Grason-Stadler gsi 39 User Manual Download

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Combo Probe -related Components

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Combo Probe (226 Hz / 1kHz Version)

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Audiometry Headset, DD45 (Version 3 and Version 4)

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Contralateral Insert Phone (Version 2 and Version 3)

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Insert Phone Ear Tips (8 sizes, 4 each) (Version 2 and Version 3)*

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Probe Eartips (6 sizes, 2 each)*

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Audiometry Headset, DD45 (Version 3 and Version 4)

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Contralateral Insert Phone (Version 2 and Version 3)

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Switching Power Adapter

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2m USB Cable

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Test Cavity

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Operating Instructions (on USB drive)

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GSI Suite (on USB drive)

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Wall Chart, 226 Hz

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4” Thermal Paper, 3 rolls

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Tubing Replacement Kit

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Probe Cleaning Kit, Floss

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Probe Mount, Wrist

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Probe Mount, Shoulder

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Wall Chart, 1kHz

Optional Accessories

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Dust Cover

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Carrying Case

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Patch Cord

•

Subject Response Handswitch

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Audiocups Earphone Sound Enclosures

•

Service Manual USB Bundle

•

Insert Phone Assembly

*Applied parts according to IEC 60601-1

Summary of Contents for gsi 39

Page 1: ...USER MANUAL A Setting The Clinical Standard www grason stadler com Grason Stadler 10395 West 70th Street Eden Prairie MN USA 55344 800 700 2282 952 278 4402 fax 952 278 4401 e mail info grason stadle...

Page 2: ...ission of Grason Stadler The information in this publication is proprietary to Grason Stadler Compliance The CE 0123 mark identifies compliance with the Medical Device Directive 93 42 EEC Grason Stadl...

Page 3: ...tion Additional Equipment 16 Warning Electric Shock Hazards 16 Warning Explosion 16 Warning Connections 16 Warning General 16 Warning Voltage Current Detectors 17 Recycling Disposal 17 Warranty and Re...

Page 4: ...flex Screen 38 Audiometry Screen 39 Tympanometry Testing Information 40 Obtaining a Seal 40 Combo Probe Insertion 42 Audiometry Testing Version 3 and Version 4 43 Instructing the Patient 43 Placement...

Page 5: ...57 Exit audiometry 57 Tests in memory 57 Page mode 58 Memory erase 58 Printing test results 58 Program Mode 59 Program Mode 59 Program Mode Menu Items 59 Program Menu Page 1 Option Descriptions 60 PRO...

Page 6: ...al Printer External Printer 69 RESET TO DEFAULTS 70 Exiting the program mode 70 Routine Maintenance 71 Pretest Tymp Checks 71 Calibration Quick Check for 226 Hz 72 Calibration Quick Check for Combo Pr...

Page 7: ...89 Gradient 89 Normal 89 Abnormal 89 Acoustic reflex 90 Normal 90 Abnormal 90 Audiometry 90 Normal 90 Abnormal 90 Special Messages and Error Codes 91 Sample Test Results 92 Computer Interface 95 Intro...

Page 8: ...s 102 Audiometry mode Versions 3 and 4 only 102 Transducers 102 Intensity Levels 103 Tone Format 103 Printer 103 Power 104 Environmental 104 Mechanical Instrument 104 Appendix C Glossary of Terms 105...

Page 9: ...id potential problems during system operation Safety Notes WARNING The GSI 39 is designed for compliance to IEC and UL 60601 1 when used in the patient vicinity To achieve this compliance the GSI 39 i...

Page 10: ...anual accompanying labels and or inserts A defective product should not be used Parts which may be broken or missing or are plainly worn distorted or contaminated should be replaced immediately with c...

Page 11: ...Page 11 of 112 Periodically have a service technician perform electrical safety checks on the unit in order to show continued compliance to IEC and UL 60601 1...

Page 12: ...nce with UL 60601 1 Classified under the Medical Device Directive 93 42 EEC as a Class IIa device Symbol for European Representative Symbol for Manufacturer Symbol for Date of Manufacture China RoHS s...

Page 13: ...uctions directions for use A copy of the operating manual is available on this website www grason stadler com A printed copy of the operating instructions can be ordered from Grason Stadler for shipme...

Page 14: ...pear on the instrument Symbol Description Type B Equipment Attention Consult Accompanying Documents Stand By Switch DC Power Patient Response Handswitch Left Ear Right Ear Printer Connector Computer C...

Page 15: ...essional skills when interpreting the results and this should be done in conjunction with other testing as deemed appropriate given their professional skills The maximum sound levels that can be gener...

Page 16: ...re intended for use with GSI approved components only Use of any other equipment may result in damage to the power unit Follow all safety standards set by each place of employment NOTE If the Instrume...

Page 17: ...s printed circuit boards electronic components wiring and other elements of electronic devices Follow all local laws and regulations for the proper disposal of batteries and any other parts of this sy...

Page 18: ...ion due to rough handling or impact dropping The lifetime of probe probe seals and eartips is dependent upon conditions of use These parts are only guaranteed against faulty materials or manufacture T...

Page 19: ...lex measurements Version 3 tympanometry alone tympanometry plus ipsilateral and contralateral screening acoustic reflex measurements and screening audiometry both manual and automated Version 4 tympan...

Page 20: ...tting equipment cellular phones etc should not be used in the close proximity of the device since this could influence the performance of the device Particular caution must be considered during use of...

Page 21: ...obility as a function of pressure While the recording is visualized in the horizontal direction X axis as a function of differential pressure across the eardrum the tracing also moves in the vertical...

Page 22: ...of the tympanogram peak height Differing tympanogram peak widths can point to different middle ear conditions even when peak height and pressure are within normal range For example middle ear effusion...

Page 23: ...nerve Since the acoustic reflex test ipsilateral or contralateral is performed at high intensity levels and since it involves a measurement of middle ear mobility acoustic reflex testing is not a test...

Page 24: ...eening test protocols define the frequencies and intensity sequence to be used to obtain a response Audiometric testing requires a behavioral response from the individual being tested This consists of...

Page 25: ...ng or damaged notify a GSI Distributor or the factory immediately NOTE Keep the original packing material and shipping container so the instrument can be well packaged if it needs to be returned to th...

Page 26: ...4 Contralateral Insert Phone Version 2 and Version 3 Switching Power Adapter 2m USB Cable Test Cavity Operating Instructions on USB drive GSI Suite on USB drive Wall Chart 226 Hz 4 Thermal Paper 3 rol...

Page 27: ...green and yellow lamps are illuminated at the same time following power on the probe is occluded or the tympanogram software did not initialize properly Simply move the power switch to the off positi...

Page 28: ...Page 28 of 112 Components DISPLAY AND PRINTER PROBE 226 HZ COMBO PROBE 226HZ AND 1KHZ Paper cover Probe holder Probe cable connector Probe Printer L C D...

Page 29: ...0601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Everyone who connects additional equipment to the signal input or signal output part con...

Page 30: ...strument is supplied with a thermal printer This type of printer requires a heat sensitive paper to create an image For maximum paper life any spare rolls of paper should be stored as follows a Store...

Page 31: ...s P1 Yellow The probe is occluded Remove the probe and inspect for cause of occlusion P2 Green lamp Blinking The instrument is ready to begin a Tymp Steady green Test successfully started and in progr...

Page 32: ...NING Ensure that the Insert phone cable plug is inserted all the way into the jack for operation WARNING To ensure the accuracy of calibration the tygon tubing supplied with the ipsilateral probe asse...

Page 33: ...am The White Flat ear tips allow the user to place the probe and hold the Probe Tip at the entrance to the patient s ear canal while the tympanogram and reflex testing are performed WARNING A GSI prov...

Page 34: ...s through the test results stored in memory F5 M Erases currently displayed page of data from memory F6 M Erases all pages of data from memory F7 Data Transfer Transfers test results to an attached co...

Page 35: ...ngage the insert earphone calibration file The symbol is shown on the center of the display if selected F13 and F14 Decrease and Increase Frequency Selecting advances the presentation tone to the next...

Page 36: ...nly mode F23 Tymp Reflex Selects Tympanometry and Reflex mode F24 226Hz Selects 226 Hz for Probe Tone Frequency F25 1KHz Selects 1000 Hz for Probe Tone Frequency F26 IPSILATERAL Selects an ipsilateral...

Page 37: ...width H Pressure sweep scale in daPa 226 Hz Tympanometry Reflex Screen A ASHA Box B Scale of Tympanogram Compliance C Test Ear D Reflex Stimulation Routing IPSILATERAL or Contralateral E Frequency of...

Page 38: ...ssure Margolis et al 1000 Hz Tympanometry Reflex Screen A Indicates 1000 Hz Probe Tone B Scale of Tympanogram Compliance C Test Ear D Reflex Stimulation Routing IPSILATERAL or Contralateral E Frequenc...

Page 39: ...Indicator G Indicates Signal is being presented when displayed H Patient Response Switch is being pressed I M A Denotes Manual or Auto HL Procedure J Transducer currently selected be sure the correct...

Page 40: ...tone on infants we recommend turning the Auto Start option off factory default setting This will allow the probe to be positioned and will allow repeated tests without removing the probe The key to s...

Page 41: ...he ear canal applying a gentle pressure to maintain a tight seal See image below Positioning the probe 226 Hz only probe 1 Watch the probe lamp As soon as a good seal is obtained the blinking green la...

Page 42: ...e eartip should be pushed firmly onto the tip of the probe until it is fully seated The three probe tubes should be nearly flush with the top surface of the eartip Inserting the Combo Probe Insert the...

Page 43: ...ou hear one of these tones raise your hand Lower your hand when you no longer hear the sound Remember raise your hand when you hear the tone and lower your hand when you do not NOTE Modify the instruc...

Page 44: ...rtip well into the ear canal Interauaral attenuation is improved with deep insertion 6 Allow foam to expand to acoustically seal ear canal 7 Discard foam eartips after a single use NOTE If using inser...

Page 45: ...t ear after the probe is placed in the ear canal 3 Examine the ear canal to determine the appropriate size eartip for the test and position the eartip on the probe Be certain that the eartip is pushed...

Page 46: ...ear canal prior to testing To begin the pressure sweep press the button The pressure sweep rate of 200 daPa second remains steady through the peak measurement and will continue to 400 daPa The green l...

Page 47: ...x sequence ends here The green lamp is no longer illuminated indicating that it is appropriate to remove the probe from the ear The display will indicate the reflex test result as a Yes as an HL value...

Page 48: ...quencies 500 2000 4000 Hz for 1000 Hz Probe Tone can be selected either temporarily or as revised default parameters To temporarily modify the default condition 1 Press the Tymp Reflex button 2 Select...

Page 49: ...ing to general convention for recording contralateral reflexes the test ear is the ear where the probe is positioned and the stimulus ear is the ear that contains the contralateral insert phone If the...

Page 50: ...iance change of 0 1 mmho is required Up to 2 intensity levels per frequency are presented NOTE The second or third intensity level presentations occur only if a response is not detected at the prior i...

Page 51: ...usingthe frequency buttons Pressthe CONTRA button and select contralateral reflexes required using the frequency buttons NOTE A total of 4 reflex frequencies are allowed It is not possible to select...

Page 52: ...is dependent upon the setting chosen in the Program mode Exit tympanometry reflex To exit Tymp Only Mode Select Tymp Reflex or Audiometry Mode Note that the appropriate screen appears on the display T...

Page 53: ...r frequency modulated tone These alternative tone formats remain selected until a different test is selected The display indicates a continuous bar when steady is selected a dashed bar when pulsed is...

Page 54: ...100 dB HL Rotating the dB HL knob to the next position beyond 100 dB causes the intensity value 100 to flash on the screen to the right of the audiogram this indicates that the maximum dB HL for the...

Page 55: ...ren 7 Select the starting frequency by pressing the or Hz buttons 8 Present the tone by pressing the Present bar 9 If the individual fails to respond increase the intensity by 10 dB and try again Pres...

Page 56: ...are determines the presentation level of the stimulus based on the Hughson Westlake Threshold estimation procedure reference The patient should be instructed to hold the button down when s he hears th...

Page 57: ...so that the test can be completed manually Performing the Auto HL Procedure 1 Instruct the patient to press the button on the handswitch when s he hears the tone and release the button when the tone g...

Page 58: ...y only No changes can be made to audiometric results To erase all tests from memory press the ERASE ALL button Printing test results The printout will begin with a header if it is selected in the prog...

Page 59: ...TTINGS EXTERNAL PRINTER REFLEX DISPLAY PRINT AUDIOGRAM PRN HEADER GSI RESET TO DEFAULTS 226 HZ REFLEX PRINT AUD TABLE PRN HEADER OFF 1 kHZ REFLEX DEF XDUCER TDH 39 PRN HEADER CUSTOM AUTO HL SETUP DEF...

Page 60: ...IONS This submenu determines tympanogram display and test options NORMAL BOX ASHA BASELINE ON 1k NORMAL BOX OFF BASELINE OFF 1k NEWBORN NRM ON 1k AUTOSTART ON 1k NEWBORN NRM OFF 1k AUTOSTART OFF 1k 50...

Page 61: ...d at 200 daPa and then subtracted from the tympanogram tracing so that it begins at the 0 mmhos position on the tympanogram display compensated tympanogram data is displayed BASELINE ON 1k you must al...

Page 62: ...psilateral or C Contralateral if available and selected b Frequency 500 1000 2000 or 4000 Hz c Intensity level where response was detected d Tracing of actual response curve Display format for TYMP RE...

Page 63: ...button The word SAVED appears in the lower right corner of the screen The previous setting is deselected An asterisk is displayed besides the new default setting 226 HZ REFLEX Ipsi 500 Contra 500 Ips...

Page 64: ...placing the cursor next to the parameter and pressing the button to engage the selection To exit this submenu move the cursor to and press Test Frequencies Hz This submenu determines the frequencies t...

Page 65: ...t up L Scoring Rule This submenu defines the number of valid responses required to determine threshold To change the Scoring Rule move the cursor next to the desired Scoring Rule and press the button...

Page 66: ...frequencies The default setting is Aud Range Normal To select the abbreviated frequency range Position the square cursor in front of the feature Aud Range Narrow Press the button to save this narrow r...

Page 67: ...tting has been saved With the PRINT AUD TABLE selected all audiometric test results will appear in a table with the frequency range typed horizontally along the top of the table followed by two lines...

Page 68: ...ED These settings are used to allow the data transfer from the GSI 39 to a computer The settings must be the same on the GSI 39 and the computer The factory defaults are defined by an POWER UP SETTING...

Page 69: ...this knob counterclockwise will sequence you through the characters in a reverse direction The available character set is A Z 0 9 and a blank space A total of 35 character spaces are available When th...

Page 70: ...ASELINE OFF 1k AUTOSTART AUTOSTART OFF 1k AUDIOMETRY RANGE AUD RANGE NORMAL DEFAULT TRANSDUCER TDH 39 PRINT HEADER PRN HEADER GSI LANGUAGE ENGLISH DATA XFER CONFIG 115 2 KBAUD NO PARITY 8 BIT XON XOFF...

Page 71: ...hecks A test cavity is provided with this instrument This test cavity enables the ability to quickly verify on a daily basis the proper calibration of the unit GSI strongly recommends that this quick...

Page 72: ...r The green lamp will resume blinking when the probe is removed from the test cavity The tympanogram on the display represents the response from the 0 5 cm3 hard walled cavity The ECV ear canal volume...

Page 73: ...sary clean the probe tip as described later in the maintenance section When the test sequence is completed the green lamp on the probe is no longer illuminated The green lamp will resume blinking when...

Page 74: ...in any way However it will affect the ECV values The altitude calibration mode allows adjustment of the Auto Tymp without the services of a qualified GSI representative 226 Hz Probe 1000 Hz Probe Alt...

Page 75: ...the custom calibration mode CUSTOM will appear on the fourth line of the display 6 The value now displayed in the cm3 display area is the volume measured and adjusted to the current altitude If the va...

Page 76: ...ems reduces test validity as it tends to mask the test signals particularly at the lower frequencies where earphone cushions provide less effective attenuation An acoustically treated room may be requ...

Page 77: ...t so that each earphone is covering the appropriate ear i e red is right and blue is left Select the right earphone by pressing the front panel button labelled R and check for the following while depr...

Page 78: ...onsidered to be non critical medical equipment and typically requires cleansing followed by low to intermediate level disinfecting depending on the nature of the contamination Cleaning should be done...

Page 79: ...can be wiped with a slightly damp cloth containing soap and water ammonia based cleaners or bleach based cleaners Gently wipe the earphone cushions with the slightly damp cloth taking care not to get...

Page 80: ...g left near the tip and grasp the nose cone of the probe in the other hand e g right 2 Rotate the nose cone portion of the probe counterclockwise until the nose cone is completely separated from the...

Page 81: ...r surface of the O Ring 2 Using a finger or a cotton swab spread a thin layer of lubricant completely around the front and outer surface of the O Ring Ensure that no lubricant spreads into the threade...

Page 82: ...lign the threads on both the probe body and the nose cone before screwing the pieces together Only screw the nose cone on until it is finger tight It may be helpful to gently squeeze the two sides of...

Page 83: ...o the probe tubes ensure that there are no sharp edges or burrs on the probe tubes that could cut the tygon tubing 1 Using the smaller sized floss for one of the smaller size metal tubes insert the fl...

Page 84: ...e 84 of 112 WARNING Avoid getting the probe moist Do not use the probe tip if it is wet or damp because the moisture may make its way to the sensitive electronic equipment at the end of the tygon tubi...

Page 85: ...ition the test headset properly and select a frequency e g 1000 Hz at 35 dB HL 2 Select the right earphone and press the Present bar 3 While the Present bar is depressed flex the earphone cord next to...

Page 86: ...t Extra rolls of paper should be kept nearby NOTE The number of tests per roll of paper will vary with the version Auto Tymp being used and the type of tests being performed See Printer Description in...

Page 87: ...occluded or against the canal wall It is also possible to collapse the canal if the probe is held too firmly against it Examine the Tympanogram and the reflex results to confirm results If they are ab...

Page 88: ...nctioning eustachian tube with possible effusion serous otitis media or glue ear NOTE If the measured compliance value is less than 0 1 cm3 the letters NP will be printed next to the heading cm3 on th...

Page 89: ...ts may show higher gradient values due to the mobility of their ear canals The range of normal is somewhat narrower for adults i e 50 to 110 daPa ABNORMAL A high gradient value greater than the high e...

Page 90: ...e reflex stimulus presentation ABNORMAL If a pressure leak occurs during the reflex testing and the pressure system is unable to correct for this leak the reflex test sequence is aborted When this occ...

Page 91: ...situations For example if there is no test result on the screen and the Print Screen button is pressed the printer will indicate No Test to Print Error codes will appear as a two digit number prefixed...

Page 92: ...g is determined by the amount of movement during the testing Little or no movement during the testing provides a smoother tracing Moving talking or crying during testing leads to a more erratic traces...

Page 93: ...Tympanogram Figure 5 226 Hz Abnormal Tympanogram Figure 6 Infant Normative Data Infant Normative Data Legend for Figure 6 C1 y 200 daPa mmho y Peak Values daPa Pressure at Peak A 5 0 8 5 1 2 5 133 B 5...

Page 94: ...Page 94 of 112 Figure 7 1000 Hz Abnormal Figure 8 1000 Hz Abnormal...

Page 95: ...these requirements If in doubt contact a qualified medical technician or your local representative When the instrument is connected to a PC or other similar items beware of not touching the PC and pa...

Page 96: ...kBAUD NO PARITY 8 BIT 57 6 kBAUD ODD PARITY 7 BIT 38 4 kBAUD EVN PARITY 7 BIT 19 2 kBAUD SPC PARITY 7 BIT 9600 BAUD XON XOFF DISABLED 4800 BAUD XON XOFF ENABLED These selections fall into three group...

Page 97: ...nt software is compatible with the GSI 39 Data transferred from the GSI 39 includes the following tympanometric tracings and numeric data reflex screening results and audiometric thresholds air conduc...

Page 98: ...the Lookup icon ii Scroll through the patient list left column or enter search criteria in the top field to sort the patient list iii Select the desired patient and then press the new session icon b F...

Page 99: ...tic Impedance Admittance Type 3 ANSI S3 6 2004 Audiometers Type 4 IEC 60645 1 Pure Tone Audiometers Type 4 2004 Specifications for Audiometers Type 4 PTB Certificate No 15 11 94 53 Pure Tone Audiomete...

Page 100: ...0 2 to 5 0 cm3 Compliance Accuracy 0 1 cm3 or 5 whichever is greater Pneumatic System Pressure Range 200 to 400 daPa NOTES 1 daPa 1 02 mmH20 2 For 226 Hz probe tone pressure sweeps to at least 100 daP...

Page 101: ...on 2 and 3 only Output Levels IPSILATERAL For 226 Hz Probe Tone 500 and 4000 Hz 80 90 100 db HL Combo Probe design 4000 Hz has 80 and 90 db HL only 1000 and 2000 Hz 85 95 105 dB HL For 1000 Hz Probe T...

Page 102: ...aximum and intensity required Probe LED Indicators 226 Hz Probe Steady yellow Occlusion Blinking green Ready to start Steady green Test in progress Steady orange Leak in pressure No Light Test is fini...

Page 103: ...Time 20 to 50 msec TONE FORMAT Tone is normally off until the Present bar is depressed Continuous Tone is steady when present bar is depressed Pulsed Tone is pulsed at 2 5 sec i e 200 msec ON 200 msec...

Page 104: ...ental Temperature Operating 59O to 104O F 15O to 40O C Warm up time 10 minutes for instruments stored at room temperature Storage Shipping 93O to 149O F 69O to 65O C Ambient Pressure 98 kPa to 104 kPa...

Page 105: ...ure peak and compliance peak values associated with normal middle ear function 150 daPa to 100 daPa 0 2 cm3 to 1 4 cm3 per ASHA 32 Supl 2 1990 17 24 only available on 226 Hz probe tone testing Pressur...

Page 106: ...s J E Tympanometry In Katz J Ed Handbook of Clinical Audiology Ed 3 Baltimore Williams Wilkins 1985 Margolis R H Bass Ringdahl S Hands W Holte L and Zapala D A 2003 Tympanometry in Newborn Infants 1 k...

Page 107: ...al equipment and RF shielded rooms of systems for magnetic resonance imaging where the intensity of electromagnetic disturbance is high Use of this instrument adjacent to or stacked with other equipme...

Page 108: ...ion class B group 1 Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The GSI 39 uses RF energy only for its internal function Therefore its RF emissions are...

Page 109: ...tion distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 22 0 1 0 37 0 37 0 705 1 1 17 1 17 2 23 10 3 70 3 70...

Page 110: ...s and voltage variations on power supply lines IEC 61000 4 11 Dips 100 reduction for 0 5 cycle voltage shift At 0 45 90 135 180 225 270 and 315 degrees Dips 100 reduction for 1 cycle voltage shift zer...

Page 111: ...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 equ...

Page 112: ...ecreased electromagnetic immunity of this equipment and result in improper operation To ensure compliance with the EMC requirements as specified in IEC 60601 1 2 it is essential to use only the follow...

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