FISHER PAYKEL BC190 FlexiTrunk Nasal CPAP Interface Instruction Manual

: June 6, 2024
: Fisher & Paykel

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Symbol Definitions
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BC190 FlexiTrunk Nasal CPAP Interface
Instruction Manual

FISHER PAYKEL BC190 FlexiTrunk Nasal CPAP Interface -

Manufacturer

Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, Auckland 2013, PO Box 14 348 Panmure, Auckland 1741, New Zealand Tel: +64 9 574 0100 Fax: +64 9 574 0158
Email: [email protected]
Web: www.fphcare.com
Importer/ Distributor
Australia (Sponsor) Fisher & Paykel Healthcare Pty Ltd, 19-31 King Street, Nunawading, Melbourne, Victoria 3131.
Tel: +61 3 9871 4900
Fax: +61 3 9871 4998
UK Fisher & Paykel Healthcare Ltd, Unit 16, Cordwallis Park, Clivemont Road, Maidenhead, Berkshire SL6 7BU,
UK Tel: 0800 132 189 Fax: +44 1628 626 146
USA/Canada Tel: 1800 446 3908 or +1 949 453 4000 Fax: +1 949 453 4001

F&P and FlexiTrunk are trademarks of Fisher & Paykel Healthcare Limited.
For patent information, see www.fphcare.com/ip
REF 185042952 REV W 2021-03 © 2021 Fisher & Paykel Healthcare Limited
**RX only

**

Intended Use
The FlexiTrunk nasal CPAP Interface is designed to deliver non-invasive positive pressure therapy to a spontaneously breathing patient weighing up to 10 kg in a hospital or the clinical setting where the patient is adequately monitored by trained medical staff.

Product Specifications

BC190
BC191
BC192| The FlexiTrunk nasal CPAP Interface is designed to connect to the Fisher & Paykel Healthcare Bubble CPAP System.
The adaptors allow connection to other manufacturers’ CPAP circuits with 7.8 or 10 mm connectors.
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Maximum input flow| 15 L/min
Maximum allowable operating pressure| 15 cmH₂O

Please refer to the last page for dimensions and components.
Not made with natural rubber latex.
Phthalate Free (PHT, DEHP, BBP, DBP Free)

Clinical Benefit
It is established in the clinical evidence that CPAP is a form of non-invasive respiratory support which can reduce the frequency and duration of invasive mechanical ventilation and the associated complications of intubation and mechanical lung injury.

Contraindications
The following are contraindications related to nasal CPAP and the use of nasal CPAP interfaces:

Non-spontaneous breathing
Congenital abnormalities or malformations where bi-nasal prongs or nasal masks are contraindicated (e.g. choanal atresia).
Congenital abnormalities or malformations where positive pressure therapies are contraindicated (e.g. diaphragmatic hernia and tracheo-oesophageal fistula).
Nasal trauma/severe deformity that might be exacerbated by the use of nasal prongs or nasal masks.

Side effects
The following are the known side effects related to nasal CPAP and the use of nasal CPAP interfaces:

Gastric distension and feeding intolerance of minor severity are undesirable side effects of using CPAP therapy.
Nasal trauma and skin injury of minor to moderate severity are undesirable side effects of using CPAP interfaces.

WARNINGS

The components of the FlexiTrunk Interface are designed for single patient use only. Reuse may result in the transmission of infectious substances, interruption to treatment, serious injury, or death.
Handle with care. Use caution when positioning or disconnecting the Interface.
Avoid excessive pull forces, sharp objects, and tubing holders. Damage to the tubing may cause loss of pressure and require immediate replacement.
This product is intended to be used for a maximum of 7 days.
DO NOT use if the product or packaging is damaged.
US Federal law restricts this device to sale by, or on the order of, a physician.
DO NOT modify this product.
Use patient oxygen monitoring.
Connection to other manufacturers’ humidification systems increases the risk of condensate and/or high gas temperature delivery to the patient.
Connect only pressure monitoring devices to the pressure monitoring port on the nasal tubing.
FlexiTrunk Interface components are supplied in a clean state. Employ suitable methods to prevent bio-contamination during use and upon disposal.
DO NOT soak, wash, sterilize, or reuse this product.
DO NOT overtighten the bonnet straps.
DO NOT cover the patient’s face with the bonnet as suffocation may occur.
USE ONLY the recommended FlexiTrunk Interface components, impaired positioning of the nasal prongs and mask can occur from non-approved substitutes.
Septal Necrosis can occur if correct sizing or placement of prongs and masks is not observed.
Always use pressure monitoring to verify that the patient is receiving the prescribed CPAP level.
DO NOT use medications containing Tyloxapol (such as Tacholiquin) as this may damage the tubing and lead to loss of CPAP pressure.
The use of this device is not without risk. Even if used as intended following all instructions and warnings provided, the following risks remain airway injury, hypoxic injury, infection, mechanical lung injury, skin burns, nasal trauma, and skin injury. These risks may result in serious injury or death.
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
Any serious incident that has occurred in relation to this device should be reported to your Fisher & Paykel Healthcare representative and the local competent authority.

Symbol Definitions

**| Consult Instructions for use| | CE Mark| | Not made with phthalates (DEHP, DBP, BBP)
---|---|---|---|---|---
| Latex-free| | Do not reuse| | Catalog number
| Authorized Representative in the European Community| Rx only| Prescription-only| | Manufacturer
| Date of manufacture| | Use by date| | Recyclable PET symbol
| Storage temperature limit| | Medical device| | Batch code
| CE Mark| | Caution| | Handle with care
S| Size Small| M| Size Medium| L| Size Large
XL**| Size Extra Large| | | |

Set-up

Refer to the F&P Bubble CPAP System instructions prior to setup of the FlexiTrunk Interface.
If using the adaptors, refer to the set-up instructions provided by the circuit manufacturer prior to the set up of the FlexiTrunk Interface.
Refer to illustrations 1-15 for correct setup.
For correct product sizing, refer to the tables on the last page.
A maximum pressure relief device MUST be used. Pressure relief settings shall be suitable for infant and neonatal CPAP.

Checks Before Operation

When the pressure monitor port on nasal tubing is not in use, the cap must be closed.
Check that all circuit connections are tight before use and after any adjustment.

Set-up Instructions

Refer to illustrations on page 1
Measure the baby’s head circumference in centimeters.
Choose the correct sized bonnet. The bonnet should be snug-fitting.
Stretch the bonnet with your hands initially for ease of placement.
Slip the bonnet onto the baby’s head, completely covering the ears and with the back edge of the bonnet at the base of the neck. The front edge of the bonnet should be just above or on the eyebrows.
Use the sizing guide to choose suitable prongs or masks.
Prongs should fill the nares completely without stretching the skin. Use the biggest possible size. Mask should not touch the edge of the nose, septum, or the eyes.
Choose the correct length of the nasal tubing. Use the shortest length possible.
The clear tubing should not extend over the patient’s forehead.
The following may be used as a guide: 50 mm ≤ 1.5 kg, 70 mm ≤ 2.5 kg, 100 mm > 2.5 kg
Connect prongs or mask to nasal tubing ensuring that it is inserted fully.
If using prongs: squeeze sides of prongs firmly to expose grooves. Start from one end and insert prong grooves into nasal tubing. Push end in firmly.
Remove tear-off strips as required to adjust the nasal tubing angle to optimize the seal. DO NOT discard tear-off strips as they may be needed when alternating between nasal prongs and masks.
Attach the circuit to the nasal tubing in either orientation.
Refer to instructions provided by the circuit manufacturer for more detail.
Note: Disconnect FlexiTrunk gently by twisting the connectors. DO NOT pull forcefully, as this may damage the tubing. Handle with care.
Set gas flow to the prescribed level.
Turn the humidifier on. Refer to manufacturer’s instructions.
Place hand close to nasal prongs or mask to ensure there is gas flow present.
If using prongs: Clear nasal secretions before inserting the nasal prongs.
Ensure the nasal prongs are positioned at least 2 mm (0.08 inches) from the septum to avoid pressure necrosis. Adjust as necessary.
Hourly checks of the septum integrity are recommended.
If using the mask: Connect to the patient by placing the mask around the nose. The mask should sit comfortably around the patient’s nose. It must not occlude the nostrils or touch the septum and should not be over the lip or over the eyes.
Set the height of the foam block by adding or removing tear-off strips. Setups with masks may require adding strips for proper positioning.
Place the strap over the foam block and tighten it to hold the tubing firmly in place.
Hook the clips from the side straps of the bonnet to the glider.
Pull both straps at the same time for central positioning.
Affix the round velcro tabs to the blue strap of the bonnet.
Use the least tension possible to maintain the prescribed CPAP level and stability of the Interface.
DO NOT use angel frames, Christmas trees or similar devices as they can puncture the FlexiTrunk tubing and cause loss of pressure.
Ensure the weight of the circuit is gently supported to reduce tension on the nasal tubing. A pillow or folded towel is recommended. The FlexiTrunk tubing must have free movement to allow the baby’s head to move without restriction.
The circuit should be kept below the level of the nasal tubing to minimize condensate at the baby.

During Use:

Check patient frequently for signs of redness, pressure sores, or irritation that may result from an extended prong or mask use. Hourly checks are recommended.
Alternating between masks and prongs can reduce the risk of irritation. Alternating every 4 to 6 hours is recommended.
The positioning of the mask should be adjusted for best fit and minimal leak. If the excessive leak is still present, the flow may be increased to compensate. The maximum allowable flow rate is 15 L/min.
Check condensate regularly and drain as required.
Replace the bonnet if it becomes loose during prolonged usage.