IFU002 Rev C.0
RELEASED
Effective Date: 2019-10-17
Spire, Inc.
Confidential & Proprietary
IFU002 Rev C.0
Instructions for Use
Page 16 of 20
Patient Manual
ENVIRONMENTAL CHARACTERISTICS
Allowable Transit Temperature
-29° C to 60° C
Recommended Storage Temperature
-29° C to 60° C
Operating Temperature
5°C to 40°C
Storage Humidity
15-85%
Operating Humidity
15% to 90%
Operating Atmospheric Pressure
700 hPa to 1060 hPa
ELECTRICAL SAFETY AND COMPATIBILITY
•
CAUTION: The MHT device needs special precautions regarding EMC and needs to be
utilized according to the EMC information provided in the following tables.
•
CAUTION: Portable and mobile RF communications equipment can affect medical
electrical equipment.
•
WARNING: The MHT device should not be used adjacent to or stacked with other
equipment.
Table 1:
Guidance and manufacturer’s declaration— electromagnetic emissions
The Medical Health Tag device is intended for use in the electromagnetic environment
specified below. The customer or the user of the Medical Health Tag device should assure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1
The Medical Health Tag device uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The Medical Health Tag device is suitable for use in home,
workplace, and alternate care settings