Clinical Benefit; Warnings - Interacoustics Sera Instructions For Use Manual

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Cleaning cloth for touchscreen
Neckstrap for preamplifier
Transducers
SnapPROBE
TM1
OWA Probe 500 mm
1
OWA Probe 1200 mm
IP 30 (50 Ω) insert earphone with Eartip
adapters Kit
1
IP 30 (50 Ω) insert earphone with EarCup
adapters Kit
1
Optional Accessories
Sera
ABRIS Pass Checker
TM
HM-E200
Label Printer
power supply and 2 rolls of thermal label
paper)
Disposables
Assortment of Ear Tips
Infant earcups
Snap Electrodes
Gauze swaps
Conductivity gel
Alcohol pads
Printer label paper
Probe tip kit
Disposables are single use only! Reuse of disposables can impact test results and the patient's safety. Refer
to sections 2.7 Safety precautions. All disposable supplies included with Sera
Supply
. The system has only been tested using disposables manufactured by Sanibel Supply
®
brand disposables could alter the behavior and results obtained with the device and is not recommended.

Clinical benefit

Undiagnosed hearing loss in infants can impact many developmental areas, including language acquisition,
social interactions, emotions, cognitive ability, academic performance and vocational skills. This may
negatively impact the patient's quality of life. The diagnosis of hearing loss can therefore have significant
benefit for the individuals as well as relatives.

Warnings

Throughout this manual, the following meanings of warnings, cautions and notices apply:
D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
1
1
Kit (includes printer,
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 is used to address practices not related to personal injury.
Optional
Optional
Optional
Optional
Optional
Optional
Optional
Optional
Optional
Optional
Optional
are supplied by Sanibel
TM
Optional
Optional
Optional
Optional
Optional
-
-
-
-
Optional
Optional
. Use of other
®
Page 3

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