M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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NOTE:
1 Position the device in a location where the operator can easily see the screen and
access the operating controls.
2 The monitor can only be used on one patient at a time.
3 This equipment is not intended for home usage.
4 If the device is discolored or damaged, then discontinue use of the device.
5 The pictures and interfaces in this manual are for reference only.
6 Regular preventive maintenance should be carried out every two years. You are
responsible for any requirements specific to your country.
7 The materials with which the patient or any other person can come into contact
conform to the standard of EN ISO 10993-1: 2013.
8 It is recommended to format the USB flash drive to the FAT file type via PC prior to
use.
9 To protect eyes from damage, don't look directly at supplementary light for long time.
10 When there's measurement beyond range, invalid measurement or no measurement
value, it will display ---.
11 In normal use, the operator shall stand in front of the monitor.
1.2.7 Protecting Personal Information
Protecting personal health information is a major component of security strategy. To protect the
personal information and ensure the proper device performance, the user should take necessary
precautions in accordance with local laws and regulations and institution’s policies. EDAN
recommends health care organizations or medical institutions to implement a comprehensive and
multifaceted strategy to protect the information and systems from internal and external security
threats.
To ensure the patients’ safety and protect their personal health information, the user should
implement security practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the monitor.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The access/operation of the monitor is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the monitor.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure.
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