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User Guide
NeoNatalie
Resuscitator
NEWBORN BAG-MASK
REUSABLE - AUTOCLAVABLE
Cat. no. 846040 QTY 1 each
CLINICAL INDICATIONS
Device Description
The NeoNatalie Resuscitator (NNR) is a self-inflating manual
resuscitator that is intended for patients requiring total or
intermittent ventilatory support.
Indication for Use
The NNR is intended for patients requiring total or intermittent ventilatory
support. Ventilation is possible with or without supplemental oxygen.
Intended Use
The NNR provides positive pressure ventilation and allows spontaneous
breathing with a face mask or an artificial airway.
It is intended for newborns and infants up to 5 kg.
Intended Users
The NNR 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 SpO
2
, EtCO
2
, blood gas analysis or other method of
analysis.
Known Side Effects
Gastric Insufflation
Oxygen Toxicity
Contraindications
No known contraindications for use.
IMPORTANT INFORMATION
Read this User Guide and become familiar with the operation and
maintenance of the product 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
Important information about the product or its operation.
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.
© 2022 Laerdal Medical AS, All rights reserved.
Manufactured in China for:
Laerdal Medical AS
P.O. Box 377, Tanke Svilandsgate 30
4002 Stavanger, Norway
Tel : +47 51 51 17 00
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.
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Oxygen kit
846141
ACCESSORIES
Cat. no
Description
846141
Oxygen kit (NeoNatalie): Oxygen Reservoir Bag,
Valve, Tubing and User Guide
850500
Expiration Diverter (OD 30 mm)
SPARE PARTS
Cat. no
Description
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*
540103
LSR Lip Valve
*Masks are bulk packed: 10 masks in 1 polybag.
20-19669
Rev A
•
Do not use the resuscitator if you have any reason to be concerned about its
functionality.
•
Care should be taken when using the NNR on patients with severe pulmonary
disease or severely immature lungs. Applied pressure should be adjusted and
monitored according to the patient's condition.
•
Care should be taken when using the NNR on patients with severe patient
anomalies or when applying other medical devices which may conflict with
the mask as mask leakage may occur. If mask face sealing is not possible to
achieve consider using alternative airway device.
•
Care should be taken when applying pressure to the mask to avoid facial
damage.
• Care should be taken when using the NNR on patients with severely congested
airways. Consider removing congestion from the oropharyngeal airway. Use of
the NNR on patients with severely congested airways may result in a reduction
in expected oxygenation.
• The NNR is not intended for use with advanced airways.
Cautions
•
Use only NeoNatalie Resuscitator parts from a Laerdal authorized source with
this resuscitator. Use of other parts may affect safety and/or performance.
•
The resuscitator may be reused provided proper cleaning and sterilization
procedures are performed between each patient use.
•
The resuscitator components 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).
•
The resuscitator is not intended for use in an ambulance.
•
The hard plastic components of the resuscitator are incompatible with polar
solvents such as ethanol and isopropyl alcohol.
• The NNR and masks should only be used by persons who have received
adequate training in the use of resuscitators.
• Resuscitators should not be used with supplemental oxygen where smoking is
permitted or when fire, flame, oil or grease is in close proximity.
• Resuscitators should not be used in toxic or hazardous atmospheres.
• The use of third party products with the NNR may affect performance.
• Please consult with the manufacturer of the third party products to verify
compatibility with the NNR and obtain information on possible performance
changes.
• An oxygen blender is recommended if more precise oxygen concentrations are
required, for example for pre-terms.
• The use of a PEEP valve (not provided by Laerdal) is recommended in the
case that PEEP is indicated for the patient. Note that it is necessary to use the
Expiration diverter to attach a PEEP valve.
• The NNR and masks are not intended for use in delivery of medications, such
as anaesthetic gases.
Notes
•
Note that the patient port connector does not have a swivel function which can
reduce the flexibility of the user to reposition the resuscitator when connected
to an advanced airway.
•
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.
CLINICAL USE
To Use
1. Connect a suitable face mask.
2. Connect to external O
2
source, if applicable.
3. Place mask over face and check for seal.
4. Squeeze the Ventilation Bag in accordance to clinical protocol.
5. Observe patient chest rise during ventilation.
6. Allow patient to exhale.
7. Stop ventilation as required by clinical protocol.
Pressure Release Valve:
The resuscitator has a pressure release (pop-off) valve which releases air
when pressure to the patient exceeds 30-40 cm H
2
O. 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 Release Valve 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
Patient Valve and rinse. If any components are loose, tighten or reassemble
the device and test in accordance.
The resuscitator may be fitted with the Laerdal LSR Expiration Diverter.
Attach firmly to the Patient Port. Attach a suited PEEP valve if PEEP is
indicated for the patient.
Check PEEP levels regularly with a manometer.
www.laerdal.com
SPECIFICATIONS
Conditions
Operating Conditions
Temperature: -18 ˚C to 50 ˚C (-0.4 ˚F to 122 ˚F)
Humidity: 15% to 95% RH
Storage Conditions
Temperature: -40 ˚C to 60 ˚C (-40 ˚F to 140 ˚F)
Humidity: 15% to 95% RH
Inspiratory resistance
<0.5 cm H
2
O at 5 LPM
Expiratory resistance
<2.5 cm H
2
O 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)
Lifetime Parameters
Shelf-life
5 years
Expected Service Life
50 cycles of reprocessing
Delivered volume range:
Tidal volume 161 ml* +/- 15 ml (standard deviation) at room temperature
* In sub-zero temperatures, the tidal volume may be approx. 20% less.
Material Chart
Hard plastic components
Polysulfone (PSU)
Soft plastic components
Silicone rubber (SI)
Spring
Stainless steel
REGULATORY
Meets ISO 10651-4:2002/EN ISO 10651-4:2009,
Lung ventilators – Particular requirements for operator–powered
resuscitators.
Symbol Glossary
Medical Device
This medical device complies with the general safety and performance
requirements of Regulation (EU) 2017/745 for medical devices.
Not made with natural rubber latex
Warranty
Refer to the Laerdal Global Warranty for terms and conditions.
For more information visit www.laerdal.com.
PEEP valve
Expiration diverter