User manual

3
Important information on ABPM-05, ABPM-04 and BlueBP-05 systems. Read carefully,
please.
This symbol on a Meditech recorder is a warning that you should read
the accompanying documentation (this manual).
ABPM-05, ABPM-04 and BlueBP-05 ambulatory blood pressure monitors
and CardioVisions software are manufactured and developed by Meditech
Ltd. All title and copyrights in and to the CardioVisions software, the
accompanying electronic and printed materials and any copies of the
CardioVisions software are owned by Meditech Ltd. The CardioVisions
software is protected by copyright laws and international treaty provisions.
For details please read the software license agreement.
Contact details:
Meditech Ltd.
1184 Budapest, Mikszáth Kálmán utca 24., Hungary
Tel.: [phone]
Fax: [phone]
Mail: [e-mail]
Web: www.meditech.eu
Contact us for further product and service information. Meditech
Ltd. maintains a quality assurance system certified according to MSZ
EN ISO 9001:2008 and MSZ EN ISO 13485:2003.
Notified body: SGS Yarsley
Unit 202b, Worle Parkway, Weston-super-Mare, BS22 0WA
Fax: [phone]
Web: www.sgs.com
!
Always consult a physician for the interpretation of the blood pressure
measurements. Note that any blood pressure recording may be affected by
the body position, the physiological condition of the patient, and other
factors.
model
BP5, BP4 or BB5
Device type. (BP5= ABPM-05, BP4= ABPM-04, BB5= BlueBP-05)
Each device complies with the requirements of the EU Medical Devices
Directive. 0120 is the identifier of Notified Body (SGS Yarsley).
MDD IIa
MDD classification IIa. EMC class B. EMC group 1.
MDR II
According to Canadian regulations the device classification is MDR II.
(Medical Device Regulation of Canada, Rule 10.1 of MDR (SOR/98-
282:13Mar2007)).
The monitors are internally powered type CF devices. Protection vs. ingress
of water: none. Mode of operation: continuous. The devices are not
protected against defibrillators or other high frequency surgical equipments.
YYYY/nnnnnn
The first four digits of the serial number of a recorder show the year of
production. The rest is the serial number. For example: 2007/123456
This symbol shows that according to regulations the monitors should be
handled as electronic waste during rollout.
The device communicates via Bluetooth connection. (Bluetooth
V2.0+EDR, class2)