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Cardinal Health SVED NPWT Patient User Manual

Negative pressure wound therapy
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Cardinal Health™
Negative Pressure Wound Therapy SVED®
Patient User Manual

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Summary of Contents for Cardinal Health SVED NPWT

  • Page 1 Cardinal Health™ Negative Pressure Wound Therapy SVED® Patient User Manual...
  • Page 2 About Your Cardinal Health™ SVED® Your doctor has chosen the Cardinal Health™ SVED® to remove fluid from your wound by using carefully controlled suction. It is important, however, for you to carefully watch the wound and the SVED® to make sure that the SVED® is working properly.
  • Page 3 WARNING: Use only the Cardinal Health™ NPWT Dressing and accessories listed in this manual. Use of other dressings and accessories can create hazardous situations, including improper therapy or delayed therapy. This could result in improper healing, damage to the wound area and infection.

  • Page 4: Table Of Contents

    Table of Contents 1. Introduction ........................... 5 1.1 Indications ................................5 1.2 Contraindications ............................... 5 1.3 Precautions ................................ 5 1.4 Safety Tips ................................6 2. Introduction to the SVED® ........................ 7 2.1 Getting to Know the SVED® ..........................7 2.2 Charging the Battery ............................8 2.3 Changing the Canister ............................

  • Page 5: Introduction

    1. Introduction 1.1 Indications The SVED® Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

  • Page 6: Safety Tips

    • During negative pressure wound therapy, the SVED® and dressings are a closed system and are NOT vented to atmosphere. • During negative pressure wound therapy, when a canister fills with fluid, it should be replaced immediately. Fluid will not be removed from the dressing once the canister is full. 1.4 Safety Tips Keep Therapy On The SVED®...

  • Page 7: Introduction To The Sved

    2. Introduction to the SVED® 2.1 Getting to Know the SVED® You may not need to use many of the buttons on the SVED®, but it is important that you are familiar with what they are and their location (see Figure 1). NOTE: The SVED®...

  • Page 8: Charging The Battery

    2.2 Charging the Battery The SVED® has an internal battery that provides up to 18 hours of operation from a fully charged battery. When the battery is running low, an alert will sound to let you know you must plug in the SVED® to charge the battery. See 3.2 Troubleshooting.

  • Page 9: Changing The Canister

    Low Battery Alert While running on battery, a Low Battery Alert “chirps” every 10 seconds and the OFF button flashes when remaining capacity of the battery is less than 20 percent (See 3.2 Troubleshooting). Typically, the SVED® continues to operate for approximately 1 hour after the Low Battery Alert sounds.
  • Page 10 4. To remove the canister, press the Canister Release Button located above the canister, grasp the canister at the bottom and gently pull downward (Figure 4). Canister Release Canister Figure 4 5. Cap the canister and ask your healthcare professional how to properly dispose of a used canister. 6.

  • Page 11: Disconnecting From The Sved

    2.4 Disconnecting from the SVED® You may disconnect the SVED® from your dressing for short amounts of time for activities such as bathing. Ask your healthcare professional about care of your dressing during bathing or showering. NOTE: The SVED® should be operated at least 22 hours out of every 24-hour period. Contact your healthcare professional immediately if therapy is terminated or is off for more than 2 hours in a 24-hour period.

  • Page 12: Operating Instructions

    SVED® is off for more than 2 hours in a 24-hour period. Your dressing must be changed by your healthcare professional. NOTE: If an alert persists and cannot be resolved, please call Cardinal Health Customer Service at 1.866.484.6798.

  • Page 13: Troubleshooting Guide

    -25mmHg for 2 minutes. minutes. CAUTION: In the event of an emergency, please contact your treating physician, caregiver, or your local emergency responders. NOTE: If an alert persists and cannot be resolved, please contact Cardinal Health Customer Service at 1.866.484.6798 for further assistance.

  • Page 14: Care & Cleaning

    4. Care & Cleaning Your healthcare professional will handle much of the care and cleaning needed for your SVED®. Please periodically check to make sure the SVED® is working properly. If the SVED® does not seem to work properly or is showing an alert, refer to 3.2 Troubleshooting or contact your healthcare professional for help.

  • Page 15: Power Adapter Inspection

    Directions for cleaning the A.C. Power Adapter • Unless soiling is observed, the A.C. Power Adapter should not be cleaned. • If cleaning the A.C. Power Adapter is necessary, unplug and wipe the exterior surfaces with a cloth dampened with isopropyl alcohol.

  • Page 16: Symbols Glossary

    5. Symbols Glossary Symbols Recognized by Standard/Law Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 13225-1, Medical devices - Symbols to be used Manufacturer Indicates the medical Clause 5.1.1 with medical device labels, labeling and device manufacturer. information to be supplied ISO 7000-3082 Graphical symbols for use on equipment...
  • Page 17 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used In Vitro Diagnostic Indicates that a medical Clause 5.5.1 with medical device labels, labeling and Medical Device device is intended to be information to be supplied used as an in vitro diagnostic medical device.
  • Page 18 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used Sterile Indicates a medical device Clause 5.2.1 with medical device labels, labeling and that has been subjected to information to be supplied a sterilization process.
  • Page 19 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used Consult Instructions Indicates user needs to Clause 5.4.3 with medical device labels, labeling and for Use consult instructions for use. information to be supplied ISO 7000-1641 Graphical symbols for use on equipment...
  • Page 20 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ASTM F2503 Standard practice for marking medical Magnetic Resonance Keep device away from devices and other items for safety in the (MR) Unsafe magnetic resonance magnetic resonance environment imaging (MRI) equipment. IS EN- Symbol for use in the labeling of medical Contains Presence of...
  • Page 21 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IEC 60601-1, Medical electrical equipment - Part 1: Type BF Applied Part Identifies a type BF applied Table D.1, Sym- General requirements for basic safety part complying with IEC bol 20 and essential performance 60601-1-11.
  • Page 22 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IEC 60530 Degrees of protection provided by Degrees of Ingress Protection against the enclosures (IP Code) Protection Provided effects of insertion of by Enclosure fingers and will not be IP22 damaged or become unsafe when exposed to vertically...
  • Page 23 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 7000-5417 Programmable duration Programmable To identify the control of Duration a programmable timer to start an operation at a specific point in time and to stop the operation at a specific point in time or after a specific duration;...
  • Page 24 Symbol Guidance Guidance Symbol Title Explanatory Text This glove has been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." This glove has been tested for permeation of various chemicals per ASTM F739, "Standard Test Method for...
  • Page 25 Symbol Guidance Guidance Symbol Title Explanatory Text TUV Listed Product is certified under TUV’ s Listing and Classification services and for TUV certifications for Canada and the USA. Device Plugged into Indicates that device is an Outlet connected to an external power source.

  • Page 26: Specifications

    6. Specifications Cardinal Health™ SVED® Dimensions ..........................19.4 x 7.2 x 18cm (7.6 x 8 x 7.1 in.) Weight ..................................0.9kg (2.0 lb.) Therapy Settings .............................-70, -120, -150mmHg IEC Classification • Medical Equipment • Type BF Applied Part • Equipment not suitable for use in presence of flammable •...

  • Page 27: Electromagnetic Compatibility

    6.1 Electromagnetic Compatibility Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment The SVED® is suitable for use in all establishments, including medical facilities, Harmonic emissions Class A domestic establishments and those directly connected to the public low-voltage IEC 6100-3-2 power supply network that supplies buildings used for domestic purposes.
  • Page 28 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2) Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level Environment-Guidance Electrostatic discharge (ESD) IEC ±6kV contact ±6kV contact Floor should be wood, concrete or ceramic tile. If floors 61000-4-2 ±8kV air ±8kV air are covered with synthetic material, the relative humidity should be at least 30 percent.

  • Page 29: Questions & Information

    7. Questions & Information For questions or additional information on the Cardinal Health™ SVED®, please contact your local Cardinal Health representative, or: Call Customer Service at 1.866.484.6798 Cardinal Health Waukegan, IL 60085 www.cardinalhealth.com Always consult a physician and product instructions for use prior to application.
  • Page 30 Cardinal Health Waukegan, IL 60085 USA Rev. D 2020-10 cardinalhealth.com © 2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, SVED, SENSISKIN and SPEEDCONNECT are trademarks or registered trademarks of Cardinal Health. Patent: cardinalhealth.com/patents 6701132PUM Rev. D...

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