Essential Performance; Side Effects Of 24-Hour Blood Pressure Monitoring; Product Description; Introduction - Welch Allyn ABPM 7100 Instrucciones De Uso

7 - Product description

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 CPWS 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 the HMS and its 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
The Buttons
ON/OFF
The ON/OFF button turns the ABPM 7100 on and off. To prevent unintended activation,
the ABPM 7100 turns on or turns off only when the button is pressed for more than 2
seconds.
START
The START button serves to
• initiate a manual measurement to ascertain whether the ABPM 7100 is working correctly.
• initiate a 24-hour measurement.
• perform a measurement outside the specified measurement cycle.
DAY/NIGHT
The DAY/NIGHT button is used to differentiate between waking and sleeping phases
during the measurement, which is important for statistics and the graphic displays.
The patient is instructed to press the DAY/NIGHT button upon going to bed and again,
when getting up in the morning. This individually adapts the measurement interval to the
patient and assists you in the analysis of the blood pressure profile.
EVENT
The patient uses the EVENT button to document the time of medication or to record any
events which may cause the blood pressure to rise or fall. Pressing the button will trigger a
measurement, the patient should note the reason for pressing the EVENT button in the
event log.
LCD Display
The LCD display is located on the front of the ABPM 7100 casing. It displays useful information for the doctor
and the patient regarding measurement data, monitor settings and measurement errors. When the START
button is pressed, the number of previously registered measurements will be shown before starting a manual
measurement.
Product description - 8