laerdal Upright with Newborn PEEP User manual

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.
User Guide
Cat. no Description
846156
846157
846165
846151
846131
846155
Regulatory
0434
-18 °C to 50 °C
-40 °C to 60 °C
Approximately 5 ml (water volume)
Approximately
74 mm x 87 mm x 217 mm
6 ± 2 cmH2O
320 ml
Total bag volume
Silicone membrane valve
Approximately 200 g
20-08849 Rev B
User Guide
Upright with
Newborn PEEP
NEWBORN BAG-MASK WITH PEEP
REUSABLE - AUTOCLAVABLE
Pressure release valve: Upright with Newborn PEEP has a
pressure release valve (“pop-off”) which limits the airway
pressure to 30-45 cmH2O. 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.
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 cmH2O.
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.
REF Cat. no. 846060 QTY 1 each
Accessories and
Spare parts
Important Product Information
Newborn Mask - Snap design – Size 0*
Newborn Mask - Snap design – Size 1*
* 10 pcs
Oxygen kit (Complete) includes oxygen
adaptor, valve, reservoir bag and tubing
Oxygen reservoir bag and tubing
Newborn PEEP membrane and cap – 1 set
Upright valves and membranes kit*
(lip valve, inlet valve disc membrane)
* 10 pcs
Upright Oxygen kit
(Complete)
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
Storage temperature
Dead space
External dimensions
(with Newborn Mask size 1)
PEEP principle of operation
Mass
(with Newborn Mask size 1)
Hard plastic components: Polysulfone (PSU)
Soft plastic components: Silicone rubber
Spring: Stainless steel
Not made with natural rubber latex. Page 1
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 : [phone]
Fax: [phone]
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.
Printed in Norway
Includes
Newborn Mask
(Snap design)
Size 0 and Size 1
Materials
PEEP value/Pressure range
Testing PEEP value:
Ventilate continuously on a manikin or test lung,
while attached to a manometer. Check that the PEEP
remains between 4-8 cmH2O between ventilations.
If a standard manometer is not available, a guidance
document can be found at www.laerdalglobalhealth.com
Expiratory resistance
15 mm
Newborn Mask
with PEEP: < 15 cmH2O at 5 LPM
without PEEP: < 2.5 cmH2O at 5 LPM
with PEEP: < 1 cmH2O at 5 LPM
without PEEP: < 1 cmH2O at 5 LPM
Inspiratory resistance
Newborn
PEEP
Deliverable tidal volume > 150 ml
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3.
2.
1.
1. 2. 3.
4
. 5.
12.a 3 5 6
1
2
3
4
5
1. 2. 4.
3.
4
Upright with Newborn PEEP
Product Overview
To dismantle Upright with Newborn PEEP, follow steps 1-6. To reassemble, follow the steps in reverse.
Pull Out Unscrew Lift Out
“LAERDAL”
“LAERDAL”
Pull firmly on tab to release
Pull Out
Do not disassemble parts beyond the steps shown. For proper function, make sure to only use parts marked “LAERDAL” (locations as shown above).
Cleaning and Disinfection Procedure
Dismantle Clean Disinfect / Sterilize
Dry and Inspect
Assemble and Test
Always dismantle
Upright with
Newborn PEEP
before cleaning.
1
2
3
4
Wash all parts in a clean tray
with clean water and mild soap.
Use a scrub or brush to remove
any soil.
Rinse parts in clean water to
remove all soil and soap.
Repeat above steps
until parts are clean.
Boiling*
Boil all parts in clean
water for 10 min.
Autoclaving
Sterilize by steam
autoclaving
at 136 °C and
2.0 kg/cm2for
10-20 min.
Dry all parts.
Visually inspect each part for damage, cleanliness
and signs of mineral deposits. If the parts become
coated in limescale immerse in equal parts of water
and white vinegar (3-5%) for 10 minutes.
Do NOT immerse PEEP membrane.
Rinse in clean water. Repeat if necessary.
PEEP membrane inspection:
Hold membrane between fingers and squeeze
softly. Check that slit opens fully, but not beyond
rip stoppers.
If in doubt about PEEP membrane function or
pressure, test as described in Testing PEEP valve,
Page 1.
Discard any damaged or worn parts.
Reassemble Upright
with Newborn PEEP.
Test using steps
shown in Testing
Before Use section.
Caution:
Make sure to attach
membrane onto the
patient connector before
attaching the cap.
Testing before Use
Lip valve function Pressure release valve and Inlet valve function Product sealing PEEP membrane function
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.
Page 2
If any of the above tests fail, dismantle Upright with Newborn PEEP, inspect the components, reassemble and repeat the complete “Testing Before Use” procedure (Section 3).
Remove damaged parts from use.
Reprocessing instructions
Hold Upright with Newborn PEEP firmly at
the yellow neck label. 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 membrane. Check that the PEEP
membrane slit opens and seals fully.
Repeat 3 times.
Ensure that the
silicone bag's lip
is not twisted or
tucked under.
Unscrew
Pull Off
2.b
2.c
Unscrew
Rip Stoppers
OR
10 minutes
100 °C Steam 136 °C
10-20 minutes
*Validated at
approximately
sea-level pressure.
Att 1 to 00021915.pdf 2 12.08.2016 10:09:32