Laerdal Silicone Resuscitator Uživatelský manuál stáhnout pdf

Scope

This manual provides the information required to fully utilise the Laerdal¨ Silicone Resuscitator,

and to help assure safe and trouble free operation over a maximum period of time. The Laerdal

Silicone Resuscitator is available in three sizes: Adult, Paediatric and Preterm. The 3 sizes have many

features and functions in common and are therefore described jointly whenever possible.

The detailed description of design and function should be read carefully by every user of the Laerdal

Silicone Resuscitators.

It is mandatory that anyone who uses a manual resuscitator receive adequate instruction.

It is also helpful if the student practices bag-valve-mask ventilation on realistic training manikins,

such as the Laerdal manikins.

Cautions and warnings

Read these Directions for Use carefully and become thoroughly familiar with the

operation and maintenance of the Laerdal Silicone Resuscitator before using it.

- Resuscitators should only be used by persons who have received adequate training.

- Federal law (US) restricts this device to sale by or on the order of a physician.

- 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.

- Before first time use of the resuscitator parts and its accessories, decontamination

is necessary.

- 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.

- Do not use parts other than genuine Laerdal parts. Use of non-Laerdal parts may

affect safety and/or performance.

- 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 and may

affect the material and/or performance.

Service

Laerdal Silicone Resuscitators are designed and engineered for utility and economy.

All components, parts and assemblies listed in the parts list may be replaced, when

necessary, by the operator who is directed to carefully inspect them during decontamination

procedures. Under normal conditions of use, no regularly scheduled factory service should be

necessary. However, whenever a question arises we hope you will contact Laerdal Medical AS

or an authorised Laerdal distributor.

Product specifications are subject to change without notice.

Limited warranty

Please refer to the Global Warranty statement for additional terms and conditions (www.laerdal.

com)

www.laerdal.com

Material Chart

Article Component Part Material

Storage Pouch Polyethylene PE

Compact Case Case Polypropylene PP

Partition wall Acryl nitrilbutadiene styrene ABS

Display Case Case Polypropylene PP

Window Styrene acrylonitril SAN

Tray Acryl nitrilbutadiene styrene ABS

Lock Polyamide PA

Bag Bag Silicone rubber SI

Valve Connector Polysulfone PSU

O-Ring Fluorelastomer VITON

Patient Valve Upper Housing Polysulfone PSU

Patient side Housing Polysulfone PSU

Lip Valve Silicone rubber SI

Disk Membrane Silicone rubber SI

Pressure Relief Valve Stem Polysulfone PSU

Housing Polysulfone PSU

Spring Stainless steel

Bush Silicone rubber SI

Intake Valve Outer part Polysulfone PSU

Inner part Polysulfone PSU

Cap Polysulfone PSU

Flap Valve Silicone rubber SI

Intake Membrane Silicone rubber SI

O2 Reservoir Bag Reservoir Bag Polyvinyl chloride PVC

Coupling for bag Polysulfone PSU

Masks No.00-0/1-2 Silicone rubber SI

No.3-4, 4-5+ Silicone rubber SI

No.0-1-2 Silicone rubber SI

Optional Equipment

Mask Cover Polysulfone PSU

Lock Clip Stainless steel

Head Strap w/Ring Strap Polyvinyl chloride PVC

Attachement Ring Polycarbonate PC

Expiration Diverter Housing Polysulfone PSU

Center gasket Silicone rubber SI

External gasket Silicone rubber SI

Extension Tube Tube Silicone rubber SI

Coupling Polysulfone PSU

Manometer Connector Polysulfone PSU

Hanging Loop Silicone rubber SI

Wall Mount Acryl nitrilbutadiene styrene ABS

Wall Bracket Acetal POM

850050 340g 12 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

850051 380g 13 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

850053 830g 1 lb 13 oz 24 x 15 x 16 cm 9.4 x 5.9 x 6.3 in

850055 1640g 3 lb 10 oz 37 x 33 x 12 cm 14.6 x 13 x 4.7 in

860050 370g 13 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

860051 510g 1 lb 2 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

860052 440g 16 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

860053 920g 2 lb 24 x 15 x 16 cm 9.4 x 5.9 x 6.3 in

860055 1760g 3 lb 14 oz 37 x 33 x 12 cm 14.6 x 13 x 4.7 in

860056 390g 14 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

870050 520g 1 lb 2 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

870051 700g 1 lb 9 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

870052 625g 1 lb 6 oz 25 x 14,5 x 13 cm 10 x 5.7 x 5.1 in

870053 1060g 2 lb 5 oz 24 x 15 x 16 cm 9.4 x 5.9 x 6.3 in

870055 2090g 4 lb 10 oz 37 x 33 x 15 cm 14.6 x 13 x 4.7 in

Shipping weights and dimensions

Cat. Nos. Weights Dimensions

Optional Equipment/Accessories

Masks

85 15 00 Silicone Mask No. 00

85 16 00 Silicone Mask No. 0/1

85 17 00 Silicone Mask No.2

86 02 20 Silicone Child Mask 3-4

w/Multi-Function Mask Cover

87 02 20 Silicone Adult Mask 4-5+

w/Multi-Function Mask Cover

86 52 00 Multi-Function Mask cover 3-4

87 52 00 Multi-Function Mask cover 4-5

Patient Valves

56 02 00 Patient Valve

54 01 03 Lip Valve

54 01 05 Disk Membranes, pkg. 10

85 12 50 Patient Valve w/ Pressure Relief Valve

85 12 52 Pressure Relief Valve (35 cm H

85 13 50 Patient Valve w/Press

Relief Valve and Lock Clip

85 11 03 Lock Clips, pkg. 10

Ventilation Bags/Intake Valve

85 01 50 Preterm Bag, 240 ml

86 01 50 Paediatric Bag, 500 ml

87 01 50 Adult Bag, 1600 ml

51 01 12 O-rings, pkg. 10

87 54 00 Intake Valve

87 19 50 Flap Valves, pkg 3

51 04 04 Intake membranes, pkg. 10

51 01 03 Cap, pkg. 3

Reservoirs

53 19 01 O2 Reservoir 2.6 litres

55 19 01 O2 Reservoir, 0.6 litre

Containers

85 07 00 Display Case cpl., Preterm

86 03 00 Display Case cpl., Paediatric

87 06 00 Display Case cpl., Adult

86 04 10 Compact Case cpl. Preterm/Paediatric

86 04 20 Compact Case cpl. Adult

Optional Equipment/Accessories

85 05 00 Expiration Diverter (OD 30 mm)

87 10 00 Silicone Extension Tube (28 cm)

85 09 00 Manometer Connector

87 04 00 Laerdal Head Strap w/Attachment Ring

87 13 00 Attachment Ring f/Standard Head Strap

87 01 20 Hanging Loop

51 17 00 Wall Bracket

52 11 00 Wall Mount, Paediatric/Preterm displ.

case

57 20 00 Wall Mount, ad. displ. case

87 05 50 Wall Poster reassembly guide

87 09 50 Directions for Use

53 19 07 Intake Valve Outer Part (23mm OD)

53 04 00 Airways, set of 4

Performance data may vary a great deal with

the conditions under which they were obtained.

Consequently, the findings in one test are not

directly comparable with data found in another test

unless test conditions were identical.

The product is in compliance with the

essential requirements of Council Directive

93/42/EEC as amended by Council

Directive 2007/47/EC

Product meets the following Product Standards:

- EN/ISO 10651-4:2002, Lung ventilators-

Particular requirements for operator-

powered resuscitators

- ISO 8382: 1988 Resuscitators intended for

Use With Humans.

- ASTM F 920 - 93, Standard Specification for

Minimum Performance and Safety

Requierments for Resuscitators Intended for

Use With Humans.

- AS 2488-1995 Resuscitators intended for

Use With Humans.

Operating environmental limits:

Operating condition: -18¡C to 60¡C.

(-0,4˚F to 140˚F)

15% to 95 %

Relative Humidity

Storage environmental limits:

Storage : -40¡C to 70¡C.

(-40˚F to 158˚F)

40% to 95 %

Relative Humidity

Dead space of Patient Valve:

Approx. 7,0 ml for all models

Expiratory resistance:

Approx. 2,6 cmH

Measured with airflow of 50 lpm

Inspiratory resistance:

w/reservoir approx. 4,2 cmH

w/o reservoir approx. 3,1 cmH

Measured with airflow of 50 lpm

Attainable delivery volume

Adult: Approx. 800ml

Paediatric: Approx. 320ml

Preterm: Approx. 150ml

Test conditions: Compliance 0,02 l/cm H

Resistance 20 cm H

O/l/s

No leakage;

Pressure Relief Valve overridden.

Technical Specifications

Storage

For storage in small space, the Adult and Paediatric

(but not the Preterm) ventilation bags may be folded

as shown in fig. 1-2-3. Fold the Paediatric in same fas-

hion as the Adult.

Long Term Storage

Laerdal Silicone Resuscitators and/or spare parts may

be placed in long term storage. They should be perio-

dically inspected and tested (at least yearly) according

to the Function Testing section in this manual.

Storage Pouch (Not illustrated)

The Adult, Paediatric or Preterm resuscitator

can be stored dust proof in the transparent

resealable pouch. A loop through a metal eyelet per-

mits hanging the pouch.

Compact Case

The Adult, Paediatric or Preterm resuscitator

and accessories can be stored as illustrated.

The Compact Case can also be wall mounted.

Display Case (Not illustrated)

A fully assembled Adult, Paediatric or Preterm resusci-

tator can be stored for immediate use.

The Display Case may be hung on optional

Wall Mount.

Wall Bracket

Separate Wall Bracket is available

Hanging Loop

The resuscitator can be hung ready for immediate use.

For mounting Hanging Loop on the resuscitator, see

separate instructions enclosed with the Hanging Loop.

ADULT: Ventilation bag volume: 1600 ml

Reservoir bag volume: 2600 ml

Delivered O

concentrations under various test conditions:

PAEDIATRIC: Ventilation bag volume: 500 ml

Reservoir bag volume: 600 ml

1 2

Adult

PRETERM: Ventilation bag volume: 240 ml

Reservoir bag volume: 600 ml

Useful Life

Laerdal Silicone Resuscitator products, accessories and parts are carefully engineered and produced using

materials that are suitable for the purpose. Care in accordance with these Directions for Use will help

ensure that each product has a long and useful lifetime. (Tested in 100 cycle decontamination study)

Spontaneous breathing patient

-flow Tidal vol. (ml) x bag cycling rate per min.O

-concentrations (%)

lpm using reservoir (without reservoir).

400x12 400x24 600x12 600x24 1000x12 1000x24

3 74 (38) 51 (39) 58 (34) 40 (34) 44 (33) 33 (30)

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)

-flow Tidal vol. (ml) x bag cycling rate per min.O

-concentrations (%)

lpm using reservoir (without reservoir).

20x40 20x60 150x20 150x30 300x12 300x24

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

8 100 (100) 100 (100) 100 (70) 100 (70) 100 (58) 100 (57)

15 100 (100) 100 (100) 100 (82) 100 (83) 100 (71) 100 (70)

-flow Tidal vol. (ml) x bag cycling rate per min.O

-concentrations (%)

lpm using reservoir (without reservoir).

20x40 20x60

3 100 (98) 100 (97)

8 100 (100) 100 (100)

15 100 (100) 100 (100)

-flow Tidal vol. (ml) x bag cycling rate per min.O

-concentrations (%)

lpm using reservoir (without reservoir).

Adult Paediatric Preterm

600x20 300x20 150x25 20x60 20x60

3 44 (39) 66 (49) 99 (62) 100 (99) 100 (99)

8 81 (54) 98 (62) 99 (75) 100 (100) 100 (100)

15 96 (74) 98 (79) 99 (87) 100 (100) 100 (100)

Feasible oxygen concentration

The feasible O

concentrations are approximated values and depend on the O

concentration

delivered.

4492 rev F Printed in Norway

1876

Laerdal Silicone Resuscitators Parts/Assembly Illustration

Patient Valve

51 01 12

54 01 03

54 01 05

86 52 20

85 12 52

85 11 03

56 02 00

87 52 00

87 02 20

86 02 20

85 12 50

51 04 04

85 16 00

Patient Valve

w/Press

Relief Valve

85 12 50

Adult Ventilation Bag, 1600 ml 87 01 50

Intake/Reservoir Valve 87 54 00

Paediatric Ventilation Bag, 500 ml 86 01 50

Preterm Ventilation Bag, 240 ml 85 01 50

Patient Valve w/Lock Clip 85 13 50

Reusable

Oxygen

Reservoir

Bag

600 ml

55 19 01

Reusable

Oxygen

Reservoir

Bag

600 ml

55 19 01

Reusable

Oxygen

Reservoir

Bag

2600 ml

53 19 01

OD 23 mm

OD 6 mm

Cap, pkg 3

51 01 03

ID 25 mm

ID 23 mm

ID15 mm

ID 22 mm

OD 22 mm

ENGLISH Directions for Use

Laerdal Silicone Resuscitators

Manufactured by:

LAERDAL MEDICAL AS

P.O. Box 377, N-4002 Stavanger

Tel. +47 51 51 17 00, Fax +47 51 52 35 57

E-mail: [email protected]

Distributed in USA by:

LAERDAL MEDICAL CORPORATION

167 Myers Corners Road, P.O. Box 1840

Wappingers Falls, New York 12590-8840

Tel. (800) 431-1055, +1 (845) 297-7770

Fax (800) 227-1143, +1 (845) 298-4545

E-mail: [email protected]

Distributed in Canada by:

LAERDAL MEDICAL CANADA LTD.

151 Nashdene Rd., Unit #45

Toronto, ON, Canada, M1V 4C3

Tel. +1 (416) 298-9600

Fax +1 (416) 298-8016

E-mail: [email protected]

PHT

DEHP

The Laerdal oxygen reservoir bag used with this product contains DEHP.

The product is only intended for short-term/transient patient application and it is not directly, or

through a liquid, in contact with the patient.

When cleaned and used according to these Directions for Use, there is no added risk involved

when treating children or pregnant or nursing women.

1 2

Shrnutí obsahu

Strany 1 - ENGLISH Directions for Use

ScopeThis manual provides the information required to fully utilise the Laerdal¨ Silicone Resuscitator, and to help assure safe and trouble free oper

Strany 2 - 70-75¼C (158-167¼F)

O2O2Indications for UseThe Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or inte

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