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DEXIS NOMAD Pro 2 - Maintenance and Repair; Maintenance Schedule and Checks

DEXIS NOMAD Pro 2
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3938
NOMAD
7.0 Maintenance and Repair
Incorrect operation or failure to maintain the device in accordance with the maintenance
schedule relieves the manufacturer or their agent from all the responsibilities for
subsequent non-compliance, damage, injury, defect and/or other malfunction. It is
strongly recommended that only authorized service representatives, trained specifically on
the NOMAD Pro 2 device, maintain and service the device.
Modifications and additions to the device (including replacement of power cords and
exposure switches) must be carried out only by personnel or third parties that are expressly
authorized by , and must comply with the applicable legal requirements.
7.1 Maintenance Schedule
The following quality checks and maintenance items can be performed by any trained
personnel. Log sheets for tracking pertinent maintenance information (e.g., what tests
were performed by who on what date) can be found in Section 7.3 Maintenance Log
Sheets.
On-going Maintenance: Observe the following steps for on-going maintenance of the
NOMAD Pro 2.
1. In order to ensure device functionality, schedule the NOMAD Pro 2 for a maintenance
inspection at the manufacturer every five years.
2. Review Section 1.1 Indications for Use and product labeling periodically in order to
verify understanding of indications for use for the NOMAD Pro 2.
3. A routine wipe-down of the NOMAD Pro 2 with a disinfectant cloth or wipe-down
between patients is recommended, along with a quarterly visual inspection for
damage. Make sure the power is off while cleaning. It is recommended for the handset
to be attached during cleaning of the device. Use a non-acetone based disinfectant
wipe or a cloth to wipe the exterior surfaces of the NOMAD Pro 2 and charging cradle.
Do not use cleaners intended for hard surfaces, since certain chemical combinations
may deteriorate the NOMAD Pro 2 plastic prematurely. Also do not use cleaners that
leave any sort of residue or sticky build-up on the device surface. Such cleaners can
eventually interfere with properly connecting and disconnecting the handset.
4. See also Section 5.0 Handset Replacement and Care for more information related to
Handset maintenance.
5. Periodically assess operator familiarity with the NOMAD Pro 2 in order to determine
whether refresher training/certification (per local, national, and jurisdictional
requirements) is needed.
6. Periodically review Section 4.9 Technique Factors Settings and Adjustments for
comprehension and to assess whether or not chart information is being incorporated
into daily use.

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