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8 Notes on Safety
In order to allow safe performance of the ALGO 7i, please read the following notes on safety
carefully and follow the provided instructions. If not followed, risks of danger to persons
and/or the device may be the consequence. Retain this manual for later use and make sure to hand
over this manual to any person who uses this device. Applicable local government rules and regulations
must be followed at all times. Please report any serious incident that has occurred in relation to the
device to the manufacturer and the competent authority of the Member State in which the user and/or
patient is established.
8.1 General Usage
Follow relevant regulations in your facility regarding maintenance and calibration of
audiometric equipment. This includes regular servicing of the device and calibration of
transducers. See section 4: Service and Maintenance.
Do not try to open or service the device and its components yourself. Return the device
to the authorized service partner for all service.
Do not operate the device if its power supply is connected to the device and shows a
damaged cord or plug. Likewise, this is true for any accessory with a separate power
supply (e.g. label printer).
The device needs to be operated in a quiet environment, so that measurements are not
influenced by ambient noises. This may be determined by an appropriately skilled person
trained in acoustics. DIN EN ISO 8253-1 section 11 defines maximum ambient noise levels
for audiometric hearing testing. If not followed, measurement data may not reliably
represent the actual hearing status. See also section 3.5.6: Test Module Information.
The device needs to be operated in an environment with low electromagnetic
disturbance. If not followed, measurement data may be deteriorated by electrical noise.
For calibrated 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.
There are no device parts, which can be serviced during use with a patient. See also
section 4: Service and Maintenance.
8.2 Handling, Transport, and Storage
Do not drop or otherwise cause undue impact to the device or any accessory. If any
damage is suspected (e.g. loose parts inside device), do not use the device, contact Natus
Technical Service or your local Natus authorized service partner for repair.
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