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Welch Allyn ABPM 7100 - Introduction; Preliminary Note; About These Instructions; Clinical Data

Welch Allyn ABPM 7100
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Introduction - 5
Introduction
Preliminary note
With the ABPM 7100 24-hour blood pressure measuring device, you now have an Ambulatory Blood
Pressure Monitoring System (ABPM System) at your disposal.
The ABPM 7100, also specified as ABP Monitor, can be prepared for a new patient in just a few minutes.
This permits the optimum use of the ABP Monitor and allows you to process one 24-hour profile per day.
The ABPM 7100 can therefore be quickly integrated into everyday practice life. The recorded blood pressure
values must be evaluated with the intended software.
In combination with the Hypertension Management Software and an appropriate license, the ABPM 7100 is
also able to process a haemodynamic analysis of the recorded pulse waves.
About these directions for use
These directions for use will familiarize you with the use of the ABPM 7100 and its accessories.
The software CardioPerfect Workstation (CPWS) is used for measurement evaluation.
Upgrades for haemodynamic evaluation may also be purchased from Welch Allyn. Please contact Welch
Allyn for further information.
With reference to specific version characteristics, only the parts relevant for your respective version will
apply.
Please refer to the CPWS directions for use for software operating instructions.
For the upgrades please refer to the respective directions for use to operate the
Hypertension Management Software (HMS), version 5.0 and above.
Note
These directions for use explain the ABPM 7100 and its accessories in the sequence in which
you setup the device for a blood pressure measurement, followed by the installation, initial
operation, measurement preparation, placement on the patient and the evaluation. Individual
functions are only explained when they are needed. You will therefore be familiarized with the
ABPM 7100 on a step-by-step basis.
This directions for use must be kept with the product for later use!
Clinical trials
The blood pressure measuring device ABPM 7100 fulfills the requirements of the ESH (European Society of
Hypertension).
The blood pressure measuring device ABPM 7100 fulfills the requirements of the BHS (British Hypertension
Society).
CE Mark
The ABPM 7100 fulfills the requirements of the following directives:
Directive 93/42/EEC (MDD)
Directive 1999/5/EC (R&TTE)
Directive 2011/65/EU (RoHS)
The ABPM 7100 bears the CE mark.

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