Product Specifications - Braun Pulse oximeter 1 Manual De Instrucciones

Product specifications

Type:
Display Type:
SpO2 Measurement range:
Accuracy:
Resolution:
PR Measurement range:
Accuracy:
Resolution:
Power Supply:
Power Consumption:
Automatically Power-off:
Dimension:
Operation Environment:
Operation Temperature:
Storage Temperature:
Operation Humidity:
Storage Humidity:
Air Pressure:
This device conforms to the following standards:
IEC 60601-1: Medical electrical equipment – Part 1: General requirements
for basic safety, and essential performance.
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral
standard: Electromagnetic disturbances - Requirements and tests.
IEC 60601-1-11: Medical electrical equipment – Part 1-11: General
requirements for basic safety and essential performance – Collateral
standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment.
ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of pulse oximeter
equipment.
ISO 10993-1 Biologival evaluation of medical devices- Part 1: Evaluation
and testing within a risk management process.
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In
Vitro cytotoxicity.
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization.
ISO 15223-1: Medical devices - Symbols to be used with medical
device labels, labeling and information to be supplied - Part 1: General
requirements.
ISO 14971 - Medical Devices - Application Of Risk Management To Medical
Devices
IEC 62366 - Medical devices - Part 1: Application of usability engineering
to medical devices
12
Braun Pulse oximeter, BPX800US
OLED display
70% - 100%
80% - 100% ±2%
70% - 79% ±3%
±1%
30BPM~254 BPM
≤ 100 ±1 BPM
> 100 ±2 BPM
±1 BPM
two AAA 1.5V alkaline batteries
below 30mAh
The product automatically shuts off
when no signal can be detected
within 8 seconds
Approx. 58mm×35mm×30mm
41 ºF ~ 104 ºF (5 ºC~40 ºC)
14 ºF ~ 104 ºF (-10 ºC~40 ºC)
15%~80%
10%~95%
70kPa~106kPa