Intended Use; Indications For Use; Contraindications; Essential Performance - Welch Allyn ABPM 7100 Instructions For Use Manual

7 - Instructions for use
Instructions 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
in the USA for the 14-20 cm (5.5-7.9 in) cuff size.
•
The ABPM 7100 is intended for use in the areas of domestic healthcare and in professional healthcare
facilities, including doctors' surgeries, first aid facilities and clinics.
•
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.

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.
Instructions for use - 8