Mindray ePM 10M - H Declaration of Conformity

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H Declaration of Conformity

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Table of Contents7
Safety25
Safety Information25
Warnings25
Cautions26
Notes26
Equipment Symbols27
Equipment Introduction29
Intended Use29
Applied Parts29
System Components30
Main Unit30
External Modules33
Input Devices34
Printing Devices34
Getting Started35
Equipment Preparation Safety Information35
Monitor Installation36
Unpacking and Checking36
Environmental Requirements36
Setting up the Equipment36
Connecting the AC Mains36
Connecting the Input Devices37
Connecting the Parameter Module37
Removing the Parameter Module37
Turning on the Monitor38
Operation and Navigation38
Using the Touchscreen38
Using the On-Screen Keyboard39
Using the Barcode Reader39
Using the Remote Controller39
Screen Display40
On-Screen Symbols41
Menus42
Quick Keys42
Operating Modes44
Monitoring Mode44
Privacy Mode45
Night Mode45
Standby Mode46
Configuring Your Monitor47
Setting the Date and Time47
Adjusting the Screen Brightness47
Adjusting the Volume47
Starting Monitoring a Patient47
Stopping a Parameter Measurement48
General Operation48
Switching on or off a Parameter48
Displaying Parameter Numerics and Waveforms48
Displaying the Parameter List48
Accessing Parameter Setup Menus49
Changing Measurement Colors49
Freezing Waveforms49
Viewing Frozen Waveforms49
Unfreezing Waveforms49
Printing Frozen Waveforms50
Capturing the Screen50
Checking Software Licenses50
Turning off the Monitor50
User Screens51
Choosing a Screen51
Normal Screen51
Entering the Normal Screen51
Configuring the Normal Screen51
The Big Numerics Screen52
Entering the Big Numerics Screen52
Configuring the Big Numerics Screen52
Minitrends Screen52
Entering the Minitrends Screen52
The Display of Minitrends Screen53
Viewing the Long Trends53
Setting Minitrends Parameters53
Setting the Minitrend Length54
Setting the Alarm Statistics Switch54
Setting the Alarm Statistics Duration54
Routine Vital/Baseline54
Aldrete Score55
The Oxycrg Screen55
Entering the Oxycrg Screen55
Oxycrg Events55
The Display of the ABD Event Area55
Setting Oxycrg Parameters56
Setting the Threshold of ABD Events56
Editing ABD Events56
The Targeted Goal Screen56
Entering the Targeted Goal Screen56
The Display of the Targeted Goal Screen57
Configuring the Targeted Goal Screen Layout57
Operating the Targeted Goal Screen57
Managing Patients59
Discharging a Patient59
5.1.1 Manually Discharging a Patient59
Admitting a Patient59
Managing Patient Information60
Entering the Patient Management Menu60
Editing Patient Information60
Loading Patient Information from the CMS60
Loading Patient Information from the ADT Server61
Exporting Patient Data61
Deleting Patient Data61
Managing Configurations63
Configuration Introduction63
Changing the Department63
Setting Default Patient Category63
Setting Default Configuration64
Saving Current Settings64
Deleting a Configuration64
Transferring a Configuration65
Exporting a Configuration65
Importing a Configuration65
Printing Configurations65
Loading a Configuration65
Modifying Configuration Password66
Networked Monitoring67
Network Introduction67
Network Safety Information67
Connecting the Monitor to the CMS67
Connecting the Egateway68
Viewing Other Patients68
Remote View68
Alarm Watch70
Auto Displaying the New Alarm Bed71
Mldap72
Connecting the Wireless Network72
Disconnecting the Wireless Network72
Interfacing with External Devices73
Introduction to Interfacing with External Devices73
Interfacing Safety Information73
Differences in Displayed Values73
Connecting an External Device74
Accessing the Integrated Devices Screen74
Displaying Parameters from External Devices75
Setting Waveform Properties for Parameters from External Devices75
Setting Alarms from External Devices75
Setting Parameters from External Devices for Display75
Setting Units for Parameters from External Devices76
Accessing the Loops Screen76
Viewing Alarms from External Devices76
Viewing Parameter Trends from External Devices76
Recording and Printing Parameter Trends from External Devices76
Alarms77
Alarm Introduction77
Alarm Safety Information77
Understanding the Alarms77
Alarm Categories77
Alarm Priorities78
Alarm Indicators78
Alarm Status Symbols79
Accessing On-Screen Help for Technical Alarms (Alarmsight)79
Checking Physiological Alarm List79
Changing Alarm Settings79
Setting Parameter Alarm Properties79
Setting Alarm Tone Properties80
Setting the Auto Limits for New Patient Switch80
Initiating Auto Alarm Limits81
Setting the Alarm Delay Time83
Restoring the Default Alarm Settings83
Setting the Length of Printed Waveforms84
Setting the Switch of the Spo Desat Alarm off84
Setting the Switch of the Apnea Alarm off84
Pausing Alarms/Pausing Alarm Tones84
Defining the Pause Function84
Pausing Alarms84
Pausing Alarm Sound85
Resetting Alarms86
Resetting Physiological Alarms86
Resetting Technical Alarms86
Latching Alarms86
Nurse Call87
Calling for Help87
CPB Mode87
Entering the CPB Mode87
Exiting the CPB Mode88
Intubation Mode88
Entering the Intubation Mode88
Exiting the Intubation Mode88
Testing Alarms88
Actions When an Alarm Occurs88
Monitoring ECG, Arrhythmia, ST and QT89
ECG Introduction89
ECG Safety Information89
ECG Display89
Preparing for ECG Monitoring91
Preparing the Patient Skin91
Applying Electrodes91
Lead Wire Color Code91
ECG Electrode Placements92
Choosing the ECG Lead Type94
Checking Paced Status94
Enabling Pacer Rejection95
Using 6-Lead Placement to Derive 12-Lead ECG (D12L)95
Changing ECG Settings95
Choosing an ECG Screen95
Setting ECG Alarm Properties96
Setting the Analysis Mode96
Changing ECG Wave Settings96
Disabling the Smart Lead off Function98
Disabling the Crozfusion Function98
Adjusting the QRS Volume99
Adjusting the Minimum QRS Detection Threshold99
Monitoring Arrhythmia99
Arrhythmia Safety Information99
Arrhythmia Events100
Displaying Arrhythmia Information101
Changing Arrhythmia Settings101
Arrhythmia Alarms103
ST Segment Monitoring105
ST Safety Information105
Enabling ST Monitoring105
Displaying ST Numerics106
Displaying ST Segments in the Waveform Area106
Entering the ST View107
Saving the Current ST as Baseline107
Entering the ST Graphic Window108
Changing ST Settings108
Adjusting ST Measurement Points109
Qt/Qtc Interval Monitoring110
Qt/Qtc Monitoring Limitations110
Enabling Qt/Qtc Monitoring111
Displaying Qt/Qtc Numerics and Segments111
Entering the QT View111
Saving the Current Qtc as Baseline112
Changing QT Settings112
ECG Relearning113
10.10.1 Auto ECG Relearning113
10.10.2 Initiating an ECG Relearning Manually113
Calibrating ECG113
Defibrillation Synchronization Pulse Output113
ECG Troubleshooting114
Resting 12-Lead ECG Analysis115
Resting 12-Lead ECG Analysis Introduction115
Entering the 12-Lead Screen115
Initiating Resting 12-Lead ECG Analysis115
Changing 12-Lead ECG Analysis Settings115
Setting the High Frequency Filter115
Setting the Baseline Drift Removal116
Glasgow Resting 12-Lead ECG Analysis Algorithm Settings116
Editing Patient Information (for Glasgow Algorithms)116
Setting Tachycardia and Bradycardia Thresholds (for Glasgow Algorithms)116
Setting the 12-Lead Interpretation Report (for Glasgow Algorithms)117
Saving the 12-Lead Interpretation Report117
Printing the 12-Lead Interpretation Report117
Exiting the ECG 12-Lead Screen117
Monitoring Respiration (Resp)119
Resp Introduction119
Resp Safety Information119
Resp Display119
Preparing for Resp Monitoring120
Preparing the Patient120
Placing the Electrodes120
Changing Resp Settings121
Setting the Resp Alarm Properties121
Setting the RR Source121
Choosing the Respiration Lead121
Setting the Resp Waveform Size122
Setting the Resp Waveform Speed122
Setting the Auto Detection Switch122
Adjusting the Resp Waveform Detection Threshold122
Resp Troubleshooting122
Monitoring Pulse Oxygen Saturation (Spo )123
Spo Introduction123
Spo Safety Information123
Spo Measurement Limitations124
Spo Display125
Preparing for Spo Monitoring126
Changing the Spo Settings126
Changing the Spo Alarm Settings126
Nellcor Sat-Seconds Alarm Management126
Setting the Nellcor Spo127
Sat-Seconds127
Setting Spo Sensitivity127
Enabling Fastsat (for Masimo Spo )128
Displaying SIQ (for Masimo Spo )128
Changing Averaging Time (for Masimo Spo )128
Changing Sensitivity (for Mindray Spo )129
Showing/Hiding PI129
Monitoring Spo and NIBP Simultaneously129
13.6.11 Changing the Sweep Speed of the Pleth Wave129
Changing the PR Settings129
Changing the PR Alarm Settings129
Changing the QRS Volume130
Setting the PR Source130
Showing/Hiding PR130
Displaying Spo2 Statistics130
Selecting the Range of each Spo131
Section and the Target Section131
Selecting the Spo131
Statistics Length131
Spo Troubleshooting131
Nellcor Information132
Masimo Information132
Masimo End-User License Agreement132
Monitoring Temperature (Temp)135
Temperature Introduction135
Displaying the Temp Numerics Area135
Temperature Display135
Preparing for Temperature Monitoring135
Changing Temperature Settings136
Setting the Temperature Alarm Properties136
Selecting the Temperature Label136
Displaying the Temperature Difference136
Temperature Troubleshooting136
Monitoring Noninvasive Blood Pressure (NIBP)137
NIBP Introduction137
NIBP Safety Information137
NIBP Measurement Limitations138
Measurement Modes138
NIBP Display138
Preparing for NIBP Measurements139
Preparing the Patient for NIBP Measurements139
Placing the NIBP Cuff139
Starting and Stopping NIBP Measurements140
Viewing NIBP Analysis140
Changing NIBP Settings141
Setting the NIBP Alarm Properties141
Setting the Initial Cuff Inflation Pressure141
Setting the NIBP Interval141
Selecting NIBP Start Mode141
Enabling the NIBP End Tone141
Setting NIBP Sequence142
Setting the NIBP Display Format142
Setting the NIBP Alarm Limits Display Switch142
Showing/Hiding PR142
15.9.10 Correcting the NIBP Measurements142
Assisting Venous Puncture142
NIBP Maintenance143
15.11.1 NIBP Leakage Test143
15.11.2 NIBP Accuracy Test143
NIBP Troubleshooting143
Monitoring Invasive Blood Pressure (IBP)145
IBP Introduction145
IBP Safety Information145
Preparing for IBP Monitoring146
IBP Equipment to Patient Connection146
Measuring an Invasive Blood Pressure146
Zeroing the IBP Transducer147
Measuring ICP Using the Codman ICP Transducer147
Zeroing the Codman ICP Transducer147
Measuring ICP147
IBP Display148
Changing IBP Settings148
Changing the IBP Alarm Settings148
Changing the Pressure Label149
Setting the Pressure Type for Display149
Changing the Sensitivity149
Setting the IBP Waveform150
Setting the Display Format of Artery Pressure150
Showing/Hiding the Alarm Limits of Artery Pressure150
Setting the Use PA-D as PAWP Switch150
Enabling PPV Measurement150
16.6.10 Overlapping IBP Waveforms151
Measuring PAWP151
PAWP Equipment to Patient Connection152
Preparing to Measure PAWP152
Measuring PAWP152
Setting the Waveforms of the PAWP Screen153
Performing Hemodynamic Calculation154
Connecting a Camino Device154
IBP Troubleshooting154
Monitoring Cardiac Output (C.O.)157
C.O. Introduction157
C.O. Safety Information157
C.O. Measurement Limitations158
C.O. Display158
C.O. Equipment to Patient Connection159
Performing C.O. Measurement159
Preparing for C.O. Measurement159
Setting C.O. Measurement159
Performing C.O. Measurement160
Changing C.O. Settings161
Setting C.O. Alarm Properties161
Selecting the Primary C.O. Parameter161
C.O. Troubleshooting161
Monitoring Carbon Dioxide (CO )163
CO Introduction163
CO Safety Information164
CO Measurement Limitations164
CO Display164
Measuring CO165
Zeroing the Sidestream/Microstream CO167
Module167
Measuring CO Using Mainstream CO Module168
Preparing to Measure CO Using Mainstream CO Module168
Zeroing the Mainstream CO Sensor169
Changing Settings for All CO Modules169
Changing CO Alarm Settings169
Setting the CO Waveform169
Setting the RR Source169
Entering the Standby Mode170
Entering the Intubation Mode170
Changing Settings for Sidestream and Microstream CO Module170
Setting the Auto Standby170
Setting Humidity Compensation170
Changing O Settings (for Sidestream CO Module Integrating O )171
Changing O Alarm Settings171
Setting the O Waveform171
Setting the Gas Compensation171
Choosing a Time Interval for Peak-Picking172
Changing Barometric Pressure172
Performing the Leakage Test172
CO Calibration172
CO Troubleshooting172
18.15.1 Troubleshooting the Sidestream/Microstream CO173
Module173
Troubleshooting the Mainstream CO 2 Module173
Oridion Information173
Monitoring Anesthetic Gas (AG)175
AG Introduction175
AG Safety Information176
AG Measurement Limitations176
AG Display176
AG Equipment to Patient Connection177
Preparing for AG Monitoring177
Zeroing the AG Module178
MAC Values178
Changing AG Settings179
Changing AG Alarm Settings179
Setting the O Compensation179
Entering the Standby Mode179
Setting Auto Standby180
Setting the Gas Waveform180
Setting the RR Source180
Entering the Intubation Mode180
Enabling or Disabling MAC Display180
Changing the Anesthetic Agent180
Performing AG Leakage Test181
Calibrating the AG Module181
AG Troubleshooting181
Monitoring Bispectral Index (BIS)183
BIS Introduction183
BIS Safety Information184
BIS Parameters185
BIS Display185
Accessing the On-Screen bis Guide186
Preparing for bis Monitoring186
Changing bis Settings187
Setting bis Alarm Properties187
Choosing the bis Smoothing Rate187
Setting the Display of bis Waveform Area187
Switching off the Filter188
Setting the Displayed bis Parameters188
Sensor Check188
Automatic Sensor Check188
Disabling Automatic Sensor Check188
Manual Sensor Check189
BIS Sensor Status189
Monitoring Bilateral bis189
Entering the bis Expand View190
Selecting bis Expand View Display190
BIS Troubleshooting191
Review193
Review Overview193
Review Page193
Accessing the Review Page193
Example Review Page193
Symbols on Review194
Common Operations194
Tabular Trends Review Page195
Graphics Trends Review Page196
Events Review Page197
Full Disclosure Review Page198
Oxycrg Review Page199
21.2.10 12-Lead ECG Review Page200
21.2.11 ST Review Page201
Reviewing Discharged Patients202
Checking the Data of a Discharged Patient202
Checking the Information of a Discharged Patient202
Clinical Assistive Applications (CAA)203
Early Warning Score (EWS)203
Displaying the EWS Numerics Area204
Accessing the EWS Screen204
Performing EWS Scoring205
EWS Alarm206
Changing EWS Settings207
Viewing Historical Scores207
Viewing Parameter Trends208
Glasgow Coma Scale (GCS)208
Displaying the GCS Parameter Area208
Accessing the GCS Menu209
Performing GCS Scoring209
Setting GCS Scoring Interval209
Reviewing GCS Trend Data210
ECG 24H Summary210
Viewing the ECG 24H Summary210
Selecting Typical ECG Strips210
Reviewing ECG Summary210
Calculation211
Calculation Overview211
Calculation Safety Information211
Drug Calculations211
Performing Drug Calculations211
Checking the Titration Table212
Drug Calculation Formula212
Titration Table Calculation Formula212
Renal Calculations217
Performing Renal Calculations217
Calculated Parameters and Formulas for Renal Calculations217
Recording219
Recorder219
Starting Recordings219
Manually Starting Recordings219
Automatic Recordings219
Stopping Recordings220
Stopping Recordings Manually220
Stopping Recordings Automatically220
Recording Related Flags220
Setting the Recorder220
Enabling Auto Recording on Alarm220
Clearing Recording Tasks221
Loading Paper221
Removing Paper Jam221
Printing223
Supported Printer223
End Case Reports223
Printing the End Case Report223
Setting a Report as an End Case Report223
Setting the End Case Report224
Setting the End Case Report Period224
Manually Starting a Printing Task224
Starting Printing from the Current Page224
Printing Realtime Reports224
Printing Normal Reports224
Automatically Printing Reports225
Stopping a Printing Task225
Setting Reports225
Setting ECG Reports225
Setting Realtime Reports226
Setting Tabular Trends Reports226
Setting Graphic Trends Reports227
Viewing Printer Status227
Printer out of Paper227
Using the On-Screen Timers229
Displaying Timers229
Controlling the Timer229
Setting the Timer229
User Maintenance Settings231
Accessing the Maintenance Menu231
The Device Location Settings231
The Patient Management Settings232
The Field Tab232
The ADT Query Tab232
The Discharge Tab232
The Location Tab233
The Display Tab233
The Alarm Settings233
The Audio Tab233
The Pause/Reset Tab234
The Latching Tab235
The Remote View Tab235
The Nurse Call Tab236
The Other Tab236
The CAA Settings237
The EWS Tab237
The GCS Tab238
The Module Settings238
The ECG Tab238
The CO Tab238
The AG Tab239
The Other Tab239
The Review Settings240
The Tabs Tab240
The Event Tab240
The Arrhy Mark Tab240
The Print Settings240
The Printer Tab240
The Report Layout Tab241
The ECG Report Tab242
The PDF File Name Tab242
The Other Tab242
The Unit Settings243
The Time Settings243
27.10.1 the Time Synchronization Tab243
27.10.2 the Daylight Savings Time Tab243
The Other Settings243
The Authorization Setup Settings244
The Version Settings245
The Battery Information Settings245
The Scanner Settings245
The 2D Barcode Tab (for the Mindray Custom 2D Barcode Reader)245
27.15.2 the 1D Barcode Tab246
27.15.3 the Scanner Information Tab246
The Identify Scanner Tab (for the Non-Mindray Custom 2D Barcode Reader)246
The Field Tab (for the Mindray Custom 2D Barcode Reader)246
The Network Setup Settings247
27.16.1 the Network Type Tab247
27.16.2 the LAN1 IP Tab247
27.16.3 the WLAN Tab247
27.16.4 the Central Station Setup Tab248
27.16.5 the Device Discover Tab248
27.16.6 the Qos Tab249
27.16.7 the ADT Tab249
27.16.8 the HL7 Configuration Tab249
27.16.9 the Information Security Tab250
27.16.10 the MLDAP Tab250
Battery251
Battery Introduction251
Battery Safety Information251
Battery Preparation251
Identifying the Battery Type252
Installing the Battery in a Built-In Battery Compartment252
Installing the Battery in a External Battery Compartment253
Battery Indications253
Battery LED253
Battery Power Indicators253
Battery-Related Alarms254
Charging the Battery254
Maintaining the Battery254
Conditioning the Battery254
Checking Battery Performance254
Storing Batteries254
Recycling Batteries255
Care and Cleaning257
Care and Cleaning Introduction257
Care and Cleaning Safety Information257
Cleaning the Monitor/Module257
Disinfecting the Monitor/Module258
Cleaning and Disinfecting the Accessories260
Cleaning the Accessories260
Disinfecting the Accessories260
Sterilization262
Cleaning the Thermal Print Head262
Impact of Improper Cleaning263
Maintenance265
Maintenance Introduction265
Maintenance Safety Information265
Maintenance and Testing Schedule266
Testing Methods and Procedures266
Performing Visual Inspection266
Performing Power-On Test267
Testing the Recorder267
Testing the Network Printer267
Checking the Battery267
Disposing of the Equipment267
Accessories269
ECG Accessories269
ECG Electrodes269
12-Pin Separable Trunk Cables270
3-Lead ECG Leadwires270
5-Lead ECG Leadwires271
Spo Accessories272
Extension Cables272
Mindray Spo Sensors272
Nellcor Spo Sensors273
Temp Probes273
NIBP Accessories274
NIBP Hoses274
Cuffs274
IBP Accessories275
ICP Accessories276
C.O. Accessories276
CO Accessories276
Sidestream CO Accessories276
Microstream CO Accessories276
Mainstream CO Accessories277
AG Accessories277
BIS Accessories278
Mount and Mounting Accessories278
Miscellaneous Accessories278
External Modules279
A Product Specifications281
Monitor Safety Specifications281
Physical Specifications281
Environmental Specifications282
Power Supply Specifications283
External Power Supply Specifications283
Battery Specifications283
Display Specifications284
Recorder Specifications284
Audio Indicator285
Monitor Interface Specifications285
Signal Outputs Specifications285
Data Storage286
Wi-Fi Specifications287
Wi-Fi Technical Specifications (MSD45N)287
Wi-Fi Technical Specifications (SX-SDMAC-2832S+)287
Wi-Fi Performance Specifications288
Measurement Specifications289
ECG Specifications289
Resp Specifications291
Spo Specifications292
PR Specifications294
Temp Specifications295
NIBP Specifications295
IBP Specifications295
CO Specifications299
A.13.10 AG Specifications302
A.13.11 bis Specifications305
B EMC and Radio Regulatory Compliance307
Emc307
Radio Regulatory Compliance310
C Default Settings311
Parameters Default Settings311
ECG, Arrhythmia, ST and QT Default Settings311
Spo Default Settings314
Temperature Default Settings317
NIBP Default Settings317
IBP Default Settings319
CO Default Settings322
BIS Default Settings324
Routine Default Settings326
Alarm Default Settings326
Review Default Settings327
Minitrends Default Settings327
Oxycrg Default Settings328
Remote View Default Settings328
Display Default Settings328
Report Default Settings329
Calculations Default Settings330
System Time Default Settings330
D Alarm Messages331
Physiological Alarm Messages331
General Physiological Alarm Messages331
Arrhythmia Alarm Messages331
ST Physiological Alarm Messages332
Resp Physiological Alarm Messages332
Physiological Alarm Messages332
PR Physiological Alarm Messages332
NIBP Physiological Alarm Messages333
IBP Physiological Alarm Messages333
AG Physiological Alarm Messages333
EWS Physiological Alarm Messages333
Technical Alarm Messages334
General Technical Alarm Messages334
ECG Technical Alarm Messages334
Resp Technical Alarm Messages335
Spo Technical Alarm Messages335
Temp Technical Alarm Messages335
NIBP Technical Alarm Messages336
IBP Technical Alarm Messages336
C.O. Technical Alarm Messages337
AG Technical Alarm Messages337
BIS Technical Alarm Messages339
EWS Technical Alarms339
Power Supply Technical Alarm Messages340
Recorder Technical Alarm Messages340
Printer Technical Alarm Messages340
Technical Alarm Messages Related to Networked Monitoring341
Other System Technical Alarm Messages341
E Electrical Safety Inspection343
Power Cord Plug343
Device Enclosure and Accessories343
Visual Inspection343
Contextual Inspection343
Device Labeling344
Protective Earth Resistance344
Earth Leakage Test344
Patient Leakage Current344
Mains on Applied Part Leakage345
Patient Auxiliary Current345
F a ECG Wave Recognition Method for Mindray Resting 12-Lead ECG Analysis Algorithm347
Preprocessing347
QRS Typing347
Selection of Required QRS Class347
Wave Measurement347
QRS Components347
ST Segment347
Evaluation Results of Absolute Interval and Wave Duration Measurements348
Evaluation Results of Interval Measurements on Biological Ecgs348
Evaluation Results of Stability of Measurements against Noise348
G Units, Symbols and Abbreviations351
Units351
Symbols352
Abbreviations353
H Declaration of Conformity361

Mindray ePM 10M - H Declaration of Conformity

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