minutes. Do not press and hold.

  • Page 23: Blockage Alert (Low Priority)

    Blockage Alert (Low Priority) This alert appears when one of three conditions exists: • Therapy pressure has not been reached. Therapy is still being applied, but at a lower than optimal pressure. • A blockage may be present. The therapy unit continues to attempt to apply therapy. •...

  • Page 24: Blockage Alarm (Medium Priority)

    Blockage Alarm (Medium Priority) This alarm appears when one of three conditions exits: • Therapy pressure has not been reached. Therapy is still being applied, but at a lower than optimal pressure. • A blockage may be present. The therapy unit continues to attempt to apply therapy. •...
  • Page 25 Blockage Alarm (Medium Priority) (cont.) 6. If the canister is not full, make sure the therapy unit is in an upright position. Make sure the control panel is facing up if the therapy unit is laid on a level surface such as a table.

  • Page 26: Leak Alarm (Medium Priority)

    Leak Alarm (Medium Priority) This alarm appears when one of three conditions exist: • The canister is not properly installed. • The therapy unit detects a significant leak. • A dressing leak has not been fixed and therapy is interrupted. This alarm is indicated by a repeating audible tone and one flashing yellow LED.
  • Page 27 7. Press and hold the Power and Therapy On/Off button for three seconds to turn the unit on and restart therapy. 8. Verify the dressing collapses. 9. If the alarm continues, install a new canister (see page 17). 10. If the alarm cannot be fixed, call KCI or your doctor or nurse. Check for Leakage If this alarm was not the result of a loose or misfit canister, the alarm is because there is a significant negative pressure leak.

  • Page 28: System Alarm (Medium Priority)

    System Alarm (Medium Priority) This alarm appears when the therapy unit detects an internal error. It is indicated by a repeating audible tone and multiple flashing LEDs. Press and release Audio Pause to silence the audible tone for two minutes. Do not press and hold.

  • Page 29: Care And Cleaning

    Care and Cleaning The following are the KCI recommended cleaning procedures for the V.A.C. SIMPLICITY™ Therapy Unit. Disposal The dressing and all other disposable items (tubing, connectors, clamps and used canisters) should be removed by your doctor or nurse. Do not discard these items with household trash.

  • Page 30: Frequently Asked Questions

    Frequently Asked Questions Q: How much does the therapy unit weigh? A: The therapy unit weighs about 2.3 lbs (about 1.04 kg) with an empty canister installed. Q: How long does it take to charge the battery? A: It takes about six hours to fully charge the battery. Q: How long will a fully charged battery last? A: The battery charge will last up to eight hours.
  • Page 31 Q: When should I order more dressings and canisters? A: Order additional supplies when you have only one case of dressings OR five canisters left. Call KCI to place your order at least three-five business days before the supplies are needed. Q: Can I travel with the V.A.C.
  • Page 32 Q: Can the V.A.C. SIMPLICITY™ Therapy System be used during diagnostic procedures? A: Use the chart below to determine whether therapy can continue during specific procedures. Therapy Unit Dressing Diagnostic Therapy Unit Dressing Procedures Compatible Compatible Compatible Compatible X-Ray Cat Scan (CT) Dye Tests Fluoroscopy Ultrasound...

  • Page 33: Customer Contact Information

    For questions regarding this product, supplies, maintenance, or additional information about KCI products and services, please contact KCI or a KCI authorized representative, or: In the US call 1-800-275-4524 or visit www.acelity.com. Outside the US visit www.kci-medical.com.
  • Page 35 V.A.C. SIMPLICITY™ THERAPY SYSTEM For Clinician Use Only Patients: Refer to Previous Section of This Manual...
  • Page 36 Clinician Table of Contents Important Safety Information Accompanies This Device ......37 WARNING: Warnings: Important Information for Users ....................38 Notice................................. 39 Introduction ................................40 Care and Cleaning ..............................41 Standard Precautions ........................... 41 Waste Disposal ............................... 41 Cleaning the V.A.C. SIMPLICITY™ Therapy Unit ................... 42 Explanation of Symbols Used ...........................

  • Page 37: Warning: Important Safety Information Accompanies This Device

    Sheet before applying V.A.C.® Therapy. If there are questions, or if this information sheet is missing, immediately contact your local KCI representative. Additional product information can be found at www.acelity.com (USA) or www.kci-medical.com (outside the USA). As with all prescription medical devices, failure to follow product...

  • Page 38: Warnings: Important Information For Users

    Warnings: Important Information for Users The V.A.C. SIMPLICITY™ Therapy Unit is a medical device, not a toy. Keep away from children, pets and pests as they can damage the dressing and therapy unit and affect performance. Keep the therapy unit free of dust and lint as they can also damage the dressing and therapy unit and affect performance.

  • Page 39: Notice

    • Do not use this product while bathing/showering or where it can fall or be pulled into a tub, shower, sink or toilet. Do not reach for a product that has fallen into water. Unplug the unit immediately if plugged into electrical source. Disconnect the unit from dressing and contact KCI.

  • Page 40: Introduction

    Introduction The V.A.C. SIMPLICITY™ Therapy System provides Negative Pressure Wound Therapy (NPWT) and Therapeutic Regulated Acute Care (SENSAT.R.A.C.™) for use on a variety of chronic and acute wound types. This wound healing therapy can be readily integrated into the healthcare provider’s wound healing practice, helping to optimize patient care and manage costs.

  • Page 41: Care And Cleaning

    Care and Cleaning The following are the KCI recommended cleaning and infection control procedures for the V.A.C. SIMPLICITY™ Therapy Unit. Standard Precautions Always follow Standard Precautions. Standard Precautions are designed to reduce the risk of transmission of microorganisms from both known and unknown sources of infection. These precautions can be applied to all patients, regardless of their diagnosis or presumed infection status, and should be used when contact is anticipated with blood and all body fluids.

  • Page 42: Cleaning The V.a.c. Simplicity™ Therapy Unit

    Cleaning the V.A.C. SIMPLICITY™ Therapy Unit Cleaning and disinfection of the V.A.C. SIMPLICITY™ Therapy Unit includes wipedown of all hard surface components. Follow your institutional procedures used for cleaning and disinfection of other hard surface durable electronic medical equipment. The V.A.C.

  • Page 43: Explanation Of Symbols Used

    Explanation of Symbols Used Warning or Caution of possible Serial Number hazard to system, patient or staff This product is designated for separate collection at an Important Operational Information appropriate collection point. Do not dispose of as household waste. Protection level against ingress of Refer to User Manual solid foreign objects and liquids Tripping Hazard...

  • Page 44: Specifications

    Specifications Specifications subject to change without notice. Dimensions: ..........................7.6 in W x 6 in H x 2.5 in D (19.3 x 15.2 x 6.4 cm) Weight (with empty canister attached): ..............about 2.3 lb (about 1.04 kg) Pressure: ............................-125 mmHg (16.6 kPa) Therapy Delivery Mode: ..........................Continuous Canister Volume:..............................about 300 ml Electrical:...

  • Page 45: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) The following are guidance and manufacturer’s declarations regarding EMC for the V.A.C. SIMPLICITY™ Therapy Unit. • The V.A.C. SIMPLICITY™ Therapy Unit needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following pages.
  • Page 46 Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The V.A.C. SIMPLICITY™ Therapy Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the V.A.C. SIMPLICITY™ Therapy Unit should assure that it is used in such an environment. Compliance Electromagnetic environment - guidance Emissions test...
  • Page 47 Table 3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The V.A.C. SIMPLICITY™ Therapy Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the unit should assure it is used in such an environment. Immunity Test IEC 60601 Compliance Level...
  • Page 48 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the V.A.C. SIMPLICITY™ Therapy Unit The V.A.C. SIMPLICITY™ Therapy Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the V.A.C. SIMPLICITY™ Therapy Unit can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and the unit as recommended below, according to the maximum output power of the communications equipment.

  • Page 49: Customer Contact Information

    For questions regarding this product, supplies, maintenance, or additional information about KCI products and services, please contact KCI or a KCI authorized representative, In the US call 1-800-275-4524 or visit www.acelity.com. Outside the US visit www.kci-medical.com.
  • Page 52 12930 IH 10 West IDA Business & Technology Park San Antonio, Texas 78249 USA Dublin Road, Athlone, www.acelity.com Co. Westmeath, Ireland www.kci-medical.com All trademarks designated herein are property of KCI Licensing, Inc., its affiliates and/or licensors. Copyright 2018 KCI Licensing, Inc. All Rights Reserved.

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