Sunset Healthcare TUB06HPR Instruction Manual
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Sunset Healthcare TUB06HPR Instruction Manual

Heated cpap tube for dreamstation and pr system one
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Instruction Manual
Heated CPAP Tube
for DreamStation and PR System One
TUB06HPR

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Summary of Contents for Sunset Healthcare TUB06HPR

  • Page 1 Instruction Manual Heated CPAP Tube for DreamStation and PR System One TUB06HPR...

  • Page 2: Table Of Contents

    Introduction The Sunset Heated CPAP Tube is designed to prevent condensation of humidified air during CPAP treatment, also known as “rainout.” When combined with a heated humidifier, the Sunset Heated CPAP Tube controls humidification by ensuring that air temperature does not cool prior to inhalation.

  • Page 3: Understanding The Heated Cpap Tube

    1. Understanding the Heated CPAP Tube 1.1 Components 1. Humidifier connector cuff 2. Connector lead 3. Squeeze release tabs 4. Mask-end cuff 5. Flexible tubing 1.2 Indications for Use The Sunset Heated CPAP Tube is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway.

  • Page 4: Warnings And Cautions

    Warnings and Cautions Please retain these instructions for use for future reference. • WARNING: The Sunset Heated CPAP Tube is validated for use with two specific humidifiers: Philips Respironics DreamStation and Philips Respironics System One. Do not use the Sunset Heated CPAP Tube in combination with other Humidifiers. •...
  • Page 5 • WARNING: Replace damaged (having holes, kinks, tears, exposed heating wires, etc. or is not functional) tube immediately. Do not try to repair the tube yourself. Damaged CPAP tubes can affect quality of the therapy or injure the patient. • WARNING: Using brushes or objects to clean the inside of the tube can damage the tubing and can affect the quality of the therapy or cause injury to the patient.

  • Page 6: Use And Care

    2. Use and Care 2.1 Directions for Use The Sunset Heated CPAP Tube features a Mask-end Cuff and a Humidifier Connector Cuff. Humidifier Connector Cuff Mask-end Cuff Before connecting, remove Sunset Heated CPAP Tube from packaging. Inspect tube for any damage. Discard and replace the tubing if damaged. To Connect Align the Sunset Heated CPAP Tube Humidifier Connector Cuff with the air outlet port on the CPAP machine humidifier.
  • Page 7 Connect the Mask-end Cuff to your mask connector. For proper placement, please consult instructions included with your mask. Ensure there is airflow through the tubing. Apply mask and use as directed by your physician or respiratory therapist, and in accordance with the instructions in your CPAP or mask ventilator system user manual.

  • Page 8: Home Cleaning And Disinfection

    2.2 Home Cleaning & Disinfection Home Cleaning Clean Sunset Heated CPAP Tube before first use and daily during use. 1. Disconnect Heated CPAP Tube from CPAP machine and mask. 2. Thoroughly rinse inside and outside of Heated CPAP Tube with cold tap water to remove excess soil.

  • Page 9: Institutional Cleaning And Disinfection

    2.3 Institutional Cleaning & Disinfection Institutional Cleaning Prior to Disinfection Clean Sunset Heated CPAP Tube before first use and daily during use. 1. Disconnect Heated CPAP Tube from CPAP machine and mask. 2. Thoroughly rinse inside and outside of Heated CPAP Tube with cold tap water to remove excess soil.

  • Page 10: Errors And Troubleshooting

    Rinsing Instructions Following removal from CIDEX® OPA Solution, thoroughly rinse the medical device by immersing it completely in a large volume (e.g. 8 liters) of sterile water. • Keep the device totally immersed for a minimum of 1 minute. • Manually flush all lumens with large volumes (not less than 100ml) of rinse water.

  • Page 11: Storage And Transport Conditions

    3.2 Storage and Transport Conditions Environmental conditions for transport and storage: This device should be transported and stored in its original packaging and protected from direct sunlight, dust, or any other form of contamination. . Temperature during storage and transport should not exceed 140°F (60°C) or fall below -4°F (-20°C) with Relative humidity can range from 5 % to 95%.

  • Page 12: Product Specifications

    3.5 Product Specifications Description Specification Sunset Heated CPAP Tube Length 6ft (1.83m) Internal Diameter 19mm Flow resistance @60 l min-1 ≤ 0.1 kPa ISO 5367:2000 ISO 8185:2007 Tubing Compliance Standards ISO 80601-2-70:2015 ISO 80601-2-74:2017 Water resistance IP22 Compatible • Philips Respironics DreamStation CPAP Machine Humidifiers •...

  • Page 13: Emc Table

    3.8 EMC Table Radiated RF Emission levels Immunity test levels Phenomenon Professional healthcare facility Home healthcare environment environment Emissions Compliance Radiated RF Emissions Group 1 CISPR 11 Radiated RF Emissions Class B CISPR 11 Proximity fields from RF wireless communication equipment, Immunity test levels: Immunity levels Immunity test levels...

  • Page 14: Symbol Glossary

    3.9 Symbol Glossary Symbol Meaning Attention, consult accompanying documents Read instruction manual carefully Catalog item number Batch code Name and address of manufacturer Date of manufacture Prescription device Caution: U.S. federal law restricts this device to sale by or Rx only on the order of a physician Protected from touch by fingers and objects greater than 12 millimeters.
  • Page 16 Sunset Healthcare Solutions E509738 180 N Michigan Ave Ste 2000 Chicago, IL 60601 IFU-00014 Rev 2.00 www.sunsethcs.com 2021-02-01...

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