EN62304
Medical device software - Software life-cycle processes.
EN62366
Medical devices - Application of usability engineering to
medical devices.
EN ISO 10993-1
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process.
Disposal
Dispose of the device in accordance with the
regulations applicable at the place of operation.
Dispose of at public collection points in the EU
countries - 2002/96/EC WEEE Directive.
For any questions, please refer to the local authorities
responsible for waste disposal.
Note: Take out the batteries if you are not going to use the
device for long periods of time.
To protect the environment, dispose of empty
batteries at appropriate collection sites
according to national and local regulations.
-12-
EMC Declaration
This digital thermometer needs special precautions
regarding EMC and needs to be installed and put into
service according to the EMC information provided in
the accompanying documents.
Wireless communications equipment such as wireless
home network devices, mobile phones, cordless
telephones and their base stations, walkie-talkies can
affect this equipment and should be kept at least a
distance d=1.0m away from the equipment.
Note:
As indicated in IEC 60601-1-2 for ME Equipment, a
typical cell phone with a maximum output power of 2W
yields d=1.0m at an immunity level of 10V/m.
Version: 1.0.0
July 12th, 2021