Symbol Definitions - F&P FlexiTrunk BC190 Gebrauchsanweisung

FlexiTrunk™ Nasal CPAP Interface
User Instructions
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
clinical setting where the patient is adequately monitored by trained medical staff.
Product Specifications
BC190 The FlexiTrunk nasal CPAP Interface is designed to
BC191 connect to the Fisher & Paykel Healthcare Bubble
BC192 CPAP System.
The adaptors allow connection to other
manufacturers' CPAP circuits with 7.8 or 10 mm
connectors.
Maximum input flow 15 L/min
Maximum allowable operating 15 cmH₂O
pressure
Please refer to last page for dimensions and components.
Not made with natural
rubber latex.
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 mask
are contraindicated (e.g. choanal atresia).
• Congenital abnormalities or malformations where positive pressure therapies are
contraindicated (e.g. diaghragmatic hernia and tracheo-osesphageal fistula).
• Nasal trauma/severe deformity that might be exacerbated by use of nasal prongs
or nasal mask.
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 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 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 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 mask 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.
Phthalate Free
(PHT, DEHP, BBP, DBP Free)

Symbol Definitions

en
Consult
Instructions
for use
Latex free
Authorized
representative
in the
European
Community
Date of
manufacture
Storage
temperature
limit
CE Mark
S
Size Small
XL Size Extra
Large
Set-up
• Refer to the F&P Bubble CPAP System instructions prior to set up of the FlexiTrunk
Interface.
• If using the adaptors, refer to the set-up instructions provided by the circuit
manufacturer prior to set up of the FlexiTrunk Interface.
• Refer to illustrations 1-15 for correct set up.
• 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 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 mask.
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 optimise
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 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 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 mask: Connect to patient by placing mask around 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 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 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 prescribed CPAP level and stability of
the Interface.
Not made
with
CE Mark phthalates
(DEHP, DBP,
BBP)
Do not Catalogue
reuse number
Prescription
Manufacturer
only
Recyclable
Use by date
PET symbol
Medical
Batch code
device
Handle with
Caution
care
Size
M L
Size Large
Medium