FISHER PAYKEL 900MR139 Auto Clavable Water Trap Instructions

June 9, 2024
Fisher & Paykel

FISHER PAYKEL 900MR139 Auto Clavable Water Trap Instructions

Autoclavable watertrap

Intended Use

The 900MR139 water trap is used to collect condensate from expiratory breathing tubes. This accessory is intended for use with Fisher & Paykel Healthcare reusable breathing circuits in hospital or clinical environments and should only be prescribed by a physician.

Product Specifications

Maximum Operating Pressure 80 hPa (cmH₂O) (8 kPa)

Warning, Cautions and Notes

WARNINGS

  • Breathing circuits and accessories should be prescribed and initially set up by a healthcare professional qualified in respiratory care and used under the supervision of trained medical personnel.
  • Do not lubricate connections, tubing or accessories. Failure to comply may result in fire, burns and loss of system performance.
  • This product is reprocessable (reusable). It must be reprocessed according to the reprocessing instructions for this product. Incorrect reprocessing may lead to the risk of cross-infection between patients and potential serious harm.
  • Visually inspect products before each use on a patient. Discard if faulty or if there is any sign of deterioration such as cracks, tears or damage. These may cause gas leaks and loss of ventilation or respiratory support.
  • Check all connections are tightly secured before use.
  • Use of non-compatible, non-ISO 5367, or non- ISO 80601-2-74 compliant circuit components may cause unintentional tube disconnection and loss of ventilation or respiratory support.
  • Ensure the water trap is positioned below the patient’s head so that condensate flows away from the patient interface.
  • Do not modify this product.
  • Do not use breathing circuits, chambers, accessories or combinations which are not approved by Fisher & Paykel Healthcare.

Failure to comply with the above warnings and cautions may impair the performance of the product or compromise safety (including causing potential serious harm).

  • California residents, please be advised of the following, pursuant to Proposition 65: This product contains chemicals known to the State of California to cause cancer, birth defects, and other reproductive harm. For more information, please visit: www.fphcare.com/prop65

Notes

  • Before use on a patient, all components must be cleaned and disinfected. Sterilization is highly recommended if products can withstand the process.
  • Ensure the complete circuit functions correctly, with the required ventilator settings, before connecting to a patient.
  • This product is designed for the delivery of air, oxygen or a mix of both gases. It is not suitable for the delivery of flammable anesthetic gas mixes, Heliox or gas solutions, suspensions or emulsions that have not been evaluated.
  • The responsible organization is accountable for the compatibility of the humidifier and all of the parts and accessories used.
  • This product is safe for use on pregnant women and breastfeeding women.
  • This product is safe for use on children.
  • Do not use the product during X-rays, MRIs or other radio-frequency procedures. If a serious incident has occurred while using this device, please contact your Fisher & Paykel Healthcare representative and Competent Authority.Contact your local Fisher & Paykel Healthcare representative for a printed copy of these user instructions.

Assembly Instructions

  1. Assemble the water trap bowl onto the water trap head.
  2. Follow the breathing circuit kit instructions and connect the breathing tubes to the water trap head.

Monitoring Instructions

WARNING

  • Monitor the water trap’s liquid level regularly and empty as required. The water container should be reassembled as soon as possible after emptying, to prevent gas leakage as per diagram below.FISHER-PAYKEL-900MR139-Auto-Clavable-Water-Trap-Instructions-FIG-2

Reprocessing Instructions

For reprocessing instructions (UI-623716), please visit www.fphcare.com/fp- reusables

WARNINGS

  • The product must be disconnected from both the power and gas source prior to cleaning.
  • Clean the product prior to use and whenever the product is visibly soiled. Follow the reprocessing instructions (UI-623716). Alternative cleaning methods may deteriorate or damage the product, reducing the product life and compromising therapy.
  • Discard the product after 50 reprocessing cycles, or five years from date of manufacture, whichever occurs earlier.

Notes

  • It is recommended that reprocessing commences as soon as is reasonably practical following use to prevent gross contaminants from drying on the product.
  • Used products must be treated as being contaminated. The user may be exposed to breathing tract fluids. Follow all local, state and federal regulations with respect to environmental protection and correct disposal of these products.

Storage

  • As a minimum, reprocessed breathing circuits and accessories are to be stored in a clean plastic bag or container and away from direct sunlight or heat if not being reused immediately.

Symbol Definitions


Product does not contain phthalates or pyrogens

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Unsafe for use in MRI environment

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European Union authorized representative

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Transportation and storage temperature limits

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Not made with natural rubber latex

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Caution symbol for warnings



CE Mark

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Use-by date

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Do not recycle



Type BF Applied Part

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Date of manufacture

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Instructions for Use



Lot number

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Manufacturer

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Medical Device




Reference number

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Prescription only

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Incorrect water level

No water|  |

REF 623684 REV A 2022-05 © 2022 Fisher & Paykel Healthcare Limited Made in New Zealand Hecho en Nueva Zelanda www.fphcare.com/fp- reusables

References

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