Introduction; Preliminary Note; About These Instructions For Use; Clinical Data - Welch Allyn ABPM 7100 Instrucciones De Uso

5 - Introduction

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 instructions for use

These instructions for use will familiarize you with the use of the ABPM 7100 and its accessories.
The instructions for use of the Hypertension Management Software are provided on the CD together with the HMS
software.
The software CardioPerfect Workstation (CPWS) can be used for the evaluation of blood pressure measurements in
regions, where Welch Allyn has registered and distributed the software for this purpose.
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 software instructions for use for software instructions for use.
•
For the upgrades please refer to the respective instructions for use to operate the
Hypertension Management Software (HMS), version 5.0 and above.
Note These instructions 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.
These instructions for use must be kept with the product for later use!

Clinical data

The blood pressure measuring device ABPM 7100 fulfills the requirements of the ESH (European Society of
Hypertension), BHS (British Hypertension Society) and ISO 81060-2.
The device has not been tested on pregnant women, including preeclamptic patients.

CE Mark

The ABPM 7100 fulfills the requirements of the following directives:
•
Directive 93/42/EEC (MDD)
•
Directive 2011/65/EU (RoHS)
The ABPM 7100 bears the CE mark.

Content

Standard
1. ABPM 7100 Monitor
2. Pressure Cuff – Size "Adult"
3. Carrying Pouch
4. PC Interface Cable
5. 4x AA Alkaline Batteries
6. ABPM 7100 Instructions for use
7. Calibration Notice
8. Pressure Cuff – Size "Adult Plus" (dependent on set)
Warning
Risk of injury posed by the use of other accessories. The use of unapproved accessories may lead to
incorrect measurement results.
•
Only use accessories approved and distributed by the manufacturer and Welch Allyn.
•
Check the accessories regarding the manufacturer's information before first use.
Introduction - 6
HMS Option
1. HMS Software
2. Quick Start Guide (dependent on upgrade
option)
3. Version dependent 16 digit License Code
(dependent on upgrade option)
EN