D-11049-2, Ver 11
Page 20 of 26
WARNING
Hazard:
The patient experiences discomfort when the ear tip is inserted into the ear canal.
Remedy:
The operator must check whether the ear tip selection is incorrect and replace with a properly fitting ear tip.
Hazard:
Audible levels are uncomfortable for the patient.
Remedy:
The operator must immediately select a lower setting for the stimulus levels.
Hazard:
In ABR testing skin at the site of the electrode application is damaged, for example, irritated (red), scratched, bruised, sore, cut, wounded,
or bleeding.
Remedy: Do not conduct skin preparation and electrode application on areas of damaged skin. Choose another electrode location, wait until
healing is complete, consult a dermatologist, or refer the patient to a healthcare professional trained to deal with skin damage.
WARNING
Electronic Disposal
DO NOT dispose of equipment in unsorted, municipal garbage.
Take discarded equipment to the appropriate electronic waste disposal facility.
Environmental Conditions for Transport and Storage
Integrity (with Battery Pack)
Integrity (without Battery Pack)
Ambient temperature of -20
C to +50
C (for 30 days)
Ambient temperature of -20
C to +40
C (for 90 days)
Ambient temperature of -20
C to +30
C (for 1 year)
Relative humidity of 10% to 100%
Atmospheric pressure range of 500 hPa to 1060 hPa
Ambient temperature of -40
C to +70
C
Relative humidity of 10% to 100%
Atmospheric pressure range of 500 hPa to 1060 hPa
Environmental Conditions for Use
Ambient temperature of 10
C to 39
C
Relative humidity of 30 % to 75 %
Atmospheric pressure range of 700 hPa to 1060 hPa
CAUTION
Following the "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Device", issued by FDA on
September 9, 1999, the customers should not use any software other than that specified, as it will violate the safety, effectiveness and design
controls of our Integrity V500 and that such use may result in an increased risk to users and patients.
Unauthorized alteration of software provided, including downloading non-validated or unauthorized off-the-shelf software may void or breach
existing service agreements and warranties. For additional information, contact Vivosonic Inc.'s Customer Support.
CAUTION
Please follow these recommendations to ensure the test data is accurate.
Substitution of any supplied components with different components may result in measurement error.
No other software may be installed onto the computer on which the Integrity™ software is installed.
Handle the system with care.
The system requires calibration of the transducers – A81/A82 Amplitrodes, A90 VivoAmp, Insert Earphones, B71W Bone Conductor, OAE
probes, and EP headphones – annually on each anniversary from the date of manufacture, and every time a transducer is dropped,
subjected to mechanical shock, or immersed in a liquid substance. Otherwise, stimuli presented to the patient as specified may lead to
incorrect test results and misdiagnoses.
DO NOT force the ear tip into the ear canal.
Always carry this device with you when traveling to avoid mishandling and damage of stored or checked luggage.
DO NOT ship this device for service in packaging other than the packaging supplied with the system from the manufacturer, or
comparable packaging.
Signal inputs and outputs are intended for analysis only in connection to the specified equipment described in this manual.
The product DOES NOT require sterilization. Alcohol can be used to clean the transducers.
This equipment does not have protection against water penetration (IPX0).
The system can only be repaired by Vivosonic Inc. or authorized dealers of Vivosonic Inc.
