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Patient Monitor User Manual                                                                                                        Specifications 

- 150 - 

Appendix 

I

 Specifications

 

A1.1 Classification 

Anti-electroshock Type 

Class I equipment and internal powered equipment 

Anti-electroshock Degree 

ECG

 

(RESP), TEMP, IBP    CF 

SpO

2

, NIBP, CO

2

           

 

BF 

Ingress Protection   

IPX1 

Disinfection/Sterilizing method 

Refer to 

Chapter 12 ~ Chapter 17

 for details. 

Working System 

Continuous operation equipment 

Compliant with Standards 

IEC 60601-1: 1988+A1: 1991+A2: 1995; EN 60601-1: 
1990+A1: 1993+A2: 1995; IEC 60601-1-2: 2001+A1: 
2004; EN 60601-1-2: 2001+A1: 2006; IEC/EN 
60601-2-27; IEC/EN 60601-2-30; IEC/EN 60601-2-34; 
IEC/EN 60601-2-49; ISO 9919; ISO 21647; EN 
12470-4; EN 1060-1; EN 1060-3; EN 1060-4; 
ANSI/AAMI EC13; ANSI/AAMI SP10 

A1.2 Specifications 

A1.2.1 Size and Weight 

Weight 

< 5 kg (not including the battery and record) 

A1.2.2 Environment 

The monitor may not meet the performance specifications given here if stored or used outside the 
specified temperature and humidity ranges.   

When the monitor and related products have differing environmental specifications, the effective 
range for the combined products is that range which is common to the specifications for all 
products. 

Temperature 

Working 

+5

°

C to +40

°

C 

Transport and Storage 

-20

°

C to +55

°

C 

Humidity 

Содержание iM8

Страница 1: ......

Страница 2: ...not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual...

Страница 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...

Страница 4: ...hecking 7 2 2 Connecting the Power Cable 7 2 3 Powering on the Monitor 8 2 4 Connecting Patient Sensors 8 2 5 Checking the Recorder 8 Chapter 3 Introduction 9 3 1 General Information 9 3 2 Screen Disp...

Страница 5: ...9 5 1 Selecting Operating Screen 39 5 2 Standard Screen 39 5 3 Trend Screen 39 5 4 oxyCRG Screen 40 5 5 Large Font Screen 40 Chapter 6 Alarm 44 6 1 Alarm Modes 44 6 1 1 Alarm Level 44 6 1 2 Alarm Mode...

Страница 6: ...ce Cleaning 72 11 1 System Check 72 11 2 General Cleaning 72 11 3 Disinfection 73 11 4 Replacement of Fuse 74 11 5 Cleaning Battery and Battery Compartment Cover 74 Chapter 12 ECG RESP Monitoring 75 1...

Страница 7: ...4 2 NIBP Safety Information 108 14 3 Measurement Procedures 109 14 4 NIBP SETUP 112 14 5 Resetting NIBP 113 14 6 Calibrating NIBP 113 14 7 Leak Test 113 14 8 NIBP Alarm Message and Prompt Message 114...

Страница 8: ...Display 151 A1 2 4 Battery 151 A1 2 5 Recorder Optional 152 A1 2 6 Recall 153 A1 2 7 ECG 153 A1 2 8 RESP 156 A1 2 9 NIBP 157 A1 2 10 SpO2 158 A1 2 11 TEMP 159 A1 2 12 IBP Optional 160 A1 2 13 CO2 Opti...

Страница 9: ...VII A3 3 ECG Default Settings 168 A3 4 RESP 170 A3 5 SpO2 170 A3 6 PR 170 A3 7 NIBP 171 A3 8 TEMP 171 A3 9 IBP 172 A3 10 CO2 172...

Страница 10: ...servicing with the cabinet access door open The monitor operates within specifications at ambient temperatures between 5 and 40 Ambient temperatures that exceed these limits could affect the accuracy...

Страница 11: ...g protective earth system is doubtful the monitor must be supplied by internal power only 1 2 5 Condensation Make sure that during operation the instrument is free of condensation Condensation can for...

Страница 12: ...be returned to the dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do not dispose them together with house hold garbage At the end of their life hand the bat...

Страница 13: ...whose life cycle has expired from the monitor immediately 8 Avoid liquid splash and excessive temperature The temperature must be kept between 5 and 40 while working And it should be kept between 20...

Страница 14: ...The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock and is suitable for use during defibrillation Caution Con...

Страница 15: ...re Manufacturer P N Part Number Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life Rx only...

Страница 16: ...or and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list Check for any mechanical damage Check all the functions c...

Страница 17: ...the monitor is in good status 2 If rechargeable batteries are provided charge them after using the device every time to ensure the electric power is enough 3 The interval between double pressing of PO...

Страница 18: ...e Its built in replaceable battery provides convenience for patient movement On the high resolution display screen 7 waveforms and all the monitoring parameters can be displayed clearly The POWER swit...

Страница 19: ...Shell figure Screen size Functions iM8 Host 319mm 154mm 267 8mm Square 12 1 inch ECG RESP SpO2 NIBP TEMP IBP CO2 iM8A Host 319mm 154mm 267 8mm Square 10 4 inch ECG RESP SpO2 NIBP TEMP IBP CO2 iM8B Hos...

Страница 20: ...Patient Monitor User Manual Introduction 11 Figure 3 3 iM8A Patient Monitor Figure 3 4 iM8B Patient Monitor...

Страница 21: ...channels TD IBP Channel 1 SYS DIA MAP Channel 2 SYS DIA MAP Dual IBP waveforms CO2 End Tidal CO2 EtCO2 Fraction of inspired carbon dioxide FiCO2 Air Way Respiration Rate AwRR CO2 waveform The monitor...

Страница 22: ...e of patient Three options Adult Pediatric Neonatal Name Name of the monitored patient when the user inputs patient name this name will be displayed on the right side of the patient type If the user d...

Страница 23: ...displayed at the right side of patient name Alarm message is displayed in the right most area FREEZE appears when the waveforms are frozen Waveform Area Seven waveforms can be displayed at the same t...

Страница 24: ...ayed corresponding to waveforms basically They are ECG Heart Rate Unit beats per minute bpm ST segment analysis of Channel 1 2 ST1 ST2 Unit mV PVCs Premature Ventricular Contraction events Unit event...

Страница 25: ...RD submenu Silence When the SYSTEM MENU MAINTAIN USER MAINTAIN ALARM SETUP is set to ON press this button to silence the alarm All the alarm audio will be closed At the same time ALARM SILENCE s and w...

Страница 26: ...n can be performed at any position at which the cursor can stay When the cursor is in the waveform area the user may immediately modify the current setup When the cursor is in the parameter area the u...

Страница 27: ...Monitor At the right side of the monitor there are a bracket of water trap for CO2 module and the recorder s paper inlet cover Figure 3 8 Right Panel Left Side of the Monitor Connectors for cables and...

Страница 28: ...Interface reserved Standard RJ45 Socket for connecting to MFM CMS of the manufacturer VGA interface optional USB port Equipotential grounding terminal for connection with the hospital s grounding sys...

Страница 29: ...ng wire and the battery terminal directly 11 If liquid leaking from the battery gets into your eyes do not rub your eyes Wash them well with clean water and go to see a doctor immediately If liquid le...

Страница 30: ...ion please change the battery or contact the service personnel 3 5 4 Replacing the Battery To install or replace the battery please follow the procedure 1 Pull the battery door downwards to open it ac...

Страница 31: ...parameters to be monitored sweeping speed of the waveforms audio signal volume and output content Press the MENU button on the front panel to call up SYSTEM MENU You can perform the following operati...

Страница 32: ...mber Range 1 254 DOCTOR Name of the doctor NAME Patient name Valid characters A Z 0 9 Maximum length 12 characters SEX Patient gender Available options F for Female M for Male PAT TYPE Patient type Av...

Страница 33: ...ides whether to monitor a new patient Figure 4 4 Confirm to Update Patient Pick YES to delete all information of the patient being currently monitored and exit the menu Pick NO to give up updating the...

Страница 34: ...ave all the setups in the parameter menu ECG lead gain and filter way as the user defined default configuration according to the patient type The dialog box as shown below will pop up Figure 4 6 Confi...

Страница 35: ...te the patient events that have impact on parameter monitoring such as dose taking injection therapy status etc The Event will be displayed on the Trend Graph and Trend Table to assist analyzing patie...

Страница 36: ...Large Font Face Select 4 5 Time Setup Select TIME SETUP item in SYSTEM SETUP menu to access the sub menu of TIME SETUP as shown below System time is in the format of MONTH DAY YEAR DAY MONTH YEAR YEAR...

Страница 37: ...tem cannot be picked SpO2 SpO2 Plethysmogram If no SpO2 waveform is currently displayed on the screen this item cannot be picked In ECG Full Lead display mode this item can be picked although no SpO2...

Страница 38: ...N 20MIN 30MIN 40MIN 50MIN 1HOUR 2HOURS 3HOURS and 4HOURS It means that the system will trigger the recording operation according to the selected time interval The recording time is fixed at 8 seconds...

Страница 39: ...re version information of this monitor 4 10 Alarm Volume The system provides five levels of alarm volume and an alarm silence function The system will give audio alarm prompt except alarm sound based...

Страница 40: ...SETUP Refer to Chapter6 Alarm for details 4 11 Key Volume Select SELECTION item in SYSTEM SETUP menu to call up SELECTION sub menu as shown below Select KEY VOL item and set the volume The selections...

Страница 41: ...t MAINTAIN item in SYSTEM MENU to open the ENTER MAINTAIN PASSWORD dialog box as shown below in which you can enter password and then customize maintenance settings Factory maintenance function is onl...

Страница 42: ...second NURSE CALL alarm if the system alarm or the audio alarm is turned off the NURSE CALL is unavailable It is connected to RJ45 socket the same port as connected to Ethernet NURSE CALL occupies th...

Страница 43: ...manufacturer or representatives authorized by the manufacturer 4 15 Data Storing Users can store the measured data into USB storage by Data store function query or delete data in the menu Select DATA...

Страница 44: ...ISK users should exit the U disk via the menu before dismounting it After selecting EXIT U DISK if the data is being stored it will indicate Transmitting Please Waiting if the U disk is dismounted suc...

Страница 45: ...time the data will be imported from the USB storage to the monitor it indicates as follows Figure 4 23 Importing data TREND TABLE users can select this item by trim knob after importing data the real...

Страница 46: ...successfully it indicates DELETE SUCCESS NOTE The data of the current monitoring patient ID can not be deleted If the data has not been saved successfully because of the power supply off or USB storag...

Страница 47: ...storage is full it indicates NO SPACE IN USB STORAGE on the screen NOTE 1 Data store function can be set to on or off in FACTORY MAINTAIN by the manufacturer or the representative permitted by the ma...

Страница 48: ...item can be selected at a time Figure 5 1 Face Select 5 2 Standard Screen In the FACE SELECT menu select the STANDARD SCREEN option to enter the Standard Screen The Standard Screen displays to us the...

Страница 49: ...rm Select oxyCRG trend length There are two hot keys at the bottom part of the oxyCRG Screen which are 4MIN 2MIN 1MIN and RR RESP WAVE By using hot keys for trend time you may select to display trend...

Страница 50: ...Patient Monitor User Manual Face Select 41 Figure 5 2 Large Font Face Select Three display modes 1 ECG SpO2 NIBP display mode Figure 5 3 ECG SpO2 NIBP display mode...

Страница 51: ...Patient Monitor User Manual Face Select 42 2 SpO2 NIBP display mode Figure 5 4 SpO2 NIBP display mode...

Страница 52: ...Patient Monitor User Manual Face Select 43 3 SpO2 display mode Figure 5 5 SpO2 display mode Exit Large Font Screen In the LARGE FONT FACE SELECT menu choose EXIT to return to FACE SELECT screen...

Страница 53: ...he monitor provides two types of alarm physiological alarms and technical alarms Also the monitor provides prompts Physiological alarms refer to those alarms triggered by patient s physiological situa...

Страница 54: ...to give the alarm prompt the monitor also gives alarm by making the font or the background of monitored parameter flash in the frequency of 1Hz refer to Chapter 6 1 3 Alarm Setup The icons for parame...

Страница 55: ...ARNING Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger Remember that...

Страница 56: ...ameter In the ALARM SETUP menu select the ALM SEL item to set up the alarm information for the following parameters They are HR ST PVCs SpO2 NIBP IBP 1 2 RESP TEMP and CO2 For example Method to set up...

Страница 57: ...eter and the high alarm limit flash at the same time BK FLASH When the measured parameter exceeds its alarm limits the background of the parameter and the alarm limit flash For High alarm the backgrou...

Страница 58: ...gical alarms But in normal sense we do not regard them as real patient health related items 6 3 Silence Enter SYSTEM MENU MAINTAIN USER MAINTAIN ALARM SETUP If the ALARM SILENCE is set to ON press Sil...

Страница 59: ...the alarm limits The following actions take place 1 Alarm message displays on the screen as described in alarm mode 2 The monitor beeps in its corresponding alarm class and volume 3 Alarm lamp flashes...

Страница 60: ...elf or use a simulator Adjust alarm limits and check that appropriate alarm behavior is observed 6 7 Adjustable Range of Alarm Limits ECG alarm limits are listed as follows unit bpm Patient Type ALM H...

Страница 61: ...LO PR 300 30 NIBP alarm limits are listed as follows unit mmHg Patient Type ALM HI ALM LO ADU SYS DIA MAP 270 215 235 40 10 20 PED SYS DIA MAP 200 150 165 40 10 20 NEO SYS DIA MAP 135 100 110 40 10 20...

Страница 62: ...follows unit mmHg ALM HI ALM LO Art 300 0 RAP 40 10 LAP 40 10 ICP 40 10 CVP 40 10 PA 120 6 P1 300 50 P2 300 50 CO2 alarm limits are listed as follows ALM HI ALM LO EtCO2 ADU 150 mmHg PED NEO 100 mmHg...

Страница 63: ...then enter the Freeze status and display the popup FROZEN menu In the Freeze status all other waveforms are frozen In other words the system will no longer refresh all other waveforms Exit Freeze Stat...

Страница 64: ...form By moving the waveform you may review a waveform of 12 minutes before it is frozen For a waveform of less than 12 minutes the remaining part is displayed as a straight line Use the rotary snob on...

Страница 65: ...that the user should not use the recorder when the low battery displays or the monitor may be turned off automatically 8 2 Recording Type The monitor provides several types of stripe recording Contin...

Страница 66: ...ding Setup for details Alarm Recording Parameter Alarm The monitor records waveforms 4 8 or 16 seconds prior to and after the alarm totally 8 16 or 32 seconds which can be selected in SYSTEM MENU All...

Страница 67: ...ms they will be printed out within the first second or when changing the lead gain and filter mode during real time recording IBP scale the first second of IBP waveform CO2 scale the first second of C...

Страница 68: ...w Pick the REC button to print out the titration currently displayed in the window Frozen waveform recording 8 second frozen waveform can be recorded 2 waveforms are selectable NOTE You can press the...

Страница 69: ...ng NOTE Be careful when inserting papers Avoid damaging the thermo sensitive print head Unless when inserting papers or shooting troubles do not leave the recorder catch open Removing Paper Jam When t...

Страница 70: ...EM MENU to call up the following menu Figure 9 1 Trend Graph Menu In the trend graph the y axis stands for the measured value and x axis time is the cursor of the trend graph the parameter value of th...

Страница 71: ...When appears on the left part of the screen the trend graph pages up for earlier trend curves as the cursor moves here Mark Event If an event is marked A B C or D then the corresponding event type wil...

Страница 72: ...BP2 CO2 FiCO2 AWRR The IBP1 IBP CO2 FiCO2 AWRR are optional according to the product models To choose a trend table of a different resolution Pick the RESOLUTION item and turn the knob to change its c...

Страница 73: ...of the trend table Operation Example To view a NIBP trend table Pick the Menu button on the lower right of the screen to access SYSTEM MENU Pick TREND TABLE Pick L RIGHT and switch to NIBP by turning...

Страница 74: ...rements When you press the RECORD button the recorder will print out the metrical data of current window NOTE When the user set the NIBP SETUP PR NIBP to ON the PR parameter will display in the menu o...

Страница 75: ...ameter whose alarm events he wants to review The selections include ALL alarm events of all parameters ECG REST SpO2 NIBP PR NIBP IBP TEMP CO2 HR_H 180 the value of HR is above the upper alarm limit H...

Страница 76: ...OFF the PR parameter will not display To view all waveforms during the alarming process Pick L RIGHT and turn the knob to view all 8 16 32 second waveforms stored To view other alarm events Events of...

Страница 77: ...ations that can be performed by the system are AMINOPHYLLINE DOBUTAMINE DOPAMINE EPINEPHRINE HEPARIN ISUPREL LIDOCAINE NIPRIDE NITROGLYCERIN and PITOCIN DRUG A DRUG B DRUG C DRUG D and DRUG E are also...

Страница 78: ...orrectness of the entered value The correct value is the guarantee for the reliability and safety of the calculated results 4 For each entered value the system will always give a dialog box asking for...

Страница 79: ...Access Titration Table Select TITRATION item in DRUG CALC menu to enter titration table display Titration table display for drug is as following Figure 10 2 TITRATION Method to operate the titration...

Страница 80: ...return to DRUG CALC menu Total amount dose volume INF rate drip rate patient weight and drug name are displayed on the top of the titration table The meaning of each English identifier is AMOUNT drug...

Страница 81: ...the material about the customer service contract from the local company s office WARNING 1 If the hospital or agency that is responding to using the monitor does not follow a satisfactory maintenance...

Страница 82: ...monitor and sensor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth 2 This company has no responsibility for the effectiveness of controlling infectiou...

Страница 83: ...e cap clockwise Fuse size 5 20 Rated value T1 6AL 250VP NOTE Switch off the power switch of the patient monitor before examining the fuse 11 5 Cleaning Battery and Battery Compartment Cover Use only n...

Страница 84: ...tor works with high frequency electrotome it will not be deadlock or restarting Every ECG channel has Pacing impulse rejection and Bandpass filter circuit Defibrillation protection needs 1K resistance...

Страница 85: ...equencies It is accordingly suggested that do not use equipment generating electrical radiation near ECG RESP monitoring devices 3 If the pacemaker signals are beyond the claimed range the heart rate...

Страница 86: ...lacing Electrodes for ECG Monitoring NOTE The following table gives the corresponding lead names used in Europe and America respectively Lead names are represented by R L F N C C1 C6 in Europe whose c...

Страница 87: ...merican standard for example see Figure 12 2 Red R electrode Be placed near the right shoulder directly below the clavicle Yellow L electrode Be placed near the left shoulder directly below the clavic...

Страница 88: ...the chest in positions corresponding to those on the left VE Over the xiphoid position V7 On the 5th intercostal space at the left posterior axillary line of back V7R On the 5th intercostal space at t...

Страница 89: ...hen using the monitor with the defibrillator or other high frequency equipment please use counteracting defibrillation ECG lead to avoid cautery 2 When using Electrosurgery ES equipment do not place a...

Страница 90: ...ith P wave much smaller than the T wave Figure 12 5 Standard ECG Waveform 12 4 ECG Screen Hot Keys Figure 12 6 Hot Key for ECG 1 Leads of channel 1 I II III AVR AVL AVF V1 V6 are available Leads on th...

Страница 91: ...e for both channels which is always displayed at the waveform place of the channel 1 ECG waveform NOTE Only in Diagnosis mode the system can provide non processed real signals In Monitor or Sugery mod...

Страница 92: ...s set ALM HI value or falls below ALM LO value NOTE Please set the alarm limits according to the clinical conditions of individual patients The upper limit shall not be 20 beats per min higher than th...

Страница 93: ...can display one ECG waveform on the main screen When LEAD TYPE is set to 5 LEADS ECG DISPLAY can be set to NORMAL DISPLAY MULTI LEADS DISPLAY and HALF SCN MULTI LEADS DISPLAY Select NORMAL DISPLAY to...

Страница 94: ...emaker set PACE to ON If monitoring a patient without a pacemaker set PACE to OFF If PACE is ON the system will not perform some types of ARR analysis For detailed information please refer to the Sect...

Страница 95: ...wise the pacing impulse may be counted as normal QRS complex which results in failure of ECG LOST error detection NOTE When PACE Switch is ON the Arrhythmia events related to PVCs will not be monitore...

Страница 96: ...e sure that all electrodes leads and patient cables are properly connected ECG LA LEAD OFF ECG electrode LA falls off the skin or the ECG cable LA falls off the monitor Low ECG RA LEAD OFF ECG electro...

Страница 97: ...e used only in ADU mode 2 When setting ST ANALYSE on the monitor should in DIAGNOSTIC mode 3 ECG RESP monitoring should select DIAGNOSTIC mode It is available to measure the variance of ST segment wit...

Страница 98: ...avoid endangering the patient s life the user should use this function cautiously ALM LEV used to set up the ST alarm level There are three selections HIGH MED and LOW ALM REC pick ON to enable report...

Страница 99: ...of the ST segment changes need to be determined by a clinician Adjusting ISO ST These two points can be adjusted by turning the knob When adjusting ST measurement point the system will show the ST Me...

Страница 100: ...neonate and adult patients in clinical detect the change of heart rate and ventricular rhythm and also save arrhythmia events and generate alarming information Arrhythmia algorithm can monitor paced...

Страница 101: ...Pick ON to enable prompt message when alarm occurs pick OFF to disable the alarm function and there will be a beside PVCs WARNING In order to avoid endangering the patient s life the user should use...

Страница 102: ...of all arrhythmia types and pick ALL REC OFF to disable this function Changing the ALM LEV can reset the alarm level of all arrhythmia types to the same value ARR RECALL Pick this item to review and e...

Страница 103: ...s ON the alarm sounds and the alarm indicator flashes Physiological alarms Prompt Applicable Patient Type Occurring Condition Alarm Level ASYSTOLE All patients No QRS is detected for 4 consecutive sec...

Страница 104: ...QRS complex RR interval 0 5s Pediatric neonatal 5 consecutive QRS complex RR interval 0 375s User selectable BRADY All patients Adult 5 consecutive QRS complex RR interval 1 5s Pediatric neonatal 5 co...

Страница 105: ...Analysis only on the patients with pacemakers Prompt message Message Cause Alarm Level ARR LEARNING The QRS template building required for Arr Analysis is in process No alarm NOTE Arrhythmia name dis...

Страница 106: ...ally causing a negative intrathoracic pressure In these cases it is better to place the two RESP electrodes laterally in the right axillary and left lateral chest areas at the maximum point of breathi...

Страница 107: ...during the RESP alarm pick OFF to disable the alarm function and there will be a besides RESP WARNING In order to avoid endangering the patient s life the user should use this function cautiously ALM...

Страница 108: ...he HOLD HI and HOLD LO are unavailable and the monitor can calculate the respiration rate automatically When it is set to MANUAL mode you can adjust the broken lines in RESP area by the HOLD HI and HO...

Страница 109: ...measurement Physiological alarms Message Cause Alarm Level RR HIGH RESP measuring value is above upper alarm limit User selectable RR LOW RESP measuring value is below lower alarm limit User selectab...

Страница 110: ...he ECG cable may be damaged or deteriorated replace it with a new one instead of continuing its application on the patient Cleaning Use fine hair cloth moistened in mild soap liquid or cleaning agent...

Страница 111: ...and oxyhemoglobin It measures how much light sent from light sources on one side of the sensor is transmitted through patient tissue such as a finger or an ear to a receiver on the other side The amo...

Страница 112: ...in More frequent examinations may be required for different patients 5 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor more than 4 hours Inspect...

Страница 113: ...by z High levels of ambient light or strobe lights or flashing lights such as fire alarm lamps Hint cover application site with opaque material z High frequency electrical noise including electro surg...

Страница 114: ...tivated when the result exceeds SpO2 ALM HI value or falls below SpO2 ALM LO value Use the knob to pick the SpO2 ALM HI or SpO2 ALM LOW item and turn the knob to select the desired alarm limit PR alar...

Страница 115: ...t site is too weak so the monitor can t detect the pulse signal High Technical alarms Message Cause Alarm Level What to do SpO2 SENSOR OFF SpO2 sensor may be disconnected from the patient or the monit...

Страница 116: ...change it to other parts 13 6 Maintenance and Cleaning WARNING 1 Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line 2 Do not su...

Страница 117: ...an error and standard deviation when compared to intra arterial measurements in a representative patient population 14 2 NIBP Safety Information WARNING 1 You must not perform NIBP measurement on the...

Страница 118: ...of blood in the limbs NOTE 1 Please confirm the result by referring to patients condition if the measurement fails or if the measurements are questionable 2 Once the measurement limits are exceeded or...

Страница 119: ...ect the required patient type 5 Select a measurement mode in the NIBP SETUP menu Refer to the following paragraphs Operation Hints for details 6 Press the Start button on the front panel to start a me...

Страница 120: ...lse In those circumstances when the patient s condition makes it difficult to detect the measurement becomes unreliable and the measuring time increases The user should be aware that the following con...

Страница 121: ...LO DIA ALM HI DIA ALM LO are for the user to set up the alarm limit for each type of pressure NIBP alarm is activated when the pressure exceeds the set upper alarm limit or falls below lower alarm li...

Страница 122: ...ere are air leaks in the NIBP airway If at the end of the test the system gives the prompt that the NIBP airway has air leaks please contact the manufacturer for repair Procedure of Leak Test z Connec...

Страница 123: ...ssage Cause Alarm Level NS HIGH NIBP SYS measuring value is above upper alarm limit User selectable NS LOW NIBP SYS measuring value is below lower alarm limit User selectable ND HIGH NIBP DIA measurin...

Страница 124: ...n of NIBP module and notify biomedical engineer or manufacturer s service staff NIBP INIT PRESSURE HIGH The initial pressure is too high during measuring Low Measure again if failure persists stop usi...

Страница 125: ...noise is too large or pulse rate is not regular Low Make sure that the patient under monitoring is motionless NIBP Range Exceeded Maybe the patient blood pressure value is beyond the measurement rang...

Страница 126: ...cover on the rubber tube to avoid liquid permeation Reusable Blood Pressure Cuff The cuff can be disinfected by immersion in decontamination solutions but remember to remove the rubber bag if you use...

Страница 127: ...complete cuff until the bag is in position Thread the rubber tubes from inside the cuff and out through the small hole under the internal flap Disposable Blood Pressure Cuffs Disposable cuffs are inte...

Страница 128: ...phase Unplug the temperature probe cable of the channe1 from the socket and then the screen will display the error message TEMP1 SENSOR OFF and the audible alarm is activated It is the same to the oth...

Страница 129: ...ccess the TEMP DEFAULT CONFIG dialog box in which the user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to be used After selecting any of the items and exiting the dialo...

Страница 130: ...ule failure or communication failure High Stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service staff 15 4 Care and Cleaning WARNING Before cleaning the mon...

Страница 131: ...acting corrosive solvent Dipping the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable Also the connector should not be dipped 5 After...

Страница 132: ...P Monitoring WARNING 1 The operator should avoid contact with the conductive parts of the appurtenance when it is connected or applied 2 When the monitor is used with HF surgical equipment the transdu...

Страница 133: ...t the Hospital Service Center immediately NOTE Calibrate the instrument either whenever a new transducer is used or as frequently as dictated by your Hospital Procedures Policy 16 3 Monitoring Procedu...

Страница 134: ...sducer interface cable 5 Monitor 6 Pressure transducer Figure 16 1 IBP Monitoring 16 4 IBP Menu Pick the IBP hot key on the screen to access the IBP SELECT menu shown as follows Figure 16 2 IBP SELECT...

Страница 135: ...ble MANUAL AUTO Set it to AUTO the pressure names of IBP become P1 and P2 and the IBP scale is adjusted by system automatically Set it to MANUAL the pressure names of IBP can choose one of ART PA CVP...

Страница 136: ...used After selecting any of the items and exiting the dialog box the system will pop up the dialog box asking for the user s confirmation EXIT used to exit the menu and return to the main interface W...

Страница 137: ...ure should be performed before the monitoring starts and at least once a day after each disconnect and connect of the cable The prompt information related to zero calibration take CH1 for example CH1...

Страница 138: ...n the menu to start calibrating channel 1 Turn the knob to select the item CH2 CAL VALUE press and turn the knob to select the pressure value to be calibrated for channel 2 Then turn the knob to selec...

Страница 139: ...t would lead to patient is off 4 Connect the 3 way connector to the 3 way stopcock that is not connected to the patient catheter 5 Open the port of the 3 way stopcock to the sphygmomanometer 6 Select...

Страница 140: ...to the instruction given below IBP label selectable from ART PA CVP RAP LAP ICP P1 P2 HI IBP value of High Limit scale its range is the measuring range of the current pressure NOTE The HI value must b...

Страница 141: ...uring value of channel 1 is above upper alarm limit User selectable IM1 LOW MAP measuring value of channel 1 is below lower alarm limit User selectable IS2 HIGH SYS measuring value of channel 2 is abo...

Страница 142: ...me from the transducer and wipe the transducer diaphragm with water Clean the transducer and cable with soap or cleaning agents listed below Cetylcide Wavicide 01 Wescodyne Cidex Lysol Vesphene Do not...

Страница 143: ...yed on the screen are defined as follows CO2 EtCO2 FI FiCO2 AWRR Air Way Respiration AwRR Resp times min WARNING 1 CO2 module shall be avoided from crash and vibration 2 Do not use the device in the e...

Страница 144: ...of battery 17 2 Monitoring Procedure The principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb 4 3 m infrared ray Absorption intensity is proportional to CO2 concen...

Страница 145: ...3 To zero the sensor Expose the sensor to room air and keep it away from all sources of CO2 including the ventilator the patient s breath and your own Start up CO2 SETUP and change WORK MODE from STA...

Страница 146: ...airway adapter or sample line from the sensor when the sensor is not in use C5 CO2 Module Setup NOTE You must perform a zero calibration as described in this procedure each time you use a new airway...

Страница 147: ...tient s breath and your own Start up CO2 SETUP menu and change WORK MODE from STANDBY to MEASURE In the CO2 SETUP menu select ZERO CAL The messages indicate zero started zero successful After the zero...

Страница 148: ...rm a zero calibration after connecting it before restarting measurement 2 Replace the airway adapter if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexp...

Страница 149: ...the measuring value returns to the normal one the information disappears CO2 ALM LO to adjust the lower alarm limit of EtCO2 If the measuring value is smaller than CO2 lower alarm limit CO2 LOW appea...

Страница 150: ...OW or HIGH selectable The default value is LOW BARO PRESS to set the barometric pressure value For gaining accurate readings you should set this barometric pressure correctly O2 COMPENS to adjust the...

Страница 151: ...ensation to be used including general compensation O2 compensate N2O compensate and ALL compensate Then determine whether to make VA compensate and BTPS compensate Work Conditions for CO2 Calculation...

Страница 152: ...dialog box asking for the user s confirmation 17 4 Alarm Information and Prompt Among physiological alarms those belonging to the type that the parameter has exceeded the limits may activate the reco...

Страница 153: ...rompt message Message Cause CO2 STANDBY STATUS Turn from measuring mode to standby mode making the module in energy saving status CO2 WARM UP The CO2 module is at warm up state 17 5 Maintenance and Cl...

Страница 154: ...040196 Adult disposable SpO2 sensor 01 57 040197 Pediatric Disposable SpO2 sensor 01 57 040198 Infant Disposable SpO2 sensor 01 57 040199 Neonatal Disposable SpO2 Sensor 02 01 210119 SH1 SpO2 Finger...

Страница 155: ...le IEC 3 lead clip Defib TPU 01 57 471095 ECG cable AHA 3 lead snap Defib TPU 01 57 471087 ECG cable AHA 3 lead clip Defib TPU 01 57 471089 ECG cable IEC 5 lead snap Defib TPU 01 57 471088 ECG cable I...

Страница 156: ...way Adapter 7053 01 11 57 078142 Adult Nasal CO2 with O2 delivery sampling cannula Respironics 3469ADU 00 11 57 078143 Pediatric Nasal CO2 with O2 delivery sampling cannula Respironics 3469PED 00 11 5...

Страница 157: ...chargeable Lithium Ion Battery TWSLB 003 01 21 064142 Rechargeable Lithium Ion Battery TWSLB 002 01 57 78035 Printing Paper 21 13 036384 Power cord USA 1 8m 11 13 01950 Power cord 3C 3m 01 13 36014 Po...

Страница 158: ...y anyone not authorized by the manufacturer d damage 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...

Страница 159: ...2 2001 A1 2006 IEC EN 60601 2 27 IEC EN 60601 2 30 IEC EN 60601 2 34 IEC EN 60601 2 49 ISO 9919 ISO 21647 EN 12470 4 EN 1060 1 EN 1060 3 EN 1060 4 ANSI AAMI EC13 ANSI AAMI SP10 A1 2 Specifications A1...

Страница 160: ...1 6AL 250VP A1 2 3 Display Display Screen 10 1 inch 10 4 inch 12 1 inch multicolour TFT LCD 10 1 inch Resolution 800 480 10 4 inch 12 1 inch Resolution 800 600 A maximum of 11 waveforms iM8 One charge...

Страница 161: ...Ah 180 min 4 2Ah 360 min Rechargeable Period Monitor is on or in standby mode A1 2 5 Recorder Optional Record Width 48 mm Paper Speed 25 mm s 50 mm s Channels 3 Recording Types Continuous real time re...

Страница 162: ...weep 6 25mm s 12 5mm s 25mm s 50mm s Bandwidth 3dB Diagnosis 0 05Hz to 150Hz Monitor 0 5Hz to 40Hz Surgery 1Hz to 20Hz CMRR Common Mode Rejection Ratio Diagnosis 95dB the Notch filter is off Monitor 1...

Страница 163: ...Pace Pulse Pulse indicator Pulse is marked if the requirements of ANSI AAMI EC13 2002 Sect 4 1 4 1 are met Amplitude 2 mV 700 mV Width 0 1 ms 2 0 ms Ascending time 10 s 100 s Pulse Rejection Pulse is...

Страница 164: ...ange of Sinus and SV Rhythm Tachy ADU 120 bpm 300 bpm PED NEO 160 bpm 350 bpm Normal ADU 41 bpm 119 bpm PED NEO 61 bpm 159 bpm Brady ADU 15 bpm 40 bpm PED NEO 15 bpm 60 bpm Range of Ventricular Rhythm...

Страница 165: ...value displays after a stable period of 20s Ventricular bigeminy 80bpm 1bpm Slow alternating ventricular bigeminy 60bpm 1bpm Rapid alternating ventricular bigeminy 120bpm 1bpm Bidirectional systoles 9...

Страница 166: ...2200 4500 leads cables 1K resistance Waveform bandwidth 0 2 to 2 5 Hz 3 dB Apnea Alarm Time 10s 15s 20s 25s 30s 35s 40s default value is 20s A1 2 9 NIBP Method Oscillometric Mode Manual Auto Continuou...

Страница 167: ...Error 5mmHg Maximum Standard Deviation 8mmHg Maximum Measuring Period Adult Pediatric 120s Neonatal 90s Typical Measuring Period 30s to 45s depend on HR motion disturbance Overpressure Protection Adu...

Страница 168: ...ate Measuring Range 25bpm to 300bpm Alarm Range 30bpm to 300bpm Resolution 1bpm Accuracy 2bpm Sensors Red Light 660 3 nm Wave Length Infrared Light 905 5 nm Emitted Light Energy 15 mW A1 2 11 TEMP Cha...

Страница 169: ...whichever is greater Unit kPa mmHg Zero calibration range 200 mmHg Filter DC 12 5Hz DC 40Hz Pressure sensor Sensitivity 5 V V mmHg Impedance 300 to 3000 A1 2 13 CO2 Optional Applicable Patient Type A...

Страница 170: ...ple Gas Flow Rate Sidestream 50 10 ml min O2 Compensation Range 0 to 100 Resolution 1 Default 16 Anesthetic Gas Compensation Range 0 to 20 Resolution 0 1 Default 0 0 Balance Gas Compensation Options N...

Страница 171: ...5 80 50 15 Dry and Saturated Gas 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 Additional worst case error when compe...

Страница 172: ...Manual Specifications 163 101 150 mmHg 5 additional error Additional worst case error when compensation for PB O2 N2O anesthetic agents or helium is correctly selected for the actual fractional gas c...

Страница 173: ...ons IEC EN 61000 3 2 Class A Voltage fluctuations flicker emissions IEC EN 61000 3 3 Complies The monitor is suitable for use in all establishments other than domestic establishments and those directl...

Страница 174: ...s characteristic of a typical location in a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 5 UT 95 dip...

Страница 175: ...GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Patient Monitor including cables than the recommended separation distance calculated from...

Страница 176: ...e and mobile RF communications equipment and the monitor The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of...

Страница 177: ...e different from those listed here A3 1 Patient Information Default Settings Patient Information Settings Patient Type Adult Pace Off A3 2 Alarm Default Settings Alarm Settings Pause Time 120s Alarm M...

Страница 178: ...sis Off PVCs Alarm Level Medium PVCs Alarm Switch Off PVCs Alarm Record Off ARR Alarm Settings Alarm Switch Alarm Level Alarm Record ASYSTOLE On High Off VFIB VTAC On High Off R ON T On Medium Off VT...

Страница 179: ...s Calculation Type Auto Resp Type Sweep 12 5mm s Amplitude 2 A3 5 SpO2 SpO2 Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 100 100 95 Alarm Low Limit 90 90 8...

Страница 180: ...Limit Map 110 90 70 Alarm Low Limit Map 60 50 25 Alarm High Limit Dia 90 70 60 Alarm Low Limit Dia 50 40 20 Inflation value 160 140 100 Unit mmHg Interval Manual A3 8 TEMP TEMP Settings ADU PED NEO Al...

Страница 181: ...Alarm Low Limit ART P1 P2 90 50 70 70 40 50 55 20 35 Alarm High Limit PA 35 16 20 60 4 26 60 4 26 Alarm Low Limit PA 10 0 0 24 4 12 24 4 12 MAP MAP MAP Alarm High Limit CVP RAP LAP ICP 10 4 4 Alarm Lo...

Страница 182: ...Patient Monitor User Manual Default Settings 173 Alarm High Limit FiCO2 4 4 4 Alarm High Limit AWRR 30 30 100 Alarm Low Limit AWRR 8 8 30 Sweep 12 5mm s Amplitude Low...

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