cautions
Contents
1. Click it to enter the parameter tab page for Pachymeter 414 Chapter 4 Operation LOGIN SET Click it to enter the user setup tab page it is not available under ADMIN system CLOCK SET Click it to enter the clock setup tab page The functions of other keys under the SETUP Interface are as follows VERSION Click it to enter version information tab page SAVE Click it to save selected result RESET Reset key Click it to restore default value LOGOFF Click it to cancel the system and reenter into the Login Interface after 1 second EXIT Click it to exit from the interface Note 1 Under other tab pages except that of SET click SAVE key will save all parameters in the A PRINT P RINT P IOP and LOGIN SET tab pages and click PRESET key will restore all parameters to default settings Please confirm before operation 2 Click SAVE or PRESET key will save the status of all parameters automatically so please make the related change cautiously 4 2 5 DATA BASE Interface The DATA BASE Interface is for patient information management as shown in Figure 4 8 2009 10 15 15 30 46 DATA BASE NAME AGE SEX 0500 TYPE Conon CLEAR DELETE EXIT SEA AGC UU Figure 4 8 DATA BASE Interface This interface lists all the saved patient information in tabular format The contents displayed include patient nam2. 8 4 1 1 Check before 5 8 4 12 Procedure eco et D E alm at 8 4 1 3 Check before 8 4 1 4 Shutdown esee seen rnh essen arre essa 9 4 2 INTERFACE INTRODU GCTION peto 9 2 1 9 4 2 2 PACHYMETEH Interface DU eet eto oe ed ien Cd 10 5 4 2 3 Patient Interface Patient Information 12 424 n et RR 13 425 DATABASE Mtera ooe E due IE 14 43 OPERATION 15 4 31 Poco 13 2 sont Cui reste UE 15 233 DATABASE on tna TT Te 16 4 3 4 Display of Saved Information Poe 17 4 3 5 Amendment and Storage of Parameters and Clock 18 CHAPTER 5 CLEANING DISINFECTION AND STERILIZATION 22 F
3. 31 7 1 MAINTENANCE AND ATTENTIONS INSTRUMENT 31 7 2 MAINTENANCE AND ATTENTIONS TO 31 7 3 MAINTENANCE OF LCD 2 2 22 44 4 4 010000 01000000 000000000 32 T4 EROUBEBEGHOOTINGS tuat 32 CHAPTER 8 SERVICE AND SUPPORT INFORMATION cccscccssssesssccssscesscccssccessccessscessscessccesses 34 WARRANTY OTI 34 8 2 ACCESSORIES AND MATERIALS arin rd eu ode 34 8 2 1 S 34 8 2 2 Deltacnabie Parte e LEE 34 8 2 3 EIER 34 8 3 SOFTWARE UPDATE AND 5 2 0020201000 000000000 rine senes seen rnn nen 34 ANNEX PRUDENT USE STATEMENT ccscccssscsssccsssccsssccsssccssscssssccssscessscssssccssscessscessseessscesseeees 36 5 AT STATE MEIN avt Edad stt QI MM 36 A 2 PRINCIPLE OF ALARA As Low As REASONABLY ACHIEVABLE 36 ANNEX B PROMPT MESSAGE 37 ANNEX C 1 ACOUSTIC OUTPUT REPORT IEC60601 2 37 38 ANNE
4. RU 5 Operation Manual 3 RU E 5000 N GILRAS Address 9990 NW 14ST Suite 105 Doral FL 33172 Phone 1 888 334 4640 Fax 1 786 621 1842 Email info gilras com 5 PRECAUTIONS IV aie EXPLANATION OF SYMBOLS deve eoe Devo INTRODUCTION 1 1 1 GENERAL DESCRIPTION ccccccccccsececccccsececcccuscccccccsseccceuscececcususecccuuucececeuuuceesecuuucecescuauceceeeuaaes 1 1 2 ar ee 1 1 3 INTENDED LOCATION OF USE 1 1 4 CONIRAINDICATIONS a 1 1 5 EXPECTED SERVICE 1 1 6 SOFTWARE VERSION ctore eoe diuo boa bas ad du M 1 CHAPTER 2 SPECIFICAHOND 2 anaes cate 2 2 1 WORKING CONDITIONS ua 2 2 2 MAIN GPEGCIFICATHONS eee er eet 2 2 3 SAFETY uo uuu MA M
5. 6 Chlorometric degree solution of sodium hypo chloride at 20 The contents of the tray must be changed after each use Demineralized or distilled water NOTES Please disconnect the probes from the instrument Please be sure the instrument is TURNED OFF before disconnecting probes Avoid splashing liquids onto probe connectors end of the cable which is connected to the machine 5 4 Preparation of Sterilization Agent STERILIZATION PREDISINFECTION 1 Proteolytic enzyme based agents 2 possibilities 1 0 5 Alkazyme solution in water 20g sachet 2 Pourin 1L warm clean water 25 30 3 Putin the unopened sachet 4 Wait for 1 minute 5 Pourin 4 L 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 Chapter 5 Cleaning Disinfection and Sterilization OR 1 0 5 Aniozyme solution in water 25g sachet 1 Pour in 1L warm water 25 30 2 Putinto the unopened sachet 3 Wait for 1 minute 4 Pourin 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 500ml when sterilization is necessary Replacing Contents of soakin
6. and sex MALE Please update the patient information in time to prevent any error 4 3 2 2 Click the Patient Information Display Area at the bottom of the screen to enter the Patient Information Interface Input patient s information as per the same method of 4 2 3 and then return to the PACHYMETER Interface If patient information is not input the system s default selection is OS and MALE which appear in the Patient Information Display Area at the bottom of the screen 4 3 2 3 Click MANUALI key to choose manual mode MANUAL automatic mode AUTOX 1 AUTO 2 AUTO 3 or enter the SINGLE interface 4 3 2 4 Give surface anesthesia to the cornea to be tested disinfect the front top of the P probe and make it dry Press the foot switch or click SCAN key and move the probe within 5 seconds onto the corresponding position of the cornea indicated by the corneal thickness distribution map cursor Touch the cornea gently and make measurement The measuring result appears in the dialogue box on the right top of the screen The key is green during measurement and returns to light blue after measurement If no suitable data acquired the instrument will stop measurement after 5 seconds and return to the status ready for measurement 4 3 2 5 Under automatic measuring mode if suitable data are acquired the instrument will input the value in the position of the cursor by itself and then the cursor will skip to the next measuring position Unde
7. 4 3 2 8 Click CLEAR key to clear the measuring data Note Please make sure front top of the P probe is dry and corneal surface is moist each time when you start measurement 4 3 3 DATA BASE Click DATA BASE key in the PATIENT Interface to enter the data base and check patient information If data are saved after measurement the patient s information will be saved in the data base 2009 10 15 15 30 46 DATA BASE NO NAME ID AGE SEX OSOD TYPE TIME BROWN 00000005 MALE 2009 06 06 09 00 OK CLEAR DELETE EXIT NAMC ID UUUUUUUU SCA WIALC UU Figure 4 9 DATA BASE Interface 16 Chapter 4 Operation The data base will display the saved patient information in tabular format as shown in Figure 4 9 The displayed information include patient name ID age sex OS OD and type of measurement Pachymeter The operator can select the patient information by clicking the position of the patient information blue bar means selected Click to call out the Measuring Data Display Interface and observe the measured result At the moment some of the functions are invalid in the Measuring Data Display Interface The invalid function keys turn to grey and there is no response after clicking Please refer to 4 3 4 for details CLEAR key is used to clear all patients information Click this key and the dialogue box will be called out to confirm the operation Selec
8. As per working mode continuous working Chapter 3 Installation Chapter 3 Installation 3 1 Structure The structure of the instrument See Figure 3 1 Foot Switch Color LCD Touch Screen Power Input Indicator Working Indicator Paper Housing Cover Paper Housing Switch Probe Holder Pachymeter Probe Socket Pachymeter Probe Power Switch pet erp ew Figure 3 1 Structure of the Instrument The Rear Panel See Figure3 2 DC Power Input Socket Foot Switch Socket USB Interface Figure 3 2 Rear Panel of the Instrument The power adaptor of the product with input voltage of AC100 240V and output voltage of DC12V 4A meets the safety requirements of medical electric device as shown in Figure 3 3 DC Power Input Plug Power Adaptor Figure 3 3 Power Adaptor Chapter 3 Installation 3 2 Environmental Requirements 1 The instrument should be operated in a clean environment Air conditioned environment is recommended 2 The instrument should be placed on a stable worktable or platform Avoid direct sunlight 3 Please use the supplied Power Adaptor which is in accordance with the safety standard of medical electric equipment do not use any other adaptors 4 The power outlet should be with good grounding Improper connection of protective earth may cause not only interference but also the risk of increasing leakage current 5 Do not block the ventilation window of the instrument
9. 1 Startup Interface Switching on the GRU 5000P the buzzer will beep shortly and then enter the Login Interface see Figure 4 1 2009 10 15 15 30 46 LOGIN ADMIN wv Figure 4 1 Login Interface Click key directly under the Login Interface will enter the PACHYMETER Interface of the default ADMIN user system Click to select other user system see Figure 4 3 after selection Click key to enter the corresponding PACHYMETER Interface of the relevant user system See 84 3 5 for amendment of the user name in which ADMIN is the particular system name that can t be amended Chapter 4 Operation 2009 10 15 15 30 46 Figure 4 2 System Selection Interface 4 2 2 PACHYMETER Interface The PACHYMETER Interface is shown in Figure 4 3 2009 10 15 15 22 00 Corneal Thickness Distribution Map THERESULT IS eae kkkk EERE HERE EERE EEE S E 2 TIT EE Lrirr o eek Patient Information Midi jc EUM T N Display Area SAVE PRINT MANUAL MENU ID 00000000 SEX MALE AGE 00 05 Figure 4 3 PACHYMETER Interface B Direction key Use clockwise and counterclockwise arrows to control the cursor s forward and reverse circular motion Thus determine the input position of measuring data SAVE Input key Click it to save the current measuring value to the cursor s position meanwhile the cursor will move to the next position OS OS
10. E MeL DR LM 2 2 4 STORAGE AND TRANSPORTATION 5 220 2 0 00000000000000002200000 2 2 4 1 Storage Condilions oce ott tu etat add 2 2 42 Transportation Conditions 2 2 5 CLASSIFICATION MONTRER 2 CHAPTER 3 INSTALLATION 4 3 1 22 eL er et SR IELTS er AE RT 4 3 2 ENVIRONMENTAL 6 2 220 00 020000000000000000000 5 3 3 EE NI 5 3 3 1 CODDecHoLnD Of PFODO ttt rS sh pac epost D pO 5 3 3 2 DISCONNECTION OF PrODO ei eue ete 5 3 3 3 Connection of Power Supply eii es RENE to EVE US 6 3 3 4 Disconnection of Power 6 3 3 5 Connection of Foot 5 2 3 3 6 Replacement of Printing 7 GHAPTER 4 Do ea eee eve eua a deed 8 4 1 STARTUP AND SHUTDOWN AE EE EL
11. Interface NEW New Patient key Click it the Patient ID will be restored to default value new patient information can be input at the moment meanwhile all data measured in other interfaces will be cleared DATABASE Click it to enter the DATABASE interface SETUP Click it to enter the SETUP interface Numerical keys are used to input number 0 9 the 4 keys are used to control the left and right movement of the cursor respectively Under the PATIENT Interface in case of changing into other interfaces the patient information entered will be displayed at the bottom of the screen The displayed information contains name ID age sex and OS OD for reference If the information is not input the default patient name is empty the ID is and the age is 4 2 4 SETUP Interface The Setup Interface as shown in Figure 4 7 2009 10 15 14 00 42 SETUP Tab Page P_PRINT P_IOP LOGNSET CLOCK VERSION AG OPERATE EYE CENTER 0000 A1 1111 A2 2222 A3 3333 B1 1111 B2 2222 B3 3333 C1 1111 C2 2222 C3 3333 D1 1111 D2 2222 D3 3333 E1 1111 E2 2222 E3 3333 F1 1111 F2 2222 F3 3333 G1 1111 G2 2222 G3 3333 H1 1111 H2 2222 H3 3333 RESET ds ID 00000000 SEX MALE AGE 00 Figure 4 7 SETUP Interface The Setup Interface consists of five parameter setup tab pages Click the corresponding key to enter each tab page P PRINT Click it to enter the print parameter tab page for Pachymeter
12. NEW DATABASE SETUP NAME ID 00000000 SEX MALE AGE 00 05 Figure 4 5 PATIENT Interface Patient Information Interface In normal measuring interface click the Patient Information Display Area at the bottom of the screen to enter the Patient Information Interface directly The Patient Information Interface is used to input patient information including patient name ID age OS OD and sex accordingly Click the position of the corresponding key the cursor appears and then input the information Patient name should be no more than 12 characters Click the text box of Will call out the alphabetical keypad click the keypad to enter patient name as shown in Figure 4 6 Click the text box of again to cancel the alphabetical keypad and complete inputting ID is made up of 8 digits with the input range from 00000000 to 999999989 click the numerical key at the right side to input numbers when the cursor is located in the text box Input age with the same method and the range for age is from 00 to 99 2009 10 15 16 13 00 PATIENT Figure 4 6 Patient Information Interface Alphabetical Keypad 12 Chapter 4 Operation There are two ways to select OS OD one is clicking OS OD key the OS and OD lights up alternatively the indicator lights up means selected the other is clicking the area of OS or OD directly for selection Patient s sex can be set with the same method PACHYMETER Click it to choose returning to the PACHYMETER
13. and IOP Coefficient The deviation of the corneal thickness measuring value to the standard can be substituted into the empirical formula to work out the IOP adjusting value AIOP The AIOP is only as the reference value of the IOP measurement The system s IOP parameter setting is Standard CCT 550 and IOP Coefficient 0 50mmHg 10 The empirical formula is AIOP Standard CCT Measuring CCT X IOP Coefficient Note Please refer to Annex D Experienced doctors may amend the set value of the parameter based on the relevant research results Click the IOP parameter text box to make amendment using the keypad to input data which can be used only after saving by clicking the SAVE key 19 55 Chapter 4 Operation 4 3 5 3 LOGIN SET Parameter Setup Unavailable under ADMIN System Under startup selection the default system is ADMIN click ENTER key directly to enter If ADMIN is selected the system will enter the default setting which means the printing setup and IOP parameter are all default settings These values can be amended and saved after amendment If other user system USER1 USER2 USERS USER4 or USERS will be selected click system selection key to select the required user system and then click key to enter The gain of this system printing setup IOP parameter and IOL calculating parameter can be set and used separately The name of the user system can be am
14. measurement of time interval between the anterior and posterior interface reflection waves to get the corneal thickness CT The GRU 5000P has a built in Thermal Printer used to print out patient information corneal thickness measuring result and corneal thickness distribution map The built in memory of the GRU 5000P can store up to 180 patients records 1 2 Intended Use The GRU 5000P is intended for corneal thickness measurement in clinical ophthalmology 1 3 Intended Location of Use The GRU 5000P is suitable to be applied in hospitals and ophthalmology clinics As the foot switch s protective degree against ingress of liquids is IPX1 it is not suitable to be used in operating room and other locations where it is easy to splash liquid 1 4 Contraindications It is prohibited to use the device on patients with eye trauma inflammation or infection 1 5 Expected Service Life Based on the experience of products sold and considering technology update cycle as well as the aging of the major part transducer will probably reduce the basic performance the product s expected service life is determined as five years according to the normal usage of six hours each working day Service life may extend if the major parts like probe are returned to manufacturer for update 1 6 Software Version V1 0 0 10 Chapter 2 Specifications Chapter 2 Specifications 2 1 Working Conditions Environmental Temperature 5 40 Relative Humid
15. t pull the probe cable strongly while unplugging probe a Connection of Probe b Disconnection of Probe Figure 3 4 Connection Disconnection of Probe 3 3 8 Connection of Power Supply Footswitch Figure 3 5 Connection of External Interface 1 Plug the DC Power Output Plug of the Power Adaptor in the Power Input Socket on the rear panel of the instrument 2 Connect one end of the Power Cable with the Power Adaptor and the other end to the wall outlet as shown in Figure 3 5 3 3 4 Disconnection of Power Supply 1 Turn off the Power Switch on the front panel 2 Disconnect the main power plug of the Power Adaptor and the wall outlet A Note Take care of safety while connecting or disconnecting the power supply 6 Chapter 3 Installation 3 3 5 Connection of Foot Switch Plug the Foot Switch connector into the Foot Switch Socket on the rear panel of the instrument as show in Figure 3 5 3 3 6 Replacement of Printing Paper The built in printer is a thermal printer that uses thermal printing paper Please purchase and replace the printing paper according to the specific model provided by the Manufacturer see 58 2 1 Consumables Replacement of printing paper 1 Press OPEN button to open the cover of the paper housing 2 Take out the reel of the paper from the paper holder and add new paper see Figure 3 6 Figure 3 6 Replacement of Printing Paper 3 Pull out the printing pap
16. OD selection key Click it to change left right eye selection SCAN Start to measure key Click it to start measuring the color of key will be changed from light blue to green CLEAR Clear key Click it to clear all measuring results 10 Chapter 4 Operation MENU Menu key Click it to enter the MENU Interface Memory key Click it to save measuring results PRINT Print key Click it to print out results IMANUAL Manual or automatic selection key Click it to select manual or automatic measurement where there are five display statuses respectively Manual AUTO 1 AUTO 2 AUTO 3 and SINGLE Singe Point Multiple Measurement The corresponding corneal thickness distribution map will be changed also DEL Delete key under the Singe Point Multiple Measurement Interface Click it to delete the selected measuring result The average value of each group and standard deviation displayed will be updated accordingly 2009 10 15 15 22 00 PACHYMETER THE RESULT 5 OS SAVE PRINT SINGLE ID 00000000 SEX MALE AGE 00 Figure 4 4 Singe Point Multiple Measurement SINGLE Interface Click the Patient Information Display Area at the bottom of the screen will enter the PATIENT Interface as well 11 Chapter 4 Operation 4 2 3 Patient Interface Patient Information Interface 2009 10 15 16 13 00 Indicator NAME ID 00000000 os OD MALE FEMALE PACHYMETER
17. OR EUROPE miel oleae uc pei Lider DNE Eod 22 5 1 How TO PREVENT 55 nennen enne eene rnn senten eset nnns senis 22 5 2 CLEANING DISINFECTION OF EYE 22 5 3 STERILIZATION PROCEDURE PRE STERILIZATION AND STERILIZATION OF THE PROBES 22 5 4 PREPARATION OF STERILIZATION 23 55 STANDARD METHOD noran bdo P DD 24 FOBUS Auc etam EI E dai ui EU 27 5 6 X CLEANING OF THE MAIN UNIT OF 80 5000 27 5 7 How TO PREVENT CROSS INFECTION 0 0400040 000000 27 oS ME HOD crue M cuc M ME cM MEE 21 5 0 1 Prepara ON o ated teta E E antc ME Opp 2 5 0 2 Thorough e oce ote ae iet x 28 5 0 9 DISIDIeCIOI 28 5 8 4 Rinsing after DISIDIeCIIORn eto Hotte Nau ditt eee 29 CHAPTER 6 e 30 6 1 EX ERNAL LABEL 30 NIEBNALID s coton E 30 CHAPTER 7 MAINTENANCE ATTENTIONS AND SIMPLE DEFECTS TREATMENT
18. R should assure that it is used in such an environment Compliance IEC 60601 test level Immunity test Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the MD1000P ULTRASONIC PACHYMETER including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF IEC 61000 4 6 3 Vms 150 kHz to 80 MHz Recommended separation distance d ET Radiated RF IEC 61000 4 3 80 MHz to 2 5 GHz d Ed 80 MHz to 800 MHz 1 d HB 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio ce
19. SONIC PACHYMETER 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 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz is d E d LW 997 d oa 1 02 1 599 40 1474 2353 For transmitters rated at maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the 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 24 Guidance and Manufacturer s Declaration AnnexE References Sunil Shah FRCS ED FRCOphth Accurate intraocular pressure mea sure ment the myth of modern ophthalmology Ophthalmology 2000 107 1805 1807 44 5 2U 5000 P 9990 NW 14 Street Suite 105 Doral FL 33172 GILRAS T 888 334 4640 E info gilras com www GILRAS com
20. When the temperature of the instrument is not normal please contact the manufacturer for service 6 Although the EMC of the instrument meets the requirements of IEC 60601 1 2 it should be placed to avoid strong electromagnetic radiation equipment such as microwave radio frequency therapy equipment etc 7 Please do not put the instrument in a place where it is difficult to disconnect the power supply 8 The instrument should be placed in a position where the operator can face the instrument and view the screen easily The distance between the instrument and the patient should enable the probe to contact the patient s eye conveniently 9 The instrument should always be placed safely to prevent falling of the probe 10 The instrument has no special protective measures for discharge effect of cardiac defibrillators it is not suitable for use with high frequency surgical equipment 3 3 Connection Note is prohibited to plug in plug out any accessories while the instrument is running 3 3 1 Connection of Probe Plug the Pachymeter probe into the socket on the right panel N Note While plugging in the probe make sure the red mark on the probe align with the red mark on the socket as shown in Figure 3 4 a 3 3 2 Disconnection of Probe To disconnect the probe please hold the ring of the connector and pull it out along the horizontal direction as shown in Figure 3 4 b Chapter 3 Installation Note Don
21. X C 2 ACOUSTIC OUTPUT REPORTING TABLE 4 eee 39 ANNEX D GUIDANCE AND MANUFACTURER S 40 ANNEX E REFERENCES c 44 Precautions and Warnings PRECAUTIONS The device should be operated by trained technicians It is prohibited to use the device on patients with eye trauma inflammation or infection Please read the manual carefully before installation and operation Please refer to Chapter 5 Cleaning Disinfection and Sterilization to avoid cross infection while using Disconnect AC power before cleaning the housing case Please refer to Chapter 7 Maintenance Attentions and Simple Defects Treatment for maintenance attentions WARNINGS The customer is fully responsible for maintenance and management of the instrument after purchasing Do not make any modification to the software and hardware of the device without authorization The power adaptor provided with the device meets the safety standard of medical electrical devices If damaged contact the Manufacturer to purchase Use of other adaptors may cause safety risk The manufacturer won t be responsible for any damage or injury caused by any failure to follow the instructions in the User Manual The manufacturer reserves the right to modify equipment characteristics without previous notice under FDA Laws and MDD 93 42 EEC R
22. a Prepare the cleaning solution by adding 1 2 Bianex Special Efficiency Multi Enzymatic Cleanser into 500ml of sterile water Additional amounts maybe required for hard to remove matter The water temperature should be from 20 C to 64 b Immerse the P Probe that need to be disinfected into the container with 500ml cleaning solution for 5 minutes Do not immerse the probe connector Clean the P Probe carefully in the cleaning solution with a soft silk brush and shake it to wash and then take it out and wipe off the cleaning solution with sterile cloth c Rinse the cleaned P Probe by immersing it in 500ml sterile water for 1 minute d Drain the P Probe and wipe it with sterile cloth Note 1 Disposable gloves eye protection and liquid proof gowns should be worn when cleaning soiled probe and or eye up 2 All detail information for Bianex amp Special Efficiency Multi Enzymatic Cleanser please refer to the manufacturer s instruction 5 8 3 Disinfection Use disinfectant solution immersion method a Activate and prepare the disinfectant solution Sporicidin Sterilizing and Disinfecting Solution according to the manufacturer s instructions b Sporicidin Indicators should be used before each use of this solution to determine whether glutaraldehyde is at or above its minimum concentration of 0 6 and phenol is at or above its minimum recommended concentration of 1 3 Do not use beyond 14 days even if the respective concentr
23. ation of active ingredients is above the minimum recommended concentration as indicated by the indicator strips C Disinfect the P Probe by immersing it completely in about 500ml of disinfectant solution for a minimum of 20 minutes at 25 C Please keep the probe connector dry during disinfection d Drain it and wipe off the disinfectant solution with sterile cloth Nuoto 1 Disposable gloves eye protection face masks and liquid proof gowns should be worn when disinfecting soiled probe and or eye up 2 Containers filled with disinfectant solution should be kept closed and stored 28 Chapter 5 Cleaning Disinfection and Sterilization in a well ventilated low traffic area at room temperature 3 All detail information for Sporicidin Sterilizing and Disinfecting Solution please refer to the manufacturer s instruction 5 8 4 Rinsing after Disinfection a Thoroughly rinse the disinfected probe by immersing it in three separate copious volumes of 500ml sterile water Each rinse should be a minimum of 1 minute in duration Use fresh portions of water for each rinse b Take out the P Probe and let it dry naturally C After disinfection processing put the P Probe into a sterile box Now the P Probe is ready for use A Note 1 Steam sterilization is prohibited 2 Disconnect the probe from GRU 5000P before disinfection the power of GRU 5000P should be turned off before disconnecting the probe hold the probe cable connect
24. be used for other purposes T 3 Maintenance of LCD Screen Clean the LCD screen with glasses cloth lens tissue or other soft material Don t touch the LCD screen with hard object which will cause irreparable damage to the screen Avoid strong shock and vibration during transportation Complete the touch screen operation with finger belly 7 4 Trouble Shooting In case of connection failure please check first if the power supply and probe are well connected In case of printing failure please check first if it is out of printing paper or paper jam In case of clock failure which can not be restored by restarting possibly the clock battery is used up The battery can t be replaced by operator please contact your distributor for repair In case of display or operation failure please switch off the power and restart check if it is back to normal In case of overheat or other abnormalities please switch off the mains power immediately to prevent danger The over current protection fuse is sealed inside the power adaptor and can t be replaced by user If the power adaptor has no DC output please pull out the main power plug and contact the manufacturer for repair If above operations are not effective please don t open the housing without authorization Contact your local distributor immediately Explain the problems in detail for proper and in time support If required we can provide the complete maintenance and repai
25. ce or ignorance of the preventive measures in the User Manual The assembly expanding readjustment improvement and repair should be operated by personnel authorized by the manufacturer Do not open the housing for repair without permission The manufacturer won t be responsible for the consequences of safety and effectiveness caused by unauthorized repair Keep the original package properly All detachable accessories should be put into the original package before moving and transportation Without written consent of the manufacturer no individual or organization is allowed to copy modify or translate any part of the User Manual For any question please contact the Manufacturer or your Local Distributor Caution CAUTIONS HOW TO PREVENT CROSS INFECTION prohibited to use the device on patients with eye trauma inflammation or infection Between uses on different patients the probe and eye cup must be thoroughly cleaned and disinfected to prevent cross infection The Manufacturer advocates a preventive action and a cleaning procedure in Chapter 5 Cleaning Disinfection and Sterilization CAUTION Federal US Law restricts this device to sale by or on the order of a physician TISSUE EXPOSURE TO ULTRASOUND ENERGY The GRU 5000 is designed for use in ophthalmology only While the manufacturer is not aware of any reports of adverse effects from using ophthalmic ultrasound scanner even at FDA pre enactment
26. d 1 Immerse eye cups in the solution of Cidex for about 20 minutes 2 Take out the eye cups and remove the remains of Cidex with alcohol and let it dry naturally 3 Put the disinfected eye cups in a sterilizing tray or box for next uses 5 3 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 xD Chapter 5 Cleaning Disinfection and Sterilization EQUIPMENT Soft silk brush surgical nail brush 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 The products must be diluted at 0 5 with warm water 25 30 from the tap or distilled water The contents of the tray must be changed every day Disinfectant type Alkacide amp Company ALKAPHARM The product must be changed diluted at 596 with distilled water The solution must be changed every day
27. e except 2 Clean the probe and the cable in the Chosen connector in solution of Alkazyme solution for 1 minute using the brush Aniozyme for 5 to 15 minutes depending on the perceived level of risk 25 Chapter 5 Cleaning Disinfection and Sterilization B Rinsing C Sterilization 3 Rinse the probe and the cable with 4 Immerse the probe and the cable except demineralized or distilled water Please do not connector a 6 chlorometric degree solution splash liquid onto the connector hypochloride for 60 min at 20 Ckeeping the connectors dry D Rinsing 5 Rinse the probe and the cable with demineralized or distilled water E Disinfection 6 Dry with a sterile compress if the rinsing water was sterile F Rinsing 7 Rinse the probe end with demineralized or distilled water keeping the connectors dry G Drying 8 Dry with a sterile compress if the rinsing water was sterile 9 The probe is ready for use 26 Chapter 5 Cleaning Disinfection and Sterilization FOR U S A 5 6 Cleaning of the Main Unit of GRU 5000P Use soft cloth with water or neutral cleanser e g diluted Bianex amp Special Efficiency Multi Enzymatic Cleanser to clean the instrument surface For further disinfection please use soft cloth with disinfectant solution e g Sporicidin Sterilizing and Disinfecting Solution to wipe the instrument surface Remove the residual cleanser or disinfectant with clean soft cloth dampe
28. e needed patient information and a blue bar displays which indicates that the current item is selected 2 Click to enter the Measuring Data Display Interface If no item is selected the dialogue box will indicate Nothing Selected In the Measuring Data Display Interface some function keys under the interface are invalid The keys are grey and there is no response when clicking 3 Under the Measuring Data Display Interface for Pachymetry the saved data can be printed out Other functions are unavailable The under this interface means there is no data input during previous measurements Click BACK key can return to the DATA BASE Interface Under the Measuring Data Display Interface the data can not be processed If clearance or deletion is required please exit from this mode and return to the DATA BASE Interface to clear or delete the selected information Click EXIT key under the DATA BASE Interface to exit and return to the normal working interface 4 3 5 Amendment and Storage of Parameters and Clock Setting Click SETUP key in the PATIENT Interface to enter the SETUP Interface in which there are five tab pages 4 3 5 1 Printing Parameter Setup for Pachymeter Click PRINT key to enter the PRINT tab page where the printing parameters of pachymetry can be set up The default printing information includes patient information corneal thickness distribution map and measuring results Each indicator indicates the corres
29. e patient ID age sex OS OD measuring type Pachymeter and storage time Patient information can be checked Click the line of corresponding patient information the blue bar appears then click to enter the Measuring Data Display Interface of the save 14 Chapter 4 Operation information and observe the measuring result Please refer to 54 3 3 DATA BASE and 84 3 4 Display of Saved Information key is used to clear all the patient information clicking this key will call out a dialog box to confirm the request of clear or not Choose YES to clear all information which can not be restored choose NO to exit directly Click key to delete the selected information only All deletions are not recoverable please operate cautiously Click EXIT key to exit 4 3 Operation 4 3 1 Positioning Place the instrument beside the patient The distance between should enable the probe to contact the patient s eye easily The instrument should face the operator and the foot switch should be placed appropriately for operation Please ensure the instrument is located safely and will not cause falling and hurting people by accidental operation Switch on the instrument after completing the above steps 4 3 2 Pachymetry 4 3 2 1 Click the Patient Information Display Area in the PACHYMETER Interface to enter the Patient Information Interface and input patient s information accordingly The default patient name is empty patient ID is age
30. ectrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air lt 5 Ur gt 95 dip in Ur for 0 5 cycle lt 5 Ur gt 95 dip in U7 for 0 5 cycle Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 40 Ur 60 dip in Ur for 5 cycles 40 60 dip in for 5 cycles 70 70 Ur MD1000P ULTRASONIC be 30 dip 30 dip in Ur powered from an uninterruptible for 25 cycles for 25 cycles power supply or a battery lt 5 Ur gt 95 dip in Ur for 5 sec lt 5 Ur gt 95 dip in Ur for 5 sec Power frequency 50Hz magnetic field IEC61000 4 8 Power frequency magnetic fields Should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE is the a c mains voltage prior to application of the test level 41 AnnexD Guidance and Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The MD1000P ULTRASONIC PACHYMETER is intended for use in the electromagnetic environment specified below The customer or the user of MD1000P ULTRASONIC PACHYMETE
31. egulation The quality guarantee of the device will be invalid if it is opened even partially modified or repaired in any way by anyone who is not authorized by the manufacturer This device is not intended for therapeutic use It is prohibited to use the device on patients with eye trauma inflammation or infection The device should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements whose ineffective cooperation may result in inaccurate measurements _IV Precautions and Warnings According to FDA laws the GRU 5000 is a prescription Device and is to be used by or under the supervision of a licensed physician This device is not intended for fetal use While plugging in the probe make sure the red mark on the probe align with the red mark on the socket While unplugging 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 If the probe drops during using or moving check the top and the housing of probe carefully and then check if it works well Stop using if there is any problem and contact the manufacturer or local distributor for service Warnings of predicable potential hazards are contained in the User Manual Please maintain vigilance at any time to those unpredictable hazards The manufacturer won t be responsible for damages and losses caused by negligen
32. ended and saved in the SETUP Interface as shown in Figure 4 13 When login again the amended name will be displayed in the LOGIN Interface 2009 10 15 14 00 42 SETUP P PRINT P IOP LOGINSET CLOCK SET VERSION ENTERTHELOGNNAME BUSH RESET aa EXIT ID 00000000 SEX MALE AGE 00 Figure 4 13 LOGIN SET Parameter Setup Complete all amendments mentioned in 84 3 5 1 84 3 5 3 and select SAVE key to save the selected result Click key to recover the initial values Click key to exit from the interface Click key to exit from the system and the system can be re selected after entering into the LOGIN Interface Note The functions of SAVE and RESET will save all parameters P PRINT P and LOGIN SET tab pages or reset all settings to initial values Please confirm before the operation 4 3 5 4 Clock Set 20 Chapter 4 Operation 14 00 42 SETUP TIME SET DATA SET YY MM DD speso m p CLOCKSET NEXT lt ID 00000000 SEX MALE AGE Figure 4 14 CLOCK SET If it is required to reset date and time please click key in this interface to enter the clock set tab page as shown in Figure 4 14 where time is displayed in real time Click key to change the clock setting At that time the clock stops click key to move the cursor in the text box to the next position successively and circularly until reaching the right position Input the co
33. er from the paper slot for about 1cm and push lightly to close the cover of the paper housing Pay attention not to let the paper stuck in the slot Close the paper housing finally Note 1 If paper doesn t run properly please check installing method and reinstall 2 The thermal paper has thermal side when the paper runs normally but nothing printed out please open the paper housing and reinstall the printing paper with the other side Chapter 4 Operation Chapter 4 Operation 4 1 Startup and Shutdown Check before Startup Before the instrument is started up please check 1 Whether the instrument is put in a proper place and whether the equipment around may cause interference 2 Whether the appearance of the instrument is fine and whether there is crack on the housing and LCD screen 3 Whether the probe is connected properly and whether there is crack or damage on the surface of probe and cable whether the probe cables are intertwined or intertwined with other cables 4 Whether the foot switch is connected properly and has mechanical response when press and whether the foot switch cable is intertwined with other cables 5 Whether there is printing paper and 6 Whether the connection of power supply is completed and the Power Indicator lights up whether the Power Cable is intertwined with other cables 4 1 2 Startup Procedure 1 Make sure there is no problem and the Power Indicator lights up before
34. es 2 Don t wind the probe cable in coil less than 9 cm 3 5 inches Check the probe cable regularly and stop using immediately if it is damaged or broken contact the manufacturer or the local distributor for service 3 Probe should be handled gently to avoid collision and drop in order to prevent break and damage 4 Avoid drop or scratch of the surface of probe when the probe is used or moved make sure the probe is removed from the main unit and put into the packing bag during transportation za s 9 Chapter 7 Maintenance Attentions and Simple Defects Treatment If the probe drops during using or moving check the top and the housing of probe carefully and then check if it works well Stop using if there is any problem and contact the manufacturer or local distributor for service The whole probe cable including the cable plug is prohibited to be immersed into water or other liquid The connection and or disconnection of probe should be done only if the system is powered off While plugging in the probe make sure the red mark on the probe align with that on the socket Hold the probe plug and don t plug probe cable while plugging off the probe If the dialogue box on the screen prompts PLEASE CHECK THE PROBE it indicates the probe connection is abnormal Click OK to close the dialogue box and check if the probe is well connected The probes provided with the instrument should be used in the instrument only and not
35. etwork that supplies flicker emissions Complies n IEC 61000 3 3 buildings used for domestic purposes 40 AnnexD Guidance and Manufacturer s Declaration Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immuni The MD1000P ULTRASONIC PACHYMETER is intended for use in the electromagnetic environment specified below The customer or the user of MD1000P ULTRASONIC PACHYMETER should assure that it is used in such an environment Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 3095 Electrical fast 2 kV for power supply 2 kV for power supply Mains power quality should transient burst lines lines that of a typical commercial or IEC 61000 4 4 hospital environment Surge 1 kV differential mode 1 kV differential mode Mains power quality should be IEC 61000 4 5 2 kV common mode 42 kV common mode that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the MD1000P ULTRASONIC PACHYMETER requires continued operation during power mains dip amp interruptions itis recommended that the Immunity test IEC 60601 test level Compliance level El
36. g 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 5 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 P Probe Sterilization 1 Immerse the probe and the cable except the 2 Clean the probe and the cable in the solution connector in the solution of Alkazyme or with the brush for 1 minute Aniozyme for 5 to 15 minutes depending on the perceived level of risk Chapter 5 Cleaning Disinfection and Sterilization 3 Rinse the probe and the cable in 4 Immerse the probe and the cable in the demineralized or distilled water Do not wet the Alkacide solution for 5 to 20 minutes depending connectors on the estimated level of risk Please keep the connectors dry 5 Rinsing Rinse the probe end with demineralized or distilled water keeping the connectors dry 6 Drying Dry it with a sterile compress 7 Now the probe is ready for use 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 Sterilization amp Pre sterilization 1 Immerse the probe and the cabl
37. ired may vary depending on different patients and clinical cases Not all examinations can be accomplished with lowest ultrasonic energy output Lowest ultrasonic energy will produce low quality image or weak Doppler signal which will influence the reliability of diagnosis However the acoustic power higher than practical use will not be helpful to improve the quality of diagnostic information but will increase the risk of biological effect The operator must be responsible for the safety of patients and use ultrasound on purpose that is to apply ultrasonic output power according to the principle of ALARA 36 Annex Prompt Message Annex Prompt Message 1 System start up prompt Switch on the system it will read parameter and self check displaying THE SYSTEM IS CHECKING PLEASE WAIT After checking it will enter the normal interface 2 Probe checking prompt If probe is not connected the system will prompt automatically when scanning The dialogue box will display PLEASE CHECK THE PROBE reminding you to check the probe connection 3 Nothing Selected prompt If the operation is wrong and unable to select the correct item the dialogue box will prompt PLEASE SELECT AN ITEM or NO DATA indicating that no correct item is selected 4 Confirming prompt for deleting or saving When deleting some item or saving the result of a patient s case the dialogue box will pop up ARE YOU SURE TO SAVE prompts
38. ity lt 80 Atmospheric Pressure 70 106 The Separate Power Supply Input AC100 240V 50 60Hz Output DC12V 4A Rate Power 50 VA 2 2 Main Specifications Ultrasonic frequency 15 20MHz Display resolution 1 Measuring scope 0 23mm 1 2mm Measuring accuracy 2 3 Safety Satisfy the requirements of IEC 60601 1 2005 and IEC 60601 2 37 2007 The acoustic output parameters see Annex C 2 4 Storage and Transportation Conditions 2 4 1 Storage Conditions The device should be stored in non corrosive gas and well ventilated room with environmental temperature of 20 C 40 and relative Humidity 80 2 4 2 Transportation Conditions The accessories such as Probe should be packed into the original package before transportation Severe impact and crash rain and snow shall be avoided 2 5 Classification As per the type of protection against electric shock Class As per the degree of protection against electric shock Type B As per the degree of protection against ingress of liquids Main unit IP XO Part of Probe that can be immersed Chapter 2 Specifications Foot switch IPX1 As per the disinfection and sterilization method recommended by the manufacturer see 55 Cleaning Disinfection and Sterilization As per the safety degree when used under flammable anesthetic gas mixed with air or under flammable anesthetic gas mixed with oxygen or Nitrous oxide not allowed
39. 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 the User 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 be minimized VI Explanation of Symbols EXPLANATION OF SYMBOLS Front Panel D OPEN PRINT Rear Panel 0123 FOOT SWITCH Right Panel P Probe User Manual IPX1 IPX7 Power On or Power Off Paper Housing Switch Thermal Printer Symbol of Type B Refer to User Manual serial Number CE Mark Manufacturer Foot Switch Socket Power Input Socket Pachymetric Probe Socket NOTE Important information that operator must read carefully The degree of protection against ingress of liquids VII Chapter 1 Introduction Chapter 1 Introduction 1 1 General Description The GRU 5000P Ultrasonic Pachymeter is an ultrasonic measuring instrument based on pulse reflection It comprises Corneal Thickness Measuring Unit Pachymeter The Pachymeter consists of a 15 20MHz pachymetric probe probe model Prb1000P and the measuring unit It is on the basis of the
40. llular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the MD1000P ULTRASONIC PACHYMETER is used exceeds the applicable RF compliance level above the MD1000P ULTRASONIC PACHYMETER should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the MD1000P ULTRASONIC PACHYMETER Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m udo x AnnexD Guidance and Manufacturer s Declaration Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the MD1000P ULTRASONIC PACHYMETER The MD1000P ULTRASONIC PACHYMETER is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MD1000P ULTRASONIC PACHYMETER can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MD1000P ULTRA
41. n the system must be product with specification designated by the Manufacturer 8 3 Software Update and Services The Manufacturer will provide users with software update information and services In case of software update due to correction of defects the Manufacturer will provide users with 34 Chapter 8 Service and Support information free software update service For the expansion of software functions the manufacturer will provide users with software update information and according to users demand provide software update service with certain charges 35 AnnexA Prudent Use Statement AnnexA Prudent Use Statement A 1 Statement Although there is no evidence so far the diagnostic ultrasound instrument will lead to biological effects in humans it is possible to prove the existence of biological effects in future applications The radiated acoustic power of the instrument itself is very low still we must use ultrasound prudently in clinical applications Do the best to complete patients examinations within shortest time and with lowest power on the premise of achieving necessary clinical information A 2 Principle of ALARA As Low Reasonably Achievable The principle of ALARA should be implemented to perform ultrasound procedure Try to use lowest level of energy that will not result in biological effect The ultrasonic energy depends on acoustic output intensity and exposure time The ultrasonic intensity requ
42. ned in sterile water Make sure the instrument is completely dry before using N Note 1 Do not use any corrosive cleanser and disinfectant when cleaning the instrument surface keep water and any other liquids away from the instrument 2 Do not immerse the instrument in disinfectant solution 5 7 How to Prevent Cross Infection The probe that are intended to come in contact with mucous membranes belong to semi critical device To prevent cross infection before initial use and in between patient use the probe must be thoroughly cleaned and subjected to a germicidal process with a broad spectrum of activity N Note It is prohibited to use the device on patients with eye trauma inflammation or infection 5 8 Method Before initial use and in between patient use the P Probe should be processed by high level disinfection The recommended procedures are as below 5 8 1 Preparation a OPERATOR S CLOTHING Liquid proof gowns Disposable gloves Eye protection and face masks b EQUIPMENT silk brush surgical nail brush Four glass containers larger than 500ml and capable of immersing the probe One off sterile cloth 27 Chapter 5 Cleaning Disinfection and Sterilization Sterile water c PRODUCTS Cleanser Bianex Special Efficiency Multi Enzymatic Cleanser Disinfectant Sporicidin Sterilizing and Disinfecting Solution K003087 5 8 2 Thorough Cleaning
43. or do not pull the probe cable While connecting the probe make sure the red mark on the probe align with the red mark on the socket See Figure 3 4 3 Do not immerse probe cable connector into water or other liquid keep the probe cable connector dry throughout the disinfection process of probe 4 After disinfection check carefully whether the surface of the probe is deformed or damaged and whether the probe cable is damaged In case of any abnormity stop using and contact the manufacturer or your local distributor for service 29 Chapter 6 Labeling Chapter 6 Labeling 6 1 External Label 1 Printing Paper Packaging Label Figure 6 1 Printing Paper Packaging Label 2 Probe Socket Label IPX7 P probe Figure 6 2 Probe Socket Label 6 2 Internal ID 1 Button cell CR2032 3V lithium cell lij SONY CR2032 Figure 6 3 ID of Button Cell inside the Main Unit 30 Chapter 7 Maintenance Attentions and Simple Defects Treatment Chapter 7 Maintenance Attentions and Simple Defects Treatment 7 1 Maintenance and Attentions to Instrument 1 The instrument should be operated in a clean environment Air conditioned environment is recommended 2 The instrument should be placed on a stable worktable or platform Avoid direct sunlight 3 Please use the supplied Power Adaptor which is in accordance with the safety standard of medical electric equipment do not use other adaptors or adaptors of other eq
44. ponding printing information on the right Yellow indicates the selected status while grey indicates the unselected status Click the position of the indicator to select the yellow indicator lights up means that this part is selected to be printed out Click again to turn off the indicator which turns to grey and means that the selected part will not be printed out Patient information is the necessary part for printing while measuring result and corneal thickness distribution map can be selected to print out one item or to print out all of them 18 Chapter 4 Operation 2009 10 15 14 00 42 SETUP PRINT P PRINT P LOGINSET CLOCK SET VERSION Patient Information CENTER 0000 1 1111 A2 2222 A3 3333 j d Distribution Map B1 1111 B2 2222 B3 3333 A LT C1 1111 C2 2222 C3 3333 D1 1111 D2 2222 D3 3333 Measuring Result E1 1111 E2 2222 E3 3333 F1 1111 F2 2222 F3 3333 G1 1111 G2 2222 G3 3333 H1 1111 H2 2222 H3 3333 RESET ID 00000000 SEX MALE AGE 00 Figure 4 11 P PRINT 4 3 5 2 IOP Parameter Setup 2009 10 15 14 00 42 STANDARD CCT IOP COEFFICIENT 0 50 mHg 10um ID 00000000 SEX Figure 4 12 IOP Parameter Setup Click key to enter the Parameter Setup tab page as shown in Figure 4 12 The Intraocular Pressure parameter consists of the Standard Central Corneal Thickness Standard CCT
45. r manual measuring mode it s required to click SAVE key or press the left switch SAVE of the foot switch to input data which appears in the position of the cursor and then the cursor will 15 Chapter 4 Operation skip to the next position If required use up and down keys to adjust the cursor and determine the next measuring position Under single point multiple measuring mode as shown in Figure 4 4 click SAVE key or press the left switch SAVE of the foot switch to input data which appears in the data box of the left cursor A maximum of five measuring data will be displayed and the average value and standard deviation will be calculated according to the input data The final average value will be input into the position of the cursor Click SAVE key will not change the measuring position If the measuring position needs to be changed use direction keys to move the indicated position If the selected position of the cursor is the position of the cornea center AIOP Intraocular Pressure adjusting value will appear on the right center of the screen after measurement Note The calculation result of AIOP is only the reference value of intraocular pressure see 54 3 5 2 for details 4 3 2 6 Click key to save or PRINT key to print out the data after measurement 4 3 2 7 To measure new patient please enter the Patient Information Interface Click key to re input patient information and enter the PACHYMETER Interface again
46. r manual to the authorized qualified engineers of service stations 239 Chapter 7 Maintenance Attentions and Simple Defects Treatment The Pachymeter is a high tech product designed and built with high level of precision Only qualified trained engineers are authorized to repair the instrument We are not responsible for problems caused by any kind of unauthorized repair Chapter 8 Service and Support information Chapter 8 Service and Support Information 8 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 Manual 2 Ifthe device does not work properly please contact your local distributor or the manufacturer immediately 3 Following repairs will be charged within warranty period Problems caused by man made damages Damages caused by unauthorized repair e Damages caused by inappropriate operation 4 We provide continuous maintenance and repair after warranty period with certain charges 8 2 Accessories and Materials 8 2 1 Consumables Beijing Xun Pu Electronic o mmx40mm Printing Paper Technology Company Thermal Printing Paper 8 2 2 Detachable Parts Hasen 8 2 3 Materials Flame Retardant ABS Engineering Plastic not less than FV 2 MCN 6000 A Note 1 The probe power adaptor and foot switch used in the system must be provided by the Manufacturer 2 The consumables used i
47. rrect time with the keypad and click SAVE key to store The amended value appears on the top right corner to display time Click key to restore to zero Click key once to exit from the clock editing status double click EXIT key to exit from the dialogue box 4 3 5 5 VERSION Click VERSION key to display the tab page of statement which includes the software version 2009 10 15 14 00 42 SETUP Version V1 0 RESET ID 00000000 SEX MALE AGE 00 Figure 4 15 VERSION ze Chapter 5 Cleaning Disinfection and Sterilization Chapter 5 Cleaning Disinfection and Sterilization FOR EUROPE 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 is usually found in hospitals Other FDA cleared disinfectants may also be used The probe can be immersed Do not immerse the connector autoclave the probes After cleaning rinse the end of the probe thoroughly with clean water to remove all traces of the liquid used e Follow the instruction on the label of commercial disinfectants The surface should then be dried with lint free cloth 5 2 Cleaning Disinfection of Eye Cup The following procedure of disinfection is suggested for the eye cups we provide
48. sory P probe Prb1000P Frequency 20MHz 38 Annex 2 Acoustic Output Reporting Table Annex C 2 Acoustic Output Reporting Table Acoustic Output Reporting Table for Track1 Non Autoscanning Mode System GRU 5000P Ultrasonic Pachymeter Transducer Model Prb1000P Operating Mode A Mode Application Ophthalmology Working Frequency 20M Hz 5 3 3 Acoustic Output ee mwiem 0 101 0 016 2 0 412 acoustic Beam Ss 0 056 a 0 056 PRE i ooa EDB m T Conditions Transducer Model Prb1000P Operation Mode A Mode Application Ophthalmology Working Frequency 20MHz Acoustic Output sPAT 3 sppa3 W cm Size 29 AnnexD Guidance and Manufacturer s Declaration AnnexD Guidance and Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS The MD1000P ULTRASONIC PACHYMETER uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The MD1000P ULTRASONIC PACHYMETER is suitable Class Group 1 for use in all establishments other than domestic Harmonic emissions IEC 61000 3 2 establishments and those directly connected to the Voltage fluctuations public low voltage power supply n
49. t YES to confirm clearance of all data The data cleared are not recoverable Select NO to exit without clearing Click DELETE key to delete one patient s information The use of DELETE key is similar with that of CLEAR key Click key to exit 1 deletions are unrecoverable so please operate cautiously 2 The maximum storage capacity of the GRU 5000P is 180 items of patient information Please process the data in time to prevent storage error 3 When the information storage is large the time required to read patient information will be longer please wait patiently 4 3 4 Display of Saved Information The GRU 5000P has the function of saving and displaying the measuring data The saved measuring interface and data at the time of measuring can be loaded according to the operator s selection which is convenient for observation and analysis See Figure 4 10 2009 10 15 14 00 42 Puro ow LENS VITR AL mm SCAN FREEZE 4 9 4 7 4 7 4 7 4 7 4 7 5 4 4 7 CITED in ont hahahah Nm MARK ID 00000001 SEX MALE AGE 00 Figure 4 10 Measuring Data Display Interface The operating method is as follows Chapter 4 Operation 1 Enter into the DATA BASE as shown in Figure 4 9 to check patient information list Click th
50. the instrument is started 2 Start the instrument Press the Power Switch button on the Front Panel for over 2 seconds the instrument starts working Now the Working Indicator lights up and the main interface appears on the screen 4 1 3 Check before Use After the instrument is started up please check 1 Whether the Working Indicator lights up 2 Whether the touch screen is effective 3 The parameter setting following 84 3 5 Amendment and Storage of Parameters and Clock Setting for operation in detail and 4 Whether disinfection of the probe has been carried out as required whether the surface of the probe is deformed or damaged and whether the probe cable is damaged In case eye cup is used check whether the eye cup has been disinfected and whether there is visible damage Chapter 4 Operation 4 1 4 Shutdown Procedure While the instrument is switched on press the Power Switch on the front panel for 2 seconds the instrument will switch off Place the instrument and its accessories properly after shutdown 1 Put the probe into the probe holder and make sure the probe cable can t be dragged by accident or disconnect the probe and put it properly 2 Put the foot switch properly and make sure the foot switch cable is placed properly to prevent others from stumbling by the cable and drop of instrument 3 Plug out the Main Power Plug of the Power Adaptor cable and put it properly 4 2 Interface Introduction 4 2
51. to confirm saving or not ARE YOU SURE TO DELETE prompts to confirm deletion or not ARE YOU SURE TO CLEAR ALL THE DATA PERMANENTLY prompts the cleared data are not recoverable and whether to continue the clearance ARE YOU SURE TO DELETE THE ITEM PERMANENTLY prompts the deleted data are not recoverable and whether to continue the deletion 5 Whistle prompt a Three short beeps of buzzer beep beep beep prompt measurement failed For Pachymeter three short beeps prompt that proper measuring data are not found b Along beep of buzzer beep prompts measurement completed For Pachymeter it prompts proper data have been found within measuring time E cR Annex C 1 Acoustic Output Report IEC60601 2 37 Annex C 1 Acoustic Output Report IEC60601 2 37 TIS TIS TIB TIB TIC Non scanning scanning Scanning scanning Index MI TIS em Global Maximum Index Value Acoustic working frequency Bounded output power P1 Attenuated output power Pa Attenuated spatial peak temporal average intensity Ispta a Attenuated peak rarefactional acoustic pressure 12dB output beam area Aaprt Break point depth Zpp Equivalent aperture Associated acoustic parameter diameter Deq Depth for TIS zs Depth for TIB z depth at max lpi a X Pa Depth at max attenuated pulse intensity integral z at max Ipi a information Supplementary information Operating acces
52. uipment with the instrument 4 Although anti interference measures which are in accordance with IEC 60601 1 2 have been adopted the instrument should be placed to avoid strong electromagnetic radiation equipment such as microwave radio frequency therapy equipment etc 5 Routine inspection and maintenance should be carried out only if the mains power is switched off None corrosive detergent is allowed to clean the housing Avoid water and liquid flowing into the housing Only a mild detergent may be used with soft tissue cloth 6 In humid area and or season if the instrument is not used for a long time it should be power on for one hour per month to get the damp out 7 Avoid drop or severe shock when moving the instrument Give particular attention to protect the probe 8 Do not block the ventilation window of the instrument When the temperature of the instrument is not normal please contact the manufacturer for service 9 The instrument should always be placed in a secure location to prevent probe falling damages 10 The instrument has no special protective measures for discharge effect of cardiac defibrillators it is not suitable for use with high frequency surgical equipment 11 Please follow the related provisions of the local environment protection when the instrument is abandoned Same way can be taken with the electronic devices computers etc 7 2 Maintenance and Attentions to Probe 1 Do not autoclave the prob
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