GEM Hemochron 100 User Manual

9 - Regulatory Compliance
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000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
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000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
Cybersecurity:
Refer to the GEM Hemochron 100 Cybersecurity and Privacy Guide (P/N: 000HZ7003).
Addressing Wireless Connectivity Problems/Coexistence:
This instrument is able to provide essential performance (assay analysis) without the use of a network
connection. In the event of a perceived or actual communications failure, relocate the instrument closer to the
desired wireless access point and/or identify and eliminate any wireless interference.
Test Limits per EMC Standards:
Complies with IEC 60601‑1‑2:2014 and EN 61326‑1/CISPR 11 Class B and meets the limits listed below:
Emissions Product Standards
Standard Test Description Test Level / Limits
CISPR 11 Radiated Emission Class B
CISPR 11 Conducted Emission Class B
IEC 61000‑3‑2 Harmonics Class A
IEC 61000‑3‑3 Flicker
Pst ≤ 1.0
PIt ≤ 0.65
dc ≤ 3.3%
dmax ≤ 4.0%
Complies with IEC 61236‑1‑2 and meets the limits of IEC 60601‑1‑2 as shown below:
Immunity Standards (Professional Healthcare Facility Environment)
Standard Test Description Test Level / Limits
IEC 61000‑4‑2 Electrostatic Discharge
±8 kV Contact Discharge
±2, 4, 8, and 15 kV Air Discharge
IEC 61000‑4‑3
Radio Frequency
Electromagnetic Field
Amplitude Modulated
80 MHz to 2.7 GHz
3 V/m
80% AM 1 kHz
IEC 61000‑4‑3
Proximity Field from
Wireless Transmitters
385 MHz: 27 V/m @ 18 Hz Pulse Modulation
450 MHz: 28 V/m @ FM Modulation
710 MHz, 745 MHz, 780 MHz: 9 V/m @ 217 Hz Pulse Modulation
810 MHz, 870 MHz, 930 MHz: 28 V/m @ 18 Hz Pulse Modulation
1720 MHz, 1845 MHz, 1970 MHz: 28 V/m @ 217 Hz Pulse Modulation
2450 MHz: 28 V/m @ 217 Hz Pulse Modulation
5240 MHz, 5500 MHz, 5785 MHz: 9 V/m @ 217 Hz Pulse Modulation
IEC 61000‑4‑4 Electrical Fast Transients
±2.0 kV AC/DC Mains
±1.0 kV Signal and Control Lines (100 kHz repetition frequency)
IEC 61000‑4‑5 Surge
±0.5 and 1 kV Line to Line (DM)
±0.5, 1, and 2 kV Line to Line (CM)
SIP/SOPS ±2.0 kV (Line to Ground)
IEC 61000‑4‑6
Radio Frequency
Common Mode
0.150 MHz to 80 MHz
3 Vrms (6 Vrms in ISM radio bands between 0.15 MHz to 80 MHz)
80% AM 1 kHz
(Applies to both enclosure and SIP/SOPS)
IEC 61000‑4‑8
Power Frequency
Magnetic Field
30 A/m (50 Hz or 60 Hz eld)
IEC 61000‑4‑11
Voltage Dips and
Interruptions
0% of Vnom
0.5 cycles at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°
0% of Vnom
1 cycle at 0°
70% of Vnom
25/30 cycles at 0°
0% of Vnom 250/300 cycles

GEM Hemochron 100 Specifications

General

Brand	GEM
Model	Hemochron 100
Category	Measuring Instruments
Language	English