COMPLIANCE
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Is it FDA compliant?
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This device is not FDA-cleared or approved. This temperature device should not be solely or primarily relied upon to diagnose or exclude a diagnosis of
COVID-19, or any other disease or health condition. Elevated body temperature in the context of use should be confirmed with secondary evaluation methods, such as a non-contact infrared thermometer or clinical grade contact thermometer.
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Is it HIPAA compliant?
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The Personnel Management Solution has not been validated against HIPAA. The Personally Identifiable information is Guests: Picture (if enabled) + temperature
+ time. For Recognition mode: Picture + Employee Number + Temperature Reading + Employee Name + Time of entry. The intent of the access kiosk is for building access / security, it’s not intended to be used for patient diagnosis.
Similarly, it does not manage or create EHR System, it only records access granted events, date and time of people with a nominal temperature. Face recognition would recognize known people, but only if they had been setup with an employee ID, name, and photo for face recognition in advance. If there is no face database no name, just an entry time and a temperature. This would be the same amount of information as you would get from a security camera or door access system.
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Is it FCC compliant?
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Yes, the applicable standard is ANSI C63.4- 2014 (Information Technology Equipment). It has been assigned against CISPR PUB. 222, FCC Part 15 Subpart B and has the FCC mark. TAF testing laboratory 1439. Attestation of conformity is available on request.
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Is the unit CE approved?
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Yes. Directive(s) REDS 2014/53/EU, Attestation number 2003118. Applicable standards ETSI EN 300 328 V2.1.1 (2016); EN 62311:2008; ETSI EN 301 489-1 V2.1.1 (2017); ETSI EN 301 489-17 V3.1.1. Attestation of conformity is available
on request.
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What certifications does it have?
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The device has FCC and CE certifications.
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SOC 2 compliant?
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If you leverage Meridian's central management server, Meridian's hosting facility is SOC 1 & 2 Compliant. This would include data once at rest.
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Is there a setting that does not store the temperatures?
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For clients with version 2.0.0.25 and an MzeroManage subscription there is a setting for Record Temperature Values that you can disable, which will log a FAIL/PASS instead of the temperature on the kiosk’s screen and in the MzeroManage server. This configuratino setting is currently not available on the kiosk side for non-MzeroManage subscribers but a local setting will be available in the next generally available release.. For non-subscribers, The kiosk will record the temperature and time of all who were approved but these would only be for nominal temperatures. On the MzeroManage side, if this is required, we can add additional code to opt-out of storage of this data. Only 1GB of scan history is retained on the device.
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Is it UL Certified?
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We are discussing adding a ULc power brick (the only source of power) to the device, the one it comes with by default is just CE only.
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Where do we send it to be
re-calibrated or certified? Is there on-site service?
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If needed, kiosk administrators can adjust the temperature compensation value of the device. To do so, navigate to Settings Screen > Temperature Detection Settings > Compensation temperature. The default value is 0.3 + for normal conditions.
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