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Cardinal Health SVED User Manual

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

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Summary of Contents for Cardinal Health SVED

  • Page 1 Cardinal Health™ Negative Pressure Wound Therapy SVED® Clinician User Manual...
  • Page 2 CAUTION: This SVED® Clinician User Manual is not a guarantee or warranty. It is intended only as an operational guide. For additional information and questions, please contact the Cardinal Health Customer Service department at 1.866.484.6798. In order for the SVED® to provide safe, reliable, and proper performance, the following conditions must be met.

  • Page 3: Safety And Warnings

    Be sure to include all of the warnings below when providing training to lay users, especially in a home care environment. Lay users and caregivers should contact Customer Support if there is a change in the performance of the SVED®.

  • Page 4: Table Of Contents

    Table of Contents 1. Introduction ........................... 5 1.1 Indications .................................5 1.2 Contraindications ...............................5 1.3 Precautions ................................6 1.4 Safety Tips ................................6 1.5 Features ................................8 2. Care & Cleaning ..........................9 2.1 Cleaning ................................9 2.2 A.C. Power Adapter Inspection .........................10 3. Patient Care ..........................12 3.1 Applying the NPWT Dressing ..........................12 3.2 Inserting the NPWT Canister ..........................14 3.3 Removing the NPWT Canister ...........................15...

  • Page 5: Introduction

    The SVED® Negative Pressure Wound Therapy (NPWT) system is comprised of the SVED®, the NPWT Dressing Kit, the NPWT Canister and the A.C. Power Adapter. In order to assure the highest safety, quality and efficacy, the SVED® should only be used with the Cardinal Health™ NPWT Dressing Kits and Cardinal Health™ NPWT disposables. Use of any other brand of wound dressings are not compatible with the SVED®...

  • Page 6: Precautions

    • Magnetic Resonance Imaging (MRI): The SVED® is not MRI-compatible and cannot be used in the presence of strong magnetic fields. Do not take the SVED® into the MRI area or any area of high magnetic fields. The SVED® contains metal components that could cause unintended movement resulting in harm due to falling objects or collisions.

  • Page 7: Spinal Cord Injury

    Unstable Structures Use the lowest Pressure Setting on SVED® over unstable body structures such as unstable chest wall or non-intact fascia. Spinal Cord Injury In the event a patient experiences autonomic hyperreflexia (sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system) discontinue use of the therapy to help minimize sensory stimulation.

  • Page 8: Features

    Battery: An internal battery in the SVED® provides up to 18 hours of operation from a single full charge. The battery charges while the SVED® is plugged into an outlet with the A.C. Power Adapter. If the battery charge is less than 20 percent, the SVED®...

  • Page 9: Care & Cleaning

    1 quart water). Use a coarse cloth and wring out any excess solution until the cloth is damp and not dripping. Bleach based disinfecting wipes for cleaning medical equipment may also be used. 1. Clean all surfaces of the SVED®, including the ports and the A.C. Power Adapter, then allow the solution to air dry on the SVED®.

  • Page 10: Power Adapter Inspection

    Do not spray liquids directly on to the SVED®. CAUTION: Avoid spilling liquid on any part of the SVED®. Spilling liquid on the SVED® may cause the SVED® to operate erratically, possibly causing a potential hazard to the patient or clinical caregiver.

  • Page 11: Patient Care

    3. Patient Care It is recommended that all sections of this manual be reviewed prior to using the product. Carefully read the 1.1 Indications, 1.2 Contraindications, 1.3 Precautions and 1.4 Safety Tips before using the SVED® for patient care. 3.1 Applying the NPWT Dressing 1.
  • Page 12 CAUTION: Do not pack the black foam into any areas of the wound. Forcing foam into any wound is contrary to approved protocols. Loosely fill all visible dead space in the wound. Do not thin black foam, as thinning may cause over collapse of the dressing and prevent fluid from moving away from wound base.
  • Page 13 10. Remove the drape’s release liner starting with tab A (Figure 5). Invert and place over the foam and peri-wound (Figure 6) and continue removing the contact layer with tabs B and C (Figures 7-8). Remove the remaining perforated tab (Figure 9). Gently press drape material down around the wound site and over the foam to ensure dressing is properly sealed.

  • Page 14: Inserting The Npwt Canister

    3.2 Inserting the NPWT Canister 1. To insert the canister, line up the two ports on the canister with the two ports on the SVED®. Press the canister up and into the SVED® until it clicks and locks into place.

  • Page 15: Removing The Npwt Canister

    • Protective eyewear • Protective mask • Disposable impervious gown 1. With the SVED® ON, lift a corner of the drape to allow air to enter the system, moving any fluid in the tubing into the canister. 2. Close suction tubing clamp.

  • Page 16: Disposal Of Used Components

    • Any solution cleared for use in topical wound irrigation can be used as the wound irrigant. • Various topical agents, such as hydrogen peroxide and solutions containing alcohol, are not intended for extended tissue contact. If in doubt about the appropriateness of using a solution with the SVED®, contact the solution’s manufacturer.
  • Page 17 To Canister To Canister Figure 15 Figure 16 Figure 17 To Irrigation To Irrigation To Canister Figure 18 Figure 19 Instructions 1. Make sure the irrigation fluid supply remains clamped off until the therapy is started and target pressure is achieved. 2.

  • Page 18: Intermittent Mode

    10. Set the drip rate per the physician order. The drip rate does not need to be exact with continuous wound irrigation. NOTE: The irrigation rate remains constant unless the Pressure Setting is changed or if the SVED® is in Intermittent Mode.

  • Page 19: Operating Instructions

    Carefully read 1.3 Precautions and 1.4 Safety Tips before attempting to operate and adjust the SVED®. CAUTION: The SVED® must only be used with the supplied A.C. Power Adapter or Global Power Adapter. The Global Power Adapter must be purchased separately. Use of any other adapter/power cord could create a shock hazard for the patient or caregiver, cause fire and/or severly damage the SVED®.

  • Page 20: Power-Up Procedure

    1. Verify the dressing is correct, the tubing is connected and the clamp is open. 2. Keep the SVED® upright. The SVED® can be placed on a table, or attached to a pole using the pole adapter, but it is recommended to keep it level with or below the wound.

  • Page 21: Intermittent Mode On/Off

    SVED® (non-resettable) and patient usage Therapy Time (resettable). The Therapy Timer Display uses the format: “d: days, H: hours, -: mins” and data is displayed sequentially on the display. When the SVED® is first turned ON, the total time is displayed. This timer cannot be reset and accumulates time as the SVED® is used.

  • Page 22: Battery Operation

    Battery Charging symbol lights up when the battery is charging. NOTE: If the SVED® is plugged in and the green light does not turn on, check to make sure the outlet is working properly. Once the battery is fully charged, the yellow light next to the Battery Charging symbol turns off, showing the battery is fully charged.

  • Page 23: Troubleshooting

    4.9 Troubleshooting Clearing an Alert Condition To manually reset an alert, turn the SVED® off then back on. The alert clears when the power is cycled. What you see Problem What to do More information or hear OFF Button is flashing.

  • Page 24: 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 25 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 26 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 27 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IEC 60601-1, Medical electrical equipment - Part 1: Refer to Instruction Indicates user needs to Table D.2, Symbol General requirements for basic safety Manual/Booklet consult instructions for use. and essential performance IEC 60601-1- Medical electrical equipment - Part 1-2: Non-ionizing...
  • Page 28 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used Does Not Contain The medical device or the Clause 5.4.5, with medical device labels, labeling and Natural Rubber Latex packaging of the medical Annex B.2 information to be supplied device does not contain...
  • Page 29 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IEC 60601-1, Medical electrical equipment - Part 1: Degrees of Ingress Manufacturer-determined Table D.3, Symbol General requirements for basic safety Protection Provided degree of particle and and essential performance by Enclosure water ingress where N1= degree of protection from...
  • Page 30 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference 21 CFR Part Labeling - Medical devices; prominence Prescription Use Only Requires prescription for 801.1(c)(1)(i)F of required label statements sale in the United States and is used in place of the statement below: CAUTION: Federal law restricts this device to sale...
  • Page 31 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 7000-5546 Battery check Battery Check To identify the battery condition indicator. ISO 7000-0623 This way up This Way Up To indicate correct upright position of the transport package. Symbols Not Recognized by Standard or Law Symbol Guidance...
  • Page 32 Symbol Guidance Guidance Symbol Title Explanatory Text This glove has been tested for permeation of various chemicals per ASTM F739, "Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact." 1 Pair of Gloves Contains a pair of gloves.

  • Page 33: Specifications

    External Power Supply Input ......................100-240VAC, 50-60Hz, 700mA External Power Supply Output .............................15VDC, 2Amp SVED® Storage Conditions Note: Storage and Operation Conditions do not apply to the Additional Parts Identified within Section 7 Temperature Range ..........................-12°C (10°F) to 43°C (110°F) Relative Humidity Range ............................

  • Page 34: Electromagnetic Compatibility

    RF communications equipment and the SVED® The SVED® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SVED® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SVED® as recommended below, according to the maximum output power of the communications equipment.

  • Page 35: Immunity Test

    To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SVED® is used exceeds the applicable RF compliance level above, the SVED® should be observed to verify normal operation.

  • Page 36: Additional Parts

    NOTE: Part numbers for Canisters, Dressings and Disposable Accessories may be obtained by visiting the Cardinal Health website (www.cardinalhealth.com). NOTE: In order to assure the highest safety, quality and efficacy of the products, the SVED® should only be used with Cardinal Health NPWT products listed above.

  • Page 37: Questions & Information

    8. Questions & Information For questions or additional information on the SVED®, please contact your local Cardinal Health representative, or: Call our 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 38 Cardinal Health Waukegan, IL 60085 USA Rev. E 2021-02 cardinalhealth.com © 2021 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 6701132CUM Rev E...

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