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Welch Allyn ABPM 7100 - Core Instructions for Use; Intended Use and Indications; Contraindications and Essential Performance; Side Effects of Monitoring

Welch Allyn ABPM 7100
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6 - Direction for use
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)
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)
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 manufacturers information before first use.
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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 adult 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.
Indications for use
The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM)
which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual
adult patient (in the patient’s environment) for a session which may last 24 hours.
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 with a standard cuff for blood pressure measurement.
It is used in those 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.
Improper use
The ABPM 7100 may not be used for any purpose other than for the blood pressure monitoring
procedures described here!
Due to the strangulation risk posed by tubing and cuff, the ABPM 7100 may not be used on patients
with limited cognitive abilities, patients under anesthetics and must not be placed within reach of
unsupervised children.
The ABPM 7100 must not be used on neonates and children under the age of 3 years. The device has
not been tested with pregnant women, including preeclamptic patients.
The ABPM 7100 must not be used for blood pressure monitoring purposes during surgeries.
The ABPM 7100 is not intended for alarm-triggering monitoring purposes in intensive care units.

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