D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US Page 3
1.6 Included and optional parts
The system consists of the following included and optional parts:
Standard Components for all versions (Screener, Screener+, Standard & Clinical)
TM
device including plug for hook cavity
Micro-Probe1
Micro-USB Power Supply for Charging the Lithium-Ion Battery
Micro B to A USB Cable for PC Communication/Charging
Ear tip Assortment Box
Package of Probe Tubes (100)
Quick Guide DPOAE and/or TEOAE
OtoRead
TM
Module & Auto Print software bundle
Accessories included only in Standard and Clinical version
Carrying Case
Cradle
Carrying Case
Cradle
Printer (with power supply & thermal paper)
1.7 Warnings
Throughout this manual, the following definitions of warning, caution and notice are used:
The WARNING label identifies conditions or practices that may present
danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE
NOTICE is used to address practices not related to personal injury.
Federal law restricts this device to sale by or on the order of a licensed medical practitioner
1.8 Data protection
The General Data Protection Regulation (GDPR) came into force on May 25, 2018 and stipulates how
patient data is handled and stored. The OtoRead
TM
instrument together with the OtoRead
TM
Module and
Auto Print software is used to test patients, store and view measurement data. It is the customer’s
responsibility to ensure that the way you use the software and device and how you share information within
your organization and with third parties is complaint with the guidelines set out in the GDPR.
1
Applied part according to IEC 60601-1
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