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Gilras GRU-5000 A Operation Manual

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  • Page 2 Address: 9990 NW 14ST Suite 105 Doral, FL 33172  Phone: +1‐888‐334‐4640  Fax: +1‐786‐621‐1842  Email: info@gilras.com...

  • Page 3: Table Of Contents

    CONTENTS CONTENTS PRECAUTIONS ..............................IV WARNINGS ................................. IV CAUTIONS ................................VI EXPLANATION OF SYMBOLS ........................VII CHAPTER 1 INTRODUCTION ........................1 ........................1 ENERAL ESCRIPTION ............................1 NTENDED ........................ 1 NTENDED OCATION OF ..........................1 ONTRAINDICATIONS ........................1 XPECTED ERVICE ..........................
  • Page 4 CONTENTS 4.2.3. Patient Interface (Patient Information Interface) ............. 12 4.2.4. MENU Interface ........................14 4.2.5. IOL Interface ..........................14 4.2.6. SETUP Interface ........................17 4.2.7. DATA BASE Interface ......................18 ............................19 PERATION 4.3.1 Positioning ............................19 4.3.2 A Biometer Unit ..........................19 4.3.3 DATA BASE .............................
  • Page 5 CONTENTS ....................46 OFTWARE PDATE AND ERVICES ANNEX A PRUDENT USE STATEMENT ....................48 ............................48 TATEMENT ） ..........48 ALARA（A RINCIPLE OF EASONABLY CHIEVABLE ANNEX B PROMPT MESSAGE ........................49 ANNEX C.1 ACOUSTIC OUTPUT REPORT (IEC60601-2-37) ............... 50 ANNEX C.2 ACOUSTIC OUTPUT REPORTING TABLE ................ 51 ANNEX D GUIDANCE AND MANUFACTURER’S DECLARATION ............

  • Page 6: Precautions

    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.
  • Page 7 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.

  • Page 8: Cautions

    Caution CAUTIONS HOW TO PREVENT CROSS-INFECTION  It is 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. ...

  • Page 9: Explanation Of Symbols

    Explanation of Symbols EXPLANATION OF SYMBOLS Front Panel Power On or Power Off OPEN Paper Housing Switch PRINT Thermal Printer Rear Panel Symbol of "Type B" Refer to User Manual Serial Number CE Mark Manufacturer FOOT SWITCH Foot Switch Socket Power Input Socket Right Panel A-Probe...

  • Page 10: Chapter 1 Introduction

    Chapter 1 Introduction Chapter 1 Introduction 1.1 General Description The GRU-5000 A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring instrument based on pulse reflection. It comprises A Mode Eye Axis Biometric Parameter Measuring Unit (A Biometer). The A Biometer consists of a 10MHz A-Scan probe (probe model: Prb1000A/10-C) and an axis biometric parameter measuring unit.

  • Page 11: Chapter 2 Specifications

    Chapter 2 Specifications Chapter 2 Specifications 2.1 Working Conditions Environmental Temperature: 5℃－40℃ Relative Humidity: ≤80% Atmospheric Pressure: 70kPa－106kPa The Separate Power Supply: Input: AC100~240V, 50/60Hz, Output: DC12V, 4A Rate Power: 50 VA 2.2 Main Specifications Ultrasonic frequency: 10MHz； Display resolution: 0.01mm； Total gain of receiver: ≥100dB；...

  • Page 12: Transportation Conditions

    Chapter 2 Specifications 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 I As per the degree of protection against electric shock: Type B As per the degree of protection against ingress of liquids: —...

  • Page 13: Chapter 3 Installation

    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 A-Biometer Probe Socket A-Biometer Probe 10.

  • Page 14: Environmental Requirements

    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;...

  • Page 15: Connection Of Power Supply

    Chapter 3 Installation   Note: Don't pull the probe cable strongly while unplugging the probe. (a) Connection of Probe (b) Disconnection of Probe Figure 3.4 Connection/Disconnection of Probe 3.3.3. Connection of Power Supply 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;...

  • Page 16: Connection Of Foot Switch

    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 §8.2.1 Consumables.

  • Page 17: Chapter 4 Operation

    Chapter 4 Operation Chapter 4 Operation 4.1 Startup and Shutdown 4.1.1. 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;...

  • Page 18: Shutdown Procedure

    Chapter 4 Operation cup is used, check whether the eye cup has been disinfected and whether there is visible damage. 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.

  • Page 19: Ascan Interface

    Chapter 4 Operation Figure 4.2 System Selection Interface 4.2.2. ASCAN Interface Enter the ASCAN Interface, the default setting of the system is automatic measurement (AUTO), contact method (CONTACT) and normal eye (NORMAL), the interface is shown in Figure 4.3. Date and Time Display Area Data Display Area Threshold...
  • Page 20 Chapter 4 Operation point of the reflected pulse front and the threshold will be the basic point to calculate transmission time of ultrasound in different tissues. Threshold Line: The threshold value displayed in graph. Date and Time Display Area: Display current date and time. GAIN: Gain control key.

  • Page 21: Patient Interface (Patient Information Interface)

    Chapter 4 Operation MEM: Memory key. Click to save data, which includes patient information, measuring data, all kinds of parameters and waveforms. If it's necessary to save complete information, please enter the IOL Interface, complete parameter input and calculation, and then click MEM key to save. To enter the PATIENT Interface directly from this interface, it's able to click directly the Patient Information Display Area at the bottom of the screen.
  • Page 22 Chapter 4 Operation Figure 4.5 Patient Information Interface (Alphabetical Keypad) 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.

  • Page 23: Menu Interface

    Chapter 4 Operation 4.2.4. MENU Interface Figure 4.6 MENU Interface Click MENU key to enter the MENU Interface, as shown in Figure 4.6. Click the six keys in the interface to enter the corresponding interface, which are: ASCAN Interface, PACHYMETER Interface, IOL Interface, PATIENT Interface, SETUP Interface and DATA BASE Interface.
  • Page 24 Chapter 4 Operation Formula Selection Key Keypad Figure 4.7 IOL Interface There are two formula selection areas for user's choice of an applicable IOL calculation formula. Click Formula Selection key to select. If the IOL calculation formula after corneal refractive surgery will be selected, click K1 or K2 key to call out the Parameter Input Dialogue Box (as shown in Figure 4.8).
  • Page 25 Chapter 4 Operation input directly by clicking the corresponding data box or by clicking A/ACD key to call out the Constant A/ACD Input Dialogue Box to input (as shown in Figure 4.9). Figure 4.9 IOL Interface (Constant A/ACD Input Dialogue Box) The meaning of each parameter is as follows: DR: Refraction Desired after IOL implantation;...

  • Page 26: Setup Interface

    Chapter 4 Operation CAL: Calculation key, click it to make calculation and enter the interface of calculating result. When clicking CAL key, if the input parameter is out of range, the system will prompt to make amendment and then recalculate. When the calculation completed, the keypad will disappear and the calculating result will appear on the screen.

  • Page 27: Data Base Interface

    Chapter 4 Operation Tab Page Figure 4.11 SETUP Interface The Setup Interface consists of three parameter setup tab pages. Click the corresponding key to enter each tab page. A-PRINT: Click it to enter the print parameter tab page for A Biometer; LOGIN SET : Click it to enter the user setup tab page (it is not available under ADMIN system).

  • Page 28: Operation

    Chapter 4 Operation Figure 4.12 DATA BASE Interface This interface lists all the saved patient information in tabular format. The contents displayed include patient name, patient ID, age, sex, OS/OD, measuring type (A Biometer) and storage time. Patient information can be checked. Click the line of corresponding patient information, the blue bar appears, then click OK to enter the Measuring Data Display Interface of the save information and observe the measuring result.
  • Page 29 Chapter 4 Operation 4.3.2.2 Mode Selection a) Selection of measuring mode There are two kinds of measuring modes: automatic measuring mode (AUTO) and manual measuring mode (MANUAL). The default mode is automatic measuring mode. Manual measuring mode is usually used in some special cases, when the system can not identify the waveform or can’t mark automatically due to the limited conditions.
  • Page 30 Chapter 4 Operation b) Selection of measuring method According to whether A-Biometer probe will contact cornea, the measuring method is divided into CONTACT method and IMMERSION method. CONTACT method indicates the A-Biometer probe will contact cornea vertex directly. The operator is required to handle the probe gently while measuring. It is applicable for both automatic and manual measurement.
  • Page 31 Chapter 4 Operation selection, then the input or selected acoustic velocity will disappear. Click OK key to save the set acoustic velocity; or click CANCEL key to exit (no parameter in this mode will be saved). The Default Acoustic Velocity set is shown below: Unit: m/s PMMA ACRYLIC...
  • Page 32 Chapter 4 Operation and smoothly. The probe can only be removed after the measurement completed, the image is automatically frozen and the data is displayed on the screen. 3) The probe should be placed align with the visual axis to guarantee the accuracy of measurement.
  • Page 33 Chapter 4 Operation the arrow for marking the peak of wave and amend the data displayed. ARROW MOVE key is used to call out the ARROW MOVE dialogue box for remarking the arrow. See Figure 4.17: The ARROW MOVE dialogue box contains   keys, ENTER key, Zoom In and Zoom Out keys, as well as AMEND key and EXIT key.
  • Page 34 Chapter 4 Operation f) If the arrow positions need to be amended during the process of determination, click AMEND key, the arrow disappears; then remark the arrow position. g) Click EXIT key after measurement and exit from the dialogue box. And click up and down keys to load the waveforms of each group of the measuring data.
  • Page 35 Chapter 4 Operation arrow does not align with the rising edge of the waveform, it's possible to remark manually. The detailed operation is as follows: a) Double click the data display area quickly to call out the ARROW MOVE dialogue box as shown in Figure 4.18, and amend the data indicated by cursors.
  • Page 36 Chapter 4 Operation Figure 4.19 IOL Interface (IOL calculation mode after corneal refractive surgery) Use the keypad to input parameters required for each formula according to the specific case. The constant A/ACD can also be input by calling out the Constant A/ACD Input Dialogue Box (as shown in Figure 4.20).

  • Page 37: Data Base

    Chapter 4 Operation Figure 4.21 IOL Interface (Constant A/ACD Input Dialogue Box - Editing Status) Select the data to be amended, click the data box to move the cursor in and input the required data with the keypad on the left. Click EDIT key again, the system will save the input parameter and the EDIT key turns to blue.

  • Page 38: Display Of Saved Information

    Chapter 4 Operation The data base will display the saved patient information in tabular format, as shown in Figure 4.22. The displayed information include: patient name, ID, age, sex, OS/OD and type of measurement (A Biometer). The operator can select the patient information (by clicking the position of the patient information, blue bar means selected).

  • Page 39: Amendment And Storage Of Parameters, And Clock Setting

    Chapter 4 Operation Enter into the DATA BASE (as shown in Figure 4.22) to check patient information list. Click the needed patient information and a blue bar displays which indicates that the current item is selected. Click OK to enter the Measuring Data Display Interface. If no item is selected, the dialogue box will indicate Nothing Selected.
  • Page 40 Chapter 4 Operation Patient Information Measuring Result Measuring Information Output Waveform Calculating Parameter Figure 4.24 A_PRINT Each indicator indicates the corresponding 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.
  • Page 41 Chapter 4 Operation Figure 4.25 LOGIN SET Parameter Setup Complete all amendments mentioned in §4.3.5.1～§4.3.5.2 and select SAVE key to save the selected result. Click RESET key to recover the initial values. Click EXIT key to exit from the interface. Click LOGOFF key to exit from the system and the system can be re-selected after entering into the LOGIN Interface.
  • Page 42 Chapter 4 Operation position. Input the correct time with the keypad and click SAVE key to store. The amended value appears on the top right corner to display time. Click RESET key to restore to zero. Click EXIT key once to exit from the clock editing status; double click EXIT key to exit from the dialogue box. 4.3.5.4 VERSION Click VERSION key to display the tab page of statement, which includes the software version.

  • Page 43: Chapter 5 Cleaning, Disinfection And Sterilization

    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.

  • Page 44: Preparation Of Sterilization Agent

    Chapter 5 Cleaning, Disinfection and Sterilization EQUIPMENT Soft silk brush (surgical nail brush)   3×500 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 ℃-30 ) from the tap or distilled ℃...

  • Page 45: Standard Method

    Chapter 5 Cleaning, Disinfection and Sterilization 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. ---- 1-0.5% Aniozyme solution in water (25g sachet): 1) Pour in 1L warm water (25-30 ) ℃...
  • Page 46 Chapter 5 Cleaning, Disinfection and Sterilization Rinse probe cable 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.
  • Page 47 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) in a 6 chlorometric degree solution splash liquid onto the connector.

  • Page 48: For U.s.a

    Chapter 5 Cleaning, Disinfection and Sterilization FOR U.S.A 5.6 Cleaning of the Main Unit of GRU-5000A Use soft cloth with water or neutral cleanser (e.g. diluted Bianex® Special Efficiency Multi-Enzymatic Cleanser) to clean the instrument surface. For further disinfection, please use soft cloth with disinfectant solution (e.g.

  • Page 49: Thorough Cleaning

    Chapter 5 Cleaning, Disinfection and Sterilization cup. —— One-off sterile cloth. —— Sterile water. c) PRODUCTS —— Cleanser: Bianex® Special Efficiency Multi-Enzymatic Cleanser —— Disinfectant: Sporicidin Sterilizing and Disinfecting Solution (K003087) 5.8.2 Thorough Cleaning a) Prepare the cleaning solution by adding 1-2ml Bianex® Special Efficiency Multi-Enzymatic Cleanser into 500ml of sterile water.

  • Page 50: Rinsing After Disinfection

    Chapter 5 Cleaning, Disinfection and Sterilization Note: 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 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.

  • Page 51: Chapter 6 Labeling

    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 Figure 6.2 Probe Socket Label 6.2 Internal ID 1） Button cell: CR2032/3V, lithium cell Figure 6.3 ID of Button Cell inside the Main Unit - 42 -...

  • Page 52: Chapter 7 Maintenance, Attentions And Simple Defects Treatment

    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;...

  • Page 53: Maintenance Of Lcd Screen

    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.

  • Page 54: Trouble Shooting

    Chapter 7 Maintenance, Attentions and Simple Defects Treatment Keep the probe unmovable; click SCAN/FREEZE key to repeat measuring. If the results show good repeatability, it indicates the biometry mode of the equipment works well. 7.5 Trouble Shooting In case of connection failure, please check first if the power supply and probe are well connected.

  • Page 55: Chapter 8 Service And Support Information

    Chapter 8. Service and Support information Chapter 8 Service and Support Information 8.1 Warranty The product has a warranty of one year from the date of purchasing, on the premise of using in accordance with the User Manual. If the device does not work properly, please contact your local distributor or the manufacturer immediately.
  • Page 56 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. - 47 -...

  • Page 57: Annex A Prudent Use Statement

    Annex A Prudent Use Statement Annex A 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;...

  • Page 58: Annex B Prompt Message

    Annex B Prompt Message Annex B Prompt Message 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. Probe checking prompt: If probe is not connected, the system will prompt automatically when scanning.

  • Page 59: Annex C.1 Acoustic Output Report (Iec60601-2-37)

    Annex C.1 Acoustic Output Report (IEC60601-2-37) Annex C.1 Acoustic Output Report (IEC60601-2-37) Index Non- Non- Non- Mode scanning scanning Scanning Scanning scanning ≤1cm ＞1cm aprt aprt Global Maximum Index Value 0.12 0.08 Acoustic working 9.27 9.27 frequency (f Bounded output power (P1) Attenuated output power 1.86...

  • Page 60: Annex C.2 Acoustic Output Reporting Table

    Annex C.2 Acoustic Output Reporting Table Annex C.2 Acoustic Output Reporting Table Acoustic Output Reporting Table for Track1 Non-Autoscanning Mode System: GRU-5000A Ultrasonic Biometer for Ophthalmology Transducer Model: Prb1000 A/10-C Operating Mode: A-Mode Application: Ophthalmology Working Frequency: 10MHz SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm...

  • Page 61: Annex D Guidance And Manufacturer's Declaration

    Annex D Guidance and Manufacturer’s Declaration Annex D Guidance and Manufacturer’s Declaration - 52 -...
  • Page 62 Annex D Guidance and Manufacturer’s Declaration - 53 -...
  • Page 63 Annex D Guidance and Manufacturer’s Declaration - 54 -...
  • Page 64 Annex D Guidance and Manufacturer’s Declaration - 55 -...

  • Page 65: Annex E Iol Formula

    Annex E IOL Formula Annex E IOL Formula Six formulae are used in the GRU-5000A, they are: SRK-II SRK-T BINKHOST-II HOLLADAY HOFFER-Q HAIGIS IOL calculation formulas after corneal refractive surgery HISTORY DERIVED METHOD —— To use this method, all historical data are required, including K1 and K2 values before corneal refractive surgery and the lens power of spectacles before and after corneal refractive surgery, that is to input all parameters of K1pre, K2pre, REFRpre and REFRpost in the dialogue box.
  • Page 66 Annex E IOL Formula See below for the selection of formula and parameter: Parameter Refractive Formula REFR REFR Surgery ? ACD ANTI/POST K1pre K2pre post × √ √ √ × × × × × × SRK_II × √ √ √ ×...

  • Page 67: Annex F References

    Annex E REFERENCES Annex F REFERENCES HAIGIS W: Biometrie, in: Augenärztliche Untersuchungsmethoden, Straub W, Kroll P, Küchle HJ (Hrsg), F.Enke Verlag Stuttgart, 255-304, 1995 RETZLAFF J: A new intraocular 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.

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