Meditech ABPM-05 User manual

Meditech ABPM-05
ambulatory blood pressure monitor
User manual

Important information – precautions for use – read carefully!
This symbol on a Meditech recorder is a warning that you should read
the accompanying documentation (this manual).
The ABPM-05 ambulatory blood pressure recorder is manufactured by
Meditech Ltd
200 Ulloi ut, Budapest, ungary www.meditech.hu
fax: [phone] e-mail: [email protected]
Contact us for further product and service information.
Meditech Ltd. maintains a quality assurance system certified according
to MSZ EN ISO 9001:2000 and MSZ EN ISO 13485:2003.
Notified Body SGS Yarsley
Unit 202b, Worle Parkway fax: [phone]
Western-super-Mare, BS22 0WA www.sgs.com
!Meditech ABPM-05 recorders should not be used if any of the
following cases apply:
•patients without an indication for ambulatory blood pressure
monitoring
•non-cooperative patients
•patients in any way unable to operate a recorder as intended
•patients requiring urgency / emergency cardiac care
•unconscious or otherwise incapable patients
•patients with serious mobility impairments without supervision
•patients with coagulation disturbances
•children without supervision
•children under the age of 8 years
!Though the blood pressure measurement algorithm used in Meditech ABP
recorders has been tested and found to function properly on 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 the interpretation blood pressure
measurements. Note that any blood pressure recording may be affected
by body position, the physiological condition of the patient, and other
factors.
Meditech ABPM-05 described in this manual complies with the
requirements of the EU Medical Devices Directive (93/42 EEC).
0120 is the identifier of Notified Body (SGS Yarsley)
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MDD
IIa MDD classification IIa. EMC class A. EMC group not applicable.
Meditech ABPM-05 is an internally powered type CF device.
Protection vs. ingress of water: ordinary.
Mode of operation: continuous.
2006/5nnnnn
The first four digits of the serial number of a recorder show the year of
production. The number “5” following the slash serves as device type
identifier. The rest is the actual serial number.
This symbol shows that according to regulations ABPM-05 should be
handled as electronic waste during rollout.
Blood pressure measurements determined with the algorithm of a
Meditech ABP 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 also fulfils the requirements of the British ypertension
Society Validation Protocol for Automated Blood Pressure Measuring
Devices (algorithm used in all Meditech ABP recorders is identical to
that used in the Meditech ABPM-04 device, which received grade B for
both systolic and diastolic accuracy; validation study published in
Blood Pressure Monitoring 1998; 3(6):363-8 by I Barna & al).
!For information on cuffs and their application, see page 11.
!Take care to avoid blocking the air flow in the tube of the cuff. Make
sure the cuff and its tubing or the lead wires do not cause strangulation
or a circulation problem. Should the patient experience arm numbness
or pain remaining after any blood pressure reading is completed, the
cuff should be removed to avoid permanent vascular or neural injury.
!No user serviceable parts inside. Meditech recorders contain high
complexity electronic and fine mechanical components. If you have any
problems, please refer your recorder to qualified service personnel.
File ID: BP5B2210
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Table of Contents
Table of Contents..........................................................................................................5
Recommended use of ambulatory blood pressure recorders.........................................6
Care and maintenance...................................................................................................6
Safety concerns.............................................................................................................7
Working with ABPM-05...............................................................................................8
Rules of monitoring..................................................................................................8
Monitoring step by step............................................................................................9
Batteries..................................................................................................................10
Cuffs and their application.....................................................................................11
Meditech ABPM-05....................................................................................................12
Accessories.............................................................................................................12
Using the buttons....................................................................................................13
Displays..................................................................................................................14
Technical parameters..............................................................................................15
Meditech product warranty information.....................................................................16
Notes...........................................................................................................................17
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