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#21215 30/09/04 10:51 AM
Joined: Dec 2001
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Sage
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Posts: 391
Only if you've got 8 fingers Adrian. eek
OVE and HAT just don't have the same meaning

Roy, would you register as a can of beans going thru the checkout at Tescos later in life


Why worry, Be happy!
#21216 01/10/04 2:13 PM
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Scholar
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The UK suppliers for the Revolution are now: Mentor Medical Systems Ltd.,
The Woolpack,
Church Street,
Wantage,
Oxon,
OX12 8BL
Tel: 01235 768758
Fax: 01235 768780

As you rightly state these do not conform to current standards relating to medical equipment and require modification prior to use.


Solihull Hospital
University Hospitals Birmingham
#21217 15/10/04 2:38 PM
Joined: Mar 2003
Posts: 61
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New Tattoo/Micropigmentation Machine Supplier
At NATN this week the company Finishing Touches (SPMU) Ltd showed a CE marked German made machine called Precision Plus that would appear to meet the clinical & safety requirements for this type of device. As this is a hard to find item you might want to make a special note of the details. Contact info:
Alison Doughty - Tel 0845 2301210/1310 Fax 0870 3501410 email info@wakeupwithmakeup.co.uk

#21218 15/10/04 3:51 PM
Joined: May 2004
Posts: 39
Visionary
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Visionary
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Posts: 39
Thanks for the info Paul will investigate smile

#21219 15/10/04 4:42 PM
Joined: Aug 2001
Posts: 150
Mentor
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This probably a silly question, but please enlighten us. Just why are tattoo machines required in a hospital environment?

#21220 15/10/04 5:21 PM
Joined: Dec 2002
Posts: 171
Mentor
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Paul.

They are used by plastic surgeons to give ladies who have had major breast surgery the appearance of a nipple surround (sorry forget the proper anatomical term for that bit, even though it is rather an interesting part).
Also used to reduce appearance of scarring.

Marc.

#21221 21/12/04 4:31 PM
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Posts: 90
Adept
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Our Trust is also looking to purchase one of these. I've a PPQ form for the Precision Plus from Finishing Touches but it's not CE marked for the Medical Devices Directive - only for the EMC Directive. Has anyone any ifo on an alternative?. What are others doing as our surgeon say the use of these is common practice?
Thanks
Graham

#21222 03/02/05 2:45 PM
Joined: Feb 2003
Posts: 380
Sage
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Our plastics team is currently after one of these and suggested Eurosurgical (01483 456007. They claim to supply a micropigmentation dermabrasion (tattoo) machine which is CE marked to the MDD.

They have sent me a PPQ which claims to be a Class IIa machine and indeed CE marked to the MDD with the Notified Body no 0535. I have asked for a copy of the CE Certificate of Conformance which they are getting from the German manufacturer (Polytech Silimed Europe GmbH)

Cost of machine is around £3,500

#21223 03/02/05 5:58 PM
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Thanks. Our surgeons are purchasing one from Finishing Touches which is not CE marked for compliance with the Medical Devices Directive. Interestingly I contacted the MHRA for guidance re using something not CE marked and was advised that this was a cosmetic procedure and therefore outside the scope of the Directive. I wonder how much other cosmetic surgery the same logic could be applied to.

#21224 07/02/05 10:32 AM
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What are MHRA playing at? It is being used on a patient within a patient environment! Surely the patient and the Trust need some assurances that the equipment being used meets a minimum level of safety, obviously not in the eyes of MHRA.

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