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Cardinal Health ALLY TO GO NPWT Patient User Manual

Negative pressure wound therapy
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Cardinal Health™ Negative Pressure
Wound Therapy ALLY TO GO™
Patient User Manual

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Summary of Contents for Cardinal Health ALLY TO GO NPWT

  • Page 1 Cardinal Health™ Negative Pressure Wound Therapy ALLY TO GO™ Patient User Manual...
  • Page 2 • All assembly, operation, adjustment, modification, maintenance and/or repair must be carried out only by qualified personnel authorized by Cardinal Health. Unauthorized modification of the ALLY TO GO™ may result in physical hazards, including delayed therapy, electrocution and fire that may lead to injury or death.
  • Page 3 These hazards could result in injury or death. 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.

  • Page 4: Table Of Contents

    Table of Contents 1. Introduction ................5 1.1 Indications .

  • Page 5: Introduction

    The ALLY TO GO™ NPWT system is intended for use in acute, extended and home care settings. The Kendall™ NPWT Incision Management Dressing Kit, when used with Cardinal Health™ ALLY TO GO™ NPWT Device, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

  • Page 6: Safety Tips

    • During negative pressure wound therapy, ALLY TO GO™ and NPWT Occlusion Detection Dressing or NPWT Incision Management Dressing are a closed system and are NOT vented to atmosphere. • When the NPWT canister is full, replace immediately (2.3 Changing the Canister). Fluids are not removed from the dressing once the canister is full.

  • Page 7: Introduction To The Ally To Go

    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 ALLY TO GO™ has an internal battery that provides up to 24 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 ALLY TO GO™ to charge the battery. See section 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 (3.2 Troubleshooting). Typically, the ALLY TO GO™ continues to operate for approximately 1 hour after the Low Battery Alert sounds.
  • Page 10 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 4). Figure 4 4. To remove the canister, press the Canister Release Button located above the canister (Figure 5), and gently pull the bottom of canister down to remove from the ALLY TO GO™.
  • Page 11 8. Gently line up the blue Twist N’ Connect™ end of the tubing to the blue Twist N’ Connect™ port on the canister, push down and twist clockwise to lock into place (Figure 7). Figure 7 9. Reopen the tubing clamp by pushing down on the top of the clamp until it releases (Figure 8). NOTE: Only applicable if clamp is present on tubing.

  • Page 12: Disconnecting From The Ally To Go

    2.4 Disconnecting from the ALLY TO GO™ You may disconnect the ALLY TO GO™ from your dressing for short amounts of time for activities such as bathing or showering. Ask your healthcare professional about care of your dressing during bathing or showering. NOTE: The ALLY TO GO™...

  • Page 13: Operating Instructions

    ALLY TO GO™ 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

    1. Low Pressure/Leak WHAT YOU SEE/HEAR BLINK BEEP BLINK WHAT TO DO Wait 30 seconds Push up on bottom of canister. If you see: If you see/hear: SOLID LIGHT BLINK BEEP BLINK Call Cardinal Health at 1.866.484.6798 Low Pressure/Leak is fixed.
  • Page 15 BLINK TWO BEEPS BLINK Call Cardinal Health at 1.866.484.6798 Canister Full/Blockage is fixed. NOTE: A false Canister Full/Blockage alert can occur if drainage moves into the canister while the ALLY TO GO™ is lying on its front (the button side) or if it is turned upside down. If this occurs, you must change the canister to...
  • Page 16 TWO BEEPS 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 ALLY TO GO™ 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 Charging Port If you see: If you see/hear: BLINK SOLID LIGHT THREE BEEPS BLINK ALLY™/ALLY TO GO™ is plugged in. Call Cardinal Health Power is connected. at 1.866.484.6798 Battery is charging. 5. Therapy Timer WHAT YOU SEE/HEAR BLINK FOUR BEEPS...
  • Page 18 No troubleshooting needed. 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 19: Care & Cleaning

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

  • Page 20: 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 21 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 22 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 23 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 24 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 25 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IEC 60601-1, Medical electrical equipment - Part 1: Type B Applied Part Identifies a type B applied Table D.1, Symbol General requirements for basic safety part complying with IEC and essential performance 60601-1.
  • Page 26 Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference 21 CFR Part Labeling - Medical devices; prominence Prescription Use Requires prescription for 801.1(c)(1)(i)F of required label statements Only sale in the United States and is used in place of the statement below: CAUTION: Federal law restricts this device to sale...
  • Page 27 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/Law Symbol Guidance...
  • Page 28 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 29 Symbol Guidance Guidance Symbol Title Explanatory Text Device Plugged into Indicates that device is an Outlet connected to an external power source. Battery Charging Device is plugged into an outlet and the internal battery is charging.

  • Page 30: Specifications

    6. Specifications Cardinal Health™ ALLY TO GO™ Dimensions ......................19.3 x 11.1 x 7.1cm (7.6 x 4.4 x 2.8 in.) Weight ................................0.4kg (0.9 lb.) Pressure Settings ......................-50, -75, -100, -125, -150mmHg IEC Classification With respect to electric shock, fire, and mechanical hazards, conforms to IEC60601-1.

  • Page 31: Electromagnetic Compatibility

    6.1 Electromagnetic Compatibility Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The ALLY TO GO™ is intended for use in the electromagnetic environment specified below. The customer or the user of the ALLY TO GO™ should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 32 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The ALLY TO GO™ is intended for use in the electromagnetic environment specified below. The customer or the user of the ALLY TO GO™ should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...

  • Page 33: Questions & Information

    7. Questions & Information For questions or additional information on the Cardinal Health™ ALLY TO GO™, 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 34 © 2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, KENDALL, ALLY TO GO, 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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