Oh dear, where to begin...
A quick look at these shows the round door knob common to a whole bunch of machines made in Ningbo (Runyes, Mingtai etc etc ) ....
About the only thing "B" class about them is the letter B is used in the user manual.
A few basic requirements of a B class autoclave made to EN 13060 standards are:
1. Temperature display to 0.1C resolution - Not present on the LED display (1C only)
2. Pressure display to 1kPA - LED display shows 2.1 bar, not 2.10
(These 2 might seem insignificant, but shows a lack of compliance)
3. The standard says the door must be locked BEFORE the commencement of the cycle. The first version of these had NO door lock, it merely latched closed & could be opened at various points during the cycle. Newer version of the Runyes has a pressure activated door lock, but thus it is still not locked before cycle or all the way through..
4. The units I looked at had no standards/approvals markings on various mains components like fuse holders / power switch etc. - SHould never pass electrical safety approval.
5. EN13060 requires that steam in the chamber be:
. within 2C between any 2 positions
. within 2c at any one point over the holding time
/ within 2c of 'ideal' or saturated steam at that pressure.
Again, units I tested for an importer a few years back did not meet any of these.
Temperatures as high as 145 were recorded in the chamber during sterilising.
This indicates BADLY superheated steam - inhibiting sterilisation....
The cause of this was twofold, the steam leaving the generator was superheated as they ran it too hot, as well as the jacket heater being on during the cycle at very high wall temps, heating the steam even higher.
Someone tried to 'fix' later ones by turning down the safety thermostat on the generator so it interrupted the heating at lower temps. Generally we saw this result in the Chamber temp falling to 132 or lower during sterilise
(with NO alarm generated, yet another point of non-compliance) .
The safety thermostat is also self reetting , not manual push button (again a fail) .
6. The vacuum test was not compliant with EN13060 (fail on 1.3 kPa leak in 10 min) it allowed 1.3 kPa PER min (10x normal) without failing.
I could go on and on, but I hope you get my point.
The original report I wrote on one of these ran to 3 pages , but could be summarised in one word. "DON'T"
As a company, we have refused to service, repair or validate these units, because I do not want my name on it when something goes wrong. Most reputable service companies in Australia are the same.
The other point to bear in mind is this: Many tattooists (& even a couple of dentists!) have bought these things off 'the bay of E' direct from China.
= No TGA registration >> no aprroval for human use in Australia (potentially a large fine & NO legal protection if ever in court)
= No Worksafe pressure vessel registration >> Big trouble if ever inspected.
= No Electrical approval in australia >> Again legal / insurance problems...
Quality doesnt come cheap. Dont get me wrong, Chinese manufacture can turn out some wonderful things at great pricing. But as far as this stuff goes, I have yet to see ANY of the that are acceptable, let alone 'good'
Oh, and to answer the original question on reliability, the material they use to seal the steam generator & the temps it runs at, basically ensures a breakdown every 6 months !
Rant over, hope I was of some help.
Autoclave / Sterilizer Advice
Re: Autoclave / Sterilizer Advice
Re: Autoclave / Sterilizer Advice
Linear Mode
