GEM Hemochron 100 - Regulatory Compliance

9 - Regulatory Compliance
101 / 112
000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
100 / 112
000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
9 Regulatory Compliance
The GEM Hemochron 100 instrument complies with the following safety standard requirements and directives:
CAN/CSA‑C22.2 No. 61010‑1:2012 + U1:2015‑07 + U2:2016‑04
CAN/CSA-C22.2 No. 61010-2-010:2015
CAN/CSA-C22.2 No. 61010-2-101:2015
EN 61010‑1:2010
EN 61010‑2‑010:2014
EN 61010‑2‑101:2017
UL 61010‑1:2012 + R:2015‑07 + R:2016‑04
UL 61010-2-010:2015
IEC 61010‑1:2012
IEC 61010‑2‑101:2015
IEC 61010‑2‑010:2014
Supplemented by UL 61010-2-101:2015
IEC 60601‑1‑2:2014
The GEM Hemochron 100 complies with applicable regulations:
● FCC Interference Statement (Part 15.105 (b))
“This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment o󰀨 and on, the user is encouraged to try to correct the
interference by one of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit di󰀨erent from that to which the receiver is connected.
– Consult the dealer or an experienced radio/TV technician for help.”
● FCC Part 15 Clause 15.21
“Changes or modications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.”
● FCC Part 15.19 (a) [Interference compliance statement]
“This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) This device may not cause harmful interference, and
2) This device must accept any interference received, including interference that may cause undesired
operation.”
● ISED RSS-Gen Notice
“This device complies with Industry Canada’s license-exempt RSSs. Operation is subject to the following
two conditions:
1) This device may not cause interference; and
2) This device must accept any interference, including interference that may cause undesired operation
of the device.”
5150–5250 MHz band is restricted to indoor operations only.