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North-Vision Tech Deluxe-100, User Manual

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User Manual for Multi-parameter Patient Monitor                                                    North-vision Tech. Inc. 

 

                                               

 

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Figure 4.16 Respiration Trend Graph 

 

 

Figure 4.17 Body Temperature Trend Graph 

 

 

Figure 4.18 SpO2 Trend Graph 

 

 

Figure 4.19 PR Trend Graph 

 

 

Figure 4.20 NIBP Trend Graph 

 

 

Figure 4.21 EtCO2 Trend Graph 

 

Summary of Contents for Deluxe-100

Page 1: ...ulti parameter Patient Monitor Deluxe 100 EBM VS 100 User Manual Version 2 0 Issued by Sara Lo Date 5 11 2020 Reviewed by Albert Huang Date 5 11 2020 Document No UM PM1 201405 01 North Vision Tech Inc 2460 ...

Page 2: ...orrect methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details The Manual is published in English and we have the ultimate right to explain the Manual No part of this manual may be photocopied reproduced or translated into another language without ...

Page 3: ...e that it is in proper working condition before being used The device connected to this monitor should be in accordance with IEC 60601 1 Please shut down the monitor and remove sensors while during MRI scanning or else induced current could potentially cause burns The monitor may affect the MRI image and the MRI unit may affect the accuracy of monitor measurements Although biocompatibility tests h...

Page 4: ...switch off power This monitor is a professional medical device can only be operated by trained personnel with qualification Please peruse the relative content about the clinical restrictions and contraindication Dispose of the expired device and its accessory according to applicable local regulations ...

Page 5: ...ER 3 INSTALLATION AND CONNECTION 4 3 1 PANEL INTRODUCTION 4 3 1 1 Front Panel 4 3 1 2 Left and Right Side Panel 6 3 1 3 Back Panel 7 3 2 INSTALLATION 8 3 2 1 Opening the Box and Check 8 3 2 2 Connecting the AC Power Cable 8 3 2 3 Starting the Monitor 8 3 3 CONNECTION 9 3 3 1 ECG Connection 9 3 3 2 Blood Pressure Cuff Connection 10 3 3 3 To connect the SpO2 11 3 3 4 TEMP Transducer Connection 12 3 ...

Page 6: ...arameter Settings 29 4 9 4 Respiration Parameter Settings 30 4 9 5 Temperature Parameter Settings 31 4 9 6 NIBP Parameter Settings 31 4 9 7 SpO2 Parameter Settings 32 4 9 8 EtCO2 Parameter Settings 32 4 9 9 Rest 33 4 10 COLOR SETTINGS SCREEN 34 4 11 FILE PATIENT MANAGEMENT SCREEN 34 CHAPTER 5 INSTRUCTION FOR IBP 35 5 1 IBP Transducer Connection 35 5 2 IBP Monitoring Screen 36 5 3 IBP Graphic Trend...

Page 7: ... 8 4 1 Operational Tips 49 8 4 2 Clinical Limitations 49 8 5 MEASURING THE PULSE OXYGEN SATURATION AND PULSE RATE 51 8 5 1 Operational Tips 51 8 5 2 Clinical Limitations 51 CHAPTER 9 MAINTENANCE 52 9 1 PROTECTIVE MAINTENANCES 52 9 2 BATTERY MAINTENANCE 52 9 3 CLEANING STERILIZATION AND DISINFECTION OF THE MONITOR 53 9 4 CLEANING STERILIZATION AND DISINFECTION OF ACCESSORIES 54 9 5 STORAGE 54 9 6 T...

Page 8: ...User Manual for Multi parameter Patient Monitor North vision Tech Inc VIII ...

Page 9: ...erature respiratory rate and SpO2 pulse rate when the measure of blood pressure is taken Nonvolatile 6hours of ECG data storage and recall High precision NIBP measuring module good repeat capability Software and hardware dual excess air pressure protection function Special SpO2 measuring device which ensures the accuracy of SpO2 and pulse rate measures Unique file management which enables recordin...

Page 10: ...stallation 1 This device should be situated in a place protected against direct sunlight so as to prevent overheating inside the equipment 2 Do not use this device in an environment with toxic or inflammable gas 3 This device should be fixed on a stand or flat platforms so as to prevent possible shock 4 Do not use with any equipment other than those expressly permitted in these instructions 5 When...

Page 11: ...veform via the SpO2 probe 3 NIBP module collects blood pressure data including the diastolic systolic and mean arterial pressure through the NIBP cuff The cuffs are sized for adult infant and neonate NIBP measure has three modes adult infant and neonatal mode 4 CPU module consists of main board multi function board and the keyboard The multi function board performs the data communication between t...

Page 12: ...is device is using mains power supply 3 DC build in battery indicator When DC indicator is on it means the battery is being used when both of AC indicator and DC indicator light are on it means that this device is using mains power supply and the battery is being recharged 4 LEAD switch Click it to shift the ECG monitoring circulatory among Ⅰ Ⅱ Ⅲ aVR aVL aVF V and GND 5 ALARM Press this key to set...

Page 13: ...tion waveform In the NIBP data listing screen it prints the NIBP data list In the SpO2 data listing screen it prints the SpO2 data list In the Trend screen it prints the system trend graph In the System menu it prints the system parameter settings In the Recall screen it prints the Recalled data list or prints current lead s ECG waveform and Recalled waveform In VPC monitoring screen it prints the...

Page 14: ...ure 3 3 1 NIBP NIBP measuring cuff jack 2 SpO2 SpO2 probe jack 3 TEMP Temperature probe jack 4 ECG RESP ECG leads jack 5 Battery cover remove the cover to install or change rechargeable battery Factory default two rechargeable batteries 12V 2 3Ah battery specification FB 12V 2300mAh TO AVOID BATTERY DAMAGE ALWAYS REMOVE BATTERY S BEFORE SHIPPING OR STORAGE With Type BF applied part With Type CF ap...

Page 15: ...panel of the monitor includes the following 1 MONITOR External monitor port 2 NET Communication port which is used to network with central monitoring system 3 Equipotential grounding port 4 FUSE 2 X T6 3A Fuse holder fuse specification T6 3AL 250V Φ5 20mm 5 AC 100V 240V Power supply socket 6 S N Serial Number 7 Nameplate ...

Page 16: ...end to the grounded three phase power jack Connect the monitor to the grounding port with the provided ground cable Caution ensure that the monitor is grounded correctly The provided battery of the monitor must be recharged after transportation or storage So if the monitor is switch on without being connected to the AC power socket it may not work properly due to insufficient power supply 3 2 3 St...

Page 17: ...chloride electrodes When dissimilar metals are used for different electrodes the electrodes may be subject to large offset potentials due to polarization Using dissimilar metals may also increase recovery time after defibrillation 3 Prepare the electrode sites according to the electrode manufacture s instructions The locations of the electrode are in the following Figure Figure 3 5 Locations of El...

Page 18: ...nt and calculation but when the cycle time of pacemaker pulse is over 2ms it may be counted In order to reduce this possibility observe the ECG waveforms on the screen carefully and do NOT rely entirely on the heart rate display and alarm system of this monitor when monitoring this kind of patients Besides the improper connection with electrosurgical unit may cause burns the monitor may be damaged...

Page 19: ...ho have severe hemorrhagic tendency or with sickle cell disease or partial bleeding will appear Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area otherwise damages may be caused to the limbs Pay attention to the color and sensitivity of the limb when measuring NIBP make sure the blood circulation is not blocked If blocked the limb will discolor please stop mea...

Page 20: ...ter liquor or cleanser completely because the sensor has no capability of waterproofness Please do not allow the cable to be twisted or bended Please do not use nail polisher or other cosmetic product on the nail The finger should be of normal length 3 3 4 TEMP Transducer Connection Multi parameter Patient Monitor has two TEMP transducers to measure different body temperature Connecting methods 1 ...

Page 21: ...ld with two thumbs to open it 2 Move the tab of rubber roller lock at the left 90 upwards to unlock it 3 Cut one end of the paper into triangle and load the paper from the underside of the rubber roller 4 Turn the roller clockwise to get the paper rolled and put the paper roll into the compartment 5 Pull the paper out of paper slot on the shield 6 Move the tab of the rubber roller lock 90 downward...

Page 22: ...tep 2 Press the knob and then gray cursor stays on the Year of the date Press the knob again and the gray cursor becomes highlighted Rotate the knob left or right to increase or decrease the year value Step 3 When the Year is set press the knob to move the gray cursor to the Month of the date Step 4 Repeat Step 2 and Step3 to adjust the Year Month Date Hour and Minute Step 5 If you have finished a...

Page 23: ...e types The option can be set in the system menu Adult The type of the monitor subject battery power indicator when the indicator is yellow and displays only one grid it means there is a little battery power left When the indicator turns red and blinks as well as less than one grid displays meanwhile the system alarm will be on to remind the battery shortage Please connect the device to the mains ...

Page 24: ...tice the second waveform is displayed screen by screen instead of continuous display in 1st waveform The 2nd waveform time 09 29 46 is displayed on the upper right corner on the 2nd waveform 3rd waveform Respiratory waveform 4th waveform SpO2 plethysmograph Data area Figure 4 3 Heart Rate Data Area HR Indicates the current display is heart rate The 60 on the right side is the heart rate measured T...

Page 25: ... when the unit is mmHg Manu The NIBP measurement mode Manual mode Figure 4 5 Respiration Data Area RR Respiration Rate The bpm after that is the unit of the respiration i e beat per min When there is no respiration wave detected the screen will display in searching 16 Respiration rate 1 Respiration gain amplification 1 2 half of the basic waveform 1 basic waveform 2 twice the size of the basic wav...

Page 26: ...temperature values C Body temperature unit and value When it shows TEMP C the temperature is in Celsius when it shows TEMP F the temperature is in Fahrenheit NIBP List Below the operating area is the data list area as shown in Figure 4 8 Figure 4 8 NIBP List Area The time stamp is the time when the NIBP measurements are taken The data lists here are different under different operating mode As show...

Page 27: ... Obsev of Disp2 on system setup screen press the DISP key to enter the monitoring screen as shown in Figure 4 9 Figure 4 9 Viewing Screen In this screen press the DISP key to switch the ECG lead or press the Print key to print the ECG waveform and the second waveform The second waveform can be selected in the System menu ...

Page 28: ...own in Figure 4 10 Figure 4 10 Frozen Screen 4 3 1 Screen Description Freezing ST segment analysis screen is similar with the main screen except the waveforms are frozen For example the Figure 4 11 is a portion of the frozen waveform The symbols on the screen were described briefly on the screen Figure 4 11 Frozen Waveform When the system setting for the freezing waveform is ALL the Freeze key wil...

Page 29: ...the yellow cross horizontally to the point to be measured on the ST segment Last press the Navigation Knob again The screen shows ST 0 xxx mV Set STDot Dirc Ver Rotate the knob to move the ST point vertically to the point to be measured on the ST segment One the main screen allows pressing the freeze key to enter the ST segment analysis screen NOTE The S point is the end point of S wave and the T ...

Page 30: ...anti clockwise the list scrolls upward i e use the arrow to scroll the data When rotating knob clockwise the list scrolls down i e use the arrow to scroll the data All the parameters in the SpO2 data list are corresponding to the time when the SpO2 measurements were taken There is only one record every 4 seconds 4 6 Trend Screen 4 6 1 Screen Description Move the gray cursor to the Trend button pre...

Page 31: ...to the Exit button and press the knob to return to the previous level screen The screen returned to is the Trend menu screen as shown in 4 14 Please note that the max value on the vertical axis of the ECG is 120 not the max value of the ECG upper limit The scaled down graph provide better waveforms When the ECG value exceeds 120 the vertical axis max value will automatically change to 240 The thre...

Page 32: ... Patient Monitor North vision Tech Inc 24 Figure 4 16 Respiration Trend Graph Figure 4 17 Body Temperature Trend Graph Figure 4 18 SpO2 Trend Graph Figure 4 19 PR Trend Graph Figure 4 20 NIBP Trend Graph Figure 4 21 EtCO2 Trend Graph ...

Page 33: ...en Figure 4 22 Waveform Recall Screen The waveform recall screen is shown in Figure 4 22 It is different from the main screen in its 2nd waveform area and the operation area We will cover them in detail below Rotate the knob and choose Recall HIST Delete and Exit button We explain each button s function below Recall press the Recall button the first list on the recall listings becomes highlighted ...

Page 34: ...ress the Current button the recall list on the left side displays the current listings When entering the recall screen the system defaults to the current listing Delete press this button the record on the recall list become highlighted Rotate the knob to choose the record being deleted Press the knob and hold for 2 seconds and release the knob The record will be deleted The current record cannot b...

Page 35: ...choose the record and display the corresponding waveform in the second ECG channel Press the knob again to exit Exit press this key to exit the arrhythmia detection screen and return to the system menu During monitoring if arrhythmia is detected the system will alarm The VPC alarm is system default and does not need setup During arrhythmia detection incorrect detection might occur if the non ECG w...

Page 36: ...ime Lang Language is the setting for the display language The factory default is English Fill When the fill setting is ON the display fills the volume for the SpO2 and Respiration When it is OFF the system displays the line graph The default is OFF Frze Freeze controls the waveforms being frozen when the Freeze button is pressed The options are All and ECG When ECG is selected the system only free...

Page 37: ...t If you choose to open then the arrhythmia paintings often triggers heart disorders appear print heart disorders screen if you select Off then print printer does not trigger the arrhythmia occurs the factory default value is close 4 9 3 ECG Parameter Settings Figure 4 29 ECG Settings Lead Can choose from I II III AVR AVL AVF V V1 V6 and GND The factory default is II Gain The ECG gain 5 options 1 ...

Page 38: ...is ON Move the cursor to the upper or lower limits of the alarm settings and press the Alarm key to turn ON and OFF the alarm for the setting Yellow color shows ON status and gray color show the OFF status Figure 4 30 Respiration Settings 4 9 4 Respiration Parameter Settings Gain Respiration amplification gain 4 options 1 2 1 2 4 the factory setting is 2 Speed Respiration display speed 2 options 6...

Page 39: ... and lower alarm limits DIA Hi Lo Diastolic pressure upper and lower alarm limits MAP Hi Lo Mean arterial pressure upper and lower alarm limits PR Hi Lo Pulse rate upper and lower alarm limits Unit the pressure unit mmHg or kPa The factory default is mmHg Mode The cuff inflation mode manual or automatic The factory default is manual The operator needs to press the NIBP button to perform NIBP measu...

Page 40: ...st leak position rotary knob will leak testing test results and blood pressure zone WARNING STAT can only be used for Adult Using this mode to Infant Neonate patient can cause serious injury 4 9 7 SpO2 Parameter Settings SpO2 Hi Lo SpO2 upper and lower alarm settings adjustable 1 100 0 99 Pulse Hi Lo Pulse rate upper and lower alarm settings adjustable 21 250 20 249 4 9 8 EtCO2 Parameter Settings ...

Page 41: ...mp flow of carbon dioxide the factory is 50ml min this content is not available to adjust and change Baro Set the local atmospheric pressure value the default value is 760mmHg Apnea Apnea alarm time in seconds When the monitor does not detect breathing time than this setting the respiratory waveform channel prompted apnea asphyxia XXX seconds Suffocation longer than 60 seconds the display suffocat...

Page 42: ...he text entry box Rotate the knob to choose the letter and press the knob to enter the letter To delete the letter move the cursor to the letter to be deleted and rotate the knob to enter spaces after the Z Use the spaces to replace the letters After finishing entering the patient ID choose Exit button and press the knob to exit the text entry The patient ID is the unique identifier for the patien...

Page 43: ...ssure tube and ensure there is no air present in the pressure tube pressure transducer or patient tube 4 The transducer must be placed at the same level with the patient s heart 5 Check if the correct label name is chosen 6 Zero the transducer ART artery pressure PA pulmonary pressure CVP central vain pressure RAP right atrium pressure LAP left atrium pressure ICP intracranial pressure Figure 5 1 ...

Page 44: ...meter Patient Monitor North vision Tech Inc 36 5 2 IBP Monitoring Screen Figure 5 2 IBP Monitoring Screen Waveform area 3rd waveform IBP1 waveform 4th waveform IBP2 waveform Data area Figure 5 3 Invasive Blood Pressure Data Area ...

Page 45: ...User Manual for Multi parameter Patient Monitor North vision Tech Inc 37 5 3 IBP Graphic Trend Figure 5 4 IBP1 Trend Graph Figure 5 5 IBP2 Trend Graph ...

Page 46: ...mended that 100mmHg calibration must be carried out only on the reusable IBP transducer 100 calibration 100mmHg calibration for the pressure value After pressing this button of PUSH FOR 100mmHg on the transducer do calibration operation It means that selecting proceed by navigation knob until this parameter changes to succeed That stands for 100mmHg calibration succeed 0mmHg calibration must be do...

Page 47: ...on the 0 mm mercury column should be calibrated for IBP Please refer to IBP Menu Setup for the method of calibration Note 1 Zero calibration is necessary Zero calibration must be done before the measuring or the readings of IBP will not accurate 2 100mmHg calibration is not necessary Usually the linearity of transducer can ensure the accurate of the measuring If the reusable IBP transducer is chos...

Page 48: ...Use the saline solution to expulse the air from the tube the methods are as follows Method 1 Turn off the stopcock Off to the direction where is no connector Input the saline solution into the patient connector by syringe and press Flash switch for opening until the saline solution run off through the vent and ensure there is no air bubbles in the tube Method 2 Connect one end of the transfusion t...

Page 49: ...mm transfusion tube and stopcock which connect with Dome are disposable and can not be reused 5 6 Cautions to Operation 1 Change the Dome Press tightly the handle of the Dome entad and push it out to the direction of transfusion tube 2 Plug the transfusion tube into the Dome and rotate the tube 45 degrees when connecting the transfusion tube and Dome 3 It is recommended that 0 calibration must be ...

Page 50: ...ion ratio CMRR 80dB 11 Time constant Monitoring Mode 0 3s Diagnosis Mode 3 2s 12 Frequency response Monitoring Mode 1Hz 25 Hz ０ ４ｄＢ ３ ０ｄＢ Diagnosis Mode 1 Hz 75 Hz ０ ４ｄＢ ３ ０ｄＢ 13 The recovery time after defibrillator charge 10sec 6 2 RESP Monitoring 1 RESP measuring range 0bpm 100bpm 2 RESP measuring accuracy 2bpm or 5 whichever is greater 6 3 TEMP Monitoring 1 TEMP measuring range 28 0 45 0 2 TEM...

Page 51: ...O2 measuring range 0 100 3 SpO2 measuring accuracy Arms is not greater than 2 for SpO2 range from 70 to 100 4 SpO2 measurement accuracy 1 70 100 2 2 Below 70 the value is only for reference without exact definition the symbol for means the SpO2 Percentage 5 PI range 0 4 20 6 6 Pulse Rate monitoring 1 Pulse rate measuring range 10bpm 300bpm 2 Pulse rate measuring accuracy 2bpm or 2 whichever is gre...

Page 52: ...re High 39 39 39 Low 35 35 35 Systolic High 180mmHg 130mmHg 110mmHg Low 60mmHg 50mmHg 50mmHg Diastolic High 120mmHg 90mmHg 90bpm Low 50mmHg 40mmHg 30bpm MAP High 160mmHg 110mmHg 100mmHg Low 50mmHg 40mmHg 30mmHg SpO2 High 100 100 100 Low 90 85 85 Pulse Rate High 180bpm 200bpm 220bpm Low 40bpm 50bpm 50bpm Alarm high and low limits when the parameter value is higher than the high limit or lower than ...

Page 53: ...kaging Dimensions 500mm x 320mm x 460mm 7 2 Accessories 1 ECG lead cable One set 2 NIBP cuff One set 3 SpO2 probe One piece 4 Body surface temperature probe One piece 5 Power cable One piece 6 Grounding wire One piece 7 Disposable electrode Ten pieces 8 User Manual One copy 9 Warranty One copy 10 Printing paper optional Five rolls 11 Dust cover One set 12 Assembly report One set 13 Packing list On...

Page 54: ...m of the heart To obtain the high quality ECG signal the hospital or the clinic should get ready the three phase power supply system with standard ground wire If excessive interference exists connect one end of the ground wire provided with this equipment to the grounding pole on the back panel of this monitor and the other end to the special ground wire water pipe or radiator A common ECG plate e...

Page 55: ... is much higher than that of human ears the oscillating method uses different definitions for measurement of diastolic pressure mean arterial pressure and systolic pressure from the Korotkoff souna method When the oscillating method is used the circuit in the measuring equipment will separate the amplitude of the cuff pressure from its change with pulsation With the oscillating method the blood pr...

Page 56: ...te may have direct effect on the measurement accuracy It also has the disadvantages of rapid air release and poor accuracy In the contrast with the oscillating method the determination is calculated on the basis of cuff pressure oscillatory wave envelope and the air release speed and heart rate has little effect on the measurement accuracy 3 Statistics show that when measuring the hypertension the...

Page 57: ...n inaccurate measure of blood pressure It is recommended the measure be taken at intervals of more than two minutes 5 With the oscillating method when blood pressure is measured the inflation pressure of the cuff will be automatically adjusted according to the previous measurement Generally the initial inflation pressure is 180mmHg for the adult mode or 100mmHg for the infant mode or 80 mmHg for t...

Page 58: ... the blood pressure measures when the oscillating method is used As a matter of fact the so called big discreteness must be a term in the sense of statistical significance of mass data Abnormal data may be observed in some individual cases It is normal in the scientific experiments It may be caused by an apparent reason or by an unknown factor in some cases Such individual doubtful experimental da...

Page 59: ...us pulsation and consequential inaccurate measure of SpO2 5 Make sure the optical path is free from any optical obstacles like adhesive tape 6 Excessive ambient light may affect the measuring result This includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc 7 Sudden and excessive movement of the subject or extreme electrosurgical interference may also affect the accurac...

Page 60: ...ven it is not allowed to apply it to the patient for any monitoring Please contact the local dealer or our company and we are to offer the best solution as soon as possible for your satisfaction After each maintenance or the yearly maintenance the monitor must be thoroughly inspected by qualified professional including function and safety examinations If the hospital fails to carry out a satisfact...

Page 61: ...th dry and clean wipe or simply air dry It is advisable to disinfect and sterilize the apparatus when necessary in the hospital maintenance program to avoid causing long term damage to the monitor and to clear the sterilizing and disinfecting tools in advance Do not let the liquid cleanser flow into the connector jack of the monitor to avoid damage Clean the exterior of the connector only Dilute t...

Page 62: ...0 Ispropanol Do not use damaged accessories Accessories can not be entirely immerged into water liquor or cleanser Do not use radial steam or epoxyethane to disinfect accessories 9 5 Storage If the apparatus will not be used for long period of time wipe it clean and keep it in the package which shall be kept in a dry place free from dust Storage environment ambient temperature 20 55 relative humid...

Page 63: ...he plate electrodes are properly located and if valid plate electrodes are used 2 Are the lead wires properly inserted If no ECG curve is displayed check if the ECG lead wires are broken 3 Does the mains outlet have standard grounding wire 4 Is the exclusive grounding wire of the apparatus properly grounded 10 3 No Blood Pressure and Pulse Oxygen Measurements 1 Check if the blood pressure cuff is ...

Page 64: ... 11 1 Abbreviation of Arrhythmia 1 ECG TACHY 2 ECG BRADY 3 ECG ARREST 4 MISS BEAT 5 VE EARLY 6 SVE EARLY 7 VE COUPLET 8 SVE COUPLET 9 VE RUN 10 SVE RUN 11 VE SHORT RUN 12 SVE SHORT RUN 13 VE BIGMINY 14 SVE BIGMINY 15 VE TRIGMINY 16 SVE TRIGMINY 17 VE INSERT 18 SVE INSERT 19 VE RONT 20 SVE RONT ...

Page 65: ...ssure and pulse e g during patient shaking motion Signal overflow Blood pressure amplifier overflow due to excessive movement Leak in gas run Leaking during the pneumatic device testing System error Abnormal condition of CPU such as register overflow divided by zero Adult The blood pressure measuring now is in adult mode In this case it is not allowed to monitoring Infant or Neonatal patient Other...

Page 66: ...l No 15 Gongye E 2nd Rd East Dist HsinChu City 30075 Taiwan R O C Tel 886 3 5771038 Fax 886 3 5771039 E mail ahuang north vision com Website http www north vision com Version 2 0 Revised date May 11 2020 Information is subject to change and or updating without notice Copyright 2020 North vision All rights reserved European Representative CMC Medical Devices Drugs S L C Horacio Lengo N 18 CP 29006 ...

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