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7.1. Physical Characteristics
• Size: 80 mm (diameter) x 43 mm (height)
• Weight: 75 g ± 10 g (including the battery)
7.2. Operating environment
• Temperature: From +5 ºC to +40 ºC
• Humidity: ≤ 80%
• Atmospheric pressure: From 86 kPa to 106 kPa
• Service life: 5 years
7.3. Transportation and storage
• Temperature: From +10 ºC to +55 ºC
• Humidity: <93%
• Atmospheric pressure: From 86 kPa to 106 kPa
7.4. Measurement of the fetal heartbeat
• Sensitivity: ≥ 90 dB
NORMALIZED SYMBOLS
• The name and the address of the Manufacturer
• Authorized Representative in the European Community
• Batch code
1. Heartbeat monitor
• Attention: Read the operating Instructions for use!
• Applied part of type B
• Disposal in accordance with Directive 2012/19/UE (WEEE)
• Complies with the European Medical Device Directive (93/42/EEC)
and amended by directive 2007/47/EC requirements.
Notified body: MEDCERT GmbH (CE0482)
• Serial number
2. Ultrasound conductive gel
• Use-by date
• Keep dry
+40°C
• Storage temperature
-10°C
• Do not re-use
• Keep away from sunlight
• Measuring range: From 50 to 210 beats per
minute
• Accuracy: ± 2 beats per minute
7.5. Electrical specifications
• Battery: Rechargeable 3.7 V Ion-Lithium
7.6. Specifications of the probe
• Type: Continuous Doppler
• Water resistance: IPX1
• Acoustic operating frequency: 2.5 MHz ± 15%
• Ultrasonic output power: ≤ 20 mW
• Effective emission area: 245 mm² ± 15%
• P: < 1 MPa
• PaIob: 20 mW/cm²
• Ispta: < 100 mW/cm²
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