Riester ri-champion N Mode D'emploi page 30

1.2. Sequence of Operations
a) Replace the cuff of the device with the metal vessel
(see 1.1 a). Connect the calibrated inspection manometer (see
1.1 b) to the cuff connector (see Fig. 1) using a "T" connector
and tubes (see 1.1. d). Using an additional "T", connect the
additional bulb (see 1.1.c) to the pneumatic system.
Now, you have to remove the battery out of the battery contai-
ner, press the start/stop button and push the button until the
batteries are reinserted into the container. When releasing the
start/stop button the device may switch into the calibration
mode, this will be confirmed by 3 tones. To leave this test mode
press the start/stop button. After leaving the calibration mode
you have to re-enter date and time (see point 4.4).
b) Test in steps of maximum 50 mmHg between 0 mmHg and
maximum value of display.
Overpressure may be randomly exceeded. Continue testing
after reducing overpressure to required reading.
Fig. 1: Test device for determination of limits of error of the
measurement display for cuff pressures.
Warning
Opening the device w ill void your guarantee.
Norm:
Electromagnetic
compatibility:
Clinical test:
30
1. Inspection manometer (see 1.1.b)
2. Sphygmomanometer to be tested
3. Metal vessel (see 1.1.a)
4. Bulb with release valve (see 1.1.c)
The device meets the european guidelines for non invasive blood
pressure devices
EN1060-1
EN1060-3
EN1060-4
ANSI/AAMI SP10
The device meets the specifications of the European Norm EN
60601-1-2
The clinical test was performed according to the EN1060-4:2004
and the BHS standard.
The specifications of the EU-guideline 93/42/EWG for medical pro-
ducts of class IIa are met.