Instruction Manual

Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0

repositories may be moved to a separate data repository for use as set forth herein. User

agrees that BSBT may use such De-identified Information for any purpose. User agrees that

BSBT is the exclusive owner of the De-Identified Information.

User licenses BSBT to store the data identified as PHI for the purposes of carrying out the

operations as requested by User. Unless otherwise permitted in this Agreement, no User shall

have direct access to Information in the data repository. Requests, if any, from User to access or

amend PHI shall be referred to BSBT.

13. Electromagnetic compatibility

Forehead sleep recorders can generate, use, and radiate radio frequency energy. This equipment

can cause electromagnetic interference between other medical or non-medical equipment and

radio communications. According to the statement of IEC 60601-1-2: 2014, this product belongs

to the first group, Class B medical equipment, to provide corresponding protection from

interference. However, there is no guarantee that electromagnetic interference will not occur under

certain installation conditions.

When this equipment is found to cause interference (requires switching equipment on and off for

confirmation), the operator or authorized maintenance personnel can eliminate the interference

according to the following measures:

1) adjust or relocate the affected equipment;

2) Increase the distance between this equipment and the affected equipment;

3) Use another power source to power this device;

4) Consult a maintenance engineer for more suggestions.

Note: Before using this equipment, please ensure that all EMC requirements in the manual

have been met;

Note: This section will list the content described in the table of IEC 60601-1-2: 2014. It is the

user's responsibility to ensure that this equipment and its nearby equipment meet the radio

frequency interference parameters indicated in the general safety requirements.

Caution: Do not intentionally transmit RF signals (smart mobile devices, radio transceivers,

or radio control products) while this equipment is in use. This may cause the operation to exceed

the specified value. When near this device, turn off this type of device. It is the responsibility of

the operator to remind patients or other personnel associated with this device to fully comply with

the above requirements.

Note: The manufacturer will not be held responsible for any interference caused by the use of

non-recommended internal connection cables or unauthorized changes or modifications to this

equipment.

For forehead sleep recorders, special precautions regarding electromagnetic compatibility (EMC)

are taken and must be installed and used according to the electromagnetic compatibility

information specified in this manual.

Portable and mobile RF communications equipment may affect this equipment.