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Schiller BR-102 PLUS - Safety Notes; Intended Use

Schiller BR-102 PLUS
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Page 7
Art. no.: 2.511076 Rev.: g
Safety Notes 1
User Guide User Profile 1.1
BR-102 plus / BR-102 plus PWA
1 Safety Notes
1.1 User Profile
Medical Personnel (Operator, User)
This blood pressure recorder as well as the analysis program are
provided for the exclusive use of qualified physicians or trained
medical personnel under their direct supervision.
Patient, Caregiver (for use in home environment)
After thorough instruction from the attending physician, the patient or
his/her caregiver may use the device on their own (see chapter 4
Patient Information and chapter 10 Patient Diary).
1.2 Intended Use
The BR-102 plus / BR-102 plus PWA is a non-invasive ambulatory
blood pressure recorder. It uses auscultatoric and oscillometric
signals, or purely oscillometric signals to measure the blood
pressure of human beings. Systolic, diastolic, mean arterial
pressure and heart rate are measured. The BR-102 plus / BR-102
plus PWA is intended as an aid to diagnosis and treatment when
it is necessary to measure an adult or adolescent patient’s blood
pressure over an extended period of time (up to 24 48 hours).
Further, with each measurement, the PWA data will be saved for
subsequent external assessments.
The BR-102 plus / BR-102 plus PWA can be used for adults and
children (3 years old onwards) of both sexes and all ethnic origins.
This blood pressure recorder can be used on pregnant patients or
patients suffering from pre-eclampsia.
Patients with special needs such as children, the elderly, the
disabled, or people lacking the capacity for judgement must be
accompanied by a caregiver who will supervise the actions as well
as monitor the recording.

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