laerdal 846060 User manual

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www.laerdalglobalhealth.com
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EN
© 2022 Laerdal Medical AS. All rights reserved.
Registered US design registration USD760376.
Laerdal® is a trademark or registered trademark
of Laerdal Medical AS.
Manufactured in China for:
Laerdal Medical AS,Tanke Svilandsgate 30
P.O. Box 377, 4002 Stavanger, Norway
Tel.: [phone]-19674 Rev A
Cat. no. 846060
User Guide
Upright with PEEP
Newborn Bag-Mask
REUSABLE - AUTOCLAVABLE
SPECIFICATIONS
Temperature and Environment
Operating temperature - 18 °C to 50 °C
Storage temperature - 40 °C to 60 °C
Performance Specications
Dead space Approx. 5 mL (water volume)
Tidal volume >150 mL
Total bag volume Approx. 320 mL
Expiratory resistance with PEEP: <15 cmH2O at 5 L/min
without PEEP: <2.5 cmH2O at 5 L/min
Inspiratory resistance with PEEP: <1 cmH2O at 5 L/min
without PEEP: <1 cmH2O at 5 L/min
PEEP value/Pressure range 6 ± 2 cmH2O
Lifetime parameters
Shelf-life 5 years
Expected Service Life 100 cycles of reprocessing
Measurements
Patient Connector
(conical)
15 mm inner diameter,
22 mm outer diameter
External dimensions
(with newborn Mask size 1)
Approximately 74 x 87
x 217 mm
Mass
(with newborn Mask size 1)
Approximately 200
grams
Materials
Hard plastic components Polysulfone (PSU)
Soft plastic components Silicone rubber
Spring Stainless steel
CLINICAL INDICATIONS
Device Description
Upright with PEEP is a self-inflating manual resuscitator that is intended
for patients requiring total or intermittent ventilatory support.
Indication for Use
Upright with PEEP is intended for patients requiring total or intermittent
ventilatory support.Ventilation is possible with or without supplemental
oxygen.
Intended Use
Upright with PEEP provides positive pressure ventilation and allows
spontaneous breathing with a face mask or an artificial airway.
Intended for patients up to 10 kg (22 lbs).
Intended Users
Upright with PEEP 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 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
• Upright with PEEP should only be used by persons who received
sufficient training in its use. Incorrect operation of the resuscitator can be
hazardous.
• Resuscitators should not be used with supplemental oxygen where
smoking is permitted or when fire, flame, oil or grease is in close
proximity.
• This resuscitator should not be used in toxic or hazardous atmosphere.
• Do not use Upright with PEEP if you have any reason to be concerned
about its functionality.
• For proper function, ensure that Upright with PEEP components are
not mixed and confused with similar-looking non-Laerdal components.
All Upright with PEEP components are marked LAERDAL. as shown on
page 2.
• Care should be taken when using the Upright with PEEP on patients
with severe pulmonary disease or severely immature lungs.Applied
pressure should be adjusted and monitored according to the patient’s
condition. Note that a manometer is not supplied by Laerdal for use
with the Upright with PEEP, but a manometer is possible to connect to
the patient port with an appropriate adapter compatible with an ISO
5356-1 connector.
• Care should be taken when using Upright with PEEP on patients with
severe 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.
• Use of the Newborn Masks provided on patients over 5 kg may result in
poor fit. Larger masks should be used on patients over 5 kg. Note that
these masks are not provided with Upright with PEEP.
REGULATORY
Meets ISO 10651-4:2002/EN ISO 10651-4:2009, Lung ventilators –
Particular requirements for operator–powered resuscitators.
• Care should be taken when using Upright with PEEP on patients
with severely congested airways. Consider removing congestion from
the oropharyngeal airway. Use of Upright with PEEP on patients with
severely congested airways may result in a reduction in expected
oxygenation.
• Upright with PEEP is not intended for use in delivery of medications,
such as anesthetic gases.
• Upright with PEEP is not intended for use with advanced airways.
• Do not pull open slit on PEEP membrane.
• Do not attempt to block the PEEP cap or port, which could prevent
patient expiration.
• High ventilation rates (> 30 breaths per minute) with high-compliance
lungs, may restrict patient expirations and increase PEEP above 8
cmH2O.
• Use of Newborn PEEP on infants larger than 5 kg may result in higher
PEEP.
• At freezing temperatures, PEEP function could be reduced or lost.
Absence of a hissing sound after each ventilation may indicate this.
• Not to be used in a respiratory circuit or for providing CPAP.
• Not suitable for providing free-flow of oxygen to patient.
• Check PEEP levels regularly with a manometer.
Cautions
• The resuscitator is not intended for use in an ambulance.
• The hard plastic components of the resuscitator and the mask cover 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.
• The use of the PEEP valve is recommended in the case that PEEP is
indicated for the patient.
• Improper assembly of Upright with PEEP after reprocessing may affect
performance.
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.
USING UPRIGHT WITH PEEP
Orientation: Upright with PEEP is operated as a normal resuscitator,
with the bag having a vertical stance over the mask.
Newborn Mask - Snap Design:The mask fits with standard 15 mm
inner-diameter conical connectors, as defined by ISO 5356-1. Check fit
before use with other devices.When used with Upright with PEEP, the
mask attaches with a snap fit when pressed completely into place.
• Upright with PEEP can provide supplemental oxygen only when used
with the Oxygen Reservoir Accessory (sold separately).
• Upright with PEEP may be reused provided reprocessing procedures
(page 2) are followed between each patient use. It must be cleaned
and disinfected before first use.
• Pressure Release Valve: Upright with PEEP has a pressure release
valve (“pop-off”) which releases air when pressure to the patient
exceeds 30-45 cm H2O. A hissing sound can be heard when the
valve opens. If higher airway pressure is needed, press downwards on
the valve with the index finger while squeezing the bag.
CLINICAL USE
Operating Upright with PEEP with face mask:
1. Connect a suitable face mask
2. Connect to external O2source, if applicable.
3. Place mask over face ard 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.
Warning
Incorrect operation of the resuscitator can be hazardous.
Notes
The oxygen source should be able to be adjusted to provide a flow relevant
to the Upright with PEEP. See tables in Upright Oxygen kit’s user guide
regarding achievable oxygen concentration at varying flows for more
information.
Manometer Use
Peak Inspiratory Pressure (PIP) and PEEP can be monitored when a
manometer is connected between Upright with PEEP’s Patient Port
Connector and the face mask. Check PEEP pressure regularly with a
manometer connected with a manometer connector between Upright
with PEEP and the mask or airway adjunct.
Positive End-Expiratory Pressure (PEEP)Valve
The included Newborn PEEP valve membrane can be attached to
Upright with PEEP’s expiration port. See section Disassembly and
Reassembly illustration to locate the expiration port.
The PEEP membrane opens with a popping sound during each patient
expiration. Other types of PEEP valves cannot be fitted to Upright with
PEEP.
PEEP can be deactivated by removing the PEEP valve membrane. Check
PEEP pressure regularly with a manometer.
Contamination: If the PatientValve becomes contaminated with vomitus
or mucus, disconnect Upright with PEEP from the patient and clear the
valve as follows:
• Tap the Patient Valve with the patient port against your gloved hand
to shake free any contaminant and squeeze the silicone bag to
deliver several sharp breaths through the Patient Valve to expel the
contaminant.
• If contaminant does not clear, disassemble the PatientValve and rinse.
Reassemble the device and test in accordance with page 2.
If any components are loose, tighten or reassemble the device in
accordance with page 2.
Patient port on Newborn
Mask Snap design fit standard
15/22 mm connector
Ø 15 mm
Expected PEEP Performance
PEEP shall be measured as the end expiratory pressure between
inflations (usually the lowest pressure delivered between inflations).
PEEP value between continuous ventilations is typically 6 cmH2O with
a tolerance range of 4-8 cmH2O, as illustrated in the graphs below. For
high ventilation rates with a high compliance lung, expected PEEP value
increases.
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0-50 cmH2O
Manometer
Connector
Manometer
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ACCESSORIES AND SPARE PARTS
Cat. no Description
846156
846157
Newborn Mask - Snap design – Size 0*
Newborn Mask - Snap design – Size 1*
846165 Newborn PEEP membrane and cap – 1 set
846151 Upright Oxygen kit Complete
846131 Oxygen reservoir bag and tubing
846155 Upright valves and membranes kit*
(lip valve, inlet valve disc membrane)
* Masks are bulk packed: 10 masks in 1 polybag.
Upright Oxygen kit (Complete)
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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 one-year Laerdal Global Warranty for terms and conditions.
For more information, visit www.laerdal.com.

2.b
2.c
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12.a 34
5
5.b
5.a
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6
5.c
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3
2
Steam 136 °C
10-20 minutes
100 °C
10-20 minutes
5.b
5.a
3
Disassembly
Overview
Items Included
Assembly Highlights
Upright with PEEP Newborn Bag-Mask
Reprocessing Instructions
Pull OutPull Out
Pull Off
Lift Out
Pull firmly on tab to release
To disassemble follow steps 1-6.
Unscrew
Unscrew
Unscrew
Caution
Do not disassemble parts beyond the steps shown.
1. Lip Valve Membrane Function 2. Pressure ReleaseValve & InletValve Function 3. Product Sealing
Squeeze the bag. Check that the yellow 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.
Hold Upright firmly at the neck. Press other hand
upwards against the mask’s sealing cuff so that air
inside the mask is pushed into Upright and out the
expiration port with the PEEP Valve membrane.
Repeat 3 times.
4. PEEP Membrane Function
Cleaning and Sterilization/ Disinfection
Function Test Before Use
Always disassemble
before cleaning.
Test using steps as shown
in Function Test Before Use
section.
Reassemble as
shown in Assembly.
Visually inspect each part for damage and cleanliness.
If not clean repeat cleaning and sterilization process.
Caution
Removed damaged, crazed, cracked or worn parts from use. Rip Stoppers
PEEP membrane inspection:
Hold membrane between fingers and
squeeze softly. Check that slit opens fully,
but not beyond Rip Stoppers.
Caution
If any of the above tests fail, disassemble Upright with PEEP, inspect the components, reassemble and repeat the complete procedure in “Function Test Before Use” section. Remove damaged parts from use.
Patient Port
Connector
“LAERDAL”
Patient Port Connector
Lip Valve Membrane
Ventilation Bag
PEEP Cap
PEEP Membrane
Inlet Housing
Inlet Valve
Disk Membrane
Pressure
Release Valve
Attach PEEP membrane
(5.a) onto the patient port
connector before attaching the
PEEP cap (5.b) during assembly.
Check that PEEP membrane slit
opens and seals fully.
Ensure that the ventilation
bag’s lip is not twisted or
tucked under in the reassembly
procedure.
PatientValve = Patient Port Connector + PEEP Membrane + PEEP Cap + Lip Valve Membrane
Inlet Valve = Inlet Valve Disk Membrane + Inlet Housing + Pressure Release Valve
Remove parts using
aseptic technique.
Wash all parts in a clean tray with clean water and
dish soap for at least 2 minutes.
Use a scrub or brush to remove any soil.
Rinse parts in clean water to remove all
soil and dish soap.
Repeat steps until parts are clean.
Before sterilization,
dry with clean gauze.
1. Disassemble 2. Manual Cleaning 3. Rinsing 4. Post-Treatment
Pre-Sterilization/ Disinfection
1. Choose one of the following methods: 2. Post-Treatment
Sterilization/ Disinfection
2. Reassemble1. Inspect
Post-Sterilization/ Disinfection
3. Function Test
Newborn Mask
Size 0 and 1
Caution
For proper function, make sure to only use parts marked “LAERDAL” .
Ventilation Bag and Inlet Valve
“LAERDAL”
Assembly
To reassemble, follow steps 1-6.
Insert Attach
Attach Attach
Screw on
Screw on
Screw on
Allow parts to cool. Dry each part
with sterile gauze or air dry in a
protected space.
Autoclaving Boil
Boil all parts in clean
water for 10 min.
Validated at
approximately
sea-level pressure
Attach
Sterilize by gravity
displacement steam
autoclaving at 136 °C
and 2.0 kg/cm2for
10-20 min.
OR