laerdal Upright with Newborn PEEP User Manual

Att 1 to 00021915.pdf 1 12.08.2016 10:09:32
User Guide
Upright with
Newborn PEEP
NEWBORN BAG-MASK WITH PEEP
REUSABLE - AUTOCLAVABLE
Includes
Newborn Mask
(Snap design)
Size 0 and Size 1
Newborn
PEEP
REF Cat. no. 846060 QTY 1 each
Accessories and
Spare parts
Cat. no Description
846156 Newborn Mask - Snap design – Size 0*
846157 Newborn Mask - Snap design – Size 1*
* 10 pcs
Newborn PEEP membrane and cap – 1 set
846165
Oxygen kit (Complete) includes oxygen
846151
adaptor, valve, reservoir bag and tubing
846131 Oxygen reservoir bag and tubing
846155 Upright valves and membranes kit*
(lip valve, inlet valve disc membrane)
* 10 pcs
Upright Oxygen kit
(Complete)
Testing PEEP value:
Ventilate continuously on a manikin or test lung,
while attached to a manometer. Check that the PEEP
remains between 4-8 cmH O between ventilations.
2
If a standard manometer is not available, a guidance
document can be found at www.laerdalglobalhealth.com
User Guide
Intended Use
Upright with Newborn PEEP is a self-inflating, manual, reusable
resuscitator with PEEP valve, intended for newborns and
infants up to 10 kg body mass who require respiratory
support.
PEEP can be deactivated by removing the PEEP valve
membrane.
Upright with Newborn PEEP can provide supplemental
oxygen only when used with the accessory oxygen kit.
Upright with Newborn PEEP may be reused provided
reprocessing procedures are followed between each patient
use. It must be cleaned and high-level disinfected or sterilized
before first use.
Caution
The patient should be constantly monitored while this product is in use.
Using Upright with Newborn PEEP
Orientation: Upright with Newborn PEEP is operated as a
normal resuscitator, with the bag having a vertical stance over
the mask.
Positive end-expiratory pressure (PEEP) retains a volume of air
in the lungs between each ventilation. For newborns with
fluid-filled or immature lungs, PEEP helps prevent repeated
lung alveolar collapse during ventilation. This helps recruit lung
volume more efficiently, clear fluid from the lungs and reduces
damage to the lung tissue.
Newborn Mask - Snap design: The mask fits with standard
15 mm inner-diameter conical connectors. Check fit before
use with other devices. When used with Upright with New-
born PEEP, the mask attaches with a snap fit when pressed
completely into place.
15 mm
Newborn Mask
Important Product Information
Regulatory
0434
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.
Newborn Mask - Snap design, is not designed in
accordance with ISO 5356-1:2015 - Anaesthetic
and respiratory equipment - Conical connectors
- Part 1: Cones and sockets.
Operating temperature -18 °C to 50 °C
Storage temperature
-40 °C to 60 °C
Dead space Approximately 5 ml (water volume)
External dimensions
Approximately
(with Newborn Mask size 1)
74 mm x 87 mm x 217 mm
Mass
Approximately 200 g
(with Newborn Mask size 1)
PEEP value/Pressure range 6 ± 2 cmH O
2
PEEP principle of operation Silicone membrane valve
Total bag volume 320 ml
Deliverable tidal volume > 150 ml
with PEEP:
Expiratory resistance
without PEEP: < 2.5 cmH
Inspiratory resistance with PEEP:
without PEEP: < 1 cmH
Materials
Hard plastic components: Polysulfone (PSU)
Soft plastic components: Silicone rubber
Spring: Stainless steel
Not made with natural rubber latex.
Pressure release valve: Upright with Newborn PEEP has a
pressure release valve ("pop-off") which limits the airway
pressure to 30-45 cmH
when the valve opens. If higher airway pressure is needed,
press downwards on the valve with the index finger while
squeezing the bag.
Vomitus or mucus: If the patient valve or PEEP valve
membrane becomes contaminated with vomitus or mucus,
remove the PEEP valve cap and membrane, clear the patient
valve by shaking Upright with Newborn PEEP and forcefully
squeezing the bag to expel the vomitus. If cleared, continue
ventilating without using the PEEP membrane and cap. If it
does not clear, disassemble the patient valve (see page 2),
rinse it in water and then reassemble.
If any components are loose, tighten or reassemble the
device and test in accordance with page 2.
Warnings
Upright with Newborn PEEP should only be used by persons trained in
operating resuscitators. Incorrect operation can be hazardous.
Do not use Upright with Newborn PEEP if you have any reason to be
concerned about its functionality.
Do not pull open slit on Newborn PEEP membrane.
Do not attempt to block the Newborn PEEP cap or port, which could
prevent patient expiration.
High ventilation rates (> 60 ventilations per minute) may restrict
patient expirations and increase PEEP above 8 cmH
Use of Newborn PEEP on infants larger than 5 kg may result in
higher PEEP.
For proper function, ensure that Upright with Newborn PEEP
components are not mixed and confused with similar-looking
non-Laerdal components. All Upright with Newborn PEEP components
are marked LAERDAL, as shown in the Product Overview section.
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.
Manufacturer Information
Global Warranty: See www.laerdal.com
Manufactured in Norway by:
Laerdal Medical AS
P.O. Box 377, Tanke Svilandsgate 30
4002 Stavanger, Norway
Tel : +47 51 51 17 00
Fax: +47 51 52 35 57
Pending US and international patent and design
registrations. Laerdal® is a trademark or registered
trademark of Laerdal Medical AS.
© 2016 Laerdal Medical AS, All rights reserved.
< 15 cmH O at 5 LPM
2 Printed in Norway
O at 5 LPM
2
< 1 cmH O at 5 LPM
2
O at 5 LPM
2
O. A hissing sound can be heard
2
O.
2
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