SBS - The best value in QMS software

Alarm “AUDIO PAUSED” of infant incubator

william guo

Starting to get Involved
#1
Hello experts,
A question about the AUDIO PAUSED requirements in IEC 60601-2-19, which requires that "the audio paused for an infant incubator warming up from cold condition may be up to 30 min", how do I measure the time under this audio paused condition, or how this condition canbe simulated?
BR
William Guo
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#2
I am not familiar with that particular standard. My experience with other particular standards informs what follows in this post.

Presumably, there is an ALARM CONDITION for 'cold' that would trigger ALARM SIGNALS, including an audible component. My guess is that this particular standard is is acceptable to allow the audible component of the ALARM SIGNAL to be AUDIO PAUSED while the incubator warms up, but no longer than 30 minutes.

My naive expectation is that when an incubator is first turned on, that it generates an ALARM SIGNAL because of the ALARM CONDITION that it is not warming the infant. Presumably an operator can pause the audible part of the ALARM SIGNAL, but for no longer than 30 minutes. If so, then I can think of a couple of test cases:

1) Standard operation: turn on the device and see that the ALARM CONDITION clears prior to 30 minutes (subject to whatever alarm latching is in the particular standard)

2) Challenge test of AUDIO PAUSE: Turn on device but defeat the 30 minute warm-up (using dry ice? Keeping the lid open? Disconnecting the warming element?). After pausing the audio, make sure that the audible part of the ALARM SIGNAL is heard prior to 30 minutes.
 

Peter Selvey

Staff member
Moderator
#3
Just to add some more detail:
There is an technical alarm in -2-19 if the measured temperature is not inside the control band (±3°C) after steady state is achieved. This would be the main alarm that needs to be paused up to 30min to allow for warm up. Also there are alarms if the baby sensor is disconnected, again which might occur during warm up as the nurse is organising the infant.

I personally would first look at the algorithm in the software to see how COLD CONDITION is determined, and then develop challenge conditions based on that to test various key aspects. It's important not only to test the 30min pause in warm up, but that there is no normal condition might also trigger the same 30min pause even after the system is warmed up. For example, if the incubator is moved from one room to the next, power supply is briefly interrupted, does the software see this as cold condition? If yes, it's a mistake.
 

william guo

Starting to get Involved
#4
Hi Tidge and Perter,
thanks for your inputs. -2-19 refer the definition of "COLD CONDITION" to the general standard, which is "condition obtained if electrical equipment is de-energized for a sufficiently long time to attain the ambient temperature".
I think the case sequence maybe
1) the infant incubator is working normally and achieved a stable temperature condition
2) An alarm conditions occurred such as fan stop or high temperature
3) the incibator detected the alarm condition and generated an audio and visual alarm, simultaneously, the power of the heater was cut off.
4) the healthcare person response to the alarm and takes some actions with a deliberate "audio paused"
5) Alarm condition cleared and the incubator starts to warm up
Question is, how the requirements of max. 30min audio paused time from warm up apply? because only if the alarm condition was cleared, the incubator can warm up, may be from the "COLD CONDITION".
BR
William
 

Peter Selvey

Staff member
Moderator
#5
The example doesn't really work since it's a hardware fault that probably needs the infant transferred to a new incubator (the fan in a normal incubator is not easily accessible especially while the infant is in there).

I expect it's not too hard to differentiate between conditions to decide when the 30min pause is OK. For example, modern systems usually have non-volatile RAM which can be used to tell the difference between a normal power off and a power interruption, and most systems would have real time clocks that can tell how long the interruption is as well as sensors to assess if everything has cooled down. With all that information, it shouldn't be too hard to develop an algorithm that makes sense, i.e. find the balance between minimizing false alarms while maximizing the alarm when needed.

It's not a perfect solution and even 30 min is a little arbitrary. The point is that simplistic software solutions such as power off (whatever reason) = cold condition = 30 min alarm pause would be wrong since there are low cost solutions that are better.

In reality, the audio pause is intended for warm up while the infant is not in there which is the normal way, you don't put the infant in while the incubator is just turned on). So an more ideal solution might be to use the incubators scales to tell if the incubator is empty or not :)
 
Thread starter Similar threads Forum Replies Date
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
M Markings for alarm mute button IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
P Obstruction alarm requirement ISO 80601-2-12 Other Medical Device Related Standards 1
I Cleanroom Actions in case of Actions Limit Alarm Qualification and Validation (including 21 CFR Part 11) 3
V Colour of indication for ALARM SIGNAL inactivation states IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
shimonv IEC 60601-1-8 - When does an error message become an alarm signal? IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
M Infusion Pump Power Failure Alarm IEC 60601-2-24 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Does anybody know in which Standard can this attached Alarm Symbol be found? Other Medical Device Related Standards 3
R Who is regulating Security Alarm Codes? Coffee Break and Water Cooler Discussions 8
O Upcoming IEC/ISO standard on "Distributed alarm systems" (80001-2-5) Medical Information Technology, Medical Software and Health Informatics 6
S MDD 93/42 Annex I 12.3 - Medical Device Electrical Alarm Requirements EU Medical Device Regulations 3
M AS 4706 (Personal Response Systems) & AS 3811 (Patient Alarm Systems) Equivalents? Other ISO and International Standards and European Regulations 4
Q Scope of Certification is Ringing Alarm Bells ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A How to set Wirebond Alarm Limit? Statistical Analysis Tools, Techniques and SPC 2
M IEC EN 60601-1-8: Battery monitor considered an alarm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
C IEC EN 60601-1-8: What defines a visual alarm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Volume of Alarm Signal per IEC 60601-1-8 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J About the Intelligent Alarm System in IEC60601-1-8 (Anaesthetic Systems) IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
M IEC 60601-1-8 2006 Alarm Auditory Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Boss' Alarm Funny Stuff - Jokes and Humour 0
T Control Chart on Paper vs. Software where trend cannot be seen (Alarm only) Statistical Analysis Tools, Techniques and SPC 8
B Opinions on Zone Alarm Internet Security Suite After Work and Weekend Discussion Topics 2
C NFPA 72 and NFPA 72 Standards - Electrical Installation and Fire Alarm Systems Various Other Specifications, Standards, and related Requirements 3
D Training for IEC 60601-1-8:2006 Alarm Systems in Medical equipment. IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
H Recommendation for a Planning tool which gives an Alarm at Specific Time & Others. Quality Tools, Improvement and Analysis 5
P MSA Attribute Studies - Calculate Cross Tabs, Effectiveness, Miss Rate, False Alarm Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
F Risk + Disaster Assessment, Fire Alarm, etc. - Records Management Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Jen Kirley Formatting an Excel .xls spreadsheet to alarm out-of-calibration status Excel .xls Spreadsheet Templates and Tools 11
N Effectiveness, miss rate and false alarm rate - Need formulas to calculate Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
P Miss rate & False Alarm Rate - What are they and how are they calculated? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
Marc How Lucas Modernised Audio in Film After Work and Weekend Discussion Topics 0
S Do you use audio-visual streaming during FDA inspection? US Food and Drug Administration (FDA) 3
C Audio Transducer as Class I Medical Device EU Medical Device Regulations 2
S Quality / 9001/ Six Sigma Audio CD Recommendations? Training - Internal, External, Online and Distance Learning 1
B What directive applies? Audio/Visual Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
B Audio Cable Classification - Class 2 wiring for the speaker outputs TL 9000 Telecommunications Standard and QuEST 11
S Computer Screen Video Capture and Recording Software with Audio After Work and Weekend Discussion Topics 5
G FMEA Severity Ranking for an Automotive Audio System FMEA and Control Plans 9
H Does Welding of the Metal Housings for Audio Equipment Need Validation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Sony Music Audio CD Anti-Piracy Software Triggers Uproar World News 5
Marc Streaming Audio on the Internet - 10 Years Old - Real Audio After Work and Weekend Discussion Topics 0
C Six Sigma Defects per Unit (DPU) - Manufacture Of Computer And Audio Parts Assembling Six Sigma 2

Similar threads

Top Bottom