laerdal NeoNatalie Resuscitator User manual

EN
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NeoNatalie Resuscitator
Oxygen Kit
REUSABLE
User Guide
This Oxygen Kit is an accessory to the Laerdal NeoNatalie Resuscitator, Cat. No.846040.
Cat.No. 846141
QTY
1 each

2

3
Contents
Clinical Indications 4
Important Information 5
Items Included 6
Attach Oxygen Valve Housing to Resuscitator 7
Function Test 8
Clinical Use 10
Disassembling and Reassembling 11
Cleaning and Disinfection 12
Specifications 13

4
Clinical Indications
Note
The following applies to the main device NeoNatalie Resuscitator, when used with the
NeoNatalie Resuscitator Oxygen Kit.
Device Description
The NeoNatalie Resuscitator is a self-inflating manual resuscitator that is intended for patients
requiring total or intermittent ventilatory support.
Indication for Use
The NeoNatalie Resuscitator is intended for patients requiring total or intermittent ventilatory
support.Ventilation is possible with or without supplemental oxygen.
Intended Use
The NeoNatalie Resuscitator with the Oxygen kit enables the delivery of oxygen-enriched air
to the newborn.
Intended Users
The NeoNatalie Resuscitator is intended to be used by healthcare professionals trained in
delivering ventilatory support and in the use of manual resuscitators.
Clinical Benefits
Positive impact on clinical outcome, by respiratory support that reduces probability of adverse
outcomes, such as morbidity and mortality caused by hypoxia.
Clinical Outcome
Desired outcome of ventilation is oxygenation of the patient, often evaluated using SpO2,
EtCO2, blood gas analysis or other method of analysis.
Known Side Effects
Gastric Insufflation
Oxygen Toxicity
Contraindications
No known contraindications for use.

5
Important Information
Read this User Guide and become familiar with the operation and maintenance of the device
prior to use.
Use the product only as described in this User Guide.
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.
Notes
A note states important information about the device or its operation.
Warnings
• This Oxygen Kit should only be used by persons who have received sufficient training in its use.
Incorrect operation of the Oxygen Kit can be hazardous. Do not use the Oxygen Kit if you have
any reason to be concerned about its functionality.
• Care should be taken when using the NeoNatalie Resuscitator on patients with severe
pulmonary disease or severely immature lungs.
• The NeoNatalie Resuscitator is not intended for use in delivery of medications, such as
anaesthetic gases.
Cautions
• The hard plastic components of the Oxygen Kit are incompatible with polar solvents such as
ethanol and isopropyl alcohol.
• An oxygen blender is recommended if more precise oxygen concentrations are required, for
example for pre-terms.
Note
Should any serious malfunction, undesirable incident with, or deterioration in the functionality or
performance of the device occur, contact Laerdal promptly.The competent authority where the
incident took place and/or the device was used should also be notified.

6
Items Included
Caution
Use only Oxygen Kit (NeoNatalie) parts from a Laerdal authorized source with this resuscitator.
Spare Parts
Cat. no Description
846130 Oxygen Reservoir Bag andTubing (NeoNatalie)
Safety When Using Oxygen
1. Build-up and transfer of high pressure to the patient is prevented since excess O2is vented
to atmosphere over the Outlet Valve of the Oxygen Kit.
2. When O2supply is insufficient, intake of ambient air for ventilation is afforded by the Inlet
Valve of the Oxygen Valve Housing.
3. An Oxygen Reservoir Bag that stays flat during the whole ventilation cycle is a visual
indication that none, or little supplemental O2is being provided.
4. In the presence of high oxygen concentrations there is danger from smoking or naked
flames. Oil or grease must not be used with the resuscitator.
Oxygen Reservoir Bag withTubing
Oxygen Tube
Oxygen Reservoir Bag
Oxygen Valve Housing
Inlet Valve for
ambient air
Outlet Valve for
excess oxygen
User Guide

7
Attach Oxygen Valve Housing to Resuscitator
Place the Oxygen Valve Housing
onto the Inlet Valve.
Screw to fasten.
1
2

8
Function Test
Check before each use.
Fill the Reservoir Bag with ambient air
by using the resuscitator as a pump.
Attach the filled Reservoir Bag to
the Oxygen Valve Housing.
1
2

9
Function Test
Squeeze the ventilation bag fully and then release quickly. Rapid re-expansion of the
Ventilation Bag confirms that the Inlet Valve efficiently draws in ambient air, for cases when
oxygen supply is inadequate.
Compress the filled Reservoir
Bag rapidly with your hand.
Check visually that the
Outlet Valve opens and
bleeds off excessive air/
oxygen, for cases when
oxygen supply is excessive.
Seal the oxygen nipple
with a finger.
Squeeze theVentilation
Bag several times until
the Reservoir Bag is
flat and empty.
3
4

10
Clinical Use
Using the Oxygen Kit
The Oxygen Valve Housing and the Inlet and Outlet valves must be cleaned and disinfected
before first patient use.
The Oxygen Kit may be reused provided proper reprocessing procedures are performed
between each patient use.
Do not attempt cleaning of Oxygen reservoir bag and tubing inside. If their inside is
contaminated, they must be disposed of.
Note
The oxygen source should be able to be adjusted to provide a flow relevant to the NeoNatalie
Resuscitator.
1. Screw the Oxygen Valve Housing onto the resuscitator’s Inlet Valve.
2. Attach the oxygen tube to the OxygenValve Housing and the oxygen source.
See Technical Information section for oxygen concentrations at typical oxygen flow rates.
3. For higher oxygen concentrations, attach the reservoir bag to the Oxygen Valve Housing.
If any components are loose, then tighten or reassemble the device and test in accordance
with page 8-9.

11
Disassembling and Reassembling
Disassembling the Oxygen Kit
Disassemble the OxygenValve before performing the cleaning procedure.
Unscrew the Oxygen Valve Housing
from the bag.
Remove Inlet and Outlet Valves from the
Oxygen Valve Housing.
1
2
Reassembling the Oxygen Kit
Discard any damaged components.
To reassemble the Oxygen Kit, perform the steps described under
Disassembling the Oxygen Kit section in reverse.

12
Cleaning and Disinfection
After each use, disassemble and clean the Oxygen Kit parts.
Oxygen Valve Housing and yellow Inlet and Outlet Valves
Cleaning
1. Manual Cleaning:Wash all parts in a clean tray with clean water and mild soap. Use a scrub
or brush to remove any soil.
2. Rinsing after cleaning: Rinse parts thoroughly in clean water to remove all soil and soap.
3. Inspect to ensure that no soil is visible. If necessary, manual washing may be repeated.
4. Allow the parts to dry completely.
5. Continue with disinfection as described.
Disinfection
The Oxygen Valve Housing and the yellow Inlet and Outlet Flap Valves can be disinfected by:
1. Steam Autoclaving*.
Autoclave with distilled water
for 10-20 minutes at 136 °C.
*Prevacuum-pulse autoclave
2. Boiling or Steaming
Boil* or Steam with clean water
at 100 °C for 10-20 minutes
*Validated at approximately sea-level
pressure
Drying and Inspection
1. Dry all parts.
2. Visually inspect each part for damage and cleanliness/mineral deposits.
3. Remove damaged or unclean parts from service.
Oxygen Reservoir Bag and Tubing
• Wipe off the Oxygen Reservoir Bag and OxygenTube with soapy water only on the outside
surfaces. Rinse the outside surfaces with clean water.
• Dry all parts.
Visually inspect for damage and cleanliness.
• Remove damaged or unclean parts from service.
Notes
The Oxygen Reservoir Bag and Oxygen Tube cannot be disinfected.
Warning
Discard Oxygen Reservoir Bag and Oxygen Tube if interior surfaces have been contaminated.
OR

13
Specifications
Meets ISO 10651-4:2002/EN ISO 10651-4:2009, Lung ventilators – Particular requirements for
operator–powered resuscitators.
Symbol Glossary
Symbol Denition
This medical device complies with the general safety and performance
requirements of Regulation (EU) 2017/745 for medical devices.
Medical Device
Not made with natural rubber latex.
Delivered oxygen concentration
Measured at approx. 23 °C (73 °F)
20 ml tidal volume
60 breaths/min
Oxygen flow Without
reservoir bag
With
reservoir bag
2 LPM 54% 56%
4 LPM 58% 84%
6 LPM 64% 91%
Use with oxygen blender at Room Temperature
Note
Oxygen reservoir bag must be used.
Setting the gas input supply flow of 6 LPM or more will ensure less than 10% dilution of the
input gas with ambient air

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Specifications
Specifications
Conditions
Operating Conditions - 18 °C to 50 °C
15% to 95% rH
Storage Conditions - 40 °C to 60 °C
15% to 95% rH
Resuscitator with Oxygen Kit
Dimensions
Approx. 440 mm x 70 mm x 180 mm
Weight Approx. 80 grams
Oxygen Reservioir Bag volume Approx. 750 ml
Lifetime Parameters
Shelf-life 5 years
Expected Service Life 50 cycles of reprocessing
Material Chart
Reservoir Bag Polyvinylchloride (PVC) and Polycarbonate (PC).
Oxygen Tube Polyvinylchloride (PVC)
Valve housing Polysulfone (PSU)
Valves Silicone Rubber (SI)
Laerdal Global Warranty
Refer to one-year Laerdal Global Warranty for terms and conditions. For more information,
visit www.laerdal.com.

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20-19670 Rev A
NeoNatalie, Laerdal and the Laerdal Logo are
trademarks of Laerdal Medical AS or its affiliates.
Ownership and all rights reserved.
© 2022 Laerdal Medical AS. All rights reserved.
Manufactured in China for: Laerdal Medical AS
P.O. Box 377,Tanke Svilandsgate 30, 4002 Stavanger, Norway
T: ([phone]
www.laerdalglobalhealth.com