Laerdal Silicone Resuscitator - Manual

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 H2O)
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 cmH2O
Measured with airflow of 50 lpm
Inspiratory resistance:
w/reservoir approx. 4,2 cmH2O
w/o reservoir approx. 3,1 cmH2O
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 H2O,
Resistance 20 cm H2O/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 2 concentrations under various test conditions:
PAEDIATRIC: Ventilation bag volume: 500 ml
Reservoir bag volume: 600 ml
1 2
3
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
O 2 -flow Tidal vol. (ml) x bag cycling rate per min.O 2 -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)
O 2 -flow Tidal vol. (ml) x bag cycling rate per min.O 2 -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)
O 2 -flow Tidal vol. (ml) x bag cycling rate per min.O 2 -concentrations (%)
lpm using reservoir (without reservoir).
20x40 20x60
3 100 (98) 100 (97)
8 100 (100) 100 (100)
15 100 (100) 100 (100)
O 2 -flow Tidal vol. (ml) x bag cycling rate per min.O 2 -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
2 concentrations are approximated values and depend on the O 2 concentration
delivered.
© 2010 Laerdal Medical AS, All Rights Reserved.
4492 rev F Printed in Norway
1 8 7 6
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.