USER`S MANUAL
Contents
1. Unit m s NORM APHA SPEC CATA Vac 1532 1532 1532 Vien t PMMA 2718 1641 1629 Acrylic 1946 Silicon 1050 Vyitr 1532 1532 1532 To modify the velocity in the parameter setup function refer to 4 7 Parameter Setup Provided by IOL manufacturer 4 6 2 Constant of Formulae 6 groups of IOL calculation formulae are provided SRK_IIl SRK_T BINK_II HOLLADAY HOFFER_Q HAIGIS Different constants are used for different formula recorded as A or ACD or SF which are provided by IOL manufacturers They can be modified and saved in the parameter SETUP function For details refer to 4 6 BINK II and HOFFER Q use ACD i e the desired anterior chamber depth constant ACD can also be calculated from constant A ACD A x 0 5663 65 60 3 595 0 9704 or ACD SF 3 595 0 9704 HOLLADAY uses SF can also be calculated from constant A User s Manual 19 Chapter 4 Operation SF A x 0 5663 65 60 or SF ACD x 0 9704 3 595 The shift from A to SF is completed automatically after constant A is entered SRK Il and SRK T use A can be calculated from the following formula A SF 65 60 0 5663 or A 109 49 1 71358 x ACD HAIGIS uses three constants a0 a1 a2 can be calculated from A ao 0 62467 x A 72 434 a 0 40 a2 0 10 4 6 3 IOL Calculation steps a Press IOL to enter the calculation mode b Sele2. 3 A m 3 A m Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Uy is the A C mains voltage prior to application of the test level User s Manual 38 Annex B Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The ODM 2100S ULTRASONIC A B SCAN FOR OPHTHALMOLOGY is intended for use in the electromagnetic environment specified below The customer or the user of the ODM 2100S should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic environment guidance test level level Immunity test Portable and mobile RF communications equipment should be used no closer to any part of the ODM 2100S including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 d 1 2 Me 80MHz to 800MHz Conducted RF 3 Vrms d 2 3 7 800MHz to 2 5GHz IEC 61000 4 6 150kHz to 80MHz 1 Vrms where P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer and d is the Radiated RF 3 V m 3 V m recommended separation distance in miters m IEC 61000 4 3 80MHz to 2 5GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be l
3. down the footswitch again or press of ultrasonic B image is completed FRZ SCN to freeze the image The collection Note Adjustment of gain control is one of the key operations that affecting B mode image quality For different conditions and diagnostic requirements the gain adjustment is different Make sure do not fix the gain however it is also not the case that the larger the gain the better the image h Pressthe 4 keys to save the current image and turn the page up and down Mark the image with P1 P8 8 images can be saved at most 4 3 3 Function Menu In B mode press the R key of the trackball to show the functional menu press any key again to hide it Select the functions with the trackball s L key User s Manual 12 Chapter 4 Operation a Press b c d e f g h ZOOM Depth control key To change the scanning scope 6 depths are available to be adjusted They are showed on the right upper screen as DEPTH 34 mm DEPTH 39 mm DEPTH 45 mm DEPTH 50 mm DEPTH 56 mm DEPTH 60 mm lt to adjust the depth It is effective after the scanning is activated PROC Gray scale control and Post image processing key Press lt keys to select the post image processing mode line
4. 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 at least 30 Electrostatic fast transient burst 2 kV for power supply lines 1 kV for 2 kV for power supply lines 1 kV for Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 4 input output lines input output lines Surge 1 kV differential 1 kV differential Mains power quality should be that of a IEC 61000 4 5 mode mode typical commercial or hospital environment 2 kV common 2 kV common mode mode Voltage dips lt 5 Ur lt 5 Ur Mains power quality should be that of a short gt 95 dip in Ut 95 dip in Ut typical commercial or hospital environment interruptions for 0 5 cycle for 0 5 cycle If the user of the ODM 2100S requires and voltage 40 Ur 40 Uy continued operation during power mains variations on 60 dip in Ur 60 dip in U7 interruptions it is recommended that the power supply for 5 cycles for 5 cycles ODM 2100S be powered from an input lines 70 U 70 U uninterruptible power supply or a battery IEC 61000 4 11 30 dip in Ur for 25 cycles lt 5 Ut gt 95 dip in Ur for5s 30 dip in Uz for 25 cycles lt 5 Ur gt 95 dip in Ur for5s Power frequency 50 60Hz magnetic field IEC 61000 4 8
5. 100V 120V 4A 200A at 250 V AC 135 1h 5x20 mm 200 120s 100 4h 200V 240V 2A 100A at 250 V AC 135 1h 5x20 mm 200 120s 2 Main unit is working but the monitor is not active or not displayed correctly Check if the probe is well connected If above operation is not effective please don t open the housing without authorization Contact the supplier immediately Explain the problems in detail for proper and in time support The scanner is a high tech product designed elaborately Only qualified trained engineers are authorized to repair the instrument We are not responsible for problems caused by any kind User s Manual 32 Chapter 6 Maintenance and Trouble Shooting of unauthorized repair If required we can provide the complete maintenance and repair manual to the authorized qualified engineers of service stations User s Manual 33 Chapter 6 Maintenance and Trouble Shooting Chapter 7 Service and Support Information 7 1 Warranty 1 The product has a warranty of one year from the date of purchasing on the premise of using in accordance with the User s Manual 2 If the device does not work properly please contact your local manufacturer or the manufacturer immediately 3 Following repairs will be charged within warranty period Problems caused by man made damages Damages caused by unauthorized repair Damages caused by inappropriate operation
6. 4 We provide continuous maintenance and repair after warranty period with certain charges 7 2 Accessories and Consumables Acoustic Gel all that approved by FDA EC can be used Fuse Voltage Range Spec Breaking Capacity TESE en DY LEI Dimension Time 100 4h 100V 120V 4A 200A at 250 V AC 135 1h 5x20 mm 200 120s 100 4h 200V 240V 2A 100A at 250 V AC 135 1h 5x20 mm 200 120s Please contact local distributor or Manufacturer if other parts are needed User s Manual 34 Annex A Acoustic Output Information Annex A Acoustic Output Information Transducer Mode B Probe Application Ophthalmic Operating B Mode Test Standard NEMA 1997 Acoustic MI IspTa 3 Isppa 3 Output mW cm mW cm Global Maximum Value 0 097 0 0375 3 50 P 3 MPa 0 315 Wo mW 0 0186 0 0186 fc MHz 10 6 10 6 10 6 Associated Z cm 2 10 2 10 Acoustic Beam X6 cm 0 0658 Parameter dimensions V6 cm 0 0662 PD usec 0 138 0 138 PRF Hz 2760 2760 EBD Az cm 1 80 Ele cm 1 80 Operating Control Conditions Non Autoscanning Mode Transducer Mode A Scan Operating A Mode Application Ophthalmic Test Standard NEMA 1997 Acoustic MI Ispta 3 Isppa 3 Output mW cm mW cm Global Maximum Value 0 160 0 0136 11 2 Pr3 MPa 0 525 Wo mW 6 18E 4 6 18E 4 fe MHz 10 8 10
7. Disinfection and SteriliZation ccccccccsssccccessnceceeeseeeeeseeecceseneecessaneeeeseeeeeseeneeeesees 23 5 1 How to prevent Cross INfection cccscccessssceeessneeeeeeseeeessnneeeeseaeeceeseneeeessneeeeseaeeeeseeeeeeseeeeesses 23 5 2 Sterilization Procedure Pre sterilization and Sterilization of the Probes cscceeeesseeeeeeees 23 5 3 Preparation of Sterilization AGENt cee eeesceccessseeeceeseeeeeseeeeeessaeeeeeseneeeessaeeeeseaeeeeeseseeeeneeaeeeeeaes 24 5 A Standard Methods cisicsdsdssz occdssiceccdssicecadeninaecdanneeccdend sacddvedsecedevdneccduaacadsdesdneeddn obceseiacdeeicaccdanidvecdentcn 25 5 5 Method for high risk patients siccccscicscescesscenscssccescessecdesccssices covsncescovsaceadevsadsasassaceassssedsasdssadeasveseceacs 28 Chapter 6 Maintenance and Trouble SHOOtING cccescceeseesseecesceeeseeeseseeeeseecsseeenseecseaeeseseeeeaeeeseeeneeeenes 31 6 1 Maintenance of the DeVice cccccccsssccceseseeeeeseneeeeseenececseaneceeseneecessaeeseneaeeeseceeesseneeeeseneeeesenees 31 6 2 Biometric TOSt isi vccecisicccetiacsccetacescecsdcnveuavacevecdsdeavenstacsveedvieavevavacevecevieaveustacsvensviseveuev sdoeaveestbeavvestbens 31 6 3 Trouble Sho Oting cisrenan ana a a E E E RE SER EER 32 Chapter 7 Service and Support Information ccccsscccesssseceessneeeeseneeeceseneecesseneecessaeeeeseseeesseneeeesseeeesenees 34 TM NW AAMC Feces sescrksccnaeds cates acne eoe toute c
8. User s Manual Chapter 2 Specifications 2 4 Firmware Firmware 21SAB V1 20 2 5 Safety In accordance to IEC 60601 1 and IEC 60601 2 37 2 6 Storage and Transportation Storage Condition Packed device should be stored in a room of Temperature 20 C 40 C Relative humidity lt 80 No corrosive gas well ventilated Transportation The accessories such as Probe should be packed in to original package before transportation Severe impact and crash rain and snow shall be avoided User s Manual Chapter 3 Installation Startup Shutdown Chapter 3 Installation Startup Shutdown 3 1 Packing List Please check the components in the package according to the following list Main Unit 1 B Probe 1 A Probe 1 Foot Switch 1 Power cord 1 Fuse 2 110V 120V 4A or 220V 240V 2A Test Object 1 User s Manual 1 3 2 Main Parts of ODM 2100S ODM 2100S consists of Main Unit 10 MHz mechanical sector B Probe 10 MHz A mode biometric probe built in video monitor and foldable keypad Its configuration is as below Monitor A Prope B Probe Keyboard Probe Holder Trackball Probe Socket Foot Switch Contrast control Brightness control Gain control 3 3 Environmental Requirements The device should be operated in clean dry and air conditioned environment The power socket used must be with good grounding otherwise it increases the risk of noise as well as creepage Do not use the equipmen
9. key of the trackball to set the velocity When aphakic APHA or special SEPC eyes are measured the velocity in the anterior chamber lens and vitreous body can be set manually For the velocity in IOL consult the manufacturer V A velocity in anterior chamber m s V L velocity in lens m s V V velocity in vitreous body m s After setup press SAVE to save permanently The parameters will be effective when the instrument is turned on next time Click TIME with L key of the trackball to set the time The format is mm dd yy hh mm with 24 hour system Click TIME again to save 4 8 Image printing If a video printer is available all images and characters on the screen can be printed by simply pressing PRINT key on the printer Please read the user s manual of the printer for details i User s Manual Chapter 5 Cleaning Disinfection and Sterilization Chapter 5 Cleaning Disinfection and Sterilization 5 1 How to prevent Cross Infection The surface of the probe must be always clean which can be cleaned with soft tissue after each use Front part of the probe may be washed with distilled water physiological saline water alcohol chloramphenicol eye drop or Cidex liquid disinfectant which are usually found in hospitals Other FDA cleared disinfectants may also be used The probe can be immersed J Do not imme
10. 8 10 8 Associated Zp cm 1 40 1 40 1 40 Acoustic Beam X6 cm 0 133 0 133 Parameter dimensions V6 cm 0 121 0 121 PD usec 0 121 0 121 PRF Hz 10 0 10 0 EBD Az cm 0 00 Ele cm 0 00 Operating Control Conditions User s Manual 35 Annex A Acoustic Output Information Test Report 20090101 Testing Mode A Mode Index label k Maximum index value Associated acoustic parameters Other information Operating control conditions Test Report 20090101 Testing Mode B Mode Maximum index value Associated acoustic parameters Other information Operating control conditions The acoustic output report IEC60601 2 37 Sample SN 2008YP355 Probe Frequency 10 MHz Probe SN 0508 5716 Acoustic output reporting table A Probe TIS TIB Non scan Scan Aam Aap Non scan 1cm v a 4 3 Min of Pa Zs lz a a zs mW E S S l a S a Z e Zp MA Z at max lga cm 4 a a eq Zo tri ds at maxlas i Sample SN 2008YP355 Probe SN B558 085312 Acoustic output reporting table B Probe wn is Index label Non scan Non scan wy 3 Min of Pa Zs lzos a Zs Z at max l a dax Zo Dim of Aer e y cm o 0 v Dim of Asm z da P za Frequency setting MHz OE AT e E User s Manual 36 Annex B Guidance and manufacturer s declaration Annex B Guidance and
11. Freeze control key Press it the instrument shifts from START SCAN to FREEZE IMAGE or from FREEZE IMAGE to START SCAN After 10 minutes of scanning it is frozen automatically to protect the probe 4 1 3 Trackball The trackball can be used to move the cursor on the screen Press L to activate the functions where the cursor is In B mode press R to display or hide the functional menu on the right side of the screen 4 1 4 Gain Control Knob In B mode or A mode the gain can be changed by adjusting this knob Change of gain is displayed on the screen at the same time GN xx dB 4 1 5 Foot switch User s Manual Chapter 4 Operation In B mode or A mode the foot switch has the same function as the start up of the probe When it is started SCN FRZ SCN i e controls is on the screen in B mode the probe waves and the image is displayed dynamically in A mode the probe indicator is on When it is frozen FRZ mode the probe indicator is off is on the screen in B mode the probe stops and the image is still in A 4 2 Suggested Position of Patient Operator and other near person In a usual measurement it s better to let patient lie down and let his head close to the device less than 1 2m The operator should take a position convenient for reach patient s head and operating the device 4 3 B Mode Mode Menu MAHI E G
12. key The next line moves up and average value is recalculated Cornea Front of the lens Back of the lens Retina Fig 4 8 A waveform with contact method Please delete the results in the following situations User s Manual 45 Chapter 4 Operation Position marker does not correspond with the top of the wave The retina wave is not sharp There is a big difference between the measuring and the average 8 Label the eye OS forleft eye OD for right eye Clear the current result and start a new measurement Repress A key or click NEW with L key of the trackball 4 4 2 Manual Measuring In some circumstances it is difficult to get the result by automatic biometry or patients have difficulties to cooperation with the operator In these cases manual biometry is selected otherwise it is not preferred Press IMANL to enter manual measurement Operating steps are similar to the automatic measurement Press FRZ SCN to start scanning adjust gain control and get a satisfactory wave Press FRZ SCN to freeze the wave mark and measure it with the trackball The operation refer to 4 5 Five Point Marking Method Manually measured mark Fig 4 9 Waveform captured manually 4 5 Five Point Marking Method When a bundle of ultrasounic goes through optic axial we can get ultrasonic reflex from five dif
13. manufacturer s declaration Guidance and manufacturer s declaration electromagnetic emissions The ODM 2100S ULTRASONIC A B SCAN FOR OPHTHALMOLOGY is intended for use in the electromagnetic environment specified below The customer or the user of the ODM 2100S should assure that it is used in such an environment Emissions test compliance Electromagnetic environment guidance The ODM 2100S uses RF energy only for its internal RF emissions TE function Therefore its RF emissions are very low and are u CISPR 11 not likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 Harmonic emissions Class A The ODM 2100S is suitable for use in all establishments IEC 61000 3 2 other than domestic and those directly connected to the public low voltage power supply network that supplies Voltage buildings used for domestic purposes fluctuations Complies flicker emissions IEC 61000 3 3 User s Manual 37 Annex B Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The ODM 2100S ULTRASONIC A B SCAN FOR OPHTHALMOLOGY is intended for use in the electromagnetic environment specified below The customer or the user of the ODM 2100S should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
14. probe built in video monitor and foldable keypad 1 2 Intended Use The device is intended to be used for ophthalmic ultrasonic diagnosis and measurement 1 3 Contraindications Eyelid trauma and severe eye infection patients are prohibited to use B scan and cornea trauma inflammation or infection patients are prohibited to use A biometric Scan User s Manual Chapter 2 Specifications Chapter 2 Specifications 2 1 Working Conditions Environmental temperature 5 C 40 C relative humidity lt 80 Power supply AC 100V 240V 50 60 Hz 2 2 B Mode Ultrasonic frequency 1OMHz Scanning method mechanical sector scan Gain control 98dB Display mode B B B B A Gray scale 256 J J Scanning scope depth 31mm 63mm scanning angle 53 Resolution axial 0 2mm lateral 0 4mm Accuracy of geometrical position axial 5 lateral 10 Capacity of digital scan converter DSC 24 5125128 bit Electronic caliper electronic cursor for distance measurement J Accuracy 0 25mm 2 3 A Mode Ultrasonic frequency 1OMHz Biometry accuracy 0 06mm Resolution 0 01mm J J J Measuring range AL 15 39mm Total gain 98dB user adjustable gain range O 55dB J Measuring parameter anterior chamber depth lens thickness vitreous length and axial length Measuring method automatic and manual IOL power calculation SRK 1 SRK T SRK II BINK 2 HOLLADAY and HOFFER Q
15. to VIDEO OUT onthe rear panel of the main unit User s Manual Chapter 3 Installation Startup Shutdown 3 5 Environmental Protection When the device is abandoned it could be treated as usual Electronic products according to the local Regulation And its package should be treated as the plastic and paper materials according to the local laws The gel bottle is made of polythene and the remaining gel is water soluble Heavy metal contents meet the requirements of cosmetic standard The treatment of the empty bottle should conform to the local environmental protection regulations It can be treated together with disposable plastics such as syringe 3 6 Startup Procedure 1 Check up all the connections including power cables Probes If not connected please connect them under the instruction of 3 4 Connection And keep the probes in the probe holder 2 Start the Power socket and then switch on the power switch on the rear panel of main unit 3 A few minutes later you could see the single B mode interface on the screen and now it could start diagnosis 3 7 Shutdown Procedure 1 Make sure all the diagnosis result and data have been printed or transferred to your workstation or computer 2 Put two probes back to the probe holder 3 Turn off the switch of main unit 4 Shutdown all the devices connected with ODM 2100S Such as printer workstation 5 Shutdown the power socket connected with ODM 2100S U
16. upper part of the eye and the bottom of the sector corresponds to the lower part of the eye Another example if the dot is on the nose side of the right eye marked as gt the image on the screen is the horizontal section of the eye The top of the sector is the nose side of the eye and the bottom of the sector is the temporal side of the eye Top of Sector Bottom of Sector Fig 4 6 User s Manual 11 Chapter 4 Operation Move the cursor with the trackball to the probe position marker press L key the marker will rotate clockwise it rotates 45 every time it is pressed 4 3 2 How to obtain a scan under B mode a Select B mode b Input patient information at the bottom of the screen NAME WANG FANG SEX FEME AGE 37 11 23 2004 11293831 Fig 4 7 NAME 13 digits of letters or numbers SEX 6 digits of letters or numbers AGE 3 digits of letters or numbers c Label the eye to be examined Press OD key for right eye press OS key for left eye d Let the patient lie on his her back slightly close the eyes e Putsome acoustic gel on eyelid gently place the B probe on the eyelid f Push down the footswitch or press FRZ SCN the probe starts scanning The real time ultrasonic sectional view of the eye will appear on the screen g Adjust the total gain knob to make the focus clear and get a satisfactory image Push
17. 00ml when sterilization is necessary Replacing Contents Of soaking trays For frequent use the contents of the trays should be replaced at the beginning of the morning and beginning of the afternoon Wait 10 minutes after the last sterilization before emptying out the Alkazyme or Aniozyme solutions 5 4 Standard method NOTES Please disconnect the probes from the machines Machines must be turned off first Please avoid splashing any liquid onto the electrical connectors User s Manual 35 Chapter 5 Cleaning Disinfection and Sterilization A Decontamination Predisinfection 1 Immerse the first 5 cm maximum in a 1 Immerse the probe and the cable except solution of either Alkazyme or Aniozyme for the connector in the solution of Alkazyme 5 to 15 minutes depending on the perceived or Aniozyme for 5 to 15 minutes depending level of risk on the perceived level of risk 4 H 2 Clean the probe and the cable in the 2 Clean the probe and the cable in the solution with the brush for 1 minute solution with the brush for 1 minute N N 3 Clean the rest of the probe body and the cables using a swab lightly dampened with the same solution Do not wet the connectors B Rinsing 4 Rinse the end of the probe in 3 Rinse the probe and the cable in demineralized or distilled water Do not wet demineralized or distilled water Do not wet User s Manual 26 Chapter 5 Cleaning Disinfection and Sterilization t
18. Each group of AL K1 K2 REFR etc can be calculated by different formulae in order to be compared with each other g The parameters and measured results can be saved as a record by click SAVE with L key of the trackball REC XX is showed at the right upper corner of the screen To review the records press a 50 records can be saved in total 4 4 7 Parameter Setup Click select Move the cursor MENU on the left upper corner of the screen with the L key of the trackball un SETUP to enter un with arrow key and enter key to enter the number where the is B TOL CONST SAVE 1 66 D UCA UCL UCU CM7 1532 1641 1532 TIME 12 31 2000 66 66 SH USER SOFTWARE VERSION 1 1 93 MANUFACTURER USE 61234 PRG SIG 0DM2100 92 99 2009 43 43 02 User s Manual 21 Chapter 4 Operation Click on IOL CONST with L of the trackball and setup IOL constants A and ACD There are two groups LEFT and RIGHT for left and right side IOL calculation respectively The number after CURRENT tells which group is active DR is desired refraction after surgery The constants setup by the manufacturer are LEFT 1 A 115 3 ACD 3 39 RIGHT 1 A 116 6 ACD 4 15 LEFT 2 A 117 9 ACD 4 91 RIGHT 2 A 118 7 ACD 5 37 CURRENT 1 Click on SPEC with L
19. N 60 4B OD P1 Status GN Gain OD OS right eye left eye P1 P8 page number Probe Position Scanned Image Gray Scale Ruler Patient Information Fig 4 1 Freeze Scn Function Menu Calendar amp Clock In mode menu SB single B mode B1 B2 double B images B A A B B mode and A mode both B image and A waves displayed Click the functional keys or the L key of the trackball to enter the corresponding work mode The screen displays as following Fig 4 2 User s Manual 10 Chapter 4 Operation MEHU HA Bl B2 BA UMBNU ESB B2 GHEGOM4B TOS IPE ki GHE6804B 0S R2 a if At RSD EAS piel MAIER Matec Tinta MIRE i ARE TE NAME Want FANG Xi FEMALE AGE 37_ l MEN NAME VARG FANG SEX FME AGE 37 Fig 4 3 Single B Mode Fig 4 4 Double B Mode The upper one is B1 and the lower one is B2 Select one of them and active it then you can scan freeze adjust the gain label the eye and save MENU SB Bi GH 68 4B OS lt _ Press the keys to move the Sample taking Line and A curve changes accordingly Fig 4 5 BtA Mode 4 3 1 Direction and Position Analysis There is a white dot on one side of the probe end This dot always corresponds to the upper part of the sector image For instance if the dot is above the eye marked as T the image on the screen is the vertical section of that eye The top of the sector corresponds to the
20. ODM 2100S ULTRASONIC A B SCANNER Version 4 1 User s Manual Contents PRECAUTIONS senorna sacl scad secs he dad eaae eai aoe aare U aa e hb bad NE a tal aeds a eaa ia a EAER i WARNING S e6cssscrecesccsssccea A E EE i CAUTION sesso secs Hae AS MASA a Le ii Labels and Indicator Sieen ontnestvosedaev E EEEE EAEE E A iv EEEE AE EO EAEE 1 Chapter 1 INtroduction cccecesccceseseceeseseceeseneecessneecensaaeeceseneeeeseaueeesseaeecesscaeecessaneeeeseaaeesensesessaneeeenenneeess 2 WA General Descriptio isirnirenrrerr ieie EE EEE AE EEA AENA 2 T2ilntended U Sesine eee EE E E a EA EEEE E E E EEA 2 1 3 Contr indicati NS osisssa iea aE REEE R E A EAE A RNE VERA 2 Chapter 2 Specifications a O a EER r EEOAE ESE EEEN 3 2 1 Working Conditions ensanse R A EE E EE 3 22 BMO Einen nan a a aa aaa eaa o aaa oaa a a O NEES 3 23 A MOU Eisini nana RE O A E a a E E a A E ERS 3 2 4 FIWA E rinrin iina EAO 4 2 5 SIE aeeoa eR EE EE AEE AEE EE E E ERE 4 2 6 Storage and TransSPOrtatiOns wvccecescceseiecsnccstdesw eset sncsevetin oveentsntvevedie dues otitsnveuedevevenedie cdvensuedinsversteaensnetees 4 Chapter 3 Installation Startup SHUtUHOWN cccsesscceesenseceeesneeceseneeeecsaeeeeecneeeeseaueeeeseaeeceeseaseseeseneeseneneeeess 5 BM Packie WiStsctict certsaccctsssaccsssdeateesetec ressiees E E 5 3 3 Environmental REquireMents ccccccccsssssccessneeceseneecessneeeeeseeecesseeeeceseeecesseseeseeeeesseneesensene
21. ar LINE logarithmic LOG CURVE exponential EXP CURVE and S S CURVE TEXT Full screen text labeling key Move the cursor with the L key of the trackball and enter the text to label the image DIST Distance Measuring key Select DIST and activate double cursor distance measuring status a appears on the screen Move the to the position where you want to start measuring then press the L key of the trackball the current will be locked Move the trackball again another is shown up Move it to the terminal of measuring and press L key again to complete the measurement The distance between two will appear on the screen The unit is mm If another measurement is needed repeat the above procedure AREA Area measuring key Press of an area with the trackball Press key to fix a start point and draw the outline L key again to get the area measurement result Multiple measurements can be made and the unit is mm CLRS To clear all the labels and measuring results on the image NEW New patient Clear the previous patient s information temporarily save ultrasonic B images and get prepared for the next examination EXIT To exit function menu User s Manual 13 Chapter 4 Operation 4 4 A Mode Ultra
22. body and the cable that were not soaked using a wipe lightly dampened with the Alkacide solution keep the connectors dry F Rinsing 10 Rinse the end of the probe with 7 Rinse the probe end with demineralized demineralized or distilled water or Distilled water keeping the connectors dry 11 Dry with a sterile compress or a single use 8 Dry with a sterile compress if the rinsing dry wipe if the rinsing water was sterile water was sterile 12 The B probe is ready for use 9 The A probe is ready for use User s Manual 30 Chapter 6 Maintenance and Trouble Shooting Chapter 6 Maintenance and Trouble Shooting 6 1 Maintenance of the Device Main power socket must be with good grounding The main unit should not be used for a long time normally not more than 4 hours continuously While no measurement is done the instrument should be in the state of freezing Avoid collision and falling of the probe Keep the top surface of the probe clean None corrosive detergent is allowed to clean the housing Avoid water and liquid get into the housing and external keyboard Only a mild detergent may be used with soft cloth In humid area and season if the instrument is not used for a long time it should be power on for two hours per month Don t shake and fall off the instrument when moving All parts should be put into the original package in case of moving especially the probe Therefore the original package should be kept
23. cornea can be recognized seperately on A measurement when immersion mode is available 5 After marking the 5 point the result of axial length will be shown on top of the screen Note Velocity between points can be set up in SETUP menu press input velocity of cornea lens and vitreous then click on User s Manual Chapter 4 Operation MENU MRI APHA SPEC CATA MANL FRZ GN 42 NEW DEL AL lt MM Pi M S gt NO 00000000 OV mr wa nv vv 00000000 o 00 WOODOOODO O N GUNN Tsa 25 84 OVO AWN OOOO OO000000 M0 a 00000000 vwvaanaanaa nD 00000000 W o wwwwwwww OM wwwwwwww N 7000000 parenenepensnens me UO NNN oF W vvvvvoow NJ MNN MOOMOAAD OE N c m n n uw n n u gt 4 n s A Fig 4 11 Fig 4 12 4 5 2 Use of Five Point marking method under A mode for Axial length measurement 1 Press A to enter A mode 2 Choose measuring mode NORM APHA SPEC CATA 3 Place A probe onto patient s cornea start foot switch and undertake an automatic measurement 4 When standard deviation S D is not clinically satisfied Five Point marking can be corrected a Press a 4 key to see A scan waves remark the ones are not satisfied b Move trackball press gt gt gt area on screen with lu key then enter Five Point marking stage c Move the cursor to A curve at th
24. ct formula with the L key of the trackball c Enter correct parameters AL Axial Length K1 K2 Keratometry DR desired Refraction When calculation mode is entered the average of axial length calculated is put in AL Press Al key to input the axial length from the MNHA MANOA T oo Sooo 000 4 ii n ASIN S SSN one mone DNDN Moen line where the cursor is located Move the cursor with arrow key and Fig 4 13 enter key to input numbers required enw d Modify and save constants A or ACD in the parameter SETUP function See 4 6 OLtype needs to be selected for formula BINK II anterior or poserior Click ANTI or POST with L key of the trackball User s Manual 20 Chapter 4 Operation Anterior chamber depth AC needs to be input for formula HAIGIS The automatically calculated average anterior chamber depth is put in AC in calculation status Press Al key the anterior chamber length from the line where the cursor gt is located is input If it is required to enter manually move cursor e f un to AC and enter the numbers Enter patient informaiton label the eye Press CAL DEM DAM IOL REFR the calculation will be completed and listed on the screen Diopter of emmetropia D Diopter of ametropia D Diopter of IOL D Refraction after implant D
25. e bottom of the screen press i key of the trackball to mark the five points if it is hard to recognize vertex and back of cornea points 1 and 2 can both be put on 1 d After marking the 5 point the measurement result average of axial length and S D will all be recaculated according to the new marking See Fig 4 12 Note Velocities under different measuring modes NORM Normal Velocity of cornea Veor 1620 m s 1 2 Velocity of anterior chamber Vac 1532 m s 2 3 Velocity of lens Vien 1641 m s 3 4 Velocity of vitreous Viir 1532 m s 4 5 CATA dense cataract Velocity of cornea or 1620 M s 1 2 Velocity of anterior chamber Vac 1532 m s 2 3 User s Manual 18 Chapter 4 Operation Velocity of lens Ven 1629 m s 3 4 Velocity of vitreous Vyitr 1532 m s 4 5 Velocities under modes of SPEC special MANL manual APHA aphakic can be set up in SETUP menu After reset the velocities press lt lt lt under A mode the results will be recalculated accordingly canbe used to adjust the threshold of A scan measurement 4 6 IOL Calculation 4 6 1 Velocity Setup The velocity refers to the spread velocity of the ultrasound within the eye This instrument has four eye modes NORM normal APHA aphakic SPEC special and CATA dense cataract The parameters are as follows
26. eeesaes 5 SA COMECON coc cedisveccetenseceedetee R Aessads Stes Sedss asGads Stes Gedss Aaseads Stes tedss caseeds dias EERE 6 3 5 Environmental ProtectiOn ccccccssccsssscsesseeeseecsseecsseecseneessneeecseecsaeecssnecseneeseseeeaeeseseeecseeeeeeeneneenes 7 3 6 Startup Proced re seisan sdassvicevetened coats seceded caudebedeasdedeaevied ovetanedsncdsssenedasedeved saumencdeneds 7 3 7 SHUTAOWN PFO CEC UNG icscsevscienscedidveeestnevencebeanencd o EEE EE RETE ET R E E EE EN 7 Chapter 4 Operation sscsssccesisscescties xsdetine ce satwenedadachicad sac ens 206 eases sad EEEE EEEE EE EE EEEE SETE EERE SNE 8 4 1 Keypad Descriptio w cwscdsicieesdvieassnesssanesduanantecvdsevordunnsnieesadenvandesnuaie cnovevendsdeuvavapesuyen Sndeversnee ROEE 8 4 2 Suggested Position of Patient Operator and other near Person ccsscceesseceeesneeeeeesteeeeseneeeees 10 4 3 Bi MOG neiii inaen E dedbe E bed cdsapsubs dans tad capes budssute bad bi san bales ute bedivads edad E E NEES 10 AAA MOJE neoan eae E EE E EE E E E 14 4 5 Five Point Marking Method ccccssceessseeceeeseceessneeecesseeeeseeeecessaeecesseneeeeseeeeeeseseecensnneeeeseneeeess 16 4A ol 6 sf fot Fedo a eee terete E EE ee rea ee ieee 19 4 7 Parameter SOtu Piscicsssccscecescteczeaceacvcesstaczts E E E EE E Ei 21 4 8 Image PrINCiING cvsccvscececevssavacdsacatsccsssavecsveeadeesvecevacsvscevsesvecavansvseevdesvacavacsvsceT estecavansveedeenteedsieuoedbeauee 22 Chapter 5 Cleaning
27. ent in which radiated RF disturbances are controlled The customer or the user of the ODM 2100S can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ODM 2100S as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of transmitter m s 150kHz to 80MHz 80MHz to 800MHz 800Mhz to 2 5GHz d 12 p d 1 2 p d 2 3 p 0 01 0 35 0 12 0 23 0 1 0 11 0 38 0 73 1 3 5 1 2 2 3 10 11 3 8 7 3 100 35 12 23 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 m according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for 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 User s Manual 40 Annex C References Annex C References HAIGIS W Biometrie in Augendrztliche Untersuchungsmethoden Straub W Kroll P Ktichle HJ Hrsg FEnke Verlag Stuttgart 255 304 1995 RETZLAFF J A new i
28. ess than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 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 predicated 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 ODM 2100S is used exceeds the applicable RF compliance level above the ODM 2100S should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ODM 2100S gt Over the frequency range 150KHz to 80 MHz field strengths should be less than 1 V m User s Manual 39 Annex B Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications equipment and the ODM 2100S ULTRASONIC A B SCAN FOR OPHTHALMOLOGY The ODM 2100S is intended for use in an electromagnetic environm
29. eye among NORM APHA SPEC CATA 3 Let the patient lie on his her back and open both eyes Anaesthetize the eye to be measured 4 Sterilize the front part of A probe with chloramphenicol eyedrop 5 Push down the footswitch or press the FRZ SCN to start scanning Let the patient stare at the probe and put the probe on the cornea vertex gently 6 Adjust the gain control to get the satisfactory wave 7 When you hear a series of beep sound the result comes out and is displayed on the screen If the beeps are not heard move the probe slightly until beeps heard and the measuring is completed Measuring is undertaken one by one automatically until eight groups of data are achieved or it can be stopped when FRZ SCN is pressed to freeze the image Eight groups of data can be achieved from each patient at most and the operator decides how many groups of data are needed Note Since auto measuring result is calculated by averaging multiple operations the operator needs to handle the probe gently and stably The image can be frozen and the probe be taken away only afier the beeps stop and the result appears on the screen Check the results amp Delete unreliable data If the measuring results are obviously unreliable delete them Press 4 keys to move the cursor gt to the line that needs to be deleted and click DEL with the trackball s L
30. ferent layers Fig 4 10 including 1 cornea vertex 2 back of cornea 3 front of lens 4 back of lens 5 retina User s Manual 16 Chapter 4 Operation Fig 4 10 five point marking Due to the specialty of eye structure ultrasonic velocity becomes different when going through different tissues as follows Velocity of cornea cor 1620 m s 1 2 Velocity of anterior chamber Vac 1532 m s 2 3 Velocity of lens Vien 1641 m s 3 4 Velocity of vitreous Vvitr 1532 m s 4 5 Axial length AL Vor t2 t1 Vac t3 t2 Vien ta t3 Vvitr ts ta 1 1 As long as the five special points can be marked precisely we can then figure out accurate axial length according to 1 1 This is what we called Five Point Marking method for axial length measurement 4 5 1 Use of Five Point marking method under B A mode for axial length measurement 1 Press B Al key to enter B A mode see Fig 4 11 2 Scan the eyeball then freeze it once satisfied image is obtained 3 Move trackball press gt gt gt area on screen with L key of the trackball then enter Five Point marking stage 4 Move the cursor to A curve at the bottom of the screen press U key of the trackball to mark the five points Note ODM 2100S has only contact mode for A measurement it is hard to recognize vertex and back of cornea so points 1 and 2 should both be put on 1 Vertex and back of
31. h distilled water The solution must be changed every day 6Chlorometric degree solution of sodium hypo chloride at 20 C The contents of the tray must be changed after each use Demineralized or distilled water NOTES Please disconnect the probes from the machines Please be sure machine is TURNED OFF before disconnecting probes Avoid splashing liquids onto probe connectors end of the cable which is connected to the machine 5 3 Preparation of Sterilization agent STERILIZATION PREDISINFECION 1 Proteolytic enzyme based agents 2 possibilities 1 0 5 Alkazyme solution in water 20g sachet 2 Pour in 1L warm clean water 25 30 C 3 Putin the unopened sachet User s Manual JA Chapter 5 Cleaning Disinfection and Sterilization 4 Wait for 1 minute 5 Pourin4L water and stir it The Alkazyme solution can be used within 8 days if kept in sealed flasks The solution can also be made up in a 4L recipient using demineralized or distilled water fill up the soaking tray from there OR 1 0 5 Aniozyme solution in water 25g sachet 1 Pour in 1L warm water 25 30 C 2 Put into the unopened sachet 3 Wait for 1 minute 4 Pour in 4L warm water and stir Sterilization Agent 1 1 0 5 Alkacide solution in water 2 Pour 5L distilled in flask 3 Pour in the Alkacide 4 Stir it The Alkacide solution can be used within 8 days if kept in sealed flask Please pour in soaking tray 5
32. he connectors the connectors Y 5 Dip the probe up to A maximum of 5 cm 4 Immerse the probe and the cable in the in the Alkacide solution for 5 to 20 minutes Alkacide solution for 5 to 20 minutes depending on the estimated level of risk Do depending on the estimated level of risk not wet the connectors Please keep the connectors dry Ao H 6 Clean the probe body and the cable that were not soaked using a wipe lightly dampened with the Alkacide solution Keep the connectors dry C Drying 7 Rinse the end of the probe with 5 Rinse the end of the probe with demineralized or distilled water Keep the demineralized or distilled water Keep the connectors dry connectors dry N Y 8 Dry it with a sterile compress 6 Dry it witha sterile compress 9 The B probe is ready for use 7 The A probe is ready for use User s Manual Chapter 5 Cleaning Disinfection and Sterilization 5 5 Method for high risk patients NOTES Please disconnect the probes from the machines Machines must be turned off first Please avoid splashing any liquid onto the electrical connectors A Decontamination Pre disinfection 1 Immerse the first 5 cm maximum in a solution of 1 Immerse the probe and the cable except either Alkazyme or Aniozyme forS to 15 minutes connector in a solution of Alkazyme or Aniozyme depending on the percreived level of risk for 5 to 15 minutes depending on the perceived level of risk 2 Clean
33. matic measuring key Press it in the status of A automatic measurement the instrument will be shifted among NORM APHA SPEC and CATA User s Manual Chapter 4 Operation NORM NORMAL EYES SPEC SPECIAL EYES APHA APHAKIC EYES CATA DENSE CATARACT EYES MANL Manual measuring key Press it to enter manual measurement of A mode IOL Press it to enter IOL calculation mode where calculation parameters can be input From A Mode to IOL the average axial length can be automatically put in AL box while if an appointed AL from 8 groups of results is necessary press Al Refer to Aal below AL Press it under IOL mode the axial length pointed by line that is measured automatically in A mode can be input to AL box for IOL calculation CAL In IOL mode press this key to calculate IOL after all constants are input correctly OS OD Indicate left or right eye which is displayed on the screen lt gt Cursor control function keys used to move the cursor and select functions Vv a v in B mode press it to turn the image page up and down and save 8 pages marked as P1 P8 in A mode press it to display the curve of automatic measurement indicated by gt In IOL mode press it to retrieve the information of axial length cornea curvature etc FRZ SCN Scan
34. ntraocular lens calculation formula Am Intra Ocular Implant Soc J 6 148 152 1980 RETZLAFF J SANDERS DR KRAFF MC Development of the SRK T intraocular lens implant power calculation formula J Cataract Refract Surg 16 3 333 340 1990 SANDERS DR KRAFF MC Improvement of intraocular lens power calculation using empirical data Am Intra Ocular Implant Soc J 6 263 267 1980 SANDERS DR RETZLAFF J KRAFF MC Comparison of the SRK II formula and other second generation formulas J Cataract Refract Surg 14 136 141 1988 HOFFER KJ The effect of axial length on posterior chamber lens and posterior capsule position Current Concepts Ophthalmic Surg 1 20 22 1984 HOLLADAY JT PRAGER TG CHANDLER TY MUSGROVE KH LEWIS JW RUIZ RS A three part system for refining intraocular lens power calculations J Cataract Refract Surg 14 17 24 1988 User s Manual 41
35. ny way by anyone who is not authorized by the manufacturer This device is not intended for fetal use According to FDA laws ODM 1000 is a prescription Device and is to be used by or under the supervision of a licensed physician Disconnect AC power before cleaning the housing case While plugging in the robe make sure the red mark on the probe align with the red mark on the socket While plugging of the probe please be sure you are pulling the connector instead of the cable Do not scratch the surface of the probe Do not drop the probes For any question please contact the Manufacturer or your Local Distributor User s Manual Precautions and Warnings CAUTION HOW TO PREVENT CROSS INFECTION Between uses on different patients the probe must be cleaned to prevent cross infection Manufacturer advocates a preventive action and a cleaning procedure in Chapter 5 Cleaning Disinfection and Sterilization CAUTION The ODM 2100S IOL calculator will calculate negative IOL values if such is predicted by the data input Wott These are displayed with a minus sign Do not ignore this sign CAUTION To preserve the equipment avoid using any abrasive cleaner If possible clean spots before they dry TISSUE EXPOSURE TO ULTRASOUND ENERGY The ODM 2100S is designed for use in ophthalmology only While the manufacturer is not aware of any reports of adverse effects from using o
36. phthalmic ultrasound scanner even at FDA pre enactment levels no other use is intended or implied The system controls limit of the output energy within the parameters specified for its intended purpose Please refer to Annex A of User s Manual No control of ultrasound energy is available to the users other than the duration of exposure considering the current concern for possible unknown hazards and despite the extremely low output intensities used in this ultrasound system The manufacturer recommends that patients exposure time during measurement User s Manual Labels and Indicators Labels and Indicators POWER IN FUSE FOOTSWITCH VIDEO OUT GAIN M q b gt o O _ N OW 5 lt Note A Probe Socket B Probe Socket AC 100V 240V Power Input 50 60Hz Power On Power Off Fuse Socket 100V 200V 4A 200V 240V 2A Footswitch socket Video Signal Output Gain Control Contrast Control Brightness Control Symbol of Type B Refer to User s Manual Equipotentiality CE mark The degree of protection against ingress of liquids only for SONY MITSUBISHI Video Printer User s Manual Chapter 1 Introduction Chapter 1 Introduction 1 1 General Description ODM 2100S Ultrasonic A B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis It consists of the main unit 10MHz mechanical sector B scan probe 10MHz A biometric
37. properly 6 2 Biometric Test There is a test object available with each equipement which imitates four J acoustical reflect interfaces of human eyes and used to test the biometric measuring Fill the object with distilled water Be sure that there is no air bubble in the water Gently place A probe onto the highest stage perpendicularly in the object see left drawing Press A to enter A scan and MANI to enter manual mode Click on FRZ SCN to start scanning move the probe Fig 6 1 gently adjust the gain properly to make the start wave and 3 reflected waves clear and sharp as shown as Fig 6 2 At this time press AUTO key the result will be seen automatically Keep the position of the probe press A and then FRZ SCN the test can be restarted If the measuring results are repeatable it means A biometric scan is working properly User s Manual 31 Chapter 6 Maintenance and Trouble Shooting Start wave Reflected wave 6 3 Trouble Shooting 1 Light indicator of the power supply is not on and the instrument doesn t work Check if the power supply plug and socket are well connected Unplug the power and check if the fuse is burnt out The fuse is 4A Fuse 110V 120V or 2A Fuse 220V 240V Be always sure to use the same standard product as below Testing Current Blow Voltage Range Spec Breaking Capacity Time Dimension i 100 4h
38. rse the connector Do not autoclave the probes After cleaning rinse the end of the probe thoroughly with clean water to remove all traces of the liquid used Follow the instruction on the label of commercial disinfectants The surface should then be dried with lint free cloth 5 2 Sterilization Procedure Pre sterilization and Sterilization of the Probes Forward Operator should use standard method to ensure satisfactory sterilization of the probe after use Operator should use risky patient protocol to ensure satisfactory sterilization of the probe every time after use on a patient where there is a risk of infection of Creutzfeld Jacob disease OPERATOR S CLOTHING One off overall Disposable gloves sterile for sterilization Glasses and anti rejection masks EQUIPMENT Soft silk brush surgical nail brush User s Manual 33 Chapter 5 Cleaning Disinfection and Sterilization 3x500 ml stainless steel or plastic autoclavable soaking trays One off hand cloths Distilled water PRODUCTS Cleaning predisinfectant Aniosyme P L A Company ANIOS or predisinfectant Alkazyme alcalin Company ALKAPHARM The products must be diluted at 0 5 with warm water 25 C 30 C from the tap or distilled water The contents of the tray must be changed every day C Disinfectant type Alkacide Company ALKAPHARM The product must be changed diluted at 5 wit
39. ser s Manual Chapter 4 Operation Chapter 4 Operation 4 1 Keypad Description The instrument can be operated by keypad and soft keys on the screen The keypad consists of alphabetic keys numeric keys and functional keys The soft keys are controlled by the trackball and its left and right key L and R 4 1 1 Alphanumerical keys Letter Number The alphabetic and numeric keys are used to input characters in the place of the cursor N A N A N Press them to input corresponding arrows in the place of the cursor Backspace key Press it to place the cursor one space back At the same time the character will be erased SPACE Space key To move the cursor to the right 4 Enter key It is used to finish the current line and go to the next line or finish the current item and go to the next one To adjust the threshold of A Scan measurement under A Mode while under the interface of OL and SETUP can be used as just plus and minus 4 1 2 Function Keys B Press it to enter single B scan B A Press it to enter B A mode B1 B2 Press them to enter double B scans and switch between images of B1 and B2 A Press it to enter A mode automatic measurement or to refresh A scanning and start a new measurement AUTO Auto
40. sonic A Biometry is used to measure the anterior chamber depth lens thickness vitreous length and to calculate the axial length according to these measurements To ensure the accuracy the ultrasound should go into the eye from the vertex of the cornea as close as possible and superpose with the axis Auto and manual modes can be selected for the measurement Auto mode is suitable for normal aphakic dense cataract and other conditions where the velocity of ultrasound is known For contact method A probe is contacted with the cornea vertex directly This method is simple and easy to control But the cornea can be injured and slightly distorted therefore affecting the results So the operator should operate very carefully and not press the cornea The contact method applies to both the auto and manual mode When A Scan is selected it enters the following screen Fig 4 8 APHA SPEC CATA MANL 1 2 3 d 5 6 7 3 S SEX KALE 3 O1 1 2808 22 Fig 4 8 NORM Normal Eye Auto AC Anterior Chamber Depth APHA Aphakic Auto LENS Thickness of Lens SPEC Special Eye Auto VITR Vitreous Length CATA Dense Cataract Auto AL Axial Length MANL Manual AV Average Measuring Result COR Thickness of Cornea sD Standard Deviation 4 4 1 Auto Measuring i User s Manual ia Chapter 4 Operation 1 Press A to enter A scan auto measuring mode NORM 2 Select the type of
41. t in locations subject to intense electric or magnetic fields Avoid excessive shock e g tooth drill and direct sunlight User s Manual 5 Chapter 3 Installation Startup Shutdown The equipment should be placed on a stable worktable Leave certain space around the instrument and avoid soft object below it for ventilation 3 4 Connection VIDEO OUT FUSE PEENES POWER SWITCH VGA POWER SUPPLY GROUNDING SOCKET Fig 3 2 1 Plug footswitch cable to FOOT SWITCH socket on the rear panel 2 Plug power cable to the power socket on the rear panel and the other end to a properly grounded power supply socket 3 Plug B probe into B Probe socket on the right panel 4 Plug A probe into A Probe socket on the right panel Note 1 While plugging the probe make sure the red mark on the probe aligns with the red mark on the socket 2 The probe should be placed in the probe holder Do not put it on table or other supporters Do not scratch the surface of the probe 3 While unplugging the probe please hold the connector Do not pull the cable 4 If the probe drops while using or moving please check the surface and shell carefully If any of them is broken then stop using it immediately and contact the manufacturer or local distributor Jor repairing 5 If a video printer is available connect the video cable to VIDEO IN of the printer and the other end
42. the end of the probe in the chosen 2 Clean the probe and the cable in the Chosen solution for 1 minute using the brush solution for 1 minute using the brush 3 Clean the rest of the probe body and the cables using a swab lightly dampened with the same solution Do not wet the connector B Rinsing 4 Rinse the end of the probe in 3 Rinse the probe and the cable with demineralized or distilled water Do not wet demineralized or distilled water Please do User s Manual 28 Chapter 5 Cleaning Disinfection and Sterilization the connectors not splash liquid onto the connector C Inactivation 5 Immerse the first 5 cm maximum in a 6 4 Immerse the probe and the cable except chlorometric degree solution of sodium connector in a 6 chlorometric degree solution hypochloride for 60 min at 20 C ensuring the hypochloride for 60 min at 20 C keeping the connectors are kept dry connectors dry A H 6 Clean the probe body and the cable that were not soaked using a wipe lightly dampened with the Alkacide solution D Rinsing 7 Rinse the end of the probe with demineralized or 5 Rinse the probe and the cable with distilled water demineralized or distilled water User s Manual 39 Chapter 5 Cleaning Disinfection and Sterilization E Disinfection 8 Dip the probe up to a maximum of 5 cm in the 6 Dry with a sterile compress if the rinsing water Alkacide solution for 15 min was sterile 9 Clean the probe
43. usads bags saeuse os scoubagusanies oh acbeeageagouse puscbubagusaoies weaiieaieseviasaet esaaenaeamaed 34 7 2 Accessories ANd CONSUMADIES cceescccesssneeeesencecceseneecessneeeceseeeecessseeeeseaeeeeseeeeesseeeeeseeaeeeeses 34 Annex A Acoustic Output INFOrMatiOn cccccecccceesneeeeesneeeeeseeeeeeseneecessneeceseeeeceseaeeceseeeeeeseeeeeesenseeenenees 35 Annex B Guidance and manufacturer s declaration ccccsesccceseseceeeeneeeeseeeeceseneeceseeeceesneeeesseneeeeseneeens 37 Annex C RETERCMGCS irisaren secedtenencas a Pesmerteden sted a e E e eae E E AEEA 41 User s Manual Precautions and Warnings PRECAUTIONS The instrument should be operated by trained doctors Please read the manual carefully before installation and operation Please refer to chapter 5 Cleaning Disinfection and _ Sterilization to avoid cross infection while using Unplug power supply before cleaning Please refer to chapter 6 for maintenance attentions WARNINGS Do not make any modification to the Device without authorization The manufacturer won t be responsible for any damage or injury caused by any failure to follow the instructions in the User s Manual The manufacturer reserves the right to modify equipment characteristics without previous notice under FDA Laws and MDD 93 42 EEC Regulation The quality guarantee of ODM 2100S will be invalid if it is opened even partially modified or repaired in a
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