BP5BB5LR_UMEN_V05-20170703
25
Device corresponds to the standards of USB (Universal Serial Bus)
Each device complies with the requirements of the EU Medical Devices Directive
0120 is the identifier of Notified Body (SGS UK)
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 Regulations 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 equipment.
IP22
Protection against environmental impact: First digit "2": Protected against mid-sized
solid objects (>12 mm). Second digit "2": Protected against splash (vertically in a
max. of 15 degrees). This protection refers only to BP5 and BB5.
SN
YYYY/nnnnn
Serial number. 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)
Blood pressure measurements determined with the algorithm of an ABPM-05, or a
BlueBP-05 recorder on adults are equivalent to those obtained by a trained observer
using the cuff/stethoscope auscultation method Korotkoff phase V, within the
limits prescribed by the American National Standard for Electronic or Automated
Sphygmomanometers. The algorithm used in ABPM-05 and BlueBP-05 also fulfills
the requirements of the British Hypertension Society Validation Protocol for
Automated Blood Pressure Measuring Devices.
