Following information is part of the intended use according to /wiki/spaces/QA/pages/1800011780 , Annex II, 1.1 c and /wiki/spaces/QA/pages/176685192 , 5.2.
Intended Medical Indication / Claim
The product is used to present information on the performance of the peripheral vestibular function by providing objective measures of eye-movement with or without stimulation of the balance organ in general as well as eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.
It enables the recording of eye movements in response to head movements without making a diagnostic statement about the user's state of health. The results are intended to serve as a tool for professionals to observe and analyze the functionality of the vestibular system.
Contraindication
Blindness
Broken nose or other face/head trauma
Problems with the cervical spine, e.g., neck trauma, acute cervical disc herniation
Recent eye surgery
Ptosis on measurement eye
Excessive eye blinks
Excessive eye make up
Contact with insured skin
Patient Population
The product is intended for patient from 6 years and up. The patient must be physically sound as the procedures include some physical stimulation/movement. Patient must be able the see the target without the use of spectacles.
Following information is part of the intended use according to /wiki/spaces/QA/pages/176685192 , 5.2.
Part of the Body / Type of Tissue Interacted With
Head / intact skin only
User Profile
The system is to be used by trained personnel only such as audiologists, ENT surgeons, neurologists, hearing healthcare professionals or personnel with a similar level of education.
Use Environment
Operating Environment |
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Environment during storage and transport |
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Operating Principle
The device is worn like a goggle and fastened with a headband. Infrared light is emitted by the goggle and reflected by the eyeball. The reflected image of the eyeball is deflected by an infrared mirror through an infrared filter through a lens to the camera. One or two cameras can be installed for recording the image of one or both eyes. The system identifies the position of the pupil in the image and tracks the pupil position over time.
The system records determines the spatial position of the head relative to an adjustable origin. The head position is tracked over time.
The system continuously calculates the speed of head motion in one of three selectable spatial dimensions. When a adjustable speed threshold is detected, the system records pupil- and head positions for 1 second. Both head and eye positions are used to calculate the speed of the eye- and head-motion during the recording. The speed of eye and head motion are presented to the examiner for comparison. A quantitative comparison of eye and head speeds are provided for convenience at specific points in time and interval.
The following information cover the additional requirements regarding the “intended use” introduced by /wiki/spaces/QA/pages/1168212010 (chapter 3.71).
Service
Repairs to the appliance may only be carried out by the manufacturer or by maintenance companies that have been instructed to do so by the manufacturer.
Cleaning
Housing, cover, face cushion: ZB125.AR1, Mikrozid universal wipes
Mirror:
ZB115.AR1, spectacle cleaning cloth
ZB115.AR2, spectacle cleaning cloth, moist
Update
Hardware updates are carried out exclusively by the manufacturer.
Firmware updates can be installed by the user via the front-end software.
The front-end software is provided via the app stores of the operating system manufacturers Microsoft and Apple.
Backend software updates are carried out by the manufacturer or by service companies instructed by the manufacturer.Storing
Download
Software updates and release notes are provided at www.hno.services together with the associated release notes. They can be installed by the manufacturer at the customer's request.
Storage
Temperature | 5 – 45°C |
Relative Humidity | 30 – 90% |
Ambient Pressure | 70 – 106 kPa |
If the device is to be temporarily stored or transported, please ensure that the storage room or vehicle is dry and that the temperature remains within the range specified in the link above during storage. This applies to both packaged and unpackaged devices.
After storage, allow the appliance to reach room temperature for at least one hour before using it.
Transport
Temperature | 5 – 45°C |
Relative Humidity | 30 – 90% |
Ambient Pressure | 70 – 106 kPa |
The appliance will be delivered to you in a cardboard box provided for this purpose. It is advisable to store the packaging. In the event of a defect or maintenance that is to be carried out by post, the original packaging is helpful and may prevent transport damage.
Please check the carton and contents for damage and completeness immediately after each shipment or transportation and notify the transport company of any defects without delay.
After transportation, allow the appliance to adjust to room temperature for at least one hour before using it.
Disposal
One day, this appliance will also become obsolete, worn out, no longer fulfill its purpose and need to be replaced. The device contains electronic components and environmentally harmful materials that must be disposed of and recycled properly. The device must not be disposed of with normal household waste. Please contact your local authority to find out about the responsible disposal companies for electronic waste, which can dispose of the device properly and in accordance with local regulations.
It is also possible to return the appliance to the manufacturer for disposal.
Warranty
The manufacturer is only liable for the safety, reliability and scope of performance of the device if the following conditions are met:
Installation, extensions, new settings, modifications and repairs may only be carried out by specialist personnel authorized by the manufacturer.
The mains supply to which the appliance is connected is earthed and complies with local IEC regulations (please consult your local electrician)
The appliance is operated in accordance with the operating instructions.
The manufacturer reserves the right to decline all responsibility with regard to the safety, reliability and operation of the appliance if it has been repaired, maintained or modified by a third party.