Contraindications - FISHER&PAYKEL BC151 Bedienungsanleitung

Bubble CPAP System - BC151/BC161 User Instructions
Intended Use
The Fisher & Paykel Healthcare Bubble CPAP System is
intended to provide CPAP to spontaneously breathing
neonates and infants who require breathing support
due to conditions associated with prematurity (such
as Respiratory Distress Syndrome) or other conditions
where CPAP is required or desired and is prescribed by
a physician.
The Bubble CPAP System is for use in the hospital clinical
environment such as the NICU (Neonatal Intensive Care
Unit) and PICU (Pediatric Intensive Care Unit).
The intended patient population is premature and full term
neonates up to a weight of 10 kg.
All components of the Bubble CPAP System are single
use only.
Product Specifications
• CPAP range (mean): 3-10 cmH O
2
• Operational input flow range is 4-15 L/min.
• An initial range of 6-8 L/min is recommended.
• The BC151 is for use with third party short binasal
prongs (e.g. Hudson prongs).
The BC161 is for use with the F&P Infant Interface.
•
• For use with F&P MR850 and MR730 humidifiers only.

Contraindications

• 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.
WARNING
DO NOT reuse any part of the BC151 or BC161. It is
manufactured for single patient use only. Reuse may
result in transmission of infectious substances,
interruption to treatment, serious harm or death.
• The Fisher & Paykel Bubble CPAP System is intended
for use by adequately trained medical practitioners.
Please contact a Fisher & Paykel Healthcare
representative for suggested training material.
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.
• Use patient oxygen monitoring.
• Always use pressure monitoring to verify that the
patient is receiving the prescribed CPAP level.
• 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.
Bubble CPAP Circuit
This Bubble CPAP circuit is designed for use with Fisher &
Paykel Healthcare humidifiers only.
Product Specifications
BC151 BC161
Circuit
Inspiratory 1.4 m Inspiratory
Length
Expiratory 1.2 m Expiratory
• Interface Connections: ISO 5356-1 Conical Connectors.
• For use with F&P MR850 and MR730 humidifiers only.
Latex free.
LATEX
WARNING
• Check that the heater wire is evenly distributed
along the blue inspiratory tube and is not bunched
or kinked.
• DO NOT soak, wash, sterilize or reuse this product.
• DO NOT use heated wire breathing circuits without
gas flow. If gas flow is interrupted turn the humidifier
off.
• Check all connections are tight before use and after
any adjustment.
• DO NOT cover the circuit with materials such as
blankets, towels or bed linen.
• DO NOT stretch or milk the tubing.
• DO NOT crush or pinch tubing.
• This circuit is designed for use with the F&P Bubble
CPAP System only.
• Avoid prolonged contact with patient skin.
• Test circuit for occlusions and pressure leaks using
the flow elbow provided before connection to the
infant.
MR290 Humidification Chamber
A single use auto-fill chamber for use with Fisher & Paykel
Healthcare humidifiers.
The chamber is to be supplied with sterile water, (USP or
equivalent), from a flexible bag or a rigid water container.
The water level is controlled by a dual float mechanism,
one float acting as a backup to prevent the chamber
from flooding should damage occur to the primary float
mechanism.
WARNING
• An MR290 chamber MUST be used with the bubble
1.1 m
CPAP system.
1.2 m
• DO NOT soak, wash, sterilize, or reuse this product.
Avoid contact with chemicals, cleaning agents, or
hand sanitizers.
• 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 degrees.