Conformity
Conformité aux normes:
Conformité aux règlements:
Parameter
Les conditions de mesure:
Pacing modes:
Fréquence de base:
(MTR
Stimulation rapide atriale:
Stimulation rapide
ventriculaire (version du
micrologiciel 1.24 et plus):
Impulsion de sortie:
Amplitude d'impulsion
nominale (500 Ω):
Amplitude d'impulsion
nominale (200 Ω ... 2000 Ω):
Durée de pulsation:
Sensibilité atriale:
Sensibilité ventriculaire:
Page 113 of 136
The cardiac pacemaker is designed
according to and meets:
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-31
European directive 2012/19/EU on waste
electrical and electronic equipment (WEEE
directive)
Europe-an directive 2011/65/EC on
restriction of the use of certain hazardous
substances in electrical and electronic
equipment (RoHS directive)
Environment temperature: 20 ± 2°C
Voltage supply: 9 ± 0.5 V
Load resistance: 500 ± 1%
Test impulse: as specified in
ISO 14702-8 (Triangle 2 ms / 13 ms)
primary:
DDD, VVI, AAI, VDD
supplementary:
D00, V00, A00, DVI, DAI, VAT, AAT,
DDD+AT, DAT
30 ... 220 ppm ± 2 %
80 ... 230 ppm ± 2 %
70 ... 1000 ppm ± 5 %
70 ... 220 ppm ± 2 %
Cathodic, biphasic, asymmetric,
capacitive coupled, passive discharge
0.1...18 V ± 10 % ± 0.05V
0.1...18 V ± 20 % ± 0.05V
0.05 ms ... 1.50 ms ± 10 % ± 0.01 ms
0.2 ... 20 mV ± 20 % ± 0.1 mV,
1.0 ... 20 mV ± 20 % ± 0.1 mV,
PACE 203 H
PACE 203H V2.0