Technical Data And Operating Conditions; Electromagnetic Compliance (Emc) - Cardiosecur Pro Benutzerhandbuch

9 Technical Data and Operating Conditions

Parameter
Model
Lead Method
Reading quality
Pulse range
Precision
Heart rate calculation
Type of protection
Filter
Storage
Maximum duration of an ECG
Electrical safety
Power supply
Temperature and humidity operation
Temperature and humidity storage
Air pressure for operation
Electrodes
Environmental use
Warning: Do not store or operate CardioSecur under the following conditions:
• Direct sunlight
• Wet or damp places
• Dusty places
• Vicinity of fire or open flames
• Places subjected to strong physical shocks
• Places subjected to high electromagnetic radiation
Information: Safety-related controls are not necessary during the product's lifetime.

10 Electromagnetic Compliance (EMC)

Warning: Note important information on electromagnetic compliance (EMC). The growing
number of electronic devices like PCs, displays, TV sets, washing machines and mobile
phones may subject medical devices to electromagnetic interference. This may cause
malfunctioning of the medical device and create potentially unsafe situations. Equally,
medical devices should not interfere with other electronic devices. The norm IEC60601-
1-2 was introduced to regulate the requirements for EMC and prevent unsafe product
situations. This norm defines the degree of immunity against electromagnetic
interference and the maximum electromagnetic emission levels for medical devices.
CardioSecur complies with norm IEC60601-1-2:2001 concerning immunity as well as
emissions. Nonetheless special precautions should be taken. Do not use devices that
cause strong electromagnetic fields in the vicinity of CardioSecur. A minimum distance
of 2 meters is recommended. In case that the distance is less than 2 meters
CardioSecur may not perform properly. In accordance with the norm IEC60601-1-
V12.0
Description
CardioSecur Pro
Bipolar, 3-lead
22-lead ECG with 4 electrodes
18 to 256 beats/minute
Bandwidth: 0,05 to 125 Hz, sampling rate: 250 Hz
Evaluation of R wave across minimum of 3 beats,
otherwise across 7 seconds
IP22
Selectable: muscle tension filter 35 Hz (-3 dB) and 50 Hz
filter
External storage on iOS device. Each gigabyte capacity is
10,000 min ECG readings
1800 seconds = 30 minutes
External power supply, application unit type BF
External power supply via iOS device
+5 °C to +40 °C, 10 % to 93 %, non-condensing
-25 °C to +70 °C, 10 % to 93 %, non-condensing
700 - 1060 hPa
Disposable electrodes
Clinical Setting, Home Use, Airplane, Car
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