VN415/VO425 Specifications

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VN415/VO425 Specifications Item No. 8105231-1 01/2014

Contents VN415 Specifications... 1 1.1 Technical Standards:...1 1.2 System Requirements:...1 1.3 Included and Optional Parts...2 VO425 Specifications... 3 1.4 Technical Standards:...3 1.5 System Requirements:...3 1.6 Included and Optional Parts...4 1.7 Electromagnetic Compatibility (EMC)...5

VN415/VO425 - Technical Specifications Page 1 1.1 Technical Standards: VN415 Specifications Camera: IEEE1394 FireWire Resolution: Images: Safety Standards: 640 x 480 Pixels 105 images per second binocular, 174 images per second monocular IEC 60601-1 (General Safety), IEC 60601-1-1 (System Safety), IEC 60601-1-2 (EMC) Physical Specifications: Google Weight with one camera 240g (non-occluded view) 320g (occluded view) With two cameras: 305g (non-occluded view) 385g (occluded view) Dispensing box with 24 pcs. of disposable google foam pads 302x216x131mm (LxWxH) Tests: Bithermal Caloric Test / Monothermal Caloric Test Spontaneous Nystagmus Test Positional Test Dix-Hallpike Test Sinusoidal Pendular Test (only with rotary chair) Step Rotation Test (only with rotary chair) 1.2 System Requirements: Hardware: Intel Core i5 processor 2.3 GHz or better Minimum 1 GB of RAM Laptop PC: One available34 mm PCExpressCard slot Desktop PC: One available PCI-ExpressCard slot Two USB 2.0 ports available (minimum) Either VGA, DVI HDMI, DisplayPort or Mini DisplayPort available for external monitor Monitor resolution 1024x768 or better Software: Windows 7 professionel(32-bit or 64-bit) Microsoft.Net 2.0 Framework. Windows Installer 3.x

VN415/VO425- Technical Specifications Page 2 1.3 Included and Optional Parts Included parts: Installation CD Combi goggle with 1 or 2 cameras Disposable combi goggle foam pads 1 box / 24 pieces TI Instruments chipset PCI-Express 1394a FireWire Card TI Instruments chipset 34mm FireWire PCExpressCard with power supply USB 2.0-connected foot pedal OtoAccess database software OtoAccess language pack 1.0 Operation manual VNG Quick Guide & Multilingual CE Instruction Booklets: How-to Guides (Tests) & Introduction to Videonystagmography VNG PowerPoint Optional parts: Rotary Chair Irrigator, water or air EN415/EO425 ENG preamplifier Additional foam for Combi Mask LCD projector Flat panel LCD TV Digital Light Bar Stand for flat panel LCD TV

VN415/VO425 - Technical Specifications Page 3 1.4 Technical Standards: VO425 Specifications Camera: IEEE1394 FireWire Resolution: Images: Safety Standards: 640 x 480 Pixels 105 images per second binocular, 174 images per second monocular IEC 60601-1 (General Safety), IEC 60601-1-1 (System Safety), IEC 60601-1-2 (EMC) Physical Specifications: Tests: Google Weight with one camera 240g (non-occluded view) 320g (occluded view) With two cameras: 305g (non-occluded view) 385g (occluded view) Dispensing box with 24 pcs. of disposable google foam pads 302x216x131mm (LxWxH) Bithermal Caloric Test / Monothermal Caloric Test Spontaneous Nystagmus Test Positional Test Dix-Hallpike Test Gaze Test Smooth Pursuit Test (Tracking) Saccade Test Optokinetic Test Sinusoidal Pendular Test (only with rotary chair) Step Rotation Test (only with rotary chair) 1.5 System Requirements: Hardware: Intel Core i5 processor 2.3 GHz or better Minimum 1 GB of RAM Laptop PC: One available34 mm PCExpressCard slot Desktop PC: One available PCI PCExpressCard slot Two USB 2.0 ports available (minimum) Either VGA, DVI HDMI, DisplayPort or Mini DisplayPort available for external monitor Monitor resolution 1024x768 or better Software: Windows 7 (32-bit or 64-bit) Microsoft.Net 2.0 Framework. Windows Installer 3.x

VN415/VO425 - Technical Specifications Page 4 1.6 Included and Optional Parts Included parts: Installation CD Combi goggle with 1 or 2 cameras Disposable combi goggle foam pads 1 box / 24 pieces TI Instruments chipset PCIExpress 1394a FireWire Card TI Instruments chipset 34mm FireWire PCExpressCard with power supply USB 2.0-connected foot pedal OtoAccess database software OtoAccess language pack 1.0 Operation manual VNG Quick Guide & Multilingual CE Instruction Booklets: How-to Guides (Tests) & Introduction to Videonystagmography VNG PowerPoint Optional parts: Rotary Chair Irrigator, water or air EN415/EO425 ENG preamplifier Additional foam for Combi Mask LCD projector Flat panel LCD TV Digital Light Bar Stand for flat panel LCD TV

VN415/VO425 - Technical Specifications Page 5 1.7 Electromagnetic Compatibility (EMC) Portable and mobile RF communications equipment can affect the VNG Install and operate the VNG according to the EMC information presented in this chapter. The VNG has been tested for EMC emissions and immunity as a standalone instrument. Do not use the VNG adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard. Guidance and manufacturer s declaration - electromagnetic emissions The VNG is intended for use in the electromagnetic environment specified below. The customer or the user of the VNG should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3 Group 1 Class B Not Applicable Not applicable The VNG uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The VNG is suitable for use in all commercial, industrial, business, and residential environments. Recommended separation distances between portable and mobile RF communications equipment and the VNG The VNG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VNG can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VNG as recommended below, according to the maximum output power of the communications equipment. Rated Maximum output power of transmitter [W] Separation distance according to frequency of transmitter [m] 150 khz to 80 MHz 80 MHz to 800 MHz d = 1.17 d = 1.17 800 MHz to 2.5 GHz d = 2.23 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.70 3.70 7.37 100 11.70 11.70 23.30 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Guidance and Manufacturer s Declaration - Electromagnetic Immunity The VNG is intended for use in the electromagnetic environment specified below. The customer or the user of the VNG should assure that it is used in such an environment. Immunity Test IEC 60601 Test level Compliance Electromagnetic Environment-Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 +6 kv contact +8 kv air +6 kv contact +8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be greater than 30%. Electrical fast transient/burst IEC61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 +2 kv for power supply lines +1 kv for input/output lines +1 kv differential mode +2 kv common mode < 5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles Not applicable +1 kv for input/output lines Not applicable Not applicable Mains power quality should be that of a typical commercial or residential environment. Mains power quality should be that of a typical commercial or residential environment. Mains power quality should be that of a typical commercial or residential environment. If the user of the VNG requires continued operation during power mains interruptions, it is recommended that the VNG be powered from an uninterruptable power supply or its battery. <5% UT

VN415/VO425 - Technical Specifications Page 6 Power frequency (50/60 Hz) IEC 61000-4-8 (>95% dip in UT) for 5 sec 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or residential environment. Note: UT is the A.C. mains voltage prior to application of the test level. Guidance and manufacturer s declaration electromagnetic immunity The VNG is intended for use in the electromagnetic environment specified below. The customer or the user of the VNG should assure that it is used in such an environment, Immunity test IEC / EN 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any parts of the VNG, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC / EN 61000-4-6 3 Vrms 150kHz to 80 MHz 3 Vrms Recommended separation distance d 1, 2 P Radiated RF IEC / EN 61000-4-3 3 V/m 80 MHz to 2,5 MHz 3 V/m d 1, 2 800 MHz P 80 MHz to d 2, 3 2,5 GHz P 800 MHz to Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, (a) should be less than the compliance level in each frequency range (b) Interference may occur in the vicinity of equipment marked with the following symbol: NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VNG is used exceeds the applicable RF compliance level above, the VNG should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VNG (b) Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m.

VN415/VO425 - Technical Specifications Page 7 To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only the following accessories: Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable lengths are as specified below: Essential performance For this product the following is considered essential performance: To generate and present stimulus signals in the audio range as specified in the applicable IEC 60645 series in normal condition Record and store patient response