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The calibration clock will count down to 0 days until calibration due, and will award a 90-day grace
period before disallowing hearing screening with that ATA Cable.
REGULATORY BACKGROUND:
For the device and its transducers, an annual metrological inspection following §11 Clause 2 of the
medical device operator act (MPBetreibV, Germany) must be conducted by a service partner who is
authorized by PATH MEDICAL. The measurement principle of acoustically evoked potentials (AEP) is
not explicitly described in MPBetreibV. Therefore, the manufacturer is obliged to define metrological
inspection instructions. DIN EN 60645-7 (AEP) suggests an annual inspection interval.
EXPLANATION:
The device and its accessories contain parts, which are exposed to environmental impacts and
contamination. In order to ensure an accurate measurement function, the fault tolerance provided by
the manufacturer or defined by applicable standards needs to be controlled by specifically designed
instrumentation and defined procedures. Therefore, metrological inspection must be conducted by
authorized service partners instructed and trained by PATH MEDICAL.
For acoustic transducers differences in environmental conditions between the point of
calibration and the point of use may influence the calibration accuracy. For more
information please refer to section 8.2: Handling, Transport, and Storage.
In addition to the annual metrological inspection, a regular visual inspection and a regular
check for correct operation of the device and its accessories is recommended. Guidelines
for routine inspections are provided e.g. in DIN EN ISO 8253-1 for pure-tone audiometry. Please follow
local regulations or guidelines.
4.3 Repair
If a defect of any kind is suspected, or calibration of cables is due, Natus, or an authorized service
partner will repair, re-calibrate or exchange the device or accessory. All repairs are subject to parts and
material availability. Prior to sending any equipment for repair, please provide relevant information to
your service partner (e.g. model, serial number, firmware version, contact information, shipping
information, detailed description of experienced issue or defect). In the United States and in countries
where Natus Medical directly distributes the device, ALGO 7i ATA Cable calibration and repair service
is performed by Natus Medical through Natus Technical Service. Outside the above- mentioned
territories, local distributors can organize ATA7i Cable calibration service and repair service through an
authorized Natus technical service center. There are no user serviceable parts inside the ALGO 7i
screener. Disassembling the ALGO 7i screener or any of its components will void the manufacturer
warranty.
In the United States, contact Natus Technical Service at (888) 496-2887 or (650) 802-0400. Outside
the United States, please contact your authorized service representative.
See also sections 4.1: General Service Information and 7: Warranty.
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