Lepu Medical K10 User manual

I

II

III










IV
Safety ..................................................................................................................................................... 1
1.1 Safety Information ....................................................................................................................................... 1
1.1.1 Warnings........................................................................................................................................... 1
1.1.2 Cautions ............................................................................................................................................ 2
1.1.3 Notes................................................................................................................................................. 2
1.2 Equipment Symbols ..................................................................................................................................... 3
1.2.1 Symbol/Icon on the Device............................................................................................................... 3
1.2.2 Icons List on the Screen .................................................................................................................... 4
1.2.3 Symbol/Icon on the Package............................................................................................................. 5
The Basics............................................................................................................................................... 6
2.1 Monitor Description..................................................................................................................................... 6
2.1.1 Product Name and Model................................................................................................................. 6
2.1.2 Intended Use..................................................................................................................................... 6
2.1.3 Features ............................................................................................................................................ 7
2.2 Main Unit ..................................................................................................................................................... 8
2.3 Display Screen............................................................................................................................................ 13
2.3.1 Message Indication Area................................................................................................................. 14
2.3.2 Statusbar......................................................................................................................................... 15
2.3.3 Parameter Area and Waveform Area.............................................................................................. 17
2.4 Views Management ................................................................................................................................... 18
Operating Instructions ......................................................................................................................... 21
3.1 Installation ................................................................................................................................................. 21
3.1.1 Unpacking and Checking................................................................................................................. 21
3.1.2 Environmental Requirements ......................................................................................................... 22
3.2 Getting Started........................................................................................................................................... 22
3.2.1 Connecting to Power Source........................................................................................................... 22
3.2.2 Turning the Monitor On.................................................................................................................. 23
3.2.3 Starting Monitoring......................................................................................................................... 24
3.3 Turning the Monitor Off............................................................................................................................. 24
3.4 Using Keys.................................................................................................................................................. 24
3.4.1 Shortcut Key.................................................................................................................................... 24

V
3.4.2 Buttons and Keyboard .................................................................................................................... 25
3.5 Using the Touchscreen............................................................................................................................... 26
3.6 Setting the Screens .................................................................................................................................... 27
3.7 Using the Main Menu ................................................................................................................................ 28
3.8 Changing System Settings .......................................................................................................................... 28
3.8.1 Changing General Settings .............................................................................................................. 28
3.8.2 Setting the Date and Time .............................................................................................................. 30
3.8.3 Network Settings............................................................................................................................. 30
3.8.4 Printer Settings ............................................................................................................................... 32
3.9 Operating Modes ....................................................................................................................................... 33
3.9.1 Real-Time Mode.............................................................................................................................. 33
3.9.2 Demo Mode .................................................................................................................................... 33
3.9.3 Night Mode..................................................................................................................................... 33
3.9.4 Privacy Mode .................................................................................................................................. 33
3.9.5 Standby Mode................................................................................................................................. 34
3.10 Connecting to a Central Monitoring System............................................................................................ 34
Patient Data Management................................................................................................................... 35
4.1 Apply an existed patient’s document ........................................................................................................ 35
4.2 Create a new patient’s document.............................................................................................................. 35
4.3 Edit a patient document ............................................................................................................................ 36
4.4 Delete a patient document ........................................................................................................................ 36
User Screens......................................................................................................................................... 37
5.1 Tailoring/Setting Your Screens ................................................................................................................... 37
5.1.1 Changing the Display Theme .......................................................................................................... 37
5.1.2 Changing the Color of Waveforms and Parameter ......................................................................... 37
5.2 Display Views ............................................................................................................................................. 38
5.2.1 General View................................................................................................................................... 39
5.2.2 Big Font View .................................................................................................................................. 40
5.2.3 All ECG Trace view........................................................................................................................... 41
5.2.4 NIBP List view.................................................................................................................................. 41
5.2.5 OxyCRG view................................................................................................................................... 42
5.2.6 Short Trends View........................................................................................................................... 42
5.2.7 CSM View........................................................................................................................................ 43

VI
Alarms .................................................................................................................................................. 45
6.1 Alarm Categories........................................................................................................................................ 45
6.2 Physiological and Technical Alarms............................................................................................................ 45
6.3 Alarm Indicators......................................................................................................................................... 49
6.3.1 Alarm lamp...................................................................................................................................... 49
6.3.2 Alarm message................................................................................................................................ 49
6.3.3 Highlighting Numeric ...................................................................................................................... 49
6.3.4 Audible Alarm Tones ....................................................................................................................... 49
6.3.5 Alarm Status Symbols ..................................................................................................................... 50
6.3.6 Changing Alarm Volume ................................................................................................................. 50
6.4 Understanding the Alarm Setting .............................................................................................................. 51
6.4.1 High and Low Alarm Setting Range................................................................................................. 53
6.4.2 Factory Default Alarm Limit Setting Value ...................................................................................... 54
6.5 Verify Alarm Function ................................................................................................................................ 56
6.6 When an Alarm Occurs .............................................................................................................................. 56
ECG Monitoring.................................................................................................................................... 57
7.1 Introduction ............................................................................................................................................... 57
7.2 Safety Information ..................................................................................................................................... 57
7.3 Preparing to Monitor ECG.......................................................................................................................... 58
7.3.1 Preparing the Patient and Device ................................................................................................... 58
7.3.2 ECG Electrodes Placement.............................................................................................................. 59
7.4 Understanding the ECG Display ................................................................................................................. 61
7.5 Changing ECG Settings ............................................................................................................................... 62
7.6 About Arrhythmia Detection and Template Learning................................................................................ 63
7.6.1 ECG arrhythmia analysis ................................................................................................................. 63
7.6.2 Understand the ARR Type ............................................................................................................... 64
7.7 About S-T Segment Monitoring ................................................................................................................. 65
7.8 Freezing Waveform .................................................................................................................................... 66
7.9 Factors Affecting ECG signal....................................................................................................................... 66
7.10 Acquire 12-lead ECG for Analysis............................................................................................................. 66
Monitoring Respiration (RESP)............................................................................................................. 68
8.1 Introduction ............................................................................................................................................... 68
8.2 Safety Information ..................................................................................................................................... 68

VII
8.3 Understanding the RESP Display................................................................................................................ 68
8.4 Changing RESP Settings.............................................................................................................................. 69
Monitoring NIBP................................................................................................................................... 71
9.1 Introduction ............................................................................................................................................... 71
9.1.1 The Oscillometric Blood Pressure Measurement ........................................................................... 71
9.1.2 The Oscillometric method vs. the Korotkoff Sound Method .......................................................... 71
9.2 Safety Information ..................................................................................................................................... 71
9.3 Measurement Limitations.......................................................................................................................... 72
9.4 Measurement Mode.................................................................................................................................. 73
9.5 Setting Up the NIBP Measurement............................................................................................................ 73
9.5.1 Preparing to Measure NIBP ............................................................................................................ 73
9.5.2 Starting and Stopping Measurements ............................................................................................ 74
9.5.3 Factors Affecting NIBP Measurement............................................................................................. 74
9.6 Understanding the NIBP Numerics ............................................................................................................ 76
9.7 Changing NIBP Settings.............................................................................................................................. 76
Monitoring Oxygen Saturation (SpO2) ............................................................................................... 79
10.1 Introduction ............................................................................................................................................. 79
10.2 Safety Information ................................................................................................................................... 79
10.3 Apply the Sensor...................................................................................................................................... 81
10.4 Using Probe and Sensor........................................................................................................................... 81
10.5 Understanding the SpO2 and PR Display ................................................................................................. 82
10.6 Changing SpO2and PR Settings................................................................................................................ 83
10.1 Nellcor SpO2Module ............................................................................................................................... 83
Monitoring Temperature ................................................................................................................... 86
11.1 Introduction ............................................................................................................................................. 86
11.2 Safety Information ................................................................................................................................... 86
11.3 Making a TEMP Measurement ................................................................................................................ 86
11.4 Understanding the TEMP Display ............................................................................................................ 87
11.5 Changing TEMP Settings .......................................................................................................................... 87
Monitoring IBP................................................................................................................................... 89
12.1 Introduction ............................................................................................................................................. 89
12.2 Safety Information ................................................................................................................................... 89
12.3 Setting Up the IBP Measurement ............................................................................................................ 90

VIII
12.3.1 Understanding IBP Icon................................................................................................................. 90
12.3.2 IBP Transducer Kit Connection...................................................................................................... 90
12.4 Understanding the IBP Display................................................................................................................. 91
12.5 Changing IBP Settings .............................................................................................................................. 92
Monitoring Carbon Dioxide (CO2)...................................................................................................... 93
13.1 Introduction ............................................................................................................................................. 93
13.2 Safety Information ................................................................................................................................... 93
13.3 CO2 Sensor Connection ............................................................................................................................ 96
13.3.1 Sidestream CO2Sensor Connection.............................................................................................. 96
13.3.2 Mainstream CO2Sensor Connection ............................................................................................ 97
13.3.3 Demonstration for Mainstream CO2Sensor Connection.............................................................. 97
13.4 Measurement Limitations........................................................................................................................ 98
13.5 Troubleshooting the Sidestream CO2Sampling System........................................................................... 98
13.6 Understanding the CO2Display................................................................................................................ 99
13.7 Changing CO2Settings.............................................................................................................................. 99
Monitoring CSM............................................................................................................................... 102
14.1 Introduction ........................................................................................................................................... 102
14.2 Safety Information ................................................................................................................................. 102
14.3 Understanding CSM Parameters............................................................................................................ 102
14.4 CSM Processes ....................................................................................................................................... 105
14.5 Changing CSM Settings .......................................................................................................................... 106
Review ............................................................................................................................................. 107
15.1 ARR Events ............................................................................................................................................. 107
15.2 Trend Graph ........................................................................................................................................... 108
15.3 NIBP List ................................................................................................................................................. 108
15.4 ECG Waveforms ..................................................................................................................................... 109
15.5 Alarm Event............................................................................................................................................ 109
15.6 SpO2Event ............................................................................................................................................. 110
15.7 CSM Records .......................................................................................................................................... 110
15.8 Exporting Data ....................................................................................................................................... 111
15.8.1 Exporting Data from Monitor to a USB Driver ............................................................................ 111
Calculations...................................................................................................................................... 113
16.1 Introduction ........................................................................................................................................... 113

IX
16.2 Safety Information ................................................................................................................................. 113
16.3 Medication Calculation (Medicine Dosage Calculation) ........................................................................ 113
16.4 Oxygenation Calculation ........................................................................................................................ 117
16.5 Ventilation Calculation........................................................................................................................... 120
16.6 Renal Function Calculation .................................................................................................................... 123
16.7 HEMO.(Hemodynamic Calculation) ....................................................................................................... 126
Tourniquet ....................................................................................................................................... 129
Printing ............................................................................................................................................ 130
18.1 Using a Printer ....................................................................................................................................... 130
18.2 Loading Printing Paper........................................................................................................................... 130
18.3 Attentions .............................................................................................................................................. 132
18.4 Performing Printing................................................................................................................................ 132
18.4.1 Print Real-Time Data ................................................................................................................... 133
18.4.2 Print History Records .................................................................................................................. 134
18.5 Cleaning the Printing Head of Printer.................................................................................................... 136
Other Functions ............................................................................................................................... 137
19.1 System Information................................................................................................................................ 137
19.2 Nurse Call Settings ................................................................................................................................. 137
Battery ............................................................................................................................................. 138
20.1 Overview................................................................................................................................................ 138
20.2 Battery Maintenance ............................................................................................................................. 138
20.3 Battery Recycling.................................................................................................................................... 139
Cleaning and Disinfection ................................................................................................................ 140
21.1 Disinfecting the Device and Accessories................................................................................................ 141
Maintenance.................................................................................................................................... 142
22.1 Daily Examination .................................................................................................................................. 142
22.2 Routine Maintenance ............................................................................................................................ 142
22.3 ECG Verification ..................................................................................................................................... 143
22.4 Pressure Accuracy Verification............................................................................................................... 143
22.5 IBP Calibration ....................................................................................................................................... 145
22.6 CO2Test.................................................................................................................................................. 146
Accessories ...................................................................................................................................... 147
23.1 ECG Accessories ..................................................................................................................................... 148

X
23.2 Temp Accessories................................................................................................................................... 148
23.3 SpO2Accessories.................................................................................................................................... 148
23.4 NIBP Accessories.................................................................................................................................... 149
23.5 CO2Accessories...................................................................................................................................... 149
23.6 IBP Accessories ...................................................................................................................................... 150
23.7 CSM Accessories .................................................................................................................................... 150
23.8 Other Accessories .................................................................................................................................. 150
Technical Specifications ................................................................................................................... 151
24.1 ECG......................................................................................................................................................... 151
24.2 RESP ....................................................................................................................................................... 153
24.3 TEMP...................................................................................................................................................... 154
24.4 NIBP ....................................................................................................................................................... 154
24.5 SpO2....................................................................................................................................................... 156
24.6 Pulse Rate .............................................................................................................................................. 157
24.7 CO2......................................................................................................................................................... 158
24.8 CSM........................................................................................................................................................ 159
24.9 IBP.......................................................................................................................................................... 159
24.10 Wi-Fi Specifications.............................................................................................................................. 160
24.11 Signal Outputs Specifications............................................................................................................... 160
24.12 Classification ........................................................................................................................................ 161
24.13 Operating Environment ....................................................................................................................... 161
24.14 Storage................................................................................................................................................. 162
24.15 Transportation ..................................................................................................................................... 162
24.16 Packaging ............................................................................................................................................. 162
24.17 Other Technical Specifications ............................................................................................................. 163
Troubleshooting............................................................................................................................... 164
25.1 Alarm or Prompt Troubleshooting ......................................................................................................... 164
25.2 Common Faults ...................................................................................................................................... 167
............................................................................ 172
......................................................................................................................................... 173

1
1.1 Safety Information
☞
WARNING for PACEMAKER PATIENTS: Although the pacemaker pulse inhibition function
is available in this device, the heart rate meter may continue to count the pacemaker rate
during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate
meter ALARMS. Keep pacemaker patients under close surveillance. See this manual for
disclosure of the pacemaker pulse rejection capability of this instrument.
Disconnect the monitor and sensors from the patient before MRI scanning. Using them
during MRI could cause burns or adversely affect the MRI image or the monitor’s accuracy.
If uncertain about the accuracy of any measurement, firstly check the patient’s vital signs
by any alternative means, and then make sure the monitor is functioning properly.
The monitor is intended only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
Monitor a single person at a time.
The monitor is defibrillation-proof. Verify that the accessories can function safely and
normally, and the monitor is grounded correctly before conducting defibrillation.
The monitor is not suitable for use in the presence of a flammable anesthetic mixture with
air, oxygen, or nitrous oxide.
Each timethemonitor is used, checkthe alarm limits to ensure thatthey are appropriatefor
the patient being monitored.
The alarm limit value shall be within the measuring range, or it may disable the alarm
system. Please refer to the related chapter for the alarm limit range.
A hazard can exist if different alarm presets are used for the same or similar device in a

2
single area.
Do not silence the audible alarm if patient safety may be compromised.
Do not use the monitor to those patients who have a severe hemorrhagic tendency or who
have sickle cell disease, for they may develop partial bleeding when this monitor is used
to take the blood pressure measurement.
All the connecting cables and tubes of the applying parts should be kept away from the
patient's neck to prevent any possible suffocation of the patient.
To prevent the risk of a short circuit and to ensure the ECG signal quality, the device must
be properly grounded.
The device should be considered an early warning device as a trend towards patient
deoxygenation is indicated; blood samples should be analyzed by a laboratory
CO-oximeter to understand the patient's condition completely.
Although biocompatibility tests have been performed on all the applied parts, some
exceptional allergic patients may still have anaphylaxis. Do NOT apply to those who have
anaphylaxis.
Please peruse the pertinent content regarding clinical restrictions and contraindications.
The clinical operator should regularly test the device and accessories. A visual and
auditory alarm signal can be checked by disconnecting accessories or by setting it in the
Demo mode to simulate an alarm event.
Do not allow service or maintenance on the device while being used on a patient.
DO not replace any of the components in the device with substitute parts. The substitution
of a component different from that supplied by the manufacturer might result in
measurement error. If necessary, please use the components provided by the
manufacturer or those that are of the same model and standards as the accessories along
with the monitor, which are provided by the same factory. Otherwise, there may be
adverse effects concerning safety and biocompatibility. No modification of this device is
allowed.
Repeatedly used accessories should be cleaned thoroughly before use on another patient.
Please refer to the related chapter for the maintenance method.
If the monitor accidentally falls, please do NOT operate it before testing its safety and
technical indexes, with positive testing results obtained.
Do not immerse the monitor or its accessories in liquid to clean.
The system might not meet its performance specifications if stored or used outside the
manufacturer’s specified temperature and humidity ranges.

3
All combinations of equipment must comply with the standard IEC 60601-1.
DO NOT position the device so that it is difficult to connect the plug of the power cord.
If the user requests more information such as circuit diagrams, parts list, and product
descriptions for repairs carried out by qualified technical personnel, please contact us.
1.2 Equipment Symbols

4
/

5
/ /
Some symbols may not appear on your equipment.

6
2.1 Monitor Description
The CE-certified patient monitors have the functions of recording and displaying
parameters in real-time of ECG, heart rate (HR), non-invasive blood pressure (NIBP, age≥
3 years old), functional oxygen saturation (SpO2), respiration rate (RESP), body
temperature (TEMP), and end-tidal CO2concentration (EtCO2) for monitoring the
physiological conditions of adult and pediatric patients.

7
ECG arrhythmia analysis function and S-T segment monitoring have not been CE-certified.
SpO2 monitoring with Nellcor module and NIBP measurement with SunTech module have
not been CE-certified.
This equipment is applicable for use in hospitals and clinical institutions. The operation
should be performed by qualified professionals only. Anyone unauthorized or untrained
must not perform any operation on it.
The physiological waveforms and parameters and the alarm information displayed by the
monitor are only for the reference of operators, but cannot be used directly to determine
the clinical treatment.



















8




This patient monitor is configurable with different parameters; the monitor you purchase
may not cover all the functions described above.
2.2 Main Unit

9