Home Articles Downloads Forum Products Services Seminar Contact
Previous Thread
Next Thread
Print Thread
Rate Thread
Page 4 of 5 1 2 3 4 5
Re: CME T34 Internal Battery
Andrew Stallard #74087 13/03/19 5:56 PM
Joined: Aug 2008
Posts: 76
Likes: 1
Adept
Offline
Adept
Joined: Aug 2008
Posts: 76
Likes: 1
If we go one step further would you state using a flowmeter nipple for Ohmeda on a Therapy equipment flowmeter would be a modification if so the world has gone mad considering they are the same size/threads.

Re: CME T34 Internal Battery
billy11 #74088 13/03/19 7:26 PM
Joined: Feb 2004
Posts: 14,193
Likes: 15
Super Hero
Offline
Super Hero
Joined: Feb 2004
Posts: 14,193
Likes: 15

I'm sure we could all come up with a hundred such examples, Billy. smile

If the NHS supplies organisation (whatever it's called these days) was properly organised, biomeds would be able to request parts from the Hospital Stores and they would be left to source the parts (carry the can, take the blame, procure the parts quickly and cheaply ... whatever).

Perhaps one day some Genius will amaze everybody by coming up with an idea called "economies of scale" - and start off by buying the batteries in question as a job lot from Panasonic and holding them against a stock number in Central Stores!

Meanwhile, those of us outside of the NHS shall no doubt carry on following Good Engineering Practices (aka Common Sense) aimed at meeting customers' expectations in a timely, cost effective and efficient manner! whistle


If you don't inspect ... don't expect.
Re: CME T34 Internal Battery
Andrew Stallard #74089 14/03/19 9:27 AM
Joined: Jan 2010
Posts: 73
Scholar
Offline
Scholar
Joined: Jan 2010
Posts: 73
For those worried about using non OEM parts, here is a link to "Managing Medical Devices" from the MHRA on the Gov.UK website

https://www.gov.uk/government/publications/managing-medical-devices

relevant quote

"To ensure that replacement parts are of the correct specification, purchase them
either directly from the manufacturer or to the same specification.
When obtaining replacement spare parts from sources other than the manufacturer,
you must take care to ensure that all aspects of the technical specification are met,
including, for example: physical dimensions, material strength, mechanical properties
and compatibility.
Any agreements to supply parts from sources other than those recommended by the
manufacturer should be properly risk assessed, costed and documented, before a
decision is made to buy them."

Re: CME T34 Internal Battery
Andrew Stallard #74090 14/03/19 9:36 AM
Joined: Feb 2007
Posts: 263
Likes: 6
Master
Offline
Master
Joined: Feb 2007
Posts: 263
Likes: 6
The key point here is ""ensure all aspects of the technical specification are met". So unless the manufacturer has provided you with the full specification and any testing they perform then you do not meet the requirements.

Also did you cost in all your time into the equation? This is not just the time you spend finding the part but all the documentation and testing to ensure you fulfil all the requirements. In the end it is just cheaper to buy from the manufacturer! Better to spend the time negotiating a good price! As I said the role of EBME is evolving so embrace the change!

Re: CME T34 Internal Battery
Andrew Stallard #74091 14/03/19 9:58 AM
Joined: Feb 2007
Posts: 263
Likes: 6
Master
Offline
Master
Joined: Feb 2007
Posts: 263
Likes: 6
An interesting point further down in the MHRA document is:
Quote
An organisation could be held responsible under health and safety law and civil liability in the event that a patient or member of personnel died or suffered personal injury or damage as a result of inappropriate replacement of batteries.
I know of a fire started in a hospital due to a battery fault in a laptop on test after repair. It resulted in damage to equipment costing them over £600,000! Should make you think about the savings you thought you made!

Re: CME T34 Internal Battery
Andrew Stallard #74092 14/03/19 10:13 AM
Joined: Jan 2010
Posts: 73
Scholar
Offline
Scholar
Joined: Jan 2010
Posts: 73
MikeX, do you have a role within an OEM by any chance? Or is it that you are so risk adverse that you do not think that a Bio med should do anything?

The risk of a battery fire ( note, on a laptop, not a medical device) is always there, a cmos support battery carrying 35mAhr is not a major risk of fire in my experience ( I used to design and develop batteries for the Navy).

Risk assessment has replaced common sense, they should be the same, but one comes with a form to back up your thinking.

Re: CME T34 Internal Battery
Andrew Stallard #74093 14/03/19 10:29 AM
Joined: Dec 2003
Posts: 16
Novice
OP Offline
Novice
Joined: Dec 2003
Posts: 16
With regards to non-OEM....

In this particular case, the battery is third-party in the first place. It's a Panasonic CR1220/FCN.
As long as that is the part being sourced from another supplier (as is the purpose of this thread), then there is no modification involved.

Slightly different, I guess, for parts made exclusively for a device.

Re: CME T34 Internal Battery
Andrew Stallard #74094 14/03/19 10:39 AM
Joined: Feb 2007
Posts: 263
Likes: 6
Master
Offline
Master
Joined: Feb 2007
Posts: 263
Likes: 6
Originally Posted by Andrew Stallard
In this particular case, the battery is third-party in the first place. It's a Panasonic CR1220/FCN.
As long as that is the part being sourced from another supplier (as is the purpose of this thread), then there is no modification involved.
This may not be true, as the medical device manufacturer may perform their own testing of the part to ensure it meets the required specification.

I know of a case where a potentiometer was replaced with one of exactly the same model as the original part (same make and part number) but this caused subsequent errors. It turned out the part supplied by the manufacturer had been selected by testing to meet stricter linearity requirements than the pot manufacturer specifications. In other words, from a batch of 100 pots only half were deemed to meet the required specification. This is a common industry practice.

Re: CME T34 Internal Battery
Andrew Stallard #74095 14/03/19 11:06 AM
Joined: Jan 2010
Posts: 73
Scholar
Offline
Scholar
Joined: Jan 2010
Posts: 73
How would you select on test a primary cell, to test it would deplete a battery, rendering it useless.

Re: CME T34 Internal Battery
Mithrandir #74096 14/03/19 11:17 AM
Joined: Feb 2007
Posts: 263
Likes: 6
Master
Offline
Master
Joined: Feb 2007
Posts: 263
Likes: 6
Originally Posted by Mithrandir
How would you select on test a primary cell, to test it would deplete a battery, rendering it useless.
Clutching at straws now? Well, you could measure the internal impedance (by applying short current discharge pules).
However, if a manufacturer specified you could only use primary cells supplied by them, I would have never considered purchasing such devices, unless the total cost of ownership matched or beat other equivalent devices.

Page 4 of 5 1 2 3 4 5

Moderated by  DaveC in Oz, RoJo 

Link Copied to Clipboard
Who's Online Now
6 members (mart, Huw, Dustcap, Malcolm, John Sandham, Angus), 546 guests, and 15 robots.
Key: Admin, Global Mod, Mod
Newest Members
hectorja, by3xxx, Nguyen Trinh, bergeng, willis
9741 Registered Users
Forum Statistics
Forums25
Topics10,639
Posts71,911
Members9,741
Most Online5,980
Jan 29th, 2020
Powered by UBB.threads™ PHP Forum Software 7.7.4