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2.4 Manufacturer’s declaration
Manufacturer:
I.E.M. GmbH
Cockerillstraße 69
52222 Stolberg, Germany
I.E.M. GmbH declares that the product type designation: "Sta-
bilograph mobil
®
"is in accordance with the relevant provisions
of Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices and Council Directive 1999/5/EC of 9 March
1999 concerning telecommunications terminal equipment.
Stolberg, August 2010,
I.E.M. GmbH
Attention
: BodyTel Europe GmbH markets the product
StabiloGraph™
®
- mobil
under the name of
PressureTel™
.
Measuring accuracy
The measuring accuracy is in accordance with the
regulations of the European Society of Hypertension
(ESH) and the British Hypertension Society (BHS).
Compatibility and costs
PressureTel
™
can only be used with
compatible mobile
phones
. A list containing those phones can be found on
www.bodytel.com.
To always transmit measured values and manually entered
events to your patient file, you either can use a WLAN or you
need to use the
mobile internet
. In that case please make
sure you have access to this service and check your mobile
phone plan for related costs. Maybe consider a data plan.
2 General
