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Cardinal Health CATALYST User Manual

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

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

  • Page 3: Safety And Warnings

    Pet hair could contaminate the wound site and prevent adhesion of the wound dressing. This could result in possible infection of the wound or reduced effectiveness of the system. CAUTION: The CATALYST™ system can be used outdoors for short periods of time (not more than 24 hours). Shelter from the rain.

  • Page 4: Table Of Contents

    2.1 Cleaning the CATALYST™ ........

  • Page 5: Introduction

    (such as diabetic or pressure), flaps and grafts. The CATALYST™ system is intended for use in acute, extended and home care settings. When used with the Cardinal Health™ Occlusion Detection Dressing, the CATALYST™ NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, surgical incisions following sutured or stapled closure, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

  • Page 6: Contraindications

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

  • Page 7: Safety Tips

    1.4 Safety Tips Keep Therapy On The CATALYST™ should be operated at least 22 hours out of every 24-hour period. Remove the Dressing if therapy is terminated or is off for more than 2 hours in a 24-hour period. Dressing Changes Clean the wound per physician order prior to dressing application.

  • Page 8: Features

    NOTE: All dressing components of the NPWT Occlusion Detection Dressing Kits and NPWT Incision Management Dressing Kits are packaged sterile. The decision to use clean versus sterile/aseptic technique is dependent upon wound pathophysiology and physician/clinician preference. All components of the NPWT Occlusion Detection Dressing Kits and NPWT Incision Management Dressing Kits are made without natural rubber latex.
  • Page 9 Alerts self-reset once the problem is corrected or can be manually reset by turning the CATALYST™ off and then back on. IV Pole Adapter: Pole clamp permits the CATALYST™ to be mounted to a wide range of standard IV poles: 2.2 to 5.0cm (0.9 to 2.0 in.) in diameter.

  • Page 10: Care & Cleaning

    CATALYST™. 2. If there is visible soilage on the CATALYST™, clean it a second time after the first cleaning has removed the soilage. 3. Wipe down the CATALYST™ with a clean, dry cloth to remove any bleach residue.

  • Page 11: Power Adapter Inspection

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

  • Page 12: Patient Care

    3. Patient Care Review all Sections of this Clinician User Manual before use of the CATALYST™. Carefully read 1.1 Indications, 1.2 Contraindications, 1.3 Precautions and 1.4 Safety Tips before using the CATALYST™ for patient care. 3.1 Applying the NPWT Occlusion Detection Dressing (Open Wound) NOTE: Does not apply to NPWT Incision Management Dressing, see 3.2 Applying the NPWT Incision...
  • Page 13 Use of White Foam Per clinician’s discretion, white foam may be used in wounds needing extra protection, such as protrusion of bone and in small tunneling and undermining. White foam should be used in an intact, single layer and covered with black foam when not used in small tunnels or in undermining.

  • Page 14: Applying The Npwt Incision Management Dressing

    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 15: Inserting The Npwt Canister

    3.3 Inserting the NPWT Canister 1. To insert the canister, line up the two ports on the canister with the two ports on the CATALYST™. Press the canister up and into the CATALYST™ until it clicks and locks into place (Figure 14).

  • Page 16: Removing The Npwt Canister

    3. Grasp the blue Twist N’ Connect™ end of the tubing attached to the canister. Gently twist counterclockwise and pull up to remove tubing from canister (Figure 18). Figure 18 4. Press Canister Release Button and gently pull the bottom of canister down to remove from the CATALYST™ (Figure 19). Figure 19 5.

  • Page 17: Delivering Simultaneous Irrigation™ Technology

    • 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 CATALYST™, contact the solution’ s manufacturer.
  • Page 18 Instructions 1. Make sure the irrigation fluid supply remains clamped off until the therapy is started and target pressure is achieved. 2. Obtain a physician order for irrigation solution type and delivery rate. 3. Apply NPWT Occlusion Detection Dressing (3.1 Applying the NPWT Occlusion Detection Dressing [Open Wound]).

  • Page 19: 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 CATALYST™ is in Intermittent Mode.

  • Page 20: Npwt Occlusion Detection Y Connector

    NOTE: Do not use with Kendall™ NPWT Incision Management Dressing Kit. NPWT Occlusion Detection Y Connector is designed to connect two Cardinal Health™ NPWT Occlusion Detection Dressings with Twist N’ Connect™ ports to a single Cardinal Health™ NPWT Occlusion Detection canister in a CATALYST™ device.

  • Page 21: Removing The Npwt Occlusion Detection Dressing Or The Npwt Incision Management Dressing

    • Protective mask • Disposable impervious gown 1. With the CATALYST™ on, lift a corner of the drape or incision management dressing to allow air to enter the system, moving any fluid in the tubing into the canister. 2. Close tubing clamp (Figure 16).

  • Page 22: Disposal Of Used Components

    3.8 Disposal of Used Components After patient use, all used disposable components of the system should be treated as contaminated. These may include: • The NPWT foam dressing and polyurethane drape • The canister • NPWT Incision Management Dressing with any drape strips •...

  • Page 23: Operating Instructions

    Carefully read 1.3 Precautions and 1.4 Safety Tips before attempting to operate and adjust the CATALYST™. CAUTION: The CATALYST™ 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 severely damage the CATALYST™.

  • Page 24: Power-Up Procedure

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

  • Page 25: Negative Pressure Wound Therapy Selection Lock/Unlock

    CATALYST™ (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 CATALYST™ is first turned on, the total time is displayed. This timer cannot be reset and accumulates time as the CATALYST™ is used.

  • Page 26: Alert Volume

    Battery Life The battery life of the CATALYST™ with a fully-charged battery and a well-sealed dressing is up to 18 hours. The actual life is dependent on the integrity of the dressing. A leak in the dressing and using Intermittent Mode can reduce overall battery longevity.

  • Page 27: Recharging The Battery

    The yellow light next to the Battery Charging symbol lights up when the battery is charging. NOTE: If the CATALYST™ is plugged in and the green light does not turn on, check to make sure the outlet is working properly.

  • Page 28: Troubleshooting

    4.9 Troubleshooting Clearing an Alert Condition To manually reset an alert, turn the CATALYST™ off then back on. The alert clears when the power is cycled. What you see or hear Problem What to do More information The battery is low •...
  • Page 29 If the CATALYST™ is placed on • If the canister is not full, turn its front, fluid causes the CATALYST™ off by pressing the OFF a false Canister Full/ Button and then turn the Blockage alert and the CATALYST™...
  • Page 30 Button and tap the OFF Button. Repeat to change back to Continuous Mode. NOTE: If an alert persists and cannot be resolved, please contact Cardinal Health at 1.866.484.6798. CAUTION: In the event of an emergency, please contact the treating physician, caregiver or emergency responders.

  • Page 31: 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 32 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 33 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 34 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 35 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 of Indicates presence of Bis 15986:2011 devices. Requirements for labeling of Phthalates (2-ethylexyl) phthalate medical devices containing phthalates. (DEHP).
  • Page 36 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 37 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 and conformity. 12, 17 Annex 12 market surveillance relating to the Directive 93/68/ CE Marking...
  • Page 38 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 39 Symbol Guidance Guidance Symbol Title Explanatory Text 1 Pair of Gloves Contains a pair of gloves. 1 Pair of Gloves Russian Registration Signifies technical Mark conformity in Russia. Open Arrow Open at arrow. Peel Here Peel here to open package. Pouch Opening Directions on how to open pouch.

  • Page 40: 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 41: Electromagnetic Compatibility

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

  • Page 42: 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 CATALYST™ is used exceeds the applicable RF compliance level above, the CATALYST™...

  • Page 43: Additional Parts

    NPWT Polyurethane Drape (10 per case) ......................47-7000 NPWT SensiSkin™ Drape (10 per case) ......................47-7100 NOTE: In order to assure the highest safety, quality and efficacy of the products, the Cardinal Health™ CATALYST™ should only be used with the Cardinal Health™ NPWT products listed above.

  • Page 44: Questions & Information

    8. Questions & Information For questions, comments or additional information pertaining to 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 45 © 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...