Symbols And Definitions; Maintenance And Storage - Braun PULSE OXIMETER 1 Manual De Instrucciones

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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

Maintenance and storage

1. Replace the batteries when low voltage symbol is lit.

2. Clean the surface of the oximeter before it is used to take a

measurement.

3. Remove the batteries if you will not use the oximeter for an

extended amount of time.

4. For product preservation store the device in -10~40 ºC

(14-104 ºF) and 10%-95% humidity.

5. It is recommended that the product should be kept dry at

all times. Excessive humidity might affect its lifetime and

even damage the product.

6. This device is factory calibrated and no further calibration is

required by the user.

To protect the environment, dispose of empty batteries

at appropriate collection sites according

to national or local regulations.

Box content

One lanyard

One user manual

2 AAA 1.5V alkaline batteries