7
Mobil-O-Graph
®
, operating instructions, Rev. 5.1 10/2015, GmbH
1. Introduction
1.1 Foreword
This Mobil-O-Graph
®
24-hour Ambulatory Blood Pressure Monitor system (ABPM) provides you with a system
using the latest specialist technology, which incorporates all our experience of the past few years with the suc-
cessful Mobil-O-Graph
®
ABP monitor. We have also incorporated our customers' wishes into the Mobil-O-Graph
®
.
The blood pressure monitor, also referred to below as ABP monitor or recorder, can be prepared for a new
patient in practice in just a few minutes. This gives you the advantage of using the ABP monitor optimally, and
the ability to complete a whole monitoring session each day. The Mobil-O-Graph
®
will thus quickly be integrat-
ed into the daily routine of the practice.
Clinical experience has shown that in addition to the ABPM, analysis of BP self-measurement is also sensible.
The client/server data management extension enables a virtual patient clinic to be established.
1.2 Operating Instructions
These operating instructions will show you quickly and simply how to use the ABP monitoring system and its
accessories. With a little practice you will see how easy it is to use the ambulatory blood pressure monitor.
For the analysis of the Mobil-O-Graph® the
Hypertension-Management-Software Client-Server
data management is used.
Where reference is made to specific characteristics, only those sections relating to your version are relevant!
Important:
The operating instructions describe the ABP monitor and its accessories in the sequence in which
you will be setting up the equipment and then using it. After the general description you will find
details of installation, setting up, preparation for monitoring, fitting to the patient and evaluation. The
individual functions are explained later, at the point at which they are to be used. You will therefore
become familiar with use of the blood pressure monitor step by step.
The user should always have the operating instructions at hand.
1.3 Clinical tests
The Mobil-O-Graph
®
blood pressure monitor fulfils the requirements of the ESH (European Society of
Hypertension).
Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer
using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard,
Manual, electronic or automated Sphygmomanometers.
1.4 CE mark
The Mobil-O-Graph
®
fulfils the requirements of the Medical Products Directive 93/42/EEC and bears
the CE mark.
The Mobil-O-Graph
®
fulfils the requirements of the R&TTE Directive 1999/5/EU and bears the CE
mark.
The declaration of conformity for this product can be downloaded from the I.E.M. website www.iem.de.
This device fulfils the requirements of the standards applicable in accordance with the Directives. In particular,
it fulfils the applicable requirements of the following standards:
1. EN 1060-1 Noninvasive blood pressure measuring equipment - Part 1: General requirements
2. EN 1060-3 Noninvasive blood pressure measuring equipment - Part 3: Supplementary requirements for
electromechanical blood pressure measuring systems
1.5 Scope of delivery
Basic set
1. Mobil-O-Graph® (NG or PWA)
2. S-, M- and L-Cuff
3. Mobil-O-Graph® Universal Case
4. Recharger including 4 NiMH batteries
5. Operating instructions
6. Measuring tape
7. Event protocol
Analysis unit HMS Client-Server:
1. HMS Client-Server on CD
2. Bluetooth-Dongle
alternatively
3. IR-MED serial or USB
alternatively
4. PC hybrid cable USB or serial