Meditech ABPM-04 User Manual page 2

This symbol on the device is a warning that you should read the accompanying
documentation (this manual).
ABPM-04 is manufactured by
Mail: H-1701 Kispest, POB 27, Hungary
E-mail: meditech@meditech.hu
Our representative in the European Union
Mail: 76124 Norrtälje, POB 380, Sweden
E-mail: info@meditech-sweden.se
Contact us on any address given above for further product and service information.
• Do not apply ambulatory blood pressure monitoring devices to unconscious or
!
otherwise incapable patients, or patients with coagulation disturbances.
• Do not apply ambulatory blood pressure monitoring devices to patients with serious
mobility or other impairments without supervision.
• Though ABPM-04 has been validated to function properly with patients with atrial
fibrillation or other common arrhythmias, the oscillometric blood pressure
measurement method is generally recommended for use only with special caution in
patients with arrhythmias, Parkinson's disease, or other diseases with tremor.
• Always consult a physician for interpretation of blood pressure measurements. Note
that any blood pressure recording may be affected by body position, the physiological
condition of the patient, and other factors.
ABPM-04 complies with the requirements of the EU Medical Devices Directive
(93/42 EEC). MDD classification IIa. EMC class A. EMC group not applicable.
ABPM-04 is an internally powered type CF device.
Protection vs. ingress of water: ordinary. Mode of operation: continuous.
Blood pressure measurements determined with Meditech ABPM-04 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. ABPM-04 also
fulfills the requirements of the British Hypertension Society Validation Protocol for
Automated Blood Pressure Measuring Devices (grade B for both systolic and diastolic
accuracy, validation study published in Blood Pressure Monitoring 1998; 3(6):363-8
by Barna I & al).
99/BP41123 The first two digits of the serial number of the device show the year of production. The
three characters following the slash serve as device type identifier (BP4).
For routine care and maintenance instructions, see page 7.
!
For information on cuffs and their application, see page 9.
No user serviceable parts inside.
!
ABPM-04 contains high complexity electronic and fine mechanical components.
If you have any problems, please refer the device to qualified service personnel.
Meditech ABPM-04 with CardioVisions
This User's Guide © Meditech Ltd. 1998 All rights reserved. PIC: BP4-D501-UK
2
Meditech Ltd.
Fax: +36 1 282 9388
Homepage: www.meditech.hu
Meditech Sverige AB
Fax: +46 176 206340
Homepage: www.meditech-sweden.se