laerdal LSR Adult User manual

Laerdal Silicone
Resuscitators
User Guide
EN
www.laerdal.com

Contents
3
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

Important Information
5
Indication for Use
4
The Laerdal Silicone Resuscitator (LSR) is a self-inflating manual
resuscitator that is intended for patients requiring total or
intermittent ventilatory support.Ventilation is possible with or
without supplemental oxygen.
Intended Use
The Laerdal Silicone Resuscitator provides positive pressure
ventilation and allows spontaneous breathing with a face mask or an
artificial airway.
The Laerdal Silicone Resuscitator is available in three sizes:
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)
to 25 kg (55 lb).
The Preterm model is intended for patients below 2.5 kg (5.5 lb).
This User Guide applies to all three models of the Laerdal Silicone
Resuscitator unless otherwise specified.
Read this User Guide and become familiar with the operation of
the product prior to use. Use the product only as described in this
User Guide.
Warning 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 manikin.
Notes
Important information about the product or its operation.
Cautions
• Caution: Federal law (US) restricts this device to sale by or on the
order of a physician.
• The LSR should only be used by persons who have received
adequate training in the use of resuscitators.
• 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.

Items Included Items Included
67
Paediatric Model
(Cat. No. 86xxxx)
Preterm Model
(Cat. No. 85xxxx)
Caution
Do not use parts other than genuine Laerdal parts. Use of non-Laerdal
parts may affect safety and/or performance.
Items may vary in appearance and are subject to change.
Adult Model
(Cat. No. 87xxxx)
Silicone Mask
(Child 3-4)
with Multi-Function
Mask Cover
Silicone Mask
(Adult 4-5)
with Multi-Function
Mask Cover
Silicone Mask
(Size 00, 0/1, 2)
Preterm Ventilation Bag
(240 ml)
Reusable Oxygen
Reservoir Bag
(600 ml)
Patient Valve with
Pressure Relief Valve
Patient Valve with
Pressure Relief Valve
Patient Valve
Paediatric Ventilation Bag
(500 ml)
Reusable Oxygen
Reservoir Bag
(600 ml)
Adult Ventilation Bag
(1600 ml)
Intake
Reservoir Valve
Intake
Reservoir Valve
Intake
Reservoir Valve
Reusable Oxygen
Reservoir Bag
(2600 ml)

89
Adult Model - Overview Adult Model - Overview
Intake Valve
Patient Valve
Reservoir FlapValves (x2)
Disk Membrane
Lip Valve
Silicone Mask
with Multi-Function
Mask Cover
Oxygen Port Reusable Oxygen
Reservoir Bag
Adult Ventilation Bag
Intake Disk Membrane

10 11
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.
Assembly and Disassembly
Adult Model - Overview Adult Model - Overview
CLICK

12 13
Paediatric Model - Overview Paediatric Model - Overview
Pressure Relief Valve
Intake Valve
Patient Valve
Reservoir FlapValves (x2)
Disk Membrane
Lip Valve
Silicone Mask
(Child 3-4)
with Multi-Function
Mask Cover
Reusable Oxygen
Reservoir Bag
Paediatric Ventilation Bag
Oxygen Port
Intake Disk Membrane

14 15
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.
Paediatric Model - Overview Paediatric Model - Overview
CLICK

16 17
Preterm Model - Overview Preterm Model - Overview
Silicone Mask
Intake Valve
Patient Valve
Reservoir FlapValves (x2)
Disk Membrane
Lip Valve
Preterm Ventilation
Bag
Reusable Oxygen
Reservoir Bag
Pressure Relief Valve
Oxygen Port
Intake Disk Membrane

18 19
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.
Preterm Model - Overview Preterm Model - Overview
CLICK

Click on - click o
Intake Valve Assembly/Disassembly Intake Valve Cap Update
20 21
New version of cap and valve are indentified by textured circle.
Post 2015 cap
Post 2015 cap
Post 2015 valve
Wider
Pre 2015 cap
Pre 2015 cap
Pre 2015 valve
CLICK

Function Test Function Test
22 23
Inspect and test valve function to ensure proper operation of
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
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.
Testing the Intake Valve
Squeeze
Release bag
Inspect Bag - must
expand
Seal neck
Try to squeeze
Inspect Bag - no air
should escape

Function Test Function Test
24 25
Testing the Disk Membrane of PatientValveTesting the Patient Valve
Caution
Ensure that a (single) Lip Valve has been installed in the Patient Valve.
Inspect Lip Valve movement
Attach reservoir bag
to Patient Valve Squeeze
Fill reservoir bag
with air
Squeeze air out
Inspect
Disk Membrane
movement

Function Test Function Test
26 27
Testing the Outlet Reservoir Flap Valve
Inspect air ow and
Outlet Reservoir Flap Valve
movement
Testing the Inlet Reservoir Flap Valve with Ambient Air
Inspect air ow and
Inlet Reservoir Flap Valve
movement
Seal oxygen port and
squeeze the bag multiple
times to empty the
reservoir
Release Bag
Attach reservoir bag to
Patient Valve
Attach reservoir bag to Intake Valve
Fill
reservoir
bag with
air
Attach reservoir
bag to
Patient Valve
Attach reservoir bag to Intake Valve
Squeeze air out
Fill reservoir
bag with air

Cleaning and Disinfection
29
Function Test
28
Testing the Pressure ReliefValve
Applies to Preterm and Paediatric models
Caution
Ensure Pressure Relief Valve is functioning prior to use.
Warning
Disposable Oxygen Reservoir Bag (870702)
Designed for single use only. Do not re-use. Re-use will lead to increased
risk of cross contamination, degradation of performance and/or device
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.
• 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
during ventilation, disconnect the resuscitator from the patient and clear
the Patient 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 Patient Valve and rinse.
Seal Patient Valve
Squeeze
Inspect
Pressure Relief Valve
movement

Cleaning and Disinfection Cleaning and Disinfection
30 31
To reduce the risk of cross-contamination, follow these instructions
after each use.
Inspection
Carefully inspect all parts for signs of wear or damage.Worn or
damaged components must be discarded and replaced with new
components.
Disassembly
Disassemble the LSR into individual parts as shown in Assembly and
Disassembly section to make surfaces accessible to cleaning.
• Separate the Expiration Diverter (if used) into its three parts
• Separate the Patient Valve into its four main parts
• Separate the Intake Reservoir Valve into its six parts
• Leave connectors in the necks of the Ventilation Bag, Extension
Tube and Reservoir Bag during the entire decontamination
procedure.
• Unscrew the Pressure Relief Valve (Preterm and Paediatric
models), but do not disassemble any further.
Washing and Rinsing
The LSR must be cleaned before high-level disinfection or sterilisation.
The LSR can be manually cleaned, or cleaned in an automatic
washer/disinfector.
Manual Cleaning
Rinse parts under cold running water.
Submerge parts in water at 30 - 40 ºC (86 - 104 ºF).
Ensure that all surfaces are submerged for at least 2 minutes.
Submerge all parts in water at 60 - 70 ºC (140 - 158 ºF) which contains dish
washing detergent.
Thoroughly clean all surfaces using a brush as necessary.
Rinse all components in detergent-free water at 30 - 40 ºC (86 - 104 ºF).
Dry the components thoroughly. Inspect all components to confirm that they
are clean and dry. If parts are worn or damaged, discard them.
Automatic Cleaning (applies to all parts except Reservoir Bags)
Washer/Disinfector
Place parts in wire baskets.
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)

Regulatory Information
33
Cleaning and Disinfection
32
To obtain high-level disinfection/sterilisation of the resuscitator,
follow one of these methods.
Sterilisation/High-level Disinfection
Method Process Parameters Post-Treatment
Temperature /
Concentration
Exposure
time
Sterilisation (applies to all parts except the Reservoir Bags)
Steam Autoclaving
(gravity-displacement)
Autoclave at
132 - 137 ºC
(270 - 279 ºF)
15 min
(+ 30s)
Allow parts to
cool and dry
Steam Autoclaving
(prevacuum-pulse)
Autoclave at
134 - 137 ºC
(273 - 279 ºF)
3 min
(+30s)
High-level Disinfection (applies to all parts)
Cidex OPA
(orthophtalaldehyde)
0.55% solution 60 min Remove traces
of disinfectant by
rinsing in warm
tap water,
30 - 40 ºC
(86 - 104 ºF), for at
least 2 mins.
Dry the
components
thoroughly.
Sodium Hypochlorite 0.5% solution 20 min
Pasteurization Pasteurization cycle
70 - 75 ºC
(158 - 167 ºF)
30 min Dry the
components
thoroughly
Reassembly
Reassemble resuscitator as shown in Assembly/Disassembly section.
The product is in compliance with the essential
requirements of Council Directive 93/42/EEC as amended
by Council Directive 2007/47/EC.
Laerdal Silicone Resuscitator meets the following Standards:
• EN 1789
• ISO 10651-4
• ISO 13485
• ISO 14971
• ISO 5356-1
• ISO 10993-1
Recommendations:
• When used in accordance with ISO 10651-4 the following
resuscitator size recommendation applies:Adult for patients over
20 kg (44 lb), Paediatric for patients from 2.5 kg (5.5 lb) to 20 kg
(44 lb) and Preterm for patients below 2.5 kg (5.5 lb).
• When used to deliver tidal volumes as recommended by the
AHA/ILCOR Guidelines 20101, the following applies. Adult for
patients over 25 kg (55 lb), Paediatric for patients from 2.5 kg
(5.5 lb) to 25 kg (55 lb) and Preterm for patients below
2.5 kg (5.5 lb).
¹AHA/ERC AED Guidelines for CPR and Emergency Cardiovascular care
(ECC) by ILCOR,AHA, ERC and others (2010).
2460

Specifications Specifications
34 35
Not made with natural rubber latex.
Adult Model
Ventilation Bag volume: 1600 ml
Reservoir Bag volume: 2600 ml
Delivered O2concentrations under various test conditions
O2 ow
(lpm)
Tidal volume (ml) x bag cycling rate per minute.
O2-concentrations (%) using reservoir (without reservoir)
400 x 12 400 x 24 600 x 12 600 x 24 1000 x 12 1000 x 24
374 (38) 51 (39) 58 (34) 40 (34) 44 (33) 33 (30)
8100 (44) 100 (44) 100 (40) 68 (40) 78 (38) 51 (34)
15 100 (51) 100 (50) 100 (47) 100 (47) 100 (42) 75 (36)
Paediatric Model
Ventilation Bag volume: 500 ml
Reservoir Bag volume: 600 ml
Delivered O2concentrations under various test conditions
O2 ow
(lpm)
Tidal volume (ml) x bag cycling rate per minute.
O2-concentrations (%) using reservoir (without reservoir)
20 x 40 20 x 60 150 x 20 150 x 30 300 x 12 300 x 24
3100 (97) 100 (97) 98 (56) 78 (57) 85 (48) 56 (46)
8100 (100) 100 (100) 100 (70) 100 (70) 100 (58) 100 (57)
15 100 (100) 100 (100) 100 (82) 100 (83) 100 (71) 100 (70)
Preterm Model
Ventilation Bag volume: 240 ml
Reservoir Bag volume: 600 ml
Delivered O2concentrations under various test conditions
O2 ow
(lpm)
Tidal volume (ml) x bag cycling rate per minute.
O2-concentrations (%) using reservoir (without reservoir)
20 x 40 20 x 60
3100 (98) 100 (97)
8100 (100) 100 (100)
15 100 (100) 100 (100)
LSR Specifications
Conditions
Operating Conditions Temperature: -18 ˚C to 60 ˚C
(0 ˚F to 140 ˚F)
Humidity: 15% to 95% rH
Storage Conditions Temperature: -40 ˚C to 70 ˚C
(-40 ˚F to 158 ˚F)
Humidity: 40% to 95% rH
Resistance
Expiratory resistance Approximately 2.6 cm H2O
Measured with airflow of 50 lpm
Inspiratory resistance With Reservoir: approx. 4.2 cm H2O
Without Reservoir: approx. 3.1 cm H2O
Measured with airflow of 50 lpm

Spare Parts and Accessories
37
Specifications
36
Attainable delivery volume
Adult Approximately 800 ml
Paediatric Approximately 320 ml
Preterm Approximately 150 ml
Test conditions Compliance 0.02 l/cm H2O,
Resistance 20 cm H2O/l/s
No leakage Pressure Relief Valve overridden
Dead space of
Patient Valve
Approximately 7 ml for all models
Useful Life
Laerdal Silicone Resuscitators should undergo the Function Test
at least once every year. If a correctly assembled LSR fails the test,
the failing parts must be replaced and disposed of.
Accessories
Catalogue # Description
871000 Silicone extension tube, 28 cm
850900 LSR Manometer connector
850500 Expiration diverter (OD 30 mm)
531907 LSR Intake Valve Outer Part (23 mm OD)
865200 Multi Function Mask Cover for Mask 3-4
875200 Multi-Function Mask Cover 4-5+
870400 LSR Head strap
870120 LSR Hanging loop
54010733 High Efficiency Filter for LSR/TheBAG(IE)(25pk)
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

Spare Parts and Accessories Spare Parts and Accessories
38 39
871300 Attachment ring for head strap
850150 Preterm Bag, 240 ml
860150 Paediatric Bag, 500 ml
870150 Adult Bag, 1600 ml
860410 LSR Compact Case
875400 Intake Reservoir Valve
531901 LSR O²reservoir 2.6 litre
531906 LSR O²reservoir 2.6 liters x 50
551901 LSR O²reservoir 0.6 litre
510404 LSR Intake membranes pkg. 10
871950 Flap Valves 2 pk.
510103 Cap for LSR IntakeValve spare part pkg. 3
860420 LSR Compact Case Adult
870600 LSR Display case cpl.Adult
860300 Display Case, Paediatric
850700 Display Case, Preterm
530400 Airways, set of 4
871950 Flap Valves 2 pk.
870708 Disposable O²-reservoir bag, 2600ml, pkg.20
851250 PatientValve w/35cm H²O Pressure Relief Valve
521100 Wall Mount Paediatric/ Preterm Display Case
Masks
Catalogue # Description
851500 LSR Silicone mask No.00
851600 LSR Silicone mask No.0/1
851700 LSR Silicone mask No.2
860220 Child Silicone mask 3-4 w/Multi Function Mask Cover
870220 Adult Silicone mask 4-5+ w/Multi Function Mask Cover
860221 Child Silicone mask 3-4 w/o Multi Function Mask Cover
870221 Adult Silicone mask 4-5+ w/o Multi Function Mask Cover
872220 Adult & Child Sil. Mask w/Multi Func. Mask Covers
For latest version of Spare Parts and Accessories, visit www.laerdal.com.
Warranty
Refer to the Laerdal Global Warranty for terms and conditions.
For more information visit www.laerdal.com.