9
Mobil-O-Graph
®
, operating instructions, Rev. 5.1 10/2015, GmbH
2. Operating instructions
2.1 Intended use
The appropriate use is 24-hour blood pressure monitoring and pulse wave analysis (PWA). The Mobil-O-Graph
®
should be used only under medical supervision.
2.2 Incorrect use
Because of the risk of strangulation from the tube and cuff, the ABPM System Mobil-O-Graph® may not be used
for patients who are legally incompetent nor for unattended children.
The Mobil-O-Graph® is not designed for the application in neonates and children under the age of 3.
The Mobil-O-Graph® must not be used for blood pressure monitoring during surgeries. It has not been designed
for alarm-giving monitoring in intensive care units.
2.3 Indication
The Mobil-O-Graph
®
ABPM system is intended for clarifying blood pressure and for use as a diagnostic aid.
The doctor can, at his or her own discretion, prescribe the use of this medical system for patients if they are
suffering from:
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hypertension,
■
hypotension,
■
borderline hypertrophy,
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impaired renal function, or
■
require antihypertensive therapy.
2.4 Side effects of 24-hour blood pressure monitoring
24-hour blood pressure monitoring is now a familiar, acceptable and valuable method of measurement, used
daily in diagnostic investigation and treatment follow-up.
When considering the use of 24-hour blood pressure monitoring, it is important to check whether the patient is
suffering from coagulation disorders or is on anticoagulant treatment. As with occasional blood pressure meas-
urement, petechial bleeding can occur.
In patients on anticoagulant therapy or patients with coagulation disorders, petechial bleeding can occur on the
measurement arm in spite of correct cuff fit. The special risk to patients due to anticoagulant treatment or coag-
ulation disorders is present in all cases irrespective of the type of equipment used in measurement.
2.5 Important instructions for the doctor
■
A measurement can be stopped at any time by pressing one of the monitor keys. This deflates the
cuff.
■
Let your patients know that they should turn the device off and take off the cuff in the event of
any pain or allergic reactions. Attention: The printing ink contains epoxy resin. In hypersensitive
patients, the ink can cause allergic reactions in very rare cases.
■
Explain to the patient how to place the cuff correctly.
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The equipment must not be used in the vicinity of an MRI scanner!
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The equipment must never be connected to a PC or other unit while still fitted to the patient.
■
The use of components not supplied with the equipment can lead to incorrect measurements. Use
only accessories offered by IEM.
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The air tube between the Mobil-O-Graph
®
recorder and the cuff must never be knotted, compressed
or stretched.
■
Observe the hygiene rules shown in the maintenance schedule.
■
Attention: Due to the risk of strangulation with the tube and cuff, the ABPM system must only be
applied in children with special care and under the permanent supervision after specific prescription
by the doctor.
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Please note that for the application of the pulse wave analysis in children there are currently no clin-
ical studies available against reference methods.
■
The pulse wave analysis provides additional indicators for possible risks, but is not admissible or
valid as a sufficient indicator for single diseases or therapy recommendations.
Warnings:
■
The shoulder strap or cuff tube can become entangled around the patient’s neck and lead to stran-
gulation.