Gima 35152 User Manual Download

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NEW CMS 8000 MULTIPARAMETER

PATIENT MONITOR

User Manual

PROFESSIONAL MEDICAL PRODUCTS

0123

M35152-GB-Rev

.0-06.20

35152 / CMS8000

CONTEC MEDICAL SYSTEMS CO., LTD

No.112 Qinhuang West Street,

Economic & Technical Development Zone,

Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA

Made in China

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537 Hamburg, Germany

Summary of Contents for 35152

Page 1: ...123 M35152 GB Rev 0 06 20 35152 CMS8000 CONTEC MEDICAL SYSTEMS CO LTD No 112 Qinhuang West Street Economic Technical Development Zone Qinhuangdao Hebei Province PEOPLE S REPUBLIC OF CHINA Made in Chin...

Page 2: ...patent rights of our company nor the rights of others Our company does not assume any liability arising out of any infringements of patents or other rights of third parties Content of this manual is...

Page 3: ...our company authorized personal This warranty shall not extend to any instrument which has been subjected to abnormal use maintenance negligence or damaged any instrument from which our company s orig...

Page 4: ...safety of patient and operator Keep the user manual near the product for convenient and timely accessed when needed Following symbols represent some important facts that you have to pay special attent...

Page 5: ...ff 14 Chapter 4 System Menu 15 4 1 Patient Information Setup 15 4 2 Default setup 16 4 3 Trend Review Measurement Review and Alarm Event Review 16 4 4 System setup 17 4 5 Machine version 23 4 6 Drug c...

Page 6: ...1 Introduction 51 10 2 Safety information 51 10 3 Monitoring Procedure 52 10 4 ECG Screen Hot Keys 56 10 5 ECG setup 57 10 6 ECG Alarm and Prompt Message 59 10 7 ST Segment Monitoring 60 10 8 ARR Moni...

Page 7: ...5 IBP Monitoring 85 15 1 Introduction 85 15 2 Safety information 85 15 3 Monitoring Procedure 85 15 4 Setting for label name 86 15 5 IBP Menu 86 15 6 IBP Scale Setup 87 15 7 IBP Pressure Zero 88 15 8...

Page 8: ...ssories 109 20 1 ECG Accessories 109 20 2 SpO2 Accessories 109 20 3 NIBPAccessories 110 20 4 TEMPAccessories 110 20 5 IBP accessories 110 20 6 CO2 Accessories 110 Chapter 21 Default Settings 112 21 1...

Page 9: ...ry equipment the operator doctor or nurse must give top priority to the patient safety l The monitor and devices connected to it shall form an equipotential system protective earthing l If the protect...

Page 10: ...r reference only please in kind prevail 1 2 Precautionary measures l In order to avoid the accumulation of electrostatic charge it is recommended to store maintain and use the equipment at a relative...

Page 11: ...CG including ST segment measurement and arrhythmia analysis RESP SpO2 PR NIBP TEMP IBP and CO2 can be monitored The monitoring information could be displayed reviewed and printed WARNING l The monitor...

Page 12: ...4 CMS8000 CMS9000 1 11 9 10 2 6 12 3 4 5 7 8 12 10 4 9 7 1 11 8 6 5 3 2...

Page 13: ...RT REC TIME item under RECORD menu 6 SILENCE Push this button to suspend the alarm with 1 minute and 2 minutes selectable and a symbol appears in the alarm area Push this button for more than 1 second...

Page 14: ...6 Side view CMS7000 CMS8000 CMS9000 1 2 3 5 6 7 8 4 9 10 1 2 3 5 6 7 8 4 9 1 0 1 2 3 5 6 7 8 4 9 10...

Page 15: ...uff 5 T2 Socket for channel 2 TEMP probe 6 IBP CO2 IBP or CO2 interface Note 6 and 7 can not be connected to a function at the same time if connected only the earlier connection is recognized 7 IBP CO...

Page 16: ...quipment use a cable to connect other equipment to the equipotential terminal of the monitor which eliminates the ground potential difference between the different devices to ensure safety 4 AC power...

Page 17: ...rea Displaying technical alarms and prompt messages cycle display for multiple pieces of information 3 Physiological alarm area Displaying physiological alarms cycle display for multiple pieces of inf...

Page 18: ...in of each channel is displayed above its waveform at the right side of the waveform there is a scale of one millivolt When a menu pops up in the interface it always locates a fixed area in the middle...

Page 19: ...e determined from the specifications of each equipment for example the risk of electric shock due to the accumulation of leakage current please contact our company or experts in the hospital related t...

Page 20: ...ried from one room to another room condensation may appears This is because it is exposed under humid air with different temperatures 3 3 Install the Monitor If everything goes well please place the m...

Page 21: ...d the other end is connected to a connector of the equipotential system If the protective grounding system is damaged the equipotential grounding system undertakes the safety function of protecting th...

Page 22: ...in power supply before the battery is fully charged n Display 1 Ensure that all text are readable and all images are clear 2 Ensure that the device brightness is normal n Main unit Check whether the t...

Page 23: ...2 characters can be input at most SEX patient s gender female male PAT TYPE patient type adult pediatric neonate ADMIT date of admission format year month day BIRTH patient date of birth format year m...

Page 24: ...configuration as the user defined default configuration But at this time the system will automatically save all the setups in the parameter menu ECG gain and filter way as the user defined default con...

Page 25: ...EM SETUP menu user can set the following items 4 4 1 Face select The system provides 5 display modes STAND SCREEN OxyCRG SCREEN TREND SCREEN BIG CHAR and VIEWBED SCREEN You can choose any one of them...

Page 26: ...o enter the following interface select OxyCRG SCREEN and then select EXIT in FACE SELECT menu OxyCRG Screen OxyCRG screen is located at the lower part of the waveform area consisting of the HR trend t...

Page 27: ...nd graph In the waveform area the trend graph is located on the right side of the corresponding waveform displaying the trends of one parameter of each module The parameter labels as well as their sca...

Page 28: ...ECT menu select VIEWBED SCREEN item and then select EXIT Viewbed Screen The monitor that used to view the situations of other monitors is called host monitor The monitor being viewed is called viewbed...

Page 29: ...by selecting corresponding parameter or canceling the selection The parameter in gray is unadjustable 3 If FULL ECG is selected the full lead ECG waveform will be displayed in the waveform area in on...

Page 30: ...art the recording process according to the selected time interval The recording time is always 8 seconds n REC RATE This item has two options 25 0mm s and 50 0 mm s n REC GRID It is used to determine...

Page 31: ...ect the MAINTAIN item in the SYSTEM MENU then select USER KEY 2 Input the password to enter the user maintain menu then you can customize the maintenance settings Items shown as below can be set n LAN...

Page 32: ...It is strongly required to use the accompanying 3G bracket provided by manufacturer CDMA2000 is appointed network but WCDMA can be ordered NOTE l The monitor supports 3G wireless and wire Wireless It...

Page 33: ...USTOM If the monitor is connected to central station the central station software need to be installed on a server with fixed IP address this address shall be set in the SERVER IP WIRELESS After selec...

Page 34: ...LOCAL NET NO the physical bed number of the monitor n SERVER IP input the IP address or domain name of the server for central station software n LOCAL IP CONFIG when the NET TYPE is CUSTOM you can set...

Page 35: ...ological parameters exceeds the alarm limits or the patient appears physiological abnormal for example HR exceeding the set limit The information of physiological alarm is displayed in physiological a...

Page 36: ...frequency n Medium alarm indicator flickers in yellow with low frequency n Low alarm indicator lights in yellow without flickering 5 3 3 Alarm message When alarm occurs alarm messages will be display...

Page 37: ...t carefully choose whether to turn off the alarm sound l In SILENCE or ALARM PAUSE status set the alarm sound is as OFF then the system will automatically terminate the status of SILENCE or ALARM PAUS...

Page 38: ...wing information can be set in parameter alarm setup u ECG ALM SETUP HR alarm alarm level alarm limits high low ST alarm setup ARR alarm setup u SpO2 ALM SETUP SpO2 ON OFF alarm level SpO2 alarm limit...

Page 39: ...the symbol disappears NOTE l After returning to the normal state the presence of an alarm depends on whether the alarm condition is appropriate but after the SILENCE button is pressed the system will...

Page 40: ...mmediate to execute button on the front panel and system buttons of MAIN and MENU n Execute any operation that may trigger the adjustment of the screen or display of a new menu After exiting the Freez...

Page 41: ...ther waveform are recorded If these two selected waveforms are all set off or not available only parameters are recorded As for the function of recording frozen waveforms you can only record the wavef...

Page 42: ...ripe recording types n Continuous real time recording n 8 seconds real time recording n Auto 8 seconds recording n Alarm recording n Freeze waveform recording n Trend graph table recording n ARR revie...

Page 43: ...cur at the same time their waveforms will be stored and then printed in turn n ST Segment Alarm The monitor records 2 channel ECG waveforms 4 8 or 16 seconds prior to and after the ST alarm totally 8...

Page 44: ...e and time 7 3 Recording Start Stop Here are the methods for how to start the recording of each type Continuous real time recording Press REC STOP to start stop the recording 8 seconds real time recor...

Page 45: ...ration information currently displayed Access the RECORD menu from the SYSTEM SETUP menu Then select the CLEAR REC TASK button all recording tasks will be stopped and all stored alarms will be cleared...

Page 46: ...troubleshooting do not leave the recorder door open Removing Paper Jam When the recorder functions or sounds improperly open the recorder door to check whether paper jam exists If yes re install the r...

Page 47: ...hat the cursor points to is displayed under the trend graph and its corresponding time is displayed above the trend Other trends except NIBP trend are displayed in continuous curves In NIBP trend grap...

Page 48: ...ured value exceeds the scale range click ATUO ZOOM button the scale will automatically adjust to proper range for current measurement Event marks on the trend graph If an event is marked A B C or D th...

Page 49: ...per part of the screen pick UP DOWN button turn the knob clockwise to view later trend data When a down arrow appears on the upper part of the screen select the same item turn the knob counterclockwis...

Page 50: ...earlier or later data Pick REC to print out all measurement data of NIBP RECALL 8 4 Alarm recall The alarm recall includes physiological alarm recall and technical alarm recall n Physiological alarm r...

Page 51: ...eters including HR PVCs ST1 SpO2 PR RR T1 T2 TD NIBP and 72 hour ECG waveform The trend data is stored per 1 minute NOTE l For the review on PC by using the sync software only ECG and SpO2 related wav...

Page 52: ...cording to the content set in patient setup The buttons at the bottom of menu includes u PAGE UP PAGE DOWN observe patient lists of other page u UP DOWN move the cursor to select a specified patient u...

Page 53: ...e cursor then press REVIEW button the trend data will be displayed in a list The resolution is 1 minute The buttons are u Page UP PAGE DOWN to view trend data of different time u LIGHT RIGHT to view t...

Page 54: ...G data is saved in many different files It need save ECG data in a new file per half an hour For example 2014 09 03 14 15 represents ECG file name it also indicates the starting time that the file is...

Page 55: ...ECG I ECG II and ECG V 5 Lead u When the lead type is 3 LEADS it can displays only one channel waveform The ECG lead is the same with the one displayed on the monitor 5 Unmount SD card Enter SD OPERAT...

Page 56: ...Dose Rate Concentration Operating method In the Drug Calculation window the operator should first select the name of the drug to be calculated and then confirm the patient weight Afterwards the operat...

Page 57: ...for only one type can be generated each time NOTE l Drug A B C D E are only codes for drugs instead of their real names The units for these five drugs are fixed The operator may select the appropriate...

Page 58: ...select step The selectable range is 1 10 3 Move the cursor to DOSE TYPE item Press the knob to select the unit 4 Move the cursor to UP DOWN item press and turn the knob to view the data in previous o...

Page 59: ...not touch the patient table nearby or the equipment during defibrillation l Use only the ECG cables and electrodes provided by our company for monitoring l When connecting the cables and electrodes pl...

Page 60: ...the electrodes let the skin dry completely 2 Attach clip or snap to electrodes prior to placement 3 Install the electrodes on the patient Before attaching apply some conductive paste on the skin if th...

Page 61: ...ar the right shoulder n LA left arm under the clavicle near the left shoulder n LL left leg left lower quadrant The 5 lead The placement of 5 lead electrodes is shown as below n RA right arm under the...

Page 62: ...ode n V3R V7R On the right side of the chest in positions corresponding to those on the left n VE Over the xiphoid position For the placement of V leads on the back it should be attached on one of the...

Page 63: ...therwise there will be a great interference with the ECG signal l When the monitor is connected to a defibrillator and other high frequency devices it is recommended to use anti defibrillation ECG lea...

Page 64: ...e for each channel from 0 25 0 5 1 2 and 4 A 1mV scale displays on each ECG channel s one side The height of the scale is directly proportional to the waveform amplitude Errore L origine riferimento n...

Page 65: ...dgement of pulse rate while the heart rate alarm will not be judged AUTO The monitor distinguishes heart rate source according to the quality of signal ECG source priority is higher than SpO2 source O...

Page 66: ...details OTHER SET Pick this item to access ECG SETUP menu n BEAT VOL 8 selections are available OFF 1 7 7 indicates maximum volume OFF indicates no sound n PACE ON means the detected signal will be ma...

Page 67: ...tion does not describe the alarm part about arrhythmia and ST analysis Among physiological alarms those belonging to the type that the parameter has exceeded the limits may activate the recorder to au...

Page 68: ...off 1 Select ECG ALM SETUP item in the ECG SETUP menu refer to the ECG SETUP for details 2 Then select ST ALM SETUP to enter its interface set the ST ANALYSIS to on or off 10 7 2 ST alarm setup Selec...

Page 69: ...below The ST measurement value for each heartbeat complex wave is the difference between the two measurement points The position of measurement points ISO and ST should be adjusted at the beginning of...

Page 70: ...User selectable ST2 HI ST measuring value of channel 2 is above the upper alarm limit User selectable ST2 LOW ST measuring value of channel 2 is below the lower alarm limit User selectable 10 8 ARR Mo...

Page 71: ...message and data record when alarm occurs pick OFF to disable the alarm function and there will be a beside PVCs parameter area n ALM LEV selectable from HI MED LO Level HIGH represents the most serio...

Page 72: ...llowing interface will pop up The recent stored ARR events are listed in this interface UP DOWN Observe event lists of other pages CURSOR Move the cursor to select an event in the list RENAME Rename t...

Page 73: ...ted out the ECG waveform of the channel being analysed 4 seconds prior to and after the alarm Alarms and prompt messages related to arrhythmia analysis are listed as below Physiological alarm Message...

Page 74: ...able during the period 1 75 times of the average R R interval only considering patients with pacemaker User selectable PNC With pacemaker When pacing pulse is available no QRS complex exists during th...

Page 75: ...As the skin is a bad conductor in order to get a good respiration signal process the skin where the electrode is placed is necessary See ECG Monitoring chapter for skin processing method For RESP mon...

Page 76: ...crease decrease 5 s after every rotating n DEFAULT select it to RESP DEFAULT CONFIG menu in which the user may select FACTORY DEFAULT CONFIG or USER DEFAULT CONFIG After selecting any of the items and...

Page 77: ...smitted depends on many factors most of which are constant However one of these factors the blood flow in the arteries varies with time because it is pulsating By measuring the light absorption during...

Page 78: ...e best value and the waveform is the most standard l The update time of measurement data is less than 10 seconds which depends on the PR value Data averaging and other signal processing have no effect...

Page 79: ...a blood pressure cuff arterial catheter or intravascular line n Significant concentrations of non functional hemoglobin such as carboxyhemoglobin COHb and methemoglobin MetHb n Bad circular perfusion...

Page 80: ...l measurement parameters perform a measurement check on yourself or by using the simulator adjust the alarm limits setting and check if the correct alarm response is triggered WARNING l Set the upper...

Page 81: ...sconnected from the patient or the monitor LOW Make sure the sensor is placed in patient s finger or other parts and the connection between the monitor and the cables is well SpO2 COMM ERR SpO2 module...

Page 82: ...01 2 30 2009 13 2 Safety information WARNING l Before measuring make sure that the monitoring mode and cuff type you selected are appropriate for your patient adult pediatric or neonate As false setti...

Page 83: ...lyzed to obtain the measurement values n Severe Shock If the patient is in severe shock or hypothermia measurements will be unreliable since the decrease for the blood flowed to the peripheries will c...

Page 84: ...l measurement and the system continues auto measuring 2 Auto measuring Select a interval value in INTERVAL item of NIBP SETUP interface to perform auto measurement then press NIBP button on the front...

Page 85: ...ressure 4 Unit mmHg or kPa 5 Diastolic pressure 6 Current cuff presure 7 Prompt information area display the prompt information related to the NIBP 8 Measurement mode 9 Systolic pressure 13 8 NIBP SET...

Page 86: ...the measurement value of last systolic pressure based on the same patient The system momorizes the value which can shorten the measurement time of the same patient and increase the measurement accurac...

Page 87: ...0 8 mmHg and airway tube to the NIBP cuff jack of the module by a T shape connector Set the monitor in CALIBRATE mode Inflate the pressure in the metal container to 0 50 and 200 mmHg by spheroidal air...

Page 88: ...er for maintenance WARNING l This pneumatic test other than being specified in the EN 1060 1 standard is to be used by the user to simply determine whether there are air leaks in the NIBP airway If at...

Page 89: ...NIBP module is failed HIGH If failure persists stop using measuring function of NIBP module notify biomedical engineer or Our service staff NIBP LOOSE CUFF Cuff is no properly wrapped or no cuff exis...

Page 90: ...adult or 90 seconds neonatal HIGH Measure again or use other measurement methods NIBP ILLEGALLY RESET Abnormal module reset HIGH Reset again MEASURE FAIL The system cannot perform measurement analysi...

Page 91: ...cording to patient type and measurement requirement 2 Insert the probe cable into the TEMP jack directly 3 Attach the TEMP probe to the patient properly 4 Confirm that the alarm settings are suitable...

Page 92: ...ccurring during TEMP measurement Physiological alarms Message Cause Alarm Level T1 HI Measuring value of channel 1 is above upper alarm limit User selectable TI LOW Measuring value of channel 1 is bel...

Page 93: ...cer is splashed on the equipment or its accessories or enters the transducer or the monitor contact the Hospital Service Center immediately NOTE l Use only the pressure transducer listed in the User M...

Page 94: ...ary Arterial Pressure CVP Center Venous Pressure RAP Right Atrial Pressure LAP Left Atrial Pressure ICP Intracranium Pressure P1 P2 Expand Pressure 15 5 IBP Menu Select the IBP hot key on the screen t...

Page 95: ...mation after selecting ON it will not alarm when selecting OFF and will appear in parameter area u ALM LEV HIGH MED and LOW u ALM LIMIT SET select it to enter IBP Alarm Limit Settings menu In this sub...

Page 96: ...3 way stopcock to the patient 2 The transducer must be vented to atmospheric pressure via the 3 way stopcock 3 Take the channel 1 as an example select IBP SETUP IBP PRESSURE ZERO CH1 ZERO then select...

Page 97: ...ied by the hospital procedure The purpose of the calibration is to ensure that the system provides an accurate measurement Before starting a calibration by the mercury pressure gauge a zero procedure...

Page 98: ...the monitor is not in DEMO mode then calibrate again if the problem exists still please contact the service personnel PRESSURE OVER RANGE FAIL Make sure the calibration value selected is reasonable t...

Page 99: ...LOW Make sure that the cable is properly connected IBP2 SENSOR OFF IBP cable of channel 2 falls off from monitor LOW Make sure that the cable is properly connected IBP 1 2 INIT ERR IBP module failure...

Page 100: ...ing value of channel 1 is beyond measurement range HIGH IBP2 SYS EXCEED Systolic measuring value of channel 2 is beyond measurement range HIGH IBP2 DIA EXCEED Diastolic measuring value of channel 2 is...

Page 101: ...respiratory gas in the patient s respiratory airway was sampled using a constant sampling flow rate and analyzed by a built in CO2 sensor CO2 measurement can provide 1 One channel CO2 waveform 2 EtCO2...

Page 102: ...cal zeroing time is 6 10 s the prompt information will disappear after zeroing WARNING l When calibrating the sensor during the measurement please disconnect it from the patient s airway NOTE l When u...

Page 103: ...pter in the breathing circuit connect the luer male head on the sampling tube to the concave port of the airway adapter NOTE l Disconnect the cannula airway adapter or sampling tube from the sensor wh...

Page 104: ...arly check flow sensor and sampling tube to prevent excessive moisture or secretions gathering 16 4 CO2 Menu Turn the knob to CO2 hot key on the screen to activate CO2 Setup menu as shown below n ALM...

Page 105: ...AVE SCALE adjust the amplitude of CO2 waveform display area two options LO or HI the default value is LO n WORK MODE change the work mode of CO2 two options MEASUREMENT or STANDBY the default is STAND...

Page 106: ...s User selectable AWRR HI AwRR measuring value is above upper alarm limit User selectable AWRR LOW AwRR measuring value is below lower alarm limit User selectable CO2 APNEA RESP stops in specific time...

Page 107: ...an it before calibrating zero CO2 NOT INITIALIZED Barometric Pressure or gas compensations have not been set after power on LOW Set the Barometric Pressure and gas compensations to clear this error Pr...

Page 108: ...low voltage will trigger high level technical alarm Low battery then you should charge to the battery otherwise it will shut down after the first alarm about 5 minutes 17 3 Battery installation Refer...

Page 109: ...LY l If the electrolyte exudes and enters your eye please don t knead your eye use clean water to rinse immediately and go to the doctor l If there is the sign of battery damage or leakage please repl...

Page 110: ...102 WARNING l Don t disassembly the battery or throw it into the fire or make it short circuit As battery burn explosion or leakage may injury to the human...

Page 111: ...vice should be cleaned periodically in the area of seriously polluted or greater sand wind cleaning frequency should be increased Before cleaning please consult or understand the regulations about dev...

Page 112: ...tions but remember to remove the gasbag if you use this method 3 After cleaning please use the new cloth or paper towel adsorbed proper tap water to wipe the residual detergent until that there is no...

Page 113: ...rgent to completely wipe the lead cable surface until that there is no obvious dirt 2 After cleaning please use the new cloth or paper towel adsorbed proper tap water to wipe the residual detergent un...

Page 114: ...ing paper conforms with specified requirements n Battery performance n Each monitoring function is in good working state n Ground impedance and leakage current conform requirements If any signs of dam...

Page 115: ...EMP measurement Symptoms Possible reasons and solutions Failure in TEMP measurement Check whether a appropriate probe is used Try the other one Other problems related to SpO2 measurement Symptoms Poss...

Page 116: ...intenance the device must be cleaned and disinfected Check maintenance items Frequency Safety check according to IEC60601 1 When replacing the power supply or after the device falls off NIBP air leaka...

Page 117: ...essory name Description Remark 2 3 04 00005 5 lead American Standard TPU gold plated button type Repeatable 2 3 04 00006 5 lead European standard TPU gold plated button type 2 3 04 00007 5 lead Americ...

Page 118: ...6 cm 20 4 TEMP Accessories TEMP probe Accessory No Accessory name Description Remark 2 3 06 00013 R25 2 252K temperature probe body surface type CMS N TEMP 2P PVC L 3 m Repeatable 2 3 06 00014 R25 2 2...

Page 119: ...ory name Description Remark 2 3 02 00194 CO2 module CO2 M02 self produced mainstream TTL scheme Airway adapter 1 4 11 00019 Adult child airway adapter P N 6063 00 Disposable Mainstream 1 4 11 00020 In...

Page 120: ...cific to a particular country These are listed here for all countries alphabetically Country Description Line Frequency Units Weight Units Height ECG Cable Color 50 60 Hz kg lb in cm IEC AAMI Afghanis...

Page 121: ...C Canada 60 kg cm AAMI Cape Verde 60 lb in AAMI Cayman Islands 60 kg cm AAMI Central African Republic 50 kg cm IEC Chad 60 lb in AAMI Chile 50 kg cm AAMI China 50 kg cm IEC Christmas Islands 60 lb in...

Page 122: ...AAMI French Southern Territories 60 lb in AAMI Gabon 50 kg cm IEC Gambia The 50 kg cm IEC Georgia 60 lb in AAMI Germany 50 kg cm IEC Ghana 50 kg cm IEC Gibraltar 60 lb in AAMI Greece 50 kg cm IEC Gre...

Page 123: ...le s Republic of 60 lb in AAMI Korea Republic of 60 kg cm AAMI Kuweit 50 kg cm AAMI Kyrgyzstan 60 lb in AAMI Lao People s Democratic Republics 50 kg cm IEC Latvia 50 kg cm IEC Lebanon 50 kg cm AAMI Le...

Page 124: ...IEC Nauru 60 lb in AAMI Nepal 60 lb in AAMI Netherlands 50 kg cm IEC Netherlands Antilles 50 kg cm AAMI New Caledonia 60 lb in AAMI New Zealand 50 kg cm AAMI Nicaragua 60 kg in AAMI Niger 50 kg cm IEC...

Page 125: ...60 lb in AAMI Sao Tome and Principe 60 lb in AAMI Saudi Arabia 50 kg cm AAMI Senegal 50 kg cm IEC Serbia 50 kg cm IEC Serbia Montenegro 50 kg cm IEC Seychelles 60 lb in AAMI Sierra Leone 50 kg cm IEC...

Page 126: ...Ukraine 60 lb in AAMI UK 50 kg cm IEC United Arab Emirates 50 kg cm AAMI United Kingdom 50 kg cm IEC United States 60 lb in AAMI United States Minor Outlying Islands 60 lb in AAMI Uruguay 50 kg cm AAM...

Page 127: ...itor HR ALM ON ALM LEV MED ALM REC OFF ALM HI 120 bpm 160 bpm 200 bpm ALM LO 50 bpm 75 bpm 100 bpm HR FROM AUTO HR CHANNEL CH1 LEAD TYPE 5 LEAD SWEEP 25 0 mm s Arrhythmia analysis Name Factory Default...

Page 128: ...Adult Pedi Neo SpO2 ALM ON ALM LEV Hi ALM REC OFF SpO2 ALM HI 100 100 95 SpO2 ALM LOW 90 90 90 SWEEP 25 mm s PR ALM ON PR ALM HI 120 bpm 160 bpm 200 bpm PR ALM LO 50 bpm 75 bpm 100 bpm 21 2 5 NIBP Na...

Page 129: ...2 0 UNIT 21 2 7 IBP Name Factory Default Adult Pedi Neo ALM ON ALM LEV MED ALM REC OFF SWEEP 25 0 mm s IBP1 UNIT mmHg IBP2 UNIT mmHg FILTER No filter Alarm limit Systolic diastolic mean pressure mmHg...

Page 130: ...Neo ALM ON ALM LEV MED ALM REC OFF CO2 ALM HI 45 CO2 ALM LO 30 NS ALM HI 4 AWRR ALM HI 30 30 100 AWRR ALM LO 8 8 30 APNEA ALM 20 s SWEEP 25 0 mm s Unit mmHg WAVE SCALE LOW WORK MODE Standby ATMOS mmHg...

Page 131: ...Working environment If used or stored outside the specified temperature and humidity range the device may not meet the performance specifications listed here Working environment Temperature 5 40 Humi...

Page 132: ...recording Waveform freeze recording Trend graph table recording ARR events review recording Alarm event review recording NIBP review recording SD card review recording Drug calculation and titration t...

Page 133: ...B NOTCH 50 60 Hz NOTCH filter can be turned on or off manually Lead off check DC for active lead 0 1 A Drive lead 1 A Baseline recovery time After defibrillation 5 s under monitoring and surgery Calib...

Page 134: ...are Bigeminy ventricular 80 bpm 1 bpm Bigeminy ventricular alternative lente 60 bpm 1 bpm Bigeminy ventricular alternative rapid 120 bpm 1 bpm Systoles bidirectional 95 bpm 1 bpm Time to ALARM for tac...

Page 135: ...TAT Measurement Interval in AUTO Mode 1 2 3 4 5 10 15 30 60 90 120 240 480 960 min Measuring Period in STAT Mode 5 min Measurement parameters SYS DIA MEAN NIBP measurement range mmHg Adult Pediatric N...

Page 136: ...llected by the secondary standard pulse oximeter equipment and the tested equipment at the same time to form data pairs which are used as an accuracy analysis Because pulse oximeter equipment measurem...

Page 137: ...it Range Step T1 T2 high limit low limit 1 50 1 T1 T2 low limit 0 high limit 1 TD high limit 0 50 A 14 IBP Measurement method Invasive and direct measurement Channel Dual channel Measurement range 10...

Page 138: ...tion expiration CO2 curve can be displayed within 15s which meets all specification within 2 minutes Sidestream At 25 inspiration expiration CO2 curve can be displayed within 20s which meets all speci...

Page 139: ...environment guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in near...

Page 140: ...0 4 5 1 kV Line to Line 2 kV Line to Earth 1 kV Line to Line 2 kV Line to Earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and...

Page 141: ...tic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz and 800 MHz th...

Page 142: ...ter W Separation distance according to frequency of transmitter m 150KHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz 0 01 0 3500 0 3500 0 2334 0 1 1 1068 1 1068 0 7378 1 3 5000 3 5000 2 3334 10 11 0860...

Page 143: ...sis HIGH Check the connection of the linking wire and the current situation of the patient ASYSTOLE Patient suffers from Arr Of ASYSTOLE HIGH Check the patient condition Check the connection between t...

Page 144: ...en the electrode and lead cable ECG LEAD OFF or RESP LEAD OFF RL lead of ECG is not connected correctly or ECG lead is not connected correctly LOW Check the connection of RL lead or ECG lead cable V L...

Page 145: ...t be used HIGH Contact the manufacturer for repair WIRELESS CONNECT ERROR The network part in the system appear problems so the system can t achieve network function MED Contact the manufacturer for r...

Page 146: ...t the manufacturer for repair NIBP RANGE EXCEEDED Problem happens when measuring the curve The system cannot perform measurement analysis or calculation LOW Check the connection of each part or replac...

Page 147: ...irway has leaks LOW Check the connection of each part or replace with a new cuff If the failure still exists contact the manufacturer for repair NIBP SYSTEM FAILURE Problem happens when measuring the...

Page 148: ...140 Appendix D SpO2 Clinical Information Clinical Result information for each sensor The table below shows ARMS values measured using SpO2 sensor S5RCH300 with Patient Monitor in a clinical study...

Page 149: ...141 The table below shows ARMS values measured using SpO2 sensor S5RCS300 with Patient Monitor in a clinical study...

Page 150: ...B decibel F fahrenheit g gram h hour Hz hertz inch inch k kilo kg kilogram kPa kilopascal L litre lb pound m meter mAh milliampere hour mcg microgram mEq milli equivalents mg milligram min minute ml m...

Page 151: ...output CCU cardiac coronary care unit CI cardiac index CISPR International Special Committee on Radio Interference CMS central monitoring system CO2 carbon dioxide COHb carboxyhemoglobin CVP central...

Page 152: ...terial pressure MetHb methemoglobin MRI magnetic resonance imaging N A not applied Neo neonate NIBP noninvasive blood pressure oxyCRG oxygen cardio respirogram Ped pediatric Pleth plethysmogram PR pul...

Page 153: ...mperature limitation Equipotentiality 95 0 Humidity limitation Serial number Authorized representative in the European community Date of manufacture Medical Device complies with Directive 93 42 EEC Ma...

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