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User Manual for Patient Monitor

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.

8.5 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

℃

～

℃

relative humidity: 10%~95%

atmospheric pressure: 50kPa

～

106kPa

8.6 Transportation

This monitor should be transported by land (vehicle or railway) or air in accordance with the contractual terms.

Do not hit or drop it with force.

Содержание Elegant-1100

Страница 1: ...Multi parameter Patient Monitor Elegant 1100 User Manual Version 3 0 Issued by Sara Lo Date 7 20 2020 Reviewed by Albert Huang Date 7 20 2020 Document No UM PM1 201405 01 North Vision Tech Inc 2460 ...

Страница 2: ...n 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 the prior written consent We reserve the righ...

Страница 3: ...that the equipment functions safely and ensure 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 m...

Страница 4: ...Please peruse the relative content about the clinical restrictions and contraindication Dispose of the expired device and its accessory according to applicable local regulations CONTRAINDICATIONS It is contraindicated for use on active patients or for prolonged use ADVERSE REACTION Continuous use of fingertip SpO2 sensor may result in discomfort or pain especially for those patients with microcirc...

Страница 5: ...3 1 PANEL INTRODUCTION 5 3 1 1 Front Panel 5 3 1 2 Left and Right Side Panel 7 3 1 3 Back Panel 8 3 2 INSTALLATION 9 3 2 1 Opening the Box and Check 9 3 2 2 Connecting the AC Power Cable 9 3 2 3 Starting the Monitor 9 3 3 CONNECTION 10 3 3 1 ECG Connection 10 3 3 2 Blood Pressure Cuff Connection 11 3 3 3 To connect the SpO2 12 3 3 4 Battery Installation 13 3 3 5 Loading Printing Paper 13 CHAPTER 4...

Страница 6: ...IONS 34 5 1 ECG MONITORING 34 5 2 NIBP MONITORING 35 5 3 SPO2 MONITORING 35 5 4 PULSE RATE MONITORING 35 5 5 DATA RECORDING 35 5 6 OTHER TECHNICAL SPECIFICATIONS 35 5 7 CLASSIFICATION 35 5 8 DEFAULT ALARMING VALUES OF ALL PARAMETERS 36 CHAPTER 6 PACKAGING AND ACCESSORIES 37 6 1 PACKAGING 37 6 2 ACCESSORIES 37 CHAPTER 7 MONITORING PARAMETERS 38 7 1 MEASURING ECG 38 7 2 THE PRINCIPLE FOR MEASUREMENT...

Страница 7: ...TION OF THE MONITOR 45 8 4 CLEANING STERILIZATION AND DISINFECTION OF ACCESSORIES 45 8 5 STORAGE 46 8 6 TRANSPORTATION 46 CHAPTER 9 TROUBLESHOOTING 47 9 1 NO DISPLAY ON THE SCREEN 47 9 2 EXCESSIVE ECG SIGNAL INTERFERENCE OR THICK BASELINE 47 9 3 NO BLOOD PRESSURE AND PULSE OXYGEN MEASUREMENTS 47 9 4 SYSTEM ALARM 47 CHAPTER 10 APPENDIX 48 10 1 OTHER TERMS AND MESSAGES 48 ...

Страница 8: ...peat 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 recording modifying deleting and saving operation of patient s information Precise alarm system different alarm events adopt different alarm degrees 3 degrees visual and audible alarm functio...

Страница 9: ...vision Elegant 1100 of Multi parameter Patient Monitor is intended to monitor display and record physiological signs of adult pediatric patients With the functions of near real time recording and displaying parameters ECG heart rate non invasive blood pressure blood oxygen saturation and pulse rate it allows comprehensive analysis of patient s physiological conditions This apparatus is applicable ...

Страница 10: ...Environment and Resources Low 1 7 Safety a Conform to IEC 60601 1 certified as Class II with Type BF and CF applied parts b Elegant 1100 Multi parameter Patient Monitor can resist against defibrillator and electrosurgical equipment interferences and can detect and filter the pacemaker generated signals ...

Страница 11: ...a 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 pediatric NIBP measure has three modes adult and pediatric mode 4 CPU module consists of main board multi function board and the keyboard The multi function board performs the data communication between the main board ECG module...

Страница 12: ... 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 setup the alarm...

Страница 13: ... ECG waveform SpO2 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 9 DISP Display Press thi...

Страница 14: ...re 3 3 1 NIBP NIBP measuring cuff jack 2 SpO2 SpO2 probe jack 3 ECG ECG leads jack 4 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 applied part and applicable during the...

Страница 15: ...r 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 ...

Страница 16: ... 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 Starting the Monitor ...

Страница 17: ...tals 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 Electrodes Note If skin rash or other un...

Страница 18: ... 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 or arouse deviations of measurement You can take some steps to avoid this situation do NOT use small ECG electrodes choosing the position which is far away fro...

Страница 19: ...sion 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 measuring or remove the cuff to other positions Doctor should examine this timely Do NOT twist the cuff tube or put heavy things on it 3 3 3 To connect the SpO2 SpO2 probe is ve...

Страница 20: ... of normal length 3 3 4 Battery Installation 1 Make sure that monitor doesn t connect to mains power supply and stays in switch off status 2 Open the battery cover insert the battery into any slot of battery compartment and pay attention to the instruction of polarity direction in the compartment Do not reverse the battery 3 Move baffle plate with hand to fasten the battery 4 Remove the battery co...

Страница 21: ...User Manual for Patient Monitor 14 Figure 3 8 Loading Printing Paper Load the paper Withdrawal of paper ...

Страница 22: ...b 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 adjusting the date a...

Страница 23: ...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 power supply in time to ensure the normal use of this monitor and the battery w...

Страница 24: ... of continuous display in 1st waveform The 2nd waveform time 09 29 46 is displayed on the upper right corner on the 2nd 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 The heart beating symbol Its flashing corresponds to the R wave of the ECG waveform The speed is ...

Страница 25: ...r 18 Figure 4 4 NIBP data area NIBP Data SYS DIA MAP The blood pressure type labels and the measured value 09 36 The time of NIBP measuring mmHg The measurement values when the unit is mmHg Manu The NIBP measurement mode Manual mode ...

Страница 26: ...SpO2 strength bar 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 shown in Figure 4 8 one screen of the data list can list up to 6 groups of data When there are more than 6 groups of data we can rotate the navi...

Страница 27: ...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 ...

Страница 28: ...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 will freeze all the wa...

Страница 29: ...rizontally 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 point is the start ...

Страница 30: ...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 press th...

Страница 31: ...tton 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 three value to cha...

Страница 32: ...18 SpO2 Trend Graph Figure 4 19 PR Trend Graph Figure 4 20 NIBP Trend Graph 4 6 2 Operating Instructions Rotate the knob choose the parameter and press the knob Review the trend graph and move the cursor to the Exit button to exit the trend graph ...

Страница 33: ...each button s function below Recall press the Recall button the first list on the recall listings becomes highlighted Rotate the knob to choose the record Press the knob to perform the recall The recalled waveform displays on the 2nd channel of the waveform area as shown in Figure 4 24 Rotate the knob to move forward and backward of the recalled waveform Press the knob to exit the waveform recall ...

Страница 34: ...ys 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 be deleted Exit press this key to return to the system setup men...

Страница 35: ...monitoring It is strictly forbidden to use Adult type on the pediatric patient Doing so can cause serious injury Mode Monitoring mode selection The Near real shows the near real time waveform i e normal monitoring state The DEMO shows the demo waveforms During the demo state all the signals and data are generated from the patient monitor for demo and testing purpose The factory default is Near Rea...

Страница 36: ...tor 29 default is 5 HL7 Monitoring to hl7 format output measurement signal Nuser Call Nurse call signal output can be provided in the monitoring process Password The need for the administrator password for a specific project input ...

Страница 37: ...ttings 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 2 1 2 4 and Auto Auto is for automatic gain control The factory default is 1 Speed ECG display speed 3 options 12 5 25 50 mm s The factory default is 25 mm s HR Hi Heart rate upper alarm setting Lo Heart rate lower alarm setting Mode ECG filter mode Three options MON DIA and OPE...

Страница 38: ...d gray color show the OFF status 4 8 4 NIBP Parameter Settings SYS Hi Lo Systolic pressure upper 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...

Страница 39: ...r alarm settings adjustable 21 250 20 249 4 8 6 Reset System parameters default key Move the cursor to RESET press the Navigation knob for 2seconds all the value of parameters will resume default except the setting of language and printer type 4 9 Color Settings Screen Figure 4 36 Color Setting Screen In this screen rotate the knob to choose the color press the knob and rotate it to change the col...

Страница 40: ...paces 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 patient When the patient ID changes the system considers the patient has changed Name Enter the patient name Bed Enter the bed number Sex Choose between M or F for male and female Age Choose the ...

Страница 41: ...atio CMRR 80dB 11 Time constant Monitoring Mode 0 3s Diagnosis Mode 3 2s 12 Frequency response Monitoring Mode 1Hz 25 Hz ０４ｄＢ３０ｄＢ Diagnosis Mode 1 Hz 75 Hz ０４ｄＢ３０ｄＢ 13 The recovery time after defibrillator charge 10sec 5 2 NIBP Monitoring Measuring method Intelligent Oscillometric method Cuff inflation time 10 seconds typical adult cuff Air release time while the measurement is canceled 2 se...

Страница 42: ...ulse rate measuring range 15bpm 300bpm Pulse rate measuring accuracy 2bpm or 2 whichever is greater 5 5 Data Recording Sensitivity selection tolerance 5 Recording speed 25mm s Recording speed accuracy 5 5 6 Other Technical Specifications Power supply 100 240VAC 50 60Hz Power consumption 100VA Display mode 10 4 inches TFT color LCD Alarming mode Audible visible alarm Communication NET RJ45 5 7 Clas...

Страница 43: ...00 100 Low 90 85 Pulse Rate High 180bpm 200bpm Low 40bpm 50bpm Alarm high and low limits when the parameter value is higher than the high limit or lower than the low limit the system will alarm In the monitoring screen press the Alarm key to activate the alarm timer The time shows up on the high limit left corner of the screen When the alarm timer is activated the system will activate the alarm fu...

Страница 44: ...packaging Dimensions 500mm x 320mm x 460mm 6 2 Accessories 1 ECG lead cable One set 2 NIBP cuff One set 3 SpO2 probe One piece 4 Power cable One piece 5 Grounding wire One piece 6 Disposable electrode Ten pieces 7 User Manual One copy 8 Warranty One copy 9 Printing paper optional Five rolls 10 Dust cover One set 11 Assembly report One set 12 Packing list One piece Note The accessories are subject ...

Страница 45: ...btain 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 electrode used toget...

Страница 46: ...efined as systolic pressure while the blood pressure at amplitude of cuff pressure backward reduced by 80 is defined as diastolic pressure The maximum change of pulse pressure occurs at these two points They are equivalent to the point with pulse sound and the point without pulse sound respectively in the Korotkoff souna method When the risk of invasive monitoring method outweighs its advantage of...

Страница 47: ...ct on the measurement accuracy 3 Statistics show that when measuring the hypertension the measure taken by the oscillating method is likely to be lower than that taken by the Korotkoff souna method When measuring the hypotension the measure taken by the oscillating method is likely to be higher than that by the Korotkoff souna method However it doesn t mean the advantages or disadvantages between ...

Страница 48: ...ure 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 pediatric mode or 80 mmHg for the newborn mode when it is powered on Following that 50mmHg fo...

Страница 49: ...ignificance 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 data may be identified and eliminated using the special statistical technique It is not a part of this manual The practitioner may eliminate the apparently unreas...

Страница 50: ... 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 accuracy 7 4 2 Clinical...

Страница 51: ...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 satisfactory maintenance program about the monitor it may get disabled and harm the patient s safety and health In c...

Страница 52: ...anser flow into the connector jack of the monitor to avoid damage Clean the exterior of the connector only Dilute the cleanser Do not use scrub materials Do not let any liquid flow into the shell or any parts of the monitor Do not let the cleanser and disinfectant stay on its surface Do not perform high pressure sterilization to the monitor Do not put any parts of the monitor in the liquid Do not ...

Страница 53: ...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 humidity 10 95 atmospheric pressure 50kPa 106kPa 8 6 Transportation This monitor should be transported by land vehicle or railway or air in accordance with the contractual terms Do not hit or drop...

Страница 54: ...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 9 3 No Blood Pressure and Pulse Oxygen Measurements 1 Check if the blood pressure cuff is properly wrapped arou...

Страница 55: ...g pressure 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 register overflow divided by zero Adult The blood pressure measuring now is in adult mode In this case it is not allowed to monitoring Pediatric patient Otherwise there m...

Страница 56: ...d 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 3 0 Issued date July 20 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 Malaga Spain TEL 34...

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