EN

Laerdal Silicone
Resuscitators
User Guide

www.laerdal.com
 Contents
Indication for Use 4
Intended Use 4
Important Information 5
Items Included 6
Adult Model Overview 8
Adult Model Assembly and Disassembly 10
Paediatric Model Overview 12
Paediatric Model Assembly and Disassembly 14
Preterm Model Overview 16
Preterm Model Assembly and Disassembly 18
Intake Valve Assembly and Disassembly 20
Intake Valve Cap Update 21
Function Test 22
Cleaning and Disinfection 29
Regulatory Information 33
Specifications 34

3
Indication for Use Important Information

The Laerdal Silicone Resuscitator (LSR) is a self-inflating manual Read this User Guide and become familiar with the operation of
resuscitator that is intended for patients requiring total or the product prior to use. Use the product only as described in this
intermittent ventilatory support. Ventilation is possible with or User Guide.
without supplemental oxygen.
Warning and Cautions
A Warning states a condition, hazard, or unsafe practice that can
Intended Use result in serious personal injury or death.
The Laerdal Silicone Resuscitator provides positive pressure A Caution states a condition, hazard, or unsafe practice that can
ventilation and allows spontaneous breathing with a face mask or an result in minor personal injury or damage to the manikin.
artificial airway.
Notes
The Laerdal Silicone Resuscitator is available in three sizes: Important information about the product or its operation.
The Adult model is intended for patients over 25 kg (55 lb).
The Paediatric model is intended for patients from 2.5 kg (5.5 lb) Cautions
to 25 kg (55 lb). • Caution: Federal law (US) restricts this device to sale by or on the
The Preterm model is intended for patients below 2.5 kg (5.5 lb). order of a physician.
• The LSR should only be used by persons who have received
This User Guide applies to all three models of the Laerdal Silicone adequate training in the use of resuscitators.
Resuscitator unless otherwise specified. • 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 and oxygen delivery devices (e.g.
filters and demand valves) with the Laerdal Silicone Resuscitator
may have an affect on LSR performance. Please consult with the
manufacturer of the third party device to verify compatability with the
LSR and obtain information on possible LSR performance changes.

4 5
Items Included Items Included
Caution Paediatric Model
Do not use parts other than genuine Laerdal parts. Use of non-Laerdal
(Cat. No. 86xxxx)
parts may affect safety and/or performance.

Adult Model Paediatric Ventilation Bag

(Cat. No. 87xxxx) Patient Valve with
Pressure Relief Valve (500 ml)

Reusable Oxygen
Silicone Mask Reservoir Bag
(Child 3-4) Intake (600 ml)
with Multi-Function Reservoir Valve
Mask Cover
Patient Valve
Adult Ventilation Bag Preterm Model
(1600 ml) (Cat. No. 85xxxx)

Reusable Oxygen
Reservoir Bag
Silicone Mask Intake (2600 ml)
(Adult 4-5) Reservoir Valve
with Multi-Function Patient Valve with Preterm Ventilation Bag
Mask Cover Pressure Relief Valve (240 ml)

Reusable Oxygen
Reservoir Bag
Silicone Mask Intake (600 ml)
(Size 00, 0/1, 2) Reservoir Valve

6 7
 Adult Model - Overview Adult Model - Overview

Reservoir Flap Valves (x2)

Lip Valve

Patient Valve

Disk Membrane
Intake Valve
Reusable Oxygen
Adult Ventilation Bag Oxygen Port Reservoir Bag

Silicone Mask Intake Disk Membrane

with Multi-Function
Mask Cover

8 9
Adult Model - Overview Adult Model - Overview
Assembly and Disassembly

Cautions
Improper assembly of the flap valves, intake membrane, disk membrane
and lip valve may affect performance. Ensure use of one lip valve.
Misassembly with two lip valves may cause inadvertent Positive End
Expiratory Pressure (PEEP) or prevent proper patient exhalation.

10 11
Paediatric Model - Overview Paediatric Model - Overview

Reservoir Flap Valves (x2)

Pressure Relief Valve

Lip Valve

Patient Valve

Disk Membrane

Intake Valve
Paediatric Ventilation Bag
Oxygen Port

Silicone Mask Reusable Oxygen Reservoir Bag

(Child 3-4)
with Multi-Function Intake Disk Membrane
Mask Cover

12 13
Paediatric Model - Overview Paediatric Model - Overview
Assembly and Disassembly

Caution
Improper assembly of the flap valves, intake membrane, disk membrane
and lip valve may affect performance. Ensure use of one lip valve.
Misassembly with two lip valves may cause inadvertent Positive End
Expiratory Pressure (PEEP) or prevent proper patient exhalation.

14 15
Preterm Model - Overview Preterm Model - Overview

Reservoir Flap Valves (x2)

Pressure Relief Valve

Lip Valve

Patient Valve

Disk Membrane

Preterm Ventilation Bag Intake Valve

Oxygen Port

Silicone Mask Reusable Oxygen Reservoir Bag

Intake Disk Membrane

16 17
Preterm Model - Overview Preterm Model - Overview
Assembly and Disassembly

Caution
Improper assembly of the flap valves, intake membrane, disk membrane
and lip valve may affect performance. Ensure use of one lip valve.
Misassembly with two lip valves may cause inadvertent Positive End
Expiratory Pressure (PEEP) or prevent proper patient exhalation.

18 19
 Intake Valve Assembly/Disassembly
Click on - click off
Intake Valve Cap Update

CLICK
New version of cap and valve are indentified by textured circle.
CLICK
CLICK
r
ide
W
Post 2015 cap
CLICK
CLICK
CLICK

CLICK CLICK

CLICK

Pre 2015 cap

Post 2015 valve

Post 2015 cap

Pre 2015 cap

Pre 2015 valve

20 21
 Testing the intake valve

Function Test Function Test

Inspect and test valve function to ensure proper operation of Testing the Intake Valve
the Laerdal Silicone Resuscitator prior to patient use. To ensure
proper operation, test valve functions after cleaning, disinfection
and reassembly.

Laerdal Silicone Resuscitators should be function tested at least

once every year.

Caution Squeeze Seal neck

If a Laerdal Silicone Resuscitator fails any of these function tests it is
to be correctly cleaned, re-assembled and tested or removed from
service and not used.

Release bag
Inspect Bag - must
expand Try to squeeze
Inspect Bag - no air
should escape

22 23
Function Test Function Test
Testing the disk membrane of patient valve
Testing the Patient Valve Testing the Disk Membrane of Patient Valve
Testing the patient valve

Caution
Ensure that a (single) Lip Valve has been installed in the Patient Valve.

Fill reservoir bag

with air

Attach reservoir bag

to Patient Valve
Squeeze

Inspect
Disk Membrane
movement

Inspect Lip Valve movement Squeeze air out

24 25
 Function Test Function Test
Testing the Outlet Reservoir Flap Valve
Testing the Inlet Reservoir Flap Valve with Ambient Air

Testing the Outlet Reservoir Flap Valve Testing the Inlet Reservoir Flap Valve with Ambient Air

Attach reservoir Fill reservoir Attach reservoir bag to Fill

bag to bag with air Patient Valve reservoir
Patient Valve bag with
air

Attach reservoir bag to Intake Valve

Attach reservoir bag to Intake Valve

Seal oxygen port and

Inspect air flow and squeeze the bag multiple
Outlet Reservoir Flap Valve times to empty the
movement reservoir

Inspect air flow and

Squeeze air out Inlet Reservoir Flap Valve
Release Bag
movement

26 27
 Function Test Cleaning and Disinfection
Testing the Pressure Relief Valve Warning
Applies to Preterm and Paediatric models Disposable Oxygen Reservoir Bag (870702)
Testing the pressure relief valve
Designed for single use only. Do not re-use. Re-use will lead to increased
Caution
risk of cross contamination, degradation of performance and/or device
Ensure Pressure Relief Valve is functioning prior to use.
malfunction. Laerdal is not responsible for any consequences of re-use.

Cautions
• Laerdal strongly discourages the use of rinsing and drying agents.
Such agents may not be compatible with the materials used in the
Laerdal Silicone Resuscitator.
Seal Patient Valve • The use of cleaning and disinfection procedures not described in
this section may have adverse effects on the LSR material and/or
performance.
• The LSR must be high-level disinfected before first time use.
• The resuscitator components must be cleaned and disinfected
before next patient use.

Note
Contamination: If the Patient Valve becomes contaminated with vomit
Inspect during ventilation, disconnect the resuscitator from the patient and clear
Pressure Relief Valve the Patient Valve as follows:
movement • Tap the Patient Valve with the patient port against your gloved
hand to shake free any contaminant and squeeze the silicone bag
Squeeze to deliver several sharp breaths through the Patient Valve to expel
the contaminant.
• If contaminant does not clear; disassemble the Patient Valve and rinse.

28 29
Cleaning and Disinfection Cleaning and Disinfection

To reduce the risk of cross-contamination, follow these instructions Washing and Rinsing
after each use. The LSR must be cleaned before high-level disinfection or sterilisation.
The LSR can be manually cleaned, or cleaned in an automatic
Inspection washer/disinfector.
Carefully inspect all parts for signs of wear or damage. Worn or Manual Cleaning
damaged components must be discarded and replaced with new
Rinse parts under cold running water.
components.
Submerge parts in water at 30 - 40 ºC (86 - 104 ºF).
Ensure that all surfaces are submerged for at least 2 minutes.
Disassembly Submerge all parts in water at 60 - 70 ºC (140 - 158 ºF) which contains dish
Disassemble the LSR into individual parts as shown in Assembly and washing detergent.
Disassembly section to make surfaces accessible to cleaning. Thoroughly clean all surfaces using a brush as necessary.
• Separate the Expiration Diverter (if used) into its three parts
Rinse all components in detergent-free water at 30 - 40 ºC (86 - 104 ºF).
• Separate the Patient Valve into its four main parts
Dry the components thoroughly. Inspect all components to confirm that they
• Separate the Intake Reservoir Valve into its six parts are clean and dry. If parts are worn or damaged, discard them.
• Leave connectors in the necks of the Ventilation Bag, Extension
Tube and Reservoir Bag during the entire decontamination Automatic Cleaning (applies to all parts except Reservoir Bags)
procedure. Washer/Disinfector
• Unscrew the Pressure Relief Valve (Preterm and Paediatric Place parts in wire baskets.
models), but do not disassemble any further. Cycle 1: 90 - 95 ºC (194 - 203 ºF) for more than 12 seconds.
Total process time: approx. 52 min.
Cycle 2: Use a Non-enzymatic alkaline detergent containing 2 - 5% NaOH.
Pasteurmatic Compact
30 min wash cycle at 32 - 43 ºC (90 - 110 ºF)

30 31
Cleaning and Disinfection Regulatory Information

To obtain high-level disinfection/sterilisation of the resuscitator, The product is in compliance with the essential
follow one of these methods. requirements of Council Directive 93/42/EEC as amended
Sterilisation/High-level Disinfection
0434 by Council Directive 2007/47/EC.
Method Process Parameters Post-Treatment
Temperature / Exposure
Laerdal Silicone Resuscitator meets the following Standards:
Concentration time • EN 1789
Sterilisation (applies to all parts except the Reservoir Bags) • ISO 10651-4
• ISO 13485
Steam Autoclaving Autoclave at 15 min
(gravity-displacement) 132 - 137 ºC (+ 30s) • ISO 14971
(270 - 279 ºF) Allow parts to • ISO 5356-1
cool and dry • ISO 10993-1
Steam Autoclaving Autoclave at 3 min
(prevacuum-pulse) 134 - 137 ºC (+30s)
(273 - 279 ºF) Recommendations:
High-level Disinfection (applies to all parts) • When used in accordance with ISO 10651-4 the following
Cidex OPA 0.55% solution 60 min Remove traces resuscitator size recommendation applies: Adult for patients over
(orthophtalaldehyde) of disinfectant by 20 kg (44 lb), Paediatric for patients from 2.5 kg (5.5 lb) to 20 kg
rinsing in warm
tap water, (44 lb) and Preterm for patients below 2.5 kg (5.5 lb).
Sodium Hypochlorite 0.5% solution 20 min 30 - 40 ºC • When used to deliver tidal volumes as recommended by the
(86 - 104 ºF), for at
least 2 mins. AHA/ILCOR Guidelines 20101, the following applies. Adult for
Dry the patients over 25 kg (5.5 lb), Paediatric for patients from 2.5 kg
components (5.5 lb) to 25 kg (55 lb) and Preterm for patients below 2.5 kg.
thoroughly.
Pasteurization Pasteurization cycle 30 min Dry the
70 - 75 ºC components
(158 - 167 ºF) thoroughly

Reassembly
Reassemble resuscitator as shown in Assembly/Disassembly section. ¹AHA/ERC AED Guidelines for CPR and Emergency Cardiovascular care
(ECC) by ILCOR, AHA, ERC and others (2010).

32 33
Specifications Specifications
Not made with natural rubber latex. Preterm Model
Ventilation Bag volume: 240 ml
Adult Model Reservoir Bag volume: 600 ml
Ventilation Bag volume: 1600 ml
Reservoir Bag volume: 2600 ml Delivered O2 concentrations under various test conditions
O2 flow Tidal volume (ml) x bag cycling rate per minute.
Delivered O2 concentrations under various test conditions (lpm) O2-concentrations (%) using reservoir (without reservoir)
O2 flow Tidal volume (ml) x bag cycling rate per minute. 20 x 40 20 x 60
(lpm) O2-concentrations (%) using reservoir (without reservoir)
3 100 (98) 100 (97)
400 x 12 400 x 24 600 x 12 600 x 24 1000 x 12 1000 x 24
8 100 (100) 100 (100)
3 74 (38) 51 (39) 58 (34) 40 (34) 44 (33) 33 (30)
15 100 (100) 100 (100)
8 100 (44) 100 (44) 100 (40) 68 (40) 78 (38) 51 (34)
15 100 (51) 100 (50) 100 (47) 100 (47) 100 (42) 75 (36)
LSR Specifications
Conditions
Paediatric Model
Ventilation Bag volume: 500 ml Operating Conditions Temperature: -18 ˚C to 60 ˚C
Reservoir Bag volume: 600 ml (0 ˚F to 140 ˚F)
Humidity: 15% to 95% rH
Delivered O2 concentrations under various test conditions Storage Conditions Temperature: -40 ˚C to 70 ˚C
(-40 ˚F to 158 ˚F)
O2 flow Tidal volume (ml) x bag cycling rate per minute. Humidity: 40% to 95% rH
(lpm) O2-concentrations (%) using reservoir (without reservoir)
20 x 40 20 x 60 150 x 20 150 x 30 300 x 12 300 x 24 Resistance

3 100 (97) 100 (97) 98 (56) 78 (57) 85 (48) 56 (46) Expiratory resistance Approximately 2.6 cm H2O
Measured with airflow of 50 lpm
8 100 (100) 100 (100) 100 (70) 100 (70) 100 (58) 100 (57)
Inspiratory resistance With Reservoir: approx. 4.2 cm H2O
15 100 (100) 100 (100) 100 (82) 100 (83) 100 (71) 100 (70) Without Reservoir: approx. 3.1 cm H2O
Measured with airflow of 50 lpm

34 35
Specifications Spare Parts and Accessories
Accessories
Attainable delivery volume
Catalogue # Description
Adult Approximately 800 ml
871000 Silicone extension tube, 28 cm
Paediatric Approximately 320 ml
850900 LSR Manometer connector
Preterm Approximately 150 ml
850500 Expiration diverter (OD 30 mm)
Test conditions Compliance 0.02 l/cm H2O,
Resistance 20 cm H2O/l/s 531907 LSR Intake Valve Outer Part (23 mm OD)

No leakage Pressure Relief Valve overridden 865200 Multi Function Mask Cover for Mask 3-4

Dead space of Approximately 7 ml for all models 875200 Multi-Function Mask Cover 4-5+
Patient Valve
870400 LSR Head strap
Useful Life
870120 LSR Hanging loop
Laerdal Silicone Resuscitators should undergo the Function Test
at least once every year. If a correctly assembled LSR fails the test, 54010733 High Efficiency Filter for LSR/TheBAG(IE)(25pk)
the failing parts must be replaced and disposed of. 572000 Wall mount, Adult Display Case

Spare Parts/Consumables
Catalogue # Description

540103 LSR Lip valve

851252 Pressure Relief Valve 35 cm H20

851103 LSR Lock clips,(pkg-10)

540105 LSR Disk membranes, pkg. 10

511700 LSR Wall bracket

531904 LSR Reservoir valve lid

560200 LSR Patient Valve

36 37
Spare Parts and Accessories Spare Parts and Accessories

871300 Attachment ring for head strap 851250 Patient Valve w/35cm H²O Pressure Relief Valve
850150 Preterm Bag, 240 ml 521100 Wall Mount Paediatric/ Preterm Display Case
860150 Paediatric Bag, 500 ml
Masks
870150 Adult Bag, 1600 ml
Catalogue # Description
860410 LSR Compact Case
851500 LSR Silicone mask No.00
875400 Intake Reservoir Valve
851600 LSR Silicone mask No.0/1
531901 LSR O² reservoir 2.6 litre
851700 LSR Silicone mask No.2
531906 LSR O² reservoir 2.6 liters x 50
860220 Child Silicone mask 3-4 w/Multi Function Mask Cover
551901 LSR O² reservoir 0.6 litre
870220 Adult Silicone mask 4-5+ w/Multi Function Mask Cover
510404 LSR Intake membranes pkg. 10
860221 Child Silicone mask 3-4 w/o Multi Function Mask Cover
871950 Flap Valves 2 pk.
870221 Adult Silicone mask 4-5+ w/o Multi Function Mask Cover
510103 Cap for LSR Intake Valve spare part pkg. 3
872220 Adult & Child Sil. Mask w/Multi Func. Mask Covers
860420 LSR Compact Case Adult

870600 LSR Display case cpl. Adult

For latest version of Spare Parts and Accessories, visit www.laerdal.com.

860300 Display Case, Paediatric Warranty

850700 Display Case, Preterm Refer to the Laerdal Global Warranty for terms and conditions.
For more information visit www.laerdal.com.
530400 Airways, set of 4

871950 Flap Valves 2 pk.

870708 Disposable O²-reservoir bag, 2600ml, pkg.20

38 39
Laerdal® is a registered trademark
of Laerdal Medical AS.

© 2016 Laerdal Medical AS. All rights reserved.

Manufacturer: Laerdal Medical AS

P.O. Box 377, Tanke Svilandsgate 30,
4002 Stavanger, Norway
T: (+47) 51 51 17 00

Distributed in US by:
Laerdal Medical Corporation
167 Myers Corners Rd, 20-09495 Rev A
Wappingers Falls, NY 12590
T: (877) 523-7325

Printed in Norway

www.laerdal.com