How to Design a Protective System for Infusion Pump

Peter Selvey

Staff member
Super Moderator
#11
1st and 2nd alarm is my own terms from testing.

At 1st alarm, pump must continue to operate (alarm 30 minutes before i.e. 30分前止). This is to allow time to arrange new pump or power supply.

At 2nd alarm, pump should stop, but alarm must continue for at least 3 min.

For this alarm, the sound should continue until manually stopped, or the battery "life" is gone. What they mean is, do not use a timer to terminate the alarm (e.g. 3 minute timer). Allow the alarm to continue as much as possible. It is still OK to terminate the 2nd alarm alarm if battery voltage goes below a certain point, e.g. to prevent battery damage, as long as >3 min is provided.
 
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Roland chung

Trusted Information Resource
#12
I indeed got your point but still confuse the standard.

After reading the standard word by word, I think the 3 min of 2nd alarm (infusion stop) is naturally included in the 30 min of 1st alarm since the alarm 30 min is also before delivery ceases. That said the reference point for both alarms is delivery ceases. The total alarm duration is 30 min, but not 33 min (30+3 min).
 

Peter Selvey

Staff member
Super Moderator
#13
It's a good idea to have the stopping point as a reference.

But I think it is 33 mins, not 30.

Start of 1st alarm is >=30 min before stopping.

Start of 2nd alarm is >=3 min before battery life ends.

Standard also says at start of 2nd alarm, delivery must stop: "At least 3 min before the end of the battery life the EQUIPMENT shall give an audible and visible alarm and cease delivery"

So, 2nd alarm is >3min after stopping.

Thus, total alarm time is 30 min before + 3 min after, i.e. >= 33 min.
 

Roland chung

Trusted Information Resource
#15
Hi Peter,

One more question I want to ask is related to the clause 50.106 (bolus test).

The bolus test is indeed simple. But I could not understand the statement of management of the test result very well. Could you help to clarify it by giving an example? Thanks

Calculate the mean and the percentage deviation from the set value. Select the deliveries with the maximum positive and maximum negative deviations from the set value. Express these as percentage deviations from the set value.
 

Peter Selvey

Staff member
Super Moderator
#16
First we should confirm we are talking about an intentional bolus, not unintentional bolus from occlusion.

For an intentional bolus, you need to measure the data in Clause 50.106, and then declare it in the instruction manual, as per 6.8.2 a) 25).

So for example a set bolus of 5ml, test result was average 5.6ml (+12%), with min 4.0 (-20%), and max 6.2 (+24%), then you need to put those figures in the instruction manual (i.e. declared performance).
 

Roland chung

Trusted Information Resource
#17
Yes, the pump has facility for delivering bolus manually. The volume of a manual bolus is determined by the duration of a key press by the user (only bolus rate can be set). Bolus delivery requires a 'background' infusion to be in progress. That means bolus cannot be delivered while the pump is stopped.

The bolus accuracy is not good since the manual technique is dependent on user skill.
 

Peter Selvey

Staff member
Super Moderator
#18
I have a memory (a few years ago now) about this problem, the standard does not really cover the situation. If my memory is correct, the test was just adapted to the situation.

For example, if the "bolus" function just means a higher rate whenever the "Bolus" button is pressed, one assumes that the user is still provided with feedback about the bolus volume. So, the test is modified to check how accurate that feedback is.
 

Roland chung

Trusted Information Resource
#19
I would think the bolus test in cl. 50.106 is just suitable for the 'automatic' bolus delivery. It does make less sense to test the manual mode since such results could become irreproducible.

But I can not find any changes in the FprEN 60601-2-24:2009.
 

Peter Selvey

Staff member
Super Moderator
#20
Why are the results not reproducible?

Can you give some example?

No matter what the situation, it is always possible to find some clinical parameter (e.g. bolus volume) which the user wants to control by some means (e.g. by display feedback of delivered volume).

A manually delivered bolus might be rough (not be very accurate, say +/-20% of display value) but this may be good enough for the clinical purpose.

Even so, it is still necessary to know how rough it is, confirm it fits the clinical purpose (MDD ER 12.8.1), and then declare it in the manual.
 
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