Introduction; Preliminary Note; About These Directions For Use; Clinical Data - WelchAllyn ABPM 7100 Instrucciones De Uso

5 - Introduction

Defibrillation-proof type BF applied part
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 directions 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 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 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 2014/53/EU (RED)

Directive 2011/65/EU (RoHS)
The ABPM 7100 bears the CE mark.
MR Unsafe Poses unacceptable risks
to the patient, medical staff or other
persons within the MR (magnetic
resonance) environment

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 Directions 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.

Direction for use

Intended use

The ABPM 7100 is intended for clarifying the blood pressure status and for use as a diagnostic aid for an
individual patient (in the patient's environment). The ABPM 7100 may only be used under medical supervision
and after detailed instruction has been provided by the doctors or healthcare professionals. The ABPM 7100
in combination with the Hypertension Management Software (HMS) provides a derived ascending aortic blood
pressure wave form and a range of central arterial indices. Analysis based on the recordings is in the sole
responsibility of the medical professional.

Indications for use


The ABPM 7100 is an automated, microprocessor controlled ambulatory blood pressure monitor (ABPM)
which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual
patient (in the patient's environment) for a session which may last 24 hours. Ambulatory monitoring is not
supported for the 14-20 cm (5.5-7.9 in) cuff size.

The ABPM 7100 is intended for use in domestic healthcare settings and in professional healthcare
facilities, including, for example, vehicles, dental practices and first aid stations.

It is used with a standard upper-arm cuff for blood pressure measurement.

The ABPM 7100 in combination with the Hypertension Management Software (HMS) provides a derived
ascending aortic blood pressure wave form and a range of central arterial indices. It is used in those adult
patients, where information related to the ascending aortic blood pressure is desired, but in the opinion
of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh
the benefits.
Direction for use - 6
HMS Option
1. HMS Software
2. Bluetooth ® -Dongle
3. Quick Start Guide (dependent on
upgrade option)
4. Version dependent 16 digit License Code
(dependent on upgrade option)
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