EDAN iM3 User Manual Download Page 3

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Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.

WARNING

label advises against certain actions or situations that could result in personal

injury or death.

CAUTION

label advises against actions or situations that could damage equipment, produce

inaccurate data, or invalidate a procedure.

NOTE

provides useful information regarding a function or a procedure.

Summary of Contents for iM3

Page 1: ......

Page 2: ...otected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such in...

Page 3: ...label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inac...

Page 4: ...2 Rear View 14 3 1 3 Side View 16 3 2 Operating and Navigating 17 3 2 1 Using Keys 20 3 3 Work Modes 22 3 4 Operating Modes 22 3 4 1 Demo Mode 22 3 4 2 Standby Mode 22 3 4 3 Night Mode 23 3 5 Changing...

Page 5: ...Security 40 7 2 Wi Fi 42 7 3 Network Disconnected Alarms 43 7 4 e link Function 44 7 5 Connecting the Monitor to MFM CMS 45 7 6 Connecting the Monitor to CMS LITE 45 7 7 Gateway Communication 46 7 8 H...

Page 6: ...11 SatSeconds Alarm Management 76 11 11 1 Describing SatSeconds 76 11 11 2 SatSeconds Safety Net 78 11 11 3 Setting SatSeconds Duration 78 Chapter 12 Monitoring PR 79 12 1 Overview 79 12 2 PR Source 7...

Page 7: ...ting Data Stored in the Internal Storage Device 107 16 6 Ejecting a Removable Device 107 16 7 Recording Data by Recorder 108 16 8 Formatting the Internal Storage Device 108 Chapter 17 Recording 109 17...

Page 8: ...A 2 2 Environment Specification 132 A 2 3 Display 133 A 2 4 Battery Specification 133 A 2 5 Recorder 134 A 2 6 Data Management 134 A 3 NIBP 135 A 4 SpO2 138 A 5 PR 139 A 6 TEMP 140 A 7 Adjustable Rang...

Page 9: ...ent such as these monitor monitoring systems must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly 4 EXPLOSION HAZAR...

Page 10: ...ly with the valid version of the standard IEC EN 60601 1 Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that i...

Page 11: ...ans from supply mains Position the monitor in a location where the operator can easily access the disconnection device 24 Assembly of the monitor and modifications during actual service life shall be...

Page 12: ...o be supplied by a multiple portable socket outlet with an isolation transformer 37 Operation of the equipment exceeding specified physiological signal or the operational specification may cause inacc...

Page 13: ...re that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones microwaves etc 2 Kee...

Page 14: ...controls 2 The monitor can only be used on one patient at a time 3 If the monitor gets damp or liquid pours on the monitor please contact the service personnel of EDAN 4 This monitor is not a device...

Page 15: ...art Number 15 General symbol for recovery recyclable 16 Disposal method 17 Operating instructions 18 Refer to instruction manual booklet Background Blue Symbol White 19 Warning Background Yellow Symbo...

Page 16: ...ns FCC ID 2AMWOFSC BT836B 28 Conforms to AAMI Std ES60601 1 IEC Std 80601 2 30 IEC Std 60601 2 49 ISO Std 80601 2 56 ISO Std 80601 2 61 Certified to CSA Std C22 2 No 60601 1 No 80601 2 30 No 60601 2 4...

Page 17: ...Wall Mounting Bracket Assembly Instruction WARNING 1 The wall mounting bracket can be fixed only on a concrete wall 2 The safe loads of the wall mounting bracket and the trolley are 7 5 kg and 11 kg...

Page 18: ...recorder s door to check if paper is properly installed in the slot If no paper exists refer to Chapter Recording for details 2 7 Setting Date and Time To set the date and time 1 Select Menu System Se...

Page 19: ...ation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interf...

Page 20: ...d on the way it has been tailored for your hospital and may not be exactly as shown here You may frequently use the follow functions SpO2 monitoring Refer to Monitoring SpO2 for more information PR mo...

Page 21: ...ed on the indicator is in green 3 Power supply switch When the monitor is connected to the AC power supply press the key to turn the monitor on When the monitor is turned on press the key over 3 secon...

Page 22: ...ow and return to main interface 9 Switch patient type In main interface press it to pop up a patient type selection window The relevant configuration will be updated after selection In other interface...

Page 23: ...o ensure that it secures the power cable 6 OTG interface nurse call port OTG interface it connects the monitor to computer via data line The data in monitor can be transmitted to computer Nurse call p...

Page 24: ...Vital Signs Monitor User Manual Basic Operation 16 3 1 3 Side View Left side Right side 1 Built in barcode scanner window 2 Heat sink 4 5 1 2 3 2 3 6...

Page 25: ...onitor is contained on its screen Almost every element on the screen is interactive Screen elements include measurement data waveforms screen keys information fields alarms fields and menus The config...

Page 26: ...al Card etc Please refer to chapter Patient Information Item Management for more details 3 Patient type click this area to view edit patient information 4 Physiological alarms area click this area to...

Page 27: ...sample above single battery status symbol dual batteries status symbol 16 Wired network symbol 17 Scroll right to display more shortcut keys 18 Date and time 19 Menu 20 TEMP measuring position symbol...

Page 28: ...axillary TEMP in PED mode Measuring rectal TEMP in PED mode Measuring ear TEMP For device with the TH Infrared TEMP 3 2 1 Using Keys The monitor has four different types of keys If the key sound is e...

Page 29: ...tandby mode Record Barcode scanning Night Mode and Score In Ward round mode the displayed keys are Review NIBP AVG NIBP measurement General Standby mode Barcode scanning and Score In spot checking mod...

Page 30: ...Refer to specific chapter for details of these 3 modes NOTE 1 The history data in each mode can be viewed only in corresponding mode 2 In these 3 modes each setting item is respectively independent ex...

Page 31: ...reset and alarm latch status are not influenced 4 Stop the recording work in progress 5 Disconnected with MFM CMS MFM CMS won t update monitoring data and will display monitor s Offline status When t...

Page 32: ...5 2 3 Adjusting Alert Volume In monitoring or spot mode to change the alert volume select Menu System Setup General and select the desired setting for the Alert Volume item six levels represent volum...

Page 33: ...act EDAN service personnel for activation user can choose Manual or Auto for Internal Scanner Mode in User Maintain to scan the barcode User can also check relevant scanner device information in Scann...

Page 34: ...ranges To admit a patient please 1 Select Menu Patient Management New Patient or press the Admit Create new patient hardkey on the front panel then a message is displayed to ask the user to confirm t...

Page 35: ...patient 3 Click on No to cancel this operation click on Yes to continue and the Quick Admit window is displayed 4 Configure Type to the correct setting and click Yes to finish the quick patient admiss...

Page 36: ...n or select Menu Review Trend Graph In the trend graph the y axis stands for the measurement value and x axis stands for the time With the exception of NIBP and TEMP other trends are displayed as cont...

Page 37: ...more NIBP measurement data Select Record to print out the NIBP measurement data by the recorder 4 5 4 Alarm Review To review the alarm event please press the Review shortcut key on the screen or sele...

Page 38: ...t Marking Event mark is used to note the classified events which are related with patient or may have influence on parameters monitoring such as take or inject medicine or kinds of treatments There ar...

Page 39: ...Type and the 1st patient info item other items can be set to show or hide 10 items at most can be set to show 3 User also can Add new patient info item or delete the item by clicking icon Click Confir...

Page 40: ...r based on the 1st patient info item and update the information to the interface of creating new patient in which the items are grey and can t be modified except bed No when network server is not conn...

Page 41: ...to enter Patient Management window and user should delete part of existing patients then return to import patient window to import again Choose NO to return to Import Patient window and user should d...

Page 42: ...easurement value Click one patient and the patient information will be displayed in the main interface Click icon to create new patient who will be displayed in the place where the icon is and whose i...

Page 43: ...te the custom parameters In the window of Add Custom Parameters the basic attribute such as Name Unit and Type should be set When Type is selected as Numeric user should set the Upper Limit Lower Limi...

Page 44: ...be displayed by default Filter operation is to display Ward round records in specified period Abnormal value is displayed in red Choose Alert to display abnormal value in specified period Choose Not...

Page 45: ...ect Patient Management Patient Info or directly click patient information area in main interface to view or modify patient information serial No is not editable If the monitor is powered off and resta...

Page 46: ...g Data Trend Table locates the bottom of main interface First line is the latest data Click triangle at the bottom to show hide trend table If monitor is powered off parameters data and trend data in...

Page 47: ...personal health information the user should implement practices or measures that include 1 Physical safeguards physical safety measures to ensure that unauthorized personnel do not have access to the...

Page 48: ...and encrypt the transmitted data to ensure the security 11 Please protect the privacy for the information and the data displayed on the screen and for the information and the data stored in the monito...

Page 49: ...input corresponding password Step 5 click Confirm NOTE 1 CA certificate is the root certificate of CA institution 2 Client certificate Server certificate are the SSL certificate obtained from CA inst...

Page 50: ...menu select Wi Fi from the Network Type list And click Config to open the Wi Fi Setup window The available networks will be listed in this window Click the desired network to check the encryption info...

Page 51: ...signal may be unstable and quality of the signal transmission may be degraded 5 When the monitor is connected to MFM CMS GATEWAY via the wireless network the user should set the router to a secure enc...

Page 52: ...devices can be displayed Select one of them to view details such as Device Name Alias MAC address etc or to delete User can also modify Alias which supports 1 20 English characters Passive Connection...

Page 53: ...ctive If the setting is on the monitor will accept time synchronization from MFM CMS 3 The time synchronization function might not be available to all software versions of MFM CMS Consult our technica...

Page 54: ...er to HL7 Communication Protocol Service Manual 7 9 Inquire for Patient Information via Network ADT If the monitor is connected to network server and ADT Query in User Maintain is also set to On defau...

Page 55: ...setting is ON when monitor is in networking and is also connected with network server the monitor will upload the Ward round record which has been saved by user or the real time spot checking measure...

Page 56: ...give an alarm and this type of alarm is called physiological alarms About the detailed alarm information please refer to the Section Physiological Alarm Information 8 1 2 Technical Alarms If one or se...

Page 57: ...arm message flashes with red background and the symbol is displayed at the alarm area Medium Mode is DO DO DO which is triggered once every 23 25 seconds The alarm indicator flashes in yellow with fre...

Page 58: ...distinguish the audio alarm 8 3 Controlling Alarm 8 3 1 Setting Parameter Alarm In monitor mode parameter alarm settings including alarm switch alarm record alarm level and alarm limit are available o...

Page 59: ...me to 60 s 120 s or 180 s When alarms are paused The audio alarm is turned off and no alarms are sounding The visual alarm indications are still displayed The monitor displays the audio alarm paused i...

Page 60: ...m off audio paused and audio off status NOTE If a new alarm occurs after the alarm is reset the new alarm will be sounding 8 4 Latching Alarms In monitor mode to configure the alarm latching setting s...

Page 61: ...arameters of the currently monitored patient exceed the predefined limit the monitor will give alert information instead of physiological alarms Enter the respective parameter setup menu to set alert...

Page 62: ...e call port which is connected to nurse call system through the nurse call cable to perform the nurse call function Enter Menu User Maintain Common Nurse Call to choose Off default High Medium Low Hig...

Page 63: ...Desat SpO2 measuring value is below the SpO2 Desat Limit High PR PR High PR measuring value is above upper alarm limit User selectable PR Low PR measuring value is below lower alarm limit User selecta...

Page 64: ...or are well connected reconnect the sensor SpO2 Comm Fail SpO2 module failure or communication failure High monitor mode Low spot checking or Ward round mode Stop using measuring function of SpO2 modu...

Page 65: ...ion of NIBP module and notify biomedical engineer or manufacturer s service staff NIBP Leak NIBP pump valve cuff or tube has a leakage Low Check the connections and the wrapped cuff to see whether the...

Page 66: ...on of NIBP module and notify biomedical engineer or manufacturer s service staff NIBP Cuff Type Error EDAN NIBP The cuff type used isn t consistent with the patient type Low Confirm the patient type a...

Page 67: ...TEMP module failure or communication failure High monitor mode Low spot checking or Ward round mode Stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service s...

Page 68: ...r error Medium Stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service staff Temp SENSOR OFF The probe is disconnected from the patient Low Connect the sensor...

Page 69: ...uring patient thermistor calibration Medium TEMP Error E3 System error during heater thermistor calibration Medium TEMP Error E4 System timing error Medium Probe Heater error Heater error Medium TEMP...

Page 70: ...nd mode Stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service staff Temp exceed limit The TEMP value is out of the range of 30 C 43 C Medium Put the probe i...

Page 71: ...m persists notify the manufacturer s service staff Recorder Out Of Paper Recorder Out Of Paper Low Please install the paper Recorder Setup Needed The user presses the RECORD button when Recorder is no...

Page 72: ...Abnormal network traffic has been detected The data traffic exceeds the limit High Disconnect the network to make the monitor work properly and then contact the professionals authorized by manufacture...

Page 73: ...after the module entering Predict state for 30 s TEMP Is Warming Up User takes the sensor out of the bracket and TEMP is warming up Warm up Over The monitor displays this message after taking the sen...

Page 74: ...rm limits are listed as follows unit bpm Adjustable Range PR SpO2 EDAN 30 300 Nellcor 30 300 PR NIBP EDAN 40 240 SunTech 30 220 NIBP alarm limits are listed as follows EDAN module Patient Type Adjusta...

Page 75: ...blank after the second parameter trend graph Re print trend graph and do not press Record shortcut key in printing process 2 When USB flash drive is inserted via OTG interface it may not be recognized...

Page 76: ...splay colors of parameter and waveform as desire Click respective parameter area to enter parameter setup menu Color Setup to make color changes on parameter and waveform NOTE The colors won t be affe...

Page 77: ...ion select Menu Default Setup On the Default menu users can choose a factory configuration adult pediatric or neonate based on the patient category Also users can choose a user configuration saved in...

Page 78: ...cation site according to the patient s condition and pressure sensor inspect the if there is sign of stress related damage in surrounding tissue and regularly change the application site For the patie...

Page 79: ...ent category setting adult pediatric and neonatal as this is used to optimize the calculation of the SpO2 and pulse numerics 2 During measurement ensure that the application site has a pulsatile flow...

Page 80: ...h latch If strap is too long thread it through second latch Connect the sensor with the monitor or with the extension cable if needed Applying Adult Pediatric Ear Clip Sensor When you perform the meas...

Page 81: ...measurements can be caused but not limited by incorrect sensor application high levels of ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluo...

Page 82: ...dity of a SpO2 Reading You can check the quality of the pleth wave and the stability of the SpO2 values to assess whether the sensor functions properly and whether the SpO2 readings are valid Always u...

Page 83: ...lues reflect the physiological event 2 The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the monitor This delay is the combination of the configured...

Page 84: ...ormal SpO2 physiological alarms alert information and PR physiological alarms alert information It will not influence other functions of the monitor 11 11 SatSeconds Alarm Management Only applicable t...

Page 85: ...onds The resulting SatSeconds values are shown below SpO2 Seconds SatSeconds 2 2 4 4 3 12 6 6 36 Total SatSeconds 52 After approximately 10 7 seconds a SatSeconds alarm will be triggered because the l...

Page 86: ...ough for the SatSeconds limit to be reached If three or more SpO2 alarm limit violations occur within a 60 second period an alarm will be triggered even if the SatSeconds limit has not been reached 11...

Page 87: ...rce PR source can be from SpO2 or NIBP and is not selectable SpO2 is preferred source if PR from SpO2 is valid If PR is on and SpO2 NIBP both are off PR parameter area will display No source 12 3 Sett...

Page 88: ...l artery arteria cruralis axillary artery brachial artery dorsalis pedis and radial artery 13 2 NIBP Safety Information WARNING 1 Do not measure NIBP on patients with sickle cell disease or any condit...

Page 89: ...may lead to the discomfort of patient Continuous measuring and automatic measuring in neonatal or pediatric mode may result in tissue damage or ischemia to the patient 4 NIBP measurement can be affec...

Page 90: ...average value Average is used in Ward round or spot checking mode only After finishing average measurement the monitor enters manual mode To change Measure Mode Interval AVG Measurement Interval and A...

Page 91: ...he first reading is taken NOTE 1 The width of the cuff is either approximately 40 of the limb circumference or 2 3 of the upper arm length The inflatable part of the cuff should be long enough to enci...

Page 92: ...after the ending of countdown which starts from the latest manual measurement During interval if user makes a continuous measurement the whole measurement will be over on the basis of continuous measu...

Page 93: ...tdown monitor continues to finish the NIBP measurement when measurement is in interval pressing the button can start measurement in advance 2 To end the whole AVG measurement please click AVG measurem...

Page 94: ...t type has been set to Adult 4 Access Menu User Maintain 5 Select Leakage Test in NIBP Then the prompt Leak Test Running will appear indicating that the system has started the leakage test For EDAN mo...

Page 95: ...NIBP Air Leakage Test 13 10 Setting Inflation Value To change the inflation value 1 Select NIBP Setup Function Inflation value 2 Choose AUTO or other inflation values from the pull down list If other...

Page 96: ...ion in menu Switch on the monitor It takes 5min for the body temperature to stabilize WARNING 1 To ensure optimal accuracy always confirm that the correct mode and alarm limit are selected Changing th...

Page 97: ...y change the MEASURE MODE and MEASURE POS measure position in menu Take out the sensor from the sensor bracket After warm up it beeps and displays WARM UP OVER in information area Load a sensor cover...

Page 98: ...the PREDICT mode into the MONITOR mode but it can not change from the MONITOR mode into the PREDICT mode 14 1 3 TEMP Setup for T2A Module Enter TEMP SETUP to set the following items MEASURE MODE Set t...

Page 99: ...and voids warranty 11 Disposal of used probe covers must be performed in accordance with current medical practices or local regulations regarding disposal of infectious biological medical waste 12 Cle...

Page 100: ...when the probe is withdrawn from the probe well and following a completed temperature measurement 5 Insert the probe end into a cover in the box Push the handle firmly until you feel the cover snap i...

Page 101: ...ans to rapidly identify patients with normal body temperatures If the patient temperature is outside of the normal range the monitor will automatically switch into its standard predictive mode to prov...

Page 102: ...ward the back of the mouth NOTE Accurate body temperature readings can only be obtained in one of these two heat pocket locations as shown Temperatures taken in other mouth locations will result in in...

Page 103: ...2 6 mm 13 mm for children 6 If three short beeps are heard it means the unit switched to Monitoring Mode for this temperature only 7 Two beeps are sounded when measurement is complete and the final t...

Page 104: ...Module takes a temperature in the ear Diagram of the Infrared Ear Thermometer WARNING 1 The infrared ear thermometer is not intended for neonatal patients 2 Only use the disposable probe covers suppli...

Page 105: ...ents lower than usual 8 For more details about using the infrared ear thermometer refer to the accompanying operating instructions of the thermometer 9 Check whether the thermometer is damaged once it...

Page 106: ...ldren over two year old and adults pull the ear straight up and back as shown below 5 Press the Scan button for one second until you hear a long beep sound which signals the end of the measurement and...

Page 107: ...the error messages refer to the accompanying operating instructions of the thermometer 10 If the infrared ear thermometer frequently signals ERR alarms the insulated board inside the thermometer hous...

Page 108: ...Vital Signs Monitor User Manual Monitoring TEMP 100 WARNING 1 Keep the battery away from children 2 Ensure the positive side is up and the negative side down...

Page 109: ...X button on the top right of the interface Before exiting interface if selected Method is score calculator the monitor can exit not only this interface but also this function if selected Method is aut...

Page 110: ...In NEWS interface select Criteria to check score criteria as following Value 3 2 1 0 1 2 3 RESP rpm 8 9 11 12 20 21 24 25 SpO2 91 92 93 94 95 96 TEMP 35 0 35 1 36 0 36 1 38 0 38 1 39 0 39 1 SYS mmHg 9...

Page 111: ...nd checking should be taken every 1 hr Or call the doctor to give appropriate actions if necessary EWS 4 5 Medium Amber Please inform medical personnel that observing and checking should be taken ever...

Page 112: ...ient s life signs and appropriate treatment can be taken 5 MEWS 9 Warning Amber The condition is urgent and may be worse Keep close observing and give treatment timely MEWS 9 Critical Red The conditio...

Page 113: ...ge Storage Device and choose the storage medium from the pop up list as desired In Ward round or spot checking mode Storage Device is fixed as Internal Storage Device NOTE In ward round or spot checki...

Page 114: ...either when the monitor is turned off or when the monitor is powered down in the process of monitoring 16 3 Reviewing Data Stored in the Storage Device In monitor mode To review data stored in the sto...

Page 115: ...nitor is connected with the PC via OTG interface you can copy the data which stored in internal storage device through the PC NOTE In monitor mode the data in internal storage device is not encrypted...

Page 116: ...ord Management or Review Spot checking Data for data review 16 8 Formatting the Internal Storage Device To format the internal storage device select Menu User Maintain Device Format internal storage d...

Page 117: ...rder Waveform record is printed at the rate of 12 5 mm s 25 mm s or 50 mm s default setting is 25 mm s 49 mm 50 mm wide printout paper Record one SpO2 waveform default setting is off User selectable r...

Page 118: ...graph the paper for recording will not be left blank after the second parameter trend graph Trend table recording In monitor mode select Menu Review Trend Table click Record in trend table window to s...

Page 119: ...itive record paper can be used otherwise the recorder may not function the recording quality may be poor and the thermosensitive printhead may be damaged 17 3 2 Proper Operation When the recorder is w...

Page 120: ...or shooting troubles do not leave the recorder catch open 17 3 5 Removing Paper Jam When the recorder functions or sounds improperly you should open the recorder casing to check for a paper jam Remove...

Page 121: ...necessary 4 Do not connect the positive and negative terminals with metal objects and do not put the battery together with metal objects which can result in short circuits 5 Do not unplug the battery...

Page 122: ...iciency it is recommended to charge the battery when the device is off or in standby mode 18 2 Battery Power Indicator The indicator labeled Battery on the front panel of the monitor illuminates in gr...

Page 123: ...fully charge the battery again for use or charge it to 40 60 for storage 18 5 Replacing the Battery To install or replace the battery please follow the procedure 1 Push the battery latch to the right...

Page 124: ...tain the batteries regularly every 3 6 months if they are not in use for a long time And recharge the batteries to 40 60 every 3 6 months when they are stored Refer to the steps in section Checking Ba...

Page 125: ...ry use Follow the manufacturer s instructions for cleaning agents disinfectants and reprocessing devices Signs of wear e g cracks deformation discoloration or peeling may occur with reprocessed produc...

Page 126: ...a clean soft non abrasive cloth or paper towel each time Refer to the cleaning agent manufacturer s instruction for use with reference to concentration temperature and contact time 19 3 1 Cleaning th...

Page 127: ...idual moisture with a dry cloth 6 Air dry the cuff thoroughly after cleaning 7 If the cuff and the air bladder are not visually clean at the end of the cleaning steps please repeat the cleaning steps...

Page 128: ...ts remain 4 After cleaning wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains 5 Wipe off residual moisture with a dry cloth 6 Le...

Page 129: ...pe away from the tip toward the cable WARNING The monitor and reusable accessories shall be disinfected to avoid patient cross infection 19 4 1 Disinfecting the Monitor WARNING Before disinfecting the...

Page 130: ...or 2 Clean and dry the SpO2 sensor according to the methods in section 19 3 2 2 prior to disinfection 3 Prepare the disinfectant solution 4 Wipe the surfaces of the sensor and cable using a soft cloth...

Page 131: ...hods of cleaning and disinfecting the monitor 19 6 After Reprocessing After reprocessing the equipment cables cuffs sensors and other accessories should be checked to ensure there are no signs of agin...

Page 132: ...o the section Uploading Data to Network Server to load the data to HIS system 4 Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competen...

Page 133: ...ervice provider if your monitor needs a safety or performance test Clean and disinfect equipment to decontaminate it before testing or maintaining it Maintenance and Test Schedule Frequency Safety che...

Page 134: ...amage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materials compo...

Page 135: ...monitors by other manufacturers NOTE Transducers and sensors have a limited shelf life Refer to the package labeling The following cables may not all be available in all countries Please check availab...

Page 136: ...57 040438 Nellcor multisite sensor 1 kg hand D YS 01 57 040440 Nellcor sticking sensor Adult 30 kg hand MAX A MAX AL 01 57 040441 Nellcor sticking sensor Neonatal Adult 3kg or 40 kg foot MAX N 01 57...

Page 137: ...disposable 01 57 471159 NIBP Cuff neonatal 3 6 cm 11 cm disposable 01 57 471160 NIBP Cuff neonatal 4 7 cm 13 cm disposable 01 57 471161 NIBP Cuff neonatal 5 8 cm 15 cm disposable 01 57 471494 APC Cuff...

Page 138: ...3000 Oral Probe 9ft 01 22 066159 Filac 3000 Oral Isolation Chamber 01 57 471314 Filac 3000 Rectal Probe 4ft 01 57 471315 Filac 3000 Rectal Probe 9ft 01 22 066160 Filac 3000 Rectal Isolation Chamber 0...

Page 139: ...can standard medical grade 01 13 036638 Power cable length 1 8 m VDE 01 13 114214 Ground Cable 01 17 052452 SD Memory Card 8GB Class4 01 13 036099 Power cable Australia 01 13 036389 Power cable Englis...

Page 140: ...peration equipment Compliant with Standards IEC 60601 1 2005 A1 2012 IEC 60601 1 2 2014 EN 60601 1 2006 A1 2013 EN 60601 1 2 2015 IEC 60601 2 49 2011 A 2 Physical Specifications A 2 1 Size and Weight...

Page 141: ...y Messages Display screen 8 inch color TFT supporting touch screen Resolution 800 600 One power on off LED green One battery charge LED yellow green One AC power LED green One alarm LED red yellow blu...

Page 142: ...rd paper Width 49 mm 50 mm Paper Speed 12 5 mm s 25 mm s 50 mm s Trace 1 Recording types Continual real time recording 8 seconds real time recording Recording manually Physiological Alarm recording Tr...

Page 143: ...ts for a single patient Custom parameters The custom parameters data Up to 20 sets for a single patient Each 1 GB space for data storage 100 thousand sets of Ward round records Up to 800 thousand sets...

Page 144: ...g to 300 mmHg Pressure Resolution 1 mmHg Maximum Mean Error 5 mmHg Maximum Standard Deviation 8 mmHg Maximum Measuring Period Adult Pediatric 120 s Neonate 90 s Typical Measuring Period 20 s to 35 s d...

Page 145: ...eter SYS DIA MAP PR Measuring Range Adult Mode SYS 40 mmHg 260 mmHg DIA 20 mmHg 200 mmHg MAP 26 mmHg 220 mmHg Pediatric Mode SYS 40 mmHg 230 mmHg DIA 20 mmHg 160 mmHg MAP 26 mmHg 183 mmHg Neonatal Mod...

Page 146: ...mmHg 80 mmHg 90 mmHg 100 mmHg 120 mmHg 140 mmHg Default 90 mmHg A 4 SpO2 Complies with ISO 80601 2 61 2017 EDAN Module Measuring Range 0 to 100 Resolution 1 Data Update Period 1 s Accuracy Adult Pedi...

Page 147: ...he accuracy will be larger than adult by 1 SpO2 Storage Interval In Ward round or spot checking mode 30 S default 1 min 2 mins 5 mins Sensor Wave length approximately 660 nm and 900 nm Emitted light e...

Page 148: ...nitor mode 0 1 C 25 C 45 C Response time 60 s Update time 1 s 2 s Warm up time 10 s Time for predicting 30 s Calibration Self test interval 5 min Measuring Mode Direct Mode Adjusted Mode Transient Res...

Page 149: ...l Adjustable range of alarm limits 35 5 C 42 C Resolution 0 1 C Accuracy Monitoring Mode and Preditive Mode 0 1 C Quick Predictive Mode 0 3 C Typical measurement time after insertion into measurement...

Page 150: ...High Limit Low Limit ADU SYS DIA MAP 270 215 235 40 10 20 PED SYS DIA MAP 230 180 195 40 10 20 NEO SYS DIA MAP 135 100 110 40 10 20 SunTech NIBP Patient Type High Limit Low Limit ADU SYS DIA MAP 260...

Page 151: ...K 17 dBm for 802 11g OFDM 16 dBm for 802 11n OFDM 5 GHz not available in USA and in Canada 10 dBm for 802 11a OFDM 9 dBm for 802 11n OFDM I U Ratio co channel 20 dB I U Ratio adjacent channel 1 dB Thr...

Page 152: ...0 3 OTG Interfaces A 10 4 Wired Network Interface Specification 100 Base TX IEEE802 3 Interface Type Standard RJ 45 network interface Number of USB Interfaces Standard 1 Drive Mode HOST interface USB1...

Page 153: ...y connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC EN 61000 3 2 Class A Voltage fluctuations flicker emissions IEC EN...

Page 154: ...requency 50 60Hz magnetic field IEC EN 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment...

Page 155: ...0 MHz to 2 7 GHz Comply with table 1 Portable and mobile RF communications equipment should be used no closer to any part of iM3 including cables than the recommended separation distance calculated fr...

Page 156: ...iM3 is used exceeds the applicable RF compliance level above iM3 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorien...

Page 157: ...o 1 m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an...

Page 158: ...a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum out...

Page 159: ...sted here C 1 Patient Information Default Settings Patient Information Settings Patient Type Adult C 2 Alarm Default Settings Alarm Settings Pause Time 120 s Alarm Latch Off C 3 SpO2 Default Settings...

Page 160: ...5 NIBP Default Settings NIBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit SYS 160 120 90 Alarm Low Limit SYS 90 70 40 Alarm High Limit MAP 110 90 70 Alarm...

Page 161: ...Limit MAP 60 50 30 Alert High Limit DIA 90 70 60 Alert Low Limit DIA 50 40 20 C 6 TEMP Default Settings TEMP Settings ADU PED Alarm Switch On Alarm Record Off Alarm Level Medium Measurement Mode Pred...

Page 162: ...current Dia Diastolic EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnetic interference ESU Electrosurgical unit FCC Federal Communication Commission FDA Food and Dru...

Page 163: ...ethysmogram PR Pulse rate PVC Premature ventricular complex R Right RA Right arm RAP Right atrial pressure RHb Reduced hemoglobin RL Right leg RR Respiration Rate Sev Sevoflurane SYS Systolic pressure...

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