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HUVITZ reserves the right to make changes in its products or product specifications at any time and without prior notice, and is not required to update this documentation to reflect such changes.
SAFETY PRECAUTIONS 1.1. Overview Safety is everyone’s responsibility. The safe use of this instrument is largely dependent upon the installers, users, operators, and managers. It is prerequisite to read and understand these specifications before installing, using, cleaning, fixing or revising. Fully understanding the whole instructions must be the first priority. For this reason, the following safety notices have been placed appropriately within the text of this manual to highlight safety related information or information requiring special emphasis.
HBM-1 Symbol Information The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic equipment which classify a connection or warn of any potential hazards. The classifications and symbols are shown below. Symbol Indication This symbol identifies a safety note. Ensure you understand the function of this control before using it.
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WEEE Symbol – EU only Disposal of your old appliance When this crossed-out wheeled bin symbol is attached to a product it means the product is covered by the European Directive 2002/96/EC. All electrical and electronic products should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities.
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HBM-1 Alternating Current (Courant alternative) Consult instructions for use (Consulter les instructions d'utilisation) The United States and Canada have mutual-recognition agreements. Therefore, if certified using a Canadian specification (CSA) for UL, the certification mark for the product will be a C-UL certification mark which means CSA specification compliance as follows.
2.1. Usage Precautions This equipment has been developed and tested in conformity with domestic & international safety standards and regulations, which guarantees the high stability of this product. This guarantees a very high degree of safety for this device. The legislator expects us to inform the user expressively about the safety aspects in dealing with the device. The correct handling of this equipment is imperative for its safe operation.
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HBM-1 CAUTION This instrument includes lithium battery. This hazardous material needs to be disposed of properly to limit environmental pollution. Please contact to the professional waste disposal company. Cet instrument comprend une pile au lithium. Cette matière dangereuse doit être éliminée correctement pour limiter la pollution de l'environnement.
Where the instrument is exposed to chemical material or explosive gas. Be cautious so that things like dust and metal do not fall inside the instrument. Don’t disassemble or open the product. HUVITZ does not take responsibility for the possible problems...
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HBM-1 Be careful not to block the fan of the instrument. Don’t plug the AC power cable into the outlet unless all parts of the instrument are completely connected. Otherwise, it will cause severe damage on the instrument. Pull out the power cable with holding the plug, not the cord.
This instrument must be connected with the accessories supplied by HUVITZ. If you are to use other accessories, their safety or usability must be checked and proved by their manufacturers or HUVITZ.
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If a user uses power save supported by Windows 10 except for the power save in User setting, it causes some trouble in HBM-1. The manufacturer isn't responsible for the problem. User must not change the setting supported by the manufacturer. This change might make some trouble in HBM-1.
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5. L'appareil doit être utilisé par une personne formée et qualifiée ou sous sa supervision 6. La réparation de cet instrument doit être effectuée par les techniciens de service HUVITZ ou d'autres personnes autorisées 7.
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/ ou le patient sont établis. 23. Si un utilisateur utilise l'économie d'énergie prise en charge par Windows 10, à l'exception de l'économie d'énergie dans le paramètre Utilisateur, cela provoque des problèmes dans HBM-1. Le fabricant n'est pas responsable du problème.
2.4. Safety Cautions CAUTION 1. Manufacturers are responsible for the safety, reliability, and performance of this instrument only when the following requirements are fulfilled. (1) When the instrument has been installed in a proper area, following the manual. (2) When the instrument has been operated and maintained according to the manual and service manual. 2.
HBM-1 INTRODUCTION 3.1. System Outline The Huvitz Optical Biometer HBM-1 is a device for the biometric measurements of ocular structures. The HBM-1's functions are combined with optical biometry and corneal topography. 3.2. Intended Use 3.3. Classification • Classification of product: Class II according to Annex IX (Rule 10) of the Medical Device Directive 93/42/EEC as...
3.5. Patient requirements The patient who undergoes and examination by this instrument must maintain concentration for a few minutes and adhere to the following instructions; After his/her face to the chinrest, headrest. Keep the eye open Understand and follow instructions when undergoing an examination. - Contact lenses must not be worn by the patient during data acquisition If the patient does not conform to these conditions, it is not possible to take a picture correctly 3.6.
HBM-1 System Overview 4.1. Configuration and Functions Front View ⑨ ⑤ ① ④ ② ③ ⑦ ⑧ ⑥ Part Name Description Display Monitor for displaying captured image and user interface icon. Chinrest button Button for moving chinrest up and down.
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Rear View ④ ① ③ ② ⑤ ⑥ ⑦ Part Name Description Headrest The part that holds the patient's head Headrest Chinrest For fixing patient’s chin. Placido disk Check the curvature of the cornea. Body Focus LED LEDs for checking patient’s eye. LAN port Port for external network (1 ports) Base...
4.3. Main Body Screen Description MEASURE screen ❶ ❷ ❿ ❸ ❹ ❺ ❻ ❼ ⓫ ⓭ ❽ ⓮ ❾ ⓬ Name Function Patient information Shows the information of patient ID and name. Patient Go back to patient detail page. Go to IOL calculation page.
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HBM-1 Measurement Mode Select the measurement mode before the measurement. It informs user to check the measurement status according to the measurement process. : waiting the process. Process Check : this turn. : already measured. RESULT screen 1. Summary result (SUM) ❶...
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HBM-1 Name Function Map: Show Topography map with various options. Map/Profile Profile: Show curvature along the meridian. Data image Show data image with the options. Eye/Map/Ring Display the image of the eye, topo map, topo rings. Axial/Tangential Select the topo map.
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❷ Name Function Map: Show the aberration map. Map/Graph/PSF Graph: Show the coefficients graph. PSF: Show the point spread function image. Echart : Show the E chart. Grid : Show the Grid chart. Echart/Grid/Radial/ETDRS Radial : Show the Radial chart. ETDRS : Show the ETDRS chart.
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HBM-1 4. AL result (AL) ❸ ❹ ❶ ❷ Name Function Signal graph Show the measured signal image. Average value Show the average measured axial length value. Show each measurement axial length values. (it is the average of detail values.) Each value is evaluated by some standard.
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5. Anterior result (ANT) ❸ ❶ ❷ Name Function Signal graph Show the measured signal image. Show the average measured Anterior values(CCT: Central Corneal Thickness, Average value ACD: Anterior Chamber Depth, LT: Lens Thickness) Show the each measurement Anterior values. Each value is evaluated by some standard.
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HBM-1 ❺ ❻ ❼ Name Function Pupil: Show the continuous image of pupil, and check the pupil changes. Pupil/Graphs Graph: Show the Latency and Decentration graph. Captured image Show captured images during the measurement. Display options Select display options. Measurement values Show measurement data.
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7. White to White result (WTW) ❸ ❶ ❷ ❼ ❹ ❻ ❺ Name Function WTW bar Calculate the WTW with the both bar distance. Edit Edit WTW bar states on the edit window. Values Show the White To White values. edit window Click the bar makes it active (pink color express the active state).
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HBM-1 IOL screen 1. IOL CALCULATION ❹ ❺ ❻ ❸ ❶ ❼ ❷ ❽ ❾ ❿ ⓫ ⓬ ⓭ ⓮ ⓯ ⓰ ⓱ ⓲ Name Function Go to Result page. Result Check the measurement data detail. Go to the Measurement Data Edit pop-up window, edit data to calculate IOL Data Edit exactly.
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It is an intrinsic constant of IOL lens model. It is necessary when calculating IOL Lens index formula. Ideal IOL Power It is an ideal IOL power that expects the target refractive value. calculation It informs 5 IOL power lists that are close to the target refractive value. result Reset Reset the calculation result.
HBM-1 Installation Procedure 5.1. System installation 1. Place the main body unit on a stable table. 2. Loosen the packing lock screw under the main body. Packing lock 3. Unscrew the user lock lever on the body. Joystick User lock 4.
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Power switch Power inlet 8. If external devices are connected, turn on external devices first. 9. Turn on the main body by pressing power switch (I position) 10. Turn on the internal PC by pressing power button. Power switch Power button 11.
HBM-1 Operation 6.1. Software 1. Press register patient icon ( ) and input patient information. If patient is resisted already, skip this step. 2. Select patient and check patient information is correct. 3. If you want to send patient information to a web viewer or delete patient information, select the circle next to the...
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4. When you select a patient, the screen changes. 5. Enter observation mode by pressing measure icon ( The screen of observation mode is as follow.
HBM-1 6.2. SETUP Mode [To choose the section to setup] - Setup mode consists of six sections: System, Patient, Measure, Connectivity, Report. You can select the section to setup from the left side. - You can navigate the setup items with the page move buttons [...
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Patient Settings Patient List Size Number of patients to be displayed per pages. Today List Today List (List of patients visited today) settings. PID Prefix The function to set the prefix of the patient ID. PID Postfix The function to set the postfix of the patient ID. PID Number Length The function to set the length of patient ID.
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HBM-1 Connectivity Settings Network Folder Network folder path. Username Network folder user name Password Network folder user password Web Viewer Server IP Web Viewer Server IP address setting. Web Viewer Sever Port Web Viewer Server port setting. Auto Data Trans Set the function to transfer the measured data to Web Viewer automatically.
6.3. DICOM SETUP Mode Worklist Setting IP Address of the PC where the server program is Server IP installed. Server Port Set Port Number. Server AE Set Server AE. Client AE Set Client AE. MPPS Setting IP Address of the PC where the server program is Server IP installed.
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HBM-1 Storage Setting IP Address of the PC where the server program is Server IP installed. Server Port Set Port Number. Server AE Set Server AE. Client AE Set Client AE. General Setting Manufacturer Set the name of the manufacturer.
6.4. Device Check Measuring Model Eye. (1) Remove chinrest paper. (2) Mount Model Eye as shown below and then fix it using two paper pins. Model Eye (3) Align the center of the Model Eye with the placido disk using joystick and chinrest button. Chinrest button Joystick (4) After focusing, press the Joystick button.
HBM-1 6.5. General Operation 1. Clean headrest and chinrest with a clean cotton swab or gauze. Remove a single sheet of chinrest paper if the chinrest paper is used. 2. Align left/right index mark (B) and front index mark (A) of body and base with joystick.
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Keratometer mode is on. Keratometry measurement is on. Axial Length measurement is on. CCT, ACD, LT measurement (Anterior measurement) is on. Pupillometry mode is on. If Keratometer mode is on, user can choose the Keratometry, AxialLength, CCT, ACD, LT measurement. •...
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HBM-1 6. Align patient’s eye to eye level mark on headrest. (1) Let the patient’s chin put on the chinrest. (2) Let the patient’s forehead adhere to headrest. (3) Move up or down chinrest with the chinrest button on the body to fit the level of patient's eye to the eye level mark on the headrest.
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(2) Move joystick little by little until orange target mark (A) appears. (3) If auto tracking is on, alignment and focus is automatically accomplished in tracking region. (4) If orange arrow (A) appears during auto tracking, it means auto tracking module go to the limit of tracking region.
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HBM-1 If CCT, ACD, LT measurement (Anterior measurement) is on, check the real-time signal to see if the anterior signal (A) comes out well and capture. 10. Press the button on joystick to capture image. 11. If pupillometry mode is on, wait until the progress bar are full, then press the joystick to stop measurement.
6.6. Maintenance 6.6.1. After operation Exit software and Power off. (1) Select the Patient information icon ( ) in the upper left corner of the screen. (2) Select the Previous screen icon ( ) in the upper left corner of the screen. (3) Select the Power Off icon ( ) from the bottom left corner of the screen.
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(4) Selecting POWER OFF icon ( ) shows a pop-up windo , Checking the Packing Mode will move chinrest and the body of HBM-1 to the lowest position before Power off (This is for packaging). NOTE To put the equipment in the packing box, select Packing Mode and then press OK to finish.
Do not use the solvents such as strongly volatile substance, thinner, benzene, etc Do not use a sponge or cloth soaked in water because the water might leak into the equipment. Clean headrest rubber and chinrest with an alcohol before sending device to authorized agent or Huvitz for maintenance.
HBM-1 6.6.3. Replacement of consumables and fuse Replacing chinrest paper (1) Pull out two fixing pins from chinrest. (2) Put a new chinrest paper on the chinrest. (3) Insert two fixing pins into the chinrest paper hole. (4) Attach the chinrest paper to the chinrest.
6.6.4. How to pack the device 1. Make sure to shut down the device with ‘Packing Mode’. Refer to “6.6.1. After operation” 2. Lift Packing locks under the bottom and turn them counterclockwise to lock the device (Important). Move the joystick to check if the device is locked firmly. Device is locked correctly if the device doesn’t move. Packing lock 3.
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HBM-1 5. Open the vinyl envelop wide. 6. Put down the device while checking the device direction. 7. Insert the foams while checking right and left side.
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8. Close the top foam and put accessories to the right position. Accessory Foam 9. Close the inner box and seal with plastic tape. Inner box outer box 10. Put the last foam, close the outer box and seal with plastic tape..
HBM-1 Troubleshooting Guide Should the device function improperly, attempt to correct the problem according to the following table before contacting sales distributors. Contact a sales distributor after turning off the power when the device does not resume normal operation even after taking the following measures.
HBM-1 Replacement 10.1 SMPS 1) Check the power switch on the bottom right of base is off. (O position) 2) Disconnect the power cable from the power inlet. Power switch Power inlet 3) Align left/right index mark (B) and front index mark (A) of body and base with joystick.
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5) Lean the device as shown below with caution. 6) Unscrew four bolts in the circle as shown below. (red: wrench bolt, blue: cross recess bolt) Remove the ‘V1_BTM-PLATE’. V1_BTM-PLATE...
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HBM-1 7) Unlock four bolts in the circle as shown below. 8) Uncouple harness connector to separate SMPS. 9) Change the SMPS with new one. 10) Reassemble in reverse order. Be careful when insert the SMPS ASSY into the main body.
Voltage fluctuations/flicker IEC 61000-3-3 Complies • Electromagnetic waves tolerance HBM-1 is to be used in the below designated electromagnetic wave environment. HBM-1 customer and user need to guarantee that the HBM-1 will be used in this type of environment. IEC 60601...
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HBM-1 • Electromagnetic waves tolerance HBM-1 is to be used in the below mentioned electromagnetic wave environment. HBM-1 purchaser or user needs to confirm whether HBM-1 is sued at this environment. IEC 60601 Tolerance test Appropriateness level test conditions 3 Vrms...
Parts below are consumable in their characteristics, or the quality of them shall degraded after the long time use. User should not replace them by him or herself. Please contact to Huvitz`s agent for the replacement if these parts are consumed enough or degraded by the longtime use.
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HBM-1 ■ U.S.A Representative COBURN TECHNOLOGIES 55 Gerber road, South Windsor, Connecticut, 06074, United states Tel: +1-860-648-4906 ■ Brazil Representative VR Medical R. BATATAES 391, CEP 01423, SÃ O PAULO Tel: +55-11-3889-0875 ■ Australia Representative OPTICARE 118 Adderley St, Auburn NSW 2144...
Documentation are protected by copyright laws and international copyright treaties, as well as other intellectual property laws and treaties. 3. SOFTWARE VERSION The Software and the Documentation may be updated or modified at HUVITZ's own discretion from time to time without any prior notice.
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7. FORCE MAJEURE In no event HUVITZ will be liable to you for any delay or failure in the performance of its obligations under this Agreement if and to the extent such delay or failure in performance arise from any cause or causes beyond the reasonable control of HUVITZ, including, but not limited to, fire, explosion, flood, earthquake, war, rebellion or riots.
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Sections of this Agreement will remain in full force and effect. 14. NO WAIVER The delay, omission or failure of HUVITZ to enforce any right or remedy in this Agreement will not be construed to be a waiver of such right or remedy of HUVITZ.
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