Laerdal LGH Upright Bag-Mask User Manual

User Guide

NEWBORN BAG - MASK

REUSABLE - AUTOCLAVABLE

Includes

Newborn Mask

(Snap design)

Size 0 and Size 1

User Guide

Upright

Intended Use

Upright Newborn Bag-Mask (”Upright”) is a self-inflating, manual, reusable resuscitator intended for newborns and infants up to 10 kg body mass who require respiratory support.

Upright can provide supplemental oxygen only when used with the accessory Oxygen kit.

Upright may be reused provided reprocessing procedures (page 2) are followed between each patient use. It must be cleaned and disinfected before first use.

Using Upright

Orientation: Upright 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, the mask attaches with a snap fit when pressed completely into place.

15 mm

Pressure release valve: Upright has a pressure release valve (“pop-off”) which limits the airway pressure to 30-45 cmH valve opens. If higher airway pressure is needed, press downwards on the valve with the index finger while squeezing the bag.

Vomitus: If the patient valve becomes contaminated with vomitus, clear the valve by shaking Upright and forcefully squeezing the bag to expel the vomitus. If it does not clear, disassemble the patient valve (see page

2), rinse it in water and then reassemble it.

If any components are loose, tighten or reassemble the device and test in accordance with page 2.

O. A hissing sound can be heard when the

Warnings

Upright should only be used by persons who have received sufficient training in its use. Incorrect operation of the Upright can be hazardous.

Do not use Upright if you have any reason to be concerned about its functionality.

REF Cat.no. 846050 QTY

1 each

Accessories and Spare parts

Cat .no Description

846156 846157

846151

846131

846155

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

Upright Valves and Membranes kit*

(Lip valve, Inlet valve disc membrane)

* 10 pcs

Upright Oxygen kit (Complete)

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 5356-1:2004 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.

Operating t emperature

-18 °C to 50 °C

For proper function, ensure that Upright components are not mixed and confused with similar-looking non-Laerdal components. All Upright components are marked LAERDAL, as shown on page 2.

Manufacturer Information

Global Warranty: See www.laerdal.com

Manufactured in China for Laerdal Medical AS, Tanke Svilandsgate 30 P.O. Box 377, 4002 Stavanger, Norway Tel : +47 51 51 17 00 Fax: +47 51 52 35 57

Email: laerdal.norway@laerdal.no

Storage t emperature

Expiratory resistance

Inspiratory resistance

Tidal volume

Dead space

External dimensions

(with Newborn Mask size 1)

Mass

(with Newborn Mask size 1)

-40 °C to 60 °C

<2.5 cm H

<0.5 cm H

>150 ml

4 ml (water volume)

Approximately 72 mm x 85 mm x 217 mm

Approximately 190 grams

O at 5 LPM

Materials

Hard plastic components: Polysulfone (PSU) Soft plastic components: Silicone rubber Spring: Stainless steel Not made with natural rubber latex.

20-06867 Rev B

Pending US and international design registration. Laerdal® is a trademark or registered trademark of Laerdal Medical AS.

Page 1

Upright NEWBORN BAG - MASK

Reprocessing instructions

1. Product overview

To dismantle, follow steps 1- 6. To reassemble, follow the steps in reverse.

1 2 3 5 6

Pull Out Unscrew Lift Out UnscrewPull Out

Pull forcefully on tab to release

“LAERDAL” “LAERDAL”

Do not disassemble parts beyond the steps shown. For proper function, make sure to only use parts marked LAERDAL (locations as shown above).

2. Cleaning and Disinfection procedure

1. Dismantle 2. Clean 3. Disinfect by one of the methods 4. Dry and Inspect 5. Assemble and Test

Always dismantle Upright before cleaning.

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.

100 °C

Boiling*

Boil all parts in clean water for 10 min.

*Validated at approximately

sea-level pressure

OR OR

Disinfect

60 minutes10 minutes

Chemical

Activated glutaraldehyde solution:

Disinfect all parts to the dis-

infectant manufacturer’s recommended procedure.

Immerse for 60 minutes.

Remove parts using aseptic

technique.

Rinse 3 times, for 1 minute using

fresh clean water each time.

+ rinse

in water

3 x 1 minute

Steam 136 °C 10-20 minutes

Autoclaving

Sterilize by steam autoclaving at 136 °C and

2.0 kg/cm 10-20 min.

for

Dry all parts.

Visually inspect each part for damage and cleanliness / mineral deposits.

Remove damaged or unclean parts from service.

Reassemble Upright.

Test usings steps shown below.

3.Testing before use

1. Lip valve function 2.

Squeeze the bag. Check that the yellow valve opens and closes with every squeeze.

If any of the above tests fail: Dismantle Upright, inspect the components, reassemble Upright and repeat the complete “Testing before use” procedure (Section 3).

Seal the mask against your hand. Squeeze the bag forcefully. Check that air is released from the pressure release valve.

Inlet valve opening

Keep the mask sealed against your hand. Release the squeezed bag. Check that the bag re-expands without resistance.

4. Product sealing3. Pressure release valve

Check that the silicone bag's lip

is not twisted or tucked under.

Keep the mask sealed against your hand. Press the pressure release valve down. Squeeze the bag and check that there is no leakage.

Page 2