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Manual - EDAN USA

1. Alarm Type SYS DIA MAP Pressure Resolution ImmHg Measuring Accuracy Maximum Mean Error 5mmHg Maximum Standard 8mmHg Deviation Adult Pediatric Neonate Normal Single Fault Normal Single fault Condition Condition Condition Condition Cuff Pressure 300 mmHg 330 mmHg 150 mmHg 165 mmHg Measuring Range Maximum Measuring Less than 160s Less than 180s Less than 80s Less than 90s Period A 11 SpOz A 11 1 SpO from EDAN Module Measuring Range 0 100 Resolution 1 Accuracy Adult including Pediatric 2 10 100 SpO Undefined 0 69 SpO gt Neonate 3 70 100 SpO Undefined 0 69 SpO gt Pulse Rate Measuring Range 25bpm 300bpm Resolution 1bpm Accuracy 2bpm Data update period Is Wave length Red light 660 3 nm Infrared light 905 5 nm Emitted light energy lt 15 mW 156 Patient Monitor User Manual A 11 2 SpO from Nellcor Module Product Specification Measuring Range 1 100 Resolution 1 Sensor Type Accuracy MAX A MAX AL MAX N MAX P 2 7096 100 SpO MAX I MAX FAST OxiCliq A OxiCliq P OxiCliq N Adult E A OxiCliq N Neonate A ORO Accuracy OxiCliq I D YS Infant to Adult 3 70 100 SpO DS 100A OXI A N OXI P I D YS including D YSE ear clip D YS including D YSPD spotclip 3 5 70 100 SpO
2. COUPLET 2 consecutive PVCs BIGEMINY Vent Bigeminy TRIGEMINY Vent Trigeminy A type of single PVC under the condition that HR lt 100 R R RONT interval is less than 1 3 the average interval followed by a compensating pause of 1 25X the average R R interval the next R wave advances onto the previous T wave PVC Single PVCs not belonging to the type of above mentioned PVCs TACHY 5 consecutive QRS complex RR interval is less than 0 5s BRADY 5 consecutive QRS complex RR interval is longer than 1 5s When HR is less than 100 beats min no heart beat is tested MISSED during the period 1 75 times of the average RR interval or BEATS When HR is higher than 100beat min no beat is tested within 1 second The patient has irregular heart rate check patient s condition IRR electrodes cables and leads After the pacemaker is paced QRS complex can not be PNC detected during 300ms PNP After the QRS complex no pace is detected during 1 75 times of RR interval VBRADY The patient has irregular HR and his average HR is less than 60bpm Check his condition electrodes cables and leads The patient has irregular heart rate check patient s condition VENT electrodes cables and leads 8 11 2 ARR Analysis Menu 8 11 2 1 Switching ARR Analysis On and Off To switch ARR Analysis on or off in the ECG Setup menu select ARR Analysis to toggle between On and Off from the popup interface 8 11 2 2 PVCs Alarm
3. Part Number Accessories Remark 11 15 40119 In line Injection temperature probe BD 684056 SP4042 11 15 40120 In line Injection temperature probe housing BD 680006 SP5045 11 57 100175 Control Syringe Medex MA387 01 57 471012 Cardiac output main cable Yuanhe 98ME07GB106 28 9 AG Accessories Part Number Accessories Remark 11 57 471042 10 IRMA Airway Adapter Disposable adult children 25 pcs package PHASEIN Mainstream 11 57 471043 10 Nomoline with Luer Lock connector L 2m Sidestream 50ml min 25 pcs package PHASEIN 12 08 208006 Multi gas analyzer IRMA AX 141 Patek Monitor User Manua Accesos 12 08 208005 Multi gas analyzer ISA AX 12 08 208007 Multi gas analyzer ISA OR 28 10 Other Accessories Part Number Accessories Remark 11 21 064142 Rechargeable Lithium lon Battery 14 8V 2 1Ah 11 21 064143 Rechargeable Lithium Ion Battery 14 8V 4 2Ah 01 57 78035 Recorder paper 12 01 19084 Thermal printer 11 21 64056 Vehicle carried Inverter 12 01 30493 Wall Mount Simple 02 01 30164 Wall Mount Only compatible with 02 01 101043 Basket Wall Mount MS3R 30164 03 28 101952 Rolling Stand MT 207 02 04 101976 Rolling Stand Basket in the bottom 11 13 114214 Ground Cable 02 01 109592 Pole clamp 1 set package 02 01 109636 Pole clamp 4 sets package 11 18 078
4. Patient Type ALM HI ALM LO SYS 250 60 ADU PED DIA 200 40 MAP 235 45 SYS 120 40 NEO DIA 90 20 MAP 100 30 TEMP alarm limits are listed as follows ALM HI ALM LO Tl 50 C 122 E 0 C 32 F T2 50 C 122 E 0 C 32 F TD 50 C 90 F 0 C 0 F 43 Patient Monitor User Manual IBP alarm limits are listed as follows unit mmHg Alarm Information Art RAP LAP CVP PA ICP P1 P2 CO alarm limits are listed as follows ALM HI ALM LO EtCO 150 mmHg 0 FiCO 50 mmHg 3 AwRR 150 rpm 2 rpm C O alarm limits are listed as follows ALM HI ALM LO TB 43 C 109 4 F 23 C 73 4 F Quick Temp alarm limits are listed as follows Patient Type ALM HI ALM LO ADU 42 C 107 6 F 35 5 C 95 9 F PED 42 C 107 6 F 35 5 C 95 9 F AG alarm limits are listed as follows Patient Type ALM HI ALM LO ADU FiCO 25 0 0 0 EtCO 25 0 0 0 FiO2 88 0 18 0 EtO2 90 0 18 0 FiN20 100 0 0 0 EtN20 100 0 0 0 EtDes 18 0 0 FiDes 18 0 0 44 Patient Monitor User Manual Alarm Information EtIso 5 096 096 Filso 5 096 096 EtHal 5 0 0 FiHal 5 0 0 EtSev 8 0 0 FiSev 8 0 0 EtEnf 5 0 0 FiEnf 5 0 0 awRR 150 rpm 0 rpm Apnea Time 40s 20s PED FiCO 25 096 0 096 EtCO 25 096 0 0 FiO 88 0 18 0 EtO 90 096 18 096 FiN2O 100 0 0 0 EtN20 100
5. Guidance and manufacture s declaration electromagnetic immunity The monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Electromagnetic Immunity test IEC EN 60601 test level Compliance level environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 kV air 48 kV air igit Or id tile IEC EN 61000 4 2 ud DRS with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power supply 2kV for power Mains power quality transient burst lines supply lines should be that of a 167 Patient Monitor User Manual IEC EN 61000 4 4 Surge IEC EN 61000 4 5 1 kV for input output signal 1 kV for line to line 2 kV for line to ground 1 kV for input output signal 1 kV for line to line EMC Information typical commercial or hospital environment Mains power quality should be that of a typical commercial or voltage variations on power supply input lines IEC EN 61000 4 11 for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 2 kV for line to hospital environment ground Power frequency 3A m 3A m Power frequency 50 60Hz magnetic fields should 5 be at levels magnet
6. 161 Patient Monitor User Manual Product Specification Response Time lt 3 seconds Accuracy Standard Conditions GAS Measurement Range Accuracy CO 0 to 15 vol 0 2 vol 2 of reading 15 to 25 vol Unspecified NO 0 to 100 vol 2 vol 2 of reading HAL ENF ISO 0 to 8 vol 0 15 vol 596 of reading 8 to 25 vol 96 Unspecified SEV 0 to 10 vol 0 15 vol 596 of reading 10 to 23 vol Unspecified DES 0 to 22 vol 0 15 vol 596 of reading 22 to 25 vol Unspecified O2 0 to 100 vol 1 vol 2 of reading Accuracy All Conditions Gas Accuracy CO 0 3kPa 4 of reading N20 2kPa 5 of reading Agents 0 2kPa 10 of reading O 2kPa 2 of reading Apnea Alarm Delay 20s 60s Item Operating conditions Storage conditions Temperature C 5 to 50 40 70 Relative humidity lt 95 RH non condensing 5 100 RH Condensing Atmospheric 525 1200hPa 200 1200hPa pressure Interfering gas and vapor effects Gas or vapour Gas level CO Agents N20 ISA CO ISA AX N20 60 vol 2 D D zi HAL 4 vol e D m TD ENF ISO SEV 5 vol 8 of D 2 75 162 Patient Monitor User Manual gt oo e R _ S Product Specification reading DES 15 vol 12 of
7. Alarm Level Medium Alarm Record Off Alarm High Limit 0 2 ST X Alarm Low Limit 0 2 ST X X stands for I II III aVR aVL aVF V V1 V2 V3 V4 V5 or V6 ARR Analysis ARR Analysis On 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 RONT On Medium Off VT gt 2 On Medium Off COUPLET On Medium Off PVC On Medium Off BIGEMINY On Medium Off TRIGEMINY On Medium Off TACHY On Medium Off BRADY On Medium Off MISSEDBEATS On Medium Off IRR On Medium Off PNC On Medium Off PNP On Medium Off VBRADY On Medium Off VENT On Medium Off C 4 RESP RESP Settings ADU PED NEO Alarm Switch On 172 Patient Monitor User Manual Default Settings Alarm Record Off Alarm Level Medium Alarm High Limit 30 30 100 Alarm Low Limit 8 8 30 Apnea Time 20s Calculation Type Auto Resp Type II Sweep 12 5mm s Amplitude 1 C 5 SpO SpO Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 100 100 95 Alarm Low Limit 90 90 88 Pitch Tone On Sweep 12 5mm s C 6 PR PR Settings ADU PED NEO PR Source SpO Alarm Switch On Alarm Record Off Alarm Level Mediu
8. All analysis results or waveforms can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see the analysis results or waveforms that do not fit in the current view by selecting and pressing the symbol Y and displayed on the 12 lead analysis review interface 20 6 2 Deleting Diagnosis Results The user can delete the analysis results displayed on the current screen by selecting Delete on the interface 20 6 3 Switching Between Waveforms and Results The user can review the analysis waveforms on the analysis result interface by selecting the Wave option and review the analysis results on the analysis waveform interface by selecting the Results option 20 6 4 Recording The monitor can record the 12 lead diagnosis waveforms or results displayed on the current screen To do so press Record on the interface For the detailed information about recording the diagnosis waveforms or results please refer to Chapter Recording 118 Patient Monitor User Manual Calculation and Titration Table Chapter 21 Calculation and Titration Table The monitor provides calculation function and titration table Calculations are patient data that are not directly measured but calculated by the monitor The monitor can perform drug calculation Hemodynamic calculation is not described in this Instructions for Use To perform one calculation select Menu gt Common Function gt Dr
9. widthScm CE 01 59 473003 10 Connecting Tube for Neonatal Cuff Only compatible with Neonatal Disposable and NIBP Tube CUFF HOSE NO 3 length3 5m CE 28 4 Temp Accessories Part Number Accessories 01 57 040185 Skin Temperature Probe 2 252KQ 01 57 040187 Skin Temperature Probe 10KQ 01 57 040184 Rectal Oral Temperature Probe 2 252K 2 01 57 040186 Rectal Oral Temperature Probe 10K 28 5 Quick Temp Accessories Part Number 02 04 110140 Accessories Oral Auxiliary Probe 02 04 110139 Rectal Probe 11 57 110159 Probe Covers 28 6 IBP Accessories Part Number Accessories 01 57 471014 IBP cable BD IBP cable used with 682000 sensor 01 57 471013 Aidehua IBP cable used with PX260 sensor 11 57 40121 Disposable pressure transducer kit BD DT 4812 01 57 471027 10 IBP cable used with 42584 sensor 01 57 471028 10 IBP cable used with DPT 248 sensor 28 7 CO Accessories Part Number Accessories 12 08 078137 Respironics ECCO Module Side stream 1022054 12 08 078166 LoFloTM Module Mounting Bracket Respironics 1027730 11 57 078139 Disposable CO Nasal Cannula Adult Respironics 3468ADU 00 11 57 078151 Adult Pediatric Airway adapter kit with dehumidification tubing 11 57 078154 Disposable Sampling Line Kit with Dehumidification Tubi
10. 11 4 Using Pulse Alarms You can change pulse rate alarm limits in the PR Setup menu by selecting Alarm Setup Pulse alarms are only generated when the active alarm source is set to PR a pulse source is set as system pulse and pulse alarms are switched on 11 5 Selecting the Active Alarm Source In most cases the HR and Pulse numerics are identical In order to avoid simultaneous alarms on HR and Pulse the monitor uses either ECG or Pulse as its active alarm source To change the alarm source select Alarm Source in the ECG Pulse Alarms menu then select HR if you want HR to be the alarm source for HR Pulse PR if you select Pulse as the active alarm source the monitor will prompt you to confirm your choice Be aware that if you select Pulse as the alarm source all arrhythmia and ECG HR alarms are switched off AUTO if the Alarm Source is set to Auto the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without an technical alarm condition The monitor will automatically switch to Pulse as the alarm source 73 Patient Monitor User Manual Monitoring NIBP Chapter 12 Monitoring NIBP 12 1 Overview This monitor uses the oscillometric method for measuring NIBP It can be used for adult pediatric and neonatal patients Oscillometric devices measure the amplitude of pressure changes in the occluding cuff a
11. 7s 8s average is 7 5s HR range 80bpm 40bpm Range 7s 8s average is 7 5s Tall T wave Rejection Exceeds ANSI AAMI EC13 2002 Sect 4 1 2 1 C minimum recommended 1 2mV T Wave amplitude Accuracy of Heart Rate Meter and Response to Irregular Rhythm Complies with ANSI AAMI EC13 2002 Sect 4 1 2 1 e The HR value displays after a stable period of 20s According with ANSI AAMI EC13 2002 Sect 4 1 2 1 e Ventricular bigeminy 80bpm 1bpm Slow alternating ventricular bigeminy 60bpm 1bpm Rapid alternating ventricular bigeminy 120bpm 1bpm Bidirectional systoles 91bpm 1bpm 16 different analyses arrhythmia Non Paced Patient Paced Patient ASYSTOLE Ron T ASYSTOLE VFIB VTAC PVC TACHY 152 Patient Monitor User Manual Product Specification COUPLET TACHY BRADY VT gt 2 BRADY PNC BIGEMINY MISSED BEATS PNP TRIGEMINY IRR VENT VBRADY 12 lead ECG Synchronization Analysis Average parameters of heart beat Heart rate bpm Time limit of P wave ms PR interval ms QRS interval ms QT QTC ms P QRS T AXIS ECG Analog Output Bandwidth 3dB Max transmission delay Diagnosis 0 05Hz 100Hz Monitor 0 5Hz 40Hz Surgery 1Hz 20Hz 500ms in diagnostic mode and with notch off Sensitivity 1V mV 10 PACE rejection enhancement Without Pace enhancement or pace rejection Defib Sync Pulse O
12. For example you might be able to access an item through its on screen setup menu via a hard key or via a shortcut key The User Manual always describes how to access items via an on screen menu You may use whichever way you find most convenient 1 2 3 a a Li 17 cm 2009 11 12 09 18 32 4 wt i Ga e E s MEN t ii Trend Graph Trend Table Alarm Rec ll NIBP Recall TrendScreen oxyCRG View Bed S A 16 15 14 13 12 1110 9 8 mO Department Bed number Patient name Patient type Alarm status area Alarm off Measurement value Menu CO o AE Dj tA A N Scroll right to display more shortcut keys 16 Patient Monitor User Manual Basic Operation 10 Date and time 11 Networking symbol 12 Battery status symbol 13 AC power supply symbol 14 Shortcut key area 15 Scroll left to display more shortcut keys 16 Mute key 17 Parameter waveform 3 2 1 Using Keys The monitor has four different types of keys 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 XI Mute key close the audio alarm to switch off the alarm 3 2 1 2 Shortcut Keys A shortcut key is a configurable graphical key located at the bottom of the main screen It gives you fast access to functions The selection of shortcut keys available on your monit
13. 0 0 0 EtDes 18 0 0 FiDes 18 0 0 EtIso 5 096 096 Filso 5 0 0 EtHal 5 0 0 FiHal 5 0 0 EtSev 8 0 0 FiSev 8 0 0 EtEnf 5 0 0 FiEnf 5 0 0 awRR 150 rpm 0 rpm Apnea Time 40s 20s NEO FiCO 25 0 0 0 EtCO 25 096 0 096 FiO 88 0 18 0 EtO 90 0 18 0 45 Patient Monitor User Manual FiN 0 EtN O EtDes FiDes Etlso Filso EtHal FiHal EtSev FiSev EtEnf FiEnf awRR Apnea Time 100 096 100 096 18 0 18 0 5 0 5 0 5 0 5 0 8 0 8 0 5 0 5 0 150 rpm 40 s 0 096 0 096 096 096 096 096 096 096 096 096 096 096 0 rpm 20s Alarm Information 46 Patient Monitor User Manual Managing Patients Chapter 6 Managing Patients 6 1 Admitting a Patient The monitor displays physiological data and stores it in the trends as soon as a patient is connected This allows you monitor a patient who is not yet admitted It is however important to admit patients properly so that you can identify your patient on recordings reports and networked devices During admission you enter data that the monitor needs for safe and accurate operation For example the patient category setting 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 1l Selelct the Admission key on the screen or 2 Select Menu Patient Setup New Pa
14. 104 F and substances listed below Never use strong solvents such as acetone or trichloroethylene Approved Cleaning Substances are Hospital Grade Ethanol 25 2 2 6 Other Accessories For cleaning other accessories please contact the manufactures for details 25 3 Disinfection WARNING Do not mix disinfecting solutions such as bleach and ammonia or it may produce hazardous gases To avoid extended damage to the equipment disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule Disinfection facilities should be cleaned first Recommended types of disinfecting agents are m Alcohol m Aldehyde CAUTION Do not use EtO gas or formaldehyde to disinfect the monitor 133 Patient Monitor User Manual Maintenance Chapter 26 Maintenance WARNING 1 Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 2 If you discover a problem with any of the equipment contact your service personnel or your authorized supplier 26 1 Inspecting The overall check of the monitor including the safety check should be performed only 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 d
15. 11 NIBP Cuff Infant 10cm 19cm reusable 01 57 471157 11 57 40074 NIBP Cuff Larger Adult 33cm 47cm reusable 11 57 40029 NIBP Cuff Adult 25cm 35cm reusable 11 57 40020 NIBP Cuff Infant 10cm 19cm reusable 11 57 40018 NIBP Cuff Child 18cm 26cm reusable NIBP Cuff Neonatal 3cm 6cm disposable Suntech 01 57 471158 NIBP Cuff Neonatal 4cm 8cm disposable Suntech 01 57 471159 NIBP Cuff Neonatal 6cm 11cm disposable Suntech 01 57 471160 NIBP Cuff Neonatal 7cm 13cm disposable Suntech 01 57 471161 NIBP Cuff Neonatal 8cm 15cm disposable Suntech M3600 01 59 102099 01 57 471078 10 OMRON NIBP Tube 3 5m CUFF HOSE NO 1 length3 5m CE OMRON CUFF CUFF NO 1 arm12 18cm width7cm LATEX CE 01 57 471079 10 OMRON CUFF CUFF NO 2 arm17 23cm width9cm LATEX CE 01 57 102100 OMRON CUFF CUFF NO 3 arm23 33cm widthl2cm LATEX CE 01 57 471080 10 OMRON CUFF CUFF NO 4 arm30 40cm widthl4cm LATEX CE 01 57 471081 10 OMRON Neonatal disposable cuff CUFF NO 10 arm3 5 6cm width2 5cm CE 01 57 471082 10 OMRON Neonatal disposable cuff CUFF NO 11 arm5 7 5cm width3cm CE 01 57 471083 10 OMRON Neonatal disposable cuff CUFF NO 12 arm7 5 10 5cm width4cm CE 139 Accessories Patient Monitor User Manual Accessories 01 57 471084 10 OMRON Neonatal disposable cuff CUFF NO 13 arm8 5 13cm
16. 3 Seine me Indek ss co cca cachet ano id ace aom 117 INI dicas a att 117 20 5 LS crolltne te SCEOETIS ode ig nla ees sumet c uL M oM 117 2016 12 lead DAMOS REVIEW Sot sheet tasso os ea 118 20 6 1 Scrolling the Screen siria e ani ias 118 20 6 2 Deleting Diagnosis Results a A AA A ete ees 118 20 6 3 Switching Between Waveforms and Results eee 118 20 6 4 NWTUOCIUP 118 Chapter 21 Calculation and Titration Table c ecce ee eee eee ee ee ee ee eere ee eee sette seta sesta 119 2 TT Dog Calculation ses ste E E E E 119 21 1 I Calculation PrOOGQUEIES aa 119 ZI T2 Calculatton E Is oed eas ind O ME 120 21 2 Itration a RUE Oud teu od e A ode cM D I e eed 120 Chapter 22 RECURRE e OE sossa s Pep 121 22 1 General Information id dianas 121 222 Performance of th Recorder O ee acu M Vit 121 DIED Recordins ia 122 22 4 Starting and Stopping Recording essen nennen enne enne 122 22 5 Recorder Operations and Status Messages eesesseseeeeeeenen nennen 123 22 5 I Record Paper Requitement a5 eroe ha tor ores ede bres dial dee tae apro 123 22 52 Proper Operatioti sra dd 123 22 MeO Paper QUE c sitos ouo et ote gu D code ete iO 123 22 34 Replacing Papet sico 123 22 3 9 REMOVING PAE oa 124 Chapter 23 Other EUncCHOS ase te n ri Ei PR ERN E RE E 126 231 NES e ds 126 Chapter 24 Using Battery A
17. 3 phase power output NOTE Connect the power line to the jack special for hospital usage 2 4 Checking Out the Monitor Make sure there is no damage on the measurement accessories and cables Then turn on the monitor check whether the monitor can start normally Make sure all alarm lamps light up and the alarm sound is heard when turning on the monitor Patient Monitor User Manual Installation WARNING If any sign of damage is detected or the monitor displays some error messages do not use it on any patient Contact Customer Service Center immediately NOTE 1 Check all the functions of the monitor and make sure that 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 POWER switch should be longer than 1 minute 4 After continuous 360 hour runtime please restart the monitor to ensure the monitor s steady performance and long lifespan 2 5 Checking the Recorder If your monitor is equipped with a recorder open the recorder s door to check if paper is properly installed in the slot If no paper exists refer to Chapter Recording for details 2 6 Setting the Date and Time To set the date and time 1 Select Menu gt System Setup gt Date Time Setup 2 Adjust the date display format based on the user s habit 3 Set the correct time of year month day hour min an
18. 6 0 6 0 Alarm Low Limit FIAA 0 0 0 0 0 0 Alarm High Limit EtN2O 55 55 55 Alarm Low Limit EtN20 0 0 0 Alarm High Limit FIN20 53 53 39 Alarm Low Limit FINO 0 0 0 Alarm High Limit EtO 90 0 90 0 90 0 Alarm Low Limit EtO 18 0 18 0 18 0 Alarm High Limit FiO 88 0 88 0 88 0 Alarm Low Limit FiO 18 0 18 0 18 0 Sweep 12 5mm s Amplitude 2 177 Patient Monitor User Manual D Abbreviations Abbreviation Abbr English Full Name Description AC Alternating current Adu Adult AG Anaesthesia gas Art Arterial aVF Left foot augmented lead aVL Left arm augmented lead aVR Right arm augmented lead awRR Airway respiration rate BP Blood pressure BTPS Body temperature and pressure saturated CI Cardiac index C O Cardiac output CISPR International Special Committee on Radio Interference CMS Central monitoring system CO Carbon dioxide COHb Carboxyhemoglobin CVP Central venous pressure DC Direct current Des Desflurane Dia Diastolic ECG Electrocardiogram EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnetic interference Enf Enflurane ESU Electrosurgical unit Et End tidal EtCO End tidal carbon dioxide EtN20 End tidal nitrous oxide 178 Abbreviation Patient Monitor
19. 92 16 4 Setting COs Waverton cup dais 94 16 3 Setting CO Corrections tonada 94 16 6 Changing COMAS io ente Ee M NRE E aE mctu toi e Im bud 94 16 7 Changing Apnea Alarm onore ln ba INMEAT Sa ek rinden 94 Chapter 17 Monitoring C O iecore P RERO VES HARNESS AMI nus tates QU eR Ape cR KE cons hea Ne PER Ud 96 VOVE ES 96 17 2 C O Safety Information adidas 96 17 3 TO Monitoring Procedures 2 o os 96 174 C C Measurement WIHOOW su oce it iste eise oe adeste f e 97 17 5 Measurement PLOCeSS nasadol Geta edit as bises aetate tetti ie nachts usta se 99 ia ds up PPP S 99 17 7 Blood Temperature MOWIOEID ot Ebert INESSE Eae eon eee Rs eee i 100 17 8 Setting the Computation Consta HM tak etadege 101 17 9 Recording C O Measurements merci rondan eR REST URY oben sais 101 17 10 Setting INJ TEMPBSQUEGG tati 101 Chapter I8 Monitoring AG iie eee eritea iio direcion 102 EMO Sa Lo A Eii 102 182 ANS Eye ONO a AS 102 18 2 1 Safety Information For ISA Analyzer ttt ista 102 18 2 2 Safety Information for IRMA Module serene 104 183 NTOBICOTIHS EPS AE 105 18 3 1 Monitoring Steps for ISA AnalyZeT oonocononoccconncccnnnncononacononacononanonononnonancnonannnonos 105 18 3 2 Monitoring Steps for IRMA Module eese 107 184 SEUA Work OTS ag E MCN AP PR 110 E e wad cs e a Uatd 111 18 6 Setting ApneaAlarm A a 111 18 7 Working Status of ISA anal Zeb aon a
20. AMINOPHYLLINE g mg mcg DOBUTAMINE DOPAMINE EPINEPHRINE ISUPREL LIDOCAINE NIPRIDE NITROGLYCERIN DRUG D PITOCIN HEPARIN Ku mu Unit DRUG E mEq When defining a drug select Drug A Drug B Drug C Drug D and Drug E based on the unit series NOTE 1 The drug calculation is displayed as invalid value before the user edits the drug name and patient weight and the user can t enter any value 2 Drip Rate and Drop Size are invalid in the neonatal mode 21 2 Titration Table After completing the drug calculation the user can open the Titration on the Drug Dose interface The user can change the following items in the titration table Basic Step Dose Type The data in the trend table will vary with the changes above And the user can perform the following Scroll up and down the screen by selecting and pressing the symbol Y and displayed on the trend graph O Record the data displayed in the current window by selecting Record 120 Patient Monitor User Manual Recording Chapter 22 Recording 22 1 General Information A thermal dot matrix recorder is used for the monitor and can support many recording types and output patient information measurement data review data waveform and so forth 3 4 1 Recording indicator 2 Recording key press this key to start or stop recording task 3 Paper outlet 4 Recorder Door 22 2 Performance of the Re
21. Comm Fail ECG iocus pue or High module and pouty communication failure biomedical engineer or manufacturer s service staff Check lead i E i ignal i i ECG Noise n oM Signal aS Low connection and greatly interrupted ta patient condition ECG electrode V1 falls off ECG V1 Lead Off the skin or ECG cables fall Low off ECG electrode V2 falls off ECG V2 Lead Off the skin or ECG cables fall Low off ECG electrode V3 falls off ECG V3 Lead Off pe skin or ECG cables fall Low Wake sute hac all D electrodes leads and ECG electrode V4 falls off dna ens Pu ECG V4 Lead Off the skin or ECG cables fall Low propery connected off ECG electrode V5 falls off ECG V5 Lead Off the skin or ECG cables fall Low off ECG electrode V6 falls off ECG V6 Lead Off the skin or ECG cables fall Low off Stop measuring function of RESP RESP Comm Fail RESP module failure or High module and notify communication failure biomedical engineer or the manufacturer s service staff 2313 Patient Monitor User Manual SpO Sensor Off SpO sensor may be disconnected from the patient or the monitor Low Alarm Information Make sure the sensor is well connected to the patient s finger or other parts SpO No Sensor SpO2 sensor was not connected well or connected to the monitor or the connection is loose Low Make sure the monitor and sensor is well connected reconnect the sensor SpO Comm Fail
22. Do not use adult pediatric type sampling line configurations with infants as this may add dead space to the patient circuit 9 Do not use infant type sampling line configurations with adults as this may cause excessive flow resistance 10 Do not use the ISA analyzer with metered dose inhalers or nebulized medications as this may clog the bacteria filter 11 Check that the gas sample flow is not too high for the present patient category 12 Since a successful zeroing requires the presence of ambient air 21 O2 and 0 CO in the gas analyzer ensure that the ISA is placed in a well ventilated place Avoild breathing near the ISA sidestream gas analyzer before or during the zeroing procedure 13 The Nomoline sampling line and its interfaces are non sterile devices To avoid damage do not autoclave any part of the sampling line 102 Patient Monitor User Manual Monitoring AG WARNING 14 Never sterilize or immerse the ISA analyzer in liquid 15 Measurements can be affected by mobile and RF communications equipment Make sure that the ISA analyzer is used in the electromagnetic environment specified in this manual 16 ISA analyzer is intended only as an adjunct in patient assessment It must be used in conjunction with other assessments of clinical signs and symptoms 17 Replace the sampling line if the sampling line input connector starts flashing red or a Nomoline occulsion message is displayed on the host 18 No modificati
23. FiHAL High FiHAL measuring value is above upper alarm limit User selectable FiHAL Low FiHAL measuring value is below lower alarm limit User selectable EtENF High EtENF measuring value is above upper alarm limit User selectable EtENF Low EtENF measuring value is below lower alarm limit User selectable FiENF High FiENF measuring value is above upper alarm limit User selectable FiENF Low FiENF measuring value is below lower alarm limit User selectable EtISO High EtISO measuring value is above upper alarm limit User selectable EtISO Low EtISO measuring value is below lower alarm limit User selectable FilSO High FIISO measuring value is above upper alarm limit User selectable FilSO Low FiISO measuring value is below lower 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 measuring value is above upper alarm limit User selectable FiSEV Low FiSEV measuring value is below lower alarm limit User selectable EtDES High EtDES measuring value is above upper alarm limit User selectable EtDES Low EtDES measuring value is below lower alarm limit User selectable FiDES High FiDES measuring value is above upper alarm limit User selectable 29 Patient Monitor User Manual Alarm Information FiDES Low FiDES measuring value is below lower alarm limit User selectable AG FiO Low FiO meas
24. Full Scr and Half Scr Select Normal to display two ECG waveforms on the main screen select Full Scr to display seven ECG waveforms which occupy the area of seven waveforms on the main screen Select Half Scr 60 Patient Monitor User Manual Monitoring ECG to display seven ECG waveforms on the screen occupying the area of four waveforms NOTE If 3 Leads is selected in the ECG Setup menu only Normal can be selected for Display in the sub menu 8 9 5 Setting Pace Status It is important to set the paced status correctly when you start monitoring ECG To change the paced status in the ECG Setup menu select Pace to toggle between On or Off When Pace is set to On Pace Pulse Rejection is switched on This means that pacemaker pulses are not counted as extra QRS complexes Paced symbol is displayed as on the main screen NOTE 1 When monitoring a patient with a pacemaker set Pace to On If monitoring a patient without a pacemaker set Pace to Off 2 If Pace is set to On the system will not perform some types of ARR analysis WARNING Some pace pulses can be difficult to reject When this happens the pulses are counted as a QRS complex and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias Keep pacemaker patients under close observation 8 9 6 ECG Calibration This item is used to calibrate ECG waveform When you select this item from ECG Setup menu again the ECG waveform
25. Output wave Square pulse Output impedance 500 Delay from R wave peak to s of pulse tart pS 35ms High level 3 5 to 5 V providing a maximum of 1 mA output current Amplitude Low level lt 0 5V receiving a maximum of 5 mA input current Mini inimum required R wave 03mV amplitude Pulse width 100ms 10 Limited current 15 mA rating Rising and falling time lt 1 ms A 8 2 12 lead Monitoring 3 Lead I IL III Lead Mode 5 Leads I II III aVR aVL aVF V 12 Lead I IL III aVR aVL aVF V1 V2 V3 V4 V5 V6 Waveform 3 Lead 1 channel waveform 5 Lead 2 channel waveform a maximum of seven waveforms 12 Lead 2 channel waveform a maximum of 13 waveforms Lead naming style AHA IEC Display Sensitivity 1 25mm mV x0 125 2 5mm mV_ x0 25 5mm mV x0 5 10mm mV x1 20mm mV x2 AUTO gain Bandwidth 3dB Diagnosis 0 05Hz to 150Hz 149 Patient Monitor User Manual Product Specification Monitor 0 5Hz to 40Hz Surgery 1Hz to 20Hz CMRR Common Mode Rejection Ratio Diagnosis gt 95dB the Notch filter is off Monitor gt 105dB the Notch filter is on Surgery gt 105dB the Notch filter is on Notch SOHZ 60Hz Notch filter can be turned on or off manually Differential Input 5MO Impendance Input Signal Range 8mV PP Accuracy of Input Signal Reconstruction The total error and frequency r
26. Select On in the menu to enable prompt message when an alarm occurs select Off to disable the alarm function and there will be a symbol A beside PVCs 64 Patient Monitor User Manual Monitoring ECG WARNING When the PVCs Alarm is set to 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 8 11 2 3 ARR Relearning Pick this item to start a learning procedure and ECG ARR LEARNING is displayed on the screen The ECG ARR LEARNING will start automatically in the following status Changing lead type Connectiong leads Updating the patients Starting ARR learning manually After the ARR analysis is switched on The module is set to on Calibration mode is changed to nomoral measurement mode Exiting the Demo mode Exiting the standby mode 8 11 2 4 ARR Alarm The users can switch on or off all arrhythmia alarms by selecting ECG Setup gt ARR Analysis gt ARR Alarm And some arrhythmia alarms can be individually switched on or off They are ASYSTOLE VFIB VTAC R ON T VT gt 2 COUPLET PVC BIGEMINY TRIGEMINY TACHY BRADY MISSED BEATS IRR PNC PNP VBRADY and VENT To switch individual alarm on or off select ECG Setup ARR Analysis ARR Alarm The user can set the individual ARR alarm from the popup interface 8 12 12 Lead ECG Monitoring 8 12 1 Diagnosis Function If iM80 is equipped with 12 le
27. Setting CO Corrections Temperature water vapor in the patient s breath barometric pressure and the proportions of O N20 and Helium in the mixture all influence CO absorption If values seem inaccurately high or low check that the monitor is using the appropriate corrections There are Baro Press O Compens Balance Gas and Anes Agent in the Other Setup menu of the CO2 Setup menu and the user can select the desired item 16 6 Changing CO Alarms This refers to CO specific alarms See the Alarms section for general alarm information To change the alarm please refer to the following steps 1 Select the CO Setup menu 2 Select EtCO Alarm Setup FiCO Alarm Setup or AwRR Alarm Setup to adjust the alarm limit About how to adjust the alarm limit please refer to section Setting alarm limits 16 7 Changing Apnea Alarm This determines the time limit after which the monitor gives an alarm if the patient stops breathing 1 Select the CO Setup menu to open it 94 Patient Monitor User Manual Monitoring CO 2 Select Apnea Alm from the menu 3 Choose the apnea alarm time from the pop up list WARNING Safety and effectiveness of the respiration measurement method in the detection of apnea particularly the apnea of prematurity and apnea of infancy has not been established 05 Patient Monitor User Manual Monitoring C O Chapter 17 Monitoring C O 17 1 Overview The Cardiac Output C O measuremen
28. Setting Resolution The monitor can support five kinds of resolutions To set an apprioate resolution please select Menu Review Trend Graph and an interface is displayed Choose Resolution on the interface to open the list and select an apprioate resolution among 1 sec 5 sec 1 min 5 min and 10 min 20 1 3 Scrolling Left and Right the Screen All trend graphs can t be displayed on the current screen due to the screen limitation The user 115 Patient Monitor User Manual Review can scroll left and right the screen manually to see measurement trends that do not fit in the current view by selecting and pressing the symbol and displayed on the trend graph 20 1 4 Switching to the Trend Table The user can switch to the trend table interface on the Trend Graph interface To do so please select Menu gt Review gt Trend Graph and select the Trend Table option from the popup interface 20 1 5 Record The monitor can make a tabular trend recording of the data in the current trend graph window The report will use the current trend interval settings For the detailed information about recording the trend graph please refer to Chapter Recording 20 2 Trend Table Review To review the trend table please press the Trend Table key on the screen or select Menu gt Review gt Trend Table then the trend table is displayed NOTE The CO module and AG module can not be measured at the same time so their trend graph can
29. Ventricular Tachycardia Gain 1 0 10 s 1 mV 206bpm Gain 0 5 10 s Gain 2 0 10 s Ventricular Tachycardia Gain 1 0 10 s 2 mV 195bpm Gain 0 5 10 s Gain 2 0 10 s Response time of Heart Rate Meter to Change in HR HR range 80 bpm 120 bpm Range 7s 8s average is 7 5s HR range 80bpm 40bpm Range 7s 8s average is 7 5s Tall T wave Rejection Accuracy of Heart Rate Meter and Response to Irregular Rhythm Exceeds ANSI AAMI EC13 2002 Sect 4 1 2 1 C minimum recommended 1 2mV T Wave amplitude Complies with ANSI AAMI EC13 2002 Sect 4 1 2 1 e The HR 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 91bpm 1bpm 16 different arrhythmia analyses Non Paced Patient Paced Patient ASYSTOLE Ron T ASYSTOLE VFIB VTAC PVC TACHY COUPLET TACHY BRADY VT gt 2 BRADY PNC BIGEMINY MISSED BEATS PNP TRIGEMINY IRR VENT VBRADY 148 Patient Monitor User Manual Product Specification ECG Analog Output Bandwidth 3dB Diagnosis 0 05Hz 100Hz Monitor 0 5Hz 40Hz Surgery 1Hz 20Hz Maximum transmission delay 500ms in diagnostic mode and with notch off Sensitivity PACE rejection enhancement 1V mV 10 Without Pace enhancement or pace rejection Defib Sync Pulse
30. When the sensor is used to neotate as recommendation the specified accuracy range of the neotate is always higher 1 than adult Pulse Rate Measuring Range 20bpm 300bpm Resolution 1bpm Accuracy 3bpm 20bpm 250bpm Sensor Wave length approximately 660 and 900nm Emitted light energy 15mW A 12 TEMP Channel 2 Sensor type YSI 10K and YSI 2 252K Measuring Range 0 C 50 C 32 F 122 F Resolution 0 1 C 0 1 F Accuracy Without sensor 0 1 C or 40 2 F Refresh Time Every 1s 2s 157 Product Specification Patient Monitor User Manual A 13 Quick TEMP Measuring Range 25 C 45 C 77 F 113 F Operating Temp 10 C 40 C 50 F 104 F Sensor Type Oral Axillary sensor Rectal sensor Resolution 0 1 C 0 1 F Accuracy 0 1 C 25 C 45 C or 0 2 F 77 F 113 F Response time lt 60s Update time ls 2s A 14 IBP Pressure measuring range 50 to 300 mmHg Resolution mmHg Accuracy without sensor 2 or 1 mmHg whichever is greater Pressure sensor Sensitivity 5 uV V mmHg Impedance 300 to 3000 Q Frequency response d c to 12 5 or 40 Hz Zero Range 200 mmHg Accuracy 1 mmHg Measuring range Art 0 mmHg to 300 mmHg PA 6 to 120mmHg CVP RAP LAP ICP 10 to 40 mmHg P1 P2 50 to 300 mmH
31. and methods listed in this chapter to clean or disinfect your equipment Warranty does not cover damage caused by using unapproved substances or methods EDAN makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection Consult your hospital s Infection Control Officer or Epidemiologist for control infection 25 1 General Points Keep your monitor cables and accessories free of dust and dirt To prevent the device from damage please follow the procedure Always dilute according to the manufacturer s instructions or use lowest possible concentration Do not immerse any part of the equipment or any accessories in liquid Do not pour liquid onto the system Never use bleach Do not allow liquid to enter the case Never use abrasive material such as steel wool or silver polish CAUTION If you spill liquid on the equipment battery or accessories or they are accidentally immersed in liquid contact your service personnel or EDAN service engineer 25 2 Cleaning WARNING Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line 25 2 1 Cleaning the Monitor Regular cleaning of the monitor enclosure and the screen is strongly recommended The solutions recommended for monitor cleaning are soft soap water Tensides Ethylate and Acetaldehyde WARNING 1 Unplug the monitor from the AC power source and det
32. battery reflects the battery performance If the running time is obviously less than the specified time in the specification please change the battery or contact the service personnel WARNING 1 Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions thoroughly 2 Do not connect the positive and negative terminals with metal objects and do not put the battery together with metal object which can result in short circuit Do not unplug the battery when monitoring Do not heat or throw battery into a fire 127 9 Patient Monitor User Manual Using Battery WARNING Do not use leave battery close to fire or other places where temperature may be above 60 C Do not immerse throw or wet battery in water seawater Do not destroy the battery do not pierce battery with a sharp object such as a needle Do not hit with a hammer step on or throw or drop to cause strong shock Do not disassemble or modify the battery Use the battery only in the monitor Do not connect battery directly to an electric outlet or cigarette lighter charger Do not solder the leading wire and the battery terminal directly 10 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 leaks of the battery splash onto your skin or clothes wash well with fresh water
33. calibration Please enter User Mode Maintain NIBP Maintain and switch to Maintain Mode to perform leak tset or pressure calibration Please Switch To Normal Mode NIBP module is in maintain mode the user can t start blood pressure measurement Please enter User Maintain gt NIBP Maintain and switch to Normal Mode to perform blood pressure measurement Quick TEMP Is Warming Up Quick TEMP Is Warming Up Place Probe On Measure Place Probe isn t placed on the measurement site CO Standby Turn from measuring mode to standby mode making the module in energy saving status CO Sensor Warm Up The CO module is in warm up state Excessive C O Temp TB measuring value is beyond measuring range 41 Alarm Information Patient Monitor User Manual Excessive Temp C O Measurement Fail C O measuring needs parameters C O measure need param HEMOD calculation needs parameters Insufficient factors for Hemod Dynamics HEMO Dynamics calculation needs parameters No Sensor C O measurement fail No Sensor C O measurement fail Measuring The C O module is performing measuring Ready for new measurement C O module is ready for new measurement Invalid C O result C O measurement result is invalid C O Measurement Complete C O Measurement is completed C O Measurement Abort C O Measurement is aborted Warm up
34. combine with oxygen then the blood has a SpO oxygen saturation of 97 The SpO numeric on the monitor will read 97 The SpO numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin The SpO2 PLETH parameter can also provide a pulse rate signal and a plethysmogram wave 10 2 SpO Safety Information WARNING 1 If the SpOs sensor can not work properly please reconnect the sensor or change a new one 2 Do not use the sterile supplied SpO sensors if the packaging or the sensor is damaged and return them to the vendor 3 Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity rubescence vesicle repressive putrescence and so on It is especially important to check the sensor placement of neonate and patient of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin More frequent examinations may be required for different patients 4 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor more than 4 hours Inspect the sensor periodically according to the sensor user manual 5 Neonate SpO sensor can only be used when required no more than 20 min at a time 6 Use only EDAN permitted sensors and extension cables with the moniter Other sensors or extension cables may cause improper monitor p
35. from the predefined analog data not the truly monitoring patients data History data the monitor will store the analog real time data in Demo mode including trend data patient information alarm event waveform and setting To exit Demo Mode select Menu Common Function Demo Mode to exit WARNING This is for demonstration purposes only You must not change into Demo Mode during monitoring In Demo Mode all stored trend information is deleted from the monitor s memory 3 3 2 Standby Mode Standby mode can be used when you want to temporarily interrupt monitoring To enter standby o mode please press the shortcut key on the screen directly To resume monitoring select anything on the screen or press any key 3 4 Changing Monitor Settings 3 4 1 Adjusting Screen Brightness To change the screen brightness please Press the Brightness key on the screen directly or 2 Select Menu Common Function Brightness and select the appropriate setting for the screen brightness 10 is the brightest 1 is the least bright Your monitor may be configured with lower brightness in standby mode and also for transport to conserve battery power 3 4 2 Changing Date and Time To change the date and time please refer to Section Setting Date and Time 19 Patient Monitor User Manual Basic Operation WARNING Change to date and time will influence the storage of trend data 3 5 Adjusting Volume 3 5 1 A
36. gt Trend Table menu and press the Record button to start recording NIBP review recording Enter the Menu gt Review gt NIBP Review menu then press the Record button to start recording 12 lead diagnosis recording Select Record on the diagnosis review interface to start the recording To stop the recording press the Record button on the front panel 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 122 Patient Monitor User Manual Recording NOTE You can press the 2 button on the front panel to stop the currently recording process 22 5 Recorder Operations and Status Messages 22 5 1 Record Paper Requirement Only standard thermosensitive record paper can be used otherwise the recorder may not function the recording quality may be poor and the thermosensitive printhead may be damaged 22 5 2 Proper Operation m When the recorder is working the record paper goes out steadily Do not pull the paper outward with force otherwise the recorder may be damaged m Do not operate the recorder without record paper 22 5 3 Paper Out When the Recorder Out OF Paper alarm is displayed the recorder cannot start Please insert record paper properly 22 5 4 Replacing Paper Pull outwards the upper arc part of the recorder casing to release the casing shown in the fo
37. immediately 11 Keep away from fire immediately when leakage or foul odor is detected 12 Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor 13 Do not use a battery with serious scar or deformation 24 4 Replacing the Battery To install or replace the battery please follow the procedure P ede Battery Door Pull the battery door downwards to open it accoding to indication on it Pull the metal retainer until the battery can be removed Insert the new battery into the battery compartment Pull the metal retainer downward to fix the battery and close the battery door 128 Patient Monitor User Manual Using Battery 24 5 Recycling the Battery When the battery no longer holds a charge 1t should be replaced Remove the old battery from the monitor and recycle it properly NOTE To prolong the life of rechargeable battery it is recommended to charge it at least once every month and it must be done after the electric energy runs out 24 6 Maintaining the Battery Batteries should be conditioned regularly to maintain their useful life Discharge the battery completely once every month And remove the battery from the monitor when the monitor isn t used for a long time 129 Patient Monitor User Manual Care and Cleaning Chapter 25 Care and Cleaning Use only the EDAN approved substances
38. in accordance with your hospital policy at least once per day You must perform a zero When you use a new transducer or tubing Every time you reconnect the transducer cable to the monitor If you think the monitor s pressure readings are not correct When using a pressure module the zero information is stored in the module 15 6 Zeroing a Pressure Measurement The zeroing procedure is listed as below 1 Turn off the stopcock to the patient 2 Vent the transducer to atmospheric pressure to compensate for the static and atmospheric pressure exerted on the transducer 3 Inthe setup menu for the pressure select Zero 86 Patient Monitor User Manual Monitoring IBP 4 When you see the message Zero Ok please close the stopcock to atmospheric pressure and open the stopcock to the patient 15 7 Troubleshooting the Pressure Zeroing Taking Art for Example The status message lists the probable cause of an unsuccessful calibration Message Corrective Action Art ZERO FAIL Make sure that the transducer is not attached to the patient Art SENSOR OFF FAIL Make sure that transducer is not off and then proceed zeroing IN DEMO FAIL Make sure that the monitor is not in DEMO mode Contact service technician if necessary PRESSURE OVER RANGE Make sure that the stopcock is vented to atmosphere If the FAIL problem persists please contact service technician PULSATILE PRESSURE Make sure that th
39. interference can cause inaccuracy of the waveform 52 Patient Monitor User Manual Monitoring ECG 2 EC EN60601 1 2 protection against radiation is 3v m specifies that the electrical field density exceeding 1v m may cause measurement error in various frequencies It is accordingly suggested that do not use equipment generating electrical radiation near ECG RESP monitoring devices 3 The simultaneous use of cardiac pacemaker and other patient connected equipment may cause safety hazard 4 f the pacemaker signals are beyond the claimed range the heart rate may be calculated incorrectly 5 In the default settings of the monitor the ECG waveforms are the first two waveforms from top in the waveform area 6 For measurements in or near the heart we recommend connecting the monitor to the potential equalization system 7 For protecting environment the used electrodes must be recycled or disposed of properly 8 3 ECG Display The figure below is for reference only The symbol indicates lead name of display waveform there are other leads for selection such as I II IH aVR aVF aVL V If you want to change the lead please refer to section Selecting Calculation Lead The symbol 2 indicates waveform gain there are several options sucn as X0 125 X0 25 X0 5 X1 X2 and Auto If you want to change it please refer to section Changing the size of the ECG Wave The symbol 8 indicates Filter setting
40. is important to facilitate good electrode contact to skin 54 Patient Monitor User Manual Monitoring ECG Select sites with intact skin without impairment of any kind Shave hair from sites 1f necessary Wash sites thoroughly with soap and water Never use ether or pure alcohol because this increases skin impedance E Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease 8 6 2 Connecting ECG Cables 1 Attach clip or snap to electrodes prior to placement 2 Put the electrodes on the patient Before attaching apply some conductive jelly on the electrodes if the electrodes are not electrolyte self supplied 3 Connect the electrode lead to the patient s cable CAUTION To protect the monitor from damage during defibrillation for accurate ECG information and to protect against noise and other interference use only ECG electrodes and cables specified by EDAN 8 7 Selecting Lead Type To change the lead type please 1 Select the ECG parameter area open the ECG Setup menu 2 Set Lead Type to 3 Leads 5 Leads or 12 Leads based on the lead used 8 8 Installing Electrodes 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 corresponding lead names in America are RA LA LL RL V V1 V6 AHA American Standard IEC Europe Sta
41. of electrically radiating equipment in close proximity to the respiration measurement unit 4 Cardiogenic artifact in impedance respiration monitoring may make it difficult to detect breaths or may otherwise be counted as breaths In some instances the breath rate may also correspond to the heart rate making it difficult to determine if the signal is due to breathing or the cardiac cycle Do not rely on RESP monitoring as the sole method for detecting cessation of breathing Follow hospital guidelines and best clinical practices for apnea detection including monitoring additional parameters that indicate the patient s oxygenation status such as etCO and SpO NOTE The RESP monitoring is not recommended to be used on patients who are very active as this can cause false alarms 9 3 Resp Display Resp 30 14 67 Patient Monitor User Manual Monitoring RESP 9 4 Electrode Placement for Monitoring Resp Correct patient skin preparation techniques for electrode placement 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 selection I lead RA and LA and II lead RA and LL Electrodes Placement for 5 lead 9 5 Cardiac Overlay Cardiac activity that affects the Resp waveform is called cardiac overlay It happens when the Resp electrodes pick up impedance changes caused
42. over The monitor displays this message after taking the sensor out of the bracket and warm up is over Measure over After the Predict measuring is over the data and message display on the interface Measure time out No measuring result after the module entering Predict state for 30s AG Standby AG module is operating in the standby status 5 4 Adjustable Range of Alarm Limits ECG alarm limits are listed as follows unit bpm Patient Type ALM HI ALM LO HR ADU 300 15 PED 350 15 NEO 350 15 ST analysis alarm limits are listed as follows unit mV ALM HI ALM LO ST 2 0 2 0 PVCs alarm upper limits are listed as follows ALM HI ALM LO PVCs 10 RESP alarm limits are listed as follows unit rpm Patient Type ALM HI ALM LO ADU 120 6 42 Patient Monitor User Manual Alarm Information PED 150 6 NEO 150 6 SpO alarm limits are listed as follows unit ALM HI ALM LO SpO 100 0 PR alarm limits is listed as follows unit bpm ALM HI ALM LO PR 300 30 NIBP alarm limits are listed as follows EDAN module unit mmHg Patient Type ALM HI ALM LO ADU SYS 270 40 DIA 215 10 MAP 235 20 PED SYS 200 40 DIA 150 10 MAP 165 20 NEO SYS 135 40 DIA 100 10 MAP 110 20 NIBP alarm limits are listed as follows M3600 module unit mmHg
43. progress Steady blue light Anesthetic agent present Steady red light Sensor error Blinking red light Check adapter 18 9 N20 and O Compensations The following models need O compensation IRMA AX IRMA CO ISA AX ISA CO The following models need N20 compensation IRMA CO and ISA CO For the compensation details please refer to the following table 111 Patient Monitor User Manual Monitoring AG O2 Range SetO Range 0 30 vol 21 30 70 vol 50 70 100 vol 85 N20 Range Set N20 Range 0 30 vol 0 30 70 vol 50 18 10 Effects of humidity The partial pressure and the volume percentage of CO N20 O2 and anesthetic agents depend on the amount of water vapor in the measured gas The O measurement will be calibrated to show 20 8 vol at actual ambient temperature and humidity level instead of showing actual partial pressure 20 8 vol O corresponds to the actual O concentration in room air with 0 7 vol H20 concentration at 1013 hPa this equals for example 25 C and 23 RH The measurement of CO N20 and anesthetic agents e g all gases measured by the IR bench will always show the actual partial pressure at the current humidity level In the alveoli of the patient the breathing gas is saturated with water vapor at body temperature BTPS When the breathing gas flows through the sampling line the gas temperature will adapt to ambient before reaching
44. recommended disinfetants cidex sporicidin microzid isopropyl alcohol 70 ethanol 70 buraton liquid 25 2 2 3 Cleaning the SpO Sensor These reusable sensors should be cleaned and disinfected but never sterilized The validated cleaning agents are listed below m Mild Detergent m Salt Solution 1 25 2 2 4 Cleaning the IBP C O Cables NOTE 1 Keep the cable free of dust and dirt 2 Never immerse or soak the cable 3 Inspect the cables after cleaning CAUTION Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface After allowing the appropriate time for the agent to work as indicated by the manufacturer wipe off residues with a cloth dampened with water Clean with a lint free cloth moistened with warm water 40 C 104 F and substances listed 132 Patient Monitor User Manual Care and Cleaning below Never use strong solvents such as acetone or trichloroethylene Approved Cleaning Substances m Mild Soaps m Tenside as active cleaning agent Cables can be cleaned with a warm damp cloth and mild soap or isopropyl alcohol 25 2 2 5 Cleaning TEMP Quick TEMP Sensor CAUTION Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface After allowing the appropriate time for the agent to work as indicated by the manufacturer wipe off residues with a cloth dampened with water Clean with a lint free cloth moistened with warm water 40 C
45. sensor into the sensor bracket Ambient temp too The Sensor temperature is L measure again after OW high higher than 40 C the ambient temperature reaches normal value Put the sensor into the sensor bracket The Sensor temperature is measure again after Ambient t too L PA dnd lower than 10 C eur the ambient temperature reaches normal value 39 Patient Monitor User Manual Probe data error Probe heater error Offline NTC resistance gt R 0 C Short NTC resistance lt R 100 C Single failure Med Med Alarm Information Put the sensor into the sensor bracket take it out and measure again If the problem persists stop using measuring function of TEMP module and notify biomedical engineer or manufacturer s service staff Put the sensor into the sensor bracket take it out and measure again If the problem persists stop using measuring function of TEMP module or notify biomedical engineer or manufacturer s service staff Probe temp too high The original temperature of sensor gt 33 C amp 440 C Low Put the sensor into the sensor bracket measure again after the sensor temperature reaches normal value Temp Sensor Off After the sensor temperature reaches Predict value it descends to the value lower than Predict value Med Reconnect the sensor and make sure that the cable is properly connected Battery Low Batter
46. the V electrode to one of the indicated positions as below VI V2 V3 V4 V5 V6 V3R V6R VE V7 VIR On the 4th intercostal space at the right sterna margin On the 4th intercostal space at the left sterna margin Midway between V2 and V4 electrodes On the 5th intercostal space at the left clavicular line On the left anterior axillary line horizontal with V4 electrode On the left middle axillary line horizontal with V4 electrode On the right side of the chest in positions corresponding to those on the left Over the xiphoid position On the 5th intercostal space at the left posterior axillary line of back On the 5th intercostal space at the right posterior axillary line of back 257 Patient Monitor User Manual Monitoring ECG V Electrode Placement for 5 lead 8 8 3 Electrode Placement for 12 lead Take the American standard for example The 12 lead electrodes should be placed on extremities and chest The electrodes for extremities should be placed on the skin of legs or arms the electrodes placed on chest should follow the doctor s advice Please see the following figure 58 Patient Monitor User Manual Monitoring ECG Electrode Placement for 12 lead 8 8 4 Recommended ECG Lead Placement for Surgical Patients WARNING When using Electrosurgery ES equipment leads should be placed in a position in equal distance from Electrosurgery electrotome and the ES grounding plate to avoid cautery Elec
47. the gas analyzer As the NOMO section removes all condensed water no water will reach the ISA gas analyzer The relative humidity of the sampled gas will be about 95 If CO values at BTPS are required the following equation can be used EtCO2 BTPS EtCO2 1 2x where EtCO EtCO value sent from ISA vol 96 Pamb Ambient pressure sent from ISA kPa 3 6 Typical partial pressure of water vapor condensed between patient circuit and ISA kPa EtCO BTPS EtCO gas concentration at BTPS vol O is assumed to be room air calibrated at a humidity level of 0 7 vol H20 112 Patient Monitor User Manual Freeze Chapter 19 Freeze 19 1 Overview When monitoring a patient the user may freeze the waveforms and examine them Generally the user can review a frozen waveform of a maximum of 120 seconds The freeze function of this monitor has the following features E Freeze status can be activated on any operating screen B Once entering the Freeze status the system exits all other operating menus Besides the system freezes all waveforms in the Waveform area of the Basic Screen and also freezes Full Lead ECG waveforms and extra waveforms on the Full Lead ECG interface if any Nevertheless the Parameter area refreshes normally BM The frozen waveforms can be reviewed and recorded 19 2 Entering Exiting Freeze Status 19 2 1 Entering Freeze Status In the Non Freeze status press the button on the control
48. the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical condition The monitor will automatically switch to Pulse as the alarm source if a valid ECG lead can no longer be measured and a pulse source is switched on and available The monitor then uses the pulse rate from the measurement currently active as system pulse While Pulse is the alarm source all arrhythmia and ECG HR alarms are switched off If an ECG lead becomes available again the monitor automatically uses HR as alarm source 8 9 2 Smart Lead Off In 5 LEADS 12 LEADS mode if CH1 and CH2 can not be measured because of the lead off or other reasons it can shift to other modes to collect an ECG waveform To change smart lead off setting please select ECG Setup Smart Leadoff then a pop up menu is displayed 8 9 3 Setting Beat Volume Beat volume is from HR or PR depending on your HR alarm setting Five selections are available 0 1 2 3 4 5 5 indicates the maximum volume 0 indicates the minimum volum To change the beat volume first select ECG Setup gt Beat Volume then select an approiate volume from the pop up list 8 9 4 ECG Display It varies with Lead Type When Lead Type is set to 3 Leads Display can be set to Normal and it can display one ECG waveform on the main screen When Lead Type is set to 5 Leads Display can be set to Normal
49. there are three options monitoring surgery diagnos If you want to change it please refer to section Changing the ECG Filter Setting 8 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 Wave Setup ECG Gain then select an apprioate factor from the pop up box to adjust the ECG waveform X0 125 to make strength of ECG signal waveform of 1mV become 1 25mm X0 25 to make strength of ECG signal waveform of 1mV become 2 5mm X0 5 to make strength of ECG signal waveform of 1mV become 5mm 53 Patient Monitor User Manual Monitoring ECG XI to make strength of ECG signal waveform of 1mV become 10mm X2 to make strength of ECG signal waveform of 1mV become 20mm Auto let the monitor choose the optimal adjustment factor for all the ECG waves 8 3 2 Changing the ECG Filter Settings The ECG filter setting defines how ECG waves are smoothed An abbreviation indicating the filter type is shown underneath the lead label on the monitor display Filter settings do not affect ST measurement To change the filter setting in the ECG Setup menu select Filter and then select the appropriate setting Monitor Use this mode under normal measurement conditions Surgery The filter reduces interference to the signal It should be used if the signal is distorted by high frequency or low frequency interference High frequency inter
50. to the following figure HR Alarm Setup Upper arrow or High lower arrow to 30 increase or Switch On Y decrease the alarm Record off v Level Mid v limit Setting value of high alarm limit Setting value of Low low alarm limit el AAA PE 24 Alarm Limit TE E Alarm Limit Patient Monitor User Manual Alarms 4 4 Latching Alarms To set the alarm latch function please select Menu gt Maintenance gt User Maintain gt Alarm Setup and set Alarm Latch from the pull down list If it is set to On when an alarm occurs the monitor will display the alarm message of the parameter in the alarm status area If the parameter resumes to normal the alarm information of this parameter still displays in the alarm display area and the alarm time is also displayed If many parameters appear to be latching alarms the alarm messages are displayed in the physiological alarm message area in turn To deselect the alarm latch please set Alarm Latch to Off When Alarm Latch is set to Off the latch function is invalid 4 5 Disabling Sensor Off Alarms To set sensor off alarm please select Menu gt Maintenance gt User Maintain and enter the required password ABC Then select Alarm Setup and set Sensor Off Alm from the pull down list If it is set to On and a sensor off alarm occurs the user can press the Mute key on the front panel to disable the alarm signal Then the alarm indicator stops flas
51. to the monitor 1 Connect the USB drive to the monitor s USB port 2 Select USB Configure in the Menu Maintenance User Maintain enter the required password ABC 3 In the USB Configure menu select Import to import configuration A status message will display after the operation NOTE 1 The U disk only supports two kinds of format FAT and FAT 32 2 The exported configuration files are saved into the folder named USERCONFIG and the user can t modify files the in the folder 3 Upto three configuration files can be saved and recognized 7 10 Default Configuration To set default configuration please select Menu Default and choose a configuration adult pediatric or neonate based on your patient category This configuration is factory configuration 51 Patient Monitor User Manual Monitoring ECG Chapter 8 Monitoring ECG 8 1 Overview The electrocardiogram ECG measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric This chapter also tells you about arrhythmia monitoring and ST monitoring 8 2 ECG Safety Information WARNING 1 Do not come into contact with the patient table or the monitor during defibrillation 2 Only use the ECG leads supplied by the manufacturer when using the monitor for ECG monitoring 3 When connecting the cables and electrodes make sure no conductive part is in contact with the ground Verify that all ECG electrodes including neu
52. two consecutive 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 can not be performed until the time reduces to zero and a message Ready for new measurement appears NOTE 1 It is strongly recommended that the user must push the injector within four seconds after pressing the Start button 2 Itis strongly recommended that you wait at least 1 minute or longer depending on the patient s clinical condition before starting the next measurement Repeat this procedure until you have completed the measurements you want You can perform a maximum of six measurement editing If you perform additional measurements the earliest measurement each time will be deleted If any of the curves in the editing window is not selected for calculation excluded from the averaging calculations the place will be taken by the new measurement 17 6 Editing C O Pick the Review button on the C O Measure menu to access the Review as shown below 99 Patient Monitor User Manual Monitoring C O CO Review ahha MCO 2 40 l min IMCO 2 42 l min MCO 2 40 l min Measure Time 16 1 Measure Time 16 1 Measure Time 16 17 MCO 2 40 l min MCO 2 41 l min co Measure Time 16 1 Measure Time 16 1 Q Average CO 2 41 l min CI 1 4 l min m Window For C O Edit Contents displayed in the window QD Six cur
53. upper alarm limit User selectable TEMP Low Measuring value of TEMP is below lower alarm limit User selectable SYS High SYS measuring value is above upper alarm limit User selectable SYS Low SYS measuring value is below lower alarm limit User selectable DIA High DIA measuring value is above upper alarm limit User selectable 97 Patient Monitor User Manual Alarm Information DIA Low DIA measuring value is below lower alarm limit User selectable MAP High MAP measuring value is above upper alarm limit User selectable MAP Low MAP measuring value is below lower alarm limit User selectable Art SYS High Art SYS measuring value is above upper alarm limit User selectable Art SYS Low Art SYS measuring value is below lower alarm limit User selectable Art DIA High Art DIA measuring value is above upper alarm limit User selectable Art DIA Low Art DIA measuring value is below lower alarm limit User selectable Art MAP High Art MAP measuring value is above upper alarm limit User selectable Art MAP Low Art MAP measuring value is below lower alarm limit User selectable PA SYS High PA SYS measuring value is above upper alarm limit User selectable PA SYS Low 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 ala
54. waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product 16 Dispose of the package material observing the waste control regulations and keeping it out of children s reach 17 After defibrillation the screen display recovers within 10 seconds if the correct electrodes are used and applied based on the manufacturers instructions 18 This equipment is not intended for family usage Patient Monitor User Manual Indication for Use and Safety Guidance CAUTION Electromagnetic Interference Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones etc Keep the environment clean Avoid vibration Keep it far away from corrosive medicine dust area high temperature and humid environment Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer Do not use autoclave or gas to sterilize the monitor recorder or any accessories The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives Disposable devices are intended for single use only They should not be reused as performance could degrade or contamination could occur Remove a battery whose life cy
55. 0 mmHg 235 mmHg Pediatric mode SYS 40 mmHg 200 mmHg DIA 10 mmHg 150 mmHg MAP 20 mmHg 165 mmHg Neonatal mode SYS 40 mmHg 135 mmHg DIA 10 mmHg 100 mmHg 154 Patient Monitor User Manual Product Specification MAP 20 mmHg 110 mmHg Cuff pressure measuring range 0 mmHg 300 mmHg Pressure resolution ImmHg Maximum mean error 5mmHg Maximum standard deviation 8mmHg Maximum measuring period Adult Pediatric 120s Neonate 90s Typical measuring period 30s 45s depend on HR motion disturbance Overpressure protection Dual overpressure protection Adult 297 3mmHg Pediatric 240 3mmHg Neonatal 147 3mmHg PR Measuring range 40 bpm 240bpm Accuracy 3bpm or 3 5 whichever is greater A 10 2 NIBP from M3600 Module Method Oscillometric Mode Manual Auto Continuous Measuring Interval in AUTO Mode 1 2 3 4 5 10 15 30 60 90 min 2 4 8h PR Range Adult Pediatric mode 40bpm 200bpm Neonatal mode 40 bpm 240bpm PR Accuracy 2 bpm or 2 of the readings Measuring Type SYS DIA MAP Measuring Range Adult Pediatric Mode SYS 60 mmHg 250 mmHg DIA 40 mmHg 200 mmHg MAP 45 mmHg 235 mmHg Neonatal Mode SYS 40 mmHg 120 mmHg DIA 20 mmHg 90 mmHg MAP 30 mmHg 100 mmHg 155 Patient Monitor User Manual Product Specification
56. 01 13 210001 EDAN SpO extension cable DB9 to LEMO TPU 2M 02 01 210122 EDAN SH4 adult soft tip SpO sensor TPU finger type patient weight more than 50kg 02 01 210123 EDAN SH4 adult silicone soft tip SpO sensor finger type patient weight more than 50kg 02 01 210121 EDAN SH5 child silicone soft tip SpO sensor finger type patient weight from 10kg to 50kg 01 57 040196 Adult disposable SpO sensor patient weight more than 30kg 01 57 040197 Pediatric Disposable SpO sensor patient weight from 10 to 50kg 01 57 040198 Infant Disposable SpO gt sensor patient weight from 3 to 20kg 01 57 040199 Neonatal Disposable SpO Sensor patient weight less than 3kg NELLCOR 11 15 30043 Nellcor Reusable Adult SpO2 Sensor DS 100A OxiMax 11 15 40096 Nellcor Reusable Adult Neonate SpO Sensor OXI A N OxiMax 11 13 30131 11 Nellcor SpO2 Extension Cable Compatible with Nellcor OXI Max SpO Module and Nellcor Sensor 138 Patient Monitor User Manual 28 3 NIBP Accessories Part Number Accessories EDAN 01 59 036118 NIBP Tube 3m Grey 01 59 36036 NIBP Tube 3m Black 01 57 471021 NIBP Tube for neonatal cuff 3m 01 57 040210 11 NIBP Cuff Larger Adult 33cm 47cm reusable 01 57 040205 11 NIBP Cuff Adult 25cm 35cm reusable 01 57 040211 11 NIBP Cuff Child 18cm 26cm reusable 01 57 040212
57. 1 Select Inj Temp Source in the C O Settings menu 2 Select Auto or Manual from the list Manual directly displaying the injectate temperature from INJ TEMP e Auto indicating the system obtains the injectate temperature through sampling 101 Patient Monitor User Manual Monitoring AG Chapter 18 Monitoring AG 18 1 Overview The monitor uses ISA sidestreasm gas analyzer hereinafter called ISA analyzer and IRMA mainstream molude hereinafter called IRMA module to monitor the anesthetic gas which can be used to measure the gases of adult pediatric and neonatal patients during anesthesia recovery and respiratory care And the anesthetic gas includes Halothane HAL Isoflurane ISO Enflurane ENF Sevoflurane SEV Desflurane DES CO and N20 18 2 Safety Information 18 2 1 Safety Information for ISA Analyzer WARNING 1 The ISA analyzer is intended for use by authorized and trained medical personnel only 2 Use only Nomoline sampling lines manufactured by PHASEIN The ISA analyzer must not be used with flammable anesthetic agents Carefully route the sampling line to reduce the risk of patient entanglement or strangulation 5 Do not re use disposable sampling line 6 Do not lift the monitor by the sampling line as it could disconnect from the monitor causing the monitor to fall on the patient 7 Used disposable sampling lines shall be disposed of in accordance with local regulations for medical waste 8
58. 127 Z4 PHAdery Poseer Indic alOE 2e dti SO A O pu so E eta fc 127 24 2 Battery Status on the Main Screen s esecep eee eter Redes heb e e EUIS rr ger see etaed 127 24 3 Checking Battery Performance ordeo too pr rcbus nud stima ion uta ee MEE 127 244 Replacing the Battery 5 2 ipeo A a cer i daft ener A 128 241 5 Recyclmg the Bat ipe edid eh deseada bm A eae tie 129 24 6 Maintaining the Batteries 129 Chapter 25 Care and Cleaning iio oh eem eee pe kiere En eH SR puTE epu re Eee EF ROUEN EE RUE eR as SUN UE euo Un 130 29spi General a o mac E Lea 130 29 2 AA di 130 25 2 TC Teaming the MODIOL ear ni oo illes 130 25 2 2 Cleaning the Accessories uit vete re an USER Se ax TE SY Ee Ys PN USE Ge 131 22 3 DIS cOn 133 Chapter 26 blam tdeo 134 RP M 134 26 2 Maintenance Task and Test cad dd ese ieu aT 134 Chapter 27 Warranty and S rVIGg ies pneter heo ae ree exte RUNE iaNUdRRo Un 136 21 1 Warranty MET 136 20 2 COMEMOS cu Du a ML DM Loa 136 Chapter 28 ACCESOO so Ine E aen oM ex po ENG PE M QNIN M GA SINE NI ew UR NIIT ME RENE 137 28 1 ECG ACTESSOTICS T E ais 137 25 2 DO ACCESO A Ec at TOURS LEN le Lus 138 28 3 NIBP ACCESSORIES E ous aaasin wate anceeantuneueee aban 139 25 4 Termip XCGeSSOTPIGS derive tees E E A E 140 25 Quick Temp ACOSSSODIES Qu ades et adulu quad OS 140 286 6 IBP ACCESSORIES conte UR pui e tuuc d leave abeatis den axa du ert P
59. 205 Security lock 11 23 068003 USB barcode scanner 142 Patient Monitor User Manual Product Specification A Product Specification A 1 Classification Anti electroshock type Class I equipment and internal powered equipment EMC type Group 1 Class A Anti electroshock degree ECG RESP TEMP IBP C O Quick Temp CF SpO NIBP CO AG BF Ingress Protection IPX1 No protection against ingress of water 1f configured with Quick TEMP module Disinfection sterilization method Refer to Chapter Care and Cleaning for details Working system Continuous operation equipment Compliant with Standards IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN 60601 1 2 2001 A1 ISO 9919 ISO 21647 IEC EN 60601 2 27 IEC EN 60601 2 30 IEC EN 60601 2 34 IEC EN 60601 2 49 ANSI AAMI SP10 IEC EN 60601 2 25 AAMI ANSI EC13 ENI2470 4 EN1060 1 EN1060 3 EN1060 4 A 2 Physical Specifications A 2 1 Size and Weight Product Size Weight 1M80 370 mm L x 175 mm W x 320 mm H 7 kg 1M50 260 mm L x 140 mm W x 205 mm H 3 6kg A 3 Environment Specification 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 sp
60. 4 inch TFT color flat panel display Up to 11 waves can be shown on 1M50 screens cv NM 3e de 5e 6e 7e 8e Q M50 Front View 1 Alarm indicator when an alarm occurs the alarm indicator will light or flash The color of light represents the alarm level 2 Power supply switch when the monitor is connected to the AC power supply press the key to turn the monitor on When the monitor is turned Patient Monitor User Manual Basic Operation on press the key to turn the monitor off 3 Battery indicator refer to Section Battery Indicator for details 4 Mute Press this button to pause the alarm All the audio alarm will be closed At the same time the message of Temporary Alarm Mute s and the symbol EA will be displayed in the information area When you repress 1t or the pause time is over the system will resume the normal monitoring status and the message of Temporary Alarm Mute s and icon will vanish Symbol EA is shown in the information area Pressing or holding the button again can resume the alarm Further Alarm Mute information can be found in the chapter Alarm Mute 5 Start Stop NIBP measurement Press this button to inflate the cuff and start blood pressure measurement During the measurement press the button to stop the measurement 6 Trend Key Press this button to enter trend table review interface 7 Freeze Unfreeze In normal mode press this button t
61. 7 Freeze Unfreeze In normal mode press this button to freeze all the waveforms on the screen In Freeze mode press this button to restore the waveform refreshing 8 Start Stop Recording Press this button to start a real time recording During the recording press this button again to stop recording 9 Menu Press this button to return to the main interface when there is no menu open 10 Rotary Knob hereinafter called knob The user can rotate the knob clockwise or anticlockwise This operation can make the highlighted item shift up down left or right to choose the desired item Remember when using the knob rotate this button to highlight and press it to select the item 13 Patient Monitor User Manual Basic Operation M80 Side View 1 Sensor port 2 AG fixation bracket 3 Recorder door 4 Battery door SEXE 13 2 3 4 12 gt 5 11 M80 Back View 14 Patient Monitor User Manual Basic Operation 1 SD Card 2 Nurse call port this port is connected to the call system When there is an alarm the monitor outputs nurse call signal to notify the nurse 3 Defibrillator synchronization analog output When the user selects Analog Output the monitor outputs the waveform through the auxillary output port When the user selects Defibrillator the monitor outputs the defibrillator synchronization sign
62. Ah minutes recording at interval of 10 minutes Charge Time 320 min Monitor is on or in standby mode Two Operating Time 240 min At 25 C continuous SpO measuring and batteries NIBP automatic measuring mode at interval of 15 2 4 2Ah minutes recording at interval of 10 minutes Charge Time 560 min Monitor is on or in standby mode 144 Patient Monitor User Manual A 6 Recorder Product Specification Record Width 48 mm Paper Speed 25 mm s 50 mm s Trace Up to 3 Recording types 8 second real time recording Auto 8 second recording Parameter alarm recording Trend recording Titration table recording A 7 Review Trend Review Short 1 hrs 1 Second Resolution Long 120 hrs 1 min Resolution Review 1200 sets NIBP measurement data 50 sets 12 lead ECG diagnosis results A 8 ECG A 8 1 3 5 lead Monitoring Lead Mode 3 Lead I II III 5 Lead I II III aVR aVL aVF V Waveform 3 Lead 1 channel waveform 5 Lead 2 channel waveform max seven waveforms Lead naming style AHA IEC Display Sensitivity 1 25mm mV x0 125 2 5mm mV x0 25 5mm mV x0 5 10mm mV x1 20mm mV x2 AUTO gain Bandwidth 3dB Diagnosis 0 05Hz to 150Hz Monitor 0 5Hz to 40Hz Surgery 1Hz to 20Hz CMRR Common Rejection Ratio Mode Diagnosis gt 95dB the Notch filter is off Monitor gt 105dB the Notch filter is on Surgery gt 105dB the No
63. C 43 C 73 4 F 109 4 F TI 1 C 27 C 30 2 F 80 6 E Resolution C O 0 1L min TB TI 0 1 C 0 1 F Accuracy C O For C O gt 4 0 L min 5 160 Patient Monitor User Manual Product Specification For C O lt 4 0 L min 0 2 L min TB 0 1 C TI 0 1 C 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 17 AG A 17 1 Phasein Sidestream Identificaiton Time Module Type ISA AX Analyzer Displaying the concentration of CO2 N20 and two anaesthesia agent and identifying the anaesthesia agent automatically portable module ISA OR Analyzer Displaying the concentration of CO O5 N20 and two anaesthesia agent and identifying the anaesthesia agent automatically portable module Measurement CO N20 O Halothane HAL Isoflurane ISO Enflurane ENF P Sevoflurane SEV Desflurane DES awRR MAC arameters Measurement CO N20 Anaesthesia Agent infra red absorption characteristic Principle O Paramagnetic method Sampling Flow 50 ml min Rate Work Mode Measurement Standby Warm up Time 20s Typical Rise Time CO lt 200ms O2 x 350ms N20 x 350ms O2 x 450ms Primary lt 0 15 vol Anaesthesia Agent Threshold Second Anaesthesia 0 2 vol 10 Agent Threshold Agent 20 seconds typically 10 seconds
64. Continuous use of the automatic measuring mode for short intervals may lead to the discomfort of patient 12 3 Introducing the Oscillometric NIBP Measurement Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure The amplitude suddenly increases as the pulse breaks through the occlusion in the artery As the cuff pressure decreases further the pulsations increase in amplitude reach a maximum which approximates to the mean pressure and then diminish 12 4 Measurement Limitations Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm or if the patient is on a heart lung machine The measurement may be inaccurate or impossible in the following situations A regular arterial pressure pulse is hard to detect Patients with cardiac arrhythmias Patients with excessive and continuous movement such as shivering or convulsions Patients with rapid blood pressure changes Patients with severe shock or hypothermia that reduces blood flow to the peripheries Patients with obesity where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery Patients on an edematous extremity 12 5 Measurement Methods ELT Patient Monitor User Manual Monitoring NIBP There are three methods of measuring NIBP Manual measurement on demand Auto continually repeated measurements be
65. ED NEO 0 350 PVCs min Resolution PVCs min ST value Range 2 0 mV 42 0 mV Accuracy The max of 0 02 mV or 10 0 8 mV 0 8 mV whichever is greater Resolution 0 01 mV HR averaging method Method 1 Normally heart rate is computed by excluding the minimum 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 1200ms then the four most recent RR intervals are averaged to compute the HR Range of Sinus and SV Rhyt hm Tachy ADU 120 bpm 300 bpm PED NEO 160 bpm 350 bpm 151 Patient Monitor User Manual Product Specification 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 Ventricular Tachycardia Ventricular Rhythm The interval of 5 consecutive ventricular wave is less than 600 ms The interval of 5 consecutive ventricular wave ranges from 600 ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular wave is more than 1000 ms Startup time for Tachycardia Ventricular Tachycardia Gain 1 0 10 s mV 206bpm Gain 0 5 10 s Gain 2 0 10 s Ventricular Tachycardia Gain 1 0 10 s 2 mV 195bpm Gain 0 5 10 s Gain 2 0 10 s Response time of Heart Rate Meter to Change in HR HR range 80 bpm 120 bpm Range
66. N 01 54 455473 10 EDANUSA 4901 Morena Blvd Suite 505 www edanusa com San Deigo CA 92117 Tel 888 850 4597
67. O Calibration and Performance At least once every two years or if you suspect the Test measurement values are incorrect AG Calibration If you suspect the measurement values are incorrect and need to calibrate please contact the manufacturer 135 Patient Monitor User Manual Warranty and Service Chapter 27 Warranty and Service 27 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty is void in cases of a damage caused by mishandling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN 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 defective because of defective materials components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 27 2 Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at sup
68. P D n reading Xe Xenon 80 vol 10 of reading He Helium 50 vol 6 of D 2D reading Metered dose Not for use with metered dose inhaler propellants inhaler propellants CoHsOH Ethanol 0 3 vol zu D D D 4 C3H7OH 0 5 vol av D D Isopropanol CH3COCH3 1 vol D D D D Acetone 2 CHu Methane 3 vol D D D D CO Carbon 1 vol D D D D monoxide NO Nitrogen 0 02 vol D D D D monoxide O 100 vol z Note 1 Negligible interference effect included in the specification Accuracy all conditions above Note 2 Negligible interference with N20 O concentrations correctly set effect included in the specification Accuracy all conditions above Note 3 Interference at indicated gas level For example 50 vol Helium typically decreases the CO readings by 6 This means that if measuring on a mixture containing 5 0 vol CO and 50 vol Helium the actual measured CO concentration will typically be 1 0 06 5 0 vol 4 7 vol CO Note 4 According to the EN ISO 21647 standard Note 5 In addition to the EN ISO 21647 standard A 17 2 Phasein Mainstream Module Type IRMA AX Displaying the concentration of CO N20 and two anaesthesia agent and indentifying two anaesthesia agent Measurement CO N20 O HAL Isoflurane ISO Enflurane ENF 163 Patient Monitor User Manual Product Specification Parameters Sevoflurane
69. RADY irregular HR and his average HR is less than 60bpm User selectable Check his condition electrodes cables and leads VENTRICULAR RHYTHM The patient has irregular VENT heart rate check patient s condition electrodes cables User selectable and leads RESP APNEA RESP can not be measured within specific time fish interval RR High RESP measuring value is above upper alarm limit User selectable RR Low RESP measuring value is below lower alarm limit User selectable HR High HR measuring value is above the upper alarm limit User selectable HR Low HR measuring value is below the lower alarm limit User selectable SpO High SpO measuring value is above upper alarm limit User selectable SpO Low SpO measuring value is below lower alarm limit User selectable SpO No Pulse The signal of the measurement Lo is too weak so the High monitor can t detect the pulse signal PR High PR measuring value is above upper alarm limit User selectable PR Low PR measuring value is below lower alarm limit User selectable T1 High Measiming value of T1 channel is above upper alarm ble limit T1 Low Measining value of T1 channel is below lower alarm saab limit T2 High Measuring value of T2 channel is above upper alarm ene limit M i I f T2 ch l is below 1 l T2 Low easuring value o channel is below lower alarm table limit M i I f TD ch li l TD High easuring value o channel is above upper alarm A limit TEMP High Measuring value of TEMP is above
70. S DIA MAP Alarm High Limit ART 160 90 110 160 90 110 160 90 110 P1 P2 P1 P2 Alarm High Limit PA 35 16 20 35 16 20 35 16 20 Alarm Low Limit PA 10 0 0 10 0 0 10 0 0 MAP MAP MAP Alarm High Limit CVP 10 10 10 RAP LAP ICP Alarm Low Limit CVP 0 0 0 RAP LAP ICP C 11 CO CO2 Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Standby Unit mmHg Apnea Time 20s O Compensate 16 175 Patient Monitor User Manual Default Settings Anes Agent 0 Alarm High Limit EtCO2 50 50 45 Alarm Low Limit EtCO 15 20 30 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 C 12 C O C O Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit TB 43 0 43 0 43 0 Alarm Low Limit TB 23 0 23 0 23 0 Injectate Temperature Auto Source Temperature Unit E Interval 30 Constant 0 542 C 13 AG AG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Measure Apnea Time 20s Unit O Compensate OFF Anes Agent HAL Alarm High Limit EtAA 8 0 8 0 8 0 176 Patient Monitor User Manual Default Settings Alarm Low Limit EtAA 0 0 0 0 0 0 Alarm High Limit FIAA 6 0
71. S Directly select this item on the screen to change the beat volume Directly select this item on the screen to enter the menu Directly select this item on the screen to mute the alarm m r Directly select this item on the screen to enter standby mode A Select this item by the knob to enable the touchscreen operation Bu 3 2 1 3 Hardkeys A hardkey is a physical key on a monitoring device such as the recording key on the front panel 3 2 1 4 Pop up keys Pop up keys are task related graphical keys that appear automatically on the screen when required For example the confirmation pop up key appears only when you need to confirm a change 3 3 Operating Mode 3 3 1 Demo Mode To change the operating mode into the demo mode please refer to the following procedure 1 Select the Demo key on the screen directly or 18 Patient Monitor User Manual Basic Operation 2 Select Menu gt Common Function then choose Demo Mode from the popup interface and input password 3045 After entering Demo Mode the monitor will perform the followings Storing no data of new patient Pausing to give all types of alarm Pausing to transmit patient data to CMS and other network devices Pausing to store the currently recorded data and clearing the memory used to store recording and printing data Real data the parameter measurement value and real waveform displayed on the screen are
72. S po E s N YOQA J SN be Pa ANA A Va C e Y b P UX 7 Y J DIAS 3 A green LED indicates that the IRMA probe is ready for use 4 Connect IRMA airway adapter 15mm male connector to the breathing circuit Y piece 107 Patient Monitor User Manual Monitoring AG 5 Connect the IRMA airway adapter 15mm female connector to the patient s endotracheal tube Alternatively connect an HME Heat Moisture Exchanger between the patient s endotracheal tube and the IPMA 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 adapter It allows free positioning of the IRMA probe as well 6 Unless the IRMA probe is protected with an HME always position the IRMA probe with the status LED pointing upwards 108 Patient Monitor User Manual Monitoring AG 18 3 2 1 Placement of IRMA Probe When connecting IRMA probe to an infant patient circuit 1t is important to avoid a direct contact between the IRMA probe and the infant s body If for whatever the reason the IRMA probe is in direct contact with any parts of the infant s body an insulation material shall be placed between the IRMA probe and the body WARNING The IRMA probe is not intended to be in long term skin contact 18 3 2 2 Performing a Pre use Check Prior to connecting the IRMA airway adapter to the breathing circuit verify the O calibration by ch
73. SEV Desflurane DES awRR MAC Measurement CO N20 anaesthesia agent infra red absorption characteristic Principle Warm up Time Concentrations are reported and the automatic agent indentification is running within 10 seconds 20 seconds for IRMA A X4 Rise Time CO x 90ms O2 lt 300ms N20 x 300ms HAL ISO ENF SEV DES lt 300ms Primary Agent 0 15 vol Threshold Secondary Agent 0 2 vol 10 of total agent concentration Threshold Agent lt 20 seconds typically less than 10 seconds Identificaiton Time Response Time lt 1 second Accuracy Standard Conditions Gas Range Accuracy CO 0 10 vol 0 2 vol 2 of reading 10 15vol 0 3 vol 2 of reading 15 25 vol Unspecified NO 0 to 100 2 vol 2 of reading HAL 0 to 8 0 15 vol 596 of reading ISO 8 to 25 Unspecified ENF SEV 0 to 10 0 15 vol 596 of reading 10 to 25 Unspecified DES 0 to 22 0 15 vol 596 of reading 22 to 25 Unspecified Accuracy All Conditions GAS Accuracy 164 Patient Monitor User Manual Product Specification CO 0 3 vol 4 96 of reading N20 2 vol 4 96 of reading Agents 0 2 vol 10 96 of reading Apnea Alarm 20s 60s Delay Temperature C 10 to 40 20 75 Relative 10 95 RH non condensing 5 100 RH condensing humidity Atmospheric 525 1200hPa 500 1200hPa pressure Interf
74. SpO module failure or communication failure High Stop using measuring function of SpO module and notify biomedical engineer or manufacturer s service staff SpO Low Perfusion The pulse signal is too weak or the perfusion of the measurement site is too low Low Reconnect the SpO sensor and change the measurement site If problem exists please notify biomedical engineer Or manufacturer s service staff NIBP Comm Fail NIBP module failure or communication failure High Stop using measuring function of NIBP module and notify biomedical engineer or manufacturer s service staff NIBP Loose Cuff Cuff is no properly wrapped or no cuff exists Low Properly wrap the cuff NIBP Excessive Pressure Pressure has exceeded the specified upper safety limit Low Measure again if failure persists stop measuring function of NIBP module and notify biomedical engineer or manufacturer s service staff 32 Patient Monitor User Manual Alarm Information Stop the patient from NIBP Signal Sturated Signal amplitude too strong Low i moving Measure again if failure persists stop measuring function NIBP Init Pressure The initial pressure is too of NIBP module and High f High high during measuring notify biomedical engineer or manufacturer s service staff Measure again if failure persists stop using measuri
75. Td 55 8 8 1 Electrode Placement for 3 lead tacon diia 56 8 8 2 Electrode Placement for 5 lead cisco isaac 56 5 0 2 Blectrode Placement for 12 Iead uoa et ces i a 58 8 8 4 Recommended ECG Lead Placement for Surgical Patients ssssse 59 8 9 ECG Men Setup MEE ai TE EEE A AS 60 e AA EN 60 5 92 Smart A PERRA ENTIBUS SUN Causa ip i UU MrI cook 60 5 0 3 Setting Beat VOMIMIE 2555 55 chicas von tidal tia tee Dee eMe ee Ute ende 60 noU ECO DISDIGN sua ako asd aset estu sa staat sat E oe dc Ecco rc on mds 60 OP Settis Pace Statis ee td 61 SO ECG Calibration A oe 61 8 9 7 ECG Wavelorrm Set ngs cosido iria saadaatadeedaees suasen RE QE SPARTE seins Fe AER OQ YO 61 8 9 5412 Leads BG Gre tom p b aca teas E T teueimi uda cautes 61 BIO SI Segment NIOWIEOFPIBE noe e E tst ane Mace ee ee eee DAR MEA 62 8 10 1 Setting ST Analysis rre EROR Tu nest AQUI RACER EI RAE PPAR SURE IE FARE EN ER 62 5 10 27 ST DISPO Ga et elaine pU ta tendis a m ag A 62 8 10 3 ST Analysis Alarm Setting siss cssccanceoessghosadaqasbecseveatevecsasvenacedguas eei ioc aere ge tavta de pego 62 8 10 4 About ST Measurement Points erret nena etn etnia ehe eda tune ciae codec 62 8 10 5 Adjusting ST and ISO Measurement Points eene 63 SM LU ATS MODO cave aa a E E E ea Ea Ae EES EEE EE EEES 63 Sl Ar OA Analysis ee Ra reditus eau decet E aE a 63 p bI ARR Amalia 64 8 2 T2 Lead ECO Mont tea 65 5 E2oF Diragnosts PURO it e a no N 65 8 12 2 Measur
76. User Manual EDANUSA iM50 iM80 Patient Monitor Version 1 0 C About this Manual P N 01 54 455473 10 Release Date Jan 2012 Copyright EDAN INSTRUMENTS INC 2012 All rights reserved Statement This manual will help you understand the operation and maintenance of the product better It is reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS INC hereinafter called EDAN can not be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected 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 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 properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modificat
77. User Manual Eto Ethylene oxide EtO End tidal oxygen FCC Federal Communication Commission FDA Food and Drug Administration Fi Fraction of inspired FiCO Fraction of inspired carbon dioxide FiN2 O Fraction of inspired nitrous oxide FiO Fraction of inspired oxygen Hal Halothane Hb Hemoglobin Hb CO Carbon mono xide hemoglobin HR Heart rate IBP Invasive blood pressure ICP Intracranial pressure ICU Intensive care unit ID Identification IEC International Electrotechnical Commission TEEE Institute of Electrical and Electronic Engineers Iso Isoflurane LA Left arm LAP Left atrial pressure LCD Liquid crystal display LED Light emitting diode LL Left leg MAP Mean arterial pressure MDD Medical Device Directive MetHb Methemoglobin MRI Magnetic resonance imaging N A Not applied N5 Nitrogen N20 Nitrous oxide Neo Neonate 179 Patient Monitor User Manual Abbreviation NIBP Non invasive blood pressure O Oxygen oxyCRG Oxygen cardio respirogram PA Pulmonary artery PAWP Pulmonary artery wedge pressure Ped Pediatric Pleth Plethysmogram PR Pulse rate PVC Premature ventricular complex R Right RA Right arm RAP Right atrial pressure Resp Respiration RHb Reduced hemoglobin RL Right leg RR Respiration Rate Sev Sevoflurane SYS Systolic pressure TB Blood Temperature TD Temperature difference TEMP Temperature USB Universal serial bus 180 P
78. able anesthetic agents Disposable IRMA airway adapters shall not be reused Used disposable airway adapters shall be disposed of in accordance with local regulations for medical wastes 4 Use only PHASEIN manufactured oxygen sensor cells Depleted oxygen sensors shall be disposed of in accordance with local regulations for batteries 5 Do not use the IRMA Adult Pediatric adapter with infants as the adapter adds 6 ml dead space to the patient circuit 6 Do not use the IRMA airway adapter with adults as this may cause excessive flow resistance 7 Measurements can be affected by mobile and RF communications equipment It should be assured that the IRMA probe is used in the electromagnetic environment specified in this manual 8 Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this may allow patient secretions to block the adapter windows and result in incorrect operation 9 To keep secretions and moisture from pooling on the windows or oxygen sensor port always position the IRMA probe in a vertical position with the LED pointing upwards t 104 Patient Monitor User Manual Monitoring AG WARNING 10 Do not use the IRMA airway adapter with metered dose inhalsers or nebulized medications as this may affect the light transmission of the airway adapter windows 11 Do not try to open the oxygen sensor assembly The oxygen sensor is a disposable product and contains a caustic electrolyte and le
79. ach all accessories before cleaning Do not immerse the unit in water or allow liquids to enter the case 130 Patient Monitor User Manual Care and Cleaning 2 If liquid is splashed on or into the main unit inadvertently or enters the conduit stop using the monitor and contact the manufacturer for service immediately Clean the monitor enclosure with soft cloth and diluent non caustic detergents recommended above Clean the screen with a dry soft cloth Clean the touch screen with a soft cloth and neutral detergent or isopropyl alcohol Do not use chemical solvents acidic or alkali solutions CAUTION 1 Although the monitor is chemically resistant to most common hospital cleaners and non caustic detergents different cleaners are not recommended and may stain the monitor 2 Many cleansers must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the monitor 3 Don t use strong solvent for example acetone 4 Never use an abrasive such as steel wool or metal polish 5 Do not allow any liquid to enter the product and do not immerse any part of the monitor into any liquid 6 Avoid pouring liquids on the monitor while cleaning 7 Don t remain any cleaning solution on the surface of the monitor NOTE 1 The monitor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth 2 The manufacturer has no responsibility for the effectiveness of co
80. ad 12 The IRMA probe is intended only as an adjunct in patient assessment It must be used in conjunction with other assessment of clinical signs and symptoms 13 Incorrect probe zeroing will result in false gas readings 14 Incorrect agent selection by the user for IRMA AX no automatic agent identification will result in false agent readings 15 Using IRMA AX no automatic identification with gas mixtures containing more than one agent will result in false agent readings 16 Replace the adapter if rainout condensation occurs inside the airway adapter 17 Use only PHASEIN manufactured IRMA airway adapters CAUTION 1 Do not apply tension to the probe cable 2 Do not operate the IRMA probe outside the specified operating temperature environment 3 Do not leave depleted oxygen sensors mounted in the IRMA probe even if the probe is not in use 18 3 Monitoring Steps 18 3 1 Monitoring Steps for ISA Analyzer 18 3 1 1 Performing a Pre use Check Before connecting the Nomoline sampling line to the breathing circuit do the following 1 Connect the sampling line to the ISA gas inlet connector LEGI 2 Check that the LEGI shows a steady green light indicating that the system is OK 3 For ISA OR and ISA AX module with O option fitted Check that the O reading on the monitor is correct 21 4 Breathe into the sampling line and check that valid CO waveforms and values are displayed on the monitor 5 Occlude the samp
81. ads monitoring the device has automatical diagnosis function To perform this function please 1 Set Lead Type in the ECG Setup menu to 12 Leads and set Display in the ECG Setup menu to 12 Leads 2 Select the ECG Analysis shortcut key on the screen 3 The Diagnosis Review interface is displayed shown in figure a And the diagnosis result is displayed on the interface after approximately 10 seconds shown in figure b 65 Patient Monitor User Manual Monitoring ECG Diagnosis Review Analysis Time m HR P QRS T Axis PR Interval RV5 SV1 Amp QRS Duration eem RV5 SV1 Amp QT QTC Interval Calculating Diag Code Diag Result Wave T E Delete Record Figure a Diagnosis Review Analysis Time 10 20 2011 15 24 30 1 2 HR Obpm P QRS T Axis 0 0 09 PR Interval Oms RV5 SV1 Amp 0 00 0 00mv QRS Duration Oms RV5 SV1 Amp 0 00mv QT QTC Interval 0 Oms Diag Code Diag Result 113 Lead Off v Wave Y Delete Record Figure b Figure b shows analysis time HR heart rate P QRS T Axis RR Interval RVS SV1 Amp RVS SV1 amplitude QRS Duration RV5 SV1 Amp RV5 SV1 amplitude QT QTC Interval and Diagnosis code More information about diagnosis review please refer to Section 12 lead Diagnosis Review 8 12 2 Measurement and Interpretation The measurement function provides the automatic measurement of these common parameters such as hear
82. al through the auxillary output port 4 VGA output 5 USB interface this port is used to connect the USB device 6 RS232 interface 7 Network interface this port is used to connect to the central monitoring system through the standard network wire 8 Anti theft lock interface 9 Heat emission hole 10 Security lock used to prevent the power supply cord from falling 11 Equipotential grounding terminal if 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 have separate connection 12 Speaker 13 Fan 3 1 3 iM50 iM80 Configuration 1M50 1M80 configuration is listed as below Function Configuration ECG RESP SpO 1M50 260 mm L x 140 mm W x 205 mm H Square NIBP IBP TEMP Quick TEMP CO ECG RESP SpO 1M80 370 mm L x 175 mm W x 320 mm H Square NIBP TEMP IBP C O CO2 AG Model Size LxWxH Figure 3 2 Operating and Navigating Everything you need to operate the monitor is contained on its screen Almost every element on the screen is interactive Screen elements include measurement numerics waveforms screen keys 15 Patient Monitor User Manual Basic Operation information fields alarms fields and menus The configurability of the monitor means that often you can access the same element in different ways
83. amage and insulativity meets requirement If the device and accessories have damage Specified accessories If the alarm system can work properly If the recorder can work properly and the paper meets the requirement Battery performance If all monitoring functions are in good conditions If the grounding resistance and leakage current meet requirement If any damage or abnormality is found please don t use the monitor and contact local Customer Service Center 26 2 Maintenance Task and Test Schedule The following tasks are for EDAN qualified service professionals only Contact an EDAN qualified service provider if your monitor needs a safety or performance test Clean and disinfect equipment to decontaminate it before testing or maintaining it Maintenance and Test Schedule Frequency Safety checks Selected tests on At least once every two years or as needed after any the basis of IEC60601 1 repairs where the power supply is removed or replaced or if the monitor has been dropped Check ECG synchronization of the At least once every two years or as needed monitor and defibrillator 134 Patient Monitor User Manual Maintenance NIBP Leakage Inspection At least once every two years or as specified by local laws NIBP Pressure Calibration At least once every two years or as specified by local laws NIBP Calibration At least once every two years or as specified by local laws C
84. asa bud etie Mnt att 140 DS COP ACCESOS LIVE t D e ti edu 140 28 8 C O ACCOSSOLIES siii ida 141 20 9 PG ACCS A O 141 28 10 Other ACCESS OLIES radianes 142 e MM 143 A a same erm aam ed Er e eu 143 A2 Physical periciales Ee tpe a 143 AZ A Size and Weight esi oras Y UNIS E sandalias 143 AX 3 Environment Specification 2d e n pd A A 143 A4 Display e 144 A S BAS PEC det R Sa es e secs les o ia 144 A 6 voirie EK ETE NE 145 PLT ing M 145 ASECO rc TH 145 A8 1 3 5 lead Monitoring sc reat ap et De Yea anciana 145 33 9 2 12 I ad MOBIOETHE ida dl inund 149 RES EN 154 ATONIB PL usd A A 154 A 10 2 NIBP from M3600 Modu le 535 3 ia 155 A PO E 156 A 11 1 SpOs from EDAN Module enit tte o tym eae t ndn uS eos sens assin sedas 156 A T1 2 SpOs from Nellcor Module ipi tete A ke Dude equa added edid 157 A a ainda e a 157 ACTS Quick TEMP is 158 wir M RA 158 WIES o a 158 A han 160 FNIT 161 ALT Pasi Side tre sito iia 161 A 17 2 Phasein Mainstream 0 cas 163 ALS Wirl ess NI WO A A A A ead Bee evade 166 B EMC InfoEniatiOn ete n ivre eura eae Ner an ER r Ir toD bu UM a See V TER Dua LORN NINE UUS eub Sa un RUE 167 B 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS ss 167 B 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS es 167 B 3 Electromagnetic Immunity f
85. ation SpO Invasive or noninvasive blood pressure dual IBP NIBP Temperature dual TEMP Expired CO and Quick Temperature Quick TEMP The monitor is equipped with alarms that indicate system faults such as loose or defective electrodes physiologic parameters that have exceeded the limits set by the operator or both The arrhythmia detection and ST Segment analysis are not intended for neonatal patients 1 2 Safety Guidance WARNING 1 Before using the device the equipment patient cable and electrodes etc should be checked Replacement should be taken if there is any evident defect or signs of aging which may impair the safety or performance 2 Medical technical equipment such as these monitor monitoring system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly 3 EXPLOSION HAZARD Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur 4 SHOCK HAZARD The power receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three prong plug from the monitor to fit a two slot outlet 5 Extreme care must be exercised when applying medical electrical equipment Many parts of the human machine circuit are conductive such as the patient connectors electrodes transducers It is very important that these conductive parts do not come into conta
86. be after power on and after changing the IRMA airway adapter before proceeding with the Zeroing Procedure The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress Zeroing for IRMA AX probes Zeroing should be performed every time the IRMA airway adapter is replaced or whenever an offset in gas values or an unspecified gas accuracy message is displayed Allow 30 seconds for warm up of the IRMA AX probes after power on and after changing the IRMA airway adapter before proceeding with the Zeroing Procedure The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress 18 3 2 4 Cleaning The IRMA probe can be cleaned using a cloth moistened with maximum 7046 ethanol or maximum 70 isopropyl alcohol Remove the disposable IRMA airway adapter prior to cleaning the IRMA probe CAUTION 1 The IRMA oxygen sensor cell and IRMA airway adapters are non sterile devices Do not autoclave the devices as this will damage them 2 Never sterilize or immerse the IRMA probe in liquid 18 3 2 5 MAC Calculation The MAC value may be calculated and displayed by using end tidal ET gas concentrations according to the following formula MAC ET AA X AA WET AA X AA 2 ET N20 100 X AA HAL 0 75 ENF 1 7 ISO 1 15 SEV 2 05 DES 6 0 18 4 Setting Work Mode There are two woke modes Measure and Standby To change the work mode please refer to the following ste
87. ble 01 57 471022 ECG trunk cable AHA 5 lead Defib TPU 01 57 471023 ECG limb wires 5 lead snap AHA 0 9m reusable 01 57 471024 ECG trunk cable IEC 3 lead Defib TPU 01 57 471025 ECG limb cable 3 lead clip IEC 0 9m reusable 01 57 040202 11 ECG trunk cable IEC 10 lead Defib TPU 01 57 040203 ECG limb wires 10 lead snap IEC 0 9m reusable 137 Patient Monitor User Manual 01 57 471095 10 Accessories ECG cable AHA 3 lead snap Defib TPU 01 57 471087 10 ECG cable AHA 3 lead clip Defib TPU 01 57 471096 10 ECG cable AHA 5 lead snap Defib TPU 01 57 471097 10 ECG cable AHA 5 lead clip Defib TPU 01 57 471098 10 ECG cable IEC 3 lead snap Defib TPU 01 57 471099 10 ECG cable IEC 3 lead clip Defib TPU 01 57 471089 10 ECG cable IEC 5 lead snap Defib TPU 01 57 471088 10 ECG cable IEC 5 lead clip Defib TPU 11 57 471056 ECG Electrodes adult disposable 30 pieces 11 57 471057 ECG Electrodes child neo disposable 50 pieces 11 57 471060 ECG Electrodes adult disposable 100 pieces 28 2 SpO Accessories Part Number Accessories EDAN 02 01 210119 LEMO SH1 adult reusable SpO sensor Only compatible with EDAN SpO module finger type patient weight more than 40kg 02 01 210120 EDAN SH adult reusable SpO finger sensor DB9 finger type patient weight more than 40kg
88. by the rhythmic blood flow Correct electrode placement can help to reduce cardiac overlay avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes This is particularly important for neonates 9 6 Chest Expansion Some patients especially neonates expand their chests laterally In these cases it is best to place the two respiratory electrodes in the right midaxillary and left lateral chest areas at the patient s maximum point of breathing movement to optimize the respiratory wave 9 7 Abdominal Breathing Some patients with restricted chest movement breathe mainly abdominally In these cases you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave NOTE Place the red and green electrodes diagonally to optimize the respiration waveform Avoid the liver area and the ventricles of the heart in the line between the RESP electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow This is particularly important for neonates 9 8 Selecting Resp Lead To change Resp lead in the Resp Setup menu select Resp Lead to pick up the apprioate lead 68 Patient Monitor User Manual Monitoring RESP from the pop up list 9 9 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
89. calibration ends NOTE The device can t be monitored during ECG calibration 8 9 7 ECG Waveform Settings To change this speed select ECG Wave Setup gt Sweep then select an appropriate setting from the pop up list The bigger the value is the wider the waveform is 8 9 8 12 Leads ECG When the monitor is installed with 12 lead it can provide 3 lead 5 lead and 12 lead ECG monitoring functions 61 Patient Monitor User Manual Monitoring ECG 8 10 ST Segment Monitoring The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions This information can be displayed in the form of ST numerics and snippets on the monitor ST segment monitoring function is shut off by default You can switch it to On when necessary When using the ST analysis function the ST analysis results will be displayed on the right of the main screen please refer to the following figure NOTE The ST algorithm has been tested for accuracy of the ST segment data The significance of the ST segment changes need to be determined by a clinician 8 10 1 Setting ST Analysis To change ST analysis please select ECG Setup ST Analysis then select On or Off from the pop up list 8 10 2 ST Display Your monitor screen may be configured to look slightly different from the illustrations ST 1 008 aVR 000 v 0 04 II 0 10 aVL 0 03 III 0 02 aVF 0 06 NOTE 1 ST Analysis on
90. cessful zeroing requires the presence of ambient air 21 O2 and 0 CO in the ISA analyzer ensure that the ISA analyzer is placed in a well ventilated place Avoid breathing near the ISA analyzer before or during the zeroing procedure 2 The sampling line should be replaced every two weeks otherwise it is clogged 18 3 1 4 Maintenance GAS readings should be verified by conducting the recommended maintenance checks For details please refer to Chapter Maintenance WARNING 1 The Nomoline sampling lines are non sterile devices To avoid damage do not autoclave any parts of the sampling line 2 Never sterilize or immerse the ISA analyzer in liquid 106 Patient Monitor User Manual Monitoring AG 18 3 1 5 MAC Calculation The MAC value may be calculated and displayed by using end tidal Et gas concentrations according to the following formula Et AAT Et AA2 96 Et N 20 X AAI X AA2 100 MAC X AA HAL 0 75 ENF 1 7 ISO 1 15 SEV 2 05 DES 6 0 NOTE Altitude patient age and other individual factors are not considereded in the formula above 18 3 2 Monitoring Steps for IRMA Module 1 Plug the IRMA connector into the IRMA input and switch the power on 2 Snap the IRMA sensor head on the top of the IRMA airway adapter It will click into place when properly seated E lH SZ p f ALAL F Y E ARA A EA o EN N ENS PILLS UP PSN F_ Es SA A Y a rm Y e P 4 e MOS eo FP gl OON N
91. cle has expired from the monitor immediately Avoid liquid splash on the device The temperature must be kept between 5 C and 40 C while working And it should be kept between 20 C and 55 C during transportation and storage To ensure patient safety use only parts and accessories manufactured or recommended by EDAN 10 Federal law restricts this device to sale by or on the order of a physician NOTE 1 Position the device in a location where the operator can easily see the screen and access the operating controls The monitor can only be used on one patient at a time If the monitor gets damp or liquid pours on the monitor please contact the service personnel of EDAN This monitor is not a device for treatment purposes The pictures and interfaces in this manual are for reference only Regular preventive maintenance should be carried out every two years You are responsible for any requirements specific to your country 1 3 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC EN60601 1 Type CF equipment The unit displaying this symbol contains an F Type isolated Ol floating patient applied part providing a high degree of protection against shock and is suitable for use during defibrillation A Patient Monitor User Manual Indication for Use and Safety Guidance This symbol indicates that the instrument is IEC EN 60601 1 Type BF equipment The unit displaying thi
92. cluster Vent beats 25 The RR interval is less than 600ms VT gt 2 3 lt the number of cluster PVCs 5 User selectable COUPLET 2 consecutive PVCs User selectable BIGEMINY Vent Bigeminy User selectable TRIGEMINY Vent Trigeminy User selectable A type of single PVC under the condition that HR 100 R R interval is less than 1 3 the average RONT interval followed by a compensating pause of 1 25X User selectable the average R R interval the next R wave advances onto the previous T wave PVC Single PVCs not belonging to the type of above in mentioned PVCs TACHY 5 consecutive QRS complex RR interval is less than dable 0 5s BRADY ap QRS complex RR interval is longer than esse When HR is less than 100 beats min no heart beat is tested during the period 1 75 times of the average RR MISSED BEATS interval or User selectable When HR is higher than 100 beat min no beat is tested within 1 second IRREGULAR RHYTHM The patient has irregular IRR heart rate check patient s condition electrodes cables User selectable and leads 26 Patient Monitor User Manual PACE NOT CAPTURE After the pacemaker is paced Alarm Information EN QRS complex can not be detected during 300ms eRe PNP PACER NOT PACED After the QRS complex no U PECORE pace is detected during 1 75 times of RR interval Pen yee VENTRICULAR BRADYCARDIA The patient has VB
93. corder B Waveform record is printed at the rate of 25 mm s or 50 mm s B 48mm wide printout paper B Itcanrecord up to three waveforms E User selectable real time recording time and waveform E Auto recording interval is set by the user and the waveform is in accordance with the real time recording NOTE It is suggested that the user should not use the recorder when the low battery displays or the monitor may be turned off automatically 121 Patient Monitor User Manual Recording 22 3 Recording Type The monitor provides several types of stripe recording Continuous real time recording Time recording Alarm recording Trend graph trend table recording Arrhythmia review recording Drug calculation titration recording NIBP review recording Alarm review recording Hemodynamic Calculation result recording 12 lead analysis recording 22 4 Starting and Stopping Recording You can start and stop the recording in the following ways Continuous real time recording Press the Record button on the front panel to start the recording and repress it to stop the recording Auto recording Record three waveforms selected in Recorder Setup menu according to the setup time interval in Recorder Setup menu It will automatically stop in 8 seconds Trend graph recording Enter the Menu gt Review gt Trend Graph menu and press the Record button to start recording Trend table recording Enter the Menu gt Review
94. ct with other grounded conductive parts when connected to the isolated patient input of the device Such contact would bridge the patient s isolation and cancel the protection provided by the isolated input In particular there must be no contact of the neutral electrode and ground Patient Monitor User Manual Indication for Use and Safety Guidance WARNING 6 Magnetic and electrical fields are capable of interfering with the proper performance of the device For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation 7 Route all cables away from patient s throat to avoid possible strangulation 8 Devices connecting with monitor should be equipotential 9 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard IEC EN 60601 1 1 Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system standard IEC EN60601 1 1 If in doubt consult our technical se
95. ctate Sensor Housing 5 Injectate 6 Delivery System 7 In line injectate Temperature probe C O Sensor Connection WARNING Make sure that the computational constant for the measurement is appropriate to the catheter used NOTE The blood temperature alarm will not function during C O measurement It will resume automatically when the measurement is over 17 4 C O Measurement Window Select the C O Option menu to enter the C O Measure window and start C O measurement If C O transducer is not connected the monitor will display No Sensor on the screen 97 Patient Monitor User Manual Monitoring C O CO Measure CO C D BSA TB D uec Y Measure Time 00 00 00 e 0 2 2 C 0 measure need param X axis 60 Sec Y axis 20C v Start Stop Cancel Review EE o Rec Orc C O Measure Window Measurement curve Prompt message area Cardiac Output Cardiac Index Body Surface Area Blood Temperature O 0 0 S Injectate Temperature Start time of the measurement Funciton keys The functional keys on the C O measure window are explained in the following table Start Start a measurement Stop If the blood temperature cannot resume in a considerably long time the measurement could not stop automatically Use this button to stop the measurement and display the C O CI calculation r
96. ctly or 2 Select Menu Display Setting View Selection Large Font to open this interface To view the large font interface of specific parameter please select the parameter pull down dialog on the interface the red circle shown in the following figure ICU JOECOLE Adult I am gl ES 05s 01 18 13 56 es Admission Trend a Table MIA Review Ns Review E 2 Menu 7 8 Changing Parameter and Waveform Colors The user can set the display colors of parameter and waveform as desire To change the display color please select Menu gt Maintenance gt User Maintain enter the required password ABC Then select Color Select to make color changes on parameter and color NOTE To make the color changes effective please restart the monitor after changing the colors 7 9 Transferring a Configuration When installing several monitors with identical user configuration it is not necessary to set each device separately An USB drive may be used to transfer the configuration from monitor to monitor 50 Patient Monitor User Manual User Interface To export the current monitor s congifuration 1 2 Connect USB device to the monitor s USB port Select USB Configure in the Menu Maintenance User Maintain enter the required password ABC In the USB Configure menu select Export to export configuration A status message will display after the operation To import the configuration on the USB drive
97. cuff to the air tubing 4 Check whether the patient mode is appropriately selected Access the Patient Setup menu from Menu Turn the knob to select the required patient Type in the Patient Info menu 5 Select a measurement mode in the NIBP Setup menu Refer to section Operation Prompts for details 6 Press the e button on the front panel to start a measurement 12 7 Operation Prompts 1 Manual Measuring Access the NIBP Setup menu and set the Measure Mode item to Manual Then press the ey button on the front panel to start a manual measurement During the idle period of measurement process press the ey button on the front panel at any time to start a manual measurement Then press the a button on the front panel to stop manual measurement and the system continues to execute auto measurement program according to the selected time interval 2 Automatical Measurement Access the NIBP Setup menu and set the Measure Mode item to Auto then press the e button on the front panel to start the automatical measurement according to the selected time interval 3 Continuous measurement Access the NIBP Setup menu and pick the Continual item to start a continuous measurement The continuous measurement will last 5 minutes 4 Stopping continuous measurement During continuous measurement press the e button on the front panel at any time to stop eT Patient Monitor User Manual Monitoring NIBP continuous measurement 12 8 C
98. d probe well are installed 2 Remove the probe from the probe well 3 Observe the oral mode indicator on the screen flashing head icon If this icon is not flashing press the Measure Pos button and set it to Oral until the head icon appears 4 Load the probe cover 5 Place the probe tip deep into the patient s sublingual pocket as shown in the following figure Sublingual Pocket Measuring Position in Mouth 6 Do not hand the probe to the patient to place in his or her own mouth 7 Always hold the probe in place maintaining tissue contact until temperature is complete If necessary repeat the measurement procedure shown above NOTE 1 After one measurement the user should put the sensor well to the sensor bracket 82 Patient Monitor User Manual Monitoring Quick TEMP and then take it out for starting a new measurement 2 To ensure optimal accuracy always confirm that the correct measurement position is selected 14 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 the display flashing lower body icon 4 Load a probe cover Apply lubricant if desired 5 Separate the buttocks and gently insert the probe only 1 5cm 5 8 inch less for infants and children L 5cn 1 5 Measuring Position in Rectal WARNING Incorrect in
99. d sec from the popup menu and press Exit 2 7 Handing Over the Monitor If you are handing over the monitor to the end users directly after configuration make sure that it is in the monitoring mode The users must be adequately trained to use the monitor before monitoring a patient To achieve this they should have access to and read the following documentation delivered with the monitor User Manual this book for full operating instructions Quick Reference Card for quick reminders during use Patient Monitor User Manual Basic Operation Chapter 3 Basic Operation This manual is for clinical professionals using the 1M50 and iM80 patient monitors Unless otherwise specified the information here is valid for all the above products This user manual describes all features and options Your monitor may not have all of them they are not all available in all geographies Your monitor is highly configurable What you see on the screen how the menus appear and so forth depends on the way it has been tailored for your hospital and may not be exactly as shown here 3 1 Introducing iM50 iM80 Series The iM50 iM80 series patient monitors offers a monitoring solution optimized for the surgical cardiac medical and neonatal care environments The monitor stores data in trend and event You can see tabular trends vital signs and document them on a local 3 1 1 M50 Major Parts and Keys The 1M50 patient monitor has an 8
100. de Halothane 60 Dry and Saturated Gas 4 0 40 mmHg 1 mmHg additional error 159 Patient Monitor User Manual Enflurane Isoflurane Sevoflurane Xenon Helium Desflurane 5 5 5 80 50 15 Product Specification 41 70 mmHg 2 5 additional error 71 100 mmHg 4 additional error 101 150 mmHg 5 additional error Additional worst case error when compensation for Pg Oz N2O anesthetic agents or helium is correctly selected for the actual fractional gas constituents present Desflurane The presence of desflurane in the exhaled breath at concentrations greater than 5 will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38mmHg Xenon The presence of Xenon in the exhaled breath will negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38mmHg Barometric Pressure on EtCO Measurement Values Quantitative effect Ambient Barometric Operational 0 40 mmHg 1 mmHg additional error 4 70 mmHg 2 5 additional error 7 100 mmHg 4 additional error 101 150 mmHg 5 additional error Additional worst case error when compensation for Pg O2 N20 anesthetic agents or helium is correctly selected for the actual fractional gas constituents present A 16 C O Method Thermodilution Technique Measuring range C O 0 1 L min 20L min TB 23
101. display the difference between two temperature values by subtracting the second value from the first The difference is labeled TD 80 Patient Monitor User Manual Monitoring Quick TEMP Chapter 14 Monitoring Quick TEMP 14 1 Overview Quick temperature measurement is to establish thermal balance between probe and human body When the probe is placed on the measurement site until a steady reading is available after approximately three minutes for oral and rectal measurements and five minutes for axillary measurements And the measurement temperature is the monitoring temperature The temperature curve in this process has a certain discipline The approximatively actual temperature curve can be simulated by temperature data sampled earlier The temperature at thermal balance is calculated through the specific algorithm based on the curve The monitor can only measure temperature of adult and pediatric patients If the user measures temperature of neonatal patient the monitor will not display data The Oral Axillary sensor and Rectal sensor are of standard configuration 14 2 Quick TEMP Safety Information WARNING 1 To ensure optimal accuracy always confirm that the 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 temperature probe cable from the socket and then the screen will di
102. djusting Key Volume The key volume is the volume you hear when you select any field on the monitor screen or when you turn the knob To adjust the key volume please 1 Select the Key Volume key on the screen directly or 2 Select Menu gt System Setup gt Key Volume then select the appropriate setting for the key volume Five is the loudest and Zero is the quietest 3 5 2 Adjusting Alarm Volume To change the alarm volume please 1 Press the Alarm Volume key on the screen directly or 2 Select Menu gt Alarm Setup gt Alarm Volume and select the desired setting from the popup interface For detailed information please refer to Section Controlling Alarm Volume 3 5 3 Adjusting Beat Volume To change the beat volume please press the Beat Volume key on the screen directly or refer to Section Setting Beat Volume 3 6 Checking Your Monitor Version To check the monitor version please select Menu gt Common Function gt About to check the monitor software revision 3 7 Networked Monitoring Your monitor can be connected to the wired network If the monitor is networked a network symbol is displayed on the screen 3 8 Setting Languages To change the language please 1 Select Menu gt Maintenance gt User Maintain then type the correct password ABC into the displayed interface 2 Select the Language option on the popup interface to open the language list 3 Select the desired language from the list To make th
103. ds for the label name gt Setup gt SYS Alarm MAP Alarm DIA Alarm 88 Patient Monitor User Manual Monitoring CO Chapter 16 Monitoring CO 16 1 Overview The monitor provides the SideStream and MainStream methods for CO monitoring LoFlo CO2 module is used for SideStream measuring and Capnostat 5 CO module C5 is used for mainStream measuring The principle of CO measurement is primarily based on the fact that CO2 molecule can absorb 4 3um infrared ray Absorption intensity is proportional to CO concentration of patient sample the CO concentration will compute according to the detecting CO absorption intensity of patient sample SideStream measurement takes a sample of the respiratory gas with a constant sample flow from the patient s airway and analyzes it with a remote CO sensor You can measure SideStream CO using the monitor s built in CO measurement MainStream measurement uses a CO sensor attached to an airway adapter directly inserted into the patient s breathing system 16 2 CO Safety Information WARNING Do not use the device in the environment with flammable anesthetic gas The device should be used by trained and qualified medical personnel authorized by EDAN Nitrous oxide elevated levels of oxygen helium xenon halogenated hydrocarbons and barometric pressure can influence the CO measurement The monitor will be damaged if any pipeline from the COz module is disconnected or the a
104. e Out the MOBIOE T 2o Checkins the Recorder rains e oed el ead 8 2 6 Setting th Dale and TiMe iir rasins aerae e ES SUN EUN ERQ a TS U ES NN UE ES 8 Dek Handme Over the MOT SS E eate UD ee Tus 8 Chapter 3 Basic Operation ass na 9 3 1 Introducing iM50 iM80 Series seri anar 9 Sel AMO Major Parts and Keys A A AT a uad uod 9 Sul 23MSO Major Ports and Keys ti se ou cay sad sts Lan utes E PR peo EU ON eiu Stn 12 3 1 3 IMS0AMS0 C oniie uration ione dee de Reet Ais 15 3 2 C Deratime and A UN 15 De My Usma Keys scoop cases A cuf ipe Mes mana ae e aereas 17 3 3 Op rating Mode sepen 18 3 9 1 Demo MO on e A E A A uc EE 18 3 3 2 Standby Mode ees stel oni r E E E A E tant Sea es eene d 19 3 4 Changing Monitor UU ia 19 3 4 1 Adjusting Screen Brightness isis scciascvcsyccesasacesasaaeseiess sonsaaes soedgnnasdenadcvarsccevanedeaasedessaata 19 3 4 2 Chanine Date and o E 19 2 9 PN UU SLATS VO NA 20 3 5 1 Adjusting Key Volumie isisi eben RUE eiia s iaa a iiS 20 3 9 2 Adjusting Alar VO DUEDE a a E dave Cori gue 20 3 9 9 Adjusting Beat VOLUMES ide 20 3 6 Checking Your Monitor Version siii Se S91 XS COS ERES En ERE ridad aislada 20 3 1 Networked MONON i iio to Sete pied ate A datos teats 20 2 0 Setting Languages iii 20 3 9 Understanding Screens usos aso is 21 310 Cali Praline Screens A f pe d edt A eeu de datis eade dels 21 3 11 Disabling the Touch Cr iii aviae toon eer Hal toli botel ede
105. e change validate please restart the monitor 20 Patient Monitor User Manual Basic Operation 3 9 Understanding Screens Your monitor comes with a set of preconfigured screens optimized for common monitoring scenarios such as OR adult or ICU neonatal A screen defines the overall selection size and position of waves numerics and shortcut keys on the monitor screen when you switch on the monitor You can easily switch between different screens during monitoring Screens do NOT affect alarm settings patient category and so forth When you switch from a complex to a less complex screen layout some measurements may not be visible but are still monitored in the background For detailed information please refer to Chapter User Interface 3 10 Calibrating Screens To calibrate the screen please refer to the following steps 1 Select the Touch Calib shortcut key on the screen directly or select Menu gt Maintenance gt User Maintain then input maintenance password ABC then select TouchScr Calibration from the popup interface 2 The symbol appears on the screen 3 Click on the central point of the symbol ES 4 After successful calibration the message of Screen Calibration Completed appears on the screen Then select Exit to finish the calibration 3 11 Disabling the TouchScreen The user can disable touchscreen operation by pressing and holding the Menu shortcut key for 3 seconds A message of Screen Locked and the symbol M a
106. e transducer is vented to air not connected ZERO FAIL to a patient and try again 15 8 IBP Pressure Calibration 1 Mercury calibration should be performed by the biomedical engineering department either whenever a new transducer is used or as frequently as dictated by your Hospital Procedures Policy 2 The purpose of the calibration is to ensure that the system gives you accurate measurements 3 Before starting a mercury calibration a zero procedure must be performed If you need to perform this procedure yourself you will need the following equipment Standard sphygmomanometer 3 way stopcock and Tubing approximately 25 cm long The calibration procedure is listed below 1 Close the stopcock that was open to atmospheric pressure for the zero calibration 2 Attach the tubing to the sphygmomanometer 3 Ensure that connection to patient is off 4 Connect the 3 way connector to the 3 way stopcock that is not connected to the patient catheter n Open the port of the 3 way stopcock to the sphygmomanometer 6 Select the channel to be calibrated in the menu and select the pressure value to which the IBP is to be adjusted 7 Inflate to make the mercury bar rise to the setup pressure value 8 Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury calibration 87 Patient Monitor User Manual Monitoring IBP 9 Press the Start button the device will begin calibrati
107. ea teen eiS 21 Sol JW site the Barcode IEA tease 21 Chapterd dria EN 22 4 T Alar Category an A E A A A a 22 4 11 Physiological damas a ii 22 2 12 Techical ATSEIS oot ocn ore a lemma setatis Mes 22 Z I 3 PrTORIDS A O de tele torsit Doa pec teal ien abt E dat 22 E O aa UPS th cuties e ia aT 22 4 5 C ontrollitie Alari tao ele eie atis Rees 23 4 3 1 Switching the Individual Alarm Off enne 23 4 3 2 Temporary Alarmi Mu ii 23 2 3 9 Alar M ed a E lt dun ESER 24 4 3 4 Controlling Alarm Volume oooonococnonccconnccconncnononcnonnnnnononononnnononononcn nc nro nn eterne nenne 24 4 3 S ette Alarm TTL ES Suns debe coop nesciens Sass sac aaa pes ened heated E 24 4 A Eatehing DIEI eta pede 25 4 5 Disabling Sensor Off Alarms viniera Pisa eh aeo pan te ke Fee aae a Len Ue PNE ERN eR Ren 25 25 Teste A oreet dd dotada oat ILE M Ct LM t MEE 25 Chapter 5 Alarm Informal s sees eene etre i sea e peau pu cH npa Rue seus el eun ce Exe pe qui capa een PEE e QE NEP NN pu Ge 26 5 1 Physiological Alarm Information seeseeeseeeeee esent enne 26 52 Technical Alarmi O AOS AN 30 O e e O tees coat tek 41 5 4 Adjustable Range of Alarm LES A AA A a eased eee 42 Chapter 6 Managing Patents dsd A Anidado 47 A o ules gues Ganado e do 47 6 1 1 Patient Category and Paced Status A e 47 6 2 Quick Admi di 48 6 2 Editing Patient Into MAN ia 48 6 4 Updating a Pa rain 48 6 5 Central Monitoring Systainer URS Ea ERE Pd Ev ae cR Be decia 48 Chap
108. ecifications for all products Temperature Working 5 C 40 C Transport and Storage 20 C 55 C Humidity Working 25 80 non condensing Transport and Storage 25 93 non condensing 143 Patient Monitor User Manual Product Specification Altitude Working 860hPa 1060hPa Transport and Storage 700hPa 1060hPa Power Supply 100V 240V 50Hz 60Hz Current 1 0A 0 5AGM50 Pmax 1 4A 0 7AGM80 FUSE T 1 6AL 250V A 4 Display Product Display Messages 1M50 Display screen 8 4 inch colour TFT A maximum of 11 waveforms Resolution 800x600 One power LED Two alarm LED One charge LED 1M80 Display screen 15 inch color TFT A maximum of 13 waveforms Resolution 1024 x 768 One power LED Two alarm LED One charge LED A 5 Battery Specification 1M50 2 1Ah Operating Time 180 min At 25 C continuous SpO measuring and NIBP automatic measuring mode at interval of 15 minutes recording at interval of 10 minutes Charge Time 200 min Monitor is on or in standby mode 4 2Ah Operating Time 420 min At 25 C continuous SpO measuring and NIBP automatic measuring mode at interval of 15 minutes recording at interval of 10 minutes Charge Time 380 min Monitor is on or in standby mode iM80 one Operating Time 120 min At 25 C continuous SpO measuring and battery NIBP automatic measuring mode at interval of 15 4 2
109. ecking that the O reading on the monitor is correct 21 See the following section on how to perform air calibration Always verify 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 adapter 18 3 2 3 Zeroing WARNING Incorrect probe zeroing will result in false gas readings In order to secure high precision of the IRMA probe measurements the following zeroing recommendations should be followed Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe without connecting the airway adapter to the patient circuit and then using the host instrument to transmit a zero reference command to the IRMA probe Special care should be taken to avoid breathing near the airway adapter before or during the zeroing procedure The presence of ambient air 2196 O and 096 CO in the IRMA airway 109 Patient Monitor User Manual Monitoring AG adapter is of crucial importance for a successful zeroing If a ZERO REQ alarm should appear directly after a zeroing procedure the procedure has to be repeated Always perform a pre use check after zeroing the probe Zeroing for IRMA CO probes Zeroing needs to be performed ONLY when an offset in gas values is observed or when an unspecified accuracy message is displayed Allow 10 seconds for warm up of the IRMA CO pro
110. ement and Interpretation oooocnnncccnnncccnoncccnonnnononanononcnonononononnnnnonennnncnnnnncnnn 66 Chapter 9 Monitoring RESP ied er PARE IA VANUS UP RR RUI HER ARE cR KE QURE COR IRE Nep R epa 67 DPN CLIC Wa ce edis cen en bitescu csdba d esu cuitteci S ki es md te cd ode Restat 67 9 2 RESP Safety Information isisisi GEN INR ER e PX S E NN e NUEVE SR alli 67 9 Resp Disp AS A ate eas ceed dde 67 9 4 Electrode Placement for Monitoring ReSP oocoonnocccnonccononcnononanononccononcnnnnnncnnnnncnnnnccnnnnccnnnnnss 68 IN Cardiac a A pde fuc m eid tese MEAE 68 9 OC hesp EXxDAHSIOD Gus a Spent oe O A 68 9 7 Abdomtimal Breathing tia 68 Ds electa Ropa dt ento elo End 68 9 9 Changing Hold Type viii nana Saa 69 9 10 Changing the Size of the Respiration WaVe oooococnnocccnnocccooncnononcnnnoncnnnnncconnnccnnnccnnnnccnnnnnss 69 OL USERS AS olle de 69 9 12 Changing the Apnea Time in iia 69 Chapter I0 Monitoring SpOz sesessocsssessscessecesocesooessocesocessocesocscocsssocessesssocesocesoossssessseessecssocssosssso 70 TiO AC me ER M TES 70 10 2 SpO Safety DiformallOfks eoe Seve E O 70 I9 Nieasurmne Sp acoso o adi eM eth ena etse matt UE EE 71 10 4 Measurement Procedures ost at c utei bateas 71 10 5 Understanding Sp Oo Alaris ri i a 12 LOG Adjusting Alarny AS a A a E A A aes 12 107 Settina SpOzas Pulse SOUEGO ii E E 12 Oe Seu Pitch RSI Te O 72 10 9 Setting Sensitivity AT VV n EN 12 Chapter 11 Monitoring PR r
111. ent monitor has a 15 inch TFT color flat panel display Up to 13 waves can be shown on iM80 screens EDAN 2 09 o 3 de 5 Ge 7 Be 9 M80 Front View 1 Alarm indicator when an alarm occurs the alarm indicator will light 12 Patient Monitor User Manual Basic Operation or flash The color of light represents the alarm level 2 Power supply switch when the monitor is connected to the AC power supply press the key to turn the monitor on When the monitor is turned on press the key to turn the monitor off 3 Battery indicator refer to Section Battery Indicator for details 4 Mute Press this button to pause the alarm All the audio alarm will be closed At the same time the message of Temporary Alarm Mute s and the symbol ZA will be displayed in the information area When you repress 1t or the pause time is over the system will resume the normal monitoring status and the message of Temporary Alarm Mute s and icon will vanish Symbol EA is shown in the information area Pressing or holding the button again can resume the alarm Further Alarm Mute information can be found in the chapter Alarm Mute 5 Start Stop NIBP measurement Press this button to inflate the cuff and start blood pressure measurement During the measurement press the button to stop the measurement 6 Trend Key Press this button to enter trend table review interface
112. erformance and or minor personal injury NOTE 1 Make sure the nail covers the light window The wire should be on the backside of the hand 2 SpO waveform is not proportional to the pulse volume 3 Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line 70 Patient Monitor User Manual Monitoring SpOs Don t use the functional tester to access the SpO accuracy The device is calibrated to display functional oxygen saturation The materials with which the patient or any other person can come into contact conform with the standard of ISO10993 10 3 Measuring SpO 1 Select the correct patient category setting adult pediatric and neonatal as this is used to optimize the calculation of the SpO and pulse numerics 2 During measurement ensure that the application site has a pulsatile flow ideally with a good circulation perfusion has not changed in its thickness causing an improper fit of the sensor 10 4 Measurement Procedure 1 Switch on the monitor 2 Attach the sensor to the appropriate site of the patient finger 3 Plug the connector of the sensor extension cable into the SpO socket on the SpOz module Mounting of the Sensor WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment If the skin quality changes move the sensor to another site Change the application site at least e
113. ering gas and vapour effects monoxide Gas or vapour Gas level CO Agents NO IRMA CO IRMA AX N20 60 vol 182 1822 D 1 HAL 4 vol e D D D ENF ISO SEV 5 vol 8 of D D D reading DES 15 vol 12 of D n D reading Xe Xenon 80 vol 10 of 3n E reading gt He Helium 50 vol 6 of D D reading Metered dose Not for use with metered dose inhaler propellants inhaler propellants CoHsOH Ethanol 0 3 vol gn D D D 4 C3H7OH 0 5 vol D D D D Isopropanol 9 CH3COCH3 vol D D D D Acetone 9 CH4 Methane 3 vol D D D D CO Carbon 1 vol D 4D D 165 Patient Monitor User Manual Product Specification O 100 vol 7 7 Note 1 Negligible interference effect included in the specification Accuracy all conditions above Note 2 For probes not measuring N5O and or O the concentrations shall be set from monitor IRMA CO measures neither N20 nor O2 IRMA AX does not measure O Note 3 Interference at indicated gas level For example 50 vol Helium typically decreases the CO readings by 6 This means that if measuring on a mixture containing 5 0 vol CO and 50 vol Helium the measured CO concentration will typically be 1 0 06 5 0 vol 4 7 vol CO Note 4 According to the EN ISO 21647 standard Note 5 In addition to the EN ISO 21647 standard A 18 Wirless N
114. esponse comply with ANSI AAMI EC13 2002 Sect 4 2 9 8 Electrode Offset Potential Tolerance Auxiliary Current Leads off detection 500mV Active electrode lt 100nA Reference electrode lt 900nA Input Offset Current lt O 1pA Recovery time after pole c 5s Defibrillation Leakage current of patient lt 10uA Scale signal ImVPP accuracy is 5 System noise lt 30u VPP ESU Protection Incision mode 300W Congelation mode 100W Restore time lt 10s Meets the requirements of ANSI AAMI EC13 2002 Sect 4 1 2 1 a Noise Suppression of Tested according to the test method in EC13 2002 Sect 5 2 9 14 Electrotome it accords with the standard Pace Pulse Pulse indicator PACE pulses are marked by the PACE indicator if the following conditions are met Amplitude 2 mV 700 mV 12 lead 150 Patient Monitor User Manual Product Specification Width 0 1 ms 2 ms Ascending time 10 us 100 us Pulse Rejection Pulse is rejected 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 ms Ascending time 10 us 100 us Minimum input slew rate gt 2 5V S Heart rate Alarm Range ADU 15 bpm 300 bpm PED NEO 15 bpm 350 bpm Accuracy 1 or 1 bpm whichever is greater Resolution 1 bpm Sensibility gt 300 uVPP PVC Range ADU 0 300 PVCs min P
115. esult Cancel Cancel the processing measurement or cancel the result after measurement Record Print out the curve Y axis Change the scale Y temperature value Three modes are available 0 0 5 C 0 1 C 0 2 0 C Adjust the scale by the temperature differences A smaller scale results in a larger curve 98 Patient Monitor User Manual Monitoring C O X axis Change the Scale X time value Two modes are available 0 30s 0 60s If you start measurement in the 0 30s mode it will be switched to 0 60s mode automatically if the measurement can not finish within 30 seconds After the switch no further adjustment can be made to the Scale X Review Enter the Review window Exit Press the item to exit C O Measure 17 5 Measurement Process Measurement should be taken when the message Ready for new measurement appears on the screen Press the Start button and then start injection The thermodilution curve current blood temperature and the injectate temperature are displayed during the measurement Curve drawing will stop automatically when the measurement finishes and the the C O and CI and in the above figure will be calculated and displayed on the screen The monitor will display C O in the parameter area and the start measurement time 8 in the above figure To ensure the accuracy of the measurement it is suggested that a reasonable interval should take place between
116. etwork Compliant with Standard and IEEE802 11b g R amp TTE Directive 99 5 EEC Directive Frequency Range 2 412 GHz 2 462 GHz America 2 412 GHz 2 484 GHz Japan 2 412 GHz 2 472 GHz ETSI Working frequency segment Chl 11 America Chl 14 Japan Chl 13 ETSI 166 Patient Monitor User Manual EMC Information B EMC Information Guidance and Manufacture s Declaration B 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions The monitor uses RF energy only for its internal CISPR 11 Gioni function Theon its RF Sesion are very low and are not likely to cause any interference in nearby electronic equipment RF emission The monitor is suitable for use in all CISPR 11 Class A establishments other than domestic establishments and those directly connected to Harmonic emissions Class A the public low voltage power supply network IEC EN 61000 3 2 that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Complies IEC EN 61000 3 3 B 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS
117. f you do it inadvertently please turn off the module in menu immediately The module enters STANDBY mode if you reconnect it to monitor which it is powered on If the readings are inaccurate you should do calibration NOTE 1 Replace the airway adapter if excessive moisture or secretions are observed in the tubing or if the CO waveform changes unexpectedly without a change in patient 93 Patient Monitor User Manual Monitoring CO status 2 To avoid infection use only sterilized disinfected or disposable airway adapters 3 Inspect the airway adapters prior to use Do not use it if airway adapter appears damaged or broken Observe airway adapter color coding for patient population 4 Periodically check the flow sensor and tubing for excessive moisture or secretion buildup 16 3 3 2 Removing Exhaust Gases from the System WARNING Anesthetics when using the mainstream CO measurement on patients who are receiving or have recently received anesthetics connect the outlet to a scavenging system to avoid exposing medical staff to anesthetics Use an exhaust tube to remove the sample gas to a scavenging system Attach it to the mainstream sensor at the outlet connector 16 4 Setting CO Waveform Setup Select the CO waveform area to open the CO waveform menu Set Mode to Curve or Filled as your desire Set Sweep to an apprioate value from the pop up list The bigger the value is the quicker the speed is 16 5
118. ference usually results in large amplitude spikes making the ECG signal look irregular Low frequency interference usually leads to a wandering or rough baseline In the operating room the Filter reduces artifacts and interference from electro surgical units Under normal measurement conditions selecting Surgery may suppress the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the monitor Diagnos Use when diagnostic quality is required The unfiltered ECG wave is displayed so that changes such as R wave notching or discrete elevation or depression of the ST segments are visible 8 4 Using ECG Alarms ECG alarms can be switched on and off and the changes to high and low alarm limits are just like other measurement alarms which are described in the Alarms section Special alarm features applying only to ECG are described here 8 5 Selecting Calculation Lead On the Normal interface the users can select either 3 LEADS or 5 LEADS for this item Normal QRS complex should be B The normal QRS should be either completely above or below the baseline and it should not be biphasic For paced patients the QRS complexes should be at least twice the height of pace pulses B The QRS should be tall and narrow B The P waves and the T waves should be less than 0 2 mV 8 6 Monitoring Procedure 8 6 1 Preparation The skin is a poor conductor of electricity therefore preparation of the patient s skin
119. g Volume displacement of MSI 4 5 x 10 in 100 mmHg A 15 CO Method Infra red Absorption Technique Unit mmHg Kpa Measuring Range EtCO 0 mmHg 150 mmHg FiCO 3 mmHg 50 mmHg 158 Patient Monitor User Manual Product Specification AwRR 0 rpm 150 rpm Resolution EtCO ImmHg FiCO ImmHg AwRR 1 rpm EtCO Accuracy 2 mmHg 0 to 40 mmHg t 5 of reading 41 to 70 mmHg t 8 of reading 71 to 100 mmHg t 10 of reading 101 to 150 mmHg AwRR Accuracy tlrpm Suffocation Alarm Delay 10s 15s 20s 25s 30s 35s 40s default value is 20 second Sample Gas Flowrate 50ml min Stability Short Term Drift Drift over 4 hours 0 8 mmHg Long Term Drift 120 hour period O Compensation Range 0 100 Resolution 1 Default 16 Initialization time It displays the value within 15s and meets the requirement for measurement accuracy within 2min Mainstream It displays the value within 20s and meets the requirement for measurement accuracy within 2min Sidestream Response time 60ms Mainstream Calibration Not required Barometric pressure User setup compensation Apnea Alarm Delay 10s 15s 20s 25s 30s 35s 40s 45s default value is 20s Interfering Gas and Vapor Effect on EtCO Measurement Values Gas or vapor Gas level Quantitative effect Comments Nitrous oxi
120. give an audible alarm when there is an alarm during the audio alarm pause and the alarm indicator and screen flash indicating there is an alarm The top of monitor displays the following 1 Alarm pause symbol IX 2 The remaining pause time is displayed in text and the word background is red 23 Patient Monitor User Manual Alarms The user can set the audio alarm pause to 60 s 120 s or 180 s based on the requirement 4 3 3 Alarm Mute To mute the alarm please select Menu gt Maintenace gt User Maintain gt Alarm Setup and set Mute to On then press the key on the front panel for more than three seconds or press the Silence shortcut key on the screen directly And alarm reminder tone DO is heard every three minutes 4 3 4 Controlling Alarm Volume The monitor provides five levels of alarm volume 1 2 3 4 and 5 For adjusting the alarm volume please refer to Section Adjusting Alarm Volume 4 3 5 Setting Alarm Limits WARNING 1 Prior to monitoring make sure that the alarm limit settings are appropriate for your patient 2 Setting alarm limits to extreme values may cause the alarm system to become ineffective To change individual measurement alarm limits take HR alarm for example please refer to the following steps 1 Select the HR Parameter area 2 Select HR Setup gt Alarm Setup Then set the alarm limit to the desired value from the popup interface For how to set the alarm limit please refer
121. h P2 DIA measuring value is above upper alarm limit User selectable P2 DIA Low P2 DIA measuring value is below lower alarm limit User selectable 28 Patient Monitor User Manual Alarm Information P2 MAP High P2 MAP measuring value is above upper alarm limit User selectable P2 MAP Low P2 MAP measuring value is below lower alarm limit User selectable EtCO High EtCO measuring value is above upper alarm limit User selectable EtCO Low EtCO measuring value is below lower alarm limit User selectable FiCO High FiCO measuring value is above alarm limits User selectable CO APNEA T M Mee interval no RESP can be detected Hish AWRR High AwRR measuring value is above upper alarm limit User selectable AWRR Low AwRR measuring value is below lower alarm limit User selectable EtO High EtO measuring value is above upper alarm limit User selectable EtO Low EtO measuring value is below lower alarm limit User selectable FiO High FiO measuring value is above upper alarm limit User selectable FiO Low FiO2 measuring value is below lower alarm limit User selectable EtN20 High EtN2O measuring value is above upper alarm limit User selectable FiN50 Low FiN2O measuring value is below lower alarm limit User selectable EtHAL High EtHAL measuring value is above upper alarm limit User selectable EtHAL Low EtHAL measuring value is below lower alarm limit User selectable
122. hing and the monitor is in temperatory mute alarm status If the user presses the Mute key again or the temperatory mute time ends the monitor resumes audible alarm And the monitor will display prompt message of sensor off alarm 4 6 Testing Alarms When you switch the monitor on a selftest is started You must check that the alarm indicator lights and that you hear a single tone This indicates that the visible and audible alarm indicators are functioning correctly For further testing of individual measurement alarms perform the measurement on yourself or use a simulator Adjust alarm limits and check that appropriate alarm behavior is observed 25 Patient Monitor User Manual Chapter 5 Alarm Information 5 1 Physiological Alarm Information Alarm Information Message Cause Alarm level ECG Too Weak Can not detect the signal in designated time period High ST measuring value is above the upper alarm limit X ST X High stands for I II III aVR aVL aVF V V1 V2 V3 V4 User selectable V5 or V6 ST measuring value is below the lower alarm limit X ST X Low stands for I II III aVR aVL aVF V V1 V2 V3 V4 User selectable V5 or V6 ASYSTOLE No QRS is detected for 4 consecutive seconds User selectable Ventricular tachycardia The fibrillation wave lasts for VFIB VTAC 4 consecutive seconds or the Bumper of continuous A Vent beats is larger than the upper limit of
123. ic field characteristic of a IEC EN 61000 4 8 typical location in a typical commercial or hospital environment Voltage dips short 596 Ur 596 Ur Mains power quality interruptions and gt 95 dip in Uy 29596 dip in Ur should be that of a for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec typical commercial or hospital environment If the user of the Patient Monitor requires continued operation during power mains interruptions it is recommended that the Patient Monitor be powered from an uninterruptible power supply or a battery NOTE Uris the a c mains voltage prior to application of the test level B 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The Patient Monitor is intended for use in the electromagnetic environment specified below The customer or the user of Patient Monitor should assure that it is used in such an 168 Patient Monitor User Manual EMC Information environment ly IEC EN 60601 test Immunity test level Conducted RF 3 Vims IEC EN 150 kHz to 80 MHz 61000 4 6 Radiated RF 3 Vim IEC EN 80 MHz to 2 5 GHz 61000 4 3 Compliance level 3 Vims 3 V m Electromagnetic environment guidance Portable and mobile RF communications equipme
124. igh pressure value Range out of pressure resume normal AG AA Id Unreliable AG module can t identify Medium Reduce gas agent the AG agent type AO SpA AO de AG module is calibrating Low Pease E bio Progress calibration finishing nem Please check whether AG Calibration Fail 2 EOS V ALDEAN Medium the module works failure properly Please check whether Unable To Calibrate i oA s Medium the module works calibrated properly AG Zero In Progress AG module is zeroing Low Please wait zeroing Th li li i Replace th li AG Occlusion e sampling lme 18 mam tep ace the sampling clogged line A dul k AG Init Fail AG module has a failure High pr ander UNS improperly AG Data Limit Error AG module has a failure High CA OS On improperly Be Patient Monitor User Manual Alarm Information AG Usa Error AG module has a failure High nm ee tes improperly A l fail t AG Cal Fail a module ails o High des module works calibrate improperly AG Zref Fail AG module fails to zero High BS OS OE improperly AG Change Oxygen Replace oxygen sensor of Please wait changing Low M Sensor AG module finishing AG No Oxygen The oxygen sensor falls off Connect the sensor High Sensor from the AG module again AG Mixed Agents AG module detects mixture Medium Close the subsidiary gas agent gas agent CO Occlude Water trap of SideStream is s Make sure the gas occluded exhaust wor
125. ing sure that there is no air present in the catheter or pressure line 4 Position the transducer so that it is at the same level with the patient s heart approximately mid axillary line 5 For the label name selection please refer to Selecting a Pressure for Monitoring 85 Patient Monitor User Manual Monitoring IBP 6 To zero the transducer please refer to Zeroing the Pressure Transducer WARNING If there are air bubbles in the pressure line or the transducer you should flush the system with the solution to be infused 15 4 Selecting a Pressure for Monitoring Tell the monitor which pressure you want to monitor by selecting its pressure label The label is a unique identifier for each type of pressure When you choose a label the monitor uses that label s stored settings for example color wave scale and alarm settings The label also determines which algorithm is used to process the pressure signal so an incorrect label can lead to incorrect pressure values To select the label please refer to the following table Label Description ART Arterial blood pressure PA Pulmonary artery pressure CVP Central venous pressure ICP Intracranial pressure LAP Left atrial pressure RAP Right atrial pressure P1 P2 Alternative non specific pressure labels 15 5 Zeroing the Pressure Transducer To avoid inaccurate pressure readings the monitor requires a valid zero Zero the transducer
126. ions or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING 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 I inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure II Table of Contents Chapter 1 Indication for Use and Safety Guidance oomoocomcs 1 TL Indication Dor USE 6 oet itadtab et caedi o seite 1 LD Salety GUISA aia 1 1 3 Explanation of Symbols on the Monitor eese eene enne nennen enne enne 3 Chapter 2 Tris Call at 0 eee PP artesa 7 2 L Initial vito 7 2 2 Mouitme the Monitor Lo ep D A A A ue piae dota edet udis uus 7 2 2 1 Installing Wall Mount for the Monitor eene nennen 7 2 3 Connecting the Power Cable inn dada cas 7 ZPCheckin
127. ir tube the air inlet the air outlet is plugged by water or other materials The accuracy of the CO measurement will be affected by the following reasons the airway was highly obstructed the leakage of air way connection or quick variation of environment temperature Follow precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment In the presence of electromagnetic devices i e electrocautery patient monitoring may be interrupted due to electromagnetic interference Electromagnetic fields up to 20V m will not adversely affect module performance Do not place the sensor cables or tubing in any manner that may cause entanglement or strangulation Do not store the CO Module at temperatures less than 40 F 40 C or greater than 158 F 70 C Do not operate the CO2 Module at temperatures less than 32 F 0 C or greater than 104 F 40 C 89 Patient Monitor User Manual Monitoring CO NOTE After the low battery alarm appears please do not start the CO measurement or the monitor may turn off for the low battery 16 3 Monitoring Procedures 16 3 1 Zeroing the sensor You must perform zeroing following the steps when using the new airway adapter 1 Expose the sensor to room air and keep it away from all sources of CO including the ventilator the patient s breath and the operator s 2 Inthe CO Setup menu please set the Work Mode to Measure 3 I
128. is selected when performing measurements It may be dangerous for the children to use an over pressure level The equipment is suitable for use in the presence of electrosurgery The equipment can provide protective means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT The equipment can protect against the effects of the discharge of a defibrillator 6 Before starting a measurement verify that you have selected a setting appropriate for your patient adult pediatric or neonatal 7 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation 74 Patient Monitor User Manual Monitoring NIBP WARNING 8 Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled 9 Do not attach the cuff to a limb being used for IV infusions as the cuff inflation can block the infusion potentially causing harm to patient NOTE 1 It is suggested that the user should not start NIBP measuring when the low battery displays or the monitor may be turned off automatically 2 If an alarm occurs or measurement fails please discontinue the measurement 3 f you spill liquid onto the equipment or accessories particularly if there is a chance that it can get inside the tubing or the measurement device contact your service personnel 4
129. ks well The CO concentration CO Out Of Range exceeds the accuracy range High Md CO2 concentration of AG module CO Sensor Faulty Stop measuring CO module failure High tuienon gi CO module notify CO Sensor Over biomedical engineer Temp le fail CO Comm Fail CO2 we E TI High communication failure CO Ram Error CO module failure High Stop using CO alarm function and notify biomedical engineer or Manufacturer s CO Rom Error CO module failure High service staff CO Zero Required Zero calibration failure Low 38 Patient Monitor User Manual Alarm Information Th la 1 ff CO Check Adapter S ieu duse E E EDW disconnected Th AA trati e concentration Redis AUR AA Out Range exceeds the accuracy range High concentration of AG module Stop measuring of AG dule d The oxygen sensor of the notif d icd O Sensor Error sidestream AG module has Medium 4 y SRS a failure engineer or Manufacturer s service staff Stop measuring function of TEMP QuickTemp Comm TEMP module failure or Hieh module and notify Fail communication failure E biomedical engineer or manufacturer s service staff The TEMP value is beyond me d m Temp exceed limit the range of 25 C Med ee FR take it out and 45 C measure again TEMP sensor is not Connect the sensor No Temp Sensor connected to the TEMP Low and the monitor well module and measure again Put the
130. layed graphically as pressure versus time on a monitor screen or numerically on digital display The monitor measures direct blood pressure of one selected blood vessel through two channels or four channels and displays waveforms and pressure of measured direct blood pressure SYS DIA and MAP 15 2 IBP Safety Information 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 transducer and the cables must be avoided from conductive connection to the HF equipment This is to protect against burns to the patient Disposable 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 the transducer or the monitor contact the Hospital Service Center immediately NOTE 1 Use only the pressure transducer listed in the IBP Accessories 2 Calibrate the instrument either whenever a new transducer is used or as frequently as dictated by your Hospital Procedures Policy 15 3 Monitoring Procedures Preparatory steps for IBP measurement 1 Plug the pressure cable into the corresponding socket and switch on the monitor 2 Flushing through the system with normal saline solution Ensure that the system is free of air bubbles 3 Connect the patient catheter to the pressure line mak
131. ling line with a fingertip and wait for 10 seconds 6 Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light 105 Patient Monitor User Manual Monitoring AG 7 If applicable Perform a tightness check of the patient circuit with the sampling line attached 18 3 1 2 System Setup for Analyzer If your system is using the plug in and measure ISA analyzer please follow the setup instructions below 1 Connect the ISA analyzer interface cable to the monitor 2 Connect a Nomoline sampling line to the ISA analyzer input connector 3 Connect the gas sample exhaust port to a scavenging system or return the gas to the patient circuit 4 Power up the monitor 5 A green LED indicates that the ISA analyzer is ready for use 6 Perform a pre use check as described in section Perform a pre use Check 18 3 1 3 Zeroing The infrared module needs to establish a zero reference level for the CO N20 and anesthetic agent gas measurement This zero calibration is here referred to as zeroing ISA analyzer performs zeroing automatically by switching the gas sampling from the respiratory circuit to ambient air The automatic zeroing is performed every 24 hours and takes less than 3 seconds for ISA CO module and less than 10 seconds for ISA analyzer If the ISA analyzer is fitted with an oxygen sensor the automatic zeroing will also include room air calibration of the oxygen sensor WARNING 1 Since a suc
132. llowing figure 2 Insert a new roll of paper into the paper cassette printing side facing upwards 123 Patient Monitor User Manual Recording 3 Ensure proper position and tidy margin 4 Pull about 2cm of the paper out and close the recorder casing 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 22 5 5 Removing Paper Jam When the recorder functions or sounds improperly you should open the recorder casing to check for a paper jam Remove the paper jam in the following way m Cut the record paper from the feeding edge m Open the recorder casing m Re insert the paper 124 Patient Monitor User Manual Recording NOTE 1 If the monitor is not installed with a recorder it will indicate RECORDER SETUP NEEDED after pressing the Record button 2 Do not touch the thermo sensitive print head when performing continuous recording 125 Patient Monitor User Manual Other Functions Chapter 23 Other Functions 23 1 Nurse Call The monitor provides dedicated nurse call port which is connected to nurse call system through the nurse call cable to perform the nurse call function 126 Patient Monitor User Manual Using Battery Chapter 24 Using Battery 24 1 Battery Power Indicator The indicator labeled Battery on the front panel of the monitor illuminates in green
133. ly can be used only in Adu mode 2 When setting ST Analysis to on the monitor should be in Diagnos mode 3 ECG monitoring should be in Diagnos mode 8 10 3 ST Analysis Alarm Setting The user can select ECG Setup ST Analysis Alarm Setup to set the upper alarm limit and lower alarm limit ALM HI can be set to 0 2 mV 2 0 mV and ALM LO can be set to 22 0 mV 0 2 mV ALM HI should be higher than ALM LO 8 10 4 About ST Measurement Points The ST value for each beat complex is the vertical difference between the ISO point and the ST point as shown in the diagram below The isoelectric ISO point provides the baseline and the ST point is at the midpoint of the ST segment The J point is where the QRS complex changes its slope as it is a fixed distance away from the ST point it can be useful to help you position the ST point correctly 62 Patient Monitor User Manual Monitoring ECG Iu 5 oT Wms 108 me DEF POINT The ST and ISO measurement points need to be adjusted when you start monitoring and if the patient s heart rate or ECG morphology changes significantly Always ensure that ST measurement points are appropriate for your patient Abnormal QRS complex is not considered in ST segment analysis 8 10 5 Adjusting ST and ISO Measurement Points Depending on your monitor s configuration the ST point can be positioned too These two points can be adjusted by turning the knob When adjusting ST measurement point the
134. m Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100 Pulse Volume 3 Alarm Source Auto C 7 NIBP NIBP Settings ADU PED NEO Alarm Switch On 173 Patient Monitor User Manual Default Settings Alarm Record Off Alarm Level Medium Alarm High Limit SYS 160 120 90 Alarm Low Limit SYS 90 70 40 Alarm High Limit Map 110 90 70 Alarm Low Limit Map 60 50 30 Alarm High Limit Dia 90 70 60 Alarm Low Limit Dia 50 40 20 EDAN Module Inflation value 160 140 100 M3600 Module Inflation value 180 180 120 Unit mmHg Interval Manual C 8 TEMP TEMP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium 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 P C 9 Quick TEMP Quick TEMP Settings ADU PED NEO Alarm Switch On Alarm Record Off 174 Patient Monitor User Manual Default Settings Alarm Level MA Alarm High Limit T1 39 0 39 0 Alarm Low Limit T1 36 0 36 0 Unit C C 10 IBP IBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Unit mmHg Filter 12 5Hz SYS DIA MAP SYS DIA MAP SY
135. m review interface If the user selects Current Time on the popup interface the alarm events occurring before the current time are displayed on the alarm event review interface If the user selects User Define he can define the review time by setting time box displayed on the interface The alarm events occuring before the User Define option are displayed on the alarm event review interface 20 5 Arr Review Select ECG Setup gt Arr Analysis gt Arr Review or Menu gt Review gt Arr Review to open the Arr review interface The interface displays the latest arrhythmia events 20 5 1 Scrolling the Screen All arrhythmia events can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see the other arrhythmia events that do not fit 117 Patient Monitor User Manual Review in the current view by selecting and pressing the symbol W and displayed on the Arrhythmia Review interface 20 6 12 lead Diagnosis Review Select Menu gt Review gt Analysis Review to open the 12 lead analysis review interface If there is no analysis result the prompt of No Analysis Result is displayed on the interface Diagnosis Review Analysis Time f HR P QRS T Axis PR Interval RV5 SV1 Amp QRS Duration RV5 SV1 Amp QT QTC Interval Diag Code Diag Result a v Wave 2 y Delete Record 20 6 1 Scrolling the Screen
136. mit to 100 which is equivalent to switching the alarm off 10 7 Setting SpOs as Pulse Source 1 In the PR Setup menu select PR Source 2 Select SpO from the pop up list 10 8 Setting Pitch Tone If tone modulation is on the PR sound lowers when the SpO level drops In the SpO Setup menu select pitch tone to toggle between On and Off 10 9 Setting Sensitivity The different sensitivity indicates different refresh frequency High indicates the refresh frequency of SpO value is the most frequent To change the sensitivity please follow the steps Selectthe SpO Setup menu 2 Select Sensitivity on the interface and select the desired sensitivity from the popup list 72 Patient Monitor User Manual Monitoring PR Chapter 11 Monitoring PR 11 1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute bpm You can display a pulse from any measured SpO signal or any arterial pressure 11 2 Setting PR Source The monitor provides PR sources options but currently only SpO is supported If the parameter as PR source is switched off the monitor will switch based on priority If all parameters producing SpO are switched off the PR parameter will be switched off 11 3 Setting PR Volume Six selections are available 0 1 2 3 4 and 5 5 indicates the maximum volume 0 indicates no sound You can change PR Volume in the PR Setup menu
137. n Minimum input slew rate gt 2 5V S Heart rate Range ADU 15 bpm 300 bpm PED NEO 15 bpm 350 bpm Accuracy 1 or 1 bpm whichever is greater Resolution 1 bpm Sensibility gt 300 uVPP PVC Range ADU 0 300 PVCs min PED NEO 0 350 PVCs min Resolution 1 PVCs min ST value Range 2 0 mV 2 0 mV Accuracy The max of 0 02 mV or 10 0 8 mV 0 8 mV whichever is greater Resolution 0 01 mV HR averaging method Method 1 Normally heart rate is computed by excluding the minimum 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 1200ms then the four most recent RR intervals are averaged to compute the HR Range 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 Ventricular Tachycardia The interval of 5 consecutive ventricular wave is less than 600 ms 147 Patient Monitor User Manual Ventricular Rhythm Product Specification The interval of 5 consecutive ventricular wave ranges from 600 ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular wave is more than 1000 ms Startup time for Tachycardia
138. ncy of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 170 Patient Monitor User Manual Default Settings C Default Settings This appendix documents the most important default settings of your monitor as it is delivered from the factory Note If your monitor has been ordered preconfigured to your requirements the settings at delivery will be different from those 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 120s Mute On Sensor Off Alarm On Alarm Latch Unlatch C 3 ECG Default Settings ECG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100 Pace Off Lead Type 5 Leads Display Normal Filter Monitor Smart Lead Off Off Heart Volume 2 ST Analysis ADU PED NEO ST Analysis Off Alarm Switch Off 171 Patient Monitor User Manual Default Settings
139. ndard Electrode Labels Color Electrode Labels Color RA White R Red LA Black L Yellow LL Red F Green RL Green N Black V Brown C White 55 Patient Monitor User Manual Monitoring ECG V1 Brown Red Cl White Red V2 Brown Yellow C2 White Yellow V3 Brown Green 3 White Green V4 Brown Blue C4 White Brown V5 Brown Orange C5 White Black V6 Brown Purple C6 White Purple 8 8 1 Electrode Placement for 3 lead Take the American standard for example see the following figure m RA placement directly below the clavicle and near the right shoulder m LA placement directly below the clavicle and near the left shoulder m LL placement on the left hypogastrium Lewis Xk ZR LA RA NE i a Fr q L gt DES A Ye e 77 E E d LL Electrode Placement for 3 lead 8 8 2 Electrode Placement for 5 lead Take the American standard for example see the following figure m RA placement directly below the clavicle and near the right shoulder m LA placement directly below the clavicle and near the left shoulder m RL placement on the right hypogastrium m LL placement on the left hypogastrium m V placement on the chest the position depends on your required lead selection 56 NOTE To ensure the patient safety all leads must be attached to the patient Patient Monitor User Manual Monitoring ECG Electrode Placement for 5 lead For 5 lead attach
140. ndicator The alarm indicator Mode is flashes in red with a flashes in red The alarm DO DO DO DO frequency of 1 4Hz message flashes with red High DO 2 8Hz The alarm background and the DO DO DO DO D message flashes with red symbol is displayed at O which is triggered background and the the alarm area once every 5 seconds symbol is displayed at the alarm area The alarm indicator No definition flashes in yellow with a frequency of 0 4Hz Mode is DO DO DO 0 8Hz The alarm Medium which is triggered once message flashes with every 25 seconds yellow background and the symbol is displayed at the alarm area The alarm indicator The alarm indicator flashes in yellow The flashes in blue The alarm Mode is DO which alarm message flashes message flashes with Low is triggered once every with yellow background yellow background and 30 seconds and the symbol is the symbol is displayed displayed at the alarm at the alarm area area The sound pressure range for audible alarm signals is from 45 dB to 85 dB 4 3 Controlling Alarm 4 3 1 Switching the Individual Alarm Off To switch the alarm off please select XX Setup Alarm Setup XX stands for parameter name and set Switch to Off from the popup list Alarm Off symbol E is displayed on the parameter area if the parameter alarm is switched to off 4 3 2 Temporary Alarm Mute The monitor will
141. ng 10 Wait for the calibrated result You should take corresponding measures based on the prompt information 11 After calibration disassemble the blood pressure tubing and the attached 3 way valve 6 1 Hydrargyrum pressure meter 2 3 way connector 3 3 way stopcock 4 Pressure transducer 5 Pressure transducer interface cable 6 Monitor IBP Calibration 15 9 Troubleshooting the Pressure Calibration The status line lists the probable reasons of an unsuccessful calibration Message Corrective Action Sensor Off Fail Make sure that sensor is not off then start the calibration Contact service technician if necessary Unable to calibrate in Demo Mode Make sure that the monitor is not in DEMO mode Contact service technician if necessary Pressure out of normal range fail Make sure that you have selected transducer value in IBP CAL then start the calibration Contact service technician if necessary Pulsate Pressure Calibration Fail Make sure that pressure value shown by hydrargyrum pressure meter is changeless Contact service technician if necessary 15 10 IBP Alarm When Alarm Switch is set to On the physiology alarm occurs if any measurement value of Systolic pressure Mean pressure or Diastolic pressure exceeds alarm limit Users can adjust the alarm limit by accessing XX Options XX stan
142. ng Respironics 3475 00 11 15 040143 Respironics CAPNOSTAT 5 EtCO Main stream Module 1015928 140 Patient Monitor User Manual 11 57 471019 Airway Adapter reusable adult children 11 57 471020 Airway Adapter reusable neonate premature baby 11 59 078155 Disposable Adult Airway Adapter 6063 00 11 59 078156 Disposable Neonatal Infant Pediatric Airway Adapter 6312 00 11 57 078142 Adult Nasal CO with O Delivery Sampling Cannula 11 57 078143 Pediatric Nasal CO with O2 Delivery Sampling Cannula 11 57 078144 11 57 101019 Infant Nasal CO with O Delivery Sampling Cannula Adult Nasal Oral CO Sampling Cannula 11 57 101020 Pediatric Nasal Oral CO Sampling Cannula 11 57 101021 Adult Nasal Oral CO with O Delivery Sampling Cannula 01 12 031598 Adult Pediatric Airway Adapter Kit 11 57 078140 Children Nasal Sampling Cannula sidestream 2 5m 11 57 078141 Infant Nasal Sampling Cannula sidestream 2 5m 11 57 078152 Pediatric Infant Airway Adapter Kit with Dehumidification Tubing 11 57 078158 Pediatric Mask Mainstream 9960PED 00 11 57 078159 Adult Standard Mask Mainstream 9960S TD 00 11 57 078160 Adult Large Mask Mainstream 9960STD 00 11 57 078161 Band Mainstream 8751 00 11 12 078162 Card Slot Mainstream 6934 00 28 8 C O Accessories Accessories
143. ng NIBP Invalid Reset The hardware pressure is Los function of E too high module and notify biomedical engineer or manufacturer s service staff Mesta ime has Measure again or use NIBP Time Out AE Low other measuring exceeded the specified time method Check the NIBP cuff NIBP Tube Leak O Mon Low and pump for leakage leakages The cuff type used isn t Confirm the patient NIBP Cuff Type Error consistent with the patient Low type and change the type cuff Check whether the airway is occluded or Environment atmospheric oa AM Air Pressure Error pressure abnormal or Low WOES DORA an system pressure abnormal OS If the problem still exists contact your service personnel NIBP Self Test Error Sensor or other hardware Hd Contact your service errors personnel 238 Patient Monitor User Manual NIBP cuff or pump has a Alarm Information Check the NIBP cuff NIBP Pneumatic Leak Low and pump for leakage leakages Contact i NIBP System Failure Hardware abnormal High MR te ee personnel NIBP cuff isn t NIBP Cuff Leak Cuff pump or airway has a Low properly connected leakage or there is a leak in the airway Check whether the airway is occluded or pressure sensor k ly i NIBP Leak Test Error Hardware abnormal High Mo d pressure meter mode If the problem still exists contact your service personnel Cuff is too lo Use other method to NIBP Weak Signal E uad Low measu
144. not be displayed at the same time 20 2 1 Setting Resolution The monitor can support seven kinds of interval To set an apprioate resolution please select Menu gt Review gt Trend Table and an interface is displayed Choose Resolution on the interface to open the list and select an apprioate interval among 1 sec 5 sec 1 min 5 min 10 min 30 min and 60 min 20 2 2 Scrolling the Screen All trend tables can t be displayed on the current screen due to the screen limitation The user can scroll left right up and down the screen manually to see measurement trend tables that do not fit in the current view by selecting and pressing the symbol Ud Y and displayed on the trend graph 20 2 3 Switching to Trend Graph The user can switch to the trend graph on the Trend Table interface To do so please select Menu gt Review gt Trend Table and select the Trend Graph option from the popup interface 20 2 4 Recording The monitor can make a tabular trend recording of the data in the current trend graph window The report will use the current trend interval settings For the detailed information about recording the trend table please refer to Chapter Recording 20 3 NIBP Review To review the NIBP measurement data select the NIBP Review key on the screen or select 116 Patient Monitor User Manual Review Menu gt Review gt NIBP Review then the NIBP Review window is displayed 20 3 1 Scrolling the Screen All measu
145. nt should be used no closer to any part of the Patient Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance dep LV 3 5 d VP 80 MHz to 800 MHz L7 Jj d WP 800 MHz to 2 5 GHz L1 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless 169 Patient Monitor User Manual EMC Information telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field s
146. nterface NOTE Discharging patient will clear the history data in the monitor associated with the patient 6 5 Central Monitoring System The monitor can be connected to the central monitoring system Through the network 1 The monitor sends patient information real time monitoring or measurement data to the central monitoring system 2 The real time monitoring information is displayed on the central monitoring system as the same to the monitor and the central monitoring system can perform some bilateral control For example changing patient information alarm limit and so forth For detailed information please refer to MFM CMS Central Monitoring System User Manual and CMS Central Monitoring System User Manual And the monitor supports HL 7 protocol 48 Patient Monitor User Manual User Interface Chapter 7 User Interface 7 1 Setting Interface Style The user can set the interface based on the requirement and the set options include the following O Sweep of the waveform O Parameters needing to be monitored Change to some settings may have the risk so only the authorized person can change them After changing the settings please notify the operator 7 2 Selecting Display Parameters The user can select the display parameters based on the monitoring and measurement requirements To select the parameter please 1 Select Menu gt System Setup gt Module Switch 2 Select the required parameters from the pop
147. nthe CO Setup menu select Zero Calibration 4 If the system briefly displays Zero In Progress the process is successful After the zeroing calibration is finished you can start CO Monitoring If the system displays Breath detected or Zero required zeroing has failed Zero calibration must be performed again 16 3 2 LoFlo CO Module NOTE You must perform a zero calibration as described in this procedure each time the ambient temperature changes more than 10 C for example during transport LoFlo CO module 16 3 2 1 Measurement Steps Plug the sensor cable into the monitor s CO input connector Allow the sensor two minutes 00 Patient Monitor User Manual Monitoring CO for warm up 2 Connect the cannula airway adapter or sample line as appropriate to the sensor It will click into place when seated correctly Connecting LoFlo module 3 To zero the sensor please refer to zeroing the sensor 4 For intubated patients an airway adapter is required Air adapter For non intubated patients Place the nasal cannula onto the patient Place the nasal cannula 91 Patient Monitor User Manual Monitoring CO NOTE 1 Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit In reverse always remove the airway adapter from the breathing circuit before removing the sensor 2 Always disconnect the cannula airway adapter or sample line from
148. ntrolling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details 25 2 2 Cleaning the Accessories 25 2 2 1 Cleaning the ECG Cables and Lead Wires NOTE 1 Use only recommended cleaning substances and disinfectants listed in this document Others may cause damage not covered by warranty reduce product lifetime or cause safety hazards 2 Keep the cable and lead wires free of dust and dirt 131 Patient Monitor User Manual Care and Cleaning 3 Never immerse or soak the ECG cable 4 Inspect the cables after cleaning CAUTION Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface After allowing the appropriate time for the agent to work as indicated by the manufacturer wipe off residues with a cloth dampened with water Clean with a lint free cloth moistened with warm water 40 C 104 F and substances listed below Never use strong solvents such as acetone or trichloroethylene Approved Cleaning Substances m Mild Soaps m Tenside as active cleaning agent Cables and leadwires can be cleaned with a warm damp cloth and mild soap or isopropyl alcohol 25 2 2 2 Cleaning the Blood Pressure Cuff Wipe cuffs with a solution of mild soap and water If the cover requires more rigorous cleaning remove the air bladder first Allow the cover to thoroughly air dry before use Cuffs have been tested to withstand the following
149. o freeze all the waveforms on the screen In Freeze mode press this button to restore the waveform refreshing 8 Start Stop Recording Press this button to start a real time recording During the recording press this button again to stop recording 9 Menu Press this button to return to the main interface when there is no menu open 10 Rotary Knob hereinafter called knob The user can rotate the knob clockwise or anticlockwise This operation can make the highlighted item shift up down left or right to choose the desired item Remember when using the knob rotate this button to highlight and press it to select the item 10 Patient Monitor User Manual Basic Operation 4 5 6 7 8 iM50 Back View 1 Fan 2 Anti theft lock interface 3 Security Lock 4 Power Supply Inlet 5 USB Interface 6 VGA Interface 7 Network Interface 8 Defibrillator Synchronization Analog Output 9 SD Card 10 Speaker 11 Equipotential grounding terminal if 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 have separate connection 11 Patient Monitor User Manual Basic Operation iM50 Side View 1 Sensor interface 2 Recorder door 3 Battery door 3 1 2 M80 Major Parts and Keys The iM80 pati
150. on of this equipment is allowed without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe operation 19 ISA analyzers are not designed for MRI environments 20 During MRI scanning the monitor must be placed outside the MRI suite 21 Use of high frequency electrosurgical equipment in the vicinity of the monitor may produce interference and cause incorrect measurements 22 Do not use external ambient cooling of the ISA device 23 Do not apply negative pressure to the Nomoline to remove condensed water 24 Too strong positive or negative pressure in the patient circuit might affect the sample flow 25 Exhaust gases should be returned to the patient circuit or a scavenging system 26 Always use a bacteria filter on the evac side if sampled gas is intended to be re breathed 27 Do not place the ISA analyzer in any position that might cause it to fall on the patient CAUTION 1 The ISA analyzers should be securely mounted in order to avoid the risk of damage to the ISA 2 Do not apply tension to the ISA analyzer cable 3 Do not operate the ISA analyzer outside the specified operating temperature environment 103 Patient Monitor User Manual Monitoring AG 18 2 2 Safety Information for IRMA Module WARNING 1 The IRMA probe is intended for use by authorized and trained medical personnel only The IRMA probe must not be used with flamm
151. oo PORNO NER NU EN ata ea 73 AO A ccd saa E gud cataatten yeaa ETA 73 11 2 Setting PR SOUtCe 4 oio te eG ains acti 19 1 FSetine PR WONG Si cid 73 11 4 Using Pulse ALTOS a Aia 73 11 5 Selecting the Active Alarm SOUTO vicodin n Leid a nin ie e RE Pd Ev ae ORO e EROR t 73 Chapter 12 Monitoring NIBP lindos RES et UNI RIF ORI e e He NE ROV EHEUME 74 INR uui ce S 74 12 2 NIBP Safety Information csi Uo e rad RIEN a diia 74 12 3 Introducing the Oscillometric NIBP Measurement sese 75 124 Measurement Limitations sintenon sisestus e e oe PRU Ret erae Pee dapes one 75 T2 34M easurement Methods a A EEEE 75 T2 0 Meas remen t Procedures siino ls e 76 12 7 Operation Prompts sea 77 12 8 Correcting the Measurement if Limb is not at Heart Level eese 78 ON Alatina a adiibatesd dato std Aass co d M EM E MaE 78 12 10 RGSCUUBE NIBP x as eic ooo ipe ro Odo SHIT aid 78 T2 rc alibraumg NIBBL o dor o necis cea 78 1212 Leak TOS O 78 1212 I Procedure of Leak Test atinada 78 Chapter 13 Monitoring TEMP ose is RP ERIN ERI MESE CH NER ORG INI ENNIO ORA NINE IRE IE 80 ll s eau 80 13 2 TEMP Safety IBEOEIIALO secedere tho dope PO ecu deti eal eise s dA Pr EM dad eae 80 13 3 TEMP Monitoring Setup feto misto e e Beth Qood uera tes bursa oca bes Geel at coc qa a estre ind 80 13 4 Calculating Temp Difference 4 eastodo c bio tees tp a aa 80 Chapter 14 Monitoring Quick TEMP isi siscesccccisssccosvsncnss
152. or EQUIPMENT and SYSTEMS that are not LIBE SUBPORTINCI ia 168 B 4 Recommended Separation Distances oe p aerei exe vehi eevee eae 170 Default SCCM SS aio Ee o IE SER PEINM SON aetna ow SU RING ERN 171 EA Patient Information Default Settngs are e qiie aaa 171 C2 Alarm Default SettIngs su iie ia eene a a a R E ERA DAN P nerd cdends 171 C3 ECG Default Settings sts is ede ouest a eds det vane 171 CARES Loa eed e s i e d e ets 172 CD Dag PEE 173 O 173 O chat 173 CS TEMP ona 174 E A ad ao tee de MU Sete te tbc op aig S re a 174 LX LES Q 175 CAICOS A bi 175 CIX O 176 CRAG ahe A AAA rs 176 IFA DDrevIadoDs ii RM 178 XI Patient Monitor User Manual Indication for Use and Safety Guidance Chapter 1 Indication for Use and Safety Guidance 1 1 Indication for Use iM80 The monitor monitors parameters such as ECG 3 lead 5 lead 12 lead selectable Respiration RESP Functional arterial oxygen saturation SpO Invasive or noninvasive blood pressure 2 4 channels IBP NIBP Cardiac Output C O Temperature dual TEMP Expired CO and Anesthetic gas AG The monitor is equipped with alarms that indicate system faults such as loose or defective electrodes physiologic parameters that have exceeded the limits set by the operator or both 1M50 The monitor monitors parameters such as ECG 3 lead 5 lead selectable Respiration RESP Functional arterial oxygen satur
153. or User Manual Installation Chapter 2 Installation NOTE 1 The monitor settings must be specified by the authorized hospital personnel 2 To ensure that the monitor works properly please read the user manual and follow the steps before using the monitor 2 1 Initial Inspection Before unpacking check the packaging and ensure that there are no signs of mishandling or damage If the shipping cartons are damaged contact the carrier for compensation and package them again Open the package carefully and remove the monitor and accessories Check that the contents are complete and that the correct options and accessories have been delivered If you have any question please contact your local supplier 2 2 Mounting the Monitor If all situations are normal please place the monitor on a flat level surface hung on the bed rail or mounted on a wall About how to install the wall mount for the monitor please refer to the following content 2 2 1 Installing Wall Mount for the Monitor For how to install wall mount for the monitor please refer to Wall Mounting Bracket Assembly Instruction 2 3 Connecting the Power Cable Connection procedure of the AC power line is listed below Make sure the AC power supply complies with the following specifications 100V 240V 50Hz 60Hz 2 Apply the power line provided with the monitor Plug the power line to inlet interface of the monitor Connect the other end of the power line to a grounded
154. or depends on your monitor configuration and on the options purchased Menu enter the main setup menu Directly select this item on the screen to quickly admit a patient 1 y Directly select this item on the screen to enter trend graph review interface Directly select this item on the screen to enter trend table review interface j Directly select this item on the screen to enter the alarm event review interface e F Directly select this item on the screen to enter the NIBP review interface gt Ca Directly select this item on the screen to enter the ARR review interface 17 Patient Monitor User Manual Basic Operation Directly select this item on the screen to enter the TrendScreen interface Directly select this item on the screen to enter the standard interface Directly select this item on the screen to enter the OxyCRG interface 3 emm Directly select this item on the screen to enter the Large Font interface Directly select this item on the screen to enter the module switch interface Directly select this item on the screen to change the key volume Directly select this item on the screen to adjust the screen brightness Directly select this item on the screen to calibrate the touch screen Directly select this item on the screen to zero the IBP sensor Directly select this item on the screen to enter the alarm setup interface eye E EJES 19 a
155. orrecting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level to the displayed value Add 0 75mmHg 0 10kPa for each centimeter Deduct 0 75mmHg 0 10kPa for each higher or centimeter lower or Add 1 9mmHg 0 25kPa for each inch higher Deduct 1 9mmHg 0 25kPa for each inch lower 12 9 NIBP Alarm When NIBP Alarm is set to On the physiology alarm occurs if any measurement value of Systolic pressure Mean pressure Diastolic pressure exceeds alarm limit The users can adjust the alarm limit by accessing NIBP Setup Alarm Setup Sys Alarm Map Alarm Dia Alarm 12 10 Resetting NIBP When the pressure does not work properly and the system fails to give a message for the problem pick Reset in the User Maintain NIBP Maintain menu to activate self test procedure and thus restore the system from abnormal performance 12 11 Calibrating NIBP NIBP is not user calibrated Cuff pressure transducers must be verified and calibrated on a yearly interval by a qualified service professional See the Service Manual for details 12 12 Leak Test This item is used for leak test Turn the knob to pick the Leak Test item in the User Maintain gt NIBP Maintain menu to start the air leakage test When the item is selected it will change into Stop If this item is selected again the system will stop air leakage test And the item returns to Leak Test WARNING This pneuma
156. panel of the monitor to exit the current menu Freeze status is entered and the popup Freeze menu is displayed In Freeze status all waveforms are frozen and will no longer be refreshed 19 2 2 Exiting Freeze Status In the Freeze status executing any of the following operations will command the system to exit the Freeze status Select the Exit option in from the Freeze menu Press the button on the control panel again Execute any operation that may trigger the adjustment of the screen or the display of a new menu After exiting Freeze status the system will clear screen waveforms and resume displaying real time waveforms In the Screen Refresh mode the system will sweep the waveforms from left to right in the Waveform Area Press the button on the control panel and the Freeze menu will appear on the bottom part of the screen At the same time the system freezes the waveforms B REC WAVE it can be set to any waveform of 8s such as IBP1 CO2 PLETH etc It can also be set to OFF Review Used to review frozen waveforms Exit The system closes the Freeze menu and exits the Freeze status 113 Patient Monitor User Manual Freeze NOTE Pressing the button repeatedly over a short period of time may result in discontinuous waveforms on the screen 19 3 Reviewing Frozen Waveform By moving the waveform you may review a waveform of 120 seconds before it is frozen For a waveform of less than 60 seconds
157. port edan com cn 136 Patient Monitor User Manual Accessories Chapter 28 Accessories You can order accessories from EDAN supplies at www edan com cn or consult your local Edan representative for details WARNING 1 Never reuse disposable transducers sensors accessories and so forth that are intended for single use or single patient use only Reuse may compromise device functionality and system performance and cause a potential hazard 2 Use only Edan approved accessories Using non edan approved accessories may compromise device functionality and system performance and cause a potential hazard 3 Do notuse a sterilized accessory if its packaging is damaged NOTE Transducers and sensors have a limited shelf life Refer to the package labeling The following cables may not all be available in all countries Please check availability with your local Edan supplier 28 1 ECG Accessories The following table lists the optional configuration for the monitor Part Number Accessories 01 57 471002 11 ECG cable IEC 3 lead clip Defib PVC 01 57 101027 11 ECG cable AHA 5 lead snap Defib PVC 01 57 109100 11 ECG trunk cable AHA 10 lead Defib TPU 01 57 109101 m wires 10 lead snap AHA 0 9m reusable only applicable to 01 57 040206 ECG trunk cable IEC 5 lead Defib TPU 01 57 040207 ECG limb wires 5 lead snap IEC 0 9m reusable 01 57 040208 ECG limb wires 5 lead clip IEC 0 9m reusa
158. ps Select the AG Setup menu 2 Select Work Mode on the interface and select Measure or Standby from the popup list 110 Patient Monitor User Manual Monitoring AG 18 5 Setting Alarms Here we take CO alarm for example This refers to CO specific alarms See the Alarms Chapter for general alarm information To change the alarm please refer to the following steps Select the CO Setup menu 2 Select EtCO Alarm High Limit or EtCO Alarm Low Limit to adjust the alarm limit 18 6 Setting Apnea Alarm Time This determines the time limit after which the monitor gives an alarm if the patient stops breathing Select the AG Setup menu to open it 2 Select Apnea Alarm from the menu 3 Choose the apnea alarm time from the pop up list 18 7 Working Status of ISA analyzer Woking status of the ISA analyzer can be indicated by the indicator For the detailed information please refer to the following table Indication Status Steady green light System OK Blinking green light Zeroing in progress Steady blue light Anesthetic agent present Steady red light Sensor error Blinking red light Check sampling line 18 8 Working Status of IRMA Module The working status of the IRMA module can be transmitted by the IRMA probe For the detailed information please refer to the following table Indication Status Steady green light System OK Blinking green light Zeroing in
159. range si patient condition Check TEMP2 measuring value is n iras Excessive T2 High connection and beyond measuring range ae patient condition Stop measuring function of TEMP i l tif TEMP Comm Fail TEMP modile failure or High modi e and ho ify communication failure biomedical engineer Or Manufacturer s service staff YY Sensor Off YY Check the sensor stands for the IBP label IBP sensor falls off Low connection and name reconnect the sensor Stop measuring yee ey Dua Ce IBP module failure or prd b x stands for the label Peru High b y name communication failure biomedical engineer Or Manufacturer s service staff 35 Patient Monitor User Manual C O Comm Fail C O module communication failure failure or High Alarm Information Stop measuring of C O module or notify biomedical engineer or Manufacturer s service staff C O TI No Sensor C O TI sensor not ix Insert injectate connected temperature sensor C O TB No Sensor fo CHA S DON Low Insert TB sensor connected TB i l i Pl heck TB TEMP Out Of Range measuring value is His ease chec above measuring range Sensor C O Lack Param C O measuring needs Hi Please input patients parameters height and weight The AA concentration Red AA AA Out Of Range exceeds the accuracy range High OR concentration of AG module Stop measuring of A 1 d The oxygen sensor of the s f
160. re blood pulse is too weak pressure Dus ti ional Make sure that the NIBP Excessive ur ee patient under noise is too large or pulse Low ee Motion monitoring 1S rate is not regular motionless Maybe the patient blood duc the Sap NIBP Range Exceeded pressure value is beyond the Low Dic pube NE is beyond the measurement range measurement range Check the The cuff pressure can t reach connections and the NIBP Air Leak the set value within 60sec Low wrapped cuff to see and 20sec in Neo mode whether they are all prepared well Inflate again and retry thrice Check The module isn t able to whether the patient NIBP Pressure Low detect the SYSTOLIC Low has an over high Apply pressure again blood pressure or it is interfered by movement 34 Patient Monitor User Manual Abnormal oscillometric Alarm Information Retry twice Check NIBP Pulse Abnormal Low for hyperkinesia or waveform arrhythmia 1 Check the patient s Pd i selena Pulse is too low to measure Low condition or the wrapped cuff Temperature cable of TEMP channel may be Make sure that the TEMP T1 Sensor Off isa cae ie Low cable is properly i connected monitor E DM a ob an Make sure that the TEMP T2 Sensor Off Es ed e Low cable is properly disconnected from the i connected monitor Check TEMPI measuring value is i E Miri Excessive T1 High connection and beyond measuring
161. re displayed at the bottom of screen if the touchscreen is disabled To enable the touchscreen operation turn the knob to select the symbol SS and press it 3 12 Using the Barcode Scanner To enter the barcode setup menu please select Menu Maintenance User Maintain after entering the required password ABC select Other Setup BarCode Setup Then the user can set serial No last Name first Name and so on If Auto Update is set to On the patient information is updated automatically by using a bar code scanner If Auto Update is set to Off the user needs to update the patient information manually 21 Patient Monitor User Manual Alarms Chapter 4 Alarms The alarm information here applies to all measurements Measurement specific alarm information is discussed in the sections of individual measurements WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area e g an intensive care unit or cardiac operating room 4 1 Alarm Category The monitor prodives three types of alarm physiological alarms technical alarms and prompts 4 1 1 Physiological alarms If one or several physiological parameters of the currently monitored patient exceed the predefined alarm limit for example SpO values exceed the alarm limit the monitor will give an alarm and this type of alarm is called physiological alarms About the detailed alarm information please refer to
162. rement data can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see measurement data that doesn t fit in the current view by selecting and pressing the symbol Y and displayed on the NIBP Review interface 20 3 2 Recording The monitor can record the measurement data in the NIBP review window For the detailed information about recording the NIBP review please refer to Chapter Recording 20 4 Alarm Review The monitor can display up to 10 technical alarm events in the current screen To review the alarm event select the Alarm Review key on the screen or select Menu gt Review gt Alarm Review then the Alarm Review Window is displayed 20 4 1 Scrolling the Screen All alarm events can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see alarm events that don t fit in the current view by selecting and pressing the symbol W and displayed on the Alarm Review interface 20 4 2 Selecting Alarm Event of Specific Parameter The monitor can review alarm event of the specific parameters To view the alarm event of the specific paramenter please select Menu gt Review gt Alarm Event and choose Event Type to select the required parameter name from the popup list 20 4 3 Setting Time Index The user can set end time of alarm review by selecting the Time Index option displayed on the alar
163. rm limit User selectable PA MAP High PA MAP measuring value is above upper alarm limit User selectable PA MAP Low PA MAP measuring value is below lower alarm limit User selectable CVP MAP High CVP MAP measuring value is above upper alarm limit User selectable CVP MAP Low CVP MAP measuring value is below lower alarm limit User selectable ICP MAP High ICP MAP measuring value is above upper alarm limit User selectable ICP MAP Low ICP MAP measuring value is below lower alarm limit User selectable LAP MAP High LAP MAP measuring value is above upper alarm limit User selectable LAP MAP Low LAP MAP measuring value is below lower alarm limit User selectable RAP MAP High RAP MAP measuring value is above upper alarm limit User selectable RAP MAP Low RAP MAP measuring value is below lower alarm limit User selectable P1 SYS High P1 SYS measuring value is above upper alarm limit User selectable P1 SYS Low P1 SYS measuring value is below lower alarm limit User selectable P1 DIA High P1 DIA measuring value is above upper alarm limit User selectable P1 DIA Low P1 DIA measuring value is below lower alarm limit User selectable P1 MAP High P1 MAP measuring value is above upper alarm limit User selectable P1 MAP Low P1 MAP measuring value is below lower alarm limit User selectable P2 SYS High P2 SYS measuring value is above upper alarm limit User selectable P2 SYS Low P2 SYS measuring value is below lower alarm limit User selectable P2 DIA Hig
164. rm limits Always check alarm limits to make sure that they are appropriate for your patient 2 For paced patients you must set Paced to On If it is incorrectly set to Off the monitor could mistake a pace pulse for a QRS and fail to give an alarm during asystole 6 2 Quick Admit If you do not have the time or information to fully admit a patient Complete the rest of the patient information later To quickly admit a patient please 1 Select Menu gt Patient Setup gt Quick Admit then a message is displayed to ask the user to confirm to update patient 2 Click on No to cancel this operation click on Yes to continue and the Patient Info window is displayed choose Type and Pace and set them to the correct mode 3 Select Exit 6 3 Editing Patient Information To edit the patient information after a patient has been admitted select Menu gt Patient Setup gt Patient Info and make the required changes on the popup interface 6 4 Updating a Patient You should always perform an update before starting monitoring for a new patient When you select Menu gt Patient Setup gt Quick Admit or Menu gt Patient Setup gt New Patient a message of Press Yes to create new patient profile by clearing all current patient data is displayed Ifthe user selects Yes the monitor will update the patient information If the user selects No the monitor won t update the patient information and returns to patient setup i
165. rvice department or your local distributor 10 Only patient cable and other accessories supplied by EDAN can be used Or else the performance and electric shock protection can not be guaranteed and the patient may be injuried 11 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 a hazard to the patient Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment 12 When interfacing with other equipment a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients 13 During monitoring if the power supply is off and there is no battery for standby the monitor will be off and only the patient information and alarm settings can be saved After reconnecting the power supply the user should turn on the monitor for monitoring 14 Keep away from fire immediately when leakage or foul odor is detected 15 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can 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 batteries over to the applicable collection points for the recycling of
166. s P Der O Sensor Error sidestream AG module has Medium y PENE a failure engineer or Manufacturer s service staff Stop measuring function of AG AG Comm Fail AG modula d or High Toute and ui communication failure biomedical engineer or Manufacturer s service staff Please perform AG Zero Required AG module requires zero Low zeroing Pl it th If AG Self Testing AG module is self testing Low bud iin x testing finishing A Replace Os Senor O sensor needs to be High Please replace the O replaced sensor Pl it check AG Check Adapter AG module checks adapter Low ed per finishing O Cali Required O needs to be calibrated Low Please calibrate O 36 Patient Monitor User Manual Alarm Information Es AG module software High Please Teplice abnormal software revision Please check whether AG Hardware Error on modile has MATOS High the hardwares work failure properly Please check whether AG Motor Error AG module motor abnormal High the motor works properly AG Uncalibrated AG module uncalibrated Low Pee Aaa e AG module AG Replace Adapter AG module needs to change High Please replace the adapter adapter O Out Of Range O is out of range High Mi MUNI resume normal AG TEMP Out Of AG module temperature out due iape AE High temperature resume Range of range normal AG Baro Press Out Of AG module baro pressure Pease makete ta H
167. s 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 gt Symbol for Caution Equipotential grounding terminal Alternating Current Power Supply switch Serial number Network port USB Universal Serial Bus Connection Audio alarm is off NIBP measurement Trend graph Freeze Record mM EE ML e ar Patient Monitor User Manual m Menu Indication for Use and Safety Guidance y VGA output External Monitor RS 232 port Nurse call port SD Card port Signal output port Signal output C The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices Authorised representative in the European community Date of manufacture id Manufacturer P N Part Number 4 Recycle Patient Monitor User Manual Indication for Use and Safety Guidance The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life i Consult Instructions For Use K Locked position CO Gas inlet T s V Gas outlet evac ISA equipped to measure CO only ISA equipped to measure multiple gases Patient Monit
168. s the cuff deflates from above systolic pressure The amplitude suddenly increases as the pulse breaks through the occlusion in the artery As the cuff pressure decreases further the pulsations increase in amplitude reach a maximum which approximates to the mean pressure and then diminish In adult and pediatric mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers ANSI AAMI SP10 1992 in relation to mean error and standard deviation when compared to auscultatory measurements in a representative patient population For the auscultatory reference the fifth Korotkoff sound was used to determine the diastolic pressure In neonatal mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers ANSI AAMI SP10 1992 in relation to mean error and standard deviation when compared to intra arterial measurements in a representative patient population 12 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 Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff 3 Ensure that the correct setting
169. ser Manual Monitoring TEMP Chapter 13 Monitoring TEMP 13 1 Overview Body temperature is measured by means of a thermistor probe a semiconductor whose resistance changes with temperature that is inserted in the rectum Two TEMP probes can be used simultaneously to measure two TEMP values and get the temperature difference The standard configuration is axilla sensor for adult 13 2 TEMP Safety Information WARNING 1 Verify probe cables fault detection before the beginning of monitoring phase Unplug the temperature probe cable of the channe1 from the socket and then the screen will display the error message TEMP T1 Sensor Off and the audible alarm is activated It is the same to the other channel 2 Take the TEMP probe and cable carefully When they are not in use you should coil up the probe and 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 NOTE Disposable TEMP probe can only be used once for one patient 13 3 TEMP Monitoring Setup E If you are using disposable TEMP probes you need to plug the TEMP cable into the monitor and then connect the probe to the cable With a reusable TEMP probe you can plug the probe directly into the monitor B Apply the TEMP probes securely to the patient W Switch on the monitor It takes 2 min 3 min for the body temperature to stabilize 13 4 Calculating Temp Difference The monitor can calculate and
170. sertion can cause bowel perforation 14 3 3 Measurements for Axillary Temperatures 1 Ensure that the white probe and probe well are installed 2 Remove the probe from the probe well 3 Press Quick TEMP Setup Measure Pos and select the Axillary mode 4 Observe the axillary mode indicator on the display flashing axillary icon 5 Load a probe cover 6 Adjust clothing to visualize the axilla 7 Avoid folds in the axilla and place the probe tip vertically as high as you can as shown 8 Place the arm at the patient s side Hold in this position without movement of the arm or probe during the measurement cycle 83 Patient Monitor User Manual Monitoring Quick TEMP Measuring Position in Axillary NOTE Do not take an axilliary temperature 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 14 4 Changing Temp Unit To change Temp Unit please 1 Select the Quick Temp Setup menu to open it and select Unit on the interface 2 Select the appropriate unit from the popup list 84 Patient Monitor User Manual Monitoring IBP Chapter 15 Monitoring IBP 15 1 Overview IBP is measured by means of a catheter inserted directly into the circulatory system A pressure transducer connected to the catheter converts the mechanical force exerted by the blood into an electrical signal which is disp
171. splay the error message TEMP SENSOR OFF and the audible alarm is activated 3 Take the TEMP probe and cable carefully When they are not in use you should coil up the probe and 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 4 The calibration of the temperature module is necessary every two years or as frequently as dictated by your Hospital Procedures Policy When you need to calibrate the temperature measurement please contact the manufacturer 5 Patient actions may interfere with accurate oral temperature readings Ingesting hot or cold liquids eating food chewing gum or mints brushing teeth smoking or performing strenuous activity may affect temperature readings for up to 20min after activity has ended 6 Do not take an axillary temperature through patient s clothing Direct probe cover to skin contact is required 7 Biting the sensor tip while taking a temperature may result in damage to the sensor 81 Patient Monitor User Manual Monitoring Quick TEMP WARNING 8 Make sure disposable TEMP sensor covers are used to limit patient cross contamination The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings 9 Quick Temp measurement isn t suitable for use during defibrillation 14 3 Measuring Procedure 14 3 1 Measurement for Oral Temperature Ensure the oral probe white probe an
172. system will show the ST Measurement Point Window The system displays the QRS complex template in the window It is adjustable for the highlight bar in the window You may select ISO or ST switch the knob left or right to move the cursor line When the cursor is at the required position you may select the base point or the measurement point 8 11 Arr Monitoring 8 11 1 Arrhythmia Analysis The arrhythmia algorithm is used to monitor ECG of neonatal and adult patients in clinics and detect the changes of heart rate and ventricular rhythm and also save arrhythmia events and generate alarming information Arrhythmia algorithm can monitor paced and non paced patients Qualified personnel can use arrhythmia analysis to evaluate patient s condition such as heart rate PVCs frequency rhythm and ectopic beat and decide the treatment Besides detecting change of ECG arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia The monitor can support up to 16 different arrhythmia analyses ARR Types Occurring Condition ASYSTOLE No QRS is detected for 4 seconds Ventricular tachycardia The fibrillation wave lasts for 4 consecutive seconds or the number of continuous Vent beats 1s VFIB VTAC larger than the upper limit of cluster Vent beats gt 5 The RR interval is less than 600ms VT gt 2 3 lt the number of cluster PVCs lt 5 63 Patient Monitor User Manual Monitoring ECG
173. t is performed by using Thermodilution method The monitor can determine blood temperature measure cardiac output You can have iced injecta using either the flow through system or individual syringes of injecta You can perform up to 6 measurements before editing the average Cardiac Output The prompt message on the screen will tell you when to inject 17 2 C O Safety Information WARNING 1 Make sure that appurtenance applied is in conformity with relevant Medical Device Safety Requirements 2 Appurtenance should be avoided from contact with conductive metal body when being connected or applied NOTE To replace the catheter thermistor please enter the catheter computation coefficient into the Constant item according to the instruction 17 3 C O Monitoring Procedures 1 Plug the C O interface cable into the C O socket and turn on the monitor 2 Attach the injectate probe connector and catheter thermistor connector to the appropriate parts of the cardiac output interface cable And open the patient information window to confirm the patinet s height and weight 3 Pick the C O Measure item in the C O Option menu 4 You can perform more than one measurement as required 5 After the completion of the measurement access the C O Measure window for Review to edit the measured data 96 Patient Monitor User Manual Monitoring C O a 3 P Y A 1 Monitor 2 Thermodilution Catheter 3 Cardiac Output Cable 4 Inje
174. t rate PR interval QRS complex duration QT interval P QRS T axis RV5 SV1 amplitude etc The interpretation function provides the automatic diagnosis of hundreds of abnormal cases such as Arrhythmia AV block ventricular conduction block myocardial infarction ventricular hypertrophy and atria enlargement ST T abnormality and electrical axes deviation 66 Patient Monitor User Manual Monitoring RESP Chapter 9 Monitoring RESP 9 1 Overview The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes The change of impedance between the two electrodes due to the thoracic movement produces a respiratory waveform on the screen 9 2 RESP Safety Information WARNING 1 If you do not set the detection level for the respiration correctly in manual detection mode it may not be possible for the monitor to detect apnea lf you set the detection level too low the monitor is more likely to detect cardiac activity and to falsely interpret cardiac activity as respiratory activity in the case of apnea 2 The respiration measurement does not recognize obstructive and mixed apneas it only indicates an alarm when a pre adjusted time has elapsed since the last detected breath 3 If operating under conditions according to the EMC Standard EN 60601 1 2 Radiated Immunity 3V m field strengths above 1V m may cause erroneous measurements at various frequencies Therefore it is recommended to avoid the use
175. tch filter is on 145 Patient Monitor User Manual Notch Product Specification 50Hz 60Hz Notch filter can be turned on or off manually Differential Input Impendance gt 5MQ Input Signal Range 8mV PP Accuracy of Input Signal The total error and frequency response comply with Reconstruction ANSI AAMI EC13 2002 Sect 4 2 9 8 Electrode Offset Potential 500mV Tolerance Auxiliary Current Leads off detection Active electrode 100nA Reference electrode 900nA ESU Protection Input Offset Current x0 1uA Recovery time after MP A 5s Defibrillation Leakage current of patient lt 10uA Scale signal ImVPP accuracy is 5 System noise lt 30u VPP Incision mode 300W Congelation mode 100W Restore time lt 10s Meets the requirements of ANSI AAMI EC13 2002 Sect 4 1 2 1 a Noise Suppression of Tested according to the test method in EC13 2002 Electrotome Sect 5 2 9 14 it accords with the standard 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 ms Ascending time 10 us 100 us Pulse Rejection Pulse is rejected 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 ms Ascending time 10 us 100 us 146 Patient Monitor User Manual Product Specificatio
176. ter T User InterEaee sone OE ie n RR EREAOEBAERRTEDRGE RE eb i a ere o o le i ee NE RE MUN 49 EA Settings Interface Style in t 49 7 2 Selecting Display Parameters eii eddie CONES TUNI ERU YT AREA T nene Vo Less dete 49 43 Changing Wave formcPOSItlon a oeque pic deep iecur ppl ed od id 49 7 4 Changme Interface Lay Out ainda deis eones 49 a oum seacoast orn ue r tes fecit cen M cse eo cec 49 PAY NAC WINS Sue C D ETT T DETTO STU IS 49 d Viewing Latge Font SO nl dd onda 50 7 8 Changing Parameter and Waveform Colors sss enne enne 50 7 9 Transferring a Configuration eiie Issa cete eene EU Ra TER Opa ea gEN DATE UE eaae reia 50 7 LO Default Cont Sur AON m 51 Chapter 8 Monitoring Uie Pa 52 ANNO AUCI T 9 52 SA ECO Safety Information sit AO ee a ae 52 Bs AGG DISDIZY say secs este Ses ast easet tee bh ISl sos pur S ona utes tag esie s o up toot fet dents 23 8 3 1 Changing the Size of the ECG Wave sia tates tetas cial opis aset gie 53 5 2 2 Changing the ECG Filter SEUS ee EO deti ea Oe INIM E d nme 54 8 4d Usms ECG ATIS S oot Ret To e da 54 B 5 Selectng C aleulatiOn eat s a eous erc bots tht nad 54 8 0 Monitoring Procedure P aa 54 o A II A Et tae t 54 5 02 Connecting ECG Cables ti dota mu taceam ii La etae re 55 8 7 Selecting Lead TP ad 55 b asInstalline Electrodos eset adiecta s kata vidil cob ce
177. the Section physiological alarm information 4 1 2 Technical Alarms If one or several technical status of the device is in abnormal status such as lead off or low battery and so on the monitor will give an alarm And this type of alarm is called technical alarms About the detailed alarm information please refer to Section fechnical alarm information 4 1 3 Prompts The monitor can give the character indication of monitoring process or other functions such as ARR Relearning and so on And this character is called prompts About the detailed alarm information please refer to Section Prompts 4 2 Alarm Levels In terms of severity the device s alarm levels can be classified into three categories high level alarms medium level alarms and low level alarms 1 High level alarms Indicating that the patient is in a life threatening situation and an emergency treatment is demanded 2 Medium level alarms The patient s vital signs appear abnormally or the device system status is abnormal indicating that prompt operator response is required 3 Low level alarms The patient s vital signs appear abnormal or the device system status appears abnormally indicating that operator awareness is required 22 Patient Monitor User Manual Alarms The high medium low level alarms are indicated by the system in following different ways Alarm Physiological alarms Technical alarms Prompt level The alarm i
178. the remaining part is displayed as a straight line Use the rotary snob on the control panel to move the cursor to the Review option in the Freeze menu Press the knob By turning the knob left or right frozen waveforms on the screen will move left or right correspondingly There is an arrow indicating upward on the right side of the last waveform 114 Patient Monitor User Manual Review Chapter 20 Review The monitor provides 120 hour trend data of all parameters storage of 1200 NIBP measurement results and 60 alarm events This chapter gives detailed instruction for review of all data 20 1 Trend Graph Review m The latest 1 hour trend is displayed every 1 or 5 seconds m The latest 120 hour trend is displayed every 1 5 or 10 minutes To review Trend Graph please press the Trend Graph key on the screen or select Menu gt Review gt Trend Graph then the trend graph interface is displayed In the trend graph the y axis stands for the measurement value and x axis stands for the time Trend Graph 10 55 44 B bpm 10 55 44 rpm 10 55 44 min Resolution p S v Cursor Trend Table Record 20 1 1 Selecting Trend Graph of Specific Parameter The monitor can review trend graph of different parameters To change the existing trend graph please select Menu gt Review gt Trend Graph and select a required parameter name from the popup list as shown in red text in the above figure 20 1 2
179. the sensor when the sensor is not in use 16 3 2 2 Removing Exhaust Gases from the System WARNING Anesthetics When using the sidestream CO measurement on patients who are receiving or have recently received anesthetics connect the outlet to a scavenging system to avoid exposing medical staff to anesthetics Use an exhaust tube to remove the sample gas to a scavenging system Attach it to the sidestream sensor at the outlet connector 16 3 3 C5 CO Module NOTE You must perform a zero calibration as described in this procedure each time you use a new airway adapter C5 CO module 16 3 3 1 Measurement Steps 1 Attach the sensor connector to the CO connector on the monitor 2 Wait two minutes allowing the sensor to reach its operating temperature and a stable thermal condition 3 Choose the appropriate airway adapter and connect it to the sensor head The airway adapter clicks into place when seated correctly 92 Patient Monitor User Manual Monitoring CO Comnecting Sensor 4 To zero the sensor please refer to zeroing the sensor 5 Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y section Connecting Airway Adapter WARNING 1 No routine user calibration required 2 Accuracy is affected by temperature and barometric pressure 3 Itis forbidden to insert or draw out the module when the monitor is working for it can cause instability of the system I
180. tic 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 the end of the test the system gives the prompt that the NIBP airway has air leaks please contact the manufacturer for repair 12 12 1 Procedure of Leak Test Connect the cuff securely with the socket for NIBP air hole Wrap the cuff around the cylinder of an appropriate size Access User Maintain NIBP Maintain Turn the knob to the Leak Test item and press the item Then the prompt of Leak Testing will appear indicating that the system has started performing leak test 78 Patient Monitor User Manual Monitoring NIBP The system will automatically inflate the pneumatic system to about 180 mmHg After 20 seconds the system will automatically open the deflating valve which marks the completion of a pneumatic measurement Ifthe prompt of Leak Test OK appears it indicates that the airway is in good situation and no air leaks exist However if the alarm information of NIBP Cuff Leak appears it indicates that the airway may have air leaks In this case the user should check for loose connection After confirming secure connections the user should re perform the pneumatic test If the failure prompt still appears please contact the manufacturer for repair Cylinder Monitor Cuff Diagram of NIBP Air Leakage Test 290 Patient Monitor U
181. tient then a message is displayed to ask the user to confirm to update patient 3 Click on No to cancel this operation click on Yes the Patient Info window is displayed 4 Enter the patient information Serial No Enter the patient s medical record number MRN for example 12345678 Last name Enter the patient s last name family name for example Smith First name Enter the patient s first name for example Joseph Gender Choose Male or Female Type Choose the patient type either Adult Pediat or Neonat BloodType N A A B AB and O Pace Choose On or Off You must select On if your patient has a pacemaker Date of Birth Enter the patient s date of birth Date of Admission Enter the patient s date of admission Height Enter the patient s height Weight Enter the patient s weight Doctor Enter any extra information about the patient or treatment 5 Select Exit 6 1 1 Patient Category and Paced Status The patient category setting 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 The paced setting determines whether the monitor shows pacemaker pulses or not When Pace is set to Off pace pulses are filtered and therefore do not show in the ECG wave 47 Patient Monitor User Manual Managing Patients WARNING 1 Changing the patient category may change the arrhythmia and NIBP ala
182. tral electrodes are securely attached to the patient but not the conductive part or ground 4 Check every day whether there is skin irritation resulted from the ECG electrodes If yes replace electrodes every 24 hours or change their sites 5 Place the electrode carefully and ensure a good contact Check if the lead connection is correct before monitoring If you unplug the ECG cable from the socket the screen will display the error message ECG LEAD OFF and the audible alarm is activated 7 When using the monitor with the defibrillator or other high frequency equipment please use defibrillator proof ECG lead to avoid burn 8 In order to avoid being burnt please keep the electrodes far away from the radio knife while using electrosurgical equipment 9 When using Electrosurgery ES equipment do not place an electrode near the grounding plate of the Electrosurgery device otherwise there will be a great deal of interference with the ECG signal 10 For patients with pacemakers the pacing impulse analysis function must be switched ON Otherwise the pacing impulse may be counted as normal QRS complex which results in failure of ECG LOST error detection 11 The electrodes should be made of the same metal materials 12 ECG cables can be damaged when connected to a patient during defibrillation Check cables for functionality before using them again NOTE 1 Interference from a non grounded instrument near the patient and ESU
183. trength in the location in which the Patient Monitor is used exceeds the applicable RF compliance level above the Patient Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Patient Monitor Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m B 4 Recommended Separation Distances Recommended separation distances between portable 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 the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the monitor as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of 1750 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d E d E d B V E E 0 01 0 12 0 12 0 23 0 1 0 36 0 37 0 74 1 1 16 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the freque
184. trosurgery equipment wire and ECG cable must not be tangled up Monitoring ECG leads are mainly used for monitoring the patient s vital signs When using the patient monitor with other electrosurgery equipment it is advised to use the counteracting defibrillation ECG lead The placement of the ECG leads will depend on the type of surgery that is being performed For example in an open chest surgery the electrodes may be placed laterally on the chest or on the back In the operating room artifacts may affect the ECG waveform due to the use of ES Electrosurgery equipment To help reduce this you can place the electrodes on the right and left shoulders the right and left sides near the 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 59 Patient Monitor User Manual Monitoring ECG NOTE 1 If an ECG waveform is not accurate while the electrodes are tightly attached try to change the lead 2 Interference from a non grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform 8 9 ECG Menu Setup 8 9 1 Setting Alarm Source To change the alarm source please select ECG Setup Alarm Source then a pop up box is displayed HR the monitor considers the HR as HR PR alarm source PR the monitor considers the PR as HR PR alarm source AUTO If the Alarm Source is set to Auto the monitor will use
185. tween 1 and 480 minute adjustable interval Sequence the measurement will run consecutively in five minutes then the monitor enters manual mode WARNING Prolonged non invasive blood pressure measurements in Auto mode may be associated with purport ischemia and neuropathy in the limb wearing the cuff When monitoring a patient examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the blood pressure measurements 12 6 Measurement Procedures 1 Connect the air hose and switch on the monitor 2 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 cuff to the patient About the cuff size selection please refer to Section NIBP accessories and make sure that the symbol is over the artery Ensure that the cuff is not wrapped too tightly around the limb Excessive tightness may cause discoloration and eventual ischemia of the extremity NOTE The width of the cuff should be either 40 of the limb circumference 50 for neonates or 2 3 of the upper arm length The inflatable part of the cuff should be long enough to encircle 50 80 of the limb The wrong size of cuff can cause erroneous readings If the cuff size is in question use a larger cuff lt 76 Patient Monitor User Manual Monitoring NIBP gt n Cuff Usage 3 Connect the
186. ug Dose NOTE The drug calculation function acts only as a calculator The patient weights in Drug Calculation menu and in Patient Information menu are independent of each other Therefore changing the Weight in Drug Calculation menu will not change the weight in the Patient Information menu 21 1 Drug Calculation 21 1 1 Calculation Procedures 1 The drug calculation window is displayed by selecting Menu gt Common Function gt Drug Dose 2 Select the right pull down box of the Drug option and select the required drug name among the 15 drugs which are listed as follows And the drug name of Drug A Drug B Drug C Drug D and Drug E can be defined by the user Drug A Drug B Drug C Drug D and Drug E AMINOPHYLLINE DOBUTAMINE DOPAMINE EPINEPHRINE HEPARIN ISUPREL LIDOCAINE NIPRIDE NITROGLYCERIN PITOCIN 3 The system generates values that can t be treated the calcaultion results The user must enter the correct parameter value based on the doctor s instruction 4 Enter the patient s weight 5 Enter the correct parameter value 6 Confirm whether the calculation result is correct 119 Patient Monitor User Manual Calculation and Titration Table 21 1 2 Calculation Unit 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 calcution units of the drugs are listed as follows Drug Unit DRUG A DRUG B DRUG C
187. un cacao rende atur satel catu de ECT cL Rm 111 18 8 Working Status of IRMA Module ui deidad 111 15 9 N O and O COMPA e ia 111 18 10 Effects of h tnidity iia 112 Chapter I9 EF6676 o esed ERU tu NE ORDRE Em Ee cH ON tene ru a RT IEEE 113 LAR A el tan a date Seana ca dacs 113 19 2 Entering Exiting Freeze Status iii delas dada 113 19 21 Entering Prez il 113 19 22 Exiting Freeze Status ed 113 19 3 Reviewing Frozen WavefOEImn eiecit tc EXE SEES ARES ES ss LU eS URS Bo HERE Soda Ev ae LR Re Vo Lene Ud 114 Chapter 20 Revi Wa cceciee i A UR E CUttu ees meet 115 2D T Trend Graph Rei Won Hob cesta rique ha ases E Eaa eto tpe dave uda edd 115 20 1 1 Selecting Trend Graph of Specific ParamMeter ooocoonnoconnnocccnoncccnoncnononcconnnccnnnnccnnnos 115 ZU T7 Setting Resolutions earn 115 20 1 3 Scrolling Left and Right the Screen ooococnnococnnncccnoncnononcnononcnononcnonnnccnnn naciona nccnnnos 115 20 1 4 Switching to the Trend Tabla asia 116 20 1 5 unnm 116 20 2 Trend Table Roa lin 116 A Resolution cain O a E 116 20 2 2 Scrolling the Serias 116 20 2 3 Switching t Trend Otal A A ii 116 20 2 4 RO bo 116 20 3 NIBP RN e td a aaO 116 20 3 Scroll the Sereen O 117 20 3 2 R cordin S sises iter e Itt ae tor ic Praef PO A ofa ese qa s EA 117 ZU Aha aris REVIEW O ER 117 20 4 1 re ICA NISI 117 20 4 2 Selecting Alarm Event of Specific Parameter esee 117 2021
188. up interface 3 Press Exit to exit the menu and the screen will adjust the parameters automatically 7 3 Changing Waveform Position The user can exchange the waveform positions of parameter A and parameter B please refer to the following steps to do so 1 Select waveform A and open the setup menu of waveform A 2 Select Change from the popup menu and select the desired label name of waveform B from the pull down list 7 4 Changing Interface Layout To change the interface layout please refer to the following steps 1 Select Menu gt Display Setting 2 Select one interface from the popup menu 3 The user can implement one kind of function screen based on the requirements If the user selects the Large Font option there is no function screen to be selected 7 5 Viewing Trend Screen To view the short trend screen the user can press the Trend Screen key on the screen directly or select Menu Display Setting View Selection TrendScreen 7 6 Viewing Oxygen Screen To view the oxygen screen the user can press the oxyCRG key on the screen or select Menu gt Display Setting View Selection oxyCRG This interface is always used in NICU because the SpO HR and Resp of the neonate are different from those of adults 49 Patient Monitor User Manual User Interface 7 7 Viewing Large Font Screen To open the large font screen please refer to the following steps 1 Select the Large Font key on the screen dire
189. urement value is too low High AG APNEA a ME beh interval no RESP can be detected High TB High TB measuring value is above upper alarm User selectable TB Low TB measuring value is below lower alarm User selectable 5 2 Technical Alarm Information NOTE The ECG alarm information listed in the below table describes the lead names in America For the corresponding lead names in Europe please refer to Section nstalling Electrodes Message Cause Alarm Level Action Taken ECG Lead Off More than one ECG electrode falls off the skin or ECG cables fall off the monitor Low ECG V Lead Off ECG electrode V falls off the skin or ECG cables fall off Low ECG LL Lead Off ECG electrode LL falls off the skin or ECG cables fall off the monitor Low ECG LA Lead Off ECG electrode LA falls off the skin or ECG cables fall off the monitor Low ECG RA Lead Off ECG electrode RA falls off the skin or ECG cables fall off the monitor Low Make sure that all electrodes leads and patient cables are properly connected ECG Signal Exceed ECG measuring value is beyond measuring range High Check connection patient condition lead and 30 Patient Monitor User Manual The amplitude of ECG Alarm Information Please modify the E ienal CE IO signal is too wide LOW ECG gain Stop measuring function of ECG ECG
190. utput wave Square pulse Output impedance 500 Delay from R wave peak to start of pulse 35ms Amplitude High level 3 5 to 5 V providing a maximum of 1 mA output current Low level lt 0 5V receiving a maximum of 5 mA input current Minimum required R wave amplitude 0 3mV Pulse width 100ms 10 Limited current 15 mA rating Rising and falling time lt 1 ms 153 Patient Monitor User Manual A 9 RESP Product Specification Method Trans thoracic impedance R F RA LL R L RA LA Respiration excitation waveform lt 300 A sinusoid 62 8 kHz 10 Measuring sensitivity 0 3 Q base impedance 200 to 4500 Q Base impedance range 200 to 2500 Q cable resistance 0 K 2200 to 4500 Q leads cables 1KQ resistance Differential input impendence gt 2 5MQ Waveform bandwidth 0 2 to 2 5 Hz 3 dB RR measuring range Adult 0 to 120 rpm Neo Ped 0 to 150 rpm Resolution 1 rpm Accuracy 2 rpm Apnea Alarm Time Setup 10s 15s 20s 25s 30s 35s 40s A 10 NIBP A 10 1 NIBP from EDAN Module Method Oscillometric Mode Manual Auto Continuous Measuring interval in AUTO 1 2 3 4 5 10 15 30 60 90 120 240 480 min Mode Continuous 5min interval is 5s Measuring type SYS DIA MAP Measuring Range Adult mode SYS 40 mmHg 270 mmHg DIA 10 mmHg 215 mmHg MAP 2
191. vacesduvonsvonesoatonsbsnncvsstentesndessyessesbnadsveonexivons 81 DEI OVCPIEW cie uphette A A ife Poi set o eee cfe 8l 14 2 Quick TEMP Safety Information a eI UE oH sisae t RUE ee oqsebicia etant ee 8l 14 3 Measuring Procedures c 82 14 3 1 Measurement for Oral Temperature acusa dod A 82 14 3 2 Measurements Tor Rectal Temperatures dida 83 14 3 3 Measurements for Axillary Temperatures ooooooononcccnoncccnonnncnonnnonnnnnnnnncnnnnnccnnnccinnnnss 83 Id dChaneme Temp Unit sien a ted e eti A A eee Pe 84 Chapter 15 Monitoring IBP os ud oon SPON a XE teu FERE PI ur oae Ne R PPM SE HEN yu 6n 85 IRAE Dau A M 85 13 2 TBP Safety IO AO Seien ik ee A E A equite dedii ecu E AN eh ae 85 15 3 Monitoring Pe Vt 85 15 4 Selecting a Pressure TOrMOonltOorTmg a cea 86 I5 5 Zerompe the Pressure Transducer ada 86 15 6 Zeroing a Pressure Measurement is 86 15 7 Troubleshooting the Pressure Zeroing Taking Art for Example sss 87 15 8 IBP Pressure Calibration eee eo erat seeds indeciso cian 87 15 9 Troubleshooting the Pressure Calibration essen ene 88 T5210 TIE A aria ee a tein a e tessera te bt rus 88 Chapter 16 Monitoring Ore 89 A A A O 89 16 2 CO Safety MLO MALMO nt adas 89 16 3 Monitoring Procedures iiie lo Addis 90 16 3 1 Zerome the Sensorman e a e teftc eos fa totae dc 90 16 32 LOFlo Op Mod lenceria pati 90 16 2 5 CO SS Md ole a qi
192. vailable and the monitor can calculate the respiration rate automatically When it is set to the Manual mode you can adjust the broken lines in RESP area by the Hold High and Hold Low items 9 10 Changing the Size of the Respiration Wave Select the Resp waveform area to open the Resp Wave Setup menu Select AMP then choose an apprioate value The value is bigger the waveform amplitude is higher Select Sweep select an apprioate setting from the pop up list 9 11 Using Resp Alarms Resp alarms can be switched on and off and the high and low alarm limits can be changed just like other measurement alarms as described in the Alarms chapter 9 12 Changing the Apnea Time The apnea alarm is a high priority red alarm used to detect apneas The apnea alarm delay time defines the time period between the point where the monitor cannot detect any respiration activity and the indication of the apnea alarm 1 In the Resp Setup menu select Apnea Alm 2 Select the appropriate setting from the popup list 69 Patient Monitor User Manual Monitoring SpOs Chapter 10 Monitoring SpO 10 1 Overview SpO is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO measuring unit SpO Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood If for example 97 of the hemoglobin molecules in the red blood cells of the arterial blood
193. very four hours NOTE Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements Interference can be caused by O High levels of ambient light or strobe lights or flashing lights such as fire alarm lamps Hint cover application site with opaque material High frequency electrical noise including electro surgical apparatus and defibrillators Ji Patient Monitor User Manual Monitoring SpOs Intravascular dye injections Significant concentrations of dysfunctional hemoglobin such as carboxyhemoglobin and methemoglobin Excessive patient movement and vibration Improper sensor application Low perfusion or high signal attenuation Venous pulsation Placement of the sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line 10 5 Understanding SpO Alarms This refers to SpO specific alarms See the Alarms section for general alarm information SpO2 offers high and low limit alarms and the users can adjust them 10 6 Adjusting Alarm Limits In the SpO Setup menu select Alarm Setup Set the SpO High Alarm Limit to an apprioate value from the popup interface Set the SpO Low Alarm Limit to an apprioate value from the popup interface WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia If this is a consideration do NOT set the high alarm li
194. ves of the six measurements and C O value 2 Average value of C O 3 Average value of CI 4 Function button in the edit window Values of selected measurements can be averaged and stored in the C O item in the HEMOD menu as the basis for Hemodynamic calculations 17 7 Blood Temperature Monitoring Blood temperature monitoring can function when C O measurement is not taken The blood temperature is measured by the thermistor situated in the distal end of the flotation catheter in the pulmonary artery The blood temperature alarm function will not work during the C O measurement When the measurement ends the function will automatically resume The current blood temperature is displayed in the C O parameter area 100 Patient Monitor User Manual Monitoring C O Flotation catheter Pulmonary artery Air celle Thermal resistance Right atrium Right ventricle Thermodilution Catheter Site 17 8 Setting the Computation Constant The computation constant is associated with catheter and injectate volume When the catheter is changed please adjust Constant in the C O Settings menu based on product description provided by the manufacturer 17 9 Recording C O Measurements C O measurement can be recorded by the recorder To record the C O measurement please select Record in the C O Measure menu 17 10 Setting INJ TEMPSource To change the INJ Temp Source please
195. when the monitor is battery powered 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 24 2 Battery Status on the Main Screen Battery status shows the status of each battery detected and the combined battery power remaining with an estimate of the monitoring time this represents There is a sign Lel in the lower left corner of screen to show the charging status and the yellow part is the electric energy of battery When the monitor is not equipped with battery the When the monitor is powered by the battery the monitor will switch off automatically if there is battery status will be shown as the sign which means no battery no electric energy in the battery When there isn t enough electric energy a sign Lu is displayed on the screen When the montor is battery powered the monitor switches off antomatically if there is no power 24 3 Checking Battery Performance The performance of rechargeable batteries may deteriorate over time Battery maintenance as recommended here can help to slow down this process 1 Disconnect the patient from the monitor and stop all monitoring and measurement 2 Switch the monitor power on and charge the battery for more than 6 hours continuously 3 Disconnect monitor from mains power and let the monitor run until there is no battery power left and the monitor shuts off 4 The running time of the
196. y Low High Please change the battery or charging Recorder Out Of Paper Recorder Out Of Paper Low Please install the paper Recorder setup needed The user presses the RECORD button when the monitor is not installed with a recorder Low Notify the manufacturer s service staff to install and set the recorder 40 Patient Monitor User Manual 5 3 Prompts Alarm Information Message Cause ECG Arm Learning The QRS template building required for Arr Analysis is in process SpO module is analyzing the patient signal and searching SpO Search Pulse for the pulse to compute the saturation when sensor is connected with patient Manual Measuring In manual measuring mode Continual Measuring In continuous measuring mode Auto Measuring In automatic measuring mode Measure Abort Measurement over Calibrating During calibrating Calibrate Abort Calibration over Leak Testing During pneumatic test Leak Test Ok NIBP module has passed leak test Leak Test Abort Pneumatic test over Resetting NIBP module in resetting Please Start NIBP module is in idle status Done NIBP measurement successfully done Continual Measuring NIBP module performs continual measuring Stat Measuring NIBP module performs STAT function NIBP module is in normal mode the user can t start leak Please Switch To Maintain test and pressure

Manual - EDAN USA

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