Contraindications; Essential Performance; Side Effects Of 24-Hour Blood Pressure Monitoring; Product Description - WelchAllyn ABPM 7100 Mode D'emploi

7 - Direction for use

Contraindications


The ABPM 7100 must not be used on neonates and children under the age of 3 years!

Due to the strangulation risk posed by tubing and cuff, the ABPM 7100 must not be placed within reach
of unsupervised children, and must not be used on unsupervised patients with limited cognitive abilities,
or patients under anesthetics!
 The ABPM 7100 is not intended for alarm triggering monitoring purposes in intensive care units, and must
not be used for blood pressure monitoring purposes in intensive care units or during surgery!

The ABPM 7100 must not be used in aircraft.

The device has not been tested on pregnant women, including preeclamptic patients.

Essential Performance

The main performance features are defined as blood pressure measurement with:
 Error tolerances of the pressure gauge and measurement results are within required limits (IEC 80601-
2-30).

Maximum change value in blood pressure determination is as specified in IEC 80601-2-30.

Cuff pressurization remains within specified limits (IEC 80601-2-30).

An error is issued in the event that successful blood pressure measurement is impossible.
The ABPM 7100 does not issue ALARMS pursuant to IEC 60601-1-8 and is not intended for use in connection
with HF surgical equipment or to clinically monitor patients in intensive care units.
Basic safety means that the patient cannot be endangered by any automatic device procedure. During any
unclear conditions, the ABPM 7100 must therefore transfer into the safe Standby mode, during which the
ABPM 7100 cannot automatically inflate the cuff, while this can be manually triggered by pushing the START
button.
In this context, any interruption of a measurement or in automatic operation by an external influence, or the
ability of the ABPM 7100 to test error conditions, is regarded as the retention or restoration of basic safety,
and not as non-adherence to the main performance features.

Side effects of 24-hour blood pressure monitoring

As with occasional blood pressure measurements, petechiae, haemorrhages or subcutaneous haematoma
may occur on the measured arm despite a correctly seated cuff. The innate patient-dependent risk resulting
from treatment with anticoagulants or in patients with coagulations disorders arises irrespective of the type of
monitoring device. Always check whether the patient displays coagulation disorders or is being treated with
anticoagulants.

Product description

Introduction

The ABPM 7100 System consists of two main components:

The ABPM 7100 with cuffs and accessories

Patient management software for the doctor to evaluate the measurement results
With the software the ABPM 7100 can be prepared for measurement, transfer stored measurement results to
the PC, display transferred measurements on the screen in various formats such as graphics, lists and
statistics and print out measurement results. Optional is the possibility to evaluate the measurement results
with upgrades.
The ABPM 7100 can be prepared immediately for the next patient. With little practice this procedure can be
completed in just a few minutes. This allows the doctor to use the ABPM 7100 around the clock on each work
day.
The ABPM 7100 is designed to allow recording and display of a blood pressure profile throughout the day and
at night. Additional parameters such as nocturnal values and blood pressure fluctuations are recognized. This
permits the doctor to prescribe optimal medical treatment for each individual.
Measurement with the ABPM 7100 can be either automated or be manually controlled by the user. In order to
start a series of automatic measurement, the user must initiate the first measurement by pressing the START
button and the doctor should check the reliability of the first measurement.
During the first measurement, the cuff is inflated in increments, to determine the cuff pressure required to
measure the systolic blood pressure value. The maximum required inflation pressure is stored and applied by
direct inflation during the subsequent automatic measurements. This procedure is called AFL – Auto
Feedback Logic.

The ABPM 7100

Components
1 Cuff connection
2 ON/OFF button
3 LCD-Display
4 START button
5 DAY/NIGHT button
6 EVENT button
7 PC Interface cable port
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