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Patient Monitor User Manual Intended Use and Safety Guidance

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Operating instructions

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Summary of Contents for iM50

Page 1: ......

Page 2: ...cted 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 infor...

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: ...View 16 3 1 2 Rear View 19 3 1 3 Side View 23 3 2 Operating and Navigating 25 3 2 1 Using Keys 26 3 3 Operating Mode 28 3 3 1 Demo Mode 28 3 3 2 Standby Mode 28 3 3 3 Night Mode 29 3 3 4 Privacy Mode...

Page 5: ...Latching Alarms 45 5 6 Disabling Sensor Off Alarms 46 5 7 Testing Alarms 46 Chapter 6 Alarm Information 47 6 1 Physiological Alarm Information 47 6 2 Technical Alarm Information 54 6 3 Prompts 70 6 4...

Page 6: ...talling Electrodes 93 9 6 ECG Menu Setup 97 9 6 1 Setting Alarm Source 97 9 6 2 Setting Beat Source 98 9 6 3 Smart Lead Off 98 9 6 4 ECG Screen Layout 98 9 6 5 Setting Pace Status 99 9 6 6 ECG Calibra...

Page 7: ...11 3 Measuring SpO2 119 11 4 Measurement Limitations 121 11 5 Assessing the Validity of a SpO2 Reading 122 11 6 SpO2 Alarm Delay 123 11 7 Perfusion Index PI 123 11 8 Measuring SpO2 and NIBP Simultane...

Page 8: ...easurements for Rectal Temperatures 139 15 3 3 Measurements for Axillary Temperatures 139 15 4 Changing Temp Unit 140 Chapter 16 Monitoring IBP 141 16 1 Overview 141 16 2 IBP Safety Information 141 16...

Page 9: ...ring Steps for Masimo ISA Module 175 19 3 3 Monitoring Steps for Dr ger Minimodule 178 19 3 4 Monitoring Steps for Masimo IRMA Module 179 19 4 Setting Apnea Alarm Time 182 19 5 O2 Compensations 182 19...

Page 10: ...Recorder Operations and Status Messages 203 24 3 1 Record Paper Requirement 203 24 3 2 Proper Operation 204 24 3 3 Paper Out 204 24 3 4 Replacing Paper 204 24 3 5 Removing Paper Jam 204 Chapter 25 Pri...

Page 11: ...1 29 2 Maintenance Task and Test Schedule 221 Chapter 30 Warranty and Service 223 30 1 Warranty 223 30 2 Contact Information 223 Chapter 31 Accessories 224 31 1 ECG Accessories 224 31 2 SpO2 Accessori...

Page 12: ...Information 286 B 1 Electromagnetic Emissions 286 B 2 Electromagnetic Immunity 286 B 3 Electromagnetic Immunity 288 B 4 Recommended Separation Distances 291 C Default Settings 292 C 1 Patient Informat...

Page 13: ...as ECG 3 lead 5 lead 12 lead selectable Respiration RESP Functional arterial oxygen saturation SpO2 Invasive or noninvasive blood pressure dual IBP NIBP Cardiac Output C O Temperature dual TEMP Expire...

Page 14: ...acemaker and other patient connected equipment may cause safety hazard 8 Magnetic and electrical fields are capable of interfering with the proper performance of the device For this reason make sure t...

Page 15: ...and other accessories supplied by EDAN can be used The performance and electric shock protection cannot be guaranteed and the patient may be injured otherwise Prior to use check if the casing of a di...

Page 16: ...n easily access the disconnection device 29 Assembly of the monitor and modifications during actual service life shall be evaluated based on the requirements of IEC60601 1 30 The monitors are MR Unsaf...

Page 17: ...pment is intended to be supplied by a multiple portable socket outlet with an isolation transformer 43 Operation of the equipment exceeding specified physiological signal or the operational specificat...

Page 18: ...ives 6 Disposable devices are intended for single use only They should not be reused as performance could degrade or contamination could occur 7 Remove a battery whose life cycle has expired from the...

Page 19: ...ets damp or liquid pours on the monitor please contact the service personnel of EDAN 4 This monitor is not a device for treatment purposes 5 The pictures and interfaces in this manual are for referenc...

Page 20: ...Number 9 Network port 10 USB Universal Serial Bus Connection 11 Bell cancel 12 NIBP measurement 13 Trend 14 Screen or video image freeze 15 Graphical recorder 16 Menu 17 Video output 18 RS 232 port 19...

Page 21: ...Date of manufacture 26 Manufacturer 27 Part Number 28 General symbol for recovery recyclable 29 Disposal method 30 Operating instructions 31 Refer to instruction manual booklet Background Blue Symbol...

Page 22: ...1 Contains FCC ID Federal Communications Commission Contains FCC ID SMQV1102EDAN 42 DO NOT RE USE 43 Catalog number model number for Masimo module 44 Lot code for Masimo module 45 Not made with natura...

Page 23: ...lates 2 5 mm and against splashing water from all directions for Masimo CO2 sidestream module 58 IP classification indicating degree of protection against ingress of solid foreign objects and water fo...

Page 24: ...Patient Monitor User Manual Intended Use and Safety Guidance 12 65 Stacking limit by number 66 Handle with care 67 Do not step on 68 Use by date NOTE The user manual is printed in black and white...

Page 25: ...install the wall mount for the monitor please refer to the Wall Mounting Bracket Assembly Instruction WARNING The wall mounting bracket can be fixed only on a concrete wall 2 3 Connecting the Power Ca...

Page 26: ...Setup 2 Adjust the Date Format and Clock Format based on the user s habit 3 Set the correct time of year month day hour min and sec NOTE 1 If the system is not used for a longer period of time its sys...

Page 27: ...ures 1 Reorient or relocate the receiving antenna 2 Increase the separation between the equipment and receiver 3 Connect the equipment into an outlet on a circuit different from that to which the rece...

Page 28: ...our monitor is highly configurable What you see on the screen how the menus appear and so forth depend on the way it has been tailored for your hospital and may not be exactly as shown here You may fr...

Page 29: ...Patient Monitor User Manual Basic Operation 17 iM60 iM70 1 2 3 4 5 6 7 8 9 10 11 1 2 3 11 4 5 6 7 8 9 10...

Page 30: ...y indicator refer to Section Battery Power Indicator for details 5 Mute Press it to suspend the output of all audible alarm signals Upon the configuration pressing this button to pause or turn off the...

Page 31: ...ton to highlight and press it to select the item 3 1 2 Rear View iM50 M50 1 Handle for lifting or moving the monitor which is convenient comfortable and fast 2 Speaker 3 Label 4 Equipotential groundin...

Page 32: ...nects the monitor to the hospital s nurse call system Alarms indications are alerted through the nurse call system if configured to do so Analog output the monitor outputs the waveform through the por...

Page 33: ...k interface It connects the monitor to MFM CMS CMS LITE or gateway via standard network cable which enables MFM CMS or gateway to achieve bidirectional communication with the monitor 7 Anti theft lock...

Page 34: ...ndications are alerted through the nurse call system if configured to do so Analog output the monitor outputs the waveform through the port Defibrillator synchronization the monitor outputs the defibr...

Page 35: ...the monitor or other processing unit are used in internal examinations on the heart ensure that the room incorporates an equipotential grounding system to which the monitor and other processing unit...

Page 36: ...n 24 iM60 iM70 1 Sensor interface enables the parameter measurement 2 CO2 module holder for holding the CO2 module 3 Recorder refer to Section Recording for details 4 Battery door for fixing and repla...

Page 37: ...affected after cleaning contact the service personnel of EDAN 3 2 Operating and Navigating Everything you need to operate the monitor is contained on its screen Almost every element on the screen is i...

Page 38: ...or gives a normal key sound when the operation is valid 3 2 1 1 Permanent Keys A permanent key is a graphical key that remains on the screen all the time to give you fast access to functions To displa...

Page 39: ...w the trend graph Adjust the screen brightness Review the trend table Zero the IBP sensor Review the alarm event Alarm setup Access the NIBP review Change the beat volume Access the ARR review Enter s...

Page 40: ...In Demo Mode all stored trend information is deleted from the monitor s memory 3 3 2 Standby Mode To enter into standby mode select Menu Common Function Standby or press the shortcut key on the scree...

Page 41: ...up Privacy Mode it is defaulted to be off Press the shortcut key on the screen the monitor enters into privacy mode after user s confirmation In privacy mode 1 The screen displays message Privacy mode...

Page 42: ...itoring data alarm information stored data and monitor status are transmitted to MFM CMS NOTE NFC mode and standby mode can t coexist When the monitor enters the standby mode the NFC mode will automat...

Page 43: ...nts the minimum volume 3 5 3 Adjusting Beat Volume Beat volume is from HR or PR depending on your setting of the beat source To change the beat volume 1 Select the shortcut key on the screen directly...

Page 44: ...interface 2 In the screen calibration interface the screen turns gray and no measurement data can be displayed 3 10 Disabling the Touch Screen The user can disable touch screen operation by selecting...

Page 45: ...le an IBP channel channel A has already been loaded and the label Art is used for channel A Then another IBP channel channel B is loaded and the label Art is also used for channel B In this case a lab...

Page 46: ...health information the user should implement security practices or measures that include 1 Physical safeguards physical safety measures to ensure that unauthorized personnel do not have access to the...

Page 47: ...list to access the wireless network 2 It is suggested to build a VLAN assign the LAN ports where the approved switch port monitor and MFM CMS are into the same VLAN and isolate it from other VLANs 11...

Page 48: ...et HL7 to On Off The monitor supports HL7 protocol to upload data To avoid hacker attacking setting HL7 to Off is normally recommended User can also set HL7 IP address of client side in User Maintain...

Page 49: ...orically connected networks After choosing certain network the user can select Forget This Network or Join This Network If the encryption information of the currently connected network is modified the...

Page 50: ...directory of USB flash drive certs wlan WARNING 1 Before monitoring patient Network Type Wired or Wi Fi should be selected and is not allowed to switch during monitoring Otherwise Wi Fi may be unavai...

Page 51: ...t or your local distributor for more information 4 When deploying the network of the monitor and MFM CMS it is recommended to isolate the network and the Intranet system of the hospital by using VLAN...

Page 52: ...Set HL7 Encryption method to Off or TLS default To set HL7 IP address of the client side select User Maintain Network Maintain Click Import Certificate to install upgrade the Certificate via USB flash...

Page 53: ...rm And this type of alarm is called technical alarms Technical alarms can t be disabled About the detailed alarm information please refer to Section Technical Alarm Information 5 1 3 Prompts The monit...

Page 54: ...d once every 10 seconds The alarm indicator flashes in red with frequency of 1 4 Hz 2 8 Hz The alarm message flashes with red background and the symbol is displayed at the alarm area Medium Mode is DO...

Page 55: ...r medium or low level alarm and for high level alarm WARNING 1 Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level or off during patien...

Page 56: ...sing the hardkey on the front panel or pressing shortcut key on the screen You can set the alarm pause time as desired The default alarm pause time is 120 s 1 Select Menu Maintenance User Maintain and...

Page 57: ...lashes in yellow Remind signal Audio alarm off symbol and Audio Alarm off on a red colored background are displayed with an interval of 2 s during the audio alarm off status Pressing the hardkey or sh...

Page 58: ...arm signal however the visual alarm indications are still displayed If it is set to Off and a sensor off alarm occurs after pressing the hardkey or permanent key sensor off status will be announced wi...

Page 59: ...V5 or V6 User selectable QTc High QTc measuring value is above upper alarm limit User selectable QTc High QTc measuring value is above upper alarm limit User selectable Advanced ARR Asystole No QRS i...

Page 60: ...cted within 3 s or longer Advanced If HR 120 bpm no beats are detected for 1 75 times average RR interval or if HR 120 bpm no beats are detected for one second User selectable Irr Rhythm Consistently...

Page 61: ...within the heartbeat pause threshold value that has been set User selectable Pauses min High The measurement value of Pause min is greater than high alarm limit that has been set User selectable PVCs...

Page 62: ...User selectable TRIGEMINY A dominant rhythm of N N V N N V User selectable R ON T A type of single PVC under the condition that HR 100 R R interval is less than 1 3 the average interval followed by a...

Page 63: ...er alarm limit User selectable SpO2 No Pulse The signal of the measurement site is too weak due to insufficient blood supply and environmental factors so the monitor can t detect the pulse signal High...

Page 64: ...PA SYS measuring value is below lower alarm limit User selectable PA DIA High PA DIA measuring value is above upper alarm limit User selectable PA DIA Low PA DIA measuring value is below lower alarm l...

Page 65: ...can be detected using CO2 module High AwRR High AwRR measuring value is above upper alarm limit User selectable AwRR Low AwRR measuring value is below lower alarm limit User selectable AG EtCO2 AG Hig...

Page 66: ...ower alarm limit User selectable EtSEV High EtSEV measuring value is above upper alarm limit User selectable EtSEV Low EtSEV measuring value is below lower alarm limit User selectable FiSEV High FiSEV...

Page 67: ...nitor Low ECG RL Lead Off When electrode type is AUTO ECG electrode RL falls off the skin or the ECG cable RL falls off the monitor 5 6 10 electrodes switches to 3 electrodes Low ECG V Lead Off ECG el...

Page 68: ...engineer or manufacturer s service staff ECG Noise ECG measuring signal is greatly interrupted Low Check lead connection and patient condition RESP RESP Comm Fail RESP module failure or communication...

Page 69: ...patient s life SpO2 SpO2 Sensor Off SpO2 sensor may be disconnected from the patient measuring site Low Make sure the sensor is well connected to the patient s finger or other parts Make sure the moni...

Page 70: ...t light electrical interference or else Low Check the condition of patient and avoid patient movement make sure the cable is well connected SpO2 Light Interference EDAN SpO2 module Ambient light aroun...

Page 71: ...service staff NIBP Time Out Measuring time has exceeded the specified time Low Measure again or use other measuring method NIBP Self Test Error Sensor or other hardware errors High Measure again if f...

Page 72: ...NIBP value is beyond the measurement range High NIBP Loose Cuff Cuff is not properly wrapped or no cuff is connected Low Properly wrap the cuff NIBP Interference Signal noise is too large or pulse rat...

Page 73: ...1 TEMP1 measuring value is beyond measuring range High Check sensor connection and patient condition Excessive T2 TEMP2 measuring value is beyond measuring range High Check sensor connection and patie...

Page 74: ...staff C O C O Comm Fail C O module failure or communication failure High Stop measuring of C O module or notify biomedical engineer or Manufacturer s service staff C O TI Sensor Off C O TI sensor not...

Page 75: ...t in the gas mixture and the concentration is high Medium Adjust the concentration of the anesthetic agents if necessary AG AA Id Unreliable Masimo AG module 1 Mainstream The airway adapter was replac...

Page 76: ...he adapter AG TEMP Out Of Range Masimo AG module The temperature of the AG module exceeds the specified working temperature range High Make sure the AG module is used within the specified temperature...

Page 77: ...ap will be full Dr ger AG module Watertrap will be full Medium Replace the watertrap AG Agent Mixture Dr ger AG module Mixture agents are detected but the monitor cannot calculate MAC because of low c...

Page 78: ...g measuring function of CO2 module notify biomedical engineer CO2 Out Of Range The CO2 concentration exceeds the accuracy range of CO2 module High Reduce CO2 concentration EtCO2 Overrange The EtCO2 co...

Page 79: ...ata of CO2 module is lost Medium CO2 Air Pressure Overrange The barometric pressure exceeds the specified working barometric pressure range High Make sure the CO2 module is used within the specified b...

Page 80: ...s higher than 40 C Low Put the sensor into the sensor bracket measure again after the ambient temperature reaches normal value Ambient temp too low The Sensor temperature is lower than 10 C Low Probe...

Page 81: ...r Recorder Probe Overheated The probe of recorder is overheated Low Stop recording and retry after the probe cools Printer Unavailable The selected printer is not available Low Check whether the netwo...

Page 82: ...y manufacturer to check the network problem 6 3 Prompts Message Cause ECG ARR Learning The QRS template building required for Arr Analysis is in process Unable to analyze ST The ST algorithm cannot pr...

Page 83: ...matic measuring mode Sequence Measuring In sequence measuring mode Measurem Canceled Press the Start stop NIBP measurement button or shortcut key to stop the measurement Calibrating During calibrating...

Page 84: ...e CO2 Zero Start CO2 module starts zero calibration CO2 Zero OK CO2 module completes zero calibration Please Press Zero Enter the IBP zeroing menu and zeroing is not performed yet Zero OK IBP complete...

Page 85: ...ibration of AG module is in progress MultiGas Zero in Progress The zeroing of AG module is in progress AG Is Starting Dr ger AG module AG module is starting AG Standby Dr ger AG module User sets Work...

Page 86: ...job No Default Printer No default printer has been set Incomplete parameter input unable to score In Warning Score System interface parameters are not completely input No WIFI module detected No Wi Fi...

Page 87: ...ange QTc 200 800 QTc 30 200 RESP alarm limits are listed as follows unit rpm Patient Type Adjustable Range RESP ADU 6 120 PED NEO 6 150 SpO2 alarm limits are listed as follows unit Adjustable Range Sp...

Page 88: ...D SYS DIA MAP 25 240 10 200 15 215 60 250 40 200 45 235 40 230 20 160 26 183 NEO SYS DIA MAP 25 140 10 115 15 125 40 120 20 90 30 100 40 130 20 100 26 110 TEMP alarm limits are listed as follows Adjus...

Page 89: ...42 C 107 6 F PED 35 5 C 95 9 F 42 C 107 6 F AG alarm limits are listed as follows EDAN Module Adjustable Range EtCO2 FiCO2 0 0 15 0 EtO2 EtN2O FiN2O 0 0 100 0 FiO2 18 0 100 0 EtHAL EtENF EtISO FiHAL...

Page 90: ...Manual Alarm Information 78 Dr ger Minimodule Adjustable Range FiCO2 EtCO2 0 13 6 FiO2 18 0 100 0 EtO2 FiN2O EtN2O 0 100 0 EtDes FiDes 0 20 0 EtIso FiIso EtHal FiHal 0 8 5 EtSev FiSev EtEnf FiEnf 0 10...

Page 91: ...tting determines the algorithm the monitor uses to process and calculate some measurements the safety limits that are applied for some measurements and the alarm limit ranges To admit a patient please...

Page 92: ...hythmia and NIBP alarm limits Always check alarm limits to make sure that they are appropriate for your patient 2 For paced patients you must set Pace to On If it is incorrectly set to Off the monitor...

Page 93: ...set before using scanner to update patient otherwise the barcode can t be recognized normally 3 Patient information obtained from network server cannot be edited 7 5 Managing Patient Information 7 5 1...

Page 94: ...Managing Patients 82 patient information NOTE The user can load patient information from the network server only when ADT Query is enabled Default setting is off Setting path Maintenance User Maintain...

Page 95: ...Module Switch 3 Select the required parameters from the popup interface 4 Exit the menu and the screen will adjust the parameters automatically 8 3 Changing Waveform Position The user can exchange the...

Page 96: ...se of adults OxyCRG is in the bottom half part of wave area it consists of HR trend SpO2 trend and RR trend or compressed respiration waveform Select OxyCRG waveform to open OxyCRG Setup menu you can...

Page 97: ...d with bed view function should share the same network segment The IP addresses of the monitors on the same LAN should be unique from each other you cannot use the bed view function in the monitors in...

Page 98: ...reset time period is expired To display the timer on the main interface 1 Select the shortcut key on the screen directly or select Menu System Setup Module Switch 2 Select Timer from the popup interfa...

Page 99: ...n be saved in the monitor User can select as desire To set default configuration select Menu Profile On the Profile menu users can choose a factory configuration adult pediatric or neonate based on th...

Page 100: ...e difference When applying the electrodes avoid bones close to skin obvious layers of fat and major muscles Muscle movement can result in electrical interference Applying electrodes on major muscles f...

Page 101: ...ser should check lead wires for damage and ensure good skin contact prior to and during use Always use fresh electrodes and follow proper skin preparation techniques 15 The monitor can only be used on...

Page 102: ...ve 9 3 1 Changing the Size of the ECG Wave If any of the displayed ECG waveform is too small or clipped you can change the size of it on the screen First select ECG Waveform Setup ECG Gain then select...

Page 103: ...equency If there is still obviously interference in the signals when select surgery filter mode it is recommended to choose the enhanced mode In this mode QRS wave rhythm information is emphasized its...

Page 104: ...re alcohol because this increases skin impedance Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease 9 5 2 Connecting ECG Cables 1 Attach clip or snap...

Page 105: ...lor Electrode Labels Color RA White R Red LA Black L Yellow LL Red F Green RL Green N Black V Brown C White V1 Brown Red C1 White Red V2 Brown Yellow C2 White Yellow V3 Brown Green C3 White Green V4 B...

Page 106: ...d to the patient For 5 electrodes attach the V electrode to one of the indicated positions as below V1 On the 4th intercostal space at the right sterna margin V2 On the 4th intercostal space at the le...

Page 107: ...st be set simultaneously in ECG Setup V1 On the 4th intercostal space at the right sterna margin V2 On the 4th intercostal space at the left sterna margin V3 Midway between V2 and V4 electrodes V4 On...

Page 108: ...and the elbow RL and LL Place leg electrodes inside of each calf between the knee and the ankle Chest electrodes V1 On the 4th intercostal space at the right sterna margin V2 On the 4th intercostal s...

Page 109: ...abdomen and the chest lead on the left side at mid chest Avoid placing the electrodes on the upper arms Otherwise the ECG waveform will be too small WARNING ECG cables can be damaged when connected to...

Page 110: ...lead becomes available again the monitor automatically uses HR as beat source and the monitor gives a Di tone with a blinking heart displaying in the HR parameter box when one heartbeat is detected W...

Page 111: ...can be selected for Screen Layout in the sub menu 2 In 10 Electrodes display interface the filter can only be set to Diagnosis 3 If 6 Electrodes is selected in the ECG Setup menu Va and Vb can be resp...

Page 112: ...ng electrodes on the patient the quality of arrhythmia is severely degraded due to the high energy level in the pacemaker pulse This can cause arrhythmia algorithms cannot detect the pacemaker without...

Page 113: ...nitoring fails to be activated users can reenter the password and try to activate this function again 9 7 2 Analysis Function If your monitor is configured with the 12 lead ECG monitoring function the...

Page 114: ...en NOTE 1 ST segment analysis is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients For this reason the recommended and default sett...

Page 115: ...itable for your patient 6 ST values may be affected by such factors as some drugs or metabolic and conduction disturbances 7 ST is calculated with a fixed delay from the R position Changes in heart ra...

Page 116: ...T Alarm Setup Select ECG Setup ST Analysis ST Alarm Setup to change the ST Alarm Mode Real Time The user can set the alarm switch alarm level alarm limit and alarm record separately for each ST or all...

Page 117: ...vertical axis shows the ST value And the bar graph is used to display the ST value result The ST histogram refreshes with ST View synchronously 9 9 Arrhythmia Monitoring 9 9 1 Arrhythmia Analysis The...

Page 118: ...of consecutive single PVC 4 within 30 s Tachy Adult RR interval for 5 consecutive QRS complex 0 5 s Pediatric neonatal RR interval for 5 consecutive QRS complex 0 375 s Brady Adult RR interval for 5 c...

Page 119: ...t the obvious f or P waves do not exist Acc Vent Rhythm 5 consecutive ventricular beats and 40 bpm ventricular HR 100 bpm Pause No QRS is detected within the heartbeat pause threshold value that has b...

Page 120: ...75 s BRADY Adult RR interval for 5 consecutive QRS complex 1 5 s Pediatric neonatal RR interval for 5 consecutive QRS complex 1 s MISSED BEATS If HR 120 bpm no beats are detected for 1 75 times averag...

Page 121: ...ls The ventricular should have a different appearance from normal heartbeat Physicians should be more alert to these patients Intermittent bundle branch block bundle branch block or other bundle obstr...

Page 122: ...should not be performed for PVC or pacing fluctuations 7 Atrial flutter cannot be detected by the atrial fibrillation algorithm because most of their RR intervals are regular 8 In following situation...

Page 123: ...o Off the monitor won t give an alarm prompt even if an alarm occurs In order to avoid endangering the patient s life the user should use this function cautiously NOTE Pacer not Capture PNC and Pacer...

Page 124: ...t events of arrhythmia 3 If ARR selflearning is performed during ventricular rhythm ventricular heartbeats may be erroneously identified as normal QRS complexes This may lead to missed ventricular tac...

Page 125: ...should always be validated by a qualified clinician 9 10 2 Switching QT Analysis On and Off To switch QT Analysis on or off in the ECG Setup menu select QT Analysis to toggle between On and Off from...

Page 126: ...2 Changing the electrode type 3 Changing the calculation lead in 3 electrodes 4 Changing the patient type 5 Admitting new patients 6 Enters or exits Demo mode If QT analysis is needed please reset the...

Page 127: ...mmended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit 4 Cardiogenic artifact in impedance respiration monitoring may make it difficult to...

Page 128: ...are important for RESP measurement you will find this information in the chapter on ECG The RESP signal is always measured between two of the ECG electrodes There are two standard ECG leads for select...

Page 129: ...e lead from the pop up list 10 8 Changing Hold Type To change the calculation mode in the RESP Setup menu set Hold Type to Manual or AUTO When it is set to the AUTO mode Hold High and Hold Low are una...

Page 130: ...surrounding skin of application 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 appl...

Page 131: ...O2 sensor in a single patient should be less than 30 days 11 3 Measuring SpO2 1 Select the correct patient category setting adult pediatric and neonatal as this is used to optimize the calculation of...

Page 132: ...al Finger or Toe Wrap Sensors When you perform the measurement position the sensor over the hand or foot with optical components opposite each other Hold the sensor and insert stretched strap into slo...

Page 133: ...ite Periodically check to ensure that the sensor remains properly positioned on the patient 11 4 Measurement Limitations Certain patient conditions can affect the measurements or cause the loss of the...

Page 134: ...increase If the dynamic averaging time reaches 40 seconds the screen will display high level alarm message SpO2 No Pulse indicating a loss of pulse condition 11 5 Assessing the Validity of a SpO2 Rea...

Page 135: ...tivity setting The lower the sensitivity configured the longer the time needed until the numerical values reflect the physiological event 2 The time between the displayed numerical values exceeding an...

Page 136: ...2 level fluctuates near an alarm limit the alarm is triggered each time the limit is violated Such frequent alarms can be distracting With the SatSeconds technique upper and lower SpO2 alarm limits ar...

Page 137: ...O2 points both positive and negative until either the SatSeconds limit is reached or the patient SpO2 returns within a normal range and remains there 11 11 2 SatSeconds Safety Net The SatSeconds Safet...

Page 138: ...n order to avoid simultaneous alarms on HR and PR the monitor uses either HR or PR as its active alarm source To change the alarm source select either ECG Setup Alarm Source or PR Setup Alarm Source t...

Page 139: ...alis pedis and radial artery 13 2 NIBP Safety Information WARNING 1 Do not measure NIBP on patients with sickle cell disease or any condition where skin damage has occurred or is expected 2 Do not mea...

Page 140: ...P measurement can be affected by extremes of temperature humidity and altitude 5 NIBP measurement value should be explained by qualified professionals 6 The pulse rate based on the NIBP measurement ma...

Page 141: ...0 15 00 16 00 and so forth 90 min 12 02 13 00 14 30 16 00 17 30 and so forth 120 min 12 02 13 00 15 00 17 00 19 00 and so forth 180 min 12 02 13 00 16 00 19 00 22 00 and so forth 240 min 12 02 13 00 1...

Page 142: ...he air hose and switch on the monitor Apply the blood pressure cuff to the patient s arm or leg and follow the instructions below Ensure that the cuff is completely deflated Apply the appropriate size...

Page 143: ...s 1 Manual Measuring Access the NIBP Setup menu and set the Measure Mode item to Manual Then press the button on the front panel or shortcut key on the main screen to start a manual measurement 2 Auto...

Page 144: ...Calibrating NIBP NIBP is not user calibrated Cuff pressure transducers must be verified and calibrated if necessary at least once every two years by a qualified service professional See the Service Ma...

Page 145: ...result For iM60 iM70 iM80 M80 with the SunTech module NOTE When applying high pressures take special care to increase the pressure at a rate that will not cause unwanted overpressure errors 300mmHg M...

Page 146: ...13 12 Assisting Venipuncture The user can use the NIBP cuff to cause a pressure close to diastolic pressure so as to block the venous blood vessel and therefore help venipuncture To assist venipunctur...

Page 147: ...cable into a loose circle If the wire inside the cable is tensely pulled it may cause mechanical damage to the probe and the cable 3 Temperature probes do not need any probe covers Please remember to...

Page 148: ...e To select the label 1 Click the TEMP parameter area to enter TEMP Setup menu 2 Select the appropriate label from the list for T1 and T2 Label Description Tskin Skin temperature Trect Rectal temperat...

Page 149: ...correct mode and alarm limit are selected Changing the measure position may lead to the change of alarm limit 2 Verify probe cables fault detection before the beginning of monitoring phase Unplug the...

Page 150: ...optimal accuracy always confirm that the correct measurement position is selected 3 The reference body site temperature is the same as the temperature of the measuring site 15 3 Measuring Procedure 15...

Page 151: ...ode 15 3 2 Measurements for Rectal Temperatures 1 Ensure that the rectal probe red probe and probe well are installed 2 Remove the red probe from the probe well 3 Observe the Rectal Mode indicator on...

Page 152: ...rature through the patient s clothing Direct contact between the patient s skin and the probe is required To obtain accurate rectal temperature use the white temperature probe 15 4 Changing Temp Unit...

Page 153: ...sable IBP transducer or domes should not be reused 4 If any kind of liquid other than solution to be infused in pressure line or transducer is splashed on the equipment or its accessories or enters th...

Page 154: ...ing a Pressure for Monitoring 7 To zero the transducer please refer to Zeroing the Pressure Transducer WARNING If there are air bubbles in the tube system you should flush the system with the solution...

Page 155: ...BP label name After confirmation the user can zero the pressure of certain channel or pressure of all channels After zeroing the interface displays the result and last calibration time 4 When you see...

Page 156: ...eforms from the options TopRuler and BotRuler 16 6 Measuring PAWP PAWP Pulmonary Artery Wedge Pressure used to assess the cardiac function is obtained by introducing a balloon tipped pulmonary artery...

Page 157: ...the patient s hemodynamic state but will merely reflect the pressure in the catheter or balloon 3 The pressure receiver in the catheter records the pressure change that occurs only at the front of the...

Page 158: ...uations are clinically significant applicable and reliable must be determined by a physician 2 In below situations the calculated PPV value may be inaccurate the respiration rate is lower than 8 rpm t...

Page 159: ...ation rate is calculated by measuring the time interval between detected breaths Mainstream measurement uses a CO2 sensor attached to an airway adapter directly inserted into the patient s breathing s...

Page 160: ...se the EtCO2 monitor for diagnostic purpose 15 CO2 APNEA alarm is based on prolonged over the threshold EtCO2 concentration 16 CO2 APNEA alarm should not be used or relied upon while the patient is un...

Page 161: ...ments are stable This zeroing procedure is indicated by the blinking green For the Respironics Mainstream CO2 Module 1 Wait until the monitor s warm up message disappears correctly install the mainstr...

Page 162: ...measurement value please check if the O rings of the water trap holder are normal and well installed If the O rings get damaged or loose contact EDAN s service staff 4 To prevent the module from abnor...

Page 163: ...always remove the airway adapter from the breathing circuit before removing the sensor 3 Always disconnect the cannula airway adapter or sample line from the sensor when the sensor is not in use 4 To...

Page 164: ...gnetic environment specified in this manual 9 Portable and mobile RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12...

Page 165: ...dead space 23 Do not use the NomoLine Adult Pediatric Airway Adapter Sets for infants neonates as the airway adapter adds 6 ml dead space 24 Do not apply negative pressure to remove condensed water fr...

Page 166: ...use existing mounting holes Drilling additional holes will void the warranty 4 Do not operate the module outside of the specific operating environment 5 The module should be mounted securely to avoid...

Page 167: ...nt the Masimo sidestream CO2 module Note A bracket designed to mount the module is available visit www masimo com 3 Connect the gas sample exhaust port on the rear of the module to a scavenging system...

Page 168: ...es to measuring mode and starts delivering gas data Capnography Display Parameters and measurements display on the screen of the monitor that the Masimo Sidetream CO2 module is connected to Cleaning C...

Page 169: ...the breathing system When using the sidestream CO2 measurement on patients who are receiving or have recently received anesthetics please avoid exposing medical staff to anesthetics Use an exhaust tu...

Page 170: ...emperature and barometric pressure NOTE 1 If the catheter falls off during the measurement it is necessary to re zero after the catheter is well connected and then measurement can be performed 2 Repla...

Page 171: ...surements can be affected by mobile and portable RF communications equipment It should be assured that the probe is used in the electromagnetic environment specified in this manual For the monitoring...

Page 172: ...ay be affected 17 5 Setting Apnea Alarm Time This determines the time limit after which the monitor gives an alarm if the patient stops breathing 1 Select CO2 Setup Apnea Alm 2 Choose the apnea alarm...

Page 173: ...bation mode During the intubation mode the monitor will display the intubation mode and remaining time in the form of text When countdown finishes or clicking End in Intubation Mode menu the monitor w...

Page 174: ...nformity with relevant Medical Device Safety Requirements 2 Appurtenance should be avoided from contact with conductive metal body when being connected or applied 3 All invasive procedures involve ris...

Page 175: ...patients height and weight 4 In C O Setup menu set C O Constant The computation constant is associated with catheter and injectate volume When the catheter is changed please adjust Constant in the C...

Page 176: ...urface Area 6 Blood Temperature 11 Y axis Change the scale Y temperature value Three modes are available 0 C to 0 5 C 0 C to 1 C 0 C to 2 0 C Adjust the scale by the temperature differences A smaller...

Page 177: ...nsecutive measurements The length of the interval can be set in the C O Setup menu Time unit second The interval time counter is displayed on the screen The next measurement cannot be performed until...

Page 178: ...mmended that the user must push the injector within four seconds after pressing the Start button 3 It is strongly recommended that you wait at least 1 minute or longer depending on the patient s clini...

Page 179: ...ons and barometric pressure can influence the AG measurement 5 The monitor will be damaged if any pipeline from the AG module s air tube the air inlet the air outlet is plugged by water or other mater...

Page 180: ...te the sampling line to reduce the risk of patient entanglement or strangulation 3 Do not lift the ISA sidestream gas analyzer by the sampling line as it could disconnect from the ISA causing the ISA...

Page 181: ...negative pressure to remove condensed water from the Nomoline Family sampling line 19 Too strong positive or negative pressure in the patient circuit might affect the sample flow 20 Strong scavenging...

Page 182: ...a risk of patient injury due to module failure 5 Do not use the module near magnetic resonance imagers MRI NMR NMI 6 During warm up reported values may not be accurate 7 If the gas sensors are not re...

Page 183: ...not reusable and must be replaced after each patient unless a bacterial filter is in place between sample line and patient 18 Always connect the gas exhaust of the medical device and anesthesia machin...

Page 184: ...e IRMA Adult Pediatric adapter with infants as the adapter adds 6 ml dead space to the patient circuit 6 Do not use the IRMA Infant airway adapter with adults pediatrics as this may cause excessive fl...

Page 185: ...on to the probe cable 4 Do not operate the IRMA probe outside the specified operating temperature environment 5 US Only Caution Federal law restricts this device to sale by or on the order of a physic...

Page 186: ...mistakenly touched 4 Based on a sample gas temperature of 37 C a room temperature of 23 C and sample relative humidity of 100 the water trap will be filled after approximately 60 hours with the flowra...

Page 187: ...t fidelity when used with the Masimo Sidestream CO2 module NomoLine sampling lines include nasal and nasal oral cannulas for non intubated patients with and without supplementary oxygen delivery and a...

Page 188: ...it with the sampling line attached 19 3 2 2 Leakage Check 1 Connect a new Nomoline sampling line with male luer lock to the ISA LEGI and check that the LEGI shows a steady green light 2 Connect a shor...

Page 189: ...nce a successful zeroing requires the presence of ambient air 21 O2 and 0 CO2 ensure that the ISA analyzer is placed in a well ventilated place Avoid breathing near the ISA analyzer before or during t...

Page 190: ...ISO 1 15 SEV 2 05 DES 6 0 NOTE Altitude patient age and other individual factors are not considered in the formula above 19 3 3 Monitoring Steps for Dr ger Minimodule 1 Fix the water trap to the water...

Page 191: ...0 For gas mixtures the respective multiples for N2O and anesthetic agents are added according to the following equation O N MAC O N conc exp Anesth MAC Anesth conc exp Anesth MAC Anesth conc exp MAC 2...

Page 192: ...atient s endotracheal tube and the IRMA probe Placing an HME in front of the IRMA probe protects the airway adapter from secretions and effects of water vapor and eliminates the need of changing the a...

Page 193: ...gas readings and waveforms on the monitor before connecting the airway adapter to the patient circuit Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA airway...

Page 194: ...irway adapters are non sterile devices Do not autoclave the devices as this will damage them 2 Never immerse the IRMA probe in liquid 19 3 4 5 Maintenance Gas readings should be verified at regular in...

Page 195: ...depend on the amount of water vapor in the measured gas The O2 measurement will be calibrated to show 20 8 vol at actual ambient temperature and humidity level instead of showing actual partial pressu...

Page 196: ...current menu Press the button or select the shortcut key again freeze status is entered and the popup Freeze menu is displayed In Freeze status all waveforms are frozen and will no longer be refreshe...

Page 197: ...waveform of 120 seconds before it is frozen For a waveform of less than 120 seconds the remaining part is displayed as a straight line Select Time on the Freeze menu and use the up down arrow keys to...

Page 198: ...Review To review the trend graph please press the Trend Graph key on the screen or select Menu Review Trend Graph In the trend graph the y axis stands for the measurement value and x axis stands for...

Page 199: ...o print out the trend graph report by the printer 21 2 Trend Table Review To review the trend table please press the Trend Table key on the screen or select Menu Review Trend Table In the trend table...

Page 200: ...Index to set end time of alarm review Current Time the alarm events occurring before the current time are displayed on the alarm event review interface User Define the user can define the review time...

Page 201: ...12 lead analysis result please press the Analysis Review key on the screen or select Menu Review Analysis Review In the 12 lead analysis review window The user can switch between results and waveform...

Page 202: ...tient Information menu 2 The calculation results are for reference only and the calculation significance must be determined by the physician WARNING The correctness of the input parameters and the sui...

Page 203: ...it Each drug has the fixed unit or unit series to calculate Among the same unit series the unit binary varies with the entered parameter value The calculation units of the drugs are listed as follows...

Page 204: ...PA MAP CVP and PAWP if they are available from the monitor by selecting Get Info 3 Select Calculate to output parameter value 22 2 2 Input Parameters Items Unit English Full Name Description PAWP mmHg...

Page 205: ...PA MAP mmHg CVP mmHg C O L min RCWI kg m m2 Right cardiac work index RCWI kg m m2 RCW kg m BSA m2 LVSW g m Left ventricular stroke work LVSW g m 0 0136 AP MAP mmHg PAWP mmHg SV ml LVSWI g m m2 Left ve...

Page 206: ...ms Unit English Full Name Description Formula BSA m2 Body surface area BSA m2 Weight0 425 kg Height0 725 cm 0 007184 VO2 ml min Oxygen consumption VO2 ml min Ca vO2 ml L C O L min Ca vO2 ml L Arteriov...

Page 207: ...ly enter the values required on this interface You can also directly obtain the values of FiO2 RR PIP and PEEP if they are available from the monitor by selecting Get Info 3 Select Calculate to output...

Page 208: ...CO2 mmHg PaCO2 mmHg 100 VA L min Alveolar volume VA L min VT ml VD ml RR rpm 1000 22 5 Renal Function Calculation 22 5 1 Calculation Procedure 1 Select Menu Common Function Calculation Renal Function...

Page 209: ...mol L 24 60 CUUN ml min Urine urea nitrogen clearance rate CUUN ml min UUN mmol L Urine ml 24h BUN mmol L 24 60 FENa Fractional excretion of sodium FENa URNa mmol L SCr mol L Ucr mol L SerNa mmol L 1...

Page 210: ...xit not only this interface but also this function if selected Method is auto score the monitor can only exit this interface instead of this function The above rule is also applicable to the switchove...

Page 211: ...Yes No In MEWS interface select Criteria to check score criteria as following Value 3 2 1 0 1 2 3 HR bpm 40 41 50 51 100 101 110 111 129 130 SYS mmhg 70 71 80 81 100 101 199 200 RESP rpm 9 9 14 15 20...

Page 212: ...WS 3 Observing Yellow 4 MEWS 6 Warning Amber One single parameter s score value 3 points MEWS 7 Critical Red NOTE The score result can be displayed on the main screen through ticking the Display on Ma...

Page 213: ...rding paper is insufficient after recording is stopped the user can press the paper feeding key on the recorder to feed more paper 24 1 Performance of the Recorder Waveform record is printed at the ra...

Page 214: ...nds the monitor stops recording automatically The runtime for each wave is 8 seconds or 20 seconds The record Interval can be set as Off 10 min 20 min 30 min 40 min 50 min 1 h 2 h 3 h 4 h The default...

Page 215: ...d again in the related windows The recorder will stop recording in the following situations The recording task is finished No paper in the recorder Malfunction stops the recorder from running properly...

Page 216: ...2 Insert a new roll of paper into the paper cassette printing side facing upwards 3 Ensure proper position and tidy margin 4 Pull about 2 cm of the paper out and close the recorder casing NOTE Be car...

Page 217: ...Patient Monitor User Manual Recording 205 Setup Needed after the Record button is pressed 2 Do not touch the thermo sensitive print head when performing continuous recording...

Page 218: ...time you use a networked printer 2 Make sure the IP of the printer and the IP of the monitor share the same network segment 3 Do not click Search Printer during printing patient reports or the printe...

Page 219: ...rt In the Ventilation window click Print to start printing Renal function calculation report In the Renal Function window click Print to start printing C O measurement report In the C O Measure window...

Page 220: ...Stored in the Storage Device Refer to Section Data Management for more information about single patient data volume You can choose to Keep Storing or Stop Storing by selecting Menu Common Function Da...

Page 221: ...m events and so on are cleared either when the monitor is turned off or when the monitor is powered down in the process of monitoring 26 3 2 Activating Deactivating Data Storing To activate deactivate...

Page 222: ...Deleting Data Stored in the Storage Device To delete data of one patient choose the patient from the list after selecting Menu Review History Patient and then click Delete data on the Review menu Furt...

Page 223: ...t the monitor after formatting is successful The internal storage device can be identified and loaded automatically 3 If formatting is failed try again Restart the monitor and retry the formatting or...

Page 224: ...essary 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 whe...

Page 225: ...and illuminates in yellow when battery is being charged The indicator is not illuminated when the monitor is not powered or when AC power is applied 27 3 Battery Status on the Main Screen Battery stat...

Page 226: ...o indication on it to open it 2 Pull the plastic retainer until the battery can be removed 3 Insert the new battery into the battery compartment 4 Pull the metal retainer downward to fix the battery a...

Page 227: ...e And recharge the batteries to 40 60 at a minimum of every 3 6 months when they are stored Refer to the steps in section Checking Battery Performance If the running time meets the specification fully...

Page 228: ...Always dilute according to the manufacturer s instructions Unless otherwise specified do not immerse any part of the equipment or any accessories in liquid Do not pour liquid onto the system Do not al...

Page 229: ...h the cleaning solution until no visible contaminants remain 2 After cleaning wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains...

Page 230: ...oth or towel dampened with tap water until no visible cleaning agent remains 3 Wipe off residual moisture with a dry cloth 4 Leave the cables to air dry 28 2 2 5 Cleaning the TEMP Sensor Quick TEMP Pr...

Page 231: ...or is switched off and disconnected from the power line To disinfect the monitor follow these steps 1 Switch off the monitor and disconnect it from the power line 2 Wipe the display screen using a sof...

Page 232: ...nt solution with a dry cloth after disinfection 3 Leave the cables to air dry for at least 30 minutes 28 3 2 5 Disinfecting the TEMP Sensor The intracavitary TEMP sensors should be reprocessed by high...

Page 233: ...by qualified personnel every 24 months and each time after fix up The following items should be checked If the environment condition and power supply meet requirement If the power supply cord has dama...

Page 234: ...checks Selected tests on the basis of IEC60601 1 At least once every two years or as needed after any repairs where the power supply is removed or replaced or if the monitor has been dropped Check al...

Page 235: ...age 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 compone...

Page 236: ...IBP and C O sterilized accessories are already sterilized refer to the package labeling for detailed method Do not use a sterilized accessory if its packaging is damaged NOTE Transducers and sensors...

Page 237: ...1 57 471226 5 lead 12 pin ESU proof Adult pediatric 01 57 471227 ECG trunk cable 5 lead 12 pin ESU proof AHA IEC 5 0 m reusable 01 57 471228 5 lead 12 pin Defib proof Adult pediatric 01 57 471229 5 le...

Page 238: ...Snap AHA 3 4m Reusable 01 57 471469 5 Lead 6 pin Defib proof Clip IEC 3 4m Reusable 01 57 471470 5 lead 6 pin Defib proof Clip AHA 3 4m Reusable 01 57 471471 5 Lead 6 pin Defib proof Snap IEC 3 4m Reu...

Page 239: ...1 57 471197 3 lead Clip IEC Neonate 01 57 471193 3 lead 6 pin Defib proof Neonate 01 57 471194 3 lead 12 pin Defib proof Neonate 01 57 471979 6 lead 12 pin Defib proof Adult pediatric 01 57 471980 6 l...

Page 240: ...lt Pediatric 1m reusable 01 13 036336 SpO2 adapter cable standard Lemo to DB9 4 0m 01 57 471235 SHD A SpO2 Sensor adult disposable 01 57 471236 SHD P SpO2 Sensor pediatric disposable 01 57 471237 SHD...

Page 241: ...ff E7 Child 16 21 5cm reusable 01 57 471329 NIBP Cuff E8 Small adult 20 5 28cm reusable 01 57 471330 NIBP Cuff E9 Adult 27 35cm reusable 01 57 471331 NIBP Cuff E10 Large adult 34 43cm reusable 01 57 4...

Page 242: ...cm 13 cm width 5 cm 01 59 473003 OMRON NIBP Tube 3 5 m CUFF HOSE NO 3 length 3 5 m Only compatible with Neonatal Disposable and NIBP Tube For SunTech Module 01 57 471157 NIBP Cuff neonatal 1 3 cm 6 c...

Page 243: ...Oral Temperature Probe 10K 31 5 Quick Temp Accessories Part Number Accessories 02 01 110130 Temperature Probe Rectal FT20 02 01 110131 Temperature Probe Oral Axillary FT10 01 57 110159 Probe Covers O...

Page 244: ...71285 Duo Flow O2 CO2 Sampling Cannula Non Sterile Size Adult 01 57 471286 Duo Flow O2 CO2 Sampling Cannula Non Sterile Size Child 01 57 471287 Capnomask O2 CO2 Sampling Cannula Non Sterile Size Adult...

Page 245: ...ics 3468PED 00 01 57 078141 Disposable CO2 Nasal Cannula Infant Respironics 3468INF 00 01 57 078152 Pediatric Infant Airway adapter kit with dehumidification tubing Respironics 3473INF 00 01 57 078158...

Page 246: ...25 box 3821 2 m 01 57 472082 NomoLine LH Adult Nasal Oral CO2 Cannula with O2 25 box 3824 2 m 01 57 472083 NomoLine LH Pediatric Nasal Oral CO2 Cannula with O2 25 box 3825 2 m 01 57 472084 NomoLine H...

Page 247: ...hermodilution Catheter is required when measuring C O Swan Ganz catheter Type 131HF7 and 741HF7 manufactured by Edwards Lifesciences Corporation has been validated to be compatible with the monitor Re...

Page 248: ...ium Ion Battery TWSLB 003 14 8V 5000mAh 02 04 241047 EPRT 48mm recorder Serial parallel port 02 01 109592 Pole clamp 1 set package 02 01 109636 Pole clamp 4 sets package 01 57 78035 Recorder paper 01...

Page 249: ...1648 MT 206 S Trolley iM50 83 60 261720 MT 206 S Trolley iM60 iM70 01 13 037122 Power cable length 1 8 m American standard medical grade 01 13 036638 Power cable length 1 8 m VDE 01 13 114214 Ground C...

Page 250: ...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 Product Size Weight standard configuration without battery iM50 M50 261 mm W 2...

Page 251: ...Fuse T3 15AH 250VP A 2 3 Display Product Display Messages iM50 M50 Display screen 8 4 inch color TFT supporting touch screen Resolution 800 600 A maximum of 13 waveforms One power LED Two alarm LED O...

Page 252: ...M50 is powered off Charge Discharge Cycle 300 times A 2 5 Recorder Record Width 48 mm Record Paper Width 50 mm Paper Speed 12 5 mm s 25 mm s 50 mm s Trace 3 Recording types Continual real time record...

Page 253: ...min NIBP measurement review 1200 sets Alarm review 200 sets Arrhythmia event 200 sets 12 lead analysis review 50 sets Full disclosure waveforms 48 hours The following storage capacity for standard ext...

Page 254: ...w function which allows users to view its information from another bed or view other bed s information from its screen The AP signal strength of the monitor should be stronger than 65 dBm When the dis...

Page 255: ...ollowing conditions are present Quantity of the monitors supported by a single AP 8 Each monitor can communicate with MFM CMS Each monitor supports bed view function which allows users to view its inf...

Page 256: ...mm s 12 5 mm s 25 mm s 50 mm s Bandwidth 3dB Diagnosis 0 05 Hz to 150 Hz Diagnosis 1 0 05 Hz to 40 Hz Monitor 0 5 Hz to 40 Hz Surgery 1 Hz to 20 Hz Enhanced 2 Hz 18 Hz Customized High pass Filter and...

Page 257: ...IEC 60601 2 27 2011 Sect 201 12 1 101 5 Frequency and Impulse Response Frequency response Input a 5 Hz 1 mV sine wave signal and the output signal amplitude remains within the range of 71 to 110 at 0...

Page 258: ...V6 Heart Rate HR Calculation Range ADU 15 bpm to 300 bpm PED NEO 15 bpm to 350 bpm Accuracy 1 or 1 bpm whichever is greater Resolution 1 bpm Sensitivity 300 VPP QRS Detection Range The detection rang...

Page 259: ...mum and maximum values from the 12 most recent RR intervals and averaging the residual 10 RR intervals Method 2 If each of three consecutive RR intervals is greater than 1200 ms then the four most rec...

Page 260: ...ive ventricular beats and ventricular HR 20 bpm Basic The interval of 5 consecutive ventricular beats is more than 1000 ms Acc Vent Rhythm 5 consecutive ventricular beats and 40 bpm ventricular HR 100...

Page 261: ...m 10 s HR high alarm 10 s Arrhythmia analyses Advanced Asystole V Fib V Tach Couplet Vent Rhythm PVC Bigeminy PVC Trigeminy Tachy R on T PVC Irr Rhythm Brady Missed Beat Pacer not Pacing Vent Brady Pa...

Page 262: ...3 Waveform Bandwidth 0 2 Hz to 2 5 Hz 3 dB Respiration Excitation Waveform Sinusoid 45 6 kHz 10 350 A RR Measuring Range Adult 0 rpm to120 rpm Neo Ped 0 rpm to150 rpm Resolution 1 rpm Accuracy Adult...

Page 263: ...Pediatric Mode SYS 25 mmHg to 240 mmHg DIA 10 mmHg to 200 mmHg MAP 15 mmHg to 215 mmHg Neonatal Mode SYS 25 mmHg to 140 mmHg DIA 10 mmHg to 115 mmHg MAP 15 mmHg to 125 mmHg Alarm Type SYS DIA MAP Cuff...

Page 264: ...ons 20 mmHg 30 mmHg 40 mmHg 50 mmHg 60 mmHg 70 mmHg 80 mmHg Neonatal Default 30 mmHg Options 20 mmHg 30 mmHg 40 mmHg 50 mmHg Omron Module Not applicable to iM50 iM60 or M50 Method Oscillometric Mode M...

Page 265: ...iod Less than 160 s Less than 180 s Less than 80 s Less than 90 s Pre inflation Pressure Adult Pediatric Mode Default 180 mmHg Range 120 140 150 160 180 200 220 240 260 280 mmHg Neonatal Mode Default...

Page 266: ...rm Type SYS DIA MAP Pressure Resolution 1 mmHg Maximum mean error 5 mmHg Maximum standard deviation 8 mmHg Maximum measuring period Adult 130 s Pediatric 90 s Neonate 75 s Overpressure protection Adul...

Page 267: ...O2 Neonate 3 70 to 100 SpO2 Undefined 0 to 69 SpO2 Sensor Red Light 660 3 nm Infrared Light 905 10 nm Emitted Light Energy 15 mW PI Measuring Range 0 10 invalid PI value is 0 Resolution 1 Nellcor Modu...

Page 268: ...is performed A 8 PR Measuring range Accuracy Resolution PR SpO2 EDAN 25 bpm to 300 bpm 2 bpm 1 bpm Nellcor 20 bpm to 300 bpm 3 bpm 20 bpm to 250 bpm 1 bpm PR NIBP EDAN 40 bpm to 240 bpm 3 bpm or 3 5...

Page 269: ...se Time 30 s Note 1 The accuracy consists of two parts as following Accuracy not including sensor 0 1 C Sensor accuracy 0 2 C A 10 Quick TEMP Only applicable to iM50 and M50 Measuring Range 25 C 45 C...

Page 270: ...4 channels iM50 iM60 iM70 M50 2 channels IBP Measure Measuring Range Art 0 to 300 mmHg PA PAWP 6 to 120 mmHg CVP RAP LAP ICP 10 to 40 mmHg P1 P2 50 to 300 mmHg Resolution 1 mmHg Accuracy not includin...

Page 271: ...0 mmHg Balance gas N2 Sample gas flowrate 100 ml min 5 of reading 41 mmHg to 70 mmHg 8 of reading 71 mmHg to 100 mmHg 10 of reading 101 mmHg to 150 mmHg 12 of reading or 4 mmHg whichever is greater Al...

Page 272: ...Alarm EtCO2 FiCO2 AwRR Apnea Alarm Delay 10 s 15 s 20 s 25 s 30 s 35 s 40 s default value is 20 s Data Sample Rate 100 Hz EtCO2 Change1 AwRR 80rpm meet the accuracy mentioned above AwRR 80 rpm EtCO2 d...

Page 273: ...Mainstram Modules Applicable Patient Type Adult pediatric and neonatal patients Technique Infra red Absorption Technique Measure Parameters EtCO2 FiCO2 AwRR Unit mmHg Kpa Measuring Range EtCO2 0 mmHg...

Page 274: ...N2O helium Stability Short Term Drift Drift over 4 hours 0 8 mmHg Long Term Drift 120 hours Zero Calibration Support Alarm Type EtCO2 FiCO2 AwRR Apnea Alarm Delay 10 s 15 s 20 s 25 s 30 s 35 s 40 s de...

Page 275: ...ent Values Quantitative Effect Ambient Barometric Operational 0 40 mmHg 1 mmHg additional error 41 70 mmHg 2 5 additional error 71 100 mmHg 4 additional error 101 150 mmHg 5 additional error Additiona...

Page 276: ...10 sml min Note 1 Volumetric flow rate of air corrected to standardized conditions of temperature and pressure 2 Flow accuracy specification for the extended temperature range 20 to 0 C is 15 10 sml m...

Page 277: ...conditions except for interference specified in Section Effects From Water Vapor Partial Pressure On Gas Readings and Section Interfering Gas Effects Effects from Water Vapor Partial Pressure on Gas R...

Page 278: ...vol Helium typically decreases the CO2 readings by 6 This means that if measuring on a mixture containing 5 0 vol CO2 and 50 vol Helium the actual measured CO2 concentration will typically be 1 0 06 5...

Page 279: ...ll be within specification for all respiration rates up to 150 bpm Measured at I E ratio 1 1 using breath simulator according to EN ISO 80601 2 55 fig 201 101 Probe 2 9 channel NDIR type gas analyzer...

Page 280: ...e 4 3 vol _ 1 _ 1 _ 1 CO Carbon monoxide 5 1 vol _ 1 _ 1 _ 1 NO Nitrogen monoxide 5 0 02 vol _ 1 _ 1 _ 1 O2 5 100 vol _ 1 2 _ 1 _ 1 Note 1 Negligible interference effect included in the specification...

Page 281: ...not including sensor NOTE At least 90 of the C O data should reside inside the bounded region and the lower 95 confidence interval should not exceed 85 A 14 AG Complies with ISO 80601 2 55 2011 EDAN G...

Page 282: ...onditions Ambient temperature 25 3 C Barometric pressure 760 10 mmHg Balance gas N2 Sample gas flowrate 100 ml min N2O 2vol 2 of reading Hal Enf Iso Sev Des 0 15vol 5 of reading O2 1 1vol 2 of reading...

Page 283: ...e sample gas flowrate 150 ml min Work Mode Standby measure O2 Compensation Manual without O2 module Range 0 to 100 Resolution 1 Default 16 Auto with O2 module Humidity Compensation Method ATPD default...

Page 284: ...ically built in module Measurement Parameters CO2 N2O O2 Halothane HAL Isoflurane ISO Enflurane ENF Sevoflurane SEV Desflurane DES AwRR MAC Measurement Principle CO2 N2O Anaesthesia Agent infra red ab...

Page 285: ...f O2 during the expiratory phase depending on whether ETO2 is higher or lower than FiO2 N2O and anesthetic agents The momentary gas concentration at the time point where ETCO2 is detected ET will typi...

Page 286: ...tal system response time 4 seconds with 2 m Nomoline Airway Adapter Set sampling line Work Mode Measure Data Update Period 1 s Measurement Range CO2 0 to 25 vol O2 0 to 100 vol N2O 0 to 82vol HAL ENF...

Page 287: ...lay 20 s 25 s 30 s 35 s 40 s default value is 20 s Alarm Providing alarms of EtCO2 FiCO2 EtO2 FiO2 EtN2O FiN2O EtAA FiAA AwRR Exhaust Emission Interface for exhaust collection is available Support Zer...

Page 288: ...igible interference effect included in the specification Accuracy all conditions above Note 2 Negligible interference with N2O O2 concentrations correctly set effect included in the specification Accu...

Page 289: ...ng alcohol 3000 ppm blood conc acetone 1000 ppm methane water vapor NO and CO O2 Range 0 to 100 Vol Accuracy 1 2 5 Vol 2 5 rel Rise Time t10 90 4 500 ms Time to Specified Accuracy 3 450 s CO2 Range 0...

Page 290: ...Resolution 1 min Note 1 In accordance to ISO 21647 2004 and ISO 80601 2 55 2011 for respiratory rates from 0 60 1 min with I E ratio of 1 1 Note 2 Duration from power on at 10 C module temperature to...

Page 291: ...fibrillator test Unaffected Drift of measurement accuracy No drift Surface temperature at ambient temp 23 C Max 46 C 115 Airway adapters Disposable adult pediatric Adds less than 6 ml deadspace Pressu...

Page 292: ...tio 1 1 using breath simulator according to EN ISO 80601 2 55 fig 201 101 Automatic agent identification Primary and secondary agents Probe 2 9 channel NDIR type gas analyzer measuring at 4 10 m Data...

Page 293: ...ng DES 0 to 22 vol 0 15 vol 5 of reading The accuracy specifications above are valid for dry single gases at 22 5 C and 1013 40 hPa Accuracy All Conditions Gas Accuracy CO2 0 3 kPa 4 of reading N2O 2...

Page 294: ...l 6 of reading 3 _ 1 _ 1 Metered Dose Inhaler Propellants 4 Not for use with metered dose inhaler propellants C2H5OH Ethanol 4 0 3 vol _ 1 _ 1 _ 1 C3H7OH Isopropanol 4 0 5 vol _ 1 _ 1 _ 1 CH3COCH3 Ace...

Page 295: ...mized When Low pass Filter 40 Hz Bandwidth is High pass Filter Low pass Filter When Low pass Filter 40 Hz Bandwidth is High pass 40 Hz Maximum Transmission Delay Diagnosis Mode 500 ms Sensitivity 1 V...

Page 296: ...mA rating Rising and Falling Time 1 ms Interface Type PS2 connector A 15 3 Nurse Call Drive Mode Voltage output Power Supply 12 6 VDC 200 mA Max Interface Signal 12 V power supply and PWM waveform In...

Page 297: ...ntal Refreshing Rate 30 94 KHZ Video Signal 0 7 Vpp 75 Ohm HSYNC VSYNC signal TTL Interface Type DB 15 female receptacle A 15 6 RS232 Interface Applicable to iM80 and M80 Level RS232 Output Voltage Ra...

Page 298: ...r than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC EN 61000 3 2 Class...

Page 299: ...ironment Power frequency 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 hospi...

Page 300: ...GHz See Table 1 3 Vrms 150 kHz to 80 MHz 6Vrmsc in ISM bands between 0 15 MHz and 80 MHz 3 V m 80 MHz to 2 7 GHz Comply with Table 1 Portable and mobile RF communications equipment should be used no...

Page 301: ...heoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in...

Page 302: ...1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 524...

Page 303: ...ommunications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz P d 2 1 80 MHz to 800 MHz P d 2 1 800 MHz to 2 7 GHz P...

Page 304: ...ult settings listed here C 1 Patient Information Default Settings Patient Information Settings Patient Type Adult Pace Off C 2 Alarm Default Settings Alarm Settings Pause Time 120 s Sensor Off Alarm O...

Page 305: ...Medium Alarm Record Off Alarm High Limit ST X 0 2 Alarm Low Limit ST X 0 2 QT Analysis Off QTc 500 480 460 QTc 60 X stands for I II III aVR aVL aVF V V1 V2 V3 V4 V5 or V6 ADU PED NEO ARR Analysis On O...

Page 306: ...gh non adjustable Off ExtremeBrady On High non adjustable Off V Tach On High non adjustable Off Wide QRS Tachy On Medium Off Non Sustain VT On Medium Off Afib On Medium Off Acc Vent Rhythm On Low Off...

Page 307: ...Medium Off VBRADY On Medium Off VENT On Medium Off C 4 RESP Default Settings RESP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 30 30 100 Alarm Low Limit 8...

Page 308: ...tch On Alarm Record Off Alarm Level Medium Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100 Pulse Volume 3 Alarm Source Auto C 7 NIBP Default Settings NIBP Settings ADU PED NEO Alarm Switch On A...

Page 309: ...edium Alarm High Limit T1 39 0 39 0 39 0 Alarm Low Limit T1 36 0 36 0 36 0 Alarm High Limit T2 39 0 39 0 39 0 Alarm Low Limit T2 36 0 36 0 36 0 Alarm High Limit TD 2 0 2 0 2 0 Unit C C 9 Quick TEMP De...

Page 310: ...VP RAP LAP ICP 10 4 4 Alarm Low Limit CVP RAP LAP ICP 0 0 0 C 11 CO2 Default Settings CO2 Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Standby Unit mmHg Apnea Tim...

Page 311: ...tive Temperature Source Auto Temperature Unit C Interval 30 Constant 0 542 C 13 AG Default Settings AG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Measure Apnea...

Page 312: ...tN2O 0 0 0 Alarm High Limit FiN2O 53 53 53 Alarm Low Limit FiN2O 0 0 0 Alarm High Limit EtHAL EtENF EnISO 3 3 3 Alarm Low Limit EtHAL EtENF EnISO 0 0 0 Alarm High Limit FiHAL FiENF FiISO 2 2 2 Alarm L...

Page 313: ...wRR Airway Respiration Rate BP Blood Pressure Brady Bradycardia BTPS Body temperature and pressure saturated CI Cardiac Index C O Cardiac Output CISPR International Special Committee on Radio Interfer...

Page 314: ...Fraction of Inspired Carbon Dioxide FiN2O Fraction of Inspired Nitrous Oxide FiO2 Fraction of Inspired Oxygen Hal Halothane Hb Hemoglobin Hb CO Carbon Mono xide Hemoglobin HR Heart Rate IBP Invasive...

Page 315: ...d Pressure Non Sustain VT Nonsustained Ventricular Tachycardia O2 Oxygen oxyCRG Oxygen Cardio respirogram PA Pulmonary Artery PAC Bigeminy Premature Atrial Contraction PAC Bigeminy PAC Trigeminy Prema...

Page 316: ...ustain VT Sustained Ventricular Tachycardia SYS Systolic Pressure Tachy Tachycardia TB Blood Temperature TD Temperature Difference TEMP Temperature USB Universal Serial Bus VEB Ventricular Escape Beat...

Page 317: ......

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