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Patient Monitor
Operation Manual
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance with its
function and intended use. Observance of this manual is a prerequisite for proper product performance and
correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not apply to your
product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so that it can be
obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge of medical
procedures, practices and terminology as required for monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data
displayed on your patient monitor.
i
Content
Preface...................................................................................................................................................................... i
Content.................................................................................................................................................................... ii
1
Overview......................................................................................................................................................... 1
1.1
Intended Use....................................................................................................................................1
1.2
Appearance......................................................................................................................................1
1.2.1
12.1-inch..................................................................................................................................2
1.2.2
Buttons.................................................................................................................................... 3
1.2.3
LED Indicator......................................................................................................................... 3
1.2.4
Connector................................................................................................................................ 3
1.2.5
Others...................................................................................................................................... 3
1.3
Display............................................................................................................................................ 4
1.4
Battery............................................................................................................................................. 5
1.5
Network...........................................................................................................................................5
2
Installation....................................................................................................................................................... 6
2.1
Unpacking and Checking................................................................................................................6
2.2
Environmental Requirements..........................................................................................................7
2.3
Power Source Requirements........................................................................................................... 7
2.4
Installation Method......................................................................................................................... 7
2.4.1
Connecting to Power Supply.................................................................................................. 7
2.4.2
Connecting Patient Sensors and Probes..................................................................................7
2.4.3
Connecting the Network Cable...............................................................................................8
2.4.4
Connecting to VGA Monitor (optional)................................................................................. 8
2.4.5
Equipotential Grounding.........................................................................................................8
2.5
Powering on the Monitor................................................................................................................ 8
2.6
Powering off the Monitor................................................................................................................9
3
General Setting..............................................................................................................................................10
3.1
Color Setting................................................................................................................................. 10
3.2
Screen Layout................................................................................................................................10
3.3
Adjust Time...................................................................................................................................12
3.4
Miscellaneous................................................................................................................................12
4
Review...........................................................................................................................................................13
4.1
Trend Graph.................................................................................................................................. 13
4.2
Trend Table................................................................................................................................... 14
4.3
Alarm Review............................................................................................................................... 15
4.4
NIBP Review................................................................................................................................ 16
4.5
Wave Review................................................................................................................................ 17
5
Alarm.............................................................................................................................................................18
5.1
Alarm Overview............................................................................................................................18
5.1.1
Alarm Categories.................................................................................................................. 18
5.1.2
Alarm Levels.........................................................................................................................18
5.1.3
Alarm Modes.........................................................................................................................19
ii
5.2
6
7
8
9
Alarm States.................................................................................................................................. 19
5.2.1
Alarm Silencing.................................................................................................................... 19
5.2.2
Alarm Pausing.......................................................................................................................20
5.3
Alarm Setting................................................................................................................................ 20
5.4
Alarm Limit...................................................................................................................................21
5.4.1
ECG Alarm Limit................................................................................................................. 21
5.4.2
ST Alarm Limit.....................................................................................................................21
5.4.3
ARR Alarm Limit................................................................................................................. 22
5.4.4
SpO2 Alarm Limit................................................................................................................. 22
5.4.5
NIBP Alarm Limit................................................................................................................ 23
5.4.6
Resp Alarm Limit................................................................................................................. 24
5.4.7
Temp Alarm Limit................................................................................................................ 24
5.4.8
CO2 Alarm Limit.................................................................................................................. 24
5.4.9
CSM Alarm Limit................................................................................................................. 25
5.4.10
Load Default Alarm Limit.................................................................................................... 26
5.5
Alarm Messages............................................................................................................................ 27
5.5.1
Technical Alarm Messages................................................................................................... 27
5.5.2
Physiological Alarm Messages.............................................................................................29
Recording...................................................................................................................................................... 32
6.1
Record Setting...............................................................................................................................32
6.2
Recorder On / Off......................................................................................................................... 33
Patient Managing.......................................................................................................................................... 34
7.1
Admit Patient................................................................................................................................ 34
7.2
Discharge Current Patient............................................................................................................. 35
7.3
Dose Calculation........................................................................................................................... 35
7.3.1
Dose Calculation Procedure..................................................................................................35
7.3.2
Drug Unit.............................................................................................................................. 36
7.3.3
Titration Table.......................................................................................................................36
ECG Monitoring............................................................................................................................................38
8.1
ECG Display................................................................................................................................. 38
8.2
ECG Setting.................................................................................................................................. 39
8.3
ECG Calibration............................................................................................................................40
8.4
ECG Monitoring Procedure.......................................................................................................... 41
8.4.1
Preparation............................................................................................................................ 41
8.4.2
Electrode Placement..............................................................................................................41
8.5
ST Analysis................................................................................................................................... 44
8.5.1
ST Display.............................................................................................................................44
8.5.2
ST Setting..............................................................................................................................44
8.6
Arrhythmia Monitoring.................................................................................................................46
8.6.1
ARR Display......................................................................................................................... 46
8.6.2
ARR Setting.......................................................................................................................... 46
SpO2 Monitoring.......................................................................................................................................... 47
9.1
SpO2 Display................................................................................................................................ 47
9.2
SpO2 Setting................................................................................................................................. 47
9.3
SpO2 Monitoring Procedure......................................................................................................... 49
9.3.1
Finger Sensor Placement...................................................................................................... 49
iii
10
11
12
13
14
15
9.3.2
Neonate SpO2 Plethysmography Measurement................................................................... 49
9.3.3
Neonatal Oxygen Probe Placement...................................................................................... 50
9.4
Measurement Restrictions.............................................................................................................51
9.5
Masimo SpO2 Monitoring (optional)........................................................................................... 51
9.5.1
Masimo SpO2 Display..........................................................................................................51
9.5.2
Masimo SpO2 Setting........................................................................................................... 52
9.5.3
Masimo SpO2 Monitoring Procedure...................................................................................53
9.5.4
Measurement Limitations..................................................................................................... 56
9.5.5
Sensors and Accessories....................................................................................................... 57
9.5.6
Masimo Information............................................................................................................. 59
NIBP Monitoring.................................................................................................................................. 60
10.1
NIBP Display................................................................................................................................ 60
10.2
NIBP Setting................................................................................................................................. 60
10.3
NIBP Pneumatic Test....................................................................................................................61
10.4
NIBP Calibration...........................................................................................................................63
10.5
NIBP Reset....................................................................................................................................64
10.6
NIBP Monitoring Procedure......................................................................................................... 64
10.7
NIBP Measurement Limits........................................................................................................... 66
Resp Monitoring....................................................................................................................................67
11.1
Resp Display................................................................................................................................. 67
11.2
Resp Setting.................................................................................................................................. 67
11.3
Electrode Placement......................................................................................................................68
Temp Monitoring.................................................................................................................................. 69
12.1
Temp Display................................................................................................................................ 69
12.2
Temp Setting................................................................................................................................. 69
12.3
Temp Sensor Type........................................................................................................................ 70
12.4
Measurement Procedure................................................................................................................70
CO2 Monitoring (optional)................................................................................................................... 71
13.1
CO2 Display..................................................................................................................................71
13.2
CO2 Setting...................................................................................................................................71
13.3
CO2 Zero.......................................................................................................................................72
13.4
CO2 Calibration............................................................................................................................ 72
13.5
Measurement Procedure................................................................................................................73
CSM Monitoring (optional).................................................................................................................. 75
14.1
CSM Display.................................................................................................................................75
14.2
CSM Setting.................................................................................................................................. 76
14.3
CSM Monitoring Procedure..........................................................................................................77
14.3.1
Skin Preparation....................................................................................................................77
14.3.2
Electrode Placement..............................................................................................................77
14.4
Device Description........................................................................................................................79
14.4.1
Device Appearance............................................................................................................... 79
14.4.2
Display and Modes............................................................................................................... 81
Maintenance.......................................................................................................................................... 82
15.1
Inspection and Maintenance......................................................................................................... 82
15.2
Cleaning........................................................................................................................................ 82
15.3
Disinfection and Sterilization....................................................................................................... 83
iv
16
17
18
19
Accessories............................................................................................................................................85
Appendix A - Safety............................................................................................................................. 86
17.1
Safety Information........................................................................................................................ 86
17.2
Equipment Symbols...................................................................................................................... 88
17.3
Patient Safety................................................................................................................................ 89
Appendix B - EMC............................................................................................................................... 91
Appendix C - Product Specifications....................................................................................................95
19.1
Safety Classifications....................................................................................................................95
19.2
Applicable Standards.................................................................................................................... 95
19.3
Environment..................................................................................................................................95
19.4
Size and Weight............................................................................................................................ 96
19.5
Power Supply................................................................................................................................ 96
19.6
Battery........................................................................................................................................... 96
19.7
Data Storage.................................................................................................................................. 96
19.8
Signal Output Specifications.........................................................................................................96
19.9
Wireless Network (optional).........................................................................................................97
19.10
Recorder Specifications (optional)............................................................................................... 97
19.11
ECG Specifications....................................................................................................................... 97
19.12
SpO2 Specifications....................................................................................................................100
19.13
Masimo SpO2 Specifications......................................................................................................101
19.14
NIBP Specifications....................................................................................................................101
19.15
Resp Specifications..................................................................................................................... 102
19.16
Temp Specifications....................................................................................................................103
19.17
CO₂ Specifications (optional).....................................................................................................103
19.18
19.19
CSM Specifications (optional)....................................................................................................103
Default Settings...........................................................................................................................104
v
1 Overview
1.1
Intended Use
The monitor is intended to be used for monitoring, recording, and alarming of multiple physiological parameters of
adults, pediatrics, and neonates in health care facilities. The devices are to be used in health care facilities by trained
health care professionals. They are not intended for home use. This device is restricted to be used by or on the order
of a physician.
WARNING
● This is not a therapeutic device.
1.2
Appearance
1
1.2.1 12.1-inch
■Front Panel
(1)
(2)
■Rear Panel
■Side Panel
2
1.2.2 Buttons
Power switch: Press this button to turn On/Off the monitor.
Alarm silence: Press this button to silence the alarms.
Alarm pause: Press this button to pause the alarms.
Waveform freeze: Press this button to freeze the waveform on the screen.
NIBP start/stop: Press this button to start/stop NIBP monitoring.
Record (Print) start/stop: Press this button to start/stop recording.
Main menu: Press this button back to the upper level menu.
Encoder knob: Turn this button left/right to select the menu. Press this button to enter the window of setting or
confirm the selection.
1.2.3 LED Indicator
Alarm LED: Flash when alarms happen.
Charging LED: It turns green when the external power is connected with the monitor.
Power On/Off LED: It turns green when the monitor turns on.
1.2.4 Connector
Temp (1/2) probe connector: Link to the temperature probe.
(Masimo) SpO2 sensor (mini) connector: Link to the SpO2 sensor.
ECG cable (mini) connector: Link to the ECG cable.
NIBP cuff connector: Link to the NIBP cuff.
IBP (1/2) connector: Link to the IBP “cuff”.
CO2 sensor connector: Link to the SpO2 sensor.
Network connector: Link to internet for updating the software of the monitor.
USB connector: Link to PC for updating the software of the monitor.
External power input connector: Link to the external power.
1.2.5 Others
Handle: Portable design.
Mounting holes for hanging bracket (1/2): Reserve for hanging bracket.
Support bracket: Adjust it to achieve different angle of the monitor.
Speaker holes (1/2): Alarms voice.
Nameplate place: The place for the nameplate.
Battery place: The place for battery.
Recorder place: The place for recorder.
Fuse: Safety.
Equipotential Grounding System: Safety.
3
WARNING
● Accessory equipment connected to the analog and digital interfaces must be certified according to the
respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC
60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the requirements of
the valid version of the system standard IEC 60601-1-1. If in doubt, consult the technical service department
or your local representative.
1.3
Display
Patient Information: Bed No., Patient type, Patient name
Technical Alarm: Technical alarm information
Physiological Alarm: Physiological alarm information
Date: Current date
Time: Current time
Network: Network state
Battery: Battery state
Waveforms: Waveforms monitoring
Parameters: Parameters monitoring
Menu: Patient, Review, Setting, Alarm Limit, Service
4
1.4
Battery
Patient monitor is equipped with a built-in rechargeable battery. In the top right corner of the screen exists a symbol
“
”, indicating the status of the battery capacity, of which the green part denoting electric quantity of the battery.
When the battery is charged, the charging condition is expressed with animation. After the battery is full-charged, the
symbol will show as “
“
”. When this monitor has not been installed the built-in battery, the symbol shows as
” indicating no battery.
When the monitor runs with the power supplied from battery, the monitor detects the volume of the battery, and
alarms when the battery is insufficient, and prompts in the information area: “**BAT LOW”. At this moment,
external power should be connected in, and immediately charge battery in time. If battery is running with the power
supplied from battery, the monitor will power off automatically when the battery exhausted.
WARNING
● If you have any doubt to the grounding layout and its performance, you must use the built-in battery to
power the monitor.
1.5
Network
The network port of the monitor is the standard RJ45 network interface, may communicate with the central
monitoring station through the Ethernet cable to achieve the function of remote monitoring. In the top right corner of
the screen, there is a network icon indicating the current network status. If the network cable is disconnected, the icon
shows as “
“
”; When the monitor has established connection with the central monitoring station, the icon shows as
”; If the monitor communicates successfully with the central monitoring system, the icon shows as “
5
”.
2 Installation
WARNING
● The installation of the monitor must be carried out by personnel authorized by us. The software copyright of
the monitor is solely owned by our company. Any action to change, copy or exchange the software copyright
by any organization or person is regarded as copyright infringement and is not allowed.
● Accessory equipment connected to this patient monitor must be certified according to the respective IEC
standards (e.g. IEC 60950 for information technology equipment and IEC 60601-1 for medical electrical
equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC
60601-1-1. Any person who connects additional equipment to the signal input or signal output is responsible to
ensure the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If
in doubt, contact our company or customer service.
● If the monitor is connected to another electrical instrument and the instrument specifications cannot tell
whether the instrument combination is hazardous (e.g. due to summation of leakage currents), you should
consult us or experts in the field to ensure the required safety of all instruments concerned.
NOTE
● The operations in this section are not all required. User-customized installation by authorized personnel is
provided.
2.1
Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the
carrier or our company.
If the packing case is intact, open the package and remove the instrument and accessories carefully. Check all
materials against the packing list and check for any mechanical damage.
Contact our Customer Service Department in case of any problem.
NOTE
● Please save the packing case and packaging material for future transport and storage.
WARNING
● Be sure to keep the packaging materials from children’s reach.
● Disposal of the packaging materials shall comply with your local requirements.
● The equipment might be contaminated in storage, transport or when used. Verify the package and the single
use accessories are intact. In case of any damage, do not apply it to patients.
6
2.2
Environmental Requirements
The operating environment of the monitor must meet the requirements specified in this manual.
The environment where this monitor is to be used should be free from noise, vibration, dust, and corrosive or
explosive and inflammable substances. For a cabinet mounted installation, allow sufficient room at the front and the
rear of the cabinet for operation, maintenance and servicing. Besides, allow at least 2 inches clearance around the
instrument for proper air circulation.
Condensation can form when the monitor is moved from one location to another, and being exposed to differences in
humidity or temperature. Make sure that during operation the instrument is free from condensation.
2.3
Power Source Requirements
The power applied to the monitor must meet the requirements specified in this manual.
WARNING
● Make sure that the operating environment and the power applied to the patient monitor complies with the
specified requirements. Otherwise its performance might not meet the specifications claimed in this manual,
and unexpected results, such as damages to the patient monitor, may be incurred.
● The monitor shall be powered according to the requirement for the system power voltage. Otherwise, serious
damage might be caused to the system.
2.4
Installation Method
2.4.1 Connecting to Power Supply
1. Use the original three-wire external power cord.
2. Connect the power cord to the receptacle for external power cord on the rear panel of the monitor.
3. Connect the other end of the power cord to a compatible 3-prong hospital grade external power outlet.
WARNING
● Connect the power line to the jack special for hospital usage.
2.4.2 Connecting Patient Sensors and Probes
Connect the necessary patient sensors or probes to the monitor. For details, see the chapters for specific parameter
monitoring in the following pages, or corresponding instructions for sensors and probes.
7
2.4.3 Connecting the Network Cable
The network connector of the monitor is a standard RJ45 connector. It connects the monitor with the central
monitoring system, or with a PC for online upgrading or data output.
1. Connect one end of the network cable with the network connector of the monitor.
2. Connect the other end of the network cable with the hub or switch of the central monitoring system, or with the
network connector of a PC.
NOTE
● Different network cable may be used for different connections. Please consult our customer service
personnel for details.
● The system upgrading through the network connector is to be executed by our authorized personnel only.
2.4.4 Connecting to VGA Monitor (optional)
This monitor can be connected with a standard color VGA monitor. The VGA monitor will display the patient
waveforms and parameters measured by the patient monitor. To connect the patient monitor with the VGA monitor,
follow the steps as below.
1. Power off the patient monitor.
2. Connect the signal cable of the VGA monitor to the VGA connector on the rear panel of the patient monitor.
3. Power on the VGA monitor and then the patient monitor.
NOTE
● The VGA monitor should be installed at a distance of more than 1.5 m from the patient.
2.4.5 Equipotential Grounding
When other equipments are used together with the monitor, a grounding cable should be used to connect the
equipotential grounding connectors of the monitor and of other equipments. This helps to reduce the potential
differences between different pieces of equipment, and ensure the safety of the operator and patient.
WARNING
● If the grounding system is in doubt, the monitor must be supplied from its internal battery.
2.5
Powering on the Monitor
After installing the monitor, please follow the procedures described below to power on the monitor:
1. Before using the monitor, please carry out corresponding safety inspection.
2. Press the Power Switch on the control panel.
8
3. The system begins self-testing and “Staring up” will be displayed on the screen.
4. Several seconds later, the system finishes the self-test and displays the main screen.
5. The system will initiate every module, and display alarm information in the top part of the screen.
6. At this time, you can operate the monitor using the control panel and press SILENCE key. Alarm information will
disappear a few seconds later.
WARNING
● If any sign of damage is detected, or the monitor displays some error messages, do not use it on any patient.
Contact biomedical engineer in the hospital or manufacturer Customer Service Center immediately.
NOTE
● During initialization process, alarms of every module detected by the system are useless, and thereby are
disabled.
NOTE
● If the monitor finds any fatal error during self-test, it will alarm.
NOTE
● Check all the functions that may be used to monitor and make sure that the monitor is in good status.
NOTE
● The battery must be recharged to the full electricity after each use to ensure adequate electricity reserve.
NOTE
● The interval between twice press of POWER should be more than 1 minute.
2.6
Powering off the Monitor
To power off the monitor, please follow the procedures below:
1. Confirm the patient monitoring is to be finished.
2. Disconnect the cables and sensors between the monitor and the patient.
3. Confirm whether to store or clear the patient monitoring data.
4. Press the Power Switch for more than 2 seconds, and the monitor will be powered off.
9
3 General Setting
3.1
Color Setting
1. Rotate the knob to select “Color Setting” in “Setting” menu.
2. Press the knob to enter the window of “Color Setting”.
3. Select colors from the lists of corresponding parameters or corresponding waves. And confirm by “Ok”.
->
Color Setting
Color Range
3.2
White, Red, Green, Blue, Cyan, Yellow, Magenta, Sky Blue, Orange, Purple, Sapphire
Screen Layout
1. Rotate the knob to select “Screen Layout” in “Setting” menu.
2. Press the knob to enter the window of “Screen Layout”.
3. Select screen type from the list of “Screen Layout”. Select trend time from the list of “Trend Time”. Select the
parameters that need to display on the screen.
->
10
Screen Layout
Screen Layout
Standard, Big Font, OxyCRG, NIBP Trend, Trend Table, Ecg Full Lead
Trend Time
1min, 3min, 5min, 7min, 10min, 15min, 20min, 30min, 40min, 50min, 60min
Parameter Switch
HR, SPO2, RR, Temp, NIBP
Wave Switch
ECG1, ECG2, ECG3, ECG4, ECG5, ECG6, ECG7, Pleth, Resp
Big Font
OxyCRG
NIBP Trend
Trend Table
ECG Full Lead
Touch Screen (optional)
11
3.3
Adjust Time
1. Rotate the knob to select “Adjust Time” in “Setting” menu.
2. Press the knob to enter the window of “Adjust Time”.
->
Adjust Time
3.4
Format
YY/MM/DD, DD/MM/YY, MM/DD/YY
Year
2005~2100
Miscellaneous
1. Rotate the knob to select “Miscellaneous” in “Setting” menu.
2. Press the knob to enter the window of “Miscellaneous”.
->
Miscellaneous
Brightness
1 ~ 10
Key Volume
0 ~ 10
Wave Smooth
Off / On
Brightness: Screen brightness (not available in 7-inch)
Key Volume: The volume of pressing buttons on the control panel.
Wave Smooth: If “Off” is selected, waves will display normally; if “On” is selected, waves will display without
jaggies.
12
4 Review
Trend Graph
4.1
1. Rotate the knob to select “Trend Graph” in “Review” menu.
2. Press the knob to enter the window of “Trend Graph”.
->
Trend Graph
3. Press “
” and “
Parameter
HR, RR, SpO2, PR, Temp
Period
1s, 5s, 1min, 5min, 10min
” to review the trend graph step by step; press”
review the trend graph page by page; press “
“
” and “
” to
” to review the trend graph 720 hours before and press
” to review the trend graph of the current time.
4. Select a parameter type from the list of “Parameter” to review the trend graph of different parameter. Select a time
interval from the list of “Period” to review the trend graph by different time interval.
NOTE
● The monitor can store Max. 720 hours of trend data.
13
4.2
Trend Table
1. Rotate the knob to select “Trend Table” in “Review” menu.
2. Press the knob to enter the window of “Trend Table”.
->
Trend Table
Period
3. Press “
” and “
1min, 2min, 3min, 4min, 5min, 10min, 15min, 30min, 60min
” to review the trend table step by step; press "
the trend table page by page; press “
” and “
” to view
” to view the trend table 720 hours before and press “
view the trend table of the current time.
4. Select a time interval from the list of “Period” to review the trend graph by different time interval.
5. Press “Record” to print the currently displayed data of trend table by recorder (if the monitor has a built-in
recorder).
NOTE
● The monitor can store Max. 720 hours of trend data.
14
” to
4.3
Alarm Review
1. Rotate the knob to select “Alarm Review” in “Review” menu.
2. Press the knob to enter the window of “Alarm Review”.
->
Alarm Review
Type
All, ECG, SpO2, NIBP, RESP,
TEMP
3. Select a parameter type from the list of “Type” to review the alarm history by different parameter type.
4. Press “
” and “
” to review the alarm history step by step; press”
review the alarm history page by page; press “
“
” and “
” to
” to review the first page of alarm history and press
” to review the last page of alarm history.
5. Press “Record” to print the currently displayed data of alarm history by recorder (if the monitor has a built-in
recorder).
NOTE
● The monitor store Max. 200 groups of alarm history data.
15
4.4
NIBP Review
1. Rotate the knob to select “NIBP Review” in “Review” menu.
2. Press the knob to enter the window of “NIBP Review”.
->
3. Press “
” and “
” to review the NIBP monitoring data step by step; press”
” to review the NIBP monitoring data page by page; press “
“
NIBP monitoring data and press “
” to review the first page of
” to review the last page of NIBP monitoring data.
NOTE
● The monitor can store Max. 1000 groups of NIBP monitoring data.
16
” and
4.5
Wave Review
1. Rotate the knob to select “Wave Review” in “Review” menu.
2. Press the knob to enter the window of “Wave Review”.
->
Wave Review
3. Press “
” and “
Wave1
ECG-Ⅰ, ECG-Ⅱ, ECG-Ⅴ, Pleth, Resp
Wave2
ECG-Ⅰ, ECG-Ⅱ, ECG-Ⅴ, Pleth, Resp
” to review the wave history step by step; press”
review the wave history page by page; press “
“
” and “
” to
” to review the wave history 12 hours before and press
” to review the wave history of the current time.
4. Select wave types from the list of “Wave1” and “Wave2” to review the wave history of different wave types.
NOTE
● The monitor can store Max. 12 hours wave history data.
● The trend data can be preserved for 720 hours after the turning off of the monitor. If the monitor is turned
on after 720 hours’ power-off, the trend data would be eliminated.
● The waveform review data can be preserved for 2 hour after the turning off of the monitor. If the monitor is
turned on after 2 hour’s power-off, the waveform review data would be deleted.
17
5 Alarm
5.1
Alarm Overview
The monitor gives audible or visual alarms to indicate the medical staff, when a vital sign of the patient appears
abnormal, or mechanical or electrical problems occur to the monitor.
Upon turning on the monitor, the alarm indicator will flash once in yellow and red. Then, a beep will be heard. This is
used to verify the audible and visual alarm function of the monitor. If no beep is heard, or the alarm indicator doesn’t
flash normally, please do not use the monitor, and contact our customer service.
5.1.1 Alarm Categories
The patient monitor’s alarms can be classified into two categories: technical alarms and physiological alarms.
1. Technical alarms
Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion
due to improper operation or mechanical problems.
2. Physiological alarms
Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set
alarm limits or an abnormal patient condition.
5.1.2 Alarm Levels
The patient monitor’s alarms can be classified into three levels: high level, medium level and low level.
Alarm Levels
Physiological alarms
Technical alarms
High level
Indicate that your patient is in a life
threatening situation and an
emergency treatment is demanded.
Indicate a severe device malfunction or an
improper operation, which could make it possible
that the monitor cannot detect critical patient status
and thus threaten the patient’s life.
Medium level
Indicate that your patient’s vital
signs appear abnormal and an
immediate treatment is required.
Indicate a device malfunction or an improper
operation which may not threaten the patient’s life
but may compromise the monitoring of vital
physiological parameters.
Low level
Indicate that you patient’s vital
signs appear abnormal and an
immediate treatment may be
required.
Indicate a device malfunction or an improper
operation, which may compromise a certain
monitoring function but will not threaten the
patient’s life.
NOTE
● The levels of all technical alarms and some physiological alarms are not user-adjustable, because they have
been fixed when the monitor is produced. However, you can change the levels of some physiological alarms in
the corresponding parameter setup menus.
18
5.1.3 Alarm Modes
When an alarm occurs, the patient monitor will indicate it to the user through visual or audible alarm indications.
1. Alarm LED: If an alarm occurs, the alarm LED will flash.
2. Alarm message: When an alarm occurs, an alarm message will appear in the technical or physiological alarm
information area.
3. Numeric color: If an alarm triggered by an alarm limit violation occurs, the color of numeric in parameter area will
change from dark color to bright color.
4. Audible alarm tones: The patient monitor uses different alarm tone patterns to match the alarm levels.
5. Reminder tones: When alarms are turned off or alarm tones are paused or turned off, the patient monitor will give a
single beep as the reminder tone in case of an active alarm condition.
Alarm Modes
Alarm LED
Alarm
Message
Symbols
Alarm Message
Background
Color
Numeric
Color
Audible Alarm Tones
High Level
flashes
quickly in red
***
red
dark colors
become bright
colors
DO-DO-DO--DO-DO
---DO-DO-DO---DODO, 1 time/8sec
Medium Level
flashes slowly
in yellow
**
yellow
DO-DO-DO, 1
time/25sec
Low Level
turns yellow
without
flashing
*
yellow
DO, 1 time/25sec
NOTE
● When multiple alarms of different levels occur simultaneously, the patient monitor will select the alarm of
the highest level and give visual and audible alarm indications accordingly.
5.2
Alarm States
5.2.1 Alarm Silencing
1. Press “SILENCE”
button on the control panel. The alarm voices including audible alarm tones, reminder
tones and human voice will be disabled. Press “SILENCE” button again. The alarm voices will be reactivated.
2. If the alarm still exists under the condition of the silence state, then the alarm information area display this alarm
information. If there is no alarm exists under the condition of the silence status, then all the alarm information will be
eliminated.
NOTE
19
● When the system is under the “SILENCE” condition, any newly triggered alarm will terminate the silence
condition, and then makes the system to restore to the normal alarm condition.
5.2.2 Alarm Pausing
1. Press “PAUSE” button on the control panel. All alarms will be disabled. “ALARM PAUSE” and countdown will
display in technical alarm area. Press “PAUSE” button again. All alarms will be reactivated.
2. The suspend time of alarm pausing can be set in the window of “Alarm Setting” in “Setting” menu.
->
NOTE
● 7-inch and 10.1-inch monitors do not have this function (button).
5.3
Alarm Setting
1. Rotate the knob to select “Alarm Setting” in “Setting” menu.
2. Press the knob to enter the window of “Alarm Setting”.
->
20
Alarm Setting
Alarm Volume
0~10
Suspend Time
1min, 2min
Flash
Off / On
Para Alarm
Non Latch, Latch
Alarm Record
Off / On
Voice Alarm
Off / On
Alarm Volume: The volume of audible alarm tones and reminder tones
Suspend Time: The duration of alarm pausing when “PAUSE” button is pressed.
Flash: If “On” is selected, displayed parameters will flash when physiological alarms happen; if “Off” is selected,
displayed parameters will not flash when physiological alarms happen.
Parameter Alarm: If “Non Latch” is selected and alarms happen, alarms will stop once physiological or technical
situation become normal; if “Latch” is selected and alarms happen, alarms will not stop unless alarms are discharged
by human (for example, press “SILENCE” button).
Alarm Record: If “On” is selected, alarms will be recorded by recorder when alarms happen (if the monitor has a
built-in recorder).
Voice Alarm: If “On” is selected, audible alarm tones and reminder tones will be trigged when alarms happen; if
“Off” is selected, voice alarms are disable.
5.4
Alarm Limit
5.4.1 ECG Alarm Limit
1. Rotate the knob to select “ECG Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “ECG Alarm Limit”.
->
ECG Alarm Limit
HR Alarm
On / Off
HR High Limit
17 ~ 300
HR Low Limit
15 ~ 298
5.4.2 ST Alarm Limit
1. Rotate the knob to select “ECG Alarm Limit” in “Alarm Limit” menu.
21
2. Press the knob to enter the window of “ECG Alarm Limit”.
->
ST Alarm Limit
ST
On / Off
High Limit
2.00 ~ -2.00mV
Low Limit
-2.00 ~ 2.00mV
5.4.3 ARR Alarm Limit
1. Rotate the knob to select “ECG Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “ECG Alarm Limit”.
->
ARR Alarm Limit
PVCs
On / Off
High Limit
0 ~ 10
5.4.4 SpO2 Alarm Limit
1. Rotate the knob to select “SpO2 Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “SpO2 Alarm Limit”.
22
->
SpO2 Alarm Limit
SpO2 Alarm
On / Off
SpO2 High Limit
1 ~ 100
SpO2 Low Limit
0 ~ 99
Pulse Rate Alarm
On / Off
Pulse Rate High Limit
21 ~ 240
Pulse Rate Low Limit
20 ~ 239
5.4.5 NIBP Alarm Limit
1. Rotate the knob to select “NIBP Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “NIBP Alarm Limit”.
->
NIBP Alarm Limit
Patient Type
Adult
Pediatric
Neonate
Systolic Alarm
On / Off
On / Off
On / Off
Systolic High Limit
32 ~ 280mmHg
32 ~ 220mmHg
32 ~ 135mmHg
Systolic Low Limit
30 ~ 278mmHg
30 ~ 218mmHg
30 ~ 133mmHg
Mean Alarm
On / Off
On / Off
On / Off
Mean High Limit
22 ~ 240mmHg
22 ~ 170mmHg
22 ~ 110mmHg
Mean Low Limit
20 ~ 238mmHg
20 ~ 168mmHg
20 ~ 108mmHg
Diastolic Alarm
On / Off
On / Off
On / Off
Diastolic High Limit
12 ~ 220mmHg
12 ~ 160mmHg
12 ~ 100mmHg
Diastolic Low Limit
10 ~ 218mmHg
10 ~ 158mmHg
10 ~ 98mmHg
23
5.4.6 Resp Alarm Limit
1. Rotate the knob to select “Resp Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “Resp Alarm Limit”.
->
Resp Alarm Limit
RR Alarm
On / Off
RR High Limit
2 ~ 125
RR Low Limit
0 ~ 123
5.4.7 Temp Alarm Limit
1. Rotate the knob to select “Temp Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “Temp Alarm Limit”.
->
Temp Alarm Limit
Channel 1 Alarm
On / Off
Channel 1 High Limit
0.2 ~ 50.0℃ (32.36 ~ 122.0℉)
Channel 1 Low Limit
0.0 ~ 49.8℃ (0.0 ~ 121.64℉)
Channel 2 Alarm
On / Off
Channel 2 High Limit
0.2 ~ 50.0℃ (32.36 ~ 122.0℉)
Channel 2 Low Limit
0.0 ~ 49.8℃ (0.0 ~ 121.64℉)
5.4.8 CO2 Alarm Limit
1. Rotate the knob to select “CO2 Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “CO2 Alarm Limit”.
24
->
CO2 Alarm Limit
RR Alarm
On / Off
RR High Limit
0 ~ 120
RR Low Limit
0 ~ 120
EtCO2 Alarm
On / Off
EtCO2 High Limit
2 ~ 100mmHg
EtCO2 Low Limit
0 ~ 98mmHg
FiCO2 Alarm
On / Off
FiCO2 High Limit
2 ~ 100mmHg
FiCO2 Low Limit
0 ~ 98mmHg
5.4.9 CSM Alarm Limit
1. Rotate the knob to select “CSM Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “CSM Alarm Limit”.
->
CSM Alarm Limit
CSI Alarm
On / Off
CSI High Limit
2 ~ 100
CSI Low Limit
0 ~ 98
25
5.4.10 Load Default Alarm Limit
1. Rotate the knob to select “Load Default Alarm Limit” in “Alarm Limit” menu.
2. Press the knob to enter the window of “Load Default Alarm Limit”.
3. Select “Yes” and press the knob, the current alarm limit settings will be deleted.
->
26
5.5
Alarm Messages
5.5.1 Technical Alarm Messages
Alarm Information
Trigger Condition
Process Method
**ECG LEAD OFF
RL or more than 2 ECG leads
falls off
Check the ECG lead connection
**ECG LEAD RA OFF
RA lead fall off
Check the ECG lead connection
**ECG LEAD LA OFF
LA lead fall off
Check the ECG lead connection
**ECG LEAD LL OFF
LL lead fall off
Check the ECG lead connection
**ECG LEAD V OFF
V lead fall off
Check the ECG lead connection
**MODULE INIT ERR
Module self-checking mistake
Restart the machine, if error still
existed, contact the factory service
***MODULE COMM STOP
The module and the main engine
communication have problems
Restart the machine, if error still
existed, contact the factory service
**MODULE COMM ERR
The module and the main engine
communication have problems
Restart the machine, if error still
existed, contact the factory service
**PARA ALARM LMT ERR
The parameter of the alarm limit
is modified by the accident
contact the factory service
**RANGE EXEED
The parameter observed value has
exceed the measurement scope
which the system can carry on
contact the factory service
**SpO₂ SENSOR OFF
SpO₂ sensor does not connected
Check SpO₂ sensor connection
**SpO₂ FINGER OFF
The finger fall off from SpO₂
Check SpO₂ sensor connecting with
sensor
the finger
SpO₂ sensor connects badly or the
Check SpO₂ sensor connection
patient move the arm
situation and patient's current
condition
**Temp1 SENSOR OFF
The body temperature channel 1
sensor do not connect
Check temperature sensor
connection
**Temp2 SENSOR OFF
The body temperature channel 2
sensor do not connect
Check temperature sensor
connection
**WATCHDOG ERR
Main engine watch-dog
self-checking defeat
Restart the machine, if wrong still
existed, contact the factory service
**SYSTEM TIME LOST
The system clock has not set
Change the system time as the
current time, if error still existed,
SEARCHING PULSE...
27
related the factory to carry on the
service
**12V HIGH
The 12V voltage examination
exceeds the normal voltage scope
Restart the machine, if error still
existed, contact the factory service
**12V LOW
The 12V voltage examination is
lower than the normal voltage
scope
Restart the machine, if error still
existed, contact the factory service
**3.3V HIGH
The 3.3V voltage examination
exceeds the normal voltage scope
Restart the machine, if error still
existed, contact the factory service
**3.3V LOW
The 3.3V voltage examination is
lower than the normal voltage
scope
Restart the machine, if error still
existed, contact the factory service
**BAT HIGH
The battery voltage examination
exceeds the normal voltage scope
Restart the machine, if error still
existed, contact the factory service
**BAT LOW
The battery capacity is
insufficient
Meets the alternating current to
carry on the charge immediately to
the battery
*NIBP LOOSE CUFF
The cuff has not connected
Reconnects the blood pressure cuff
The cuff has not connected good
or the air course leaks air
check the pipe connection situation
or replace cuff, if the breakdown
still existed, please contact the
factory service
When blood pressure
measurement deflates has the
problem
check the tube connection or
replace cuff, if the error still
existed, please contact the factory
service
When blood pressure
measurement the pulse signal too
weak, is unable to calculate the
blood pressure
Examined the patient type set
whether correctly, check the tube
connection or replace cuff, if the
error still existed, please contact the
factory service
When blood pressure
measurement the blood pressure
or the pulse signal exceeds the
normal range, is unable to carry
on the measurement
check he tube connection or replace
cuff, if the error still existed, please
contact the factory service
*NIBP AIR LEAK
*NIBP DEFLATE ERR
*NIBP WEAK SIGNAL
*NIBP OUT OF RANGE
*NIBP MOVEMENT
Patient arm move
Check the patient situation or
replace cuff, if the error still
existed, please contact the factory
service
**NIBP OVER PRESSURE
The pressure value exceeds the
measurement scope
check the pipe connection situation
or replace cuff, if the error still
existed, please contact the factory
service
*NIBP SATURATE
When blood pressure
measurement the pulse signal
exceeds the normal range, is
unable to carry on the
Check the patient situation or
replace cuff, if the error still
existed, please contact the factory
service
28
measurement
*NIBP PNEUMATIC FAIL
The cuff has not connected good
or the air course leaks air
check the pipe connection situation
or replace cuff, if the error still
existed, please contact the factory
service
**NIBP SYSTEM ERR
Blood pressure system self-check
defeat
Restart the machine, if the error
still existed, please contact the
factory service
**NIBP TIME OUT
Blood pressure measurement
overtime
Restart the machine, if the error
still existed, please contact the
factory service
**NIBP CUFF TYPE WRONG
Patient type for adult when has
used the neonate cuff
Check the patient type or replace
cuff, if the error still existed, please
contact the factory service
**NIBP MEASURE FAIL
This blood pressure measurement
has not been able to calculate the
blood pressure
Check the patient situation or
replace cuff, if the error still
existed, please contact the factory
service
**NIBP RESET ERR
When blood pressure
measurement exceptionally reset
Restart the machine, if the error
still existed, please contact the
factory service
**CO₂ STANDBY
CO₂ is on standby mode
Set CO₂ to run mode
***CO₂ COMM STOP
CO₂module and the main engine
Restart the machine, if error still
existed, contact the factory service
communication have the problem
**CSI COMM STOP
CSI module and the main engine
communication have the problem
Restart the machine, if error still
existed, contact the factory service
**CSI SENSOR OFF
CSI sensor does not connected
Check CSI sensor connection
CSI SQI LOW
CSI sensor does not connected or
skin dirty
Check CSI sensor connection
5.5.2 Physiological Alarm Messages
Alarm Information
Trigger Condition
***ASYSTOLE
Over 4 seconds non- palpitations signals
***APNEA
In a setting time without breath signal
***NO PULSE
Over 15 seconds without pulse signals
**HR TOO HIGH
The heart rate exceeds the alarm high limit
**HR TOO LOW
The heart rate is lower than the alarm low limit
**ST-I TO HIGH
the ST value correlate with I surpass the upper alarm limit
29
**ST-I TOO LOW
the ST value correlate with I surpass the lower alarm limit
**ST-II TO HIGH
the ST value correlate with II surpass the upper alarm limit
**ST-II TOO LOW
the ST value correlate with II surpass the lower alarm limit
**ST-III TO HIGH
the ST value correlate with III surpass the upper alarm limit
**ST-III TOO LOW
the ST value correlate with III surpass the lower alarm limit
**ST-AVR TOO HIGH
the ST value correlate with AVR surpass the upper alarm limit
**ST-AVR TOO LOW
the ST value correlate with AVR surpass the lower alarm limit
**ST-AVL TOO HIGH
the ST value correlate with AVL surpass the upper alarm limit
**ST-AVL TOO LOW
the ST value correlate with AVL surpass the lower alarm limit
**ST-AVF TOO HIGH
the ST value correlate with AVF surpass the upper alarm limit
**ST-AVF TOO LOW
the ST value correlate with AVF surpass the lower alarm limit
**ST-V TOO HIGH
the ST value correlate with V surpass the upper alarm limit
**ST-V TOO LOW
the ST value correlate with V surpass the lower alarm limit
**PVCs TOO HIGH
The PVCs value exceeds the alarm high limit
The oxygen saturation exceeds the alarm high limit
**SPO₂ TOO HIGH
The oxygen saturation is lower than the alarm low limit
**SPO₂ TOO LOW
**Pulse rate TOO HIGH
The Pulse rate surpass the alarm high limit
**Pulse rate TOO LOW
The Pulse rate are lower than the alarm low limit
**NIBP SYS TOO HIGH
NIBP systolic pressure exceeds the alarm high limit
**NIBP SYS TOO LOW
NIBP systolic pressure is lower than the
**NIBP MEAN TOO HIGH
NIBP mean pressure exceeds the alarm high limit
**NIBP MEAN TOO LOW
NIBP mean pressure is lower than the alarm low limit
**NIBP DIA TOO HIGH
NIBP diastolic pressure exceeds the alarm high limit
**NIBP DIA TOO HIGH
NIBP diastolic pressure is lower than the alarm low limit
**RR TOO HIGH
The Breath rate exceeds the alarm high limit
**RR TOO LOW
The Breath rate is lower than the alarm low limit
**TEMP1 TOO HIGH
The body temperature channel 1 exceeds the alarm high limit
**TEMP1 TOO LOW
The body temperature channel 1 is lower than the alarm low limit
**TEMP2 TOO HIGH
The body temperature channel 2 exceeds the alarm high limit
**TEMP2 TOO LOW
The body temperature channel 2 is lower than the alarm low limit
**EtCO₂TOO HIGH
EtCO₂exceeds the high
**EtCO₂ TOO LOW
EtCO₂ is lower than the low limit
30
limit
lower alarm limit
**FiCO₂ TOO HIGH
FiCO₂exceeds the high
limit
**FiCO₂ TOO LOW
FiCO₂ is lower than the low limit
**AwRR TOO HIGH
AwRR exceeds the high
**AwRR TOO LOW
AwRR is lower than the low limit
**CSI TOO HIGH
CSI is higher than the low limit
**CSI TOO LOW
CSI is lower than the low limit
limit
NOTE
● When different level of alarm simultaneously exists, the sound of the alarm is the highest level alarm.
● In alarm suspend condition, Monitoring will not process any alarm information.
31
6 Recording
6.1
Record Setting
1. Rotate the knob to select “Record Setting” in “Setting” menu.
2. Press the knob to enter the window of “Record Setting”.
->
Record Setting
Rec Wave1
Off, ECG-Ⅰ,ECG-Ⅱ,ECG-Ⅲ,ECG-AVR,ECG-AVL,ECG-AVF,ECG-Ⅴ, Pleth, Resp
Rec Wave2
Off, ECG-Ⅰ,ECG-Ⅱ,ECG-Ⅲ,ECG-AVR,ECG-AVL,ECG-AVF,ECG-Ⅴ, Pleth, Resp
Rec Wave3
Off, ECG-Ⅰ,ECG-Ⅱ,ECG-Ⅲ,ECG-AVR,ECG-AVL,ECG-AVF,ECG-Ⅴ, Pleth, Resp
Rec Length
8s, Continuous
Rec Period
Off, 10min, 20min, 30min, 40min, 50min, 60min, 2hour, 3hour, 4hour
Rec Speed
12.5mm/s, 25mm/s, 50mm/s
Rec Grid
Off / On
■ Record Wave 1~3: The parameter waves that need to be recorded, the user can decide to record one of them, two
of them or three of them.
■ Record Length: Recording length, if “8s” is selected, when “RECORD” button is pressed, the recorder will record
8s of parameter waves each time; if “Continuous” is selected, when “RECORD” button is pressed, the recorder will
keep recording the parameter waves until “RECORD” button is pressed again or recording function is closed.
■ Record Period: The time interval between recording outputs.
■ Record Speed: Recording speed
■ Record Grid: If “On” is selected, the background grid will output; if “Off” is selected, the background grid will
not output.
32
6.2
Recorder On / Off
1. Rotate the knob to select “User Setting” in “Service” menu.
2. Press the knob to enter the window of “User Setting”.
3. If “On” is selected from the list of “Recorder”, the recorder will be available. If “Off” is selected from the list of
Recorder, the recorder will be disabled.
->
33
7 Patient Managing
7.1
Admit Patient
1. Rotate the knob to select “Admit New Patient” in “Patient” menu.
2. Press the knob to enter the window of “Patient Info”.
3. Input the patient’s information and confirm by “Ok”. The patient will be admitted.
->
Admit Patient
Bed Number
1 ~ 100
Patient Type
Adult, Pediatric, Neonate
Patient Name
Supports inputting by letter and number
Gender
Male, Female
Height
20 ~ 250 cm
Weight
2 ~ 250 kg
Doctor Name
Supports inputting by letter and number
Blood Type
A, B, O, AB, NA
MRN
Supports inputting by letter and number
Birth Year
1900/1/1 ~ 2099/12/31
Admit Year
1900/1/1 ~ 2099/12/31
34
7.2
Discharge Current Patient
1. Rotate the knob to select “Discharge Current Patient” in “Patient” menu.
2. Press the knob to enter the window of “Discharge Current Patient”.
3. Select “Yes” and press the knob. The current patient’s information will be deleted.
->
NOTE
● If do not relieve the patient firstly before receive new patient, new patient’s measurement data would be
save in the preceding patient's data. The monitor can not distinguish the new patient data from the old one.
7.3
Dose Calculation
7.3.1 Dose Calculation Procedure
1. Rotate the knob to select “Dose Calculation” in “Patient” menu.
2. Press the knob to enter the window of “Dose Calculation”.
3. Select a drug name from the list of “Drug Name”. Input the patient’s “Weight” and other known values. The
corresponding values will be calculated and displayed.
->
35
Dose Calculation
Drug Name
Drug A, Drug B, Drug C, Drug D, Drug E, Aminophylline, Dobutamine, Dopamine, Epinephrine,
Heparin, Inocor, Insulin, Isuprel, Lidocaine, Nipride, Nitroglycerin, Norepinephrine, Pitocin,
Procainamide, Vasopressin
Weight
0.50 ~ 250.00 kg
Amount
0.00 ~ 9999.00 mg
Volume
0.00 ~ 9999.00 ml
Dose/min
0.00 ~ 9999.00 mcg(ug)
Dose/hr
0.00 ~ 9999.00 mg
Dose/kg/min
0.00 ~ 9999.00 mcg(ug)
Dose/kg/hr
0.00 ~ 9999.00 mcg(ug)
Inf Rate
0.10 ~ 4999.50 ml/hr
Drip Rate
0.10 ~ 999.98 GTT/hr
Drop Size
0.10 ~ 999.97 GTT/ml
Inf Time
0.10 ~ 999.98 hr
7.3.2 Drug Unit
Drug Unit Table
Drug
Unit
Drug A, Drug B, Drug C, Aminophylline,
Dobutamine, Dopamine, Epinephrine, Inocor,
Isuprel, Lidocaine, Nipride, Nitroglycerin,
Norepinephrine, Procainamide
mg, mcg (ug)
Drug D, Heparin Insulin, Pitocin, Vasopressin
UNIT, m UNIT
Drug E
mEq, uEq
7.3.3 Titration Table
1. Select “Titration Table” in the window of “Dose Calculation”.
2. Press the knob to enter the window of “Titration Table”.
36
->
2. Press “
” and “
” to view the titration table step by step; press”
the titration table page by page; press “
” and “
” to view the first page of titration table and press “
” to view
” to
view the last page of titration table.
3. Charge the values of “Dose Type”, “Item” or “Step”. The corresponding values will change in the titration table.
4. Press “Record” to print the currently displayed data of titration table by recorder (if the monitor has a built-in
recorder).
37
8 ECG Monitoring
8.1
ECG Display
1. The heartbeat icon flashes in the same rate with the patient’s heartbeat or pulse.
2. ST1, ST2 and ST3 display only when ST Switch is “On”; PVCs displays only when ARR Switch is “On”.
->
38
8.2
ECG Setting
1. Rotate the knob to select “ECG Setting” in “Setting” menu. Press the knob to enter the window of “ECG Setting”.
->
ECG Setting
Pace
Off / On
Ch1 Lead
Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF, Ⅴ
Ch2 Lead
Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF, Ⅴ
Ch3 Lead
Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF, Ⅴ
Size
x0.25, x0.5, x1, x2
Notch
Off / On
Lead Type
3 Lead, 5 Lead
Filter
Diagnostic, Monitor, Surgery
Heart Volume
0~10
Wave Speed
12.5mm/s, 25mm/s, 50mm/s
HR Source
ECG, SpO2, auto
ST Switch
Off / On
ARR Switch
Off / On
■ Pace
♦ On: When “On” is selected, a detected pacemaker signal is indicated by a "|" symbol above the ECG waveform.
♦ Off: When “Off” is selected, the pacemaker analysis is disabled.
■ Ch1~3 Lead
Lead type.
■ Size
Adjust the amplitude of the ECG waveforms. A “1mV” scale is displayed at the right side of each ECG waveform,
the height of the 1mV bar is directly proportional to the ECG waveform amplitude.
■ Notch
Determines whether filter or not.
♦ On: When “On” is selected, the monitor protects the signals from the noise generated by the power line.
♦ Off: When “Off” is selected, there is no filtering for outside signals.
■ Lead Type
39
■ Filter
The filtering enables clearer and more detailed waveforms. There are three filter methods for selection.
♦ Diagnostic: The monitor displays the ECG waveforms without filter;
♦ Monitor: It effectively filters the artifacts that might cause false alarms;
♦ Surgery: This filter is used to reduce the artifacts and interference from electrosurgery equipment.
The selected filter is applied to both channels, but the filter label is merely displayed above the first ECG waveform.
■ Heart Volume
■ Wave Speed
■ HR Source
HR comes from “ECG”, “SpO₂”, “Auto”.
♦ ECG: HR is always calculated from ECG.
♦ SpO2: If the ECG signal is seriously interfered, you can select SpO2, which means PR will be derived from PLETH
waveform.
♦ Auto: The monitor determines the heart rate source depending on the signal quality. The priorities for heart rate
calculation are: ECG, SpO2.
■ ST Switch
The function of ST analysis is optional. In the factory configuration, ST analysis is disabled.
■ ARR Switch
Arrhythmia Analysis. In the factory configuration, ST analysis is disabled.
WARNING
● Don’t touch the patient or the monitor in the period of defibrillating.
● In order to ensure the patient safety, all leads must be connected to the patient
● When the electricity surgical (ES) equipment is used, lay the ECG-lead in the middle of both the ES ground
plate and ES to avoid burning. The cable of the electricity surgical equipment cannot twist with the
ECG-cable.
● When the electricity surgical (ES) equipment is used, don’t place the electrode on the ground plate near the
electricity surgical equipment. Otherwise, the ECG-signal will be disturbed.
● If monitoring a patient with the pacemaker, set “PACE” to On. If monitoring a patient without pacemaker,
set “PACE” to Off.
● Regarding the pacemaker patient, the pacing switch must be “On”, otherwise, it is possibly to consider the
pacing pulse as the normal QRS.
8.3
ECG Calibration
Rotate the knob to select “ECG Calibration” in “Service” menu. Press the knob to enter the window of “ECG
Calibration”. If “On” is selected, the monitor will have a self-calibration for ECG waves. If “Off” is selected,
self-calibration will stop.
40
->
ECG Calibration
Calibrate
8.4
Off / On
ECG Monitoring Procedure
8.4.1 Preparation
1. Skin preparation
The quality of ECG information displayed on the monitor is a direct result of the quality of the electrical signal
received at the electrode. Proper skin preparation is necessary for good signal quality at the electrode. A good signal
at the electrode provides the monitor with valid information for processing the ECG data. Choose flat area to place
electrodes. Following is a suggested guideline for skin preparation:
a. Shave hair from skin at chosen sites.
b. Gently rub skin surfaces at sites to remove dead skin cells.
c. Thoroughly cleanse the site with a mild soap and water solution (do not use ether or pure alcohol because they will
increase skin impedance).
d. Dry the skin completely before applying the electrodes.
2. Attach the ECG lead wire to the electrodes.
3. Place the electrodes on the patient. (conductive ointment can be applied to the electrodes to improve the skin
conductance if it is necessary)
4. Connect the ECG lead wire to the ECG connector of the monitor.
5. Make sure the monitor is turned on and is ready for monitoring.
6. Make sure the monitor have a proper ECG setting.
8.4.2 Electrode Placement
8.4.2.1 3-Leadwire Electrode Placement
3-Leadwire electrode placement is showed by European standard as follow:
41
■ R (right arm) electrode: near the right shoulder, directly below the clavicle.
■ L (left arm) electrode: near the left shoulder, directly below the clavicle.
■ F (left leg) electrode: on the left hypogastrium.
American Standard
(AHA)
European Standard
(IEC)
Label
Color
Label
Color
RA
White
R
Red
LA
Black
L
Yellow
LL
Red
F
Green
8.4.2.2 5-Leadwire Electrode Placement
5-Leadwire electrode placement is showed by American standard as follow:
■ RA (right arm) electrode: near the right shoulder, directly below the clavicle.
■ LA (left arm) electrode: near the left shoulder, directly below the clavicle.
■ RL (right leg) electrode: on the right hypogastrium.
■ LL (left leg) electrode: on the left hypogastrium.
■ V (precordial) electrode: on the chest.
American Standard
(AHA)
European Standard
(IEC)
Label
Color
Label
Color
RA
White
R
Red
LA
Black
L
Yellow
LL
Red
F
Green
42
RL
Green
N
Black
V
Brown
C
White
WARNING
● When connecting the cables and electrodes, make sure no conductive part is in contact with the ground.
Verify that all ECG electrodes, including neutral electrodes, are securely attached to the patient.
WARNING
● Verify lead fault detection before start of monitoring. Unplug the ECG cable from the socket, the screen will
display the error message “ECG LEAD OFF” and the audible alarm is activated.
WARNING
● Use five lead wires. Use only silver - silver chloride (Ag-AgCl) ECG electrodes and cables that meets AAMI
standards.
WARNING
● Set out the following table are standard in Europe and the United States the name of the lead.
8.4.2.3 Electrode Placement for Surgical Patients
Electrode placement during surgery is dependent on the type of surgery being performed. For example, with open
chest surgery, the electrodes might be placed laterally on the chest or on the back. In the operating room, artifact can
sometimes affect the ECG waveform due to the use of electrosurgery equipment. To help reduce this, place the
electrodes on the right and left shoulders, the right and left sides near the stomach, and place the chest lead on the left
side at mid-chest. Avoid placing the electrodes on the upper arms. This will cause the ECG waveform to be too small.
A good characteristic of the ECG-waveform:
The QRS wave height is great and narrow with no notches.
The R wave height is big and located completely above the baseline or under.
The amplitude of the P wave and the T wave is smaller than 0.2mV.
WARNING
● Do not touch the patient, table nearby, or the equipment during defibrillation.
WARNING
43
● When apply the ECG cable with no resistances to patient monitor or other patient monitors which
themselves with no current limit resistance, it can’t be applied to defibrillation.
NOTE
● Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy
of the waveform.
WARNING
● When using ESU equipment, leads should be placed in a position in equal distance from ESU electrotome
and the grounding plate to avoid cautery. ESU equipment wire and ECG cable must not be tangled up.
8.5
ST Analysis
8.5.1 ST Display
8.5.2 ST Setting
1. Rotate the knob to select “ECG Setting” in “Setting” menu.
2. Press the knob to enter the window of “ECG Setting”.
->
3. Select “On” from the list of “ST Switch” and confirm by “Ok”. ST Setting will appear in “Setting” menu.
4. Select “ST Setting” and press the knob to enter the window of “ST Setting”.
44
->
■ ISO: The isoelectric point provides the baseline for the measurement.
■ ST: The ST point provides the other measurement point.
ST Setting
ISO
0 ~ 500ms
ST
0 ~ 500ms
The ST measurement for each beat complex is the vertical difference between two measurement points.
WARNING
● ST analysis is not intended for neonatal patients.
● 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.
NOTE
● The function of ST analysis is optional. In the factory configuration, ST analysis is disabled.
● The ST measurement points need to be adjusted when you start monitoring, and if the patient’s heart rate or
ECG morphology changes significantly.
● Artifactual ST segment depression or elevation may occur if the ISO or the ST point is incorrectly set.
● Abnormal QRS complex is not considered in ST analysis.
45
8.6
Arrhythmia Monitoring
8.6.1 ARR Display
8.6.2 ARR Setting
1. Rotate the knob to select “ECG Setting” in “Setting” menu.
2. Press the knob to enter the window of “ECG Setting”.
3. Select “On” from the list of “ARR Switch” and confirm by “Ok”. Arrhythmia monitoring is activated.
->
46
9 SpO2 Monitoring
9.1
SpO2 Display
The Oxygen Saturation (SpO₂) parameter measurement the artery blood oxygen saturation, it is the percentage of the
oxygen gathers hemoglobin .For example, if in the artery blood red blood cell, 97% hemoglobin combine with the
oxygen, then this blood has 97% oxygen saturation, the value reading on the monitor should be 97%, this value
demonstrated the percent of the carry oxygen hemoglobin molecule which forms the oxygen gathers hemoglobin.
9.2
SpO2 Setting
1. Rotate the knob to select “SpO2 Setting” in “Setting” menu.
2. Press the knob to enter the window of “SpO2 Setting”.
->
SpO2 Setting
47
Pulse Volume
0~10
Sensitivity
High, Medium, Low
Wave Speed
12.5mm/s, 25mm/s
Pulse Rate
Off / On
Wave Mode
Line, Fill
Pitch Tone
Off / On
WARNING
● If it has the carbon oxygen hemoglobin, metahemoglobin or dye dilution chemicals, then the oxygen
saturation value can have the deviation;
● Electricity surgical department equipment electric cable cannot twine with the sensor cable in the same
place;
● Do not place the sensor at the body has the ductus arteriosus or the vein syringe;
● Guarantees the nail to block the lights. Sensor should at the back of hand;
● Do not place SpO₂ or the blood pressure oversleeve blood pressure measurement on the same body, because
in the blood pressure measurement process the blood stream unenlightened can affect the oxygen saturation
reading;
● Continually, the excessively long time monitor possibly can increase do not hope danger that the skin
characteristic change occurs, for example exceptionally sensitive, changes red, bubbles or pressure necrosis,
specially in the neonate or has pour barrier as well as the change or juvenility skin kind sickness person;
● In the long time continuous monitoring process, about every 2 hours inspects the measurement SpO₂ the end
circulation situation and the skin situation, if discovered changes not good, should change the measurement
SpO₂ promptly, simultaneously should periodical inspection the sensor fastness situation, avoids the sensor
fastness situation change caused by the moving and so on the factors affect the accuracy of the measurement;
● If the test SpO₂ and the sensor cannot locate accurately, possibly causes the oxygen saturation reading
inaccurate, even unable to search the pulse wave result in unable to carry on the blood oxygen monitor, this
time should relocate;
48
● Measurement SpO₂ move excessively possibly creates measurements inaccurate, this time should cause the
patient peaceful or the replacement measurement SpO₂, reduces the influence of moves excessively to the
measurement.
9.3
SpO2 Monitoring Procedure
9.3.1 Finger Sensor Placement
1. Power on the monitor.
2. Select the proper sensor according to patient type.
3. Attach the sensor to the proper site on the patient.
4. Plug the connector of the sensor extension cable into the SpO2 connector on monitor.
NOTE
● Place the SpO2 sensor cable at the backside of the patient hand. Make sure the fingernail is just opposite to
the light emitted from the sensor.
9.3.2 Neonate SpO2 Plethysmography Measurement
Neonate SpO2 sensor consists of a Y-shape SpO2 sensor and its sheath. Insert the LED and PD ends of the Y-shape
SpO2 sensor respectively into the upper and lower grooves on the sheath (Figure 7-2). The Figure 7-3 shows us the
neonate SpO2 sensor after insertion.
(1)
(2)
49
9.3.3 Neonatal Oxygen Probe Placement
Wind the SpO2 sensor around a hand or foot of a neonate patient. Hold the sensor, pull the belt and fit one of its sides
with “V” edge into the “V” groove on the corresponding side of the sheath. Appropriately elongate the belt to about
20mm, and fit the “V” edge of the other side of the belt into the “V” groove of the other side of the sheath. Then,
loosen the belt. After the “V” edges of the two sides of the belt fit well into the “V” grooves on the two sides of the
sheath, put the belt into the first lock bar to fasten the belt. If the belt is too long, you may put it into the second lock
bar. You must position the SpO2 sensor in this way so as to make the photoelectric component face the correct
position. Besides, note not to elongate the belt too much, which may lead to inaccurate measurement and block the
blood circulation severely.
NOTE
● No calibration curve for the pulse oximeter.
● No normalization for the waveform.
● If the sensor cannot be positioned accurately to the part to be measured, it may result in inaccurate SpO2
reading, or even that the SpO2 cannot be measured because no pulse is detected. If this is true, you must
position the sensor again.
● The excessive patient movement may result in inaccurate reading. In this situation, you must keep the
patient quiet or change the part for monitoring to reduce the adverse influence of excessive movement.
● Function tester cannot evaluate the accuracy of the probe and the patient monitor.
Special use for the probe:
Patient Type
Adult
Pediatric
Neonate
Age
≧18years
1month-12years
≦28days
Weight
>30 ㎏
10-50 ㎏
2.5-4 ㎏
Type of the
probe
Finger type for adult
Finger type for Pediatric
Tied type for neonate
Sensor
position
Finger
Finger
Palm or leg
Application
condition
Normal temperature,check the
peripheral circulation and the
skin every 2 hours, keep the
patient quiet.
Normal temperature,check the
peripheral circulation and the
skin every 2 hours, keep the
patient quiet.
Normal temperature,check the
peripheral circulation and the
skin every 2 hours, keep the
patient quiet.
WARNING
● The probe should be non-poisonous.
● In the process of extended and continuous monitoring, you should check the peripheral circulation and the
skin every 2 hours. If any unfavorable changes take place, you should change the measured position in time.
50
● In the process of extended and continuous monitoring, you should periodically check the position of the
sensor. In case that the position of the sensor moves during monitoring, the measurement accuracy may be
affected.
The temperature of the probe should be less than 41℃, otherwise the patient will be burned.
9.4
Measurement Restrictions
In the operating process, following factors may affect the accuracy of the oxygen saturation measurement:
1) High-frequency electrical jam, such as the disturbance which is produced by monitor system oneself or comes
from such as the electricity surgery instrument disturbance which connected with the system;
2) In magnetic resonance image formation scanning (MRI) period do not use the blood oxymeter and the blood
oxygen sensor, the induced current possibly can cause the burn;
3) In vein dye;
4) Patient too frequently migration;
5) Outside ray radiation;
6) Sensor installment inappropriate or contact the improper position with the object;
7) Body temperature (best body temperature should in 28℃- 42℃);
8) Lay aside the sensor in the body has the blood pressure cuff, in the ductus
9) Arteriosus or the cavity on the pipeline body;
10) The density of the non- function hemoglobin like carbon oxygen hemoglobin (COHb) and blood and iron
hemoglobin (MetHb) and so on;
11) Oxygen saturation lowly;
To be circular poured is not good at the test part;
Shock, anemia, the low temperature and applies the vasoconstriction medicine and so on all possibly cause the artery
blood stream to be reduced to the level which was unable to measurement;
12) Measurement is also decided on the oxygen gathers hemoglobin and the absorption situation of the return oxygen
gathers hemoglobin to the special wave length light. If other substances which absorb the same wave length light
exist, they can cause the measurement to appear pseudo or the low oxygen saturation value. For example: Carbonizes
the hemoglobin, the blood and iron hemoglobin, the methylene blue, indigo carmine.
9.5
Masimo SpO2 Monitoring (optional)
9.5.1 Masimo SpO2 Display
51
9.5.2 Masimo SpO2 Setting
1. Rotate the knob to select “SpO2 Setting” in “Setting” menu.
2. Press the knob to enter the window of “SpO2 Setting”.
->
Masimo SpO2 Setting
Pulse Volume
0~10
Sensitivity
Max, Normal, APOD
Average
2-4s, 4-6s, 8s, 10s, 12s, 14s, 16s
FastSat
Off / On
Wave Speed
12.5mm/s, 25mm/s
Pulse Rate
Off / On
Wave Mode
Line, Fill
Pitch Tone
Off / On
■ Pulse Volume
■ Sensitivity
Max: the patient monitor is more sensitive to minor signals. When monitoring critically ill patients whose pulsations
are very weak, it is strongly recommended that the sensitivity is set to “Maximum”.
Normal: When monitoring neonatal or non-critically ill patients who tends to move a lot, noise or invalid signals
may be caused. In this case, it is recommended that the sensitivity is set to “Normal” so that the interference caused
by movement can be filtered and therefore the measurement stability can be ensured.
APOD: Masimo Adaptive Probe-Off Detection Technology
■ Average
Determines the average SpO2 calculation time.
■ FastSat
FastSat enables rapid tracking of arterial oxygen saturation changes, making Masimo SET the highest fidelity pulse
oximetry available today.
52
Rapid changes in arterial oxygen saturation are typically 'smoothed-out' by pulse oximeter averaging algorithms,
yielding blunted readings. FastSat captures and reports these rapid oxygen saturation changes.
■ Wave Speed
Waveform speed
■ Pulse Rate
■ Wave Mode
■ Pitch Tone
SpO2 and PR alarm limits
Parameter
Max. upper limit
Min. lower limit
Step
SpO2
100
0
1
PR
240
25
1
The default SpO2 and PR alarm limits
Parameter
Patient type
Upper limit
Lower limit
Adult
100
90
Pediatric
100
90
Neonate
95
80
Adult
120
50
Pediatric
160
75
Neonate
200
100
SpO2
PR
WARNING
● Setting the SpO2 upper alarm limit to 100% will disable the upper alarm limit. High oxygen levels may
predispose a premature infant to retrolental fibroplasia. Therefore, the upper alarm limit for oxygen
saturation must be carefully selected in accordance with the commonly accepted clinical practices.
9.5.3 Masimo SpO2 Monitoring Procedure
NOTE
● This section is only applicable to the monitor equipped with a Masimo SpO2 module.
9.5.3.1 Principles of Operation
The pulse oximetry measurement module (Masimo Set, which is called MS-7) is based on three principles:
■ Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry).
■ The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse
(plethysmography).
■ Arterio-venous shunting is highly variable, and the fluctuating absorbance by venous blood is a major component
of noise during the pulse.
53
The working principle of MS-7 uses is similar to the traditional SpO2 module. It calculates the SpO2 value by
passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle.
The red and infrared light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, and the photodiode
serves as the photodetector.
Traditional pulse oximeter assumes that all pulsations in the light absorbance signal are caused by oscillations in the
arterial blood volume. This assumes that the blood flow in the region of the sensor passes entirely through the
capillary bed rather than through any arterio-venous shunts. The traditional pulse oximeter calculates the ratio of
pulsatile absorbance (AC) to the mean absorbance (DC) at each of two wavelengths, 660 nm and 940 nm:
Re d (660 )  AC (660 ) / DC (660 )
Ir (940)  AC (940) / DC (940)
This traditional instrument then calculates the ratio of these two arterial pulse-added absorbance signals:
R  Re d (660) / Ir (940)
This value of R is used to find the SpO2 in a look-up table built into the instrument’s software. The values in the
look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in
induced hypoxia studies.
This MS-7 assumes that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is
the major component of noise during the pulse. The MS-7 decomposes S(660) and S(940) into an arterial signal plus
a noise component and calculates the ratio of the arterial signals without the noise:
Re d (660)  Sr  Nr
Ir (940)  Si  Ni
R  Sr / Si
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the saturation SpO2
in an empirically derived equation into the software. The values in the empirically derived equation are based upon
human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.
The above equations are combined and a noise reference (N’) is determined:
N '  Re d (660)  Ir (940)  R
The equation for the noise reference is based on the value of R, the value being seeked to determine the SpO2. This
instrument’s software sweeps through possible values of R that correspond to SpO2 values between 1% and 100%
and generates an N’ value for each of these R values. The S (660) and S (940) signals are processed with each
possible N’ noise reference through an adaptive correlation canceler (ACC) which yields an output power for each
possible value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete Saturation Transform
(DST™) plot of relative output power versus possible SpO2 value as shown in the following figure where R
corresponds to SpO2 = 97%:
54
The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO2 value. This
entire sequence is repeated once every two seconds on the most recent four seconds of raw data. The SpO2 value
therefore corresponds to a running average of arterial hemoglobin saturation that is updated every two seconds.
9.5.3.2 Precautions
WARNING
● The pulse wave from the MS-7 module must NOT be used for apnea monitoring.
● As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory
co-oximeter to completely understand the patient’s condition.
● If an alarm condition (other than exceptions listed herein) occurs in the Alarms Silenced status, the monitor
only gives visual alarm symbols.
● Measure the monitor’s leakage current whenever an external device is connected to the serial port. Leakage
current must not exceed 100 microamperes.
● To ensure patient electrical isolation, connect only to other equipment with electronically isolated circuits.
● Do not connect to an electrical outlet controlled by a wall switch or dimmer.
● Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
● Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The level of increase is
approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes,
that change usual arterial pigmentation may cause erroneous readings.
● Do not use this instrument and the sensors during magnetic resonance imaging (MRI). Induced current
could potentially cause burns. The monitor may affect the MRI image, and the MRI unit may affect the
accuracy of the oximetry measurements.
● The SpO2 value might be overestimated in the presence of Hb-CO, Met-Hb or dye dilution chemicals.
● Verify sensor cable fault detection before beginning monitoring. Unplug the SpO2 sensor cable from the
connector. The screen displays the prompt information “SPO2 SENSOR OFF” and the audible alarm is
activated.
55
● Do not use the supplied sterile SpO2 sensors if the packaging or the sensor is damaged. Return them to the
distributor or manufacturer.
● Do not perform SpO2 and NIBP measurements on the same limb simultaneously. Obstruction of blood flow
during NIBP measurements may adversely affect the reading of the SpO2 value.
● Prolonged and continuous monitoring may increase the risk of burns at the site of the sensor. It is especially
important to check the sensor placement, and ensure proper attachment on neonates and patients of poor
perfusion or skin sensitive to light. Check the sensor location every 2–3 hours and move to another location if
the skin deteriorates. More frequent examinations may be required for different patients.
NOTE
● Place the SpO2 sensor cable at the backside of the patient hand. Make sure the patient nail is just opposite to
the light emitted from the sensor.
9.5.3.3 Basic Steps
1. Power on the monitor.
2. Attach the sensor to the proper site on the patient.
3. Plug the connector of the sensor extension cable into the SpO2 connector on monitor.
The process of SpO2 plethysmogram measurement is generally the same. But the SpO2 sensor selection and
placement depend on the patient type. When choosing a site for a sensor, refer to the directions for that sensor.
9.5.4 Measurement Limitations
If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by an alternate
method. Then check the instrument for proper function. Inaccurate measurements may be caused by:
■ Incorrect sensor application or use;
■ Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or methemoglobin);
■ Intravascular dyes such as indocyanine green or methylene blue;
■ Exposure to excessive illumination, such as surgical lamps (especially ones
■ With a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure
to excessive illumination can be corrected by covering the sensor with a dark material);
■ Excessive patient motion;
■ Venous pulsations;
■ Placement of a sensor on the same extremity with a blood pressure cuff, arterial catheter, or intravascular line;
■ The monitor can be used during defibrillation. However, the readings may take a short period of time to return to
normal.
Loss of pulse signal can occur in the following situations:
■ The sensor is too tight;
■ There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight;
■ A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor attached;
■ The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia;
■ There is arterial occlusion proximal to the sensor;
■ The patient is in cardiac arrest or is in shock.
56
9.5.5 Sensors and Accessories
If your monitor is equipped with a Masimo SpO2 module, use only Masimo oximetry sensors for SpO2
measurements. Other sensors may cause improper pulse oximeter performance. Before use, carefully read the
directions for the LNOP sensor. Tissue damage can be caused by incorrect application or use of a sensor. An example
is wrapping the sensor too tightly. Inspect the sensor site as specified in the directions to ensure skin integrity, correct
positioning, and adhesion of the sensor.
CAUTION
● Do not use damaged sensors. Do not use a sensor with exposed optical components. Do not immerse the
sensor in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not
sterilize by irradiation, steam, or ethylene oxide.
● Do not use damaged patient cables. Do not immerse the patient cables in water, solvents, or cleaning
solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene
oxide.
9.5.5.1 Selecting a Masimo sensor
When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the available sensor sites, and the
duration of monitoring. For more information refer to the following table or contact Masimo. Use only Masimo
sensors and sensor cables. Select an appropriate sensor, apply as directed, and observe all warnings and cautions
presented in the directions for use accompanying the sensor.
High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. To
prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with dark,
opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate
measurements.
Sensor
Usage
Patient weight (W)
LNOP ADT
Disposable
Adult W>30 kg
LNOP PDT
Disposable
Adult 10kg<W<50kg
LNOP NEO
Disposable
Neonate W<10kg
LNOP NEO PT
Disposable
Neonate W<1kg or patient with poor skin integrity
LNOP DCI
Reusable
Adult and pediatric W>30kg
LNOP DCIP
Reusable
Pediatric 10kg<W<50kg
LNOP DCSC
Reusable
Adult and pediatric W>30kg
LNOP EAR
Reusable
Adult and pediatric W>30kg
LNOP YI Multisite
Reusable
Adult, pediatric, infant and neonate W>1 kg
57
9.5.5.2 Selecting Masimo Sensor Cables
Only use Masimo oximetry patient cables for SpO2 measurements. Other patient cables may cause improper pulse
oximeter performance.
Reusable patient cables of various lengths are available. All cables that marked by the Masimo SET logo are designed
to work with any Masimo LNOP sensor, and with any pulse oximeter or multi-parameter instrument marked by the
Masimo SET logo.
NOTE
● Carefully route patient cables to reduce the possibility of patient entanglement or strangulation.
● If the sensor fails to track the pulse consistently, the sensors may be incorrectly positioned. Reposition the
sensor or choose a different monitoring site.
9.5.5.3 Cleaning and Reusing a Masimo LNOP Sensor
Reusable sensors can be cleaned per the following procedure:
1. Remove the sensor from the patient.
2. Disconnect the sensor from the monitor.
3. Wipe the entire sensor with a 70% isopropyl alcohol pad, and clean with a dry cloth.
4. Allow the sensor to air-dry before returning it to operation.
This method can be used to clean emitting and receiving parts too. The cables should be cleaned with a 3% Hydrogen
peroxide, a 70% isopropyl alcohol or other solutions. Keep the cleaning solution away from the sensor connections.
Reattaching a Disposable Adhesive Sensor:
■ LNOP single use sensors may be reapplied to the same patient if the emitter and detector windows are clear and the
adhesive still adheres to the skin;
■ The adhesive can be partially rejuvenated by wiping with a 70% isopropyl alcohol wipe and allowing the sensor to
thoroughly air-dry prior to replacement on the patient.
WARNING
● To avoid cross contamination only use Masimo LNOP disposable sensors on the same patient.
● Before cleaning the monitor or the sensor, make sure the equipment is switched off and disconnected from
AC power.
CAUTION
● Do not reuse Masimo LNOP disposable sensors.
● Do not soak or immerse patient cables in any liquid solution. Do not sterilize patient cables by irradiation
steam or ethylene oxide. See the cleaning instructions for use for reusable Masimo patient cables.
58
9.5.6 Masimo Information
The MASIMO SET® Product
1. Masimo Patents
This device is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986,
6,157,850, 6,263,222, 6,501,975, 7,469,157 and other applicable patents listed at: www.masimo.com/patents.htm.
2. No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or
more of the patents relating to this device.
59
10 NIBP Monitoring
10.1 NIBP Display
10.2 NIBP Setting
1. Rotate the knob to select “NIBP Setting” in “Setting” menu.
2. Press the knob to enter the window of “NIBP Setting”.
->
■ Unit: Blood pressure unit
■ Mode
Manual: Measurement on demand; Auto: Continually repeated measurements at set intervals; Stat: A continuous
measurement for five minutes.
■ Period
Period is adjustable only when mode is “Auto”. Different time intervals can be selected to determine the interval
between automatic measurements.
■ Beep
On: The monitor will have a beep “DO” when NIBP monitoring is finished; Off: The monitor will not have a beep
“DO” when NIBP monitoring is finished.
NIBP Setting
Unit
mmHg, kPa
Mode
Aanual, Auto, Stat
60
Period
Off, 1min, 2min, 3min, 4min, 5min, 10min, 15min, 30min, 60min, 90min, 2hour, 3hour, 4hour, 8hour
Beep
Off / On
10.3 NIBP Pneumatic Test
1. Set Patient Type to Adult.
a. Rotate the knob to select “Admit New Patient” in “Patient” menu.
b. Press the knob to enter the window of “Patient Info”. Select “Adult” from the list of “Patient Type” and confirm by
“Ok”
->
2. Connect a rigid metal container or vessel (with a capacity of 500 ml ± 5%) to the NIBP cuff connector of the
monitor.
3. Rotate the knob to select “NIBP Pneumatic Test” in “Service” menu. Press the knob. The monitor begin to have a
NIBP Pneumatic Test. After approximately 20 seconds, the monitor will automatically open the deflate valve, ending
the test. If there is a failure, contact our Customer Service.
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4. Rotate the knob to select “Stop Test” in “Service” menu. Press the knob. The monitor will stop the NIBP
Pneumatic Test. Or press the “NIBP” button on the control panel. The monitor will stop the NIBP Pneumatic Test.
WARNING
● Can’t carry on the noninvasive blood pressure on the patient who have the sickle cell anemia or have the
skin disrepair or will have damage.
● To the patient who has the serious hemoglutination machine-made barrier, must according to the clinically
appraise decided whether carries on the automatic blood pressure measurement, because the place where the
body and the cuff friction will has have the haematoma danger.
● Before start the measurement, you must confirm the patient type is correct(adult, pediatric, neonate).
● Do not enwind the cuff to the body have the venous transfusion or inserted the drive pipe, while cuff
charging period, when the transfusion reduces speed or stops up, possibly causes damage around the drive
pipe.
● If the time of the automatic pattern noninvasive blood pressure measurement pull too long, then the body
connected with the cuff possibly have the purpura, lack the blood and the neuralgia. When guarding patient,
must inspect the luster, the warmth and the sensitivity of the body far-end frequently. Once observes any
exception, please immediately stop the blood pressure measurement.
● The calibration of the noninvasive blood pressure measurement is supposed to be carried on one time every
year. (Or according to the maintenance regulation of your hospital).
● The cuff width should be 40% size of the body perimeter. (Neonate is 50%), or the 2/3 of the upper arm
length. The length of the cuff charging part should long enough surround 50~80% of the body, the
inappropriate size cuff can have the wrong reading. If the cuff size has the question, should use the bigger cuff
to reduce the mistake.
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10.4 NIBP Calibration
1. Connect a rigid metal container or vessel (with a capacity of 500 ml ± 5%) to the NIBP cuff connector of the
monitor.
2. Connect a calibrated reference manometer (with an error less than 1mmHg) and a ball pump using “T” connectors
as shown.
3. Rotate the knob to select “NIBP Calibration” in “Service” menu and press the knob.
5. The indicated pressure of the monitor will appear in the NIBP parameters displayed area on the screen.
4. Inflate the metal container by using the ball pump until the reference manometer reads 0, then 50, and finally 200
mmHg.
5. The difference between the indicated pressure of the reference manometer and the indicated pressure of the
monitor will not exceed 3 mmHg. Contact our Customer Service if these values are not met.
6. Rotate the knob to select “Stop Calibration” in “Service” menu. Press the knob. The monitor will stop the NIBP
calibration. Or press the “NIBP” button on the control panel. The monitor will stop the NIBP calibration.
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NOTE
● The calibration of the NIBP measurement should be performed every two years or performed according to
the Hospital Procedure.
10.5 NIBP Reset
1. If the monitor fails to give a visual indication when the pressure pump is working improperly, have a NIBP Reset
to activate a self-test procedure, and restore the monitor to normal performance.
2. Rotate the knob to select “NIBP Reset” in “Service” menu. Press the knob. The monitor will restore the initial
settings of the pressure pump.
10.6 NIBP Monitoring Procedure
WARNING
● Use accessories specified by manufacturer only, otherwise; the device may not function normally.
WARNING
● Before starting a measurement, verify that you have selected a setting appropriate for your patient (adult,
pediatric or neonate.)
● 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.
WARNING
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● Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor
tangled.
NOTE
● The blood pressure of the patient as the basis for establishing therapy may be obtained by using other
method such as the cuff/stethoscope auscultation method. Accordingly, the clinical doctor must note that the
values obtained by using other method and DK-8000S may be different.
NOTE
● NIBP monitoring uses the oscillometric method of measurement. Blood pressure determined with this device
are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method and an
intra-arterial blood pressure measurement device, within the limits prescribed by the ANSI/AAMI SP10.
The initial air inflation is 160mmHg for adult, 120 mmHg for pediatric and 70 mmHg for neonate.
NOTE
● This equipment is suitable for use in the presence of electro-surgery.
1) Insert the gas tube into the blood pressure socket of the monitor;
2) Tie the blood pressure cuff on the patient upper arm or the thigh;
3) Use the suitable size cuff for the patient, guaranteed the symbol Ф is located above to the suitable artery.
Guarantee the cuff to twine the body is not too tight, otherwise possibly causes the body far-end to change color even
lacks the blood;
4) Inspects the edge of the cuff to fall in the range signed <->.If it is not this, exchange a more appropriate cuff;
5) Confirm the cuff deflated completely;
6) Cuff and gaseous tube coupling. The body which will be measured should put in the same horizontal position with
the patient heart. If it is unable to achieve, must use the following adjustment method to make the revision to the
measurement result
If the cuff is higher than the heart horizontal position, each centimeter disparity should add 0.75mmHg(0.10kPa) in
the value.
If the cuff is lower than the heart horizontal position, each centimeter disparity should reduce 0.75mmHg(0.10kPa) in
the value.
7) Confirm the patient type whether correct (patient type shows in the block of information on the monitor, the right
side of bed number), if needs to change the patient type, please enter “the patient information” window, change “the
patient type”;
8) Press down the blood pressure measurement button on the front panel, start to measures the blood pressure.
65
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, then use a larger cuff.
NOTE
● For Neonate measurement, the maximum pressure of the cuff is 147mmHg. The maximum pressure is
140mmHg when the cuff is used normally. The initial inflating pressure of the cuff is 70mmHg during
measurement.
Size of reusable cuff for neonate/children/adult
Patient Type
Limb perimeter
Cuff width
Neonate
10 ~19 cm
8 cm
Pediatric
18 ~ 26 cm
10.6 cm
Adult 1
25 ~ 35 cm
14 cm
Adult 2
33 ~ 47 cm
17 cm
Thigh
46 ~ 66 cm
21 cm
Hose
1.5 m or 3 m
Size of disposable cuff for neonate/children/adult
Size No.
Limb perimeter
Cuff width
1
3.1 ~ 5.7 cm
2.5 cm
2
4.3 ~ 8.0 cm
3.2 cm
3
5.8 ~ 10.9 cm
4.3 cm
4
7.1 ~ 13.1 cm
5.1 cm
Hose
1.5 m or 3 m
10.7 NIBP Measurement Limits
This machine NIBP measuring technique is the vibration mothod, this kind of measuring technique basis has the
certain limit according to difference metrical object. The user should realize at following several situations, the
observed value changes unreliable, or the time measured press increases or the measurement is unable to carry on.
1) Patient movement: If the patient is moving, trembles or the convulsion;
2) Arrhythmia: the irregular heart beat caused by the arrhythmia;
3) Heart-lung machine: such as the patient uses the heart-lung machine connection;
4) Pressure variation: such as while in blood pressure measurement the patient blood pressure rapid change;
5) Serious shock: such as the patient is being in the serious shock or the hypothermia;
6) The heart rate exorbitant or lower: The heart rate is lower than 40bpm (heart beat/minute) and is higher than
240bpm (heart beat/minute), cannot carry on the blood pressure measurement;
7) Obese patient: The excessively thick fat stratum can reduce the accuracy of the measurement, because the fat can
cause the artery pulse signal cannot arrive the cuff.
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11 Resp Monitoring
11.1 Resp Display
11.2 Resp Setting
1. Rotate the knob to select “Resp Setting” in “Setting” menu.
2. Press the knob to enter the window of “Resp Setting”.
->
Resp Setting
Apnea Time
Off, 10s, 15s, 20s, 25s, 30s, 35s, 40s
Wave Size
x0.25, x0.5, x1, x2, x4
Wave Speed
6.25 mm/s, 12.5 mm/s, 25 mm/s
Resp Lead
Ⅰ, Ⅱ
■ Apnea Time Determines whether the patient’s cessation of breath is an apnea event.
■ Wave Size
Waveform gain.
■ Wave Speed Wave speed.
■ Resp Lead
Respiration lead type.
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11.3 Electrode Placement
Electrode Placement of ECG Lead I
Electrode Placement of ECG Lead II
NOTE
● Resp monitoring is not recommended on patient who moves a lot, because this possibly causes wrong alarm.
NOTE
● Place the RA and the LL electrode in the patient opposite angle of the body in order to obtain the best
breath wave. Should avoid the liver area and the ventricle at the breath electrode’s lines, this may avoid the
false difference to be caused by the heart beat or pulsing blood stream, this is especially important to the
neonate.
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12 Temp Monitoring
12.1 Temp Display
NOTE
● 7-inch and 10-inch have one channel temperature monitoring only.
12.2 Temp Setting
1. Rotate the knob to select “Temp Setting” in “Setting” menu.
2. Press the knob to enter the window of “Temp Setting”.
->
Temp Setting
Unit
℃, ℉
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12.3 Temp Sensor Type
1. Rotate the knob to select “Temp Sensor Type” in “Service” menu.
2. Press the knob to enter the window of “Temp Sensor Type”. Select the temperature sensor type from the list of
“Sensor Type” and confirm by “Ok”.
->
Temp Sensor Type
Sensor Type
2.25K, 10K
12.4 Measurement Procedure
1. Select an appropriate probe for your patient.
2. Plug the temperature cable to the temperature connector of the monitor. (If a disposable probe is used, connect the
probe to the temperature cable. Then plug the temperature cable to the temperature connector of the monitor.)
3. Attach the probe to the patient correctly.
4. Power on the monitor.
5. Check that the temperature alarm settings are appropriate for your patient.
NOTE
● The battery and single-use temperature probe should be recycled or destroyed according to regular rules.
● The measurement range is 0 to 50℃, the maximum permissible errors is ±0.1℃ (not including the probe) and
±0.2℃ (including the probe).
● The minimum time to get an accurate data is 150 seconds.
WARNING
● Before start to use the temperature measuring, please examine whether the sensor cable is normal. Unplug the
temperature sensor cable from the socket, the screen will display the error message “Temp sensor off” and sends out
the sound alarm.
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13 CO2 Monitoring (optional)
13.1 CO2 Display
13.2 CO2 Setting
1. Rotate the knob to select “CO2 Setting” in “Setting” menu.
2. Press the knob to enter the window of “CO2 Setting”.
->
CO2 Setting
Work Mode
Run, Stanby
Apnea Time
Off, 10s, 15s, 20s, 25s, 30s, 35s, 40s
CO2 Wave Scale
30mmHg, 40mmHg, 50mmHg, 60mmHg, 70mmHg, 80mmHg, 90mmHg, 100mmHg,
110mmHg, 120mmHg, 130mmHg, 140mmHg, 150mmHg
Wave Speed
6.25mm/s, 12.5mm/s, 25mm/s
71
CO2 Unit
mmHg, kPa, %
O2 Compensation
0% ~ 100%
Balance
Air, N2O, Helium
Agent
0.0% ~ 20.0%
Temperature
0Celsius ~ 50Celsius
Baro Pressure
400mmHg ~ 850mmHg
CO2 Wave Mode
Line, Fill
13.3 CO2 Zero
1. Rotate the knob to select “CO2 Setting” in “Setting” menu.
2. Press the knob to enter the window of “CO2 Setting”.
3. Select “Zero” and press the knob to activate a CO2 zero procedure.
->
13.4 CO2 Calibration
1. Rotate the knob to select “User Setting” in “Service” menu.
2. Press the knob to enter the window of “User Setting”.
72
->
3. Select “CO2 Calibration”. Press the knob to activate a CO2 zero procedure or a CO2 calibration procedure.
13.5 Measurement Procedure
73
1. Plug the water trap into its receptacle before the measurement.
2. Set CO2 “Work Mode” to “Run” in the window of “CO2 Setting” in “Setting” menu.
a. Rotate the knob to select “CO2 Setting” in “Setting” menu.
b. Press the knob to enter the window of “CO2 Setting”. Select “Run” in the list of “Work Mode” and confirm by
“Ok”.
->
74
14 CSM Monitoring (optional)
14.1 CSM Display
The Cerebral State Index (CSI) has been designed to be used in the monitoring of the level of consciousness of a
person during the application of general anaesthesia or in intensive care. This is accomplished by registering the
electroencephalographic signal (EEG) by means of surface electrodes which is then analyzed by a digital process.
As a result of the applied calculation, an index “CSI” is obtained, which serves as guidance to the experts who use it
to determine the level of consciousness of the patient during surgery.
Cerebral State Index (CSI)
CSI
Clinical State
90-100
Awake
80-90
Drowsy
60-80
Light anaesthesia
75
40-60
Range consider as adequate for surgical anaesthesia
10-40
Deep anaesthesia, in most cases accompanied by BS (Burst Suppression)
0-10
Close to coma. BS greater than 75. When CSI is below 3, the EEG is practically is o-electric
WARNING
● Not to be used in the presence of flammable gases; explosion risk.
● When used with High Frequency(HF) surgery please note the positioning of the sensors. In order to reduce
the hazard of burns the sensors should not be located between the surgical site and the electro-surgical unit
return sensor.
● Pay attention if the monitor is connected to a patient connected to other equipment. The total of leakage
current may exceed the allowable limit and cause a possible hazard to the patient.
● The conductive parts of sensors and the connectors, including the neutral sensor, should not contact other
conductive parts including earth.
● The monitor will not accurate readings when used on patients with severe neurological disorders and
patients under 2 years of age.
● The use of pacemakers might cause either long periods of artifacts or elevated CSM values.
CAUTION
● The monitor should be used in conjuction with other patient monitoring parameters and clinical signs. This
will ensure the optimum balance of the anaesthesia/sedation administration.
● Do not use CSM monitor when cardiac defibrillator is used.
● Patient cable are not protected against defibrillation.
14.2 CSM Setting
1. Rotate the knob to select “CSM Setting” in “Setting” menu.
2. Press the knob to enter the window of “CSM Setting”.
->
76
CSM Setting
EEG Wave Size
±10uV, ±20uV, ±40uV, ±80uV, ±150uV, ±200uV,
Wave Speed
6.25mm/s, 12.5mm/s, 25mm/s
14.3 CSM Monitoring Procedure
14.3.1 Skin Preparation
TO insure low sensor impedance, cleanse skin using mild soap and water.
NOTE
● Alcohol is not recommended as skin cleanser; it leaves a film layer that may cause high sensor impedance. If
alcohol is used, ensure 30 seconds drying time.
14.3.2 Electrode Placement
The CSM Procedure Pack contains a skin preparation product and 3 neuro sensors.
NOTE
● The performance of the CSM is only guaranteed by the manufacturer when the CSM Procedure Pack is
used.
Dry-abrade the skin gently using the skin prep product or with a dry wash cloth or gauze, to remove the
non-conductive skin layer. See diagram below.
CAUTION
● Make sure no part of the sensor is in contact with any other conductive parts including earth/ground.
● If skin rash or other unusual symptoms develop, remove sensors from patient.
● Change sensors every 24 hours to check skin integrity.
Position the three sensors from your CSM Procedure Pack according to the diagram below:
77
The diagram above shows a left-side setup; right-side is also acceptable. Place sensor at the side furthest from the
surgical area.
The advanced signal processing of the monitor ensures that a deviation in the positioning of the sensors up to 2 cm
(0.78 in) has no significant influence on the index. However, it is recommended to place the sensors on an area of the
skull where only a few muscle fibers are present in order to achieve the best quality signal.
NOTE
● Once the sensors have been secured to the skin, attach the color-coded wires on the patient cable to the
appropriate sensor.
78
14.4 Device Description
14.4.1 Device Appearance
Overview
Keys
79
Key Description
80
14.4.2 Display and Modes
81
15 Maintenance
WARNING
● Failure on the part of the responsible hospital or institution employing the use of the monitoring equipment
to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health
hazard.
● The safety inspection or maintenance, which requires opening the monitor housing, must be performed by
trained and authorize personnel only.
● Otherwise, equipment failure and possible health hazard may be caused.
15.1 Inspection and Maintenance
Make sure the qualified service personnel have implemented a complete inspection before putting the monitor into
operation, after monitor servicing or system upgrading, or after the monitor has been used for 6-12 consecutive
months. This is to ensure the normal operation of the system.
Follow these guidelines when inspecting the equipment:
The environment and the power supply meet the specified requirements.
Inspect the keys, control knob, connectors and accessories for damage.
Inspect the power cords for fraying or other damage and check the insulation.
The grounding cables are correctly connected.
Only specified accessories like electrodes, sensors and probes are applied.
The monitor clock is correct.
The audible and visual alarms functions normally.
The recorder functions normally and the recorder paper meets the requirement. (optional)
Batteries are in good status and can operate normally.
The defibrillator synchronization function must be verified according to your hospital regulations, and be checked by
a qualified technician once every 3 months.
In case of any damage or exception, do not use the monitor. Contact the technician in your hospital or our Customer
Service immediately.
WARNING
● If the hospital or agency that is responding to using the monitor does not follow a satisfactory maintenance
schedule, the monitor may become invalid, and the human health may be endangered.
15.2 Cleaning
WARNING
● Turn off the power and disconnect the line power before cleaning the monitor or the sensor/probe.
82
● The Multi-Parameter Patient Monitor must be kept dust-free.
● It is recommended that you should clean the outside surface of the monitor enclosure and the display screen
regularly. Only use non-caustic detergents such as soap and water to clean the monitor enclosure.
CAUTION
● Pay special attention to avoid damaging monitor:
1. Avoid using ammonia-based or acetone-based cleaners such as acetone.
2. Most cleaning agents must be diluted before use. Dilute the cleaning agent as per the manufacturer's
direction.
3. Do not use the grinding material, such as steel wool etc.
4. Do not let the cleaning agent enter the monitor. Do not immerse any part of the system into liquid.
5. Do not leave the cleaning agents at any part of the equipment.
Except the solutions specified in the above Caution, you can use any of the solutions listed below as the cleaning
agent.
■
■
Diluted Ammonia Water
Diluted Sodium Hyoichlo (Bleaching agent).
NOTE
The diluted sodium hyoichlo from 500ppm (1:100 diluted bleaching agent) to 5000ppm (1:10 bleaching agents)
is very effective. The concentration of the diluted sodium hyocihlo depends on how many organisms (blood,
mucus) are left on the surface of the enclosure.
■
■
■
■
Diluted Formaldehyde 35% -- 37%
Hydrogen Peroxide 3%
Alcohol
Isopropanol
NOTE
You can use hospital-grade ethanol to clean DK-8000S monitor and its sensor/probe and leave it to dry
naturally or use clean cloth to dry it.
NOTE
Manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical
agents. Please contact infectious disease experts in your hospital for details.
15.3 Disinfection and Sterilization
Sterilization or disinfection may cause damage to the equipment. We recommend the sterilization and disinfection are
contained in the hospital’s servicing schedule only when necessary. The equipment should be cleaned prior to
sterilization and disinfection.
Recommended sterilization material: Alcohol based (Ethanol 70%, Isopropanol 70%), and aldehyde based.
83
CAUTION
● Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest possible concentration.
● Do not let liquid enter the monitor.
● Do not immerse any part of the monitor into liquid.
● Do not pour liquid onto the monitor during sterilization.
● Use a moistened cloth to wipe off any agent remained on the monitor.
● Do not use EtO gas or formaldehyde to disinfect the monitor.
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16 Accessories
WARNING
Use accessories specified in this chapter. Using other accessories may cause damage to the patient monitor or not
meet the claimed specifications.
The operating and storage conditions of the patient monitor should meet the specifications claimed by respective
accessories. For environmental specifications of each accessory, refer to instructions for use of respective accessories.
Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the
measurement accuracy.
Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.
Type
Model
NIBP Cuff
Y000T1
ECG cable
3 meter
SpO2 Sensor
S0044B-S
Temp Sensor
W0001A
Supplier
Mayhap (Suzhou)Co.,Ltd.
Masimo SpO2 Accessories
6Pin SpO2 Cable
LNCS NeoPt Neonatal SpO2 Adhesive Disposable Sensor
LNCS Neo Neonatal SpO2 Adhesive Disposable Sensor
LNCS Inf Infant SpO2 Adhesive Disposable Sensor
LNCS Pdt Pediatric SpO2 Adhesive Disposable Sensor
LNCS Adt Adult SpO2 Adhesive Disposable Sensor
LNCS DC-I Pediatric Resuable Sensor
85
17 Appendix A - Safety
17.1 Safety Information
WARNING
CAUTION
NOTE
Points to be noted to avoid injury to the patient and the operator.
Points to be noted to avoid damage to the equipment.
Points to be noted to avoid injury to the patient and the operator.
WARNING
● Do not rely only on audible alarm system to monitor patient. When monitoring adjusting the volume to very
low or completely muting the sound may result in the disaster to the patient. The most reliable way of
monitoring the patient is at the same time of using monitoring equipment correctly, manual monitoring should
be carried out.
● This multi-parameter patient monitor is intended for use only by medical professionals in health care
institutions.
● To avoid electrical shock, you shall not open any cover by yourself. Service must be carried out by qualified
personnel.
● Use of this device may affect ultrasonic imaging system in the presence of the interfering signal on the screen
of ultrasonic imaging system. Keep the distance between the monitor and the ultrasonic imaging system as far
as possible.
● It is dangerous to expose electrical contact or applicant coupler to normal saline, other liquid or conductive
adhesive. Electrical contact and coupler such as cable connector, power supply and parameter module
socket-inlet and frame must be kept clean and dry. Once being polluted by liquid, they must be thoroughly
dried. If to further remove the pollution, please contact your biomedical department or Factory.
WARNING
● Monitor can only monitoring one patient at a time.
WARNING
● There could be hazard of electrical shock by opening the monitor casing. All servicing and future upgrading
to this equipment must be carried out by personnel trained and authorized by Factory.
WARNING
● You must verify if the device and accessories can function safely and normally before use.
WARNING
● Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substance in
combination with air, oxygen-enriched environments, or nitrous oxide.
WARNING
86
● You must customize the alarm setups according to individual patient situation and make sure that alarm
sound can be activated when alarm occurs.
WARNING
● Do not touch the patient, table, or the device during defibrillation.
WARNING
● Do not use cellular phone in the vicinity of this device. High level electromagnetic radiation emitted from
such devices may greatly affect the monitor performance.
WARNING
● Devices connected to the monitor shall form an equipotential system (protectively earthed).
● Connect the grounding wire to the equipotential grounding terminal on the main system. If it is not evident
from the instrument specifications whether a particular instrument ombination is hazardous or not, for
example due to summation of leakage currents, the user should consult the manufacturers concerned or else
an expert in the field, to ensure that the necessary safety of all instruments concerned will not be impaired by
the proposed combination.
WARNING
● When used with Electro-surgery equipment, you (doctor or nurse) must give top priority to the patient
safety.
WARNING
● Do not place the monitor or external power supply in any position that might cause it to fall on the patient.
Do not lift the monitor by the power supply cord or patient cable, use only the handle on the monitor.
WARNING
● Consult IEC-601-1-1 for system interconnection guidance. The specific requirements for system
interconnection are dependent upon the device connected to the monitor and the relative locations of each
device from the patient, and the relative location of the connected device to the medically used room
containing the monitor. In all circumstance the monitor must be connected to a grounded AC power supply.
The monitor is referred to as an IEC 601/F device in the summary of situations table contained in IEC 601-1-1.
WARNING
● Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of
children’s reach.
WARNING
● Grounding:
Connect the monitor only to a three-wire, grounded, hospital-grade receptacle. The three-conductor plug must
be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified
electrician must install one in accordance with the governing electrical code.
Do not under any circumstances remove the grounding conductor from the power plug.
Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged.
If there is any doubt about the integrity of the protective earth conductor arrangement, operate the monitor
on internal battery power until the AC power supply protective conductor is fully functional.
87
WARNING
● For continued safe use of this equipment, it is necessary that the listed instructions be followed. However,
instructions listed in this manual in no way supersede established medical practices concerning patient care.
WARNING
● It is important for the hospital or organization that employs this equipment to carry out a reasonable
maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.
CAUTION
● If you have any doubt to the grounding layout and its performance, you must use the built-in battery to
power the monitor.
17.2 Equipment Symbols
NOTE
Some symbols may not appear on your equipment.
Power On/Off key
Power On/Off (key)
Battery indicator
Battery indicator
External power indicator
SILENCE alarm key
FREEZE waveforms key
NIBP start/stop key
RECORD key
MENU main screen Key
This symbol indicates that the instrument is IEC 60601-1 Type BF equipment.
TYPE BF applied part. Defibrillator-proof protection against electrical shock.
Connector has special protection against electric shocks and is defibrillator proof.
External power connector
88
Network connector
USB connector
Equipotential grounding
Video output connector
Refer to accompanying documents
The product bears CE mark indicating its conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of
Annex I of this directive.
17.3 Patient Safety
The Patient Monitor is designed to comply with the International National Safety requirements for medical electrical
equipment, IEC60601-1, EN60601-2-27 and EN60601-2-30. This device has floating inputs and is protected against
the effects of defibrillation and electrosurgery. If the correct electrodes are used and applied in accordance with the
manufacturer instructions (see Chapter ECG/RESP Monitoring), the system can restore screen display within 10
seconds after defibrillation.
This symbol indicates that the instrument is IEC60601-1 Type CF equipment. The unit displaying this symbol
contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is
suitable for use during defibrillation.
WARNING
● Do not come into contact with patients, bed or the monitor during defibrillation.
Environment
Follow the instructions below to ensure complete and safe electrical installation. The environment where the
PM-5000 Multi-Parameter Patient Monitor will be used should be reasonably free from vibration, dust, corrosive or
explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation, allow sufficient
room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open.
The Patient Monitor operates within specifications at ambient temperatures between 0℃ and 40℃. Ambient
temperatures that exceed these limits may affect the accuracy of the instrument and cause damage to the modules and
circuits. Allow at least 2 inches (5cm) clearance around the instrument for proper air circulation.
Power Requirements
See Chapter 14 Appendix - Specifications.
Grounding
89
To protect the patient and hospital personnel, the enclosure of the Patient Monitor must be grounded. Accordingly,
the Patient Monitor is equipped with a detachable 3-wire cable which grounds the instrument to the power line
ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not available,
consult the hospital electrician.
WARNING
● Do not use a 3-wire to 2-wire adapter with this instrument.
The ground equipment and other potential associated to the ground terminal. From the instrument specifications
confused whether a particular combination of dangerous equipment, such as leakage current caused by the
accumulation of dangerous, the user should consult the manufacturers or other experts in this field to ensure that all
instruments which necessary security will not be damaged by the proposed combination.
Equipotent grounding
When other devices used in conjunction with the monitor, you should also use the wire to the rear panel monitors and
other potential ground terminal and other equipment such as potential ground terminal connected to different
equipment to eliminate potential difference between the grounds and ensure safety.
Condensation
In the work, to ensure no condensation apparatus, when the equipment from one room to another room to go, it may
form a condensation. This is because the equipment exposed to humid air and the temperature difference among the
reasons.
WARNING
● If there are places where flammable anesthetics used, there will be a risk of explosion.
90
18 Appendix B - EMC
The monitor meets the requirements of IEC 60601-1-2:2001
Caution
The use of unapproved accessories may diminish the monitor performance.
Note
The monitor should not be used adjacent to or stacked with other equipment. If adjacent or tacked use is
necessary, the monitor should be observed to verify normal operation in the configuration in which it will be
used.
Note
The monitor needs special precautions regarding EMC and needs to be installed and put into service according to
the EMC information provided below.
Note
Portable and mobile RF communications equipment can affect this monitor. See tables 1,2,3, and 4 below.
TABLE 1
Guidance and declaration — electromagnetic emissions
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.
Emissions test
Compliance
Electromagnetic environment — guidance
RF emissions
CISPR 11
Group1
The monitor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Harmonic
Emissions
IEC61000-3-2
Class B
The monitor is suitable for use in all establishments
other than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes
Voltage
Fluctuations/
Flicker
Emissions IEC
61000-3-3
Compliance
TABLE 2
91
Guidance and 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.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment —
guidance
Electrostatic
Discharge(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
Transient/burst
IEC 61000-4-4
±2 kV for power
supply lines ±1
kV for
input/output lines
(>3m).
±2 kV for power
supply lines ±1
kV for
input/output lines
(>3m).
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC
61000-4-5
±1 kV differential
mode ±2 kV
common mode
±1 kV different
mode ±2 kV
common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
Short
interruptions and
voltage variation
on power supply
input lines IEC
61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycle
40% UT
(60% dip in UT)
for 5 cycle
70% UT
(30% dip in UT)
for 25 cycle
70% UT
(30% dip in UT)
for 25 cycle
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of our
product requires continued
operation during power mains
interruptions, it is recommended
that our product be powered from
an uninterruptible power supply or
a battery.
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 5 sec
3 A/m
3 A/m
Power frequency
(50/60 HZ)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
UT is the A.C. mains voltage prior to application of the test level.
TABLE 3
Guidance and 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
Immunity
test
IEC 60601
Test level
Compliance
level
Electromagnetic environment — guidance
92
Conduced RF
IEC
61000-4-6
3 Vrms 150kHz
to 80MHz
3 Vrms
Portable and mobile RF communications
equipment should be used no closer to any
part of the monitor, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2 x P
d = 1.2 x P 80 MHz to 800 MHz
d = 2.3 x P 800 MHz to 2.5GHz
Radiated RF
IEC
61000-4-3
3 V/m 80MHz
to 2.5 GHz
3V/m
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 meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range b Interference may occur
in the vicinity of equipment marked with the
following symbol:
Note — At 80 MHz and 800 MHz, the higher frequency range applies.
Note — These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
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 strength in the location in which the monitor is used exceeds the
applicable RF compliance level above, the monitor should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the monitor.
Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.
TABLE 4
Recommended separation distances between portable and mobile RF
communication and the monitor
The monitor is intended for use in an electromagnetic environment in which radiated RF
disturbance 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 communication equipment (transmitters) and the monitor as recommended below, according
to the maximum output power of the communication equipment.
93
Separation Distance According to Frequency of Transmitter
M (Meters)
Rated Maximum
Output power of
Transmitter W
(Watts)
150kHz -2MHz
80MHz -800MHz
800MHz -2.5GHz
d  1 .2 P
d  1 .2 P
d  2 .3 P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.34
10
3.69
3.69
7.38
100
11.67
11.67
23.34
For transmitters at a maximum output power not listed above, the recommended separation
distanced in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note — At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note — These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
94
19 Appendix C - Product Specifications
WARNING
The patient monitor may not meet its performance specification if stored or used outside the manufacturer’s specified
temperature and humidity range.
19.1 Safety Classifications
Item
Specification
MDD classification
Class IIb
Anti-electroshock degree
Class I equipment with internal power supply
Anti-electroshock degree
TEMP/SpO2/NIBP: BF
ECG/RESP: CF
Explosion proof level
Ordinary equipment,without explosion proof
Harmful liquid proof degree
IPX1
Working system
Continuous running equipment
Equipment type
Portable
19.2 Applicable Standards
Medical Device Directive 93/42/EEC
EN60601-1:2005 or IEC60601-1:2005, Medical Electrical Equipment, Part 1: General Requirements for Safety
EN60601-1-1 or IEC60601-1-1, Medical Electrical Equipment, Part 1-1: General Requirements for Safety, Collateral
Standard: Safety Requirements for Medical Electrical Systems
IEC60601-1-4, Medical Electrical Equipment, Part 1-4: General Requirements for Safety, Collateral Standard:
Programmable Electrical Medical Systems
IEC60601-2-49, Medical Electrical Equipment, Part 2-49: Particular Requirements for the Safety of Multifunction
Patient Monitoring Equipment
IEC 60601-1-2:2007, Electromagnetic Compatibility, Medical Electrical Equipment
19.3 Environment
Temperature
Working
0 ~ 40 ℃
Storage
-20 ~ 50 ℃
Humidity
Working
15 % ~ 90 %
Storage
15 % ~ 90 % (no coagulation)
Atmospheric pressure
Working
86.0 kPa ~ 106.0kPa;
Storage
86.0 kPa ~ 106.0kPa
95
19.4 Size and Weight
Model
Color TFT LCD
Size
Weight
12.1-inch
12.1-inch, 800×600 pixels
306×287×172 mm
3.4Kg
19.5 Power Supply
Model
External power required
Input power
Fuse
12.1-inch
AC 100V~240V, 50Hz/60Hz
Pmax=90VA
T 1.5A, 250V
19.6 Battery
Model
Battery capacity
Battery operating time
12.1-inch
2200 mAh 14.8V rechargeable lithium battery
3.5 hours
NOTE
● Operating time after the first alarm of low battery will be about 5 minutes.
● Maximum charging time is less than 6 hours.
19.7 Data Storage
Trend graph and table
720 hours
Alarm review
200 events
NIBP review
1000 groups
Wave review
2 hours
NOTE
● All storage data are Non-Volatile.
19.8 Signal Output Specifications
Network connector
Standard RJ45 connector
96
19.9 Wireless Network (optional)
Standards
IEEE 802.11g, Wi-Fi compatible
19.10 Recorder Specifications (optional)
Paper width
Speed
Wave channel
48 mm
25/50 mm/s
3 channels
NOTE
No recorder for DK-8000M, available for other models
19.11 ECG Specifications
Heart rate calculation method
The average of the last 4 R-to-R intervals, when last 3 R-to-R intervals > 1200msec. Otherwise, the average of the
last 12 R-to-R intervals, minus the maximum and minimum values. The update rate of the Heart Rate on the display
is once per second.
Heart rate meter accuracy and arrhythmia response
After 20s stable time, the monitor will display
a): heart rate display 40bpm ± 5bpm;
b): heart rate display 30bpm ±5bpm;
c): heart rate display 120bpm±5bpm;
d): heart rate display 45bpm±5bpm.
a) Couplet rhythm — two waves of duration is 1500ms; if calculate all the QRS complex, heart rate is 80bpm, if only
calculate large R wave or S-wave, the heart rate is 40bpm.
b) Slow change couple rhythm — if calculate all the QRS complex, heart rate is 60bpm, if only calculate large waves,
heart rate is 30bpm.
97
c) Fast couple rhythm — if the calculate all the QRS complex, heart rate is 120bpm.
d) bi-directional contraction — if calculate all the QRS complex, heart rate is 90bpm, if only large waves, heart rate is
45bpm.
Lead mode
5 Leads: RA、LA、LL、RL、V; Lead mode: I, II, III, AVR, AVL, AVF, V
Gain
×2.5mm/mV, ×5.0mm/mV, ×10mm/mV, ×20mm/mV
Sweep speed
12.5mm/s, 25mm/s, 50mm/s
Heart rate
Measure range
Adult
15 ~ 300 bpm
Neonatal/Pediatric 15 ~ 350 bpm
Accuracy
±1%
Resolution
1 bpm
Sensitivity
> 200 μV P-P
Differential Input Impedance
> 5 M ohm
Bandwidth
Surgery
1 ~ 20 Hz
98
Monitor
Diagnostic
0.5 ~ 40 Hz
0.05 ~ 130 Hz
CMRR
Diagnostic Mode
Monitor Mode
Surgery Mode
>90 dB
>110 dB
>110 dB
Electrode offset potential
300mV
Input dynamic range
The device shall be capable of responding to and displaying differential voltages of ±5 mV varying at a rate up to 320
mV/s from a dc offset voltage in the range of .300 mV to +300 mV, when applied to any lead. The time-varying
output signal amplitude shall not change by more than ±10 percent over the specified range of dc offset.
Pace pulse suppression
When the pace switch is “On”, the patient monitor can inhibit pace pulse without affect heart rate calculation: ± 2 mV
~ ± 700mV, width: 0.1ms ~ 2ms, rise time: 10us ~ 100μs normal QRS wave single pulse without overshoot pacing
pulse.
When the pace switch is “On”, the patient monitor can inhibit pace pulse without affect heart rate calculation: ± 2 mV
~ ± 5mV, width: 0.5ms ~ 2ms, rise time: 10us ~ 100μs single pulse overshoot normal QRS waves of pacing pulses.
Overshoot (a0) range should 0.025ap to 0.25ap range, independent of the choice of time constant, but not more than
2mV;
When the pace switch is “On”, pace pulse inhibition of rapid ECG signal to 1V / s RTI minimum input slew rate.
QRS wave amplitude and period range between
The minimum range of QRS amplitude (ar + as) is 0.5 mV to 5 mV, and the duration of the QRS wave is between 70
ms and 120 ms (40 ms and 120 ms for neonatal/pediatric monitors). For monitors set for adult patients, the heart rate
meter shall not respond to signals having a QRS amplitude of 0.15 mV or less, or a duration of 10 ms or less with an
amplitude of 1 mV. Response to either or both of these types of signals is permitted in monitors set for
neonatal/pediatric patients.
Line frequency voltage tolerance
The maximum line frequency peak-to-valley sinusoidal voltage amplitude that can be superimposed on a train of
QRS signals without exceeding the error limits of ±10% for indicated heart rate accuracy shall be no less than 100 µV
p-v. The QRS signal shall have an amplitude of 0.5 mV, a duration of 100 ms, and a repetition rate of 80 bpm.
Drift tolerance
The monitor shall indicate the heart rate within the error limits of 80bpm ± 8bpm when a 0.1 Hz triangular wave of 4
mV p-v amplitude is superimposed on a train of QRS signals of 0.5 mV amplitude, 100 ms duration, and 80 bpm
repetition rate.
Baseline stability
Reset: reset recovery time is not greater than the 3s;
Baseline Stability: After boot, 10s baseline drift in the output rate should not exceed 10μV / s RTI; After boot, 1h,
total drift should not exceed 500μV / s RTI;
Working temperature should not exceed 50μV / ℃
99
System noise
No more than 30μV (p-v RTI)
Multi-channel crosstalk
Any input signal limited in amplitude and rate of change as per 14.7.12, applied to any one lead of a multi-channel
monitor, and with all unused inputs connected to patient reference through a 51 kilohm resistor in parallel with a 47
nF capacitor, shall not produce an unwanted output greater than 5% of the applied signals (multiplied by the gain) in
those channels where no signal is applied.
Electro surgery interference suppression
The heart rate shall not change by more than ±10 percent of the rate before electrosurgical interference was activated
while the interference is applied for less than 10s.
Pace pulse display capabilities
An indication of the pacemaker pulse shall be visible on the display with an amplitude of no less than 0.2 mV RTI.
Heart rate response time
The maximum response time is less than 10 s, for step change of heart rate from 80bpm to 120bpm;
The maximum response time is less than 10 s, for step change of heart rate from 80bpm to 40bpm;
Baseline Recovery
< 3 s After defibrillation.
Signal Range
±8 mV p-p
Calibration Signal
1 mV p-p, ±5% accuracy
19.12 SpO2 Specifications
Measurement Range
0 ~ 100 %
Resolution
1%
Accuracy
70% ~ 100% ±2 %
<69%
unspecified
Pulse Rate
Measure and Alarm Range
Resolution
Accuracy
20~250bpm
1bpm
±3bpm
100
19.13 Masimo SpO2 Specifications
SpO2
Measurement range
Resolution
Accuracy
Refreshing rate
Updated period
PR
Measurement range
Resolution
Accuracy
Refreshing rate
Updated period
Low Perfusion
Conditions
SpO2 accuracy
PR accuracy
1 to 100%
1%
70 to 100%: ±2% (measured without motion in adult/pediatric mode)
70 to 100%: ±3% (measured with motion in neonate mode)
70 to 100%: ±3% (measured with motion)
0% to 69%: Not specified.
1s
8 s, 16 s
25 to 240 bpm
1 bpm
±3 bpm (measured without motion)
±5 bpm (measured with motion)
1s
8 s, 16 s
Pulse amplitude: >0.02%
Light penetration: >5%
±2%
±3 bpm
19.14 NIBP Specifications
Method
Oscillometry
Measure mode
Manual, Auto, STAT
Measure Interval in AUTO Mode
1,2,3,4,5,10,15,30,60,90,120,180,240,480 min
Measure Period in STAT Mode
5 min
Pulse Rate Range
40 ~ 240 bpm
Measure and Alarm Range
101
Adult Mode
SYS
40 ~ 280 mmHg
DIA
10 ~ 220 mmHg
MEAN 20 ~ 240 mmHg
Pediatric Mode
SYS
40 ~ 220 mmHg
DIA
10 ~ 160 mmHg
MEAN 20 ~ 170 mmHg
Neonatal Mode
SYS
40 ~ 135 mmHg
DIA
10 ~ 100 mmHg
MEAN 20 ~ 110 mmHg
Static pressure accuracy
 3 mmHg
Resolution
1mmHg
Accuracy
Maximum Mean error
Maximum Standard deviation
5mmHg
8mmHg
Overpressure Protection
Adult
300 mmHg
Pediatric
240 mmHg
Neonatal
150 mmHg
19.15 Resp Specifications
Method
Impedance between RA-LL
Respiration Impedance Range
0.3~3Ω
Base Impedance Range
200Ω-4000Ω
Bandwidth
0.3 ~ 2.5 Hz
Gain
×0.25, ×0.50, ×1, ×2, ×4
Respiration Rate
102
Measurement Range
Adult
Neonatal / Pediatric
Resolution
Accuracy
0 ~ 120 BrPM
0 ~ 150 BrPM
1 BrPM
0~6 BrPM: unspecified
7~150 BrPM: ±2 BrPM
Apnea Alarm
10 ~ 40 s
19.16 Temp Specifications
Sensor Type
Channel
Measure and Alarm Range
Resolution
Accuracy(no sensor)
10K series,2.25K series
DK-8000M、DK-8000 and DK-8000N are one, others are two
0 ~ 50 ℃
0.1 ℃
± 0.1 ℃ (0℃ – 50℃)
19.17 CO₂ Specifications (optional)
Measurement Range
0% ~ 13%
Resolution
1 mmHg
Accuracy
2 mmHg @ < 5.0% CO₂ (at ATPS)
Breath Rate
Breath Rate
3 - 150 bpm, ±1 bpm
19.18 CSM Specifications (optional)
EEG sensitivity
CMRR
Input Impedance
CSI
±475 uV
> 100 dB
> 50 Mohm
0-100
103
ESR
EMG
0-100%
0-100
19.19 Default Settings
Patient Information
Patient Type
Bed number
Gender
Adult
1
Male
Alarm Setting
Alarm Volume
Flicker
Parameter Alarm
Alarm Record
Voice Alarm
Off
None bolt-lock
Off
On
Record Setting
Record Waveform 1
Record Waveform 1
Record Length
Inter-record Gap
Record Speed
Record Grid
ECG1
ECG2
8S
Off
25mm/s
On
ECG Setting
Pacemaker
Channel 1 Lead
Channel 1 Amplitude
Channel 2 Lead
Channel 2 Amplitude
Notch
Filter
Heartbeat Volume
Waveform Speed
HR Source
Off
II
X1
I
X1
On
Monitor
5
25mm/s
Auto
Resp Setting
Apnea Time
Waveform Size
Waveform Speed
40s
X2
6.25 mm/s
SpO2 Setting
Pulse Volume
Sensitivity
Waveform Speed
5
Medium
25mm/s
5
104
PR
Waveform Mode
Off
Line
NIBP Setting
Unit
Mode
Period
mmHg
Auto
10 minutes
Temp Setting
Unit
℃
Alarm Limits Setting
Parameters
HR High Alarm Limit
HR Low Alarm Limit
Resp High Alarm Limit
Resp Low Alarm Limit
SpO2 High Alarm Limit
SpO2 Low Alarm Limit
PR High Alarm Limit
PR Low Alarm Limit
Sys High Alarm Limit
Sys Low Alarm Limit
Mean High Alarm Limit
Mean Low Alarm Limit
Dia High Alarm Limit
Dia Low Alarm Limit
Temp High Alarm Limit
Temp Low Alarm Limit
Adult
120
50
30
8
100
90
20
50
160
90
110
60
90
50
39.0
36.0
Pediatric
160
75
30
8
100
90
160
75
120
70
90
50
70
40
39.0
36.0
Neonate
200
100
100
30
95
80
200
100
90
40
70
25
60
20
39.0
36.0
105
Unit
bpm
bpm
brpm
brpm
%
%
bpm
bpm
mmHg
mmHg
mmHg
mmHg
mmHg
mmHg
℃
℃
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