laerdal NeoNatalie User manual

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OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
in clean water
in clean water
in clean water
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
in clean water
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
in clean water
in clean water
in clean water
in clean water
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
in clean water
in clean water
in clean water
in clean water
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
in clean water
in clean water
+ rinse
in clean water
+ rinse
+ rinse
+ rinse
in clean water
+ rinse
+ rinse
in clean water
+ rinse
+ rinse
in clean water
in clean water
in clean water
in clean water
+ rinse
in clean water
+ rinse
+ rinse
in clean water
+ rinse
+ rinse
+ rinse
in clean water
+ rinse
in clean water
in clean water
+ rinse
+ rinse
+ rinse
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
in clean water
+ rinse
+ rinse
in clean water
+ rinse
+ rinse
+ rinse
in clean water
+ rinse
in clean water
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
+ rinse
in clean water
+ rinse
in clean water
in clean water
+ rinse
in clean water
+ rinse
in clean water
+ rinse
in clean water
in clean water
in clean water
+ rinse
+ rinse
in clean water
in clean water
in clean water
in clean water
in clean water
+ rinse
+ rinse
+ rinse
+ rinse
in clean water
+ rinse
in clean water
+ rinse
in clean water
+ rinse
in clean water
+ rinse
in clean water
+ rinse
in clean water
+ rinse
+ rinse
in clean water
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
3 x 1 minute
+ rinse
+ rinse
in clean water
in clean water
+ rinse
+ rinse
in clean water
in clean water
in clean water
+ rinse
+ rinse
+ rinse
in clean water
in clean water
in clean water
in clean water
+ rinse
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
7
5
4
6
2
3
1
OR OR
Steam 136 °C
10-20 minutes
+ enjuague
en agua
3 x 1 minutos
Disinfect
60 minutes
Disinfect
60 minutes
+ rinse
in clean water
3 x 1 minute
100 °C
in clean water
10-20 minutes
+ rinse
in clean water
3 x 1 minute
Steam 100 °C
10-20 minutes
Steam 100 °C
10-20 minutes
1. Product Overview
To disassemble, follow steps 1-7.To reassemble, follow the steps in reverse.
NeoNatalie Resuscitator
Reprocessing instructions
If any of the above tests fail, dismantle NeoNatalie Resuscitator, inspect the components, reassemble and repeat the complete procedure in 3.Testing Before Use. Page 2
Remove damaged parts from use.
Squeeze the bag. Check that the Lip Valve
Membrane valve opens and closes with every
squeeze.
Seal the mask with a hand. Squeeze the bag
forcefully. Check that air is released from
the Pressure Release Valve.
Keep the mask sealed against hand. Release the
squeezed bag. Check that the bag re-expands
without resistance.
Keep the mask sealed
against the hand. Press
the Pressure Release Valve
down. Squeeze the bag
and check that there is no
leakage.
Inlet Valve
Pre-disinfection
Disinfection
Post Disinfection
2. Post-Treatment:
1. Remove parts using
aseptic technique.
2. Allow parts to cool. Dry each
part with sterile gauze or air dry
in a protected space.
1. Choose one of the following disinfection methods:
Follow chemical
manufacturer’s instructions *Validated at approximately
sea-level pressure
1. Immediate
Pre-Cleaning
Wipe and clean
the outside of the
resuscitator with a piece
of clean gauze soaked in
0.5 % chlorine solution.
1. Inspection
Visually inspect each
part for damage and
cleanliness / mineral
deposits.
Remove damaged or
unclean parts from
service.
2. Reassembly
Reassemble as shown above in
1. Product Overview.
3. Function Test
See 3.Testing before Use
below.
4. Storage
Store in a clean,
enclosed space.
Descaling
If parts become
coated in limescale
immerse equal parts
of water and white
vinegar (3-5%) for
10 minutes. Rinse in
clean water. Repeat if
necessary.
4. Rinsing after
cleaning
Rinse parts
thoroughly in clean
water to remove all
soil and soap.
Wash all parts in
a clean tray with
clean water and
mild soap. Use a
scrub or brush to
remove any soil.
2. Disassembly
Autoclaving Boil or Steam*Chemical
Activated glutaraldehyde 2.4%
5. Post-Treatment
3. Manual Cleaning
Always dismantle
before cleaning.
Repeat steps 3-4 until
parts are clean. Before disinfection,
dry with clean gauze or cloth.
Patient Valve
Pull Off
Unscrew
Take Out
Pull Out
Unscrew
Pull Out
Pull Off
2. Cleaning and Disinfection Procedure
3.Testing before Use
1. Lip Valve function 2. Pressure Release Valve 3. Inlet Valve opening 4. Product sealing
Inlet Valve
Disk Membrane
Self-inflating
Ventilation Bag
Pressure
Release Valve
Patient Valve Housing
upper part
Inlet Valve Housing
Lip Valve
Membrane
Patient Port
Connector
Patient Valve
lower part
Mask No. 1
Caution: Do not disassemble parts beyond the steps shown.
Also included:
Mask No. 0

User Guide
EN
2460
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User Guide
NeoNatalie
Resuscitator
NEWBORN BAG-MASK
REUSABLE - AUTOCLAVABLE
Cat. no. 846040 QTY 1 each
Oxygen kit
846141
Read this User Guide and become familiar with the operation
and maintenance of the product prior to use.
Warnings and Cautions
A Warning states a condition, hazard, or unsafe practice that
can result in serious personal injury or death.
A Caution states a condition, hazard, or unsafe practice that
can result in minor personal injury or damage to the product.
Intended Use
The NeoNatalie Resuscitator is a self-inflating, manual
resuscitator intended for newborns and infants up to 5 kg
body mass who require respiratory support.
• The resuscitator may be reused provided proper cleaning
and sterilization procedures are performed between
each patient use.The resuscitator must be cleaned and
disinfected before first patient use.
• This resuscitator can provide supplemental oxygen
only when used with the Oxygen Kit.The NeoNatalie
Resuscitator is not supplied with the Oxygen Kit and its
User Guide (sold separately).
Please ensure that following precautions are taken to ensure
that the resuscitator functions properly during use.
Warnings
• This resuscitator should only be used by persons who have
received sufficient training in its use. Incorrect operation of the
resuscitator can be hazardous.
• This resuscitator should not be used in poisonous or
hazardous atmospheres.
• Do not use the resuscitator if you have any reason to be
concerned about its functionality.
Caution
Use only NeoNatalie Resuscitator parts from a Laerdal authorized
source with this resuscitator.
Using the Resuscitator
• Pressure ReleaseValve:The resuscitator has a pressure
release (pop-off) valve which releases air when pressure to
the patient exceeds 30-40 cmH2O. A hissing sound can be
heard when the valve opens.This valve may be overridden
if more pressure to the patient is needed.To override:
press downwards on the Pressure ReleaseValve with your
index finger.
• For ventilation training with the NeoNatalie Newborn
Simulator, use the largest mask (no.1). For ventilation of a
real patient, use the mask size that provides the best seal
to the patient’s face.
• If the Patient Valve becomes contaminated with vomit,
remove from patient and shake free any contaminant and
squeeze the ventilation bag several times to expel the
contaminant. If contaminant does not clear; disassemble
the PatientValve and rinse. If any components are loose,
tighten or reassemble the device and test in accordance.
Important Product
Information
This product is in compliance with the essential
requirements of Council Directive 93/42/EEC
as ammended by Council Directive 2007/47/EC.
Technical Information
Meets ISO 10651-4:2002/EN ISO 10651-4:2009,
Lung ventilators – Particular requirements for
operator–powered resuscitators.
Operating
temperature
- 18 oC to 50 oC (-0.4 oF to 122 oF)
Storage
temperature
- 40 oC to 60 oC (- 40 oF to 140 oF)
Dead space 4 ml (water volume)
Tidal volume 161 ml* +/- 15 ml (standard
deviation) at room temperature
Expiratory resistance <2.5 cm H2O at 5 LPM
Inspiratory resistance <0.5 cm H2O at 5 LPM
Patient Connector
(conical) 15 mm inner diameter, 22 mm outer diameter
External dimensions
(with Mask) Approx. 220 mm x 70 mm x 120 mm (8.66 x 2.76 x 4.72 inches)
Mass
(with Mask size 1) Approximately 170 grams (6 ounces)
* In sub-zero temperatures, the tidal volume may be
approx. 20% less.
Materials
Hard plastic components: Polysulfone (PSU)
Soft plastic components: Silicone rubber (SI)
Spring: Stainless steel
Not made with natural rubber latex
Global Warranty:
Refer to the Laerdal Global Warranty for terms and
conditions. For more information visit www.laerdal.com
Manufactured in China for:
Laerdal Medical AS
P.O. Box 377,Tanke Svilandsgate 30
4002 Stavanger, Norway
Tel : [phone]
Fax: [phone]
NeoNatalie Resuscitator; Newborn - Reusable,
the Laerdal Logo, and “helping save lives” are all
trademarks of Laerdal Medical AS.
Laerdal® is a trademark or registered
trademark of Laerdal Medical AS.
© 2017 Laerdal Medical AS, All rights reserved.
Printed in China
Accessories
and Spare Parts
Cat. no Description
846141 Oxygen kit (NeoNatalie): Oxygen Reservoir Bag,
Valve,Tubing and User Guide
846130 Oxygen Reservoir Bag and Tubing (NeoNatalie)
846145 Valves/Membranes, Complete set (NeoNatalie)
846136 Silicone Mask no. 0 (NeoNatalie) Qty. 10*
846137 Silicone Mask no. 1 (NeoNatalie) Qty. 10*
*Masks are bulk packed: 10 masks in 1 polybag.
20-05166 Rev D