Manual Monitor Contec 6000 PDF
Manual Monitor Contec 6000 PDF
Manual Monitor Contec 6000 PDF
User manual
35151 / CMS8000
0123
M-35151-GB-Rev.1.03.19
Copyright
Statement
Our company owns all rights to this unpublished work and intends to maintain this work as confidential.
We may also seek to maintain this work as an unpublished copyright. This publication is to be used solely
for the purposes of reference, operation, maintenance, or repair of our equipment. No part of this can be
disseminated for other purposes.
In the event of inadvertent or deliberate publication, our company intends to enforce its rights to this work
under copyright laws as a published work. Those having access to this work may not copy, use, or disclose
the information in this work unless expressly authorized by us to do so.
All information contained in this publication is believed to be correct. Our company shall not be liable
for errors contained herein nor for incidental or consequential damages in connection with the furnishing,
performance, or use of this material. This publication may refer to information and protected by copyrights
or patents and does not convey any license under the patent rights of our company, nor the rights of others.
Our company does not assume any liability arising out of any infringements of patents or other rights of third
parties.
Content of this manual is subject to changes without prior notice.
• all installation, expansion, change, modification and repair of this equipment are conducted by our
qualified personnel; and,
• applied electrical appliance is in compliance with relevant National Standards; and,
• the monitor is operated under strict observance of this manual.
Note
This equipment is not intended for family usage.
Warning
This monitor is not a device for treatment purpose.
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.
Upon request, our company may provide, with compensation, necessary circuit diagrams, calibration illu-
stration list and other information to help qualified technician to maintain and repair some parts, which our
company may define as user serviceable.
Warranty
Workmanship & Materials
Our company’s guarantees new equipment other than accessories to be free from defects in workmanship
and materials for a period of 18 months (six months for multi-site probes and SpO2 sensor) from date of
shipment under normal use and service. Our company’s obligation under this warranty is limited to repairing,
at our company’s option, any part which upon our company’s examination proves defective.
this warranty is exclusive and is in lieu of all other warranties, expressed or implied, including warranties of
merchant ability or fitness for any particular purpose.
Exemptions
Our company’s obligation or liability under this warranty does not include any transportation or other charges
or liability for direct, indirect or consequential damages or delay resulting from the improper use or appli-
cation of the product or the substitution upon it of parts or accessories not approved by us or repaired by
anyone other than a our company authorized representative.
This warranty shall not extend to any instrument which has been subjected to misuse, negligence or acci-
dent; any instrument from which our company’s original serial number tag or product identification markings
have been altered or removed, or any product of any other manufacturer.
• the Monitor is not used in accordance with the instructions for use, or the electrical installation of the re-
levant room does not comply with NFPA 70: National Electric Code or NFPA 99: Standard for Health Care
Facilities (Outside the United States, the relevant room must comply with all electrical installation
regulations mandated by the local and regional bodies of government).
Preface
This manual gives detailed description to the Monitor concerning its performance, operation, and other
safety information. Reading through this manual is the first step for the user to get familiar with the
equipment and make the best out of it.
Following symbols indicates some important facts that you have to pay special attention to:
Warning Points to be noted to avoid injury to the patient and the operator.
This manual is intended for persons who are trained in the use of this field and have adequate experience in
operation of monitoring equipment.
4
Index
Chapter 1 Introduction................................................................................................................................ 6
1.1 General Information................................................................................................................... 7
1.2 Screen Display.......................................................................................................................... 8
1.3 Button Functions..................................................................................................................... 10
1.4 Interfaces................................................................................................................................ 11
1.5 Built-in Battery........................................................................................................................ 13
Chapter 2 Getting Started......................................................................................................................... 13
2.1 Open the Package and Check................................................................................................ 13
2.2 Connect the Power Cables..................................................................................................... 13
2.3 Power on the Monitor.............................................................................................................. 14
2.4 Connect Patient Sensors........................................................................................................ 14
2.5 Check the Recorder................................................................................................................ 14
Chapter 3 System Menu............................................................................................................................ 14
3.1 Patient Information Setup....................................................................................................... 15
3.2 Default Setup.......................................................................................................................... 15
3.3 Recall...................................................................................................................................... 16
3.4 System Setup.......................................................................................................................... 16
3.5 Monitor Version....................................................................................................................... 23
3.6 Drug Calculation...................................................................................................................... 23
3.7 Maintenance............................................................................................................................ 23
3.8 DEMO Function....................................................................................................................... 26
Chapter 4 Alarm......................................................................................................................................... 26
4.1 Alarm Modes........................................................................................................................... 26
4.2 Alarm Verification during Power On........................................................................................ 28
4.3 Alarm Cause............................................................................................................................ 28
4.4 SILENCE and PAUSE.............................................................................................................. 28
4.5 Parameter Alarm..................................................................................................................... 29
4.6 When an Alarm Occurs........................................................................................................... 29
Chapter 5 Freeze........................................................................................................................................ 29
5.1 General.................................................................................................................................... 29
5.2 Enter/Exit Freeze Status.......................................................................................................... 29
5.3 FREEZE Menu......................................................................................................................... 30
5.4 Reviewing Frozen Waveform .................................................................................................. 30
5.5 Recording Frozen Waveform................................................................................................... 30
Chapter 6 Recording.................................................................................................................................. 31
6.1 General Information on Recording.......................................................................................... 31
6.2 Recording Type....................................................................................................................... 31
6.3 Recording Startup.................................................................................................................. 33
6.4 Recorder Operations and Status Messages........................................................................... 33
Chapter 7 Recall......................................................................................................................................... 35
7.1 Trend Graph............................................................................................................................ 35
7.2 Trend Table.............................................................................................................................. 36
7.3 NIBP Recall............................................................................................................................. 37
7.4 Alarm Event Recall.................................................................................................................. 37
7.5 SD Operate ............................................................................................................................ 38
Chapter 8 Drug Calculation and Titration Table...................................................................................... 44
8.1 Drug Calculation...................................................................................................................... 44
8.2 Titration Table.......................................................................................................................... 45
Chapter 9 Patient Safety........................................................................................................................... 46
Chapter 10 Care / Cleaning....................................................................................................................... 48
10.1 System Check....................................................................................................................... 48
10.2 General Cleaning................................................................................................................... 48
10.3 Cleaning Agents.................................................................................................................... 49
10.4 Disinfection........................................................................................................................... 49
Chapter 11 ECG/RESP Monitoring........................................................................................................... 49
11.1 What is ECG Monitoring........................................................................................................ 49
11.2 Precautions during ECG Monitoring.................................................................................... 50
11.3 Monitoring Procedure........................................................................................................... 50
11.4 ECG Screen Hot Keys........................................................................................................... 53
11.5 ECG Menu............................................................................................................................. 54
5
Chapter 1
Introduction
• For an overall introduction to the monitor, please refer to General Information.
• For various messages displayed on the screen, please refer to Screen Display.
• For basic operating instructions, please refer to Button Function.
• For allocation of interface sockets, please refer to Interfaces.
• For important facts to be noted during the battery recharging procedure, please refer to Built-in Battery.
Warning
• The Monitor is intended for clinical monitoring application with operation only granted to appropriate
medical staff.
• The monitor can be used on only one patient at a time.
• 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 our company.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• 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.
• You must verify if the device and accessories can function safely and normally before use.
• You must customize the alarm setups according to individual patient situation and make sure that alarm
sound can be activated when alarm occurs.
• 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.
• Do not touch the patient, table, or the device during defibrillation.
• Devices connected to the monitor shall form an equipotential system (protectively earthed).
• When used with Electro-surgery equipment, you (doctor or nurse) must give top priority to the patient
safety.
• 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.
• Consult IEC60601-1-1 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 60601-1-1.
• Dispose of the packaging material, observing the applicable waste control regulations and keeping it out
of children’s reach.
• 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.
Note
• The software was developed per IEC62304. The possibility of hazards arising from errors in the software
program is minimized.
Caution
• The monitor’s service life is 5 years.At the end of its service life, the product described in this manual,
as well as its accessories, must be disposed of in compliance with the guidelines regulation the disposal
of such products. If you have questions concerning disposal of the product, please contact us or its
representatives.
• If you have any doubt to the grounding layout and its performance, you must use the built-in battery to
power the monitor.
7
General instruction:
The monitor has abundant monitoring functions and is used for the clinical monitoring of adult, pediatric and
neonate (SpO2 function is inapplicable on neonate in American). In addition, the user may select the different
parameter configuration according to different requirements.
The monitor can be connected to the central monitoring system via our network so as to form a network
monitoring system.
This machine can monitor vital signals as ECG, Respiratory Rate, SpO2, NIBP, and Dual-TEMP, Dual-
IBP,CO2. It integrates parameter measuring modules, display and recorder in one device, featuring in
compactness, lightweight and portability. Replaceable built-in battery facilitates transportation of patient.
Large high-resolution display provides clear view of 8 waveforms and full monitoring parameters.
The POWER switch is on the front panel. The POWER switch lights when the device is powered on.
The ALARM indicator is on the front panel. The ALARM indicator flashes or lights when alarm occurs.
The sockets of the sensors are at the left side. The recorder socket is at the right side. Other sockets
and power plug-in are at the rear panel.
This monitor is a user-friendly device with operations conducted by a few buttons and a rotary knob
on the front panel. Refer to 1.3 Button Functions for details.
The monitor provides extensive functions as visual & audible alarm, storage and report printout for trend
data, NIBP measurements, and alarm events, oxyCRG, ViewBed,and drug dose calculation function
is provided too.
8
2 3
Information Area
The Message Area is at the top and bottom part of the screen, displaying the current status of both the
monitor and the patient.
• flag for alarm PAUSE. Press “SILENCE” button once (less than 1 second) to mute all alarm sounds
and the flag appears at the same time. Press the button again to terminate the PAUSE status. The duration
for PAUSE status can be 1 minute, 2 minutes or 3 minutes.
• flag for alarm SILENCE. Press “SILENCE” button once (more than 1 second) to manually mute all
the sounds and this flag appears at the same time. The SILENCE status terminates when you discharge
the status or new alarm occurs.
• flag for Alarm Volume Off. It appears indicating that you have closed the alarm sound permanently.
This status terminates when you discharges the status.
Note
• If symbol appears, the system will no longer give audible alarm sound. You must be very careful
in using this function. Two ways can be used to discharge this status. One is to set the alarm volume to
an option other than OFF in the USER MAINTAIN menu. The other method is to press SILENCE button to
make the flag turn to . And then press SILENCE again and the system will restore the normal alarm
status.
• Parameter alarm information is displayed always in the upper right corner of the screen.
• When the waveforms on the screen are frozen, the FREEZE prompt will appear in the bottom part of the
screen.
9
All the waveforms in the system are listed out in the “WAVE SETUP” menu. The user may adjust their
displaying positions. The specific method is illustrated in the part: WAVE SETUP.
The name of the waveform is displayed on the upper left part of the waveform. The user may choose ECG
lead based on the requirements. The gain of the channel are also displayed on each ECG waveform. A 1mV
scale bar is also displayed to one side of ECG waveform. The IBP waveform scale can also be selected
according to the actual requirement. In the IBP waveform area, the waveform scale is displayed. The three
dotted lines for each IBP waveform form up to down represent respectively the upper limit scale, reference
scale and lower limit scale. The values of these three scales can be set. The specific method is given in the
part: Measure IBP.
When menu is wanted during screen operation, the menu always occupies the fixed position in the middle
part of the waveform area, therefore part of waveform can not be viewed temporarily. After exiting the menu,
the system will restore the original screen.
The user may set up the rate to refresh the waveform. The method to adjust the refreshing rate of each
waveform is discussed in the setup description of each parameter.
ECG
- Heart rate or pulse rate (unit: beats/minute)
- The ST analyzing result of channel 1 and 2: ST1, ST2 (unit: mV)
- PVCs (unit: times/minute)
NIBP
- From left to right, there are Systolic pressure, Mean pressure and Diastolic pressure (unit: mmHg or kPa)
SpO2
- SpO2 (unit: %)
- Pulse Rate (unit: beats/minute) (When “BOTH” item is selected)
IBP
- The blood pressure of channel 1 and 2. From left to right, there are Systolic pressure, Mean pressure and
Diastolic Pressure (unit: mmHg / kPa / cmH2O)
CO2
- EtCO2 (unit: mmHg or kPa)
- INS CO2 (unit: mmHg or kPa)
- AwRR (times/minute)
RESP
- Respiration Rate (unit: times/minute)
TEMP
- Temperature of channel 1 and 2: T1, T2 and the difference between them TD. (unit: °C or °F)
10
Warning
Always verify the self-check function of audible and visual (LED) alarms when powers on.
• MAIN
Whatever levels of menu the system is in, press the button and the system will always return to the main
screen.
• FREEZE
Press this button and the system will access the FREEZE status. In this status the user may review the
waveform of 34 seconds. Also, the frozen waveform can be printed out. In the FREEZE status, press this
button again to discharge the FREEZE status. For detailed information, refer to related chapter: Freeze.
• SILENCE
Push this button for less than 1 second to suspend alarm for maximum 3 minutes (with 1 minute, 2 minutes
and 3 minutes selectable). In Alarm PAUSE status, a symbol appears in the Message Area. Push this
button for more than 1 second to mute all kinds of sounds (including alarm sound, heart beat, pulse tone, key
sound). At the same time, a symbol appears in the Message Area. Push this button again to restore all
Note
• If new alarm occurs in Alarm Silence status, the system will discharge Pause/Silence status automatically.
For specific rules, see Chapter Alarm.
• The system will begin to give alarm information again once there exist alarm-triggering event. Nevertheless,
remember pushing SILENCE button can permanently shut off audible alarm sound of ECG LEAD OFF and
SpO2 SENSOR OFF alarms.
• START
Press to inflate the cuff to start a blood pressure measurement. When measuring, press to cancel the
measurement and deflate the cuff.
• REC/STOP
Press to start a real time recording. The recording time is set in RECORD SETUP. Press during recording to
stop the recording. For detailed information, refer to related chapter.
• MENU
Press this button to call up the SYSTEM MENU, in which the user may set up system information and perform
review operation. For detailed information, refer to related chapter: System Menu and related chapter: Trend
and Event.
• Rotary knob
The user may use the rotary knob to select the menu item and modify the setup. It can be rotated clockwise
or counter-clockwise and pressed like other buttons. The user may use the knob to realize the operations
on the screen and in the system menu and parameter menu.
When the cursor is in the waveform area, the user may immediately modify the current setup. When the cursor
is in the parameter area, the user may open the setup menu of the corresponding parameter module so as to
set up the menu items of the module.
Operating method:
• Move the cursor to the item where the operation is wanted
• Press the knob
• One of the following four situations may appear:
1. The cursor with yellow frame becomes into the one with cyan frame, which implies that the content in the
frame can change with the rotation of the knob.
2. Menu or measuring window may appear on the screen, or the original menu is replaced by the new menu.
3. A check mark “√” appears at the position, indicating that the item is confirmed.
4. The system immediately executes a certain function.
1.4 Interfaces
For the convenience of operation, the different kinds of interfaces are in different parts of the monitor.
• Front view
1 5
1 Recorder
12
4
1
5
6
2
3 7
Indicates that the instrument is IEC 60601-1 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.
• Rear view
4
2
3 5
1 Network Interfaces, Standard RJ45 Socket, connecting with other beds or central monitoring system
through standard network cable
2 USB, used for program upgrading, SD card data storage, connecting with central monitoring system by
wireless mode
3 Equipotential grounding terminal for connection with the hospital’s grounding system
4 Fuse T1.6AL250V
5 Power Supply,100-240V~ 50/60Hz
13
Warning
Through network interface only our company’s Central Monitoring System can be connected in.
Warning
• Don’t pull off battery during monitoring.
• Remove the battery if the ME EQUIPMENT is not likely to be used for long time.
• The battery shall be only applied on this device. Any maintenance or replacement upon the battery should
be processed by the service personnel trained and authorized by our company.
• When operating on battery, the monitor will prompt alarm and shut off automatically when the energy
is low. When the electric energy is going out, the monitor will sound continuous level 1 alarm beeping
and display “BATTERY LOW” in the Message Area. Connect the monitor to AC power at this moment
can recharge the battery while operating. If keep operating on the battery, the monitor will shut off
automatically (about 5 minutes since alarming) upon exhaustion of the battery.
Chapter 2
Getting Started
• Open the package and check
• Connect the power cables
• Power on the monitor
• Connect patient sensors
• Check the recorder
Note
To ensure that the monitor works properly, please read Chapter Patient Safety, and follow the steps before
using the monitor.
Note
• Connect the power line to the jack special for hospital usage.
• Connect to the ground line if necessary. Refer to Chapter Patient Safety for details.
• Make sure that the POWER lamp now lights. If it does not light, check your local power supply.
If the problem still exists, contact the local Customer Service Center.
14
• If the power supply is not properly connected before turning on the monitor, it may not work properly
because of insufficient power. Connect the power supply to charge the battery.
Note
• If the monitor finds any fatal error during self-test, it will alarm.
• Check all the functions that may be used to monitor and make sure that the monitor is in good status.
• When the supply mains is interrupted ,the monitor will work with battery.
• The battery must be recharged to the full electricity after each use to ensure adequate electricity reserve.
• The interval between twice press of POWER should be more than 1 minute.
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 our Customer Service Center immediately.
Note
For information on correct connection, refer to related chapter 11-16.
Chapter 3
System Menu
This monitor features flexible configurations. You can customize monitoring content, waveform sweep
speed, sound volume, and output content.
Press the MENU button on the front panel of the monitor to call up the “SYSTEM MENU”. You can perform
following operations in this menu.
Trend graph/table review, NIBP review and alarm review are discussed in Chapter 7 Recall.
15
Pick [YES] to initialize the previous menu and exit the menu.
Pick [NO] to give up updating the patient and the system will keep the information of the currently patient
and exit the menu.
In this sub-menu, you can select both the factory default and the user-defined default. Also in this sub-menu,
you can save the current system configuration as the user-defined default configuration. But at this time, the
system will automatically save all the setups in the parameter menu, ECG gain and filter way as the user-
defined default configuration according to the patient type. Also, the dialog box as shown below will pop up.
Note
After selecting any item in the DEFAULT menu and exiting the box, the “CONFIRM TO SAVE” Dialog box will
pop up, in which you can select [YES] to confirm your selection or [NO] to give up your selection.
Warning
All configurations in the system will be replaced by “default configurations”.
3.3 Recall
In the “SYSTEM MENU”, there are [TREND GRAPH], [TREND TABLE], [NIBP RECALL] and [ALARM RECALL]
items. Please refer to Chapter 7 Recall for detailed information.
1.STANDARD SCREEN
The standard screen is the default screen. If the current screen is not the standard screen, you may enter the
standard screen by selecting STANDARD SCREEN and then selecting EXIT in FACE SELECT menu.
2.OxyCRG SCREEN
OxyCRG screen is located at the lower part of the waveform area, consisting of the HR trend, the SpO2
trend, and the RR (respiration rate) trend or the compressed respiration waveform. Below the RR trend
or the compressed respiration waveform is the scale of the trend time. In addition, three labels are displayed
beneath the time scale. The labels are detailed as below.
1. Trend length
This label allows you to select the time duration of the trend graphs displayed. You can select either
1 MIN, 2 MIN or 4 MIN.
2. Compressed respiration waveform/RR trend
With this label, you can select to display the compressed respiration waveform or the RR trend beneath
the SpO2 trend.
3. Recording
You can select the REC label to print out the the trends or the waveform displayed in the oxyCRG screen
using the recorder.
18
3.TREND SCREEN
• Trend graph
Trend graphs locate to the right of the corresponding waveforms in the waveform area, and display
the trends of one parameter of each module. The parameter labels,as well as their scales, are displayed
to the left of the trend graph.
• Trend length
The trend length, located below the trend graph, is 2 hours.
• Selecting a trend parameter
If a module has multiple trend parameters, you can select one from the parameter label options of
the corresponding trend graph. The trend graph of the selected parameter will be displayed. For example,
in the ECG trend graph, you can select either from the parameter lable options: HR, ST and PVCs.
4.BIG CHAR
It can make you view parameter
values more clear in a long
distance.
5.VIEWBED SCREEN
This monitor can view one parameter waveform and measured data from another patient monitor (viewbed
monitor) on the same monitoring network. To enter the following screen, open FACE SELECT menu, select
VIEWBED SCREEN, and then select EXIT.
The monitor you are viewing from is called “host monitor”. The monitor being viewed is called “viewbed
monitor”. The viewbed screen is always displayed at the lower part of the host monitor’s waveform area.
It consists of the following parts.
1. Viewbed monitor label
The viewbed monitor lable allows you to select the viewbed monitor you want to view. It displays the bed
number of the viewbed monitor. If the host monitor is not connected with any other monitor on the same
network, the label displays N/A.
2. Viewbed parameter area
All parameter data of the viewbed monitor is displayed in this area.
3. Viewbed waveform label
The viewbed waveform label allows you to select a waveform of the viewbed monitor. If the viewbed
monitor does not dispaly any waveform, this label displays N/A.
4. Viewbed waveform area
The viewbed waveform area is located beneath the viewbed waveform label. It displays the waveform
selected through the viewbed waveform label. Information relating to the viewbed waveform is shown above
the waveform.
You can choose the parameters to be monitored in this menu. This can avoid the interference from the
parameters that need not attention. This function can be select only when you have ordered the
corresponding optional module.
Note
You shall set up the system time upon turning on the monitor (if you need to set up the system time);
otherwise, when you review the content with time information, the system may not display the correct time.
You can highlight the [ALARM VOL] item and then turn the knob to set up the alarm volume. There are 7
options:1~7.
22
In this menu, the user can set up to output two waveforms. The waveforms that can be selected include:
ECG1-ECG2 Two ECG waveforms on the screen (If no ECG waveform is currently displayed on the screen,
this item cannot be picked).
SpO2 SpO2 Plethysmogram.(If no SpO2 waveform is currently displayed on the screen, this item
cannot be picked).
RESP RESP waveform (If no RESP waveform is currently displayed on the screen, this item cannot
be picked).
CO2 Displayed waveform either of anesthetic or gas or generated by CO2 module.
IBP1 The first IBP waveform on the screen.(If no IBP waveform is currently displayed on the
screen, this item cannont be picked)
IBP2 The second IBP waveform on the screen(If less than two IBP waveforms)
OFF No display for this waveform.
• RT REC TIME this item has two options, CONTINUAL and 8s. “CONTINUAL” means once pushing the
“REC/STOP” button on the recorder panel or the monitor panel, the recorder will continuously print out the
waveform or parameter until this button is pushed again.
• TIMING REC TIME OFF used to set up the time interval between two recordings. 10 selections are availa-
ble: “OFF, 10min, 20min, 30min, 40min, 50min, 1hour, 2hours, 3hours and 4hours”. The system will start
the recording process according to the selected time interval. The recording time is always 8 seconds.
Note
• RT REC takes priority over TIMING REC.
• REC RATE: this item has two options, 25.0 and 50.0 mm/s.
• REC GRID: used to decide output format: OFF is without grid, and ON is with grid.
• CLEAR REC TASK: used to clear the alarm event that has been generated and is waiting for recording out.
• If two same waveforms are selected, the system will automatically change one of the waveform to a
different one.
How to mark the event: Use the rotary knob to select one from event A, B, C and D. The @ symbol will
appear in the frame of the event being selected. Once making a wrong selection, you can push the knob
on the event again to give up the selection. Select [EXIT] to exit the menu and consequently the selection
will come into effect.
Event function has following significance:
To classify the records into different categories, such as those having influence on patients and those having
influence on parameter monitoring including dose taking, injection, therapy status. Event will be displayed on
the trend graph/table in order to assist the analysis on the patient parameters when the event happens.
3.4.10 SD OPERATE
Please refer to chapter 7 Recall.
3.7 Maintenance
Select the [MAINTAIN] item in the “SYSTEM MENU” to call up the “SYSTEM MAINTAIN” dialog box as
shown below, in which you can enter password and then customize maintenance settings. You cannot
execute factory maintenance function, which is only available for the service engineers of our company.
Input the password into the “SYSTEM MAINTAIN” box and press [CONFIRM], the “USER MAINTAIN” menu
will pop up, in which you can set up following items.
24
Warning
• When the alarm volume is set to “OFF”, you will not hear the alarm sound if new alarm occurs.
Therefore, you must be very careful in using this selection.
• If setting the alarm volume to “OFF” when the system is in Silence or Pause status, the system will
automatically discharge Silence or Pause status.
• If you select “Silence” or “Pause” when the alarm volume is set to “OFF”, the system will restore the alarm
volume before the alarm volume is set to “OFF” and enter Silence or Pause status.
Note
• After the alarm volume is set to OFF, a symbol will appear in the Technical Alarm Area.
• Setting Alarm Volume to “OFF” is valid only when the monitor is turned on for this time. After turning on the
monitor next time, this setup will restore its value of the previous time when the system is turned on.
• NET TYPE:CMS/CUSTOM
CMS: the Server IP is fixed, “202.114.4.119”, “LOCAL IP CONFIG” is unavailable.
CUSTOM: when this item is selected, CMS and machine’s IP can be changed as you need.The following is
“LOCAL IP SETUP” menu.
25
Select corresponding router for connecting according to actual requirement, and then press “CONNECT”.
If connecting with safe router,enter correct password, the equipment will link to network automatically.
Wire
Wire network mode links to wire LAN complied with IEEE802.3 by RJ45 mode.LAN links to Internet by WAN.
• LOCAL NET NO:the physical Bed No.
• SERVER IP:when net type is CUSTOM ,you can change Central Monitoring System’s IP.
• LOCAL IP CONFIG:only when the net type is “CUSTOM”this item is available.You can set the current
machine’s IP.Press this button to pop out “LOCAL IP SETUP”menu.
• SELECT ROUTE:press this item to pop “WIRELESS CONFIG”menu.
26
Chapter 4
Alarm
This chapter gives general information about the alarm and corresponding remedies.
Alarm setup and prompt messages are provided in respective parameter setup sections.
Warning
• When the monitor is powered on, the system may verify the audio and visual alarm function.
• Upon turning on the monitor, a “Do” will be heard and at the same time the indicator will flash once in
orange. This is used to verify the audio and visual alarm function of the system. Therefore, the user should
be carefully observe the status. If the audio and visual alarm function is not normal, it indicates that the
monitor cannot be used to monitor a patient. Please contact our company or service center.
High-level alarm indicates the patient’s life is in danger or the monitor under using has serious problem in
technical respect. It is the most serious alarm.
Medium-level alarm means serious warning.
Low-level alarm is a general warning.
Alarms are classified into three categories, which are physiological alarm, technical alarm and general alarm.
Physiological alarm refer to those alarms triggered by patient’s physiological situation which could be
considered dangerous to his or her life, such as heart rate (HR) exceeding alarm limit (parameter alarms).
Technical alarm refer to system failure which can make certain monitoring process technically impossible
or make monitoring result unbelievable. Technical alarm is also called System Error Message. General alarm
belongs to those situations that can not be categorized into these two cases but still need to pay some
attention.
The monitor has preset the alarm level for the parameters. You can also modify the alarm level using the
method described in this chapter.
Alarm level of the System Error Message (technical alarm) is pre-set in the system.
All technical alarm level and general alarm level, some of the physiological alarm level are pre-set in the
system and can not be changed by user.
27
Note
• The Physiological Alarm area is on the upper right part of the screen. The Technical Alarm area is to the left
side of the Physiological Alarm area.
• The concrete presentation of each alarm prompt is related to the alarm level.
Screen Display
When an alarm occurs,the parameter value triggering the alarm will become red. “*” signal appears on
the screen indicating the occurrence of alarm. Red “***” indicates high-level alarm, yellow “**” indicates
medium-level alarm, and yellow “*” indicates low-level alarm. Technical alarm will not prompts “*” signal.
Lamp light
The high/medium/low-level alarms are indicated by the system in following different visual ways:
Alarm Sound
The high/medium/low-level alarms are indicated by the system in following different audio ways:
Alarm level Audio prompt
High Mode is “DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”, which is triggered once
every 8 seconds.
Medium Mode is “DO-DO-DO”, which is triggered once every 8 seconds.
Low Mode is “DO-”, which is triggered once every 8 seconds.
Note
When alarms of different levels occur at the same time, the monitor prompts the one of the highest level.
Alarm Setup
• C. General alert
In some circumstances, alerts will behave as physiological alarm but in normal sense, we don’t regard
them as real patient health related items.
Note
When the sensor or probes are disconnected with the monitor, the monitor will give general prompt
information. When the sensors or probes are intentionally disconnected by the operator because of
inappropriate operation, the monitor will alarm with the mode of low alarm. Temporality the operator could
press the button of “SILENCE”, the mode of low alarm will turn to general prompt information.
• PAUSE
Press the SILENCE button on the panel once to close all audio and visual prompt and description about all
the physiological alarms and to make the system enter ALARM PAUSE status. The rest seconds for alarm
pause is displayed in the Physiological Alarm area. And the symbol is displayed in the System Prompt
area.
The user may set up the time for Alarm Pause in the ALARM SETUP menu. Three selections are available:
1min, 2min and 3min.
When in the PAUSE status, press the SILENCE button to restore the normal alarm status. Besides, during
PAUSE status, newly occurring technical alarm will discharge the PAUSE status and the system will access
the normal alarm status. The symbol disappears, too.
Note
Whether an alarm will be reset depends on the status of the alarm cause. But by pressing SILENCE button
can permanently shut off audio sound of Lead Off/Sensor Off alarms.
29
For the parameters whose alarm is set to ON, the alarm will be triggered when at least one of them exceeds
alarm limit. The following actions take place:
1. Alarm message displays on the screen as described in alarm mode;
2. The monitor beeps in its corresponding alarm class and volume;
3. Alarm lamp flashes;
4. Store all parameter values during the alarm and 4,8 or 16 second waveform prior to and after alarm.
5. If alarm recording is on, the recorder starts alarm recording. For further information on alarm recording,
please refer to Chapter Recording.
The alarm message appears at the top of the screen on the right side. It is needed to identify the alarm and
act appropriately, according to the cause of the alarm.
1. Check the patient’s condition.
2. Identify the cause of the alarm.
3. Silence the alarm, if necessary.
4. When cause of alarm has been over, check that the alarm is working properly.
You will find the alarm messages for the individual parameter in their appropriate parameter chapters of this
manual.
Chapter 5
Freeze
• General
• Freeze & Unfreeze
• Review & Record Frozen Waveforms
5.1 General
When monitoring a patient, you may freeze the waveforms of interest so as to view them carefully. Generally
you can review maximally 34 seconds of a frozen waveform. If required, you may also use recorder to print
out a frozen waveform. The Freeze function of this monitor has following features:
• Freeze status can be activated on any operating screen.
• At the same time of entering the Freeze status, the system exits all other operating menus. Besides,
the system freezes all waveforms in the Waveform area of the Basic Screen, or Full-lead ECG waveforms
and the extra waveform (if available) on the Full-lead ECG screen. Nevertheless the Parameter area
refreshes normally.
• In the Freeze status, it does not affect the display and refresh of the Trend Graph area on the trend
screen, the display and refresh of oxyCRG on the Dynamic Refresh screen, or the display and refresh
of the ViewBed window on the ViewBed screen.
• The frozen waveforms can be reviewed or recorded.
• WAVE 1: used to select the first frozen waveform to record. The pull-down list of this item gives you the
names of all frozen waveforms displayed on the screen.
• WAVE 2: used to select the second frozen waveform to record. The pull-down list of this item gives you the
names of all waveforms displayed on the screen.
• RECALL: used to review frozen waveforms.
• REC: after selected, the system begins recording the frozen waveforms selected in “WAVE 1” and “WAVE
2”.
• EXIT: after pressed, the system closes the FREEZE menu and exits the Freeze status.
Note
Pressing the “FREEZE” button repeatedly in a short time may result in discontinuous waveforms on the screen.
the “REC/STOP” button on the front panel. If the recorder does not exist, selecting the “REC” option can
only call out the prompt “Recorder does not exist” in the STATUS bar. For more detailed information about
recording, please refer to the chapter “Recording”.
Chapter 6
Recording
• General information on recording
• Instructions for configuring and recording
• Recording messages
Real-time Recording
Real-time recording starts as you press the REC/STOP button on the recorder.
The waveforms for continuous real-time recording and continuous 8 second recording are automatically set
by the monitor (usually the first two waveforms displayed on the screen). You can also configure it through
the menu. Refer to related section for details.
In RECORD SETUP menu, the user can choose two waveforms to be printed out. The User can setup one
waveform off. Thus, the real time record will print out one waveform. If two waveforms are off, the real time
record will print out measure parameters only.
Note
If certain recording is in process, and another parameter demands alarm recording, it will only be executed
after the earlier recording is finished.
Auto recording
The monitor starts the recorder for 8 seconds according to interval time set in the “TIMING REC TIME” of the
“RECORD SETUP ” menu. Refer to Chapter 3.4.8 Recorder Setup for details.
Alarm Recording
Parameter Alarm
The monitor records waveforms 4, 8, or 16 seconds prior to and after the alarm (totally 8, 16 or 32 seconds)
(which can be selected in System Menu). All parameter values during the alarm will also be recorded.
32
When parameter alarm occurs, two recorded waveforms can be printed out.
In order to avoid repeated printout of alarm waveforms:
• If more than two parameter alarms are switched on and triggered simultaneously, the recorder will print out
those of the highest level. If of the same alarm level, the latest alarm will be printed out.
• If an alarm occurs during the alarm of another parameter, it will be printed out after the current recording is
finished.
• If many alarms occur at the same time, some of waveforms will be stored for printout in turn.
ST Segment Alarm
The monitor records 2-channel ECG waveforms 4, 8, or 16 seconds prior to and after the alarm (totally 8, 16,
or 32 seconds) (which can be selected in the ECG SETUP menu). All parameter values during the alarm will
also be recorded.
Arrhythmia Alarm
The monitor records 2-channel ECG waveforms 4 seconds prior to and after the alarm (totally 8 seconds).
All measurement results during the alarm will also be recorded.
Titration Table
The monitor can print out the messages in the current TITRATION window.
Notes on Recording
• Recording texts:
Real time Report
Periodic Report
Para Alarm Report: XXX (name of the alarm parameter)
Arrhythmia Report: XXX (Arrhythmia type)
Freeze Wave Report
Trend Graph
Trend Table
Para Alarm Review
NIBP Test Review
Titration Table
• Alarm parameters, alarm time and freeze time
• Patient bed number,sex, height, weight, date of birth, admission date
• Parameter name and value
• Recording time
• Waveform name
• Waveform scale (for ECG waveform)
• ECG lead, scale, filter mode, (if having ECG waveforms, it will be printed out within the first second
or when changing the lead, gain and filter mode during real-time recording.)
• Date and time
33
If two waveforms are off, the measure parameters in frozen are printed
out only.
Trend graph recording Pick ”REC” button in the “TREND GRAPH” menu when viewing
the trend graph to print out the currently displayed tr-end graph.
Trend table recording Pick ”REC” button in the “TREND TABLE” menu when viewing
the trend table to printout the currently displayed trend table.
Arrhythmia review recording Access ARR RECALL window from ARR ANALYSIS of ECG SETUP
menu and Pick ”WAVE” button to access “ARR WAVE RECALL” menu.
Then press “REC” button to output the Arr. Waveform and related
information currently displayed on the screen.
Alarm review recording Access the “ALM RECALL” window from “ALARM RECALL TIME”
menu from “SYSTEM MENU” and pick “REC” button to print out
the alarm review waveform and related information currently displayed
in the “ALARM RECALL” window.
NIBP review recording Access the “NIBP RECALL” window from “SYSTEM MENU” and pick
“REC” button to print out the NIBP information currently displayed
in the window.
Titration table recording Access the “DRUG CALC” menu from the “SYSTEM MENU” menu.
Pick the “TITRATION” button in the menu to access the “TITRATION”
window. Pick the “REC” button to print out the titration currently
displayed in the window.
Note
• You can press REC/STOP button on the recorder to stop the current recording process.
• Access the “RECORD” menu from the “SYSTEM SETUP” menu. Then pick the “CLEAR REC TASK” button
to stop all recording tasks, and clear all store of alarm.
Function Properly
• When the recorder is working, the record paper goes out steadily. Do not pull the paper, or the recorder
will be damaged.
• Do not operate the recorder without record paper.
Paper Out
When “RECORDER OUT OF PAPER” alarm is displayed, the recorder cannot start. Please insert record
paper properly.
34
Inserting Paper
• Open the recorder catch.
• Insert a new roll of paper into the paper cassette, printing side facing the thermosensitive printhead.
• Give out the paper from the recorder outlet.
• Close the recorder catch.
Note
• Be careful when inserting paper. Avoid damaging the thermosensitive printhead. Unless when inserting
paper or shooting troubles, do not leave the recorder catch open.
• Removing Paper Jam.
• When the recorder functions or sounds improperly, open the recorder catch to check for a paper jam. If the
paper jam only re-insert the paper.
After shutdown and re-start, if error still exists, contact out service engineers.
35
Chapter 7
Recall
The monitor provides 480-hour trend data of all parameters, storage of 4800 NIBP measurement results and
72 alarm events. This chapter gives detailed instruction for review of all data.
The uppermost part is the name of the parameter, in which y-axis stands for value and x-axis time.
Indicates the value of the parameter, which it points to, is below the x-axis, with corresponding time
displayed beyond the trend graph. Other trends except NIBP trend are displayed as continuous curves. three
symbols “*” indicate the position of the NIBP value ,including systolic value, diastolic value, mean value.
Mark event
If an event is marked A, B, C, or D, then the corresponding event type will display on the axis time of the
trend graph. The event sign (A, B, C or D) is displayed in a frame.
36
Operation example
To view the NIBP trend graph of the last 1 hour:
• Pick the MENU hot key lower right of the screen.
• Pick TREND GRAPH item.
• Pick the first item and switch to NIBP by turning the knob.
• Adjust the second item to be 1 or 5 sec.
• Pick the ZOOM button and turn the knob to view changes of the trend graph time and trend curve.
• Stop at requested trend time section for careful review. Pick the ZOOM button to adjust the display scale if
necessary.
• For measurement result of a specific time, pick CURSOR to move the cursor to the point, corresponding
time and value will display on above and below respectively.
• For printout of trend graph, pick REC to start report printing of NIBP trend of this hour.
• Pick EXIT to return to trend graph display.
Time in response to each group of trend data is displayed at the leftmost list with date in bracket. Marked
event corresponds to marking time. Trend data of each parameter is divided into 8 groups.
HR, PVCS
ST1, ST2
RR
T1, T2, TD
SpO2, PR
IBP1(S/D/M), IBP2(S/D/M)
CO2, INS, AwRR
NIBP (S/M/D)
NIBP trend data presents different specificity. A certain NIBP measuring time is displayed below the TEST AT
item, as well as the measurement value. For more than one measurement in one time, it can display only one
group, and mark a “*” on the MORE to indicate two and above measurement results.
Mark event
If an event is marked A, B, C, or D, the corresponding event type will display on the axis time of the trend
table.
Operation example
To view a NIBP trend table:
• Pick MENU button on the front panel of the monitor to access “SYSTEM MENU”.
• Pick TREND TABLE.
• Pick L-RIGHT and switch to NIBP by turning the knob.
• Pick the first item from the left and select requested time interval.
• Pick UP-DOWN and turn the knob to view NIBP trend data of different time.
• For printout of trend table, pick REC ALL to start report printing of all NIBP
• Pick EXIT to return to SYSTEM MENU.
Data is listed chronologically from the latest to the earliest. 9 measurements can be displayed in one screen.
Pick UP-DOWN to view other trend curve up to 4800 results. Pick REC to print out all measurement data of
NIBP RECALL.
In this menu, the user may select the conditions for alarm review, including:
• ALARM RECALL
The ALARM RECALL window is as shown below, in which following data are displayed:
1. Time span (Format: month-day-year hour: minute- month-day-year hour: minute).
2. Event type.
3. Serial number (Format: NO. xx of XX ).
4. The value at the time of alarm. NIBP result is with time.
5. Two 8/16/32-second waveforms.
1
2
3
4
Recording
Pick REC to print our all data and waveform of this event.
7.5 SD Operate
The user can review patient data on the monitor or on PC by SD card. Here only introduce reviewing method
on the monitor.
Prepare an empty SD card which capacity is at least 2G. The SD card mounted on the monitor can savetrend
data respectively for HR,PVCs,ST1,SpO2,PR,RR,T1,T2 ,TD and 72-hour waveform of ECG. The trend data’s
resolution is 1 minute.
39
Note
• Please first set the patient’s information correctly before inserting SD CARD.
• Need to save different patient’s data in one SD CARD, you should unmount SD CARD successfully, and
then modify patient’s information. Make sure that Patient No. is different.
Select “SD OPERATE>>” in the menu, “SD CARD OPERATE” menu pops up.
2. Insert SD CARD
If SD CARD has been inserted and works normal, the prompt “SD is found,please mount” appears.
40
Note
If information “SD device wasn’t found,please enter SD card” will prompts, you should exit “SD CARD
OPERATE”menu, check if SD CARD or USB interface is normal. If condition still exists, reboot the monitor.
3. Mount SD CARD
If the monitor has found SD CARD,press”MOUNT DEVICE”,the system will display SD CARD state that if the
SD CARD has been mounted successfully.
Note
You can review trend or ECG waveform when SD CARD has been mounted successfully for 90 seconds .
Otherwise the two button “REVIEW TREND” and “REVIEW ECGWAVE” are invalid.
4. Review trend
Select “REVIEW TREND” in SD OPERATE menu to call up the following menu. In this menu, you can select
which patient you want to review.
41
From left to right is :list no /patient No. /patient name /admission date /birth date.
• PAGE UP/DOWN: Observe patient lists of other page
• LEFT/RIGHT:move the cursor to observe a specified patient’s information
• REVIEW: press this button to call up the following menu.
The table head is: Patient no. / Patient name /date of last reviewing SD card / (current page /sum page)
• Page UP-DOWN: press to view trend data of different time.
• L-RIGHT: press to view trend data of different parameter.
• REC (invalid).
• When the lead type is 3, it can displays only one channel. The ECG lead name is the same to the one
displaying on the main interface.
Chapter 8
Drug Calculation and Titration Table
This Portable Patient Monitor provides Drug calculation and titration table display functions for fifteen drugs
and outputs the content of titration table on the recorder.
Operating method:
In the Drug Calculation window, the operator should first select the name of the drug to be calculated, and
then confirm the patient weight. Afterwards, the operator should also enter other known values.
Turn the knob to select the value of the item to be calculated. Turn the knob to change the value. When it is
the required value, press the knob to view the calculation result. Each item has its calculation range. If the
result exceeds the range, display “---.--”
45
Note
• For the drug calculation, the prerequisite is that the operator must first of all enter the patient weight and
drug name. The system first gives a group of random initial values, which cannot be used by the operator
as the calculation reference. Instead, he should enter a new group of values at the doctor’s instruction.
• Each drug has its fixed unit or unit series. Operator must select the proper unit at the doctor’s instruction.
If the result exceeds the system-defined range, it will display “---”.
• After entering a value, a conspicuous prompt will appear in the menu warning the operator to confirm
the correctness of the entered value. The correct value is the guarantee for the reliability and safety of the
calculated results.
• In neonate mode, Drip Rate and Drop Size items are disabled.
• For each entered value, the system will always give a dialog box asking for the user’s confirmation.
You must be careful when answering each box. The calculated result is reliable only after the entered value
is confirmed to be correct.
Note
A,B,C,D,E are only codes for drugs instead of their real names. The units for these five drugs are fixed.
The operator may select the appropriate units according to the convention of using these drugs. The rules
for expressing the units are:
“mg” series units are fixedly used for drug A, B and C: g, mg, mcg.
“unit” series units are fixedly used for drug D: unit, k unit, m unit.
“mEq” is fixedly used for drug E.
Patient weight:
After accessing the DRUG CALC window, the operator should enter the patient weight into the first or the
second item. The entered weight will be used as the independent data only for the calculation of drug
concentration.
Note
This drug calculation function acts only as a calculator. That means the patient weight in Drug Calculation
menu and the patient weight in Patient Information menu are independent from each other. Therefore if the
Weight in Drug Calculation changes, the Weight in Patient Information does not change. In this way, we can
say, the Drug Calculation menu is independent from other menus in the system. Any change of it will not
affect other information about the patient being currently monitored.
Total amount, dose, volume, flow-rate, drop rate and patient weight and drug name are displayed on the top
of the titration table. Meaning of each English identifier is:
Chapter 9
Patient Safety
This Portable Patient Monitor is designed to comply with the International National Safety requirements
for medical electrical equipment. 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, the screen display will recover within 5 seconds after defibrillation.
This symbol indicates that the instrument is IEC 60601-1 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 touch the patient, bed or instrument during defibrillation.
• Please use anti-defibrillation ECG cable during defibrillation.
Environment
Follow the instructions below to ensure a completely safe electrical installation. The environment where the
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 Monitor operates within specifications at ambient temperatures between 5°C and 40°C. Ambient
temperatures that exceed these limits could affect the accuracy of the instrument and cause damage
to the modules and circuits. Allow at least 2 inches (5cms) clearance around the instrument for proper air
circulation.
Warning
Do not use a 3-wire to 2-wire adapter with this instrument.
47
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 combination 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.
Equipotential Grounding
Protection class 1 instruments are already included in the protective grounding (protective earth) system
of the room by way of grounding contacts in the power plug. For internal examinations on the heart or the
brain, the Monitor must have a separate connection to the equipotential grounding system. One end of the
equipotential grounding cable (potential equalization conductor) is connected to the equipotential grounding
terminal on the instrument rear panel and the other end to one point of the equipotential grounding system.
The equipotential grounding system assumes the safety function of the protective grounding conductor if
ever there is a break in the protective grounding system. Examinations in or on the heart (or brain) should
only be carried out in medically used rooms incorporating an equipotential grounding system. Check each
time before use that the instrument is in perfect working order. The cable connecting the patient to the
instrument must be free of electrolyte.
Warning
If the protective grounding (protective earth) system is doubtful, the monitor must be supplied by inner
power only.
Condensation
Make sure that during operation, the instrument is free of condensation. Condensation can form when equip-
ment is moved from one building to another, thus being exposed to moisture and differences in
temperature.
Warning
Possible explosion hazard if used in the presence of flammable anesthetics.
This symbol indicates that the instrument is IEC 60601-1 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.
Alternating current
Stand-by
USB interface
Serial number
Date of manufacture
Manufacturer
WEEE (2002/96/EC)
This way up
Keep dry
5
The same packing stacked up to 5-layers
106kPa
Atmospheric pressure limitation.
50kPa
30°C
Temperature limitation
2°C
%
95%
Humidity limitation.
0%
European Representative.
This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993,
a directive of the European Economic Community.
Chapter 10
Care / Cleaning
10.1 System Check
Before using the monitor, do the following:
If you find any damage on the monitor, stop using the monitor on patient, and contact the biomedical
engineer of the hospital or our Customer Service immediately.
The overall check of the monitor, including the safety check, should be performed only by qualified
personnel once every 6 to 12 month, and each time after fix up.
You should check the synchronism of the defibrillator in the frequency described in the hospital regulations.
At least every 3 months, it should be checked by a qualified customer service technician.
All the checks that need to open the monitor should be performed by qualified customer service technician.
The safety and maintenance check can be conducted by persons from our company. You can obtain the
material about the customer service contract from the local office.
The circuits diagrams, parts lists and calibration instructions of the monitor can be provided by the
manufacturer.
Note
To ensure maximum battery life, it is recommended that, at least once a month, the monitor be run on
battery until it turns itself off and then recharged.
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.
• Refer the battery replacement only to our service technician.
Note
• Please pay special attention to the following items:
1. Avoid using ammonia-based or acetone-based cleaners such as acetone.
2. Most cleaning agents must be diluted before use. Follow the manufacturer’s directions carefully to avoid
damaging the monitor.
3. Don’t use the grinding material, such as steel wool etc.
4. Don’t let the cleaning agent enter into the chassis of the system.
5. Don’t leave the cleaning agents at any part of the equipment.
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) on the surface of the chassis to be cleaned.
1. Diluted Formaldehyde 35% -- 37%
2. Hydrogen Peroxide 3%
3. Alcohol
4. Isopropanol
• The monitor and sensor surface can be cleaned with hospital-grade ethanol and dried in air or with crisp
and clean cloth.
• Our company has no responsibility for the effectiveness of controlling infectious disease using these
chemical agents. Please contact infectious disease experts in your hospital for details.
10.4 Disinfection
To avoid long-term damage to the device, we suggest to disinfect the device only necessary during the
maintenance plan. And we suggest to clean the device first before disinfection.
Advised disinfection material: ethanol group, aldehyde group
Please refer to relative chapters for the disinfection of ECG lead, SpO2 sensor, NIBP cuff and TEMP probe.
Caution
• Do not use EtO gas or formaldehyde to disinfect the monitor.
• Dilute the disinfectant according to manufacture’s instruction or adopt the disinfectant with concentration
as low as possible.
• Do not let any liquid ingress into the device.
• Do not immerse any part of the device in any liquid.
• During disinfection, do not pour any liquid on the device.
• Do not leave any disinfectant on the surface of device, wipe it up immediately with a wet cloth.
Chapter 11
ECG/RESP Monitoring
11.1 What is ECG Monitoring
Monitoring the ECG produces a continuous waveform of the patient’s cardiac electric activity to enable
an accurate assessment of his current physiological state. Only proper connection of the ECG cables can
ensure satisfactory measurement. On the Normal Display, the monitor provides display of 2-channel ECG
waveforms.
• The patient cable consists of 2 parts;
The cable that connects to the monitor;
The lead set that connects to the patient.
50
• Using a 5-lead set, the ECG can derive up to two waveforms from two different leads. For requested lead,
you may choose from the left side of ECG waveform.
• The monitor displays the Heart Rate (HR), ST segment and Arrhythmia analysis.
• All of the parameters above can be set as alarm parameters.
Note
• In the default settings of the monitor, the ECG waveforms are the first two waveforms from top in the
Waveform Area.
Note
Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of
the waveform.
Note
For protecting environment, the electrodes must be recycled or disposed of properly.
Warning
• Check everyday whether there is skin irritation resulted from the ECG electrodes. If so, replace electrodes
every 24 hours or change their sites.
• Verify lead fault detection prior to the start of monitoring phase. Unplug the ECG cable from the socket,
the screen will display the error message “ECG LEAD OFF” and the audible alarm is activated.
Note
The following table gives the corresponding Electrode names used in Europe and America respectively.
(Electrode names are represented by R, L, N, F and C respectively in Europe, whose corresponding Electro-
de names in America are RA, LA, RL, LL and V.)
51
America Euro
Electrode names Color Electrode names Color
RA White R Red
LA Black L Yellow
LL Red F Green
RL Green N Black
V Brown C White
Note
To ensure patient safety, all leads must be attached to the patient.
For 5-lead set, attach the C-electrode to one of the indicated positions as below (Figure 11-2):
The placing of the ECG leads will depend on the type of surgery that is being performed. For example, with
open chest surgery the electrodes may be placed laterally on the chest or on the back. In the operating
room, artifacts can sometimes affect the ECG waveform due to the use of ES (Electrosurgery) equipment. To
help reduce this you can place the electrodes on the right and left shoulders, the right and left sides near the
stomach, and the chest lead on the left side at mid-chest. Avoid placing the electrodes on the upper arms,
otherwise the ECG waveform will be too small.
Warning
• When using Electrosurgery equipment, leads should be placed in a position in equal distance from
Electrosurgery electrotome and the grounding plate to avoid cautery. Electrosurgery equipment wire
and ECG cable must not be tangled up.
• ECG cables can be damaged when connected to a patient during defibrillation. Check cables for
functionality before using them again.
• Pacemaker failure: During complete heart block or pacemaker failure to pace/capture, tall P-waves (greater
than 1/5 of the average R-wave height) may be erroneously counted by the monitor, resulting in missed
detection of cardiac arrest.
• External pacing electrodes: When a pacemaker with external pacing electrodes is being used on a patient,
arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse.This may
result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.
• During surgery: Use the special electrode ECG safety cable, for measuring ECG in the operating room.
These cables have extra circuitry to protect the patient from burn and decrease electrical interference.
This also reduces the hazard of burn in case of a defective neutral electrode at the HF device. These
cables cannot be used for measuring respiration.
• When using Electrosurgery equipment, never place an electrode near the grounding plate of the
Electrosurgery device, otherwise there will be a great deal of interference with the ECG signal.
Note
• If a ECG waveform is not accurate, while the electrodes are tightly attached, try to change the lead.
• Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy
of the waveform.
For getting 1 mv calibrated ECG wave, choose ECG CAL button in ECG SETUP menu. A message “when
CAL, can’t monitor! “ prompts on the screen.
R
P T
Q S
Figure 11-4 Standard ECG Waveform
Warning
Do not touch the patient, table nearby, or the equipment during defibrillation.
2
4
1 Leads of channel 1:
1) The selectable leads are I, II, III, aVR, aVL,aVF, V.
2) When the ECG is 5-lead, the selectable leads are: I, II, III, aVR, aVL, aVF; V. when ECG is 3-lead,
the selectable leads are: I,II,III.
3) Leads on the ECG wave must not have the same name. Otherwise, the system will automatically
change the ECG waveform name that has the same name as the waveform being currently adjusted
to another name.
2 Waveform gain of channel 1: used to adjust the size of ECG waveforms
Select gain value for each channel from ×0.25,×0.5,×1,×2,×4. A 1mv scale displays on each ECG channel’s
one side. The height of 1mV bar is directly proportional to the waveform amplitude.
Note
When the input signals are too large, the peak of the waveform may be not able to be displayed. In this case
the user may manually change the setup method of ECG waveform according to the actual waveform so as
to avoid the occurrence of the unfavorable phenomena.
3 Filter method: used for displaying clearer and more detailed waveform
There are three filter modes for selection. DIAGNOSTI, MONITOR and SURGERY modes may reduce per
turbance and interference from Electrosurgery equipment. The filter method is the item applicable for both
channels, which is always displayed at the waveform place of the channel 1 ECG waveform.
Note
Only in Diagnosis mode, the system can provide non-processed real signals. In Monitor or Surgery mode,
54
ECG waveforms may have distortion of different extent. In either of the latter two modes, the system can
only show the basic ECG and the results of ST analysis may also be greatly affected. In Surgery mode,
results of ARR analysis may be somewhat affected. Therefore, it is suggested that in the environment having
relative small interference, you’d better monitor a patient in Diagnosis mode.
Note
Pacemaking signal detected is marked by a “|” above the ECG waveform.
• ALM LEV: selectable from HIGH, MED,LOW. Level HIGH represents the most serious case.
• ALM REC: pick “ON” to enable report printing upon ECG alarm.
• ALM HI: used to set up the upper limit of ECG alarm.
• ALM LO: used to set up the lower limit of ECG alarm.
ECG alarm is activated when the heart beat exceeds set ALM HI value or falls below ALM LO value.
HR alarm range:
Note
Please set the alarm limits according to clinical condition of individual patient. The upper limit shall not
exceed 20 beat/min higher than the patient’s heart rate.
• HR FROM
ECG, SpO2, AUTO and BOTH may detect heart rate. AUTO distinguishes heart rate source according to
the quality of signal. By picking ECG, the monitor prompts HR and activates HR beep. By picking SpO2,
the monitor prompts PULSE and activates pulse beep. BOTH mode displays HR and PR simultaneously,
when this item is picked, PR parameter is displayed to the right side of SpO2. As for the sound of HR or PR
in BOTH mode, HR is given the priority, i.e., if HR is available, whose sound will be sent out, but if HR is not
available, then the sound will be for PR.
• HR CHANNEL
“CH1” to count the heart rate by CH 1 waveform
“CH2” to count the heart rate by CH 2 waveform
“AUTO” the monitor selects a channel automatically
55
Note
• If monitoring a patient with the pacemaker, set “PACE” to On. If monitoring a patient without pacemaker,
set “PACE” to Off.
• If “PACE” is on, the system will not perform some types of ARR analysis. For detailed information, please
refer to the section: ARR ALARM. In the table, the ARR type marked by All types applies to the analysis in
all situations, marked by Non-paced applies only to the analysis in the situation when the patient does not
use pacemaker.
• NOTCH:ON/OFF.
• PITCH TONE:ON/OFF.
• ECG CAL: pick this item to start calibrating ECG. The method to end CAL: re-select the CAL key in the
menu or re-select the lead name on the screen.
• DEFAULT: pick this item to access the ECG DEFAULT CONFIG dialog box, in which the user may select
whether the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to be used. After selecting
any of the items and exiting the dialog box, the system will pop up the dialog box asking for the user’s
confirmation.
Warning
For pacemaker patient, the pacing impulse analysis function must be switched on, otherwise, the pacing
impulse may be counted as normal QRS complex, which results in failure of “ECG LOST” error detection.
Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance.
Note
• When calibrating ,Please set the filter way to “Diagnosis”.
• For monitor with ST segment & Arrhythmia analysis software, refer to ST Segment Monitoring and
Arrhythmia Analysis for details.
• When Pacer Switch is On, the Arrhythmia events related to PVCs will not be monitored. At the same time,
the ST analysis will not be performed either.
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Physiological alarms:
Message Cause Alarm level
ECG LOST No ECG signal of the patient is detected. HIGH
HR TOO HIGH HR measuring value is above the upper alarm limit User-selectable
HR TOO LOW HR measuring value is below the lower alarm limit User-selectable
Technical alarms:
Message Cause Alarm level Remedy
ECG LEAD OFF
ECG V LEAD OFF or
ECG C LEAD OFF
ECG electrodes fall off the LOW Make sure that all electrodes, leads
ECG LL LEAD OFF or skin or ECG cables fall and patient cables are properly
ECG F LEAD OFF off the monitor. connected.
ECG LA LEAD OFF or
ECG L LEAD OFF
ECG RA LEAD OFF or
ECG R LEAD OFF
ECG INIT ERR
ECG INIT ERR1
ECG INIT ERR2
ECG INIT ERR3 Stop using measuring function
ECG INIT ERR4 ECG module failure HIGH provided by ECG module, notifies
biomedical engineer or Our service
ECG INIT ERR5 staff.
ECG INIT ERR6
ECG INIT ERR7
ECG INIT ERR8
ECG COMM STOP Occasional communication HIGH If failure persists, notify biomedical
failure engineer or Our service staff.
ECG COMM ERR Occasional communication HIGH If failure persists, notify biomedical
failure engineer or Our service staff.
HR ALM LMT ERR Functional safety failure HIGH Stop using HR alarm function, notify
biomedical engineer or
Our service staff.
ECG NOISE ECG measuring signal LOW Make sure the patient is quiet,
is greatly interfered. the electrodes are properly
connected and AC power system
is well grounded.
57
Note
When setting ST ANALYSIS on, the monitor will select “DIAGNOSTIC” mode. You can set it to “MONITOR”
mode or “OPERATE” mode as required. However at this time ST value has been severely distorted.
• It is available to measure the variance of ST segment with ST analysis at the waveform tracks for selected
lead. The corresponding ST measurement result displays numerically at ST1 and ST2 in the Parameter
Area. The trend can be viewed with table or graphic form.
• Measurement unit of ST segment: mV.
• Measurement symbol of ST segment: “+” = elevating, “-” = depressing.
• Measurement range of ST segment: -2.0 mV, ~ + 2.0 mV.
Pick the ST ANALYSIS item in the ECG SETUP menu to access the ST ANALYSIS sub-menu as shown
below.
ST ANALYSIS menu
• DEF POINT pick this item to access the DEF POINT window, in which the position of ISO and ST point can
be set up.
- ISO Base point.
- ST Measurement point.
The operator can adjust the position of both ISO and ST measurement points.
The reference point is the position where the peak of R-wave locates (see Figure 11-10).
R Wave
T
P
} ST Value
Q
S
ISO -78 ms ST +109 ms
Figure 11-10 DEF Point
The ST measurement for each beat complex is the vertical difference between the two measurement points.
Note
The ST measurement point should be adjusted if the patient’s HR or ECG morphology changes significantly.
• Adjusting ISO, ST
These two points can be adjusted turning the knob.
When adjusting ST measurement point, the system will show the ST Measurement Point Window. The QRS
complex template displays in the window (If the template is not established, a horizontal line will display.
If the channel is not at ON position, a horizontal line will also display). It is adjustable of the highlight bar in
the window. You may select ISO or ST, then switch the knob left or right to move the cursor line. When the
cursor is at the required position, you may select the base point or the measurement point.
Note
• Abnormal QRS complex is not considered in ST segment analysis.
• ST Alarm Message
• The alarm limits for two ST measurements are identical. No setting of alarm limits can be made only for
one channel.
Among physiological alarms, those belonging to the type that the parameter has exceeded the limits may
activate the recorder to automatically output the parameters and related measured waveforms when the
alarms occur on the condition that the alarm record switch in the related menu is On.
59
Tables below describe the possible physiological alarms, technical alarms and prompt messages during ST
measurement.
Physiological alarms:
Technical alarms:
Message Cause Alarm Level Remedy
ST ALM LMT ERR Functional safety failure HIGH Stop using ST alarming
function, notify biomedical
engineer or Our service staff.
• The arrhythmia monitoring is shutoff by default. You can enable it when necessary.
• This function can call up the doctor’s attention to the patient’s heart rate by measuring and classifying
the arrhythmia and abnormal heart beat and triggering the alarm.
• The monitor can conduct up to 13 different arrhythmia analyses.
• The monitor can store the latest 60 alarm events when taking arrhythmia analysis to a peculiar buffer.
The operator can edit these arrhythmia events through the menu below.
Pick the item ARR ANALYSIS in ECG SETUP menu to access the ARR ANALYSIS sub-menu.
• ALM LEV: selectable from HI, MED, LO. Level HIGH represents the most serious case.
• ALM REC: pick “ON” to enable report printing upon PVCs alarm.
PVCs alarm is activated when the PVCs exceeds set PVCs ALM HI value.
Physiological alarms:
Message Cause Alarm Level
PVCs TOO HIGH PVCs measuring value is above upper alarm limit. User-selectable
Technical alarms:
Message Cause Alarm Level Remedy
PVCs ALM LMT ERR Functional safety failure HIGH Stop using PVCs alarming
function, notify biomedical
engineer or Our service staff.
Set ALM to ON/OFF to enable/disable the alarm function; Set REC to ON/OFF to enable/disable alarm
record function, turn the knob under LEV column to set alarm level to HIGH, MED or LOW.
You can pick ALL ALM ON to enable alarm function of all arrhythmia types and pick ALL ALM OFF to disable
this function. Likewise, you can pick ALL REC ON to enable recording function for all arrhythmia types and
pick ALL REC OFF to disable this function. Changing the ALM LEV can reset alarm level of all arrhythmia
types to the same value.
• ARR RECALL Pick this item to review and edit the ARR analysis result.
The latest arrhythmia events (up to 60) are displayed.
61
Note
If there are more than 60 Arrhythmia events, the latest will be retained.
ARR ALARM
The alarm is triggered when an Arrhythmia occurs. If the ALM is ON, the alarm sounds and the alarm indica-
tor flashes. If the REC is ON, the alarm record will be printed out (4 seconds prior to and after the alarm, with
the ECG waveforms of analysis channel).
62
Physiological alarms:
Prompt Applicable Occurring Condition Alarm Level
Patient Type
ASYSTOLE All patients No QRS is detected for 4 consecutive User-selectable
seconds
VFIB /VTAC Without Fibrillatory wave for consecutive 4 seconds; User-selectable
pacemaker or The number of continuous Vent beats
is larger than the upper limit of cluster Vent
beats (>5). The RR interval is less than 600ms.
VT>2 Without 3 < the number of cluster PVCs < 5 User-selectable
pacemaker
COUPLET Without 2 consecutive PVCs User-selectable
pacemaker
BIGEMINY Without Vent Bigeminy User-selectable
pacemaker
TRIGEMINY Without Vent Trigeminy User-selectable
pacemaker
R ON T Without A type of single PVC under the condition User-selectable
pacemaker that HR<100,R-R interval is less than 1/3
the average interval, followed by a
compensating pause of 1.25X the average
R-R interval(the next R wave advances
onto the previous T wave).
PVC Without Single PVCs not belonging to the type User-selectable
pacemaker of above mentioned PVCs.
TACHY All patients 5 consecutive QRS complex , RR interval User-selectable
is less than 500ms.
BRADY All patients 5 consecutive QRS complex, RR interval User-selectable
is longer than 1.5s.
MISSED BEATS Without When HR is less than 100 beats/min., no heart User-selectable
pacemaker beat is tested during the period 1.75 times
of the average RR interval; or When HR is
larger than 100 beats/min., no beat is tested
with 1 second.
PNP With pacemaker No QRS complex and pacing pulse are User-selectable
availabe during the period 1.75 times
of the average R-R interval (only considering
patients with pacemaker.)
PNC With pacemaker When pacing pulse is available, no QRS User-selectable
exists during the period 1.75 times
of the average RR interval (only considering
patients with pacemaker.)
Patient type:
All patients: refers to perform Arr.analysis on patients either with pacemakers or without pacemakers.
Without pacemaker: refers to perform Arr. Analysis only on the patients without pacemakers.
With pacemaker: refers to perform Arr. Analysis only on the patients with pacemakers.
Prompt message:
Message Cause Alarm Level
ARR LEARNING The QRS template building required for Arr. Analysis is in No alarm
process.
63
Note
Arrhythmia name displays in the Alarm Message Area.
Note
The RESP monitoring is not recommended to be used on patients who are very active, as this can cause
false alarms.
Note
Place the red and green electrodes diagonally to optimize the respiration waveform. Avoid the liver area and
the ventricles of the heart in the line between the RESP electrodes so as to avoid cardiac overlay or artifacts
from pulsating blood flow. This is particularly important for neonates.
• APNEA ALM: to set the standard of judging an apnea case. It ranges from 10 to 40 seconds, increases /
decreases by 5.
• SWEEP: Available options for RESP SWEEP are 6.25, 12.5 and 25.0 mm/s.
• WAVE AMP: The user may set up the displaying amplitude of the RESP waveform. The selections are×
0.25,× 0.5,× 1,× 2,× 4.
• DEFAULT: pick this item to access the RESP DEFAULT CONFIG dialog box, in which the user may select
whether the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to be used. After selecting
any of the items and exiting the dialog box, the system will pop up the dialog box asking for the user’s
confirmation
Physiological alarms:
Message Cause Alarm Level
RR TOO HIGH RESP measuring value is above upper alarm limit. User-selectable
RR TOO LOW RESP measuring value is below lower alarm limit. User-selectable
RESP APNEA RESP can not be measured within specific time interval. HIGH
Technical alarms:
Message Cause Alarm Level Remedy
RESP ALM LMT ERR Functional safety failure HIGH Stop using RESP alarming
function, notify biomedical
engineer or Our service staff.
65
Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected
from the power line.
If there is any sign that the ECG cable may be damaged or deteriorated, replace it with a new one instead of
continuing its application on the patient.
• Cleaning:
Use fine-hair cloth moistened in mild soap liquid or cleaning agent containing 70% ethanol to clean the
equipment.
• Disinfection
To avoid long-term damage to the device, we suggest to disinfect the device only necessary during the
maintenance plan. And we suggest to clean the device first before disinfection.
Advised disinfection material:
1. Ethanol group: 70% alcohol, 70% isopropanol
2. Aldehyde group
Chapter 12
SpO2 Monitoring
12.1 What is SpO2 Monitoring
SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the
arterial blood. If, for example, 97% hemoglobin molecules in the red blood cells of the arterial blood combine
with oxygen, then the blood has a SpO2 oxygen saturation of 97%. The SpO2 numeric on the monitor will
read 97%. The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with
oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse rate signal
and a plethysmogram wave.
Warning
• Pulse oximeter can overestimate the SpO2 value in the presence of Hb-CO, Met-Hb or dye dilution chemi-
cals.
• ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up.
• Do not put the sensor on extremities with arterial catheter or venous syringe.
Note
Do not perform SpO2 measuring and NIBP measuring on same arm at one time, because obstruction of
blood flow during NIBP measuring may adversely affect the reading of SpO2 value.
Warning
• Check if the sensor cable is in normal condition before monitoring. After unplugging the SpO2 sensor cable
from the socket, the system shall display the error message “SpO2 SENSOR OFF” and give the audible
alarm.
• When operating at the beginning, the operator inserts his finger, and setup the SpO2 ALM HI lower than
the current measured value, then the machine will start alarm. The pulse rate alarm test is the same with
the above.
• Do not use the SpO2 sensor once the package or the sensor is found damaged. Instead, you shall return it
to the vendor.
• Prolonged and continuous monitoring may increase jeopardy of unexpected change of dermal condition
such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially
important to check the sensor placement of neonate and patient of poor perfusion or immature dermogram
by light collimation and proper attaching strictly according to changes of the skin. Check per 2~3 hours the
sensor placement and move it when the skin deteriorates. More frequent examinations may be required for
different patients.
Figure 12-4
Note
• 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.
Warning
• 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.
• 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.
68
Warning
• Setting the SpO2 upper alarm limit to 100% is equivalent to switching off the alarm on upper 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 commonly accepted clinical practices.
• The upper and lower limit of SpO2 alarm will be displayed continuously in the SpO2 parameter area.
Physiological alarm:
Message Cause Alarm Level
SpO2 TOO HIGH SpO2 measuring value is above upper alarm limit. User-selectable
SpO2 TOO LOW SpO2 measuring value is below lower alarm limit. User-selectable
PR TOO HIGH PR measuring value is above upper alarm limit. User-selectable
PR TOO LOW PR measuring value is below lower alarm limit. User-selectable
Technical alarms:
Message Cause Alarm Level Remedy
SpO2 SENSOR OFF SpO2 sensor may be di- LOW Make sure that the monitor and
sconnected from the patient the patient are in correct connec-
or the monitor. tion with the cables.
SpO2 INIT ERR SpO2 module failure HIGH Stop using the measuring fun-
SpO2 INIT ERR 1 ction of SpO2 module, notify bio-
medical engineer or our service
SpO2 INIT ERR 2 staff.
SpO2 INIT ERR 3
SpO2 INIT ERR 4
SpO2 INIT ERR 5
SpO2 INIT ERR 6
SpO2 INIT ERR 7
SpO2 INIT ERR 8
70
SpO2 COMM STOP SpO2 module failure or com- HIGH Stop using the measuring
munication error function of SpO2 module, notify
biomedical engineer or our
service staff.
SpO2 COMM ERR SpO2 module failure or com- HIGH Stop using the measuring
munication error function of SpO2 module, notify
biomedical engineer or our
service staff.
SpO2 ALM LMT ERR Functional safety failure HIGH Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
PR ALM LMT ERR Functional safety failure HIGH Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
Warning
• Turn off the monitor and disconnect the line power before cleaning the monitor or the sensor
• Do not subject the sensor to autoclaving.
• Do not immerse the sensor into any liquid.
• Do not use any sensor or cable that may be damaged or deteriorated.
Cleaning:
• Use a cotton ball or a soft mull moistened with hospital-grade ethanol to wipe the surface of the sensor,
and then dry it with a cloth. This cleaning method can also be applied to the luminotron and receiving unit.
• The cable can be cleaned with 3% hydrogen dioxide, 7% isopropanol, or other active reagent. However,
connector of the sensor shall not be subjected to such solution.
Chapter 13
NIBP Monitoring
13.1 Introduction
• Reference to the European standard EN 1060-1: Specification for Non-invasive sphygmomanometers
Part 1, General requirements.
• The Non-invasive Blood Pressure (NIBP) module measures the blood pressure using the oscillometric
method.
• It is applicable for adult, pediatric, and neonatal usage.
• There are three modes of measurement available: manual, automatic and continuous. Each mode displays
the diastolic, systolic and mean blood pressure.
71
• In the MANUAL mode, only one measurement is conducted for each time.
• In the AUTO mode, the measurement is cycled; you can set the interval time to 1/ 2/ 3/ 4/ 5/ 10/
15/30/60/90/120/240/480/960 minutes.
• In the continuous mode, the monitor measures the blood pressure as many times as possible in five
minutes.
Warning
• You must not perform NIBP measurements on patients with sickle-cell disease or under any condition
which the skin is damaged or expected to be damaged.
• For a thrombasthemia patient, it is important to determine whether measurement of the blood pressure
shall be done automatically. The determination should be based on the clinical evaluation.
• Ensure that the correct setting is selected when performing measurements on children. It may be dange-
rous for the children to use an over pressure level.
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.
• Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor
tangled.
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.
• Make sure that the cuff edge falls within the range of mark <->. If it does not, use a larger or smaller cuff
that fits better.
3. Connect the cuff to the air hose. The limb chosen for taking the measurement should be placed at the
same level as the patient’s heart. If this is not possible you should apply the following corrections to the
measured values:
• If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa) for each inch of difference.
• If it is placed lower than the heart level, deduct 0.75 mmHg (0.10 kPa) for each inch of difference.
4. Check whether the patient mode is appropriately selected. Access PATIENT SETUP menu from SYSTEM
MENU and pick PAT TYPE item and turn the knob to select the required patient type.
5. Select a measurement mode in the NIBP SETUP menu. Refer to the following paragraphs Operation Hints
for details
6. Press the START button on the front panel to start a measurement.
Operation Hints
1. To start auto measuring:
Access NIBP SETUP menu and pick the INTERVAL item, in which the user may choose the selections
other than MANUAL to set up the time interval for auto measurement. After that, press START button on
the front panel to start the auto measuring according to the selected time interval.
2. To stop auto measuring:
During auto measuring press START button on the front panel at any time to stop auto measurement.
3. To start a manual measuring:
• Access NIBP SETUP menu and pick the INTERVAL item. Select the MANUAL selection. Then press
the START button on the front panel to start a manual measurement.
• During the idle period of auto measuring process, press the START button on the front panel at any time
to start a manual measurement. Then press the START button on the front panel to stop manual
measurement and the system continues executes auto-measuring program according to selected time
interval.
4. To start a manual measuring during the AUTO mode
Press START button on the front panel.
5. To stop a manual measuring
Repress the START button on the front panel again.
6. To perform continuous measuring
Access NIBP SETUP menu and pick the CONTINUAL item to start the continuous measurement. The mo-
nitor will measure as many times of NIBP as possible within 5 minutes.
7. To stop continuous measuring
During continuous measuring press START button on the front panel at any time to stop continuous
measurement.
Warning
• Prolonged non-invasive blood pressure measurements in Auto mode may be associated with purport,
ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities
of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the
blood pressure measurements.
• Prolonged non-invasive blood pressure measurements in Continuous mode may be associated with
purport, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the
extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed,
stop the blood pressure measurements.
• If liquid is inadvertently splashed on the equipment or its accessories, or may enter the conduit or inside
the monitor, contact local Customer Service Center.
Note
If you are in doubt about the accuracy of any reading(s), check the patient’s vital signs by an alternative
method before checking the functioning of the monitor.
Measurement Limitations
To different patient conditions, the oscillometric measurement has certain limitations. The measurement is
in search of regular arterial pressure pulse. In those circumstances when the patient’s condition makes it
difficult to detect, the measurement becomes unreliable and measuring time increases. The user should be
aware that the following conditions could interfere with the measurement, making the measurement unrelia-
ble or longer to derive. In some cases, the patient’s condition will make a measurement impossible.
73
• Patient Movement
Measurements will be unreliable or may not be possible if the patient is moving, shivering or having
convulsions. These motions may interfere with the detection of the arterial pressure pulses. In addition,
the measurement time will be prolonged.
• Cardiac Arrhythmia’s
Measurements will be unreliable and may not be possible if the patient’s cardiac arrhythmia has caused
an irregular heartbeat. The measuring time thus will be prolonged.
• Heart-lung Machine
Measurements will not be possible if the patient is connected to a heart-lung machine.
• Pressure Changes
Measurements will be unreliable and may not be possible if the patient’s blood pressure is changing rapidly
over the period of time during which the arterial pressure pulses are being analyzed to obtain the
measurement.
• Severe Shock
If the patient is in severe shock or hypothermia, measurements will be unreliable since reduced blood flow
to the peripheries will cause reduced pulsation of the arteries.
• Heart Rate Extremes
Measurements can not be made at a heart rate of less than 40 bpm and greater than 240 bpm.
Time of measurement
• SYS ALM HI, SYS ALM LOW, MEAN ALM HI, MEAN ALM LO, DIA ALM HI, DIA ALM LO are for the user
to set up the alarm limit for each type of pressure. NIBP alarm is activated when the pressure exceeds set
upper alarm limits or falls below lower alarm limits.
• UNIT
Pick this item to set measurement unit. (Option: mmHg or kPa)
• INTERVAL
Interval time for automatic measuring. Available selections: 1/2/3/4/5/10/15/30/60/90/120/240/480/960
minutes. Press START/STOP button on the NIBP module to start the first auto measuring.
Pick MANUAL selection in INTERVAL item to set up the measuring mode to MANUAL.
• INFLATION
Can be set only for some customized module.
• RESET
Restore measurement status.
Pick this item to restore initial settings of the pressure pump.
When the pressure does not work properly and the system fails to give message for the problem, pick this
item to activate self-test procedure, thus restore the system from abnormal performance.
• CONTINUAL
Start continuous measuring.
When this item is picked, the menu will disappear automatically.
• CALIBRATE
Calibrate the cuff pressure reading with a calibrated reference manometer. Pick the CALIBRATE item
to start the calibration and the item will change into STOP CAL, which if picked, the system will stop
calibration.
Warning
The calibration of the NIBP measurement is necessary for every two years (or as frequently as dictated by
your Hospital Procedures Policy). The performance should be checked according to the following details.
• PNEUMATIC
This item is used for air leakage test. Turn the knob to pick the item to start the air leakage test. Then the
item will change into STOP PENUM, which if picked, the system will stop air leakage test.
Warning
• This pneumatic test other than being specified in the EN 1060-1 standard is to be used by the user to sim-
ply determine whether there are air leaks in the NIBP airway. If at the end of the test the system gives the
prompt that the NIBP airway has air leaks, please contact the manufacturer for repair.
• DEFAULT
Pick this item to access the NIBP DEFAULT CONFIG dialog box, in which the user may select whether
the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to be used. After selecting any of the
items and exiting the dialog box, the system will pop up the dialog box asking for the user’s confirmation.
Physiological alarms:
Message Cause Alarm Level
SYS TOO HIGH NIBP SYS measuring value is above upper alarm limit. User-selectable
SYS TOO LOW NIBP SYS measuring value is below lower alarm limit. User-selectable
DIA TOO HIGH NIBP DIA measuring value is above upper alarm limit. User-selectable
DIA TOO LOW NIBP DIA measuring value is below lower alarm limit. User-selectable
MEAN TOO HIGN NIBP MAP measuring value is above upper alarm limit. User-selectable
MEAN TOO LOW NIBP MAP measuring value is below lower alarm limit. User-selectable
76
To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the rubber tubes line up
with the large opening on the long side of the cuff. Now roll the bag lengthwise and insert it into the opening
on the long side of the cuff. Hold the tubes and the cuff and shake the complete cuff until the bag is in
position. Thread the rubber tubes from inside the cuff, and out through the small hole under the internal flap.
Note
For protecting environment, the disposable blood pressure cuffs must be recycled or disposed of properly.
78
Chapter 14
TEMP Monitoring
14.1 TEMP Monitoring
Two TEMP probes can be used together to obtain 2 temperature data and compare them to work out the
temperature difference.
Warning
• Verify probe cables fault detection before beginning of monitoring phase. Unplug the temperature probe
cable of the channel 1 from the socket, the screen will display the error message “TEMP SENSOR1 OFF”
and the audible alarm is activated. The other channel is the same.
The calibration of the temperature measurement is necessary for every two years (or as frequently as
dictated by your Hospital Procedures Policy). When you need calibrate the temperature measurement,
contact the manufacture please.
Note
• Disposable TEMP probe can only be used once for one patient.
• The self-test of the temperature measurement is performed automatically once per hour during the
monitoring. The test procedure lasts about 2 seconds and does not affect the normal measurement of the
temperature monitoring.
• ALM LEV: used to set up the alarm level, selectable from HIGH, MED or LOW.
• ALM REC: used to start/stop recording TEMP alarms. Pick “ON” to enable report printing upon TEMP
alarm.
• Alarm for T1, T2 and TD occurs when the measured temperature exceeds set alarm high limit or falls below
alarm low limit.
T1 is Channel-1 temperature, T2 is Channel-2 temperature, TD is the temperature difference between the
above two.
79
Physiological alarms:
Message Cause Alarm Level
T1 TOO HIGH Measuring value of channel 1 is above upper alarm limit.
TI TOO LOW Measuring value of channel 1 is below lower alarm limit.
User-selectable
T2 TOO HIGH Measuring value of channel 2 is above upper alarm limit.
T2 TOO LOW Measuring value of channel 2 is below lower alarm limit.
TD TOO HIGH Difference between two channels is larger than upper limit.
Technical alarms:
Alarm Message Cause Alarm Remedy
Level
T1 SENSOR OFF Temperature cable of channel 1 LOW Make sure that the cable is properly
may be disconnected from the connected.
monitor.
T2 SENSOR OFF Temperature cable of channel 2 LOW Make sure that the cable is properly
may be disconnected from the connected.
monitor.
T1 ALM LMT ERR Functional safety failure HIGH Stop using alarming function of TEMP
module, notify biomedical engineer or
Our service staff.
T2 ALM LMT ERR Functional safety failure HIGH Stop using alarming function of TEMP
module, notify biomedical engineer or
Our service staff.
TD ALM LMT ERR Functional safety failure HIGH Stop using alarming function of TEMP
module, notify biomedical engineer or
Our service staff.
Prompt message:
Message Cause Alarm Level
T1 EXCEED Measuring value of channel 1 is beyond measuring range. HIGH
T2 EXCEED Measuring value of channel 2 is beyond measuring range. HIGH
80
Note
• Disposable TEMP probe must not be re-sterilized or reused.
• For protecting environment, the disposable TEMP probe must be recycled or disposed of properly.
Chapter 15
IBP Monitoring(optional)
15.1 Introduction
The Monitor measures direct blood pressure (SYS, DIA and MAP) of one selected blood vessel through two
channels, and displays two BP waveforms measures direct blood pressure (SYS, DIA and MAP).
The available pressure labels are:
Label Definition
ART Arterial Blood Pressure
PA Pulmonary Arterial Pressure
CVP Center Venous Pressure
RAP Right Atrial Pressure
LAP Left Atrial Pressure
ICP Intracranium Pressure
P1-P2 Expand Pressure
Note
• Use only the pressure transducer listed in the Chapter Accessories and Ordering Information.
• The specified transducer is designed to have the special ability to protect against the electricity shock
(especially for the leak current allowed), and it is protected against the effects of a discharge of a cardiac
defibrillator. It can be used in the surgical operation. When the patient is in the defibrillation, the waveform
81
of the pressure maybe distorted temporarily. After the defibrillation, the monitoring will go on normally, the
operation mode and the user configuration are not affected.
• Calibrate the instrument either whenever a new transducer is used, or as frequently as dictated by your
Hospital Procedures Policy.
Warning
• If there are air bubbles in the pressure line or the transducer, you should flush the system with the solution
to be infused.
4. Position the transducer so that it is at the same level with the patient’s heart, approximately mid-axillary
line.
5. Check if you have selected the correct label name. See the next section for details.
6. Zero the transducer. See the next section for details.
Pick the IBP SETUP item to call up the IBP SETUP menu as following:
82
• ALM LEV: used to set up the alarm level. Three levels are available: HI, MED, LO.
• ALM REC: Select “ON” to enable recording during the IBP alarm or to OFF to disable the alarm recording
function.
• SWEEP: used to select the scanning speed of the IBP wave. Two selections are available: 12.5 mm/s
or 25 mm/s.
• IBP1 UNIT/IBP2 UNIT: used to select the pressure unit (mmHg / kPa / cmH2O).
• FILTER:non filter,smooth,normal.
• ALM LIMIT SET: used to access the sub-menu of IBP ALM LIMIT SET, in which the user may set up the
upper and lower alarm limit of systolic pressure, diastolic pressure and mean pressure respectively for
channel 1 and channel 2.
• SCALE ADJUST: used to access the sub-menu of IBP PRESS RULER ADJUST, in which the user may
adjust the position of the high, reference and low scales for the two waveforms displayed on the screen.
• EXPAND PRESSURE: used to access the sub-menu of IBP EXPAND PRESS SET, in which the user may
select the pressure name to be represented by P1, P2.
• DEFAULT: pick this item to access the IBP DEFAULT CONFIG dialog box, in which the user may select
whether the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to be used. After selecting
any of the items and exiting the dialog box, the system will pop up the dialog box asking for the user’s
confirmation.
• EXIT: used to exit the menu and return to the main screen.
Warning
• Before set the alarm limits, confirm to choose the correct label.
The alarm occurs when the value exceeds the set limits.
Note
It is the responsibility of the user to ensure that a zero procedure has recently been done on the transducer,
otherwise there will be no recent, valid zero value for the instrument to use, which may result in inaccurate
measurement results.
Caution
• Turn off patient stopcock before you start the zero procedure.
• The transducer must be vented to atmospheric pressure before the zero procedure.
• The transducer should be placed at the same height level with the heart, approximately mid-axially line.
• Zero procedure should be performed before starting the monitoring and at least once a day after each
disconnect-and-connect of the cable.
IBP Calibration
Press the IBP PRESSURE CALIBRATION button on the IBP SELECT menu to call up the IBP PRESSURE
CALIBRATE menu as shown below:
84
Caution
• Mercury calibration should be performed by the biomedical engineering department either whenever a new
transducer is used, or as frequently as dictated by your Hospital Procedures Policy.
• The purpose of the calibration is to ensure that the system gives you accurate measurements.
• Before starting a mercury calibration, a zero procedure must be performed.
• If you need to perform this procedure yourself you will need the following pieces of equipment:
1. Standard sphygmomanometer
2. 3-way stopcock
3. Tubing approximately 25 cm long
• The Calibration Procedure: (SEE Figure Errore. L’origine riferimento non è stata trovata.-10)
Warning
• You must never perform this procedure while patient is being monitored.
1. Close the stopcock that was open to atmospheric pressure for the zero calibration.
2. Attach the tubing to the sphygmomanometer.
3. Ensure that connection that would lead to patient is off.
4. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient catheter.
5. Open the port of the 3-way stopcock to the sphygmomanometer.
85
6. Select the channel to be calibrated in the menu and select the pressure value to which the IBP is to be
adjusted.
7. Inflate to make the mercury bar rise to the setup pressure value.
8. Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury
calibration.
9. Press the Start button, the device will begin calibrating.
10. Wait for the calibrated result. You should take corresponding measures based on the prompt information.
11. After calibration, disassemble the blood pressure tubing and the attached 3-way valve.
If the following messages prompt up, refer to relevant instructions (take channel-1 for instance):
• “SENSOR OFF, FALL”
Make sure that sensor is not off, then proceed calibration.
• “IN DEMO, FAIL”
Make sure that the monitor is not in DEMO mode. Contact service technician if necessary.
• “PRESSURE OVER RANGE, FAIL”
Make sure that you have selected transducer value in IBP CAL, then proceed calibration.
The waveform and corresponding scale appears in the IBP Waveform Area with 3 dotted lines representing
High Limit Scale, Reference Scale, and Low Limit Scale from the top to the bottom. Values of the three
scales can be user-set according to the instruction given below.
• IBP label: selectable from ART, PA, CVP, RAP, LAP, ICP, P1, P2;
• HI: IBP value of High Limit scale, the range is the measuring range of the current pressure.
Note
• The HI value must be higher than the LO value.
LO: IBP value of Low Limit scale, the range is the measuring range of the current pressure.
• The LO value must be lower than the HI value.
VAL: IBP value of Reference scale (between HI and LO).
• When change HI scale, Low scale or Reference scale of IBP waveform and the corresponding IBP
waveforms are displayed under the menu window, the waveform will come penetratingly through the menu
window for observing.
Physiological alarms:
Message Cause Alarm Level
IS1 TOO HIGH SYS measuring value of channel 1 is above User-selectable
upper alarm limit.
IS1 TOO LOW SYS measuring value of channel 1 is below User-selectable
lower alarm limit.
ID1 TOO HIGH DIA measuring value of channel 1 is above User-selectable
upper alarm limit.
ID1 TOO LOW DIA measuring value of channel 1 is below User-selectable
lower alarm limit.
IM1 TOO HIGH MAP measuring value of channel 1 is above User-selectable
upper alarm limit.
IM1 TOO LOW MAP measuring value of channel 1 is below User-selectable
lower alarm limit.
IS2 TOO HIGH SYS measuring value of channel 2 is above User-selectable
upper alarm limit.
IS2 TOO LOW SYS measuring value of channel 2 is below User-selectable
lower alarm limit.
ID2 TOO HIGH DIA measuring value of channel 2 is above User-selectable
upper alarm limit.
ID2 TOO LOW DIA measuring value of channel 2 is below User-selectable
lower alarm limit.
IM2 TOO HIGH MAP measuring value of channel 2 is above User-selectable
upper alarm limit.
IM2 TOO LOW MAP measuring value of channel 2 is below User-selectable
lower alarm limit.
Technical alarms:
Message Cause Alarm Remedy
Level
IBP1 SENSOR OFF IBP cable of channel 1 falis LOW Make sure that cable is properly con-
off from monitor. nected.
IBP2 SENSOR OFF IBP cable of channel 2 fails LOW Make sure that cable is properly con-
off from monitor. nected.
IBP (1,2) INIT ERR
IBP (1,2) INIT ERR1
IBP (1,2) INIT ERR2
IBP (1,2) INIT ERR3 Stop using measuring function of IBP
IBP (1,2) INIT ERR4 IBP module failure HIGH module, notify biomedical engineer or
Our service staff.
IBP (1,2) INIT ERR5
IBP (1,2) INIT ERR6
IBP (1,2) INIT ERR7
IBP (1,2) INIT ERR8
IBP (1,2) COMM STOP IBP(1,2) module failure or HIGH Stop using measuring function of IBP
communication failure module, notify biomedical engineer or
Our service staff.
IBP (1,2) COMM ERR IBP(1,2) communication HIGH Stop using measuring function of IBP
error module, notify biomedical engineer or
Our service staff.
87
IBP1 ALM LMT ERR Functional safety failure HIGH Stop using measuring function of IBP
module, notify biomedical engineer or
Our service staff.
IBP2 ALM LMT ERR Functional safety failure HIGH Stop using measuring function of IBP
module, notify biomedical engineer or
Our service staff.
Warning
• Before cleaning the monitor or the transducer, make sure that the equipment is switched off and
disconnected from the power line.
Note
• The disposable transducers or domes must not be re-sterilized or re-used.
• For protecting environment, the disposable transducers or domes must be recycled or disposed of pro-
perly.
88
Sterilization
Warning
• The sterilize temperature must not exceed 70°C (158°F). Plastics in the pressure transducer may deform or
melt above this temperature.
Chapter 16
CO2 Measuring(optional)
16.1General
This chapter offers some relevant data concerning CO2 monitoring.
The monitor provides two kinds of CO2 measuring methods as per the requirements of users,which are
MainStream and SideStream.
The module is used to monitor continuous carbon dioxide and report the End Tidal carbon dioxide (ETCO2),
Inspired CO2 (InsCO2) and Air Way Respiratory Rate(AWRR) values of the intubated and non-intubated
adult, pediatric ,infant and neonatal patient.
CO2: EtCO2
INS: Inspired Minimum CO2(InsCO2).
AWRR: Air Way Respiration (AwRR)(Resp. times/MIN).
Note
• Before use, if the measurement is MainStream,you must set the “work mode” to “measure”in the submenu
“OTHER SET” of “CO2 SETUP”,otherwise the module will not work correctly.
• Don’t use the device in the environment with flammable anesthetic gas.
• The device can only be operated by personnel having taken professional training and familiar with this
manual.
Warning
• CO2 module shall be avoided from crash and vibration.
• Do not operate the CO2 Module when it is wet or has exterior condensation.
• Do not connect the exhaust tube to the ventilator circuit.
• This product and its accessories are latex free.
• DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min +/- 10 ml/min from the
airway or patients that can not tolerate the added dead space to the airway.
The relation between the partial pressure and the CO2 concentration is given below:
CO2 partial pressure (mmHg) =CO2 concentration (%) × Pamp (ambient pressure, mmHg)
Of CO2 MainStream and CO2 SideStream modules, whichever is selected by the user, autorun measuring
mode is adopted.
1. The Sidestream module can be used for intubated and non-intubated patient.
2. Insert LEMO interface to socket( CO2) of the monitor
3. Connect the sample cell to the module,the sampling pump automatically turns on.Perform sample cell
zero.
4. Place the sampling line on the patient. Removal the sample cell automatically turns sampling pump off.
5. Capnogram displayed in less than 20 seconds, at an ambient temperature of 25°C, full specifications
within 2 minutes.
• Mainstream
Warning
• Do not use the accessory if the packaging or the internal accessory is damaged. Return it to the
manufacturer.
• The sidestream sampling line is disposable. It should not be disinfected for reuse or cross-used
by different patients.
• In the long-term use, dust or other substances may lower the air permeability of the filter material in the
sample cell and may block the airway. In this situation, the sampling line must be replaced.
• No routine user calibration required. For mainstream,an airway adapter zero is required when changing to
a different style of airway adapter.
• UNIT: to change the display units of CO2 and InsCO2 parameters. “mmHg” and “kPa” are available for
selection.
• Exit: to close CO2 SETUP menu.
Note
“APNEA ALM” cannot be closed.
• OTHER SET: pick this item in the menu to call up CO2 more setup sub-menu.
Now we introduce you to the functions of each item in CO2 SETUP submenu.
• WAVE SCALE: to adjust full scale size of CO2 waveform display area with “LO” or “HI” selectable.
The default value is “LO”.
• WORK MODE: in the MainStream measurement ,you must set the work mode to “MEASUREMENT”.
• ATMOS:This setting is used to set current Barometric Pressure.
Resolution: 1 mmHg (400mmHg~850mmHg), Default:760mmHg.
• O2 COMPENSATE:Use this setting to correct for the compensation of the gas mixture administered to the
patient. Resolution: 1% (0~100%), Default: 16%.
• BALANCE GAS: Use this setting to correct for the compensation of the gas mixture administered to the
patient. “room air”, “N2O”, “Helium” Will be selected. Default: “room air”.
• ANEA: Use this setting to correct for the compensation of the gas mixture administered to patient.
Resolution: 0.1% (0.0~20.0%), Default: 0.0%.
Note
• Anesthetic agent is ignored when the balance gas is set to helium.
• Zero: A “Sample Cell Zero “is a quick process that allows the module to accommodate the optical
characteristics of each of the different adapter type ..A Sample Cell Zero should be performed whenever
the type of adapter being used with the module is changed. For optimal accuracy , a Sample Cell Zero
should also be performed whenever the module is connected to the host system.
Note
• No routine calibration required.An airway adapter zero is required when changing to a different style of
airway adapter.
• To perform a Sample Cell Zero:
1. Set the Host to the zeroing function.
2. Connect the CO2 Module and, if necessary, wait for the sensor warm-up message to clear.
3. Connect a Sampling accessory to the module ,and make certain that the accessory is exposed to room
air and away from all sources of CO2,including the ventilator ,the patient’s breath and your own.
4. Start the Sample Cell Zero .The maximum time is 40 seconds .The typical time for a zero is 15-20
seconds.
• When not using CO2 monitoring function, it is suggested that the “ WORK MODE” should be adjusted to
“STANDBY” .
• DEFAULT: pick this item to access the CO2 DEFAULT CONFIG dialog box, in which the user may select
whether the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to be used. After selecting
any of the items and exiting the dialog box, the system will pop up the dialog box asking for the user’s
confirmation.
EtCO2 upper alarm limit: when parameter value exceeds this limit, there will be alarm for exceeding the
upper limit.
92
Default:
Adult: 50 mmHg
Pediatric: 50 mmHg
Neonatal: 45 mmHg
EtCO2 lower alarm limit: when parameter value is smaller than the lower limit, there will be alarm for excee-
ding lower limit.
Default:
Adult: 15 mmHg
Pediatric: 20 mmHg
Neonatal: 30 mmHg
InsCO2 upper alarm limit: when parameter value exceeds this limit, there will be alarm for exceeding upper
limit.
Default:
Adult: 4 mmHg
Pediatric: 4 mmHg
Neonatal: 4 mmHg
AwRR upper alarm limit: when parameter value exceeds this limit, there will be alarm for exceeding upper
limit.
Default:
Adult: 30 rpm
Pediatric: 30 rpm
Neonatal: 100 rpm
AwRR lower alarm limit: when parameter value is smaller than the limit, there will be alarm for exceeding
lower limit.
Default:
Adult: 8 rpm
Pediatric: 8 rpm
Neonatal: 30 rpm
Besides, for alarm function of CO2 module, refer to Chapter Alarm, for its recording function, refer to
Chapter Recording, and for information about alarm event review, graphic and tabular trend of CO2
parameters, refer to Chapter Trend and Event.
Physiological alarms:
Message Cause Alarm Level
CO2 TOO HIGH EtCO2 measuring value is above upper alarm limit. User-selectable
CO2 TOO LOW EtCO2 measuring value is below lower alarm limit. User-selectable
INS TOO HIGH InsCO2 measuring value is above alarm limits. User-selectable
AWRR TOO HIGH AwRR measuring value is above upper alarm limit. User-selectable
AWRR TOO LOW AwRR measuring value is below lower alarm limit. User-selectable
CO2 APNEA In specific time interval, no RESP can be detected HIGH
using CO2 module.
Technical alarms:
Message Cause Alarm Remedy
Level
CO2 Sensor Faulty The Sensor Source Current HIGH Check that the sensor is properly
Failure plugged in. Reinsert or reseat the
sensor if necessary. If error persists,
return sensor to factory for servicing.
CO2 Sensor Over The sensor temperature HIGH Make sure sensor is not exposed to
temp is greater than 40°C extreme heat. If error persists, return
sensor to factory for servicing.
CO2 Check Sam- This error occurs whenever the LOW Check that the sampling line is not
pling Line pneumatic pressure is outside occluded or kinked.
the expected rang
CO2 Zero Error An error was found during Zero LOW To clear, check airway adapter and clean
if necessary. If this does not correct the
error, perform an adapter zero.
CO2 Out of Range The value being calculated is LOW If error persists, perform a zero.
greater than the upper CO2
limit.
CO2 Check Airway Usually caused when the LOW To clear, clean airway adapter if mucus or
Adapter airway adapter is removed moisture is seen. If the adapter is clean,
from the sensor or when there perform a Zero.
is an optical blockage on the
windows of the airway adapter.
May also be caused by failure
to perform Zero to When
adapter type is changed.
CO2 not initialized Barometric Pressure or gas LOW Set the Barometric Pressure and gas
compensations have not been compensations to clear this error.
set since power on.
Prompt message:
Message Cause Alarm Level
CO2 Zero in Progress A Zero is currently in progress No alarm
CO2 Sensor Warm Up Shows that the sensor is in warming-up stage. No alarm
CO2 Check Adapter No alarm
CO2 Zero Required No alarm
CO2 Sample Line This is no sidestream sampling set connected No alarm
Disconnected to the CO2 sensor
94
Chapter 17
Accessories and Ordering Information
This chapter lists the recommendation accessories used in this device.
Warning
• The accessories list below are specified to be used in this device of our company. The device will be
possibly damaged or lead some harm if any other accessories are used.
Chapter 18
Default Settings Appendix
This appendix documents the most important default settings of your monitor as it is delivered from the
factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied
with your monitor. The monitor’s default settings can be permanently changed in Configuration Mode.
Note
If your monitor has been ordered preconfigured to your requirements, the settings at delivery will be different
from those listed here.
Appendix I
Product Specification
1 Classification
Anti-electroshock type Class I equipment and internal powered equipment
EMC type Class A
Anti-electroshock degree ECG(RESP), SpO2, NIBP, IBP,TEMP,CO2 CF
Harmful liquid proof degree Ordinary equipment (sealed equipment without liquid proof)
Disinfection/sterilizing method Refer to Chapter 11 ~ Chapter 16 for details.
Working system Continuous running equipment
99
2 Specifications
2.1 Size and Weight
Size Monitor 314 x 145 x 264 mm
Weight Monitor 3.9 kg
2.2 Environment
Temperature
Working +5°C ~ +40 °C
Transport and Storage -40°C ~ +55 °C
Humidity
Working 30%~75%
Transport and Storage ≤95 %(no coagulate)
Barometric
Working 700hPa ~ 1060hPa
Transport and Storage 500hPa ~ 1060hPa
2.3 Display
Device 12.1 in. Color TFT, 3 LED
Resolution: 800x600
Messages 8 Waveforms Maximum
1 Alarm LED (Orange/Red)
1 Power LED (Green)
1 Battery Charge LED (Yellow)
3 Sound Mode corresponding Alarm Mode
2.4 Battery
Rechargeable 3500mAh 7.4V Li battery
Operating time under the normal use and full charge greater than 90 minutes
Operating time after the first alarm of low battery will be about 5 minutes
Charging: up to 90% after charging 4 hours, fully charged after 5 hours
2.6 Recall
Trend Recall
Short 1 hrs, 1 Second Resolution
Long 480 hrs, 1 Min. Resolution
100
SD card
72 hrs ECG waveform
TREND review
2.7 ECG
Lead Mode 5 Leads (R, L, F, N, C or RA, LA, LL, RL, V)
Lead selection I, II, III, aVR, aVL, aVF, V,
Waveform 2 ch
Lead mode 3 Leads ( R, L, F or RA, LA, LL)
Lead selection I, II, III,
Waveform 1 ch
Gain 2.5mm/mV, 5.0mm/mV, 10mm/mV, 20mm/mV, 40mm/mV
Scan speed 12.5mm/s, 25mm/s, 50mm/s
HR
Measure and Alarm Range
Adult 15 ~ 300 bpm
Neonate/Pediatric 15 ~ 350 bpm
Accuracy ±1% or ±1bpm, which great
Resolution 1 bpm
Sensitivity > 200 uV P-P
Differential Input Impedance > 5 MΩ
CMRR
Monitor ≥ 100dB
Operation ≥ 100 dB
Diagnosis ≥60dB
Electrode offset potential ±300mV
Leakage Current < 10 μA
Baseline Recovery ≤ 5 s After Defi.
Input bias current (lead off detection) ≤ 0.1 μA(driver lead ≤ 1 μA)
ECG Signal Range ±8 mV (Vp-p)
Notch 50Hz/60Hz(Notch filter can be turned on or off manually)
Bandwidth
Surgery 1 ~ 20 Hz(+0.4dB,-3dB)
Monitor 0.5Hz~40Hz(+0.4dB,-3dB)
Diagnostic 0.05Hz~75Hz(+0.4dB,-3dB);76Hz~150Hz(+0.4dB,-4.5dB)
Calibration Signal ST Segment Monitoring Range Measure and Alarm
-2.0 ~ +2.0 mV
Accuracy -0.8 ~ +0.8mV ±0.04mV or ±10% which is greater
Other unspecified
ARR Detecting
Type ASYSTOLE, VFIB/VTAC, COUPLET, BIGEMINY, TRIGEMINY,
RONT, VT>2, PVC, TACHY, BRADY, MISSED BEATS, PNP, PNC
Alarm Available
Review Available
Tall T-wave rejection capability 1.2mV
Heart rate averaging the average value of the latest 6 R-R intervals which
have ignored the maximum and minimum
Updating rate of the display 1s
Heart rate meter accuracy and response to irregular rhythm:
Bigeminy ventricular 80±1bpm
Bigeminy ventricular alternative lente 60±1bpm
Bigeminy ventricular alternative rapid 120±1bpm
Systoles bidirectional 90±1bpm
101
Pace Pulse
Pulse indicator Pulse is marked if the requirements of ANSI/AAMI EC13:2002,Sect.4.1.4.1 are met:
Amplitude: ±2mV ~ ±700mV
Width: 0.1ms ~ 2ms
Pulse Rejection Pulse is rejected if the requirements of ANSI/AAMI EC13-2002:Sect.4.1.4.1 are met:
Amplitude: ±2mV ~ ±700mV
Width: 0.1ms ~ 2ms
2.8 RESPIRATION
Method Impedance between R-F(RA-LL)
Differential Input Impedance >2.5 MΩ
Measuring Impedance Range: 0.3~5.0Ω
Base line Impedance Range: 0.1 KΩ– 2.5 KΩ
Bandwidth 0.3 ~ 2.5 Hz
Scan speed 6.25mm/s, 12.5mm/s, 25mm/s
Resp Rate
Measuring and Alarm Range
Adult 0 ~ 120 rpm
Neonate/Pediatric 0 ~ 150 rpm
Resolution 1 rpm
Accuracy ±2 rpm
Apnea Alarm 10 ~ 40 s
Alarm limit range (rpm)
Alarm high limit (low limit+1)~150
Alarm low limit Adult: 0~(high limit-1) - Pediatric and neonate: 0~(high limit-1)
Alarm limit range Step (rpm) 1
2.9 NIBP
Method Oscillometric
Mode Manual, Auto, STAT
Measuring Interval in AUTO Mode 1, 2, 3, 4, 5, 10, 15, 30, 60, 90,120,240,480,960 Min
Measuring Period in STAT Mode 5 Min
Alarm Type SYS, DIA, MEAN
Neonatal Mode
SYS 40 ~ 135 mmHg
DIA 10 ~ 100 mmHg
MEAN 20 ~ 110 mmHg
Resolution
Pressure 1mmHg
Accuracy
Pressure
Mean error ±5mmHg
Maximum Standard deviation 8mmHg
Software Overpressure Protection
Adult Mode 297±3 mmHg
Pediatric Mode 240±3 mmHg
Neonatal Mode 147±3 mmHg
2.10 SpO2
Measuring Range 0 ~ 100%
Alarm Range 0 ~ 100 %
Resolution 1%
Accuracy 70% ~ 100% ±2 %
0% ~ 69% unspecified
Actualization interval about 1Sec.
Alarm Delay 10 Sec.
Scan speed 12.5mm/s, 25mm/s
Pulse Rate
Measuring and Alarm Range 30~250bpm
Resolution 1bpm
Accuracy ±2bpm
2.11 TEMPERATURE
Channel 2
Measuring and Alarm Range 0 ~ 50 ℃
Resolution 0.1℃
Accuracy ±0.1℃
Actualization interval about 1 Sec.
Average Time Constant < 10 Sec.
2.12 IBP
Channel 2
Label ART, PA, CVP, RAP, LAP, ICP, P1, P2
Measuring and alarm range -10~300mmHg
Press Sensor
Sensitivity 5 uV/V/mmHg
Impedance 300-3000Ω
Resolution 1mmHg
Accuracy ±2% or 1mmHg which great
Actualization Interval about 1 Sec
2.13 CO2
Method Infra-red Absorption Technique
Measuring mode MainStream and Sidestream
Side-stream mode sampling gas flow rate 50ml/Min±10ml/Min
Measuring range
CO2 0~150mmHg
INSCO2 0~150mmHg
103
Appendix II
System Alarm Prompt
"ECG LEAD OFF" ECG lead is not connected correctly. Check the connection of ECG lead wire.
The V lead wire of ECG is not con-
"ECG V LEAD OFF"; Check the connection of V lead wire.
nected correctly.
The LL lead wire of ECG is not con-
"ECG LL LEAD OFF"; Check the connection of LL lead wire.
nected correctly.
The LA lead wire of ECG is not con-
"ECG LA LEAD OFF"; Check the connection of LA lead wire.
nected correctly.
The RA lead wire of ECG is not con-
"ECG RA LEAD OFF"; Check the connection of RA lead wire.
nected correctly.
Alarm information:
May be an incorrect sensor, or a
defective sensor or cable. Insert sensor
Sensor not fully inserted into
into the connector. Disconnect and
the connector.
SpO2 NO SENSOR reconnect sensor. Refer to the
instructions for the sensor being used.
Disconnect and reconnect he sensor
Sensor inserted upside down.
with the logos matching.
SpO2 sensor may be disconnected
SpO2 SENSOR OFF Disconnect and reconnect the sensor.
from the patient or the monitor.
This message appears when the sen-
SpO2 SENSOR FAULT Reattach sensor.
sor is faulty
Stop using the measuring function of
SpO2 UNRECOGNI-
board does not recognize the sensor. SpO2 module, notify biomedical engineer
ZED SENSOR
or our service staff.
Make sure that the monitor and the
SpO2 INCOMPATIBLE This message is displayed when the
patient are in correct connection with
SENSOR sensor is finding incompatible sensor.
the cables.
Outside signal or energy preventing Make sure that the monitor use
SpO2 INTERFERENCE
reading. incompatible sensor.
SpO2 PULSE Unit is searching for the patients
Remove outside interference.
SEARCH pulse.
If values are not displayed within 30
seconds, disconnect and reconnect
SpO2 LOW
Signal too small. sensor. If pulse search continues, remove
PERFUSTION
sensor and replace on a better perfused
site.
Too much light on patient(sensor).
SpO2 TOO MUCH
Inadequate tissue covering sensor Move sensor to better perfused site.
LIGHT
detector.
SpO2 LOW SIGNAL Remove or reduce lighting. Cover sensor
Low signal quality.
IQ from light.
This message appears when the Set
SpO2 BOARD FAULT Reposition sensor.
board malfunctions.
This message is displayed when the
SpO2
front end module is having problems Ensure proper sensor application. Mover
COMMUNICATION
communicating ( ie: framing errors sensor to a better perfused site.
ERROR
or bad checksums) with the board.
SpO2 This message is displayed when Stop using the measuring function of
COMMUNICATION the host can not receive the data from SpO2 module, notify biomedical engineer
STOP board for 5 seconds or our service staff.
This message is displayed when Stop using the measuring function of
SpO2 INIT ERR the SpO2 module initialization error SpO2 module, notify biomedical engineer
happened. or our service staff.
"SYSTEM WD
FAILURE"
"SYSTEM SOFTWARE
ERR"
"SYSTEM CMOS
FULL"
"SYSTEM CMOS
ERR"
"SYSTEMEPGA
FAILURE"
"SYSTEM FAILURE2" Re-start up the system. If the failure still
The system has serious error.
"SYSTEM FAILURE3" exists, contact the manufacturer.
"SYSTEM FAILURE4"
"SYSTEM FAILURE5"
"SYSTEM FAILURE6"
"SYSTEM FAILURE7"
"SYSTEM FAILURE8"
"SYSTEM FAILURE9"
"SYSTEM FAILURE10"
"SYSTEM FAILURE11"
"SYSTEM FAILURE12"
Appendix III
Guidance and manufacture’s declaration-electromagnetic emission
Electromagnetic immunity 1
Electromagnetic immunity 2
3V/m d= 3.5 √P
V1
(800-2500MHz)
d= 3.5 √P 80MHz to 800MHz
E1
d= 71 √P 800MHz to 2.5GHz
E
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 1 At 80MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) 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 Patient Monitor is used exceeds the applicable RF compliance level above, the Patient Monitor should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Patient Monitor.
b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 1V/m(80-800MHz)
&3V/m(800-2500MHz).
113
Appendix IV
SpO2 Clinical Information
Clinical Result information for each sensor
The table below shows ARMS values measured using SpO2 sensor (S5RCH300) with CMS8000 Patient
Monitor in a clinical study.
114
The table below shows ARMS values measured using SpO2 sensor (S5RCS300) with CMS8000 Patient
Monitor in a clinical study.
115
Symbols
106kPa
Stand-by 50kPa
Atmospheric pressure limitation
30°C
USB interface 2°C Temperature limitation
95%
Equipotential grounding system 0%
%
Humidity limitation
Authorized representative
Serial number
in the European community
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specific recycling point for electric
and electronic equipment. For further information on recycling points contact the local
authorities, the local recycling center or the shop where the product was purchased.
If the equipment is not disposed of correctly, fines or penalties may be applied in accordance
with the national legislation and regulations.