Resuscitator Specifications:
Body Mass Range
>40kg (Adult)
Operating Environmental Limits
-18° C to 50°C
Storage Environmental Limits
-40° C to 60°C
Exhalation Port
30mm
Patient Connection
15mm I.D. x 22mm O.D.
Maximum Bag Volume
1200mL
Delivered Volume Range
(1 hand) 530mL (2 hand) 690mL
Deadspace (without mask)
9.6mL
Backward and Forward Leakage
Negligible
Expiratory Resistance
< 5 cm H2O (0.5kPa) @ 50LPM
Inspiratory Resistance
< 5 cm H2O (0.5kPa) @ 50LPM
Resuscitator External Dimensions
301mm length/116mm diameter
Resuscitator Mass (w/o mask)
373 g
Delivered Oxygen Concentration (%) Average Values:
Oxygen Flow Rate
•
Frequency (12 BPM)
•
Tidal Volume (600mL)
5
10
15
Oxygen Concentration:
Standard
71
91
94
Activated
60
63
64
INTENDED USE FOR ADJUSTABLE PEEP VALVE:
•
The postive end expiratory pressure (PEEP) valve is designed to be used in
conjunction with a manual resuscitation bag exhalation port to allow the user to
select positive end expiratory pressure from 5 to 20cm H2O. Attachment of this
valve requires no modification to either the resuscitator or valve. If PEEP is not
desired, remove PEEP valve.
CAUTIONS:
•
This product must only be used by qualified personnel in the techniques of
pulmonary resuscitation.
•
During use, the patient’s condition must be monitored.
•
This product is not intended to be disassembled by the user; disassembly may
result in improper valve function.
WARNINGS:
•
PEEP may produce adverse effects. Close observation and reliable assessments
are essential when using PEEP in patients with low circulatory blood volume,
impaired cardiac function, bullous lung disease or higher than normal lung
compliance. Assess the patient’s hemodynamic, ventilatory, and oxygenation
status whenever using PEEP.
•
Use of sterilization or cleaning solutions may leave this product nonfunctional.
•
This product is a one-way valve intended for respiratory use only and must not
be used on anesthesia circuits.
•
Do not use PEEP valve if it becomes occluded. An occluded PEEP valve obstruct
patient’s exhalation and result in potential injury. Remove valve from exhalation
port and discard.
•
Do not use PEEP unless you are qualified in the indications, benefits, side effects,
contraindications, and goals of PEEP therapy.
•
Do not use PEEP unless pressure is verified with a manometer.
DIRECTIONS FOR USE:
1.
Prior to use, check to be sure the device is free of obstructions and verify proper
valve function.
2.
Firmly seat the valve onto the resuscitation bag exhalation port.
3.
The valve is furnished with graduations at approximate PEEP levels of 5, 10, 15,
and 20cm H2O. Using a manometer, verify PEEP settings prior to use.
4.
Adjust the cap on the PEEP valve to acheive the desired PEEP levels. Clockwise
rotation will increase PEEP levels.
5.
Observe the position below cap of the indicator markings in relation to the
pressure scale label to determine the approximate amount of PEEP being gener-
ated. Actual PEEP may vary with patient lung compliance and resistance. Verify
pressure with a manometer.
6.
If PEEP valve becomes occluded, remove from exhalation port and discard. A
new PEEP valve can be readily attached to exhalation port.
7.
Discard valve after use.
INTENDED USE FOR DISPOSABLE PRESSURE MANOMETER:
To provide visual indication of a patient’s airway pressure during ventilation. It may be attached to
the manometer port of proximal port on ventilation devices such as resuscitation bags, hyperinfla-
tion bags, CPAP masks, or CPAP circuits.
INSTRUCTIONS:
1.
Attach the manometer with its flexible connector onto the device’s manometer port.
2.
Occlude the patient port on the attached device and pressurize the manometer to maximum
scale reading on the manometer.
3.
Release the pressure and check that the float returns smoothly back to “0” cm H2O mark.
4.
Attach the system to the patient and monitor the patient to assure proper ventilation.
5.
For a point of reference, set the “O” ring to be approximately at the desired pressure reading.
6.
When repeated use is requiredfor the same patient, check the function and accuracy of the
manmeter prior to each use.
7.
Discard after use.
WARNINGS:
•
For single patient use. Do not clean or sterilize as this may affect the accuracy or function of
the manometer.
•
Check function and accuracy prior to each use, including when repeated use is required for
the same patient.
•
A minimal amount of leakage of ariway gas is normal. The effects of this leakage must be
evaluated for each patient.
CAUTIONS:
•
This device must be used only by qualified personnel in the techniques of pulmonary resus-
citationor airway management.
•
During use, the patient’s condition must be monitored. Should the performance of this de-
vice appear to be erratic during use, the device must be removed and replaced as required.
MANOMETER ACCURACY:
±1 cm H2O from 0-10 cm H2O
±2 cm H2O from 10-40 cm H2O
±3 cm H2O from above 40 cm H2O
OPTIONAL ACCESSORIES:
•
PEEP VALVE
•
DISPOSABLE PRESSURE MANOMETER
•
FILTER
INTENDED USE FOR FILTER (AERO-PRO COMPACT STRAIGHT):
This Depth Filter is designed for use with ventilators, anesthesia machines and open flow systems
where filtration of inspired and/or expired gases is desired.
Product Specifications and Information are listed in the table below.
Set Up:
1.
Place the Filter in the circuit in the desired location, at the machine end, connected to the
Inspiratory outlet and/or expiratory inlet, or between the artificial airway and the proximal
breathing circuit.
2.
Attach gas sampling line to luer port, if present.
3.
Ensure connections are secure.
4.
Check for airflow and function as part of circuit checkout procedure prior to use.
Cautions:
1.
Do not resterilize, soak, rinse or reuse.
2.
Ensure all connections are secure at all times.
3.
Replace unit immediately if there is any contamination, occlusion or any indication of
malfunction.
4.
The dead space of this product should be taken into consideration when determining tidal
volume and patient ventilation requirements.
5.
Dispose of properly.
6.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Warnings:
•
Replace Filter at least every 24 hours or earlier if increased resistance is noted.
Contraindications:
1.
Filter should not be used in the proximal airway with patients producing fulminating frothy
secretions within their airways, or patients with hemoptysis.
2.
Do not use in conjunction with conventional humidifiers.
3.
Do not add moisture to the Filter.
4.
During delivery of inhaled medication the Filter should be removed or bypassed.
Product
Resistance to Flow
(cmH2O @ L/min)
Dead
Space (mL)
Weight
(g)
Bacterial
Efficiency
Viral
Efficiency
Tidal Volume
(mL)
Aero-Pro Compact
Straight
2.0 @ 60
31.5
23.7
99.999
99.99
150-1000
SELECT VALVE POSITIONS:
STANDARD
ACTIVATED
STANDARD: The valve has no restriction and is acting as
an unrestricted BVM.
ACTIVATED: The valve is restricted to produce a con-
trolled tidal volume and timed refill.
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