46
02.02.2021
AW6527(1)
5
Neonatal
with Water Trap and Universal Connector Pack
Single Heated Breathing Circuit
Neonatal
with Water Trap, Universal Connector Pack and Autofeed Chamber
Single Heated Breathing Circuit
C4202
C4203
C4125
C4225
Please read and understand this instruction before use.
1. Product Name:
Neonatal Single Heated Breathing Circuit with Water Trap
2. Model:
. Main Performance Parameters
Operating conditions: Ambient Temperature 18°C - 28°C, 64.4°F - 82.4F
6. Product Structure
Patient category
Flow resistance limit
Compliance limit
Leakage limit
Neonatal
Circuit length
1.6m
≤
30ml/min@(60±3)cmH
2
O
REF
DESCRIPTION
Neonatal
with Water Trap
Single Heated Breathing Circuit
Neonatal
with Water Trap and Autofeed Chamber
Single Heated Breathing Circuit
Neonatal
with Water Trap and Flow Restrictor (SLE2000)
Single Heated Breathing Circuit
Neonatal
with Water Trap, Flow Restrictor (SLE2000) and Autofeed Chamber
Single Heated Breathing Circuit
C4210
C4211
20
10
20
10
QTY
20
10
Atmospheric Pressure 700hPa - 1060hPa
Relative Humidity 30% - 80%
Maximum Operating Pressure 60hPa
Neonatal Single Heated Breathing Circuit with Water Trap
Neonatal
with Water Trap and Flow Restrictor (SLE5/6000)
Single Heated Breathing Circuit
Neonatal
with Water Trap, Flow Restrictor (SLE5/6000) and Autofeed Chamber
Single Heated Breathing Circuit
C4215
C4216
Neonatal
with Water Trap (Babylog 8000)
Single Heated Breathing Circuit
Neonatal
with Water Trap (Babylog 8000) and Autofeed Chamber
Single Heated Breathing Circuit
C4206
C4207
20
10
20
10
15F - 9.5F
22M/15F
15F
22F
15M
4-6M
22M/15F
15F - 9.5F
4M - 3M/4M
12M - 12F
8M - 15M/12F
11F - 15M/12F
22M/15F - 15M
15M
22F
≤
0.74cmH
2
O/l/[email protected] l/min
≤
1.5ml/cmH
2
O@(60±3)cmH
2
O
These circuits are for flow rates greater than 5L/min.
Connectors meet the requirements of ISO 5356-1: 2015.
This product is intended to be used for a maximum of 7 days.
Neonatal
with Water Trap
Single Heated Breathing Circuit
Neonatal
with Water Trap and Autofeed Chamber
Single Heated Breathing Circuit
C4230
C4231
20
10
1282
TM
FirstBreath
Instruction For Use - Neonatal Single Heated Breathing Circuit with Water Trap
COMPLETE RESPIRATORY CARE
3. Intended Use
The Neonatal Breathing Circuit device is intended to deliver breathing gases for administration to an infant/neonate patient requiring respiratory
support.
15F - 9.5F
4. Indication for Use
To transfer gas or gas mixture to patient receiving respiratory support as part of a ventilation system. These are invasive ventilation circuits and consist
of a heated inspiratory limb and an unheated expiratory limb. The water trap is placed in the expiratory limb to collect any water from the condensation
caused by the humidified gases and needs to be emptied by the user. To be used in conjunction with a Humidification Chamber.
7.5M - 10M
6M - 15M/12F
Pressure monitoring line
Incubator limb
Swivel wye
Inspiratory limb
Expiratory limb
Universal connector pack
Ventilator to humidifier chamber limb
Straight adaptor
Restrictor
Water trap
Page 3 of 5
8. Directions for Use
(1) Open the product package by tearing off side opening. DO NOT use scissors or sharp instruments to open the package.
(2) Before set-up, check tubing and connectors for damage and that all connections are secure.
(12) Perform a pressure and leak test on the breathing circuit and check for occlusions before connecting to a patient.
(13) Make sure all ports like sampling, pressure measuring and temperature are closed when they are not in use.
(14) Patients should be monitored constantly whenever they are using the product.
(15) Check the product periodically; it must always be replaced when it becomes unfit for its intended use.
(16) When the product is not connected to the patient, protect the patient side of the product to prevent the intrusion of foreign bodies.
(17) After using the circuit, remove it from the humidification system and discard in accordance with applicable hospital requirement
or local laws and regulations.
(4) Connect the Ventilator to Humidifier Chamber Limb to the ventilator and the Heated Humidifier chamber.
(5) Connect the Inspiratory Limb (Blue) to the Heated Humidifer chamber.
(6) When used with an incubator the incubator limbmust be used to allow the temperature probe to sit outside the incubator.
When used without an incubator the incubator limb must be removed from the circuit.
(7) Connect the Expiratory Limb (White) to the Ventilator.
(8) Insert both the chamber and patient probes ensuring that both probes are pushed home.
(9) Connect the heating wires of the Heated Humidifier to the circuit.
(11) Verify that all connections are properly made.
9. Warnings
(1) Do not stretch or milk the tubing. Do not crush the tube.
(2) Do not cover the breathing circuit with materials such as blankets, towels or bed linen.
(3) DO NOT STERILISE. Soaking, rinsing or steam sterilization of the product may leave harmful residues on it and lower its performance.
(4) Avoid contact with chemicals, cleaning agents or hand sanitizers.
(5) In the unlikely event in certain environmental condition condensation (rain out) may form. In these conditions turn off the flow and
disconnect the circuit. Drain off any excess fluid or change the circuit. Reconnect as necessary.
(6) This product is intended to be used for a maximum of 7 days.
TM
FirstBreath
Instruction For Use - Neonatal Single Heated Breathing Circuit with Water Trap
COMPLETE RESPIRATORY CARE
(3) When mounting a humidifier adjacent to a patient ensure that the humidifier is always positioned lower than the patient.
(10) Connect the pressure monitoring line to the ventilator.
Doc No. AW6493-4 Date: 11/12/2020
Pressure monitoring
line
Ventilator
Patient temperature probe
Patient probe
Incubator limb
Ventilator to humidifier
chamber limb
Expiratory limb
Inspiratory limb
Chamber probe
Humidifier
Heated wire cable
Incubator
Patient temperature probe
Neonatal Single Heated Breathing Circuit with Water Trap