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Cardinal Health CATALYST NPWT Patient User Manual

Negative pressure wound therapy
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Cardinal Health™ Negative Pressure
Wound Therapy CATALYST™
Patient User Manual
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Summary of Contents for Cardinal Health CATALYST NPWT

  • Page 1 Cardinal Health™ Negative Pressure Wound Therapy CATALYST™ Patient User Manual...
  • Page 2 About Your Cardinal Health™ CATALYST™ Your doctor has chosen the Cardinal Health CATALYST™ to remove fluid from your wound by using carefully controlled suction. It is important, however, for you to carefully watch the wound and the CATALYST™ to make sure that it is working properly.
  • Page 3 WARNING: Use only the Cardinal Health™ NPWT Occlusion Detection Dressing or Kendall™ NPWT Incision Management 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 .

  • Page 5: Introduction

    The Cardinal Health™ NPWT CATALYST™ System is intended for use in acute, extended and home care settings. 1.2 Contraindications The CATALYST™...

  • Page 6: Safety Tips

    1.4 Safety Tips Keep Therapy On The CATALYST™ should be operated at least 22 hours out of every 24-hour period. Contact your healthcare professional if negative pressure wound therapy stops or if the CATALYST™ is off for more than 2 hours in a 24-hour period. Your dressing must be changed by your healthcare professional. Troubleshooting If the CATALYST™...

  • Page 7: Introduction To The Catalyst

    The Kendall™ Negative Pressure Wound Therapy Incision Management Dressing Kit is a wound dressing kit to be used with Cardinal Health™ Negative Pressure Wound Therapy (NPWT) CATALYST™, ALLY™ and ALLY TO GO™ systems (K171499). The disposable single-use sterile Kendall™ NPWT Incision Management Dressing Kit consists of five dressing configurations, tubing and drape strips.

  • Page 8: Charging The Battery

    2.2 Charging the Battery The CATALYST™ 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 sounds to let you know you must plug in the CATALYST™ to charge the battery. See 3.2 Troubleshooting.
  • Page 9 Average Battery Life The battery life of the CATALYST™ with a fully-charged battery is up to 18 hours. The actual life is dependent on the integrity of the dressing. A leak in the dressing can significantly reduce overall battery longevity. Average Time for Recharging To ensure the battery has been fully charged, the CATALYST™...

  • Page 10: Changing The Canister

    2.3 Changing the Canister When the CATALYST™ detects that the canister needs to be changed, a Canister Full/Blockage alert sounds. The CATALYST™ continues to work until the canister completely fills. When the canister is completely full, the CATALYST™ turns off. To change the canister: 1.
  • Page 11 4. To remove the canister, press the Canister Release Button located above the canister (Figure 6), grasp the canister at the bottom and gently pull downward. Figure 6 5. Cap the canister and ask your healthcare professional how to properly dispose of a used canister. 6.

  • Page 12: Disconnecting From The Catalyst

    9. Reopen the tubing clamp by pushing down on the top of the clamp until it releases (Figure 9). NOTE: Only applicable if clamp is present. If clamp is not present, skip to the next step. Figure 9 10. Turn the CATALYST™ on by pressing the ON Button to resume negative pressure wound therapy. 2.4 Disconnecting from the CATALYST™...

  • Page 13: Operating Instructions

    CATALYST™ 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. CAUTION: In the event of an emergency, please contact your treating physician, caregiver or your local...

  • Page 14: Troubleshooting

    WHAT YOU Pressure/ SEE/HEAR Leak BLINK BEEP BLINK WHAT TO DO Push up Wait 30 seconds on bottom of canister. If you see: If you see/hear: BLINK BEEP BLINK SOLID LIGHT Low Pressure/Leak Call Cardinal Health at 1.866.484.6798 is fixed.
  • Page 15 BLINK BEEP BLINK Canister Full/Blockage Call Cardinal Health is fixed. at 1.866.484.6798 NOTE: A false Canister Full/Blockage alert can occur if drainage moves into the canister while the CATALYST™ is lying on its front (the button side) or if it is turned upside down. If this occurs, you must change the canister to resume device...
  • Page 16 BEEP BLINK Canister Full/Blockage Call Cardinal Health at 1.866.484.6798 is fixed. NOTE: A false Canister Full/Blockage alert can occur if drainage moves into the canister while the CATALYST™ is lying on its front (the button side) or if it is turned upside down. If this occurs, you must change the canister to resume...
  • Page 17 For more information, contact your healthcare professional. NOTE: If an alert persists and cannot be resolved, please call Cardinal Health Customer Service at 1.866.484.6798. CAUTION: In the event of an emergency, please contact your treating physician, caregiver or your local...

  • Page 18: Care & Cleaning

    4. Care & Cleaning Your healthcare professional will handle much of the care and cleaning needed for your CATALYST™. Periodically check to make sure the CATALYST™ is working properly and look for signs that fluid has entered into the CATALYST™. If the CATALYST™...

  • Page 19: 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 device Clause 5.1.1 with medical device labels, labeling and manufacturer.
  • Page 20 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 21 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 a information to be supplied sterilization process.
  • Page 22 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 23 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IS EN- Symbol for use in the labeling of medical Contains Presence Indicates presence of Bis 15986:2011 devices. Requirements for labeling of of Phthalates (2-ethylexyl) phthalate medical devices containing phthalates. (DEHP).
  • Page 24 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 water and essential performance by Enclosure ingress where N1=degree of protection from particles...
  • Page 25 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference Directive 93/42/ Council Directive 93/42/EEC of 14 June The requirements Signifies European technical EEC Articles 4, 11, 1993 concerning medical devices for accreditation conformity. 12, 17 Annex 12 and market surveillance relating Directive 93/68/ CE Marking...
  • Page 26 Symbols Not Recognized by Standard/Law Symbol Guidance Guidance Symbol Title Explanatory Text INDA and EDANA INDA and EDANA Flushability Guidelines Do Not Flush Do not flush in toilet. Flushability Guidelines This container can and should be recycled. Powder Free Gloves are powder free. Synthetic Indicates medical device contains synthetic latex.
  • Page 27 Symbol Guidance Guidance Symbol Title Explanatory Text Open Arrow Open at arrow. Peel Here Peel here to open package. Pouch Opening Directions on how to open pouch. Pouch Opening 1 Single Glove Contains a single glove. 1 Single Glove TUV Listed Product is certified under TUV’...

  • Page 28: Specifications

    6. Specifications Cardinal Health™ CATALYST™ Dimensions ......................19.4 x 7.2 x 18cm (7.6 x 2.8 x 7.1 in.) Weight ............................... 0.9kg (2.0 lb.) Pressure Settings ..........................-70, -120, -150mmHg IEC Classification With respect to electric shock, fire, and mechanical hazards, conforms to IEC60601-1.

  • Page 29: Electromagnetic Compatibility

    6.1 Electromagnetic Compatibility Guidance and Manufacturer’s Declaration: Electromagnetic Emissions (IEC 60601-1-2) Emissions Test Compliance Electromagnetic Environment Harmonic emissions Class A The CATALYST™ is suitable for use in all establishments, including medical facilities, domestic establishments and those directly connected to the IEC 61000-3-2 public low-voltage power supply network that supplies buildings used for domestic purposes.
  • Page 30 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 31: Questions & Information

    7. Questions & Information For questions or additional information on the Cardinal Health™ CATALYST™, 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 32 © 2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, KENDALL, CATALYST, TWIST N’ CONNECT, SENSISKIN and SPEEDCONNECT are trademarks or registered trademarks of Cardinal Health and may be registered in the US and/or in other countries. Patent: cardinalhealth.com/patents...

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