Introduction; Preliminary Note; About These Directions 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 directions for use

These directions for use will familiarize you with the use of the ABPM 7100 and its accessories.
The software CardioPerfect Workstation (CPWS) is used for measurement evaluation.
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 CPWS 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 1999/5/EC (R&TTE)
•
• 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 Directions For Use
7. Calibration Notice
8. CPWS Software (dependent on set)
9. 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.
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!
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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