10 11
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 aect 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
Symbols and definitions
5
40
C
C
Type BF Applied
Part
Operating
Humidity
Operating
Temperature
Consult
Instructions for
Use
Batch
Code
Serial
Number
Medical
Device
Catalogue
Number
Manufacturer Voltage
Storage
Humidity
Storage
Temperature
Authorized
representative
in the European
Community
IP22: Protected against solid foreign
objects greater than 12.5 mm in
diameter and dripping water when
tilted at 15º
English
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