| Clause |
Outline/Key Points |
Comment/Discussion |
5 Connectors
5.1 Patient Connectors |
The patient connection ports of a resuscitator
shall have a 15mm female fitting and a 22mm male fitting. These
fittings must comply with AS 2496 Breathing Attachments for anaesthetic
purposes for human use |
This is so that an Endotracheal Tube or similar
invasive type of airway support will connect to the 15mm female as well as
face masks will connect to the 22mm male fitting. |
6.2 Dismantling and reassembly
of valves |
This clause states that the device should be
easily reassembled in the correct order so it will work properly. It
should not be able to be assembled incorrectly. A diagram should be
provided stating number and order of assembly. |
This is to prevent incorrect performance. Its
also important to note that valves should not be disassembled by untrained
people. |
| 6.6 Bag refill Valves |
Bag Refill Valves shall not have a provision for
manual operation. |
This is to prevent a situation where the button
or lever on a demand valve being used as a bag refill valve is
accidentally activated and the gas flows through the valve into a Bag
Valve Mask and into the patient. |
| 8.1.1.2 Gas Powered resuscitators |
An oxygen concentration of at least 85% oxygen
must be delivered |
|
| 8.3 Expiratory Resistance |
The clause states a resistance of no more than
5cmH2O is allowed |
Each and every single unit that leaves our workshop is
tested for this. |
| 8.4
Inspiratory Resistance |
The pressure shall not be below -5cmH2O |
Each and every single unit that leaves our
workshop is tested for this. |
| 8.7 Apparatus dead space |
The device when tested according to the correct
method shall not have a dead space of more than 5ml plus 10% of the tidal
volume specified for the class of the resuscitator |
The importance of this clause to the user is
that if a resuscitator is altered via long extension tubes etc. It may be
rendered as non compliant to the standard. |
| 8.8.1 Tidal Volume |
When intended for use with children and
infants resuscitators shall be grouped according to body weight
based on 15ml per Kilogram. All devices that deliver a tidal volume
of 600ml and over shall be for adults
|
This makes it almost impossible to say a demand
valve is compliant for a child. Because young lungs very are fragile
we will not recommend a demand valve for them. We generally advise a
manually powered child BVM be carried in all resuscitators. All
demand valves with child settings should probably be removed from service
unless they are specifically designed for infants and children alone and
are volume sensitive and not only flow adjustments.
|
8.9 Gas-powered resuscitators
8.9.1 Pressure-limiting system |
This clause states that the airway pressure
shall not exceed 60cmH20. And and an audible or physical warning should occur
when the pressure-limiting device activates.
|
All units leaving our facility are individually
checked for this performance. It is one of the tests that must be
carried out on a frequent basis and recorded. |
| 8.9.2 Inspiratory flow |
Shall be capable of delivering a flow in the
range of 40L/min to 60L/min against a backpressure of 2kPa when the device
is activated by a trigger or button. Plus they must be able to provide at
least 100L/min if the patient breaths spontaneously. |
This is another test that should be done
frequently. Unfortunately it requires specialised equipment.
See our section on
Test Equipment click to jump there. |
|

Robert Shaw
|
The demand valve on the left is a Robert Shaw
head which flows up to 160L/min on trigger activation. This does not meet the
standard and should be replaced. Some units are restricted to 40
L/min and as such do not meet the "on demand" element of the
standard.
The unit on the right is an MTV this meets the standard and has multiple
safety features above the standard requirements. It flows at 40L/min
on trigger/button activation. It supplies 100+L/min on patient
demand.
|

MTV
|
8.10 Demand valves
8.10.1 Pressure for initiation |
The maximum negative pressure required to
initiate a gas flow shall be no more than -2cmH20
|
This is another test that should be done
frequently. Every unit leaving our facility is tested for
this. The reason for this performance requirement is to ensure a
patient does not have to struggle to initiate flow if they have weak
inspiratory strength. Eg. They do not have to suck to hard! |
| 8.10.2 Peak inspiratory flow |
Minimum peak inspiratory flow when demanded by
the patient, not by the operator shall be at least 100L/min when a
negative pressure of -8cmH20 is applied |
This another test that should be done
frequently. Every unit leaving our facility is tested for
this. This standard exists to ensure a patient can get the flow they
require without finding resistance at the peak portion of the inspiratory
wave. |
 |
The control system on the left is designed to
limit the flow for children on trigger activation. However, not only
does it not allow at least 100L/min in demand, it does not limit the tidal
volume to that which is specified for children. |
These type of controls are used on Robert Shaw
heads in some older resuscitators and as such do not comply. |
| 8.10.3 Termination pressure |
The demand valve shall stop flow when the
sensing device is at ambient atmospheric pressure |
This is to prevent a slow constant flow. This
another test that should be done frequently. Every unit leaving our
facility is tested for this. |
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If you have any questions please do not hesitate to give us a call or drop
us an email click here to go to our contacts
page. |
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