laerdal 84501 Manual

Manual Single-Use Self-Inflating Resuscitator
DIRECTIONS FOR USE
Manufactured in China by: olymed (Xiamen) lastic Industrial Co.,
Ltd Unit B, 1~5 F, Block G,Warehouse & rocess Complex Building,
Xiangyu F.T. Z., Xiamen, China.
C ution: Rx only.
Authorized EU Representative: Laerdal Medical AS,
Tanke Svilandsgate 30, .O. Box 377
4002 Stavanger, Norway. Tel. [phone].
Fax [phone]. E-mail:
Laerdal.norwa[email protected]
www.laerdal.com
The BAG, Laerdal, the Laerdal Logo, and “helping save lives” are all
trademarks of Laerdal Medical.
© 2007, Laerdal Medical AS.All rights reserved. RevB
(Shipped in cartons of 12 each)
Cat. no. 845011 Qty 1
Cat. no. 845021 Qty 1
Cat. no. 845031 Qty 1
Cat.no. 845041 Qty 1
The BAG Disposable Resuscitator,Adult w/Mask #5
The BAG Disposable Resuscitator, Child w/Mask #3
The BAG Disposable Resuscitator, Infant w/Mask #1
The BAG Disposable Resuscitator,Adult w/Mask #4
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Figure 1.The BAG configur tions nd p rts.
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Indic tions for Use
The BAG resuscitator is a self-inflating, manual resuscitator that is intended for patients requiring total or
intermittent ventilation support.The BAG resuscitator provides positive pressure ventilation and also allows
for spontaneous breathing either with an artificial airway or with a face mask (3)(a), (b) or (c).
C utions nd W rnings
• Resuscitators should only be used by persons who have received specific training in their use.
• When using supplemental oxygen, do not allow smoking or use unit near sparking equipment, open
flame, oil or other flammable chemicals.
• The BAG should not be used in toxic or hazardous atmospheres.
• Infant and Child units are equipped with a pressure-limiting device (2) which opens at a pressure of
approx. 35±5 cmH2O. However, an abrupt, high-volume manual breath may cause the unit to exceed this
level.The pressure relief valve can be overridden by depressing the plunger momentarily with light finger
pressure or locked in place by using the push-twist locking feature.
• The resuscitator is for single patient use only. Do not reuse. Do not sterilize.
• Use the appropriate resuscitator size (8)(a), (b) or (c).The wrong size can result in inadequate or
excessive air pressure being delivered to the patient. See the Performance and Specifications table for
sizing.
• When using supplemental oxygen, the flow from its source should be monitored. Delivery of
supplemental oxygen greater than 30 LPM (Liters Per Minute) may result in inadvertent positive
end expiratory pressure (P P).
• The use of third party products and oxygen delivery devices (e.g. filters and demand valves) with The
BAG Disposable Resuscitator may have an affect on product performance. Please consult with the
manufacturer of the third party device to verify compatibility withThe BAG and obtain information on
the possible performance changes.
Limited W rr nty
The BAG Disposable Resuscitator is warranted against defects in workmanship and materials only.
Please refer to the GlobalWarranty statement for additional terms and conditions (www.laerdal.com).
Pr ctic l Oper tion
1. Remove the resuscitator from the outer protective poly bag. xpand the Adult or Child resuscitator
from collapsed configuration to its operating position.
2. Inspect the unit to be sure the system is complete.
3. PRE-OPERATIVE FUNCTIONALTEST:
• Compress the ventilation bag (8) with one hand then release the grip on the bag. Rapid bag
re-expansion confirms efficient air intake.
• Block the patient valve/mask connector part and try to compress the bag. If the bag cannot be
compressed with reasonable force, the valve is efficiently preventing backward escape of air.
• Place a reservoir bag, (6) or (7), or test lung (if available) over the patient valve. Compress the
bag several times.This should fill the reservoir or test lung and confirm that the patient valve is
able to efficiently direct air to the patient.
• Compress the filled reservoir bag.Air should vent to the atmosphere as indicated by lifting of the
disk membrane at the base of the mask connector and not return to the ventilation bag (8).
4. PRESSURE RELIEF REGULATOR:The Infant and Child resuscitators feature a patient valve with a
special pressure limiting device (2) mounted on the upper valve housing. If inspiration meets with
pulmonary resistance of approximately 35±5 cmH2O, the device opens, reducing the risk of stomach
distension and / or barotrauma. A hissing sound can be heard when the device opens. If higher
ventilation pressure is required, the pressure limiting device can be overridden with finger pressure on
the plunger or disabled by depressing and turning the plunger.
5. If high concentrations of oxygen are needed, attach oxygen tubing (4) to the bag and an adjustable
oxygen source, and attach an oxygen reservoir bag (6) or (7) to the bag.
6. Adjust oxygen flow to insure the oxygen reservoir bag remains fully or partially inflated during use.
7. When using a mask (3) attached to the resuscitator, be sure you have a tight seal and secure fit.
8. When using an endotracheal tube or tracheotomy tube,remove mask (3) and attach the resuscitation unit
directly to the tube.The mask elbow provides a 15 mm I.D. port for this purpose.
9. HAND STRAP: Grab the bag with your hand.Adjust the hand strap (9) by loosening the loop from the
hook then pull the strap to fit your hand, and finally reattach the loop to the hook.
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Oper tion Instructions
If supplemental oxygen is needed, connect the oxygen source to the resuscitation bag oxygen connector.
1. Open patient’s airway.
2. Clear patients mouth of foreign matter.
3. Apply mask firmly to the face. If the patient is intubated, attach the patient valve connector
directly to the endotracheal tube. Squeeze and release the bag allowing enough time between
inspirations for the patient to exhale and the bag to re-expand. Follow local protocol.
4. Observe the rise and fall of the patient’s chest and listen for the air flow from the valve as the
patient exhales.
IMPORTANT: If the patient’s chest does not rise and fall with each breath or no airflow is present, the
patient’s airway or the patient valve itself may be blocked.
WARNING:TAK IMM DIAT ACTION by performing artificial respiration (mouth-to-mouth, mouth-to-
barrier, mouth-to-tube resuscitation) or follow local protocol.The airway must be cleared before proceeding.
Perform nce nd Specific tions1
Technic l Specific tions:
Operating nvironmental Temperature Limits: -18°C to +50°C
Storage nvironmental Temperature Limits: -40°C to +60°C
xpiratory Resistance: 1.8 cmH2O @ 50 LPM
Inspiratory Resistance: 1.5 cmH2O @ 50 LPM
PatientValve Dead Space: 6.8 ml
M teri ls List:
Dispos l: Dispose of according to local protocols.
Distributed in USA by: LA RDAL M DICAL CORPORATION, 167 Myers Corners Road,P.O. Box 1840,Wappingers Falls, NewYork 12590-8840.
Tel. [phone]. Fax [phone]. -mai: [email protected]
Distributed in Canada and Latin America by: LA RDAL M DICAL CANADA LTD.,151 Nashdene Rd., Unit #45.Toronto, ON, Canada,
MIV 4C3.Tel. [phone]. Fax. [phone]. Quebec [phone] -mail: sa[email protected]
Unique product reference. Manufacturing batch code. Do not reuse.
1Tested according to ISO 10651-4:2002 and ASTM-F920-93 product standards.
P rts M teri l
Face masks Polyvinylchloride (PVC)
Flexible valve parts Silicone Rubber (SI)
Compression bags Polyvinylchloride (PVC)
Transparent valve parts Polycarbonate (PC)
O2reservoir & O2tubing Polyvinylchloride (PVC)
Hand strap hook and loop Polypropylene
Symbols:
R SUSCITATOR MOD L ADULT (>20KG) CHILD (10-20KG) INFANT (5-12kg)
MAXIMUM RAT 85 BPM 144 BPM 180 BPM
D LIV R D TIDALVOLUM
(ON HAND R SUSCITATION) 830 ml 330ml 180 ml
PR SSUR R LI F VALV Not provided (Nominal)
35±5 cm H2O
(Nominal)
35±5 cm H2O
OXYG N CONC NTRATION %
FLOWRAT (LPM)
FR QU NCY (BPM)
TIDALVOLUM (ml)
% O2W/ R S RVOIR
% O2W/O R S RVOIR
3510
12 12 12
500 500 500
90% 98% 99%
34% 47% 66%
10
20
250
100%
70%
4
30
40
100%
85%
MAXIMUM M ASUR DVOLUM
BAG
R S RVOIR 1650ml
2900 ml
500 ml
2900 ml
230 ml
810 ml
English
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