F&P 850 Bi-level/CPAP Circuit - User Instructions

Product Description

The RT319 circuit is indicated for use with spontaneously breathing adult patients requiring respiratory support, Bi-level or CPAP therapy. Therapy is to be set up and maintained by trained medical professionals in a hospital or institutional environment with patient monitoring in place.

Contraindications

When using the exhalation port, it should not be used on patients who:

• Are unconscious, unable to breathe spontaneously, uncooperative or unresponsive.
• Have copious secretions, at risk of nausea/vomiting, or at high risk of aspiration of emesis.

If symptoms of these conditions occur, discontinue treatment immediately.

Technical Specifications

• Compatible with: Fisher & Paykel Healthcare MR850 Humidifiers.
• Interface Connections: ISO 5356-1 Conical Connectors
• Compressible Volume: 1.7 L
• Compliance @ 60 cmH₂O: 5.12 ± 0.32 mL/cmH₂O (including 0.03 mL/cmH₂O measurement uncertainty)
• Resistance to Flow @ 30 L/min:
  • With Accessories: 1.1 ± 0.04 cmH₂O
  • Without Accessories: 0.26 ± 0.04 cmH₂O
  (including 0.03 cmH₂O measurement uncertainty)
• Minimum Operating Pressure (Bi-level/CPAP): 4 cmH₂O
• Maximum Operating Pressure: 80 cmH₂O
• Circuit Length: 1.8 m
• Gas Leakage @ 60 cmH₂O: <40 mL/min
• Overall Performance at 20 °C to 26 °C Ambient Temperature:
  • Noninvasive Mode: Humidification Output >12 mg/L, Flow Rate 3 – 120 L/min
  • Invasive Mode: Humidification Output >33 mg/L, Flow Rate 16 – 60 L/min
• Filtration Efficiency:
  • Viral: >99.99% (Organism ФX174 Bacteriophage)
  • Bacterial: >99.999% (Organism Bacillus subtilis)
  • Mean particle size: 3 μm
  • NaCl: 98.04%

Symbol Definitions

• Incorrect water level, replace MR290 chamber: ?
• Prescription only: Rx only
• Correct water level in the MR290 chamber: ✔️
• CE Marking (93/42/EEC): CE 0123
• Consult operating instructions: ?
• Date of manufacture: ?
• Type BF applied part: BF
• Manufacturer: ?
• Not made with phthalates: ?
• Use-by date: ?
• Not made with natural rubber latex: ?
• Caution/Consult instructions for use: ⚠️
• Single use: ?
• 7 Days maximum use: 7️⃣
• Lot number: ?
• Transportation and storage temperature limits: ?️
• Reference number: REF
• European Union authorised representative: EC REP

Warnings, Cautions, and Notes

Warnings

• DO NOT reuse this product. Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.
• The use of breathing circuits, chambers, accessories, or combinations which are not approved by Fisher & Paykel Healthcare may result in poor humidification system performance, ventilator malfunction and harm to the patient/user.
• Appropriate patient monitoring (e.g. oxygen saturation) must be used at all times. Failure to monitor the patient (e.g. in the event of an interruption to gas flow) may result in serious harm or death.
• DO NOT touch the heater-plate or chamber base. Surfaces may exceed 85 °C. Failure to comply may result in a skin burn.
• Exhalation port must be used with a non-vented interface on a single limb system. Failure to comply may lead to patient inhaling excess carbon dioxide resulting in hypercapnia.
• Failure to comply with the following warnings may impair performance of the device or compromise safety (including potentially cause serious harm):
  • Ensure that the humidifier is always positioned lower than the patient’s airway.
  • DO NOT use beyond 7 days maximum duration of use.
  • DO NOT cover circuit with materials such as blankets, towels or bed linen.
  • DO NOT stretch or milk the tubing.
  • DO NOT soak, wash, or sterilize this product. Avoid contact with chemicals, cleaning agents, or hand sanitizers.
  • DO NOT use the chamber if the water level rises above the maximum water level line.
  • DO NOT use the chamber if the seals are not intact when received, or if it has been dropped.
  • DO NOT operate the chamber at an angle in excess of 10°.
  • DO NOT spike the water source until the blue caps have been removed. Should the primary float fail, splashing into the circuit may occur if the chamber is being operated in excess of 80 L/min.
  • Visually inspect breathing sets for damage (e.g. a crushed tube or cracked connector) before use, and replace if damaged.
  • DO NOT crush tube.
  • The water source must be at least 50 cm higher than the chamber.
  • DO NOT use heated wire breathing circuits without gas flow. If gas flow is interrupted, turn the humidifier off.
  • Ensure there is a water supply connected to the chamber and that water is present within the chamber.
  • Change filter every 24 hours, or sooner if noticeable deterioration occurs, following standard hospital procedure.
  • DO NOT fill the chamber with water in excess of 37 °C.
  • DO NOT block or seal the vent holes on the exhalation port.
  • DO NOT use with any expiratory limbs.
  • 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

Attention

• Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.
• Avoid prolonged contact of heated tubes with patient’s skin.
• Before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed.
• Use USP sterile water for inhalation or equivalent for humidification. DO NOT add other substances to the water.
• Regularly monitor and drain condensate build-up in the circuit.
• Check all connections are tight before use.
• Check that the heater wire is evenly distributed along the circuit and not bunched or kinked.
• When nebulized drugs are used, resistance to flow should be monitored, and the filter replaced following standard hospital procedure.
• Check for occlusions in both inspiratory and pressure line before connecting to patient.

Notes

• For use under the supervision of trained medical personnel.
• Refer to Hospital protocol for disposal methods. User may be exposed to breathing tract fluids during disposal.
• The responsible organization is accountable for the compatibility of the humidifier and all of the parts and accessories used to connect to the patient and other equipment before use.