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Vivosonic Integrity V500, Быстрая справка

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D-11049-2, Ver 11 

 

Page 22 of 26 

 

 

Radio Transmissions 

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. 
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment 
generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, 
may  cause  harmful  interference  to  radio  communications.    However,  there  is  no  guarantee  that  interference  will  not  occur  in  a 
particular installation.  If this equipment does cause harmful interference to radio or television reception, which can be determined 
by  turning  the  equipment 

off

  and 

on

,  the  user  is  encouraged  to  try  to  correct  the  interference  by  one  of  more  of  the  following 

measures: 

 

Reorient or relocate the receiving antenna. 

 

Increase the separation between the equipment and receiver. 

 

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 

 

Consult the dealer or an experienced radio/TV technician for help. 

 

This device complies with Part 15 of the FCC Rules and RSS 210 of Industry Canada.  Operation is subject to the following two 
conditions: 

(1)  this device may not cause harmful interference, and 
(2)  this device must accept any interference received, including interference that may cause undesired operation of this device. 
 

 CAUTION: Exposure to Radio Frequency Radiation. 

This device must not be co-located or operating in conjunction with any other antenna or transmitter. 

 

 WARNING 

Changes or modifications not expressly approved by Vivosonic could void the user′s authority to operate the equipment. 
 

B

ASIC 

T

ROUBLESHOOTING

 

Fully charged battery pack loses charge after < 1 hour. 

 

Replace your battery pack with a new one 

The system starts, but displays error messages. 

 

Printer drivers installed by the operator may not be compatible with the Integrity System. 

 

Contact customer support if this problem persists. 

Bluetooth® wireless connection fails. 

 

Move your Link within 30 ft. (10 m) of your computer. 

 

Power off and on your VivoLink™ to reset it.  Check for low battery ( 

 ). 

 

Refer to the Bluetooth Troubleshooting section of the Integrity V500 User's Manual installed on 
the Integrity Computer. 

 

Contact customer support if this problem persists. 

Noise remains high after troubleshooting (diagnostic) 

 

Retest at another time. 

Noise remains high after troubleshooting (screening) 

 

Rescreen at another time. 

Maximum test time is reached 

 

Calm patient, reduce noise and interference. Rescreen as appropriate. 

Customer Support: 1-877-255-7685 (Canada & US), 1-416.231.9997 (Intl) 

 

 

 

Содержание Integrity V500

Страница 1: ...Generation 2 G2 Please refer to the Integrity User s Manual D 11049 for complete software operating instructions A PDF of the User s Manual is on the desktop of your Integrity computer QUICK REFERENCE ...

Страница 2: ...grity V500 system They have been tested and verified to work with our system and provide the optimal results To order additional electrodes please contact Vivosonic Customer Support at 877 255 7685 Canada US or 1 416 231 9997 Intl WINDOWS INTEGRITY V500 SETTINGS Your Integrity V500 system has been optimized to work with the Windows Operating System Vivosonic has configured the system settings to w...

Страница 3: ...plitrode is protected by US Pat No 7 206 625 and 7 548 774 Other patents pending in the US and other countries Integrity Amplitrode VivoAmp VivoLink and Vivosonic are all either registered trademarks or trademarks of Vivosonic Inc in the U S and other countries All other trademarks are the property of their respective owners COPYRIGHT NOTICE 2017 This Quick reference guide is copyrighted by Vivoso...

Страница 4: ...ould be taken if the incident occurs CAUTION Messages with this heading indicate information regarding any special care to be exercised by the practitioner and or patient for the safe and effective use of the device All precautions should be followed to ensure data and system integrity ATTENTION Messages with this heading indicate a possible loss of data Follow the procedures to ensure data integr...

Страница 5: ...before use Clean surfaces of equipment with disinfectant Eliminate where possible the electro magnetic noise in the room INSTALL THE BATTERY PACK INTO THE VIVOLINK Battery packs have a life expectancy of 5 7 months You may have to replace the battery packs after this period 1 Open the VivoLink battery compartment 2 Remove and set aside any previously used batteries 3 Place the battery pack in the ...

Страница 6: ...ed from the list by clicking on the left most row header shown the grey area shown below 6 Click on the Test button to display the Test Window 7 Select a Test Type from the side menu 8 Wait until the initialization process is complete This may require up to 20 to 30 seconds The wireless Bluetooth connection indicator blinks on and off during this time 9 When initialization is completed check the f...

Страница 7: ...imited shelf life after which they start to lose their effectiveness SKIN ELECTRODE AND AMPLITRODE VIVOAMP CLIP APPLICATION After proper skin preparation procedures electrodes can be attached to the skin The electrodes are intended for single use only and should not be reused to prevent patient cross contamination and to ensure good electrode skin contact To apply an Ambu Neuroline Electrode to th...

Страница 8: ...s use the spring release button on the VivoAmp clips when clipping to or unclipping from skin electrodes do not pull on the VivoTab electrodes EAR TIP INSERTION Before starting a test using Insert Earphones ear tips the ear canal must be clean free of damage or disease and clear of any obstructions to ensure good continuity between the surface of the ear tip and the tissue of the ear 1 Inspect the...

Страница 9: ...nes Use when performing ABR testing using air conduction B71W Bone Conductor Use when performing ABR bone conduction testing To perform data collection connect the B71W Bone Conductor to either the left or right mastoid or the forehead Secure the headband supplied with the B71W Bone Conductor Ensure that the entire circular surface of the Bone Conductor is in full contact with the skin Only use th...

Страница 10: ...will be displayed stating either that the level is acceptable or it will indicate which electrode needs to be reapplied Before reapplying the electrode repeat the skin preparation procedure See User s Manual on Computer Desktop RUN THE TEST 1 Select the appropriate protocol Please refer to the Integrity User s Manual PDF on the computer desktop for more detailed instruction 2 Select the appropriat...

Страница 11: ...OOSE A TRANSDUCER PREPARE THE PATIENT Refer to the Patient Preparation section for Electrode application Ear preparation and ear tip insertion Skin preparation ELECTRODE SITES FOR ABR SCREENING High forehead black clip Shoulder green clip ground Nape of neck blue clip RUN A SCREENING TEST 1 Select the Auto ABR Test button on the Main screen 2 Enter information into the Patient Information screen o...

Страница 12: ...ested to display the EcochG trace AP up 9 Clip the non inverting Amplitrode or 1 2 VivoAmp clip to the snap on the cable that corresponds to the other ear Use the reverse set up to get the EcochG trace AP down APPLY GROUND ELECTRODE AND CLIP FOR 1 CHANNEL ECOCHG A81 A90 For EcochG testing one snap electrode is applied to the low forehead of your patient This electrode functions as the ground elect...

Страница 13: ... be placed in a chair or on a couch whichever is more comfortable for the patient and the operator Tests are conducted with the patient relaxed lying down or in a chair with the neck supported Patients are encouraged to sleep during the test Infant Patient Tests are conducted with the infant sleeping or lying down and very relaxed Place the VivoLink next to the infant close enough for the Amplitro...

Страница 14: ...sure that your OAE probe is correctly calibrated 1 Place your OAE probe into the OAE probe holder 2 Select the Cavity Check button on the Test Window 3 Wait for the results to appear in the message area of the Test Window 4 You can proceed with testing when the messages indicate Cavity Check Passed If cavity check fails inspect the probe for debris and clean the probe if necessary Reinsert the OAE...

Страница 15: ... couch whichever is more comfortable for the patient and the operator Tests are conducted with the patient relaxed lying down or in a chair with the neck supported Patients should remain awake Infant Patient 40 Hz ERP testing may not yield repeatable results in infants If nevertheless you wish to conduct tests on infants conduct the tests with the infant lying down and very relaxed but not while t...

Страница 16: ...se sensitive It is set in the System Window The default password is blank 3 Highlight a record in the database by clicking on the leftmost row header grey area to preview the test results Each test type has a different database preview window seen in the figures below QUERY THE DATABASE 1 Select a column in the query area of the Database Window For example Patient Info is a common column to query ...

Страница 17: ...ard drive failure it is recommended that your database be backed up regularly The system backs up automatically as well when the system is closed BACKUP YOUR DATABASE 1 Select the System button to display the System Window 2 Select the Backup Database button 3 Complete the Save Backup File As window with the location and name of your BAK backup file RESTORE YOUR DATABASE FROM A PREVIOUS BACKUP 1 S...

Страница 18: ...ther batteries may damage the charging system and or the batteries and endanger the user Use only the Battery Charger REF 100351 and Battery Pack Cradle REF 100410 supplied with your product to charge the Vivosonic Battery Packs REF 100020 Do not use the Battery Charger REF 100351 and Battery Pack Cradle REF 100410 to charge any other batteries The Battery Packs are meant to be replaced after abou...

Страница 19: ...uipment is not suitable for use in the presence of an inflammable anesthetic mixture with air oxygen or nitrous oxide Changes or modifications not expressly approved by Vivosonic Inc could void the user s authority to operate the equipment To avoid accidental swallowing of inhalation of an ear tip do not leave ear tip s within reach of a child Patients should be attended during preparation and tes...

Страница 20: ... 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 existin...

Страница 21: ...hetic the r h should be at least 30 EFT IEC 61000 4 4 2kV Mains 1kV I Os N A Battery Operated Device N A Surge IEC 61000 4 5 1kV Differential 2kV Common N A Battery Operated Device N A Voltage Dips Dropout IEC 61000 4 11 95 Dip for 0 5 Cycle 60 Dip for 5 cycles 30 Dip for 25 Cycles 95 Dip for 5 Sec N A Battery Operated Device N A Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 3A m 3A m Powe...

Страница 22: ... the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation of this device CAUTION Exposure to Radio Frequency Radiation This device must not be co located or operating in conjunction with any other antenna or transmitter WARNING Changes or modifications not expressl...

Страница 23: ...emove particles from the sound canals and vent with the wax removal tool The vent a tiny hole above the cable at the back of the Probe is to ensure the release excessive pressure from the occluded ear canal DISINFECTING THE OAE PROBE 1 The Probe should be wiped with disinfecting wipes after each use Hold the Probe tip down to avoid any ear wax or sanitizing liquid from entering the microphone soun...

Страница 24: ...red H 800 1 Item if ABR Screening is Ordered REF Model Part Qty VivoAmp A90 1 VivoAmp Alligator clips WA065 1 Insert Earphone ER 3C 800 1 VivoTab Electrodes 100001 10 pkgs Insert Earphones Eartips Kit RA063 1 Ear Phone Adapter Set ER3 06 ABR 1 Foam Eartips 10 mm ER3 14B Manufacturer Etymōtic Research 1 pkg Silicone Eartips 3 5 mm ER3 14D Manufacturer Etymōtic Research 1 pkg PDI Electrode Prep Pads...

Страница 25: ...njury or damage to health is possible IEC 62304 2006 Wireless Communication Type Bluetooth 2 402 to 2 480 MHz Hopping Contains transmitter module FCC ID ED9LMX9838 IC 1520A LMX9838 Wireless Signal Strength 0 66 mW EIRP Emission Designation 2M00G1D Duty Cycle 77 02 Wireless Communication Range 30 feet 10 meters Dimensions of Main Unit L 7 1 18 cm x W 3 6 9 1 cm x H 1 2 3 2 cm Weight of Main Unit 0 ...

Страница 26: ...e Cell battery AA Cell size NiMH Nickel Metal Hydride battery NiMH CE Mark with notified body number TÜV SÜD certification 81763 FCC mark The National Institute of Metrology Standardization and Industrial Quality Inmetro UL do Brasil UL of Brazil 02864 09 05756 Agência Nacional de Telecomunicações Brazilian telecommunications regulator our registration number The equipment shall not be disposed of...

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