laerdal LSR Adult, LSR Paediatric, LSR Preterm User Manual

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Page 1

Laerdal Silicone

Resuscitators

User Guide

www.laerdal.com

Page 2

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

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Important Information

Indication for Use

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 injur y 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.

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Items Included Items Included

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)

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Adult Model - Overview Adult Model - Overview

Intake Valve

Patient Valve

Reservoir Flap Valves (x2)

Disk Membrane

Lip Valve

Silicone Mask

with Multi-Function

Mask Cover

Oxygen Port

Reusable Oxygen

Reservoir Bag

Adult Ventilation Bag

Intake Disk Membrane

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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

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Paediatric Model - Overview Paediatric Model - Overview

Pressure Relief Valve

Intake Valve

Patient Valve

Reservoir Flap Valves (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

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Assembly and Disassembly

Caution

Paediatric Model - Overview Paediatric Model - Overview

CLICK

Page 9

Preterm Model - Overview Preterm Model - Overview

Silicone Mask

Intake Valve

Patient Valve

Reservoir Flap Valves (x2)

Disk Membrane

Lip Valve

Preterm Ventilation

Bag

Reusable Oxygen

Reservoir Bag

Pressure Relief Valve

Oxygen Port

Intake Disk Membrane

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Assembly and Disassembly

Caution

Preterm Model - Overview Preterm Model - Overview

CLICK

Page 11

Click on - click o

Intake Valve Assembly/Disassembly Intake Valve Cap Update

New version of cap and valve are indentified by textured circle.

Post 2015 cap

Post 2015 valve

Wider

Pre 2015 cap

Pre 2015 valve

CLICK

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Function Test Function Test

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

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Function Test Function Test

Testing the Disk Membrane of Patient ValveTesting 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

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Function Test Function Test

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

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Cleaning and Disinfection

Function Test

Testing the Pressure Relief Valve

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

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Cleaning and Disinfection Cleaning and Disinfection

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 Diver ter (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 Reser voir 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)

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Regulatory Information

Cleaning and Disinfection

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

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Specifications Specifications

Not made with natural rubber latex.

Adult Model

Ventilation Bag volume: 1600 ml Reservoir Bag volume: 2600 ml

Delivered O2 concentrations 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

74 (38) 51 (39) 58 (34) 40 (34) 44 (33) 33 (30)

100 (44) 100 (44) 100 (40) 68 (40) 78 (38) 51 (34)

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 O2 concentrations 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

3 100 (97) 100 (97) 98 (56) 78 (57) 85 (48) 56 (46)

100 (100) 100 (100)

100 (70) 100 (70) 100 (58) 100 (57)

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 O2 concentrations 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

100 (98) 100 (97)

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

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Spare Parts and Accessories

Specifications

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 br acket

531904 LSR Reservoir valve lid

560200 LSR Patient Valve

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Spare Parts and Accessories Spare Parts and Accessories

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 O² reservoir 2.6 litre

531906

LSR O² reservoir 2.6 liters x 50

551901

LSR O² reservoir 0.6 litre

510404 LSR Intake membranes pkg. 10

871950 Flap Valves 2 pk.

510103 Cap for LSR Intake Valve 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

Patient Valve 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.

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20-10368 Rev C

Laerdal® is a registered trademark of Laerdal Medical AS.

Manufactured in China for 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, Wappingers Falls, NY 12590 T: (877) 523-7325

Printed in China

www.laerdal.com