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EMC GUIDANCE
SPECIFICATIONS
EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning: Do not use near active HF surgical equipment and the RF shielded room of an ME system for
magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external
external antennas
)
should be used no closer than 30 cm (12
inches)
to any part of the equipment SMBP802-
GS-003 or SMBP802-GS-004, including cables. Otherwise, degradation of the performance of this equipment
could result.
Technical description
：
1
，
All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard
to electromagnetic disturbances for the excepted service life.
2
，
Guidance and manufacturer’s declaration -electromagnetic emissions and immunity
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11
Group 1
Class [ B ]
Class A
Comply
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test
IP21: It means the device could be protected
against solid foreign objects of 12,5mm Ф and
greater, and against vertically falling water drops.
Protection against
water ingress
Device Classification
Battery Powered Mode:
Internally Powered ME Equipment
AC Adapter Powered Mode:
Class II ME Equipment
General Environment
- home use, not intended for professional use
- indoor use only
- not for use in shower, bath tub or sink
Normal working
condition
A temperature range of: +5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water vapour
partial pressure greater than 50 hPa
An atmospheric pressure range of:
700 hPa to 1060 hPa
Storage & transportation
condition
Temperature: -20°C to +60°C
A relative humidity range of ≤ 93%,
non-condensing, at a water vapour pressure
up to 50 hPa
Conditions of visibility
Ambient luminance range: 100 Ix to 1500 Ix
≤50 dB in the range of 100 Hz — 8 kHz
Background sound
pressure level
Software Version
A01
Service life
2 years
WARNING: No modification of this equipment is allowed.
