laerdal NeoNatalie Resuscitator User manual

EN
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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 Benets
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.
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 : [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.
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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 O2source, 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 H2O. 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 PatientValve 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.
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 H2O at 5 LPM
Expiratory resistance <2.5 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)
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

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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
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
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.
• If NeoNatalie Resuscitator fails function tests it is to be removed from service and not used. Inspect all parts for damage. Replace any damaged parts if necessary and retest.
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
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:
*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.
Caution
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*
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
Note
Improper assembly of the NNR after reprocessing may affect performance.
*Prevacuum-
pulse autoclave
Cautions
• The resuscitator is not provided sterile.The resuscitator and mask must be cleaned and disinfected prior to initial use.
• It is recommended that the highest level of disinfection/sterilization possible is used for patients that may have compromised immune defense, such as a pre-term baby or in the case of outbreaks of highly transmissible pathogens.
• If NNR is stored as back-up in an area with potentially high levels of airborne pathogens, it should be considered to store the NNR in an air-tight container to avoid contamination.
• The use of cleaning and disinfection procedures not described in this section may have adverse effects on the NNR material and/or performance and may not be effective for disinfecting the NNR.
OR
Caution
Ensure Pressure Relief Valve
is functioning prior to use.
Inspect and test valve function to ensure proper operation of the NNR prior to patient use. To ensure proper operation, test valve functions after cleaning, disinfection and reassembly.
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