natus Echo-Screen III Pro, Instructions For Use Manual

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026057 RevE 2 © 2020 Natus Medical Incorporated
Safety Information Echo-Screen III Pro Instructions for Use
Safety Information
Definitions
This manual describes three types of precautionary information, all of which are equally
important to the safe and effective use of the device. These types of information are identified
and used in this manual as follows:
IMPORTANT: An instruction provided to help ensure correct clinical results and provide quality
assurance to screening procedures.
Precautions
The following warnings and cautions pertain to the use of the Echo-Screen III Pro hearing
screener. Additional warnings and cautions are provided throughout this manual as they apply
to specific content.
WARNING A condition or practice that might present danger or possible injury to the patient and/or
user. Refer to accompanying documentation.
CAUTION An instruction that, if not followed, can result in damage to the device or loss of data.
WARNING

Do not use the screener if you suspect it is not functioning properly or if any parts
appear damaged or missing. Contact Natus Technical Service or your authorized
service provider for assistance.

Do not use the Echo-Screen III Pro device for screening while it is docked in the
docking station or plugged into external power.

Do not connect external power or a USB cable from the device to a computer while
the device is connected to a patient.

Single-use screening supplies (ear couplers, sensors/electrodes, ear tips/inserts)
and their packaging materials, as well as parts of the screening system that may
come into contact with the bassinet, contain small parts that may present a choking
hazard. Supplies and packaging should be placed away from the baby’s head and
hands while preparing to screen. When screening is completed, screening supplies
and all packaging materials should be accounted for and disposed of properly.

The OAE/ATA port is intended to connect the OAE cable or ATA cable to the
Echo-Screen III Pro device. No other cable should be connected to this port.

The PCA cable port is intended to connect the PCA electrode cable to the
Echo-Screen III Pro device. No other cable should be connected to this port.

Make sure that any platform, table, cart, or other surface used during the operation,
transport, or temporary or permanent storage of the system and its components is
adequate, sturdy, and safe. Natus is not responsible for any injury or damage that
may result from inadequate, poorly constructed, or unapproved transports, carts, or
operating surfaces.

Any use of the earphones or the ATA earphone cable other than that described in this
manual may result in screening at unknown and uncontrolled decibel levels.

AC adapter units are not interchangeable. Use only the AC adapter supplied with the
Echo-Screen III Pro device. Using an AC adapter supplied for other devices, such as
notebook computers or printers, can cause damage to the Echo-Screen III Pro
device.

A communications failure or data coupling error between the Echo-Screen III Pro
device and the external PC can create a loss of data and delay in diagnosis