Wellue JR2000B Portable Patient Monitor User Manual

Wellue JR2000B Portable Patient Monitor

Specifications:

• Environment:
  • Temperature: Working 0 ~ 40 (C), Transport and Storage -20 ~ 60 (C)
  • Humidity: Working 20% ~ 85%, Transport and Storage 10% ~ 95%
• Warranty: 12 months for main unit, 6 months for accessory (except man-made damage)
• Date of Production and S/N NO.: Check the back label of the device
• Life Expectancy: Main unit – 5 years, Built-in lithium battery – 500 charges and discharges

Chapter 1: Introduction

For an overall introduction to the monitor, please refer to the General Information section. For various messages displayed on the screen, please refer to the Screen Display section. For basic operating instructions, please refer to the Button Function section. For allocation of interface sockets, please refer to the Interfaces section. For important facts to be noted during the battery recharging procedure, please refer to the Battery Recharging section.

1.1 General Information

Make sure to read this manual, all safety information, and specifications before using the Portable Patient Monitor. Please note that this equipment is not intended for family usage.

Transport and Storage:

The device should be transported and stored according to the agreement, avoiding rain and snow splash and mechanical collision.
It should be stored in a dry and well-ventilated room, away from strong sunlight and other corrosive gases.

Important Note:

The monitor should only be used by qualified personnel and in compliance with relevant National Standards. Failure to do so may result in damage or improper functioning of the monitor.

FAQs

• Q1: Can the Portable Patient Monitor be used at home?
  • A1: No, this equipment is not intended for family usage. It should only be used by qualified personnel.
• Q2: What is the warranty period for the main unit and accessory?
  • A2: The warranty for the main unit is 12 months, and for the accessory is 6 months (except for man-made damage).
• Q3: How long is the life expectancy of the main unit and the built-in lithium battery?
  • A3: The main unit has a life expectancy of 5 years, while the built-in lithium battery has a life of 500 charges and discharges.

Portable Patient Monitor
(8 inch)
Model:JR2000B
User Manual

Statement
1 Our company owns all rights to this unpublished work and intends to maintain this work as confidential. Our company may also seek to maintain this work as an unpublished copyright.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 equipment. No part of this can be disseminated for other purposes. 2In 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 Our company to do so. 3 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 , 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. 4Content of this manual is subject to changes without prior notice. PROPERTY OF ALL RIGHTS RESERVED Responsibility on the manufacturer party Our company is responsible for safety, reliability and performance of this equipment only in the condition that: all installation, expansion, change, modification and repair of this equipment are
conducted by Our company 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. Important! Before use, carefully read this manual, all safety information and
specifications. The warranty for main unit is 12 months, and 6 months for accessory, except
man-made damage. Transport: According to agreement, additionally, it should avoid rain and snow
splash and mechanical collision. Storage: The device should be stored in a dry and well-ventilated room, away
from strong sunlight and other corrosive gases. Date of production and S/N NO. : See the back label of the device. The life for main unit is 5 years. The built-in lithium battery has a life of 500 charges and discharges.
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 illustration list and other information to help qualified technician to maintain and repair some parts, which Our company may define as user serviceable. Warranty
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Workmanship & Materials topplor Our company guarantees new equipment other than accessories to be free from defects in workmanship and materials for a period of one year (six months for multi-site probes and SpO2 sensor) from date of shipment under normal use and service. ‘s obligation under this warranty is limited to repairing, at ‘s option, any part which upon ‘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 1It’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 application of the product or the substitution upon it of parts or accessories not approved by Our company or repaired by anyone other than a authorized representative. 2This warranty shall not extend to any instrument which has been subjected to misuse, negligence or accident; any instrument from which ‘s original serial number tag or product identification markings have been altered or removed, or any product of any other manufacturer. Safety, Reliability and Performance Our company is not responsible for the effects on safety, reliability and performance of the JR2000B Portable Patient Monitor if: JR2000B assembly operations, extensions, re-adjusts, modifications or repairs are
carried out by persons other than those authorized by . the Portable Patient Monitor is not used in accordance with the instructions for use, or
the electrical installation of the relevant 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). Return Policy Return Procedure In the event that it becomes necessary to return a unit to , the following procedure should be followed: Obtain return authorization. Contact the Our company Service Department and obtain a Customer Service Authorization number. The number must appear on the outside of the shipping container. Return shipments will not be accepted if the number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. Freight policy. The customer is responsible for freight charges when equipment is shipped to our company for service (this includes customs charges). Preface 1This manual gives detailed description to Portable Patient 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. 2Following 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. Caution Points to be noted to avoid damage to the equipment.
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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 1 Portable Patient Monitor is intended for clinical monitoring application with operation only granted to appropriate MEDICAL INSTRUMENT staff. 2 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 . 3Possible explosion hazard if used in the presence of flammable anesthetics. 4The user must check that equipment and accessories function safely and see that it is in proper working condition before being used. 5Alarm must be set up according to different situation of individual patient. Make sure that audio sounds can be activated when alarm occurs. 6 Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic radiation emitted from such devices may result in strong interference with the monitor performance. 7Do not touch the patient, table nearby, or the equipment during defibrillation. 8The equipment and devices connected to it should form an equipotential body to ensure effective grounding. 9When the monitor is used with Electrosurgery equipment, the operator (surgeon and nurse) must give top priority to the patient safety.
1.1 General Information
Environment: Temperature Working 0 ~ 40 (C) Transport and Storage -20 ~ 60 (C) Humidity Working <= 85 % Transport and Storage <= 93 % Altitude Working -500 to 4,600m(-1,600 to 15,000ft)
Transport and Storage -500 to 13,100m(-1,600 to 43,000ft) Power Supply 100~250 (V)AC, 50/60 (Hz) Pmax=40VA FUSE T 1.6A General instruction: Patient Monitor (Figure 1-1) is adaptable to adult, pediatric and neonatal usage. It can monitor vital signals as ECG, Respiratory Rate, SpO2, NIBP, TEMP, and ETCO2(optional). 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 5 waveforms and full monitoring parameters. The POWER switch is on the left quarter of the front panel (in Figure 1- 1). The POWER indicator(in Figure 1- 1) and the BATT indicator ( in Figure 1- 1) lights when the device is
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powered on. The ALARM indicator flashes or lights when alarm occurs ( in Figure 1- 1).The sockets of the sensors are at the right side. The recorder socket is at the left side. Other sockets and power plug-in are at the back.
message area

wavefor m area

parameter area

Hotkey icon area
Figure 1- 1 Portable Patient Monitor Hotkey icon explain:
icon explain(from left to right)silenceprintfeezepatient informationTrend review nibpparameter set;hotkey sw;screen change;menu Portable Patient Monitor performs monitoring of: ECG Heart Rate (HR), 3 or 5-channel ECG waveforms, S-T segment analysis, Arrhythmia RESP Respiratory Rate (RR) Respiration Waveform SpO2 Oxygen Saturation (SpO2), Pulse Rate (PR) SpO2 Plethysmogram NIBP Systolic Pressure (NS), Diastolic Pressure (ND), Mean Pressure (NM) TEMP Temperature DATA CO2 CO2 waveforms CO2 DATA JR2000B provides extensive functions as visual & audible alarm, storage and report printout for trend data, NIBP measurements, and alarm events, and drug dose calculation function is provided either. The monitor is a user-friendly device with operations conducted by a few buttons on the front panel (Figure 1- 1) and a rotary knob (Figure 1- 1). Refer to Button Functions for details.
1.2 Screen Display
The display of JR2000B may be color or monochrome liquid crystal display. The patient parameters, waveforms, alarm messages, bed number, date, system status and error messages can be reflected from the screen. 1Message Area
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The Message Area is at top of the screen displaying operating state of the monitor and

status of the patient.

The messages and their meanings are:

2BED NO

Bed number of the monitored patient

3ADU

Type of patient

4″2006-5-13″ Current date

5″13:51:32″ Current time

The above messages appear on the screen throughout the monitoring process.

Other information of the Message Area comes up only with respective monitoring status.

They are:

Signs indicating the operating status of the monitor and the sensors are displayed at

the right side of time numeric. When appears, this message will cover the sex and

name information of the patient. ” ” Indicates that all sounds are disabled manually. It appears z SILENCE button is

pressed for more than 1 seconds. ” ” flag for alarm SILENCE. Press “SILENCE” button once (more than 1 second)

to manually mute the alarm sound and this flag appears at the same time. The SILENCE status terminates when you discharge the status or new alarm occurs. ” ” Is the mark indicating that the alarm volume is closed. When select the “OFF” item in the ALARM SETUP menu, this mark appears indicating that the operator has permanently closed the audio alarm function. This audio alarm function can resume only after the operator discharges the closing alarm volume setup. NOTE When ” ” mark appears, the system can not give the audio alarm prompt. Therefore, the operator should be considerate in using this function. One method of discharging this status is in the ALARM SETUP menu, select the item that the alarm volume is in Non-close. Another method is to press the SILENCE button so as to make the mark change into a” “. Then press SILENCE button again, the system will immediately restores the normal alarm status. Alarm message is displayed at the right most area. “FREEZE” appears when the waveforms are frozen. Waveform/Menu Area 1five waveforms can be displayed at the same time. The waveforms from top to bottom

are: ECG I, ECG II, SpO2 Plethysmogram, RESP (possibly coming from ECG module).

Waveforms to be displayed are user-selectable. Refer to Tracing Waveforms Selection for details. 2The names of the waveforms are to their left. Gain and filter of this ECG channel are displayed as well. A 1mv scale is marked on the left of ECG waveform. The same menu always appears at a fixed area on the screen. When the menu is displayed, some waveforms become invisible. The size of the menu is also fixed, covering the lowest 2, 3 or 4 waveforms. 3The waveforms are refreshed in a user-set rate. Refer to the related chapters for details of

sweep speed.

Parameter Area Parameters are displayed at a fixed position.

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1ECG: Heart Rate ( Unit: bpm) ST-segment analysis of Channel 1 & 2 (Unit: mv) 2NIBP: (From left to right) Systolic, Mean, Diastolic (Unit: mmHg or kPa) 3SpO2: SpO2 (Unit: %) 4RESP: Respiration Rate (Unit: breath/min) 5TEMP: Temperature (Unit: or ) 6The above monitoring results are displayed in the Parameter Area. The parameters refresh every second, except that NIBP values refresh each time the measurement is over. User can select the monitor parameters, and the screen display will change accordingly. Alarm indicator: In normal mode, no indicator lights. In alarm mode, the alarm indicator lights or flashes.
1.3 Button Function
All the operations to the monitor are through the buttons and a knob at the bottom of the screen. The names of the buttons are above them. They are (from left to right, Figure 1-3):
Figure 1- 3 Buttons and Knob NIBP (Figure 1- 3) Press to inflate the cuff to start a blood pressure measurement. When measuring, press to cancel the measurement and deflate the cuff. SILENCE(ALARM)(Figure 1- 3) 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 kinds of sounds and the ” “symbol appears from the screen.
Note 1 If new alarm occurs in Alarm Pause/Silence status, the system will discharge Pause/Silence status automatically. For specific rules, see Chapter Alarm. 2The 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. FREEZE(Figure 1- 3) Press this button and the system will access the FREEZE status. In this status the user may review the waveform of 40 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. MENU(Figure 1- 3) 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.
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POWER(Figure 1- 3) POWER ON/OFF switch Rotary knob(Figure 1- 3) 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. Method to use the knob to operate on the screen: The rectangular mark on the screen that moves with the rotation of the knob is called “cursor”. Operation can be performed at any position at which the cursor can stay. 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 background color may become into the frame without background color, 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. Rotary Knob 1e square frame that moves with the knob turning is referred to as “cursor”. 2 en the cursor is placed at any of the first six items, the user can change the current settings. 3When at any of the last six items, related parameter menu can be called up for setting changes. Operation is as follows: When you move the cursor to a certain item, and press the knob, then: 1. A menu pops up, or the current menu is replaced by a new one; or, 2. The cursor frame turns to dotted line, indicating contents in the frame can be changed by turning the knob; or, 3. A “” mark appears indicating “selected”; or, 4. A certain function executes.
1.4 Interfaces
For the convenience of operation, the different kinds of interfaces are in different parts of the monitor. At the left side are the connectors to patient cables and the sensors, as shown in Figure 1- 4.
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Figure 1- 4 left Side
This symbol means “BE CAREFUL”. Refer to the manual.
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. Other symbols in the monitor are explained in chapter Patient Safety.
Figure 1-5 On the rear panel are the following sockets, shown in Figure 1-5 Power Supply: 90~250 (VAC), 50/60 (Hz) Equipotential Grounding Equipotential grounding terminal for connection with the hospital’s grounding system. FUSE: T1.6A/250V
5MM GND connect internet connect Warning
1Through network interface only Clinical Information Center can be connected in. 2 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for MEDICAL INSTRUMENT equipment). Furthermore all configurations shall comply with the valid version of the system
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standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a MEDICAL INSTRUMENT system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.
1.5 Built-in Battery
Patient Monitor is equipped with a rechargeable battery. The battery in the Monitor can automatically recharge when connected to AC INPUT until it is full. A symbol ” ” is displayed on the bottom of the screen to indicate the status of recharging, in which the yellow part represents the relative electric energy of the battery.
Warning Don’t pull off battery when the monitor is working. 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 TOO 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.
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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.
2.1 Open the Package and Check
Open the package and take out the monitor and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list. Check for any mechanical damage. Check all the cables, modules and accessories. If there is any problem, contact the distributor immediately.
2.2 Connect the Power Cables
Connection procedure of the AC power line: Make sure the AC power supply complies with following specification: 100~250 VAC,
50/60 Hz. Apply the power line provided with the monitor. Plug the power line to INPUT
interface of the monitor. Connect the other end of the power line to a grounded 3-phase power output. NOTE 1Connect the power line to the jack special for hospital usage. 2Make 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. 3The battery need to be charged after transportation or storage. 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.
2.3 Power on the Monitor
Press POWER to power on the monitor. Then a beep will be heard and at the same time the indicator will flash twice in yellow and red. After 10 seconds or so, the system will enter monitoring screen after self-test, and you can perform normal monitoring now.
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During self-test, the software version will display. NOTE 1If the monitor finds any fatal error during self-test, it will alarm. 2 Check all the functions that may be used to monitor and make sure that the monitor is in good status. 3 The battery must be recharged to the full electricity after each use to ensure adequate electricity reserve. 4The 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 INSTRUMENT engineer in the hospital or Customer Service Center immediately.
2.4 Connect Patient Sensors
Connect all the necessary patient sensors between the monitor and the patient.
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Chapter 3

System Menu

PATIENT MANAGE , MONITOR SETUP, ALARM MENU, MAINTAIN, RECALL, DRUG CALG, DEMO or EXIT DEMO, HELP
Patient Monitor features flexible configurations. You can configure various aspects of the monitor, including the parameters to be monitored, sweeping speed of the waveforms, audio signal volume, and printout text.
Press the “MENU” hot key on the lower right part of the screen to call up “SYSTEM MENU”. The configuration is realized through operations on the SYSTEM MENU, as shown below.

Figure 3- 1 SYSTEM MENU Figure 3- 2 PATIENT SETUP

3.1 Patient Information Setup

NOTE

To erase present patient data, refer to the section of New Patient Enrolment for

details.

Pick “PATIENT MANAGE” in SYSTEM MENU to call up the following menu.

You can setup the following patient record: Figure 3- 2 PATIENT SETUP

DEPARTMENT Department in which the patient receives treatment.

D NO

Patient bed number (Range: 1-200)

PACE

Pace ON or OFF

SEX

Patient gender (Available options: “F” for Female, “M” for Male)

PAT TYPE

Patient type (Available options: ADU, PED, and NEO)

NEW PATIENT Admission of new patient

Also in this menu, the user may select “NEW PATIENT” item to access “CONFIRM TO

UPDATE PATIENT” dialog box as shown below, in which the user decide whether to

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monitor a new patient. Figure 3- 3

Figure 3- 3 NEW PATIENT Menu

Figure 3- 4 CONFIRM SAVE DEFAULT

CONFIG

Pick YES to erase stored record of the previous patient and exit the menu.

Pick NO to refuse the new patient and keep the previous information and exit the menu.

Note

Selecting “YES” will delete all information about the currently monitored patient.

3.2 Default Setup

Note Select any item in this sub-menu to cancel the current setup and use the selected default setup. In this sub-menu, the user can select both the factory default and the user-defined default. Also in this sub-menu, the user can save the current system configuration as a user-defined default configuration. But at this time, the old user-defined configuration will be replaced by the current one. To restore all settings of parameter menu and the ECG lead, gain, and filter to default settings, select the desired default, and pick EXIT to call up the following menu: Figure 3- 4 CONFIRM SAVE DEFAULT CONFIG Pick YES to erase stored record of the previous patient and exit the menu. Pick NO to refuse the new patient and keep the previous information and exit the menu. NOTE After selecting “EXIT” item, the “CONFIRM SAVE DEFAULT CONFIG” dialog box will pop up, in which the user may choose YES to confirm the selection or NO to give up the selection.

3.3 Trend Function

Pick RECALL in the SYSTEM MENU, as shown in the figure below. Figure 3- 5 RECALL

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Figure 3- 5 RECALL

Figure 3- 6 NIBP RECALL

3.3.1 NIBP Recall

The monitor can review the latest 1000 NIBP measurement data.

Pick NIBP RECALL in the SYSTEM MENU to invoke the result and time of the latest 10

measurements, as shown in the figure below. Figure 3- 6 NIBP RECALL

Data is listed chronologically from the latest to the earliest. 10 measurements can be

displayed in one screen. Pick UP-DOWN to view other trend curve up to 1000 results. Pick

REC to print out all measurement data of NIBP RECALL.
3.3.2 Alarms recall Can review about 1000 records of recent alarms, and review alarm parameters and waveform. 3.3.3 Trend graph review Can display the latest 1-hour trend graph in increment of one data every second or every 5 seconds
Can display the latest 96-hour trend graph in increment of one data every minute or every 5 minutes or 10 minutes. Select “trend graph “in the menu, you will see the below window:

Figure 3-7 trend graph
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vertical axis indicates the measurement value, horizontal axis indicates measurement time, the symbol” “is trend graph cursor,the measured data of the position indicated by the cursor was shown below the graph,while the measurement time was shown above the graph. All the trends are displayed as continuous curve(expect for NIBP).On NIBP trend graph,”SYS”is for Systolic blood pressure; and “DIA”is for diastolic blood pressure, “MAP”is for mean blood pressure.
Select different parameters for trend graph display Select option for ” parameter selection ” , press the knob when it appears the exact parameter you want, you will see the relevant trend graph then.
Select 1-hour or 96-hour trend: Select option for ” Resolution ” , if want to review trend graph within 1-hour, select resolution 1second or 5 seconds; if want to review trend graph within 96-hour, select resolution 1minute or 5 minutes or 10 minutes.
To review trend graph even more earlier or latter: If there’s an” “press the “right”buttonturn the knob clockwise, to review the latter graph, and if there’s ” “press the “left”buttonturn the knob anti-clockwise, to review earlier graph.
To revise display scale: Use the “Adjust Amplitude” button to revise the vertical scale and the trend curve scale will change accordingly. the data greater than the maximum will be represented using the maximum data.
How to get exact data for a specific moment on current trend graph: Select the cursor, and turn the knob left or right, the cursor will move accordingly, time changes too, the data will be shown below the horizontal axis. If there’s” “on right side of the screen, when cursor move to this position,the trend graph will automatically come to next page; while if there’s ” “on the left side of screen, when cursor move to this position,the trend graph will automatically come to a former page, so you can see the earlier trend graph then.
Operation examples: To review NIBP trend graph for past 1-hour press”menu”buttonthen press”system menu” select”recall”optionthen select”trend graph” select parameterselect”parameter selection”optionturn the knobuntil there is “NIBP”
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select”resolution”option, can select “1 second”or”5 seconds” select”left & right”turn the knobcheck the change on time and trend curve stop when it comes to the time period you want to recheck, can revise the display scale to see more clearly. (by press the “adjust amplitude” button) if want to know exact data for a specific moment on current trend graph, select the cursor,move the cursor to the exact position to check, time will be shown above, and measure data will be shown at bottom. press “quit” to exit trend graph.
3.3.4 trend table review recent 336-hour trend table can be shown with resolution 1 minute, 5 minutes, 10 minutes, 30 minutes, 60 minutes. Press “system menu”and then press “trend table review”, you will see below interface
Figure 3-8 trend table The time relevant to each group of trend data is displayed in the left side of column, with the date in parentheses.The event column will show the events have been marked, which corresponds to the time marked the event. The parameters in the trend table can be divided into 10 groups as below: HRSPO2PRSYSMAPDIARRT1T2TD The display of NIBP trend data has its particularity.Beside the measured value, time for NIBP measurement is also displayed under “Measuring Point”. If there are multiple measured values during this time period, only one value can be displayed on screen,others will be displayed at “MORE” with a “*” means there are two or more measurement results.
How to review trend table with different resolution: Select cursor, then select ” resolution ” , turn the knob to revise the option, then select different time interval.
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To review trend table even more earlier or latter: If there’s an” “press the “upper”buttonturn the knob clockwise, to review the latter table, and if there’s ” “press the “down”buttonturn the knob anti-clockwise, to review earlier table.
Select different parameters for trend table Select “left & right”, can review one of the parameters among the 14 of them.there’s ” ” on the right side of the parameter, which means can come to the right page; there’s ” ” on the left side of the parameter, which means can come to the left page. Monitor Information
3.4 Monitor Information
Select the [VERSION] item in the “SYSTEM MENU” to know the software version of the monitor.

Figure 3- 9 Version Figure 3- 10 Monitor Info

Figure 3- 11 Monitor Setup

Select the [DEVICE CONFIG LIST] to know the configuration of the monitor. Figure

3- 10 Monitor Info

3.5 Monitor Set

Select the [MONITOR SETUP] item in the “SYSTEM MENU” to know Below Figure 3- 11 Monitor Setup 3.5.1 Alarm Limit The system can display and setup the alarm limit. The method is:

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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. Select “SELECTION” item in “SYSTEM MENU” to access “SELECTION” sub-menu, in which the user may set up the alarm limit. Set “ALM LIMIT” to ON to display the alarm limits of the parameters displayed on the screen or OFF to hide the alarm limits. 3.5.2 Length of Alarm Records The system may record the information prior to and after the occurring of alarm if physiological alarm occurs. Three recording time is provided: 8s, 16s and 32s, which are the total length of the time prior to and after the alarm. For example, 8s contains the respective information of 4s before and after the alarm. 16s contains the respective information of 8s before and after the alarm, etc. The user may select different recording time based on clinical requirement. The method is listed below; Select “ALARM SETUP” in “MONITOR SETUP” to access the sub-menu of “ALARM SETUP”. In the “ALARM REC TIME” item, the user may choose the length of alarm record. There are three options for user to select: 8s, 16s or 32s. 3.5.3 Time Setup Select “TIME SETUP” item in “MONITOR SETUP” menu to access the sub-menu of “TIME SETUP” as shown below. System time is in format of year, month, day, hour, minute and second. Pick the item you wish to modify and turn the knob, the figure will increase or decrease by 1 at each switch. Then select “EXIT” item to return to the previous menu.
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Figure 3- 12 TIME SETUP Figure 3- 13 MARK EVENT Menu Figure 3- 14 RECORD Menu

3.5.4 Mark Event

There are four types of events that you can define.

Select “MARK EVENT” item in “MONITOR SETUP” to call up the following menu:

Figure 3- 13 MARK EVENT Menu

To mark the event: Use the rotary knob to select one from event A, B, C and D. There is a

“@” signal for the one selected. To cancel your selection, repress the knob at selected item.

Press EXIT to return to the previous menu.

You can use event function:

To differentiate the patient events that have impact on parameter monitoring, such as dose

taking, injection, therapy status, etc.

3.5.5 Recorder Setup

Select “RECORD” in “MONITOR SETUP” menu to call up the following menu:

Figure 3- 14 RECORD Menu

In the sub-menu, the user may select the waveforms to be output in “REC WAVE1” and

“REC WAVE2” items.

ECG1-ECG The first to the seventh ECG waveform on the screen (there are seven

7

ECG waveforms in full leads display) (If no ECG waveform is currently

displayed on the screen, this item cannot be picked)

SPO2

SpO2 Plethysmogram.

RESP

RESP waveform (If no RESP waveform is currently displayed on the

screen, this item cannot be picked,).

OFF

No display for this waveform

RT REC TIME represents “real-time recording time”, for which two selections are available: CONTINUAL and 8S. “CONTINUAL” means once pressing the `REC/STOP’ button on the recorder or on the panel, the recorder will continuously print out the waveform or parameter until this button on the recorder is pressed again.
TIMING REC TIME represents “time interval between two times of timing recording”. 10 selections are available: “OFF, 10MIN, 20MIN, 30MIN, 40MIN,
19

50MIN, 1HOUR, 2HOURS, 3HOURS and 4HOURS”. It means that the system will trigger the recording operation according to the selected time interval. The recording time is fixed at 8 seconds. NOTE 1RT REC TIME has the priority compared with TIMING REC TIME. REC RATE has two selections: 25.0 and 50.0 mm/s. REC GRID is used to decide output format: OFF is without grid, and ON is with grid. CLEAR REC TASK can be used by the user to stop recorder from printing out too many tasks that are triggered by alarm events. 2The recorder is an optional part. 3 If two same waveforms are selected, one of them is switched to a different waveform automatically.
3.6 Maintenance
Select “MAINTAIN” item in “SYSTEM MENU” access “ENTER MAINTAIN PASSWORD” dialog box as shown below, in which the user may enter password and set up the user-defined maintenance settings. The user may not execute the factory maintenance function, which is only available for appointed personnel of the Company. The user may select “STATUS” to access “STATUS” sub-menu, in which the user may view the information of the monitor start up and errors detected.

Figure 3- 15 ENTER MAINTAIN PASSWORD

Figure 3- 16 STATUS

In “STATUS” sub-menu, the user may use rotary knob to select “UP-DOWN” item and

then turn the knob clockwise or counter-clockwise to view the monitor information such as

start up time, alarm and the like. The user may select the “REC” item by using knob to

print out the currently displayed information via the recorder. Figure 3- 16 STATUS

For user default, enter the user key and press the “CONFIRM” key to access “USER

MAINTAIN” menu. Following is the detailed description on the settings able to be realized

in this menu.

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Figure 3- 17 User Maintain Figure 3- 18 COLOR SELF-DEFINE Figure 3-19 Input Demo Key
LANUGAGE: two selections are available:CHINESE and ENGLISH. LEAD: refers to the net No. COLOR SELF-DEFINE: is used by the user to define the color of the waveform
displayed on the screen. Five colors can be chosen from green, cyan, red, yellow and white. Figure 3- 15 COLOR SELF-DEFINE
3.7 DEMO function
Select the [DEMO] item in the “SYSTEM MENU” to call up the “ENTER DEMO PASSWORD”. After entering the password, the system enters DEMO status. Figure 3-19 Input Demo Key The purpose of waveform demonstration is only to demonstrate the machine performance, and for training purpose. In clinical application, this function is not forbidden because the DEMO will mislead the MEDICAL INSTRUMENT staff to treat the DEMO waveform and parameter as the actual data of the patient, which may result in the delay of treatment or mistreatment. Therefore before entering this menu, you shall enter password.
3.8 Parameters setup
Set ECGRESPTEMPSPO2NIBPCO2parameters.
21

Chapter 4

Patient Safety

The Portable Patient Monitor is designed to comply with the International National Safety requirements for MEDICAL INSTRUMENT 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 10 seconds after defibrillation.
This symbol indicates that the instrument is IEC60601-1 Type CF equipment. The
unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.
Warning Do not touch the patient, bed or instrument during defibrillation. Environment Follow the instructions below to ensure a completely safe electrical installation. The environment where the JR2000B Portable Patient Monitor will be used should be reasonably free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation, allow sufficient room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open. The Portable Patient Monitor operates within specifications at ambient temperatures between 0 and 40. 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 (5cm) clearance around the instrument for proper air circulation. Grounding the Portable Patient Monitor To protect the patient and hospital personnel, the cabinet of the JR2000B Portable Patient Monitor must be grounded. Accordingly, the JR2000B Portable Patient Monitor is equipped with a detachable 3-wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not available, consult the hospital electrician. If completeness of the protective grounding wire is in doubt, the equipment must be operated with internal power supply.
Warning Do not use a 3-wire to 2-wire adapter with this instrument. 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.
22

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 JR2000B Portable Patient 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 MEDICAL INSTRUMENTly 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 1If 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 equipment is moved from one building to another, thus being exposed to moisture and differences in temperature. 2Possible explosion hazard if used in the presence of flammable anesthetics. Explanation of Symbols in the Monitor
1s symbol means ‘BE CAREFUL ‘. Refer to the manual.
2is symbol indicates that the instrument is IEC60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation. This symbol indicates that the instrument is IEC60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.
3Equipotential grounding system
4 Protective earth ground
5Partial On/Off
23

Chapter 5

Care / Cleaning

5.1 System Check
Before using the monitor, do the following: check if there is any mechanical damage; check all the outer cables, inserted modules and accessories; check all the functions of the monitor to make sure that the monitor is in good
condition. If you find any damage on the monitor, stop using the monitor on patient, and contact our 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.
Warning 1. 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. 2. Refer the battery replacement only to our service technician. 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.
5.2 General Cleaning
Warning Before cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected from the power line. The Monitor must be kept dust-free. Regular cleaning of the monitor shell and the screen is strongly recommended. Use only non-caustic detergents such as soap and water to clean the monitor shell.
Note
24

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. 6. 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. Reusable TEMP Probes 1. The TEMP probe should not be heated above 100 (212 ). It should only be
subjected briefly to temperatures between 80 (176) and 100 (212). 2. Only detergents containing no alcohol can be used for disaffection. 3. The rectal probes should be used, if possible, in conjunction with a protective rubber
cover. 4. To clean the probe, hold the tip with one hand and with the other hand rubbing the
probe down in the direction of the connector using a moist lint-free cloth. Disposable TEMP probe must not be re-sterilized or reused. For protecting environment, the disposable TEMP probe must be recycled or disposed of properly.
5.3 Cleaning Agents
Examples of disinfectants that can be used on the instrument casing are listed below: Diluted Ammonia Water Diluted Sodium Hyoichlo (Bleaching agent).
Note The diluted sodium hyoichlo from 500ppm(1:100 diluted bleaching agent) to 5000ppm (1:10 bleaching agents) is very effective. The concentration of the diluted sodium hyocihlo depends on how many organisms (blood, mucus) on the surface of the chassis to be cleaned. Diluted Formaldehyde 35% — 37%, Hydrogen Peroxide 3% Alcohol, Isopropanol
Note 1 the monitor and sensor surface can be cleaned with hospital-grade ethanol and dried in air or with crisp and clean cloth. 2 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.
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5.4 Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first. Recommended sterilization material: Ethylate, and Acetaldehyde. Appropriate sterilization materials for ECG lead, blood pressure cuff are introduced in Chapters ECG/RESP Monitoring, Chapter NIBP Monitoring respectively.
Caution Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest
possible density. Do not let liquid enter the monitor. No part of this monitor can be subjected to immersion in liquid. Do not pour liquid onto the monitor during sterilization. Use a moistened cloth to wipe up any agent remained on the monitor.
5.5 Disinfection
To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first. Appropriate disinfection materials for ECG lead, SpO2 sensor, blood pressure cuff, TEMP probe, and CO2 cable are introduced in Chapters 12-18 respectively.
Caution Do not use EtO gas or formaldehyde to disinfect the monitor.
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Chapter 6

Alarm

This chapter gives general information about the alarm and corresponding remedies. Alarm setup and prompt messages are provided in respective parameter setup
sections.
6.1 Alarm Modes
6.1.1 Alarm Level Each alarm, either technical or physiological, has its own level. For alarm of higher level, when it occurs, the system will give prompt in a more alert way. Some alarm’s level can be set by the user via software. Others can not by changed once defined by the system. Alarms in JR2000B are divided into three levels, that is, high, medium and low. 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. JR2000B 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. 6.1.2 Alarm Modes When alarm occurs, JR2000B may raise the user’s attention in at least three ways, which are audio prompt, visual prompt and description. Audio and visual prompt is given by TFT/touch screen display device, the speaker on the display device and the alarm indicator. Description is displayed on the screen. Physiological alarm is displayed in the Physiological Alarm area. Most of technical alarms are displayed in the Technical Alarm area. Technical alarms related to NIBP measurement are displayed in the NIBP Technical Alarm area at the bottom of NIBP parameter area. NOTE 1 The Physiological Alarm area is on the upper right part of the screen. The
27

Technical Alarm area is to the left side of the Physiological Alarm area.

2 If JR2000B is connected to the external alarm prompt system (e.g. the alarm

speaker and indicator connected onto the rear panel of JR2000B ), when alarm occurs,

the external alarm prompt system responds in the same way as the JR2000B .

3The concrete presentation of each alarm prompt is related to the alarm level.

Alarm prompt of the parameter exceeding the alarm limit.

When physiological alarm of the monitored parameter exceeds the alarm limit, besides

using the above-mentioned three ways to give the alarm prompt, the monitor also gives

alarm by making the monitored parameter flash in the frequency of 1Hz. If at this time the

upper and lower limits of the parameter are displayed, they will flash in the same frequency

(1Hz).

Screen Display

When an alarm occurs, the parameter triggering the alarm flashes. “*” 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 level

Visual prompt

High

Alarm indicator flashes in red with high frequency.

Medium

Alarm indicator flashes in yellow with low frequency.

Low

Alarm indicator lights on in yellow.

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 24 seconds.

Low

Mode is “DO-“, which is triggered once every 24 seconds.

NOTE When alarms of different levels occur at the same time, the monitor prompts

the one of the highest level.

6.1.3 Alarm Setup

The setup of the alarms can be realized in the alarm menu.

Press the “ALARM SETUP” button on the MONITOR SETUP menu to call up “ALARM

SETUP” menu (default menu) as shown below. In the “ALM SEL” item, the user may set

up the information about common alarm setup (represented by “COMMON ALM SETUP”)

and the alarm setup of each parameter.

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Figure 6- 1 ALARM SETUP COMMON ALM SETUP Select “COMMON ALM SETUP” selection in “ALM SEL” item. This operation may call up the dialog box as the default one. ALARM VOL: which has three selections: OFF, LOW, MED and HIGH. ALM REC TIME: which has three selections: 8S, 16S, 32S. ALM PAUSE TIME: refers to the alarm suspension time span, which has three
selections: 1MIN, 2MIN, 3MIN. PARA ALM TYPE: which has two selections: LATCH, UNLATCH. LATCH refers to
the situation once alarm occurs, the system will alarm always until the intervention of the operator (press PAUSE or SILENCE on the panel). UNLATCH refers to the situation that once the alarm condition is discharged, the alarm will disappear automatically. Alarm setup of each parameter In “ALARM SETUP” menu select “ALM SEL” item to set up the alarm information of following parameters. They are HR, ST, PVC, SPO2, NIBP, RESP, TEMP. For example: Method to set up alarm information of HR: Step 1: Select “HR ALM SETUP” in “ALM SEL” item to call up the dialog box “ALARM SETUP” for HR only. Step 2: Five items are available for the user to set up, which are HR ALM (on/off of the alarm switch), ALM LEV(alarm level), ALM REC(alarm recording switch), ALM HI (higher limit of HR alarm), ALM LO (lower limit of HR alarm). When use the knob to select each item and press the knob, a pull-down list appears for the user to choose his desired selection. The method for setting the alarm information of other parameters is the same as HR.
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6.2 Alarm Cause
Alarm occurs when: 1.Physiological alarm is evoked; 2. Alarm for error of the system (technical alarm) is evoked; 3. General alert occurs. A. Conditions that activate the parameter alarms: When the measurement value exceeds the alarm limit and the alarm is set “ON”. Alarm will not activate if the alarm is set “OFF”. B. Conditions that activate the system alarms (technical alarm): Upon the system error, the monitor prompts alarm immediately and proceeds corresponding remedy, stops all monitoring and eliminates the final results in order to avoid faulted treatment. If more than one error occur, they will be displayed by turns. 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.
6.3 SILENCE and PAUSE
SILENCE Press the SILENCE button on the panel for more than 1 seconds can shut off all
sounds until the SILENCE button is pressed again. When the system is in SILENCE status, any newly generated alarm will discharge the SILENCE status and make the system give normal status giving audio and visual alarm. 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.
6.4 Parameter Alarm
The setup for parameter alarms is in their menus. In the menu for a specific parameter, you
30

can check and set the alarm limit, alarm status. The setup is isolated from each other. When a parameter alarm is off, a symbol displays near the parameter. If the alarms are turned off individually, they must be turned on individually. 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.
6.5 When an Alarm Occurs
NOTE When an alarm occurs, you should always check the patient’s condition first. 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.
6.6 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.
6.7 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.
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Chapter 7

ECG/RESP Monitoring

7.1 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, JR2000B provides display of 2-channel ECG waveforms. The patient cable consists of 2 parts(See Chapter Accessories and Ordering
Information for detail information of the ECG accessories); The cable that connects to the monitor; The lead set that connects to the patient. 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 ECG waveforms are the first two waveforms from top in the Waveform Area.
7.2 Precautions during ECG Monitoring
Warning 1Do not touch the patient, table nearby, or the equipment during defibrillation. 2Use only the original JR2000B ECG cable for monitoring. 3 When connecting the cables and electrodes, make sure no conductive part is in contact with the ground. Verify that all ECG electrodes, including neutral electrodes, are securely attached to the patient. NOTE Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform.
7.3 Monitoring Procedure
7.3.1 Preparation 1. Prepare the patient’s skin prior to placing the electrodes. The skin is a poor conductor of electricity, therefore preparation of the patient’s skin is
important to facilitate good electrode contact to skin. Shave hair from sites, if necessary. Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because
this increases skin impedance).
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Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease.
2. Attach clip or snap to electrodes prior to placement. 3. Put the electrodes on the patient. Before attaching, apply some conductive jelly on the electrodes if the electrodes are not electrolyte self-supplied. 4. Connect the electrode lead to the patient’s cable. 5. Make sure the monitor is ready with power supply.
Warning 1. Check everyday whether there is skin irritation resulted from the ECG
electrodes. If so, replace electrodes every 24 hours or change their sites. 2. 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 For protecting environment, the electrodes must be recycled or disposed of properly. 7.3.2 Installing ECG lead Placing the Electrodes for ECG Monitoring Electrode placement for 5-lead set (Figure 8- 2) Red (R) electrode – Be placed near the right shoulder, directly below the clavicle. Yellow (L) electrode – Be placed near the left shoulder, directly below the clavicle. Black (N) electrode – Be placed on the right hypogastrium. Green (F) electrode – Be placed on the left hypogastrium. White (C) electrode – Be placed on the chest as illustrated in the F Figure 8- 3 Note: the following table gives the corresponding lead names used in Europe and America respectively. (Lead names are represented by R, L, N, F and C respectively in Europe, whose corresponding lead names in America are RA, LA, RL, LL and V.)
Figure 7-1 Electrode placement for 5-lead set 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
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Warning 1When 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. 2The 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, 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. Using 5-lead ECG set The default setting is ECG CH1 corresponding to Channel II, and ECG CH2 to Channel I, you can modify the setting to meet your needs. You can set them to correspond to any two from I, II, III, AVR, AVL, AVF and V. If you set both to the same value, one of them will be adjusted to another option automatically. (Figure 8- 4)
F
Figure 7- 2 ECG lead NOTE If a ECG waveform is not accurate, while the electrodes are tightly attached, try to change the lead. NOTE Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform. Normal QRS complex should be: Tall and narrow with no notches. With tall R-wave completely above or below the baseline. With pacer spike no higher than R-wave height.
34

With T-wave less than one-third of the R-wave height. With P-wave much smaller than the T-wave. For getting 1 mv calibrated ECG wave, pick the ECG CAL button in the ECG SETUP menu. A message “when CAL, can’t monitor! ” prompts on the screen.
Figure 7-3 Standard ECG Waveform Warning Do not touch the patient, table nearby, or the equipment during defibrillation.
7.4 ECG Menu
ECG SETUP Menu Pick the ECG hot key on the screen, and the following menu will popup.
Figure7-4 ECG SETUP menu ECG alarm setting HR ALM: pick “ON” to enable prompt message and data record during the ECG
alarm; pick “OFF” to disable the alarm function, and there will be a beside “ECG”. 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. ECG alarm is activated when the heart beat exceeds set ALM HI value or falls below ALM LO value. NOTE Please set the alarm limits according to clinical condition of individual patient. The
35

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 LEAD TYPE Used to select either 5 LEADS or 3 LEADS. SWEEP Available options for SWEEP are 12.5, 25.0, and 50.0 mm/s. ST ANALYSIS Pick this item to access ST ANALYSIS menu, the detailed information about the menu is to be discussed in the following section. ARR ANALYSIS Pick this item to access ARR ANALYSIS menu, the detailed information about the menu is to be discussed in the following section. OTHER SETUP Pick this item to access ECG SETUP menu as shown below:
Figure 7-5 ECG SETUP menu In the sub-menu, following functions are available: BEAT VOL Four selections are available: OFF, LOW, MED, HIGH. HIGH indicates maximum volume. OFF indicates no sound. PACE “ON” detected signal will be marked by a ” ” above the ECG waveform. “OFF” for non-pacemaking patient NOTE If monitoring a patient with the pacemaker, set “PACE” to ON. If monitoring a
36

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. ECG CAL Pick this item to start calibrating ECG. The method to end CAL: re-select the ECG 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. Note: For monitor with ST segment & Arrhythmia analysis software, refer to ST Segment Monitoring and Arrhythmia Analysis for details. NOTE 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.
7.5 ECG Alarm Information and Prompt
Alarm Message Alarms occurring in the process of ECG measurement contain two types: physiological alarm and technical alarm. Prompt message may also appear in the mean time. For the audio and visual features during the appearance of these alarms and prompt messages in the process of ECG measurement, please refer to the related description in Chapter Alarm. In the screen, physiological alarm messages and the prompt messages able to trigger alarms (general alerts) all displayed in the alarm area of the monitor while technical alarms and prompt messages unable to trigger alarms are then displayed in the information area of the monitor. This section does not describe the content about Arr. and ST analysis. 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. Tables below describe respectively the possible various alarms those may occur during the measurement.
37

Physiological alarms:

Message

Cause

Alarm level

ECG LOST HR TOO HIGH OR TOO LOW
Technical alarms:

No ECG signal of the patient is detected. HR measuring value is above the upper or below the alarm limit

HIGH User-selectable

Message Cause

Alarm level

Remedy

ECG LEAD OFF
ECG COMM STOP
HR ALM LMT ERR

ECG electrodes fall off the skin or ECG cables fall off the monitor.
Occasional communication failure
Functional safety failure

LOW HIGH HIGH

ECG NOISE

ECG measuring signal is greatly interfered.

LOW

Prompt messages (include general alerts):

Make sure that all electrodes, leads and patient cables are properly connected. If failure persists, notify our engineer or service staff.
Stop using HR alarm function, notify our engineer or service staff. Make sure the patient is quiet, the electrodes are properly connected and AC power system is well grounded.

Message

Cause

Alarm Level

HR EXCEED HR measuring value exceeds the measurement range. HIGH

7.6 ST Segment Monitoring
ST segment monitoring function is shutoff by default. You can switch it to ON when necessary.
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. 7.6.1 ST ANALYSIS menu

38

Figure 7-6 ST ANALYSIS menu

ST analysis alarm setting ST ANAL: the switch for ST analysis. Set it to ON to activate the ST analysis or OFF

to disable the ST analysis. ST ALM: pick “ON” to enable prompt message and data record during the ST analysis

alarm; pick “OFF” to disable the alarm function, and there will be a beside ST. ST

alarm is activated when the result exceeds set ST HI value or falls below ST LO value. ALM LEV: used to set up the ST alarm level. There are three selections: HIGH, MED

and LOW. ALM REC: pick “ON” to enable report printing upon ST analysis alarm. ALM HI: used to set up the upper limit of ST alarm. The max. higher limit is 2.0. The

minimum higher limit is 0.2 larger than the set lower limit. ALM LOW: used to set up the lower limit of ST alarm. The minimum lower limit is

­2.0. The max. lower limit is 0.2 lower than the set higher limit.

ST analysis alarm limits

Max. ST HI Min. ST LO

Step

ST 2.0 mv

-2.0 mv

0.1

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. Default is 78 ms.

ST

Measurement point.

Figure 7-7 DEF POINT window 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 8- 10).
39

R Wave

T P

Q S

ISO

ST

-78 ms

+109 ms

Figure 7-8 DEF Point

} ST Value

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

Note: 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.

Tables below describe the possible physiological alarms, technical alarms and prompt

messages during ST measurement.

Physiological alarms:

Message

Cause

Alarm Level

STI TOO LOW

ST measuring value of channel 1 is below the lower alarm limit.

User-selectable

40

ST2 TOO HIGH ST2 TOO LOW

ST measuring value of channel 2 is above the upper alarm limit.
ST measuring value of channel 2 is below the lower alarm limit.

User-selectable User-selectable

Technical alarms:

Message

Cause

ST ALM Functional LMT ERR safety failure

Alarm Level
HIGH

Remedy
Stop using ST alarming function, notify our engineer or service staff.

Prompt messages (include general alerts):

Message

Cause

Alarm Level

ST1 EXCEED ST2 EXCEED

ST measuring value of channel 1 exceeds the measurement range.
ST measuring value of channel 2 exceeds the measurement range.

HIGH HIGH

7.7 Arr. Monitoring

Arrhythmia Analysis The arrhythmia algorithm is used to monitor ECG of neonate and adult patient in clinical, detect the changing of heart rate and ventricular rhythm, and also save arrhythmia events and generate alarming information. Arrhythmia algorithm can monitor paced and non-paced patients. Qualified personnel can use arrhythmia analysis to evaluate patient’s condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and decide the treatment. Besides detecting changing of ECG, arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia. 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. ARR ANALYSIS Menu

Figure 7-9 ARR ANALYSIS Menu
41

ARR ANAL: Pick “ON” during monitoring. Default set is “OFF”. ALM: Pick “ON” to enable prompt message and data record when alarm occurs; pick

“OFF” to disable the alarm function, and there will be a beside “PVCs”. ALM LEV: selectable from HIGH, MED, LOW. Level HIGH represents the most

serious case. ALM REC: pick “ON” to enable report printing upon PVCs alarm. ALM HI: PVCs alarm is activated when the PVCs exceeds set PVCs ALM HI value.

PVCs alarm upper limits:

Max

Min

Step

PVCs

10

1

1

PVCs alarm and prompt message:

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.

Tables below describe the possible physiological alarms, technical alarms and prompt

messages occurring during PVCs measurement.

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 Functional LMT ERR safety failure

HIGH

Stop using PVCs alarming function, notify bioMEDICAL INSTRUMENT engineer or service staff.

ARR RELEARN Pick this item to start a learning procedure.

ARR ALARM Pick this item to access the ARR ALARM dialog box to set arrhythmia

alarm parameters.

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.

Figure7-10 ARR ALARM Menu
42

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.

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 indicator 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).

Physiological alarms:

Arr. Type

Applicable Patient Type

Occurring Condition

Prompt

Alarm Level

ASYSTO All patients LE

No QRS is detected for 4 consecutive seconds

ASYSTOLE

User-selecta ble

Fibrillatory wave for consecutive 4

VFIB /VTAC

Without pacemaker

seconds; or The number of continuous Vent beats is larger than the upper limit of cluster Vent beats (>5). The RR

VFIB/VTAC

User-selecta ble

interval is less than 600ms.

VT>2

Without pacemaker

3 < the number of cluster PVCs < 5

VT>2

User-selecta ble

COUPLE Without 2 consecutive PVCs

T

pacemaker

COUPLET

User-selecta ble

BIGEMI Without Vent Bigeminy

NY

pacemaker

BRGEMINY

User-selecta ble

TRIGEM Without Vent Trigeminy

TRIGEMIN User-selecta

INY

pacemaker

Y

ble

A type of single PVC under the condition that HR<100R-R interval

R ON T

Without pacemaker

is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval(the

R ON T

User-selecta ble

next R wave advances onto the

previous T wave).

Single PVCs not belonging to the type

PVC

Without of above mentioned PVCs. pacemaker

PVC

User-selecta ble

TACHY All patients BRADY All patients
BEAT Without MISS pacemaker

5 consecutive QRS complex , RR interval is less than 500ms.

TACHY

User-selecta ble

5 consecutive QRS complex, RR interval is longer than 1.5s.

BRADY

User-selecta ble

When HR is less than 100 beats/min.,

no heart beat is tested during the period

1.75 times of the average RR interval; or

BEAT MISS

User-selecta ble

When HR is larger than 100 beats/min.,

no beat is tested with 1 second.

43

No QRS complex and pacing pulse are

PNP

With pacemaker

availabe during the period 1.75 times of the average R-R interval (only

PNP

considering patients with pacemaker.)

When pacing pulse is available, no

PNC

With pacemaker

QRS exists during the period 1.75 times of the average RR interval (only

PNC

considering patients with pacemaker.)

User-selecta ble
User-selecta ble

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 process.

NOTE

Arrhythmia name displays in the Alarm Message Area.

No alarm

7.8 Measuring RESP

7.8.1 How to measure RESP? The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes. The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. 7.8.2 Setting Up RESP measurement 1For RESP monitoring, it is not necessary for additional electrodes, however, the placing of electrodes is important. 2 Some patients, due to their clinical condition, expand their chest laterally, causing a negative intrathoracic pressure. In these cases it is better to place the two RESP electrodes laterally in the right axillary and left lateral chest areas at the maximum point of breathing movement to optimize the respiratory waveform. NOTE It is not recommended using the RESP monitoring on patients who are very active, as this can cause false alarms. Checklist for RESP Monitoring 1. Prepare the patient’s skin prior to placing the electrodes. 2. Attach snap or clip to the electrodes and attach the electrodes to the patient as
described below. 3. Switch on the monitor. 7.8.3 Installing electrode for RESP measurement
44

Placing the Electrodes for Respiratory Monitoring
L Yellow R Red

N Black

F Green

Figure 7-13 Electrodes placement (5-lead)

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.

7.8.4 RESP menu

RESP SETUP Menu

Pick RESP hot key on the screen to call up the following menu:

Figure 7-14 RESP SETUP Menu

RESP alarm setting ALM: pick “ON” to enable prompt message and data record during the RESP alarm;

pick “OFF” to disable the alarm function, and there will be a

beside “RESP”.

ALM REC: pick “ON” to enable report printing upon RESP alarm.

RESP alarm is activated when the respiration rate exceeds set ALM HI value or falls below

ALM LO value.

RESP alarm limits: 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 are 6.25, 12.5 and 25.0 mm/s.

WAVE AMP: The user may set up the displaying amplitude of the RESP waveform.

45

The selections are 0.25, 0.5, 1, 2, 3, 4, 5. HOLD TYPE: AUTO/MANUAL adjustable. When it is AUTO mode, HOLD HI and
HOLD LO menus cannot be used and the monitor automatically calculates the RESP RATE. HOLD HI and HOLD LO: When the HOLD TYPE is MANUAL, the user can use the knob to pick either HOLD HI or HOLD LO and turn the knob to adjust the two dashed lines in the RESP WAVEFORM area respectively. The positions of the dashed lines will be used to calculate the upper and lower limits of RESP RATE by the monitor. 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 RESP Alarm Msessage 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.

Tables below describe the possible physiological alarms, technical alarms and prompt

messages occurring during RESP measurement.

Physiological alarms:

Message

Cause

RR TOO HIGH RESP measuring value is above upper alarm limit.

RR TOO LOW RESP measuring value is below lower alarm limit.

RESP APNEA

RESP can not be measured within specific time interval.

Technical alarms:

Alarm Level User-selectable User-selectable
HIGH

Message

Cause

Alarm Level Remedy

RESP ALM Functional LMT ERR safety failure

HIGH

Prompt message (general alerts):

Stop using RESP alarming function, notify our engineer or service staff.

Message

Cause

Alarm Level

RR EXCEED RR measuring value exceeds the measure range. HIGH

46

Chapter 8

SpO2 Monitoring

8.1 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. 8.1.1 How the SpO2 / PLETH Parameter Works Arterial oxygen saturation is measured by a method called pulse oximetry. It is a
continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger or an ear), to a receiver on the other side. The sensor measurement wavelengths are nominally 660nm for the Red LED and 940nm for Infrared LED. Maximum optical power output for LED is 4 mW. The amount of light transmitted depends on many factors, most of which are constant. However, one of these factors, the blood flow in the arteries, varies with time, because it is pulsating. By measuring the light absorption during a pulsation, it is possible to derive the oxygen saturation of the arterial blood. Detecting the pulsation gives a PLETH waveform and pulse rate signal. The SpO2 value and the PLETH waveform can be displayed on the main screen. Warning Pulse oximetry can overestimate the SpO2 value in the presence of Hb- CO, Met-Hb or dye dilution chemicals. 8.1.2 SpO2 / Pulse Monitoring Warning 1ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up. 2Do not put the sensor on extremities with arterial catheter or venous syringe. Note Do not perform SpO2 measuring and NIBP measuring in same arm at one time, because obstruction of blood flow during NIBP measuring may adversely affect the reading of SpO2 value.
8.2 Precautions during SpO2/Pulse Monitoring
Note Make sure the nail covers the light window; The wire should be on the backside of the hand. Note SpO2 value always displays at the same position. Pulse Rate will display when HR FROM
47

is set at “SPO2”, “BOTH” in the ECG SETUP menu. Note SpO2 waveform is not proportional to the pulse volume.
Warning 1Verify sensor cable fault detection before beginning of monitoring phase. Unplug the SpO2 sensor cable from the socket, the screen will display the error message “SPO2 SENSOR OFF” and the audible alarm is activated. 2 Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor. 3Prolonged 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.
8.3 Monitoring Procedure
SpO2 plethysmogram measurement 1. Switch on the monitor. 2. Attach the sensor to the appropriate site of the patient finger. 3. Plug the connector of the sensor extension cable into the SpO2 socket on the
JR2000B.
Figure8-1mounting of the sensor
8.4 Limitations for Measurement
Measurement Limitations In operation, the accuracy of oximetry readings can be affected by: High-frequency electrical noise, including noise created by the host system, or noise
from external sources, such as electrosurgical apparatus, which is admitted by the host system. Do not use oximeters and oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. Intravascular dye injections Excessive patient movement Improper sensor application Sensor temperature (maintain between 28°C and 42°C for best operation )
48

Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter, or intravascular line.
Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and methemoglobin.
External illumination more than 5,000 lumens/square meter (typical office lighting) Venous pulsations It is recommended to use SpO2 sensors described in chapter Accessories and Ordering
Information.
8.5 SpO2 Menu
SPO2 SETUP Menu Pick the SPO2 hot key on the screen to call up the SPO2 SETUP menu as shown below.
Figure 8-2 SPO2 SETUP menu 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. SpO2 alarm setting ALM: pick “ON” to enable prompt message and data record during the SpO2 alarm;
pick “OFF” to disable the alarm function, and there will be a beside “SpO2”. ALM REC: pick “ON” to enable report printing upon SpO2 alarm. SWEEP Available options are 12.5, 25.0 mm/s. PR SOUND Pulse beep volume. Options are OFF, HIGH, MED, LOW. AVG TIME 4S, 8S, 16S represent times that SpO2 average value is counted. DEFAULT: Pick this item to access the SPO2 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.
49

8.6 Alarm Description and Prompt

SpO2 Alarm Message

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.

Tables below describe the possible physiological alarms, technical alarms and prompt

messages occurring during SpO2 measurement.

Physiological alarm:

Message

Cause

Alarm Level

SPO2TOO 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
SPO2 SENSOR OFF

Cause
SpO2 sensor may be disconnected from the patient or the monitor.

Alarm Level LOW

Remedy
Make sure that the monitor and the patient are in correct connection with the cables.

Prompt message (include general alerts):

Message

Cause

Alarm Level

SEARCH PULSE NO PULSE

SpO2 module is searching for pulse.

No alarm

SpO2 module cannot detect SpO2 signal for a long time.

HIGH

8.7 Maintenance and Cleaning

Care and Cleaning Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected from the power line. 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. For 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.

50

Chapter 9

TEMP Monitoring

9.1 TEMP Monitoring
TEMP monitoring setup If you are using disposable TEMP probes you need to plug the TEMP cable into the
monitor and then connect the probe to the cable. With a reusable TEMP probe you can plug the probe directly into the monitor Apply the TEMP probe(s) securely to the patient. Switch on the system. Warning 1Verify probe cables fault detection before beginning of monitoring phase. Unplug the temperature probe cable from the socket, the screen will display the error message “TEMP SENSOR OFF” and the audible alarm is activated. 2The 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 1Disposable TEMP probe can only be used once for one patient. 2The 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.
9.2 TEMP SETUP Menu
Pick the TEMP hot key on the screen to call up the TEMP SETUP menu shown as below:
Figure 9-1 TEMP SETUP Menu TEMP alarm setting ALM: pick “ON” to enable prompt message and data record during the TEMP alarm; pick “OFF” to disable the alarm function, and prompt the symbol beside TEMP numeric. 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 TEMP occurs when the measured temperature exceeds set alarm high limit or falls below alarm low limit.
51

TEMP alarm limits:

Max. TEMP HI

Min. TEMP LO

Step

TEMP

50

0

0.1

UNIT

To set temperature unit (ºC or ºF).

DEFAULT

Pick this item to access the TEMP 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.

9.3 TEMP Alarm message

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. Tables below describe the possible physiological alarms, technical alarms and prompt messages occurring during TEMP measurement. Physiological alarms:

Message

Cause

Alarm Level

TEMP TOO HIGH TEMP TOO LOW

Measuring value of sensor is above upper alarm limit.
Measuring value of sensor is below lower alarm limit.

User-selectable User-selectable

Technical alarms:

Alarm Message
TEMP SENSOR OFF
TEMP ALM LMT ERR

Cause Temperature cable may be disconnected from the monitor.
Functional safety failure

Alarm Level Remedy

LOW

Make sure that the cable is properly connected.

HIGH

Stop using alarming function of TEMP module, notify our engineer or service staff.

Prompt message:

Message

Cause

Alarm Level

TEMP EXCEED Measuring value of sensor is beyond measuring range. HIGH

52

Chapter 10

NIBP Monitoring

10.1 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. 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
1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes. In the continuous mode, the monitor measures the blood pressure as many times as
possible in five minutes. Warning 1. 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. 2. 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. 3. Ensure that the correct setting is selected when performing measurements on children. It may be dangerous for the children to use an over pressure level.
10.2 NIBP Measuring
10.2.1 NIBP Measuring 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.
1. Plug in the air hose and switch on the system. 2. Apply the blood pressure cuff to the patient’s arm or leg following the instructions
below (Figure 10- 1). Ensure that the cuff is completely deflated. Apply the appropriate size cuff to the patient, and make sure that the symbol “” is
over the appropriate artery. Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremities.
53

Figure 10- 1 Applying Cuff

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.

Size of reusable cuff for neonate/children/adult

Patient Type

Limb perimeter

Cuff width

Hose

Infant Child Adult Large Adult Thigh

10 ~19 cm 18 ~ 26 cm 25 ~ 35 cm 33 ~ 47 cm 46 ~ 66 cm

8 cm 10.6 cm 14 cm 17 cm 21 cm

1.5 m or 3m

Size of disposable cuff for neonate/children/adult

Size No.

Limb perimeter

Cuff width

Hose

1

3.1 ~ 5.7 cm

2.5 cm

2 3

4.3 ~ 8.0 cm 5.8 ~ 10.9 cm

3.2 cm 4.3 cm

1.5 m or 3 m

4

7.1 ~ 13.1 cm

5.1 cm

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 NIBP 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 NIBP button on the front panel to start the auto measuring according to the

selected time interval.

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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. 2. To stop auto measuring: During auto measuring press NIBP 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 NIBP button on the front panel to start a manual measurement. During the idle period of auto measuring process, press the NIBP button on the front panel at any time to start a manual measurement. Then press the NIBP button 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 NIBP button on the front panel. 5. To stop a manual measuring Repress the NIBP button again. 6. To perform continuous measuring: Access NIBP SETUP menu and pick the CONTINUAL item to start the continuous measurement. The monitor will measure as many times of NIBP as possible within 5 minutes. 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. 7. To stop continuous measuring: During continuous measuring press NIBP button on the front panel at any time to stop continuous measurement. 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. Warning 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. 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
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interfere with the measurement, making the measurement unreliable or longer to derive. In some cases, the patient’s condition will make a measurement impossible. 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. 10.2.2 NIBP monitoring screen NIBP measurement result and corresponding message are displayed as follows:
10.3 NIBP SETUP menu
Pick the NIBP hot key on the screen to call up the NIBP menu shown as below:
Figure 10-2 NIBP SETUP Menu
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NIBP alarm setting ALM: pick “ON” to enable prompt message and data record during the NIBP alarm;
pick “OFF” to disable the alarm function, and there will be a beside “NIBP”. ALM LEV: selectable from HIGH, MED to LOW. HIGH represents the most serious
case. ALM REC: pick “ON” to enable report printing upon NIBP alarm. Sys alm hi, sys alm lo, 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. NIBP alarm limits: Adult Mode : SYS 40-270 mmHgDIA 10-215 mmHg Mean 20-235 mmHg Pediatric Mode: SYS 40-200 mmHgDIA 10-150 mmHg Mean 20-165 mmHg Neonatal Mode: SYS 40-135 mmHgDIA 10-100 mmHg Mean 20-110 mmHg 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. INTERVAL Interval time for automatic measuring. Available selections: 1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes. Press NIBP button on the front panel to start the first auto measuring. Pick MANUAL selection in INTERVAL item to set up the measuring mode to MANUAL. UNIT Pick this item to set measurement unit. (Option: mmHg or kPa) 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. 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. 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. Procedure of the Pressure Transducer Calibration: Replace the cuff of the device with a rigid metal vessel with a capacity of 500 ml 5%. Connect a calibrated reference manometer with an error less than 0.8 mmHg and a ball
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pump by means of a T-piece connector and hoses to the pneumatic system. Set the monitor in CALIBRATE mode. Inflate the pneumatic system to 0, 50 and 200 mmHg by ball pump separately. The difference between the indicated pressure of the reference manometer and the indicated pressure of the monitor will not exceed 3 mmHg. Otherwise, please contact our customer service. 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 PNEUM, 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 simply determine whether there are air leaks in the NIBP airway. If at the end of the test the system gives the prompt that the NIBP airway has air leaks, please contact the manufacturer for repair. Procedure of the air leakage test: 1. Connect the cuff securely with the socket for NIBP air hole. 2. Wrap the cuff around the cylinder of an appropriate size. 3. Access the NIBP SETUP menu. 4. Turn the knob to the PNEUMATIC item and press the knob. Then the prompt “Pneum
testing…” will appear on the bottom of the NIBP parameter area indicating that the system has started performing pneumatic test. 5. The system will automatically inflate the pneumatic system to about 180mmHg. 6. After 20 seconds or so, the system will automatically open the deflating valve, which marks the completion of a pneumatic measurement. 7. If no prompt appears on the bottom of the NIBP parameter area, it indicates that the airway is in good situation and no air leaks exist. However if the prompt “PNEUMATIC LEAK” appears in the place, it indicates that the airway may have air leaks. In this case, the user should check for loose connection. After confirming secure connections, the user should re-perform the pneumatic test. If the failure prompt still appears, please contact the manufacturer for repair.
10.4 Maintenance and Cleaning
Warning Do not squeeze the rubber tube on the cuff. Do not allow liquid to enter the connector socket at the front of the monitor. Do not wipe the inner part of the connector socket when cleaning the monitor. When the reusable cuff is not connected with the monitor, or being cleaned,
always place the cover on the rubber tube to avoid liquid permeation.
Reusable Blood Pressure Cuff The cuff can be sterilized by means of conventional autoclaving, gas, or radiation sterilization in hot air ovens or disinfected by immersion in decontamination solutions, but remember to remove the rubber bag if you use this method. The cuff should not be dry-cleaned. The cuff can also be machine-washed or hand-washed, the latter method may prolong the
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service life of the cuff. Before washing, remove the latex rubber bag, and for machine-washing, close the Velcro fastening. Allow the cuff to dry thoroughly after washing, then reinsert the rubber bag. 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. Disposable Blood Pressure Cuffs Disposable cuffs are intended for one-patient use only. Do not use the same cuff on any other patient. Do not sterilize or use autoclave on disposable cuffs. Disposable cuffs can be cleaned using soap solution to prevent infection. Note For protecting environment, the disposable blood pressure cuffs must be recycled or disposed of properly.
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Chapter 11

CO2 Measuring

(Optional)

11.1 General

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(optional) and SideStream(optional) .

This module can be applied in operation room, monitor units etc, it can measure the CO2

partial pressure or concentration of patient Air Way, obtain EtCO2, Inspired Maximum

CO2 (InsCO2), Air Way Respiration Rate (AwRR), and display CO2 concentration

waveforms. The parameter symbols displayed on the screen are defined as following:

CO2EtCO2 INS: InsCO2

AWRR: Air Way Respiration (AwRR)(Resp. times/MIN)

Note

1Don’t use the device in the environment with flammable anesthetic gas.

2 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.

11.1.1 Monitoring Procedure

Principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb

4.3um infrared ray. Absorption intensity is proportional to CO2 concentration of patient

sample, the CO2 concentration will compute from the detecting CO2 absorption intensity

of patient sample. The relation between partial pressure and percentage of CO2

concentration is given below : P(mmHg) = Percentage(%) * Pamp( ambient pressure )

Of CO2 MainStream and CO2 SideStream modules, whichever is selected by the user,

Autorun measuring mode is adopted. Rate for waveform sampling is 31 msec/time. The

operating series for the two modules are respectively:

MainStream work sequence: After the system is powered on, CO2 module automatically

begins warming-up for about 45S to 90S. Then the sensor motor is activated. After 5S to

10S, the light source of infrared ray is opened. After 10S, the system enters the normal

measuring status.

SideStream work sequence: Except the procedures that after being powered on, the system

needs not warming-up and the air pump should be activated, other procedures are the same

as those in MainStream sequence.

CO2 measurement setups:

Verify the type of the configured CO2 module (MainStream or SideStream);

For MainStream, connect the sensor to the receptacle of CO2 module. For SideStream,

plug the water trap onto its fixing chassis. Add a permanently used nafion tube between the

sampling line and the watertrap to further remove the influence of water vapor.

Power on the system. For MainStream, technical prompt information of “CO2 WARM UP”

is always displayed on the screen until the sensor reaches to the operating temperature.

After CO2 module is activated and enters the normal status, for MainStream, “MAIN” is

displayed following CO2 waveform identifier, and for SideStream, the “SIDE” is displayed

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following CO2 waveform identifier.
Figure 11- 1 Sidestream Connection Mainstream Sensor
Airway Adapte
Figure 11- 2 Mainstram Connection Do not use the sterile supplied CO2 Water trap set (for side stream including water
trap and sample line and cannula) and Air adapter (for main stream) if the packaging or the sensor is damaged and return them to the vendor. “CO2 WARM UP” or “CO2 SENSOR START UP” displayed on the screen indicates that the sensor is in warm-up or starting-up. After the information disappears from the screen, the standard measurement can then be generated. Monitor has water trap beside it, which is used to prevent the moisture or water drops produced by patient’s respiration from entering the module. The sample line and the water trap are one-off consumables that can not be repeatedly used by different patients.
11.2 CO2 Menu
Parameter setup and adjustment Turn the knob to select and press CO2 hot key on the screen to activate “CO2 Setup” menu as shown below:
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Figure 11- 3 CO2 Setup Menu

Following functions can be realized via CO2 SETUP menu.

ALM: select “ON” to enable and store alarm prompt when CO2 parameters have

alarms. Select “OFF” to disable alarm and display beside CO2. The default is “ON”.

ALM REC: select “ON” to generate output from the recorder ever since CO2

parameter alarm occurs. The default is “OFF”.

ALM LEV: select from HIGH, MED and LOW. Level HIGH represents the most

serious alarm, followed by Level MED and Level LOW with a decrease of seriousness.

Change in “ALM LEV” can only affect the physiological alarm levels of CO2 parameters

including EtCO2 upper limit, EtCO2 lower limit, InsCO2 upper limit, AwRR upper limit

and AwRR lower limit. The default alarm level is “MED”.

CO2 ALM HI: to adjust the upper alarm limit of EtCO2. If the measuring value is

larger than CO2 upper alarm limit, “CO2 TOO HIGH” appears on the screen. After the

measuring value returns to the normal one, the information disappears.

CO2 ALM LO: to adjust the lower alarm limit of EtCO2. If the measuring value is

smaller than CO2 lower alarm limit, “CO2 TOO LOW” appears on the screen. After the

measuring value returns to the normal one, the information disappears.

INS ALM HI: to adjust the upper alarm limit of InsCO2. If the measuring value is

larger than InsCO2 upper alarm limit, “INS TOO HIGH” appears on the screen. After the

measuring value returns to the normal one, the information disappears.

AWRR ALM HI: to adjust the upper alarm limit of AwRR. If the measuring value is

larger than the upper alarm limit of AwRR, “AWRR TOO HIGH” appears on the screen.

After the measuring value returns to the normal one, the information disappears.

AWRR ALM LO: to adjust the lower alarm limit of AwRR. If the measuring value is

smaller than the lower alarm limit of AwRR, “AWRR TOO LOW” appears on the screen.

After the measuring value returns to the normal one, the information disappears.

UNIT: to change the display units of CO2 and InsCO2 parameters. “mmHg” and

“kPa” are available for selection.

SWEEP: to adjust the display rate of CO2 waveforms with “6.25 mm/s”, “12.5 mm/s”,

or “25.0 mm/s” selectable.

Exit: to close CO2 SETUP menu.

Note

“APNEA ALM” cannot be closed.

When various alarms occur simultaneously, the alarm information of highest level

will be displayed on the screen.

OTHER SETUP: pick this item in the menu to call up CO2 more setup sub-menu.

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Figure 11- 4 CO2 More Setups 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 “LOW”
or “HIGH” selectable. The default value is “LOW”. WORK MODE: to change the work mode of CO2 with “MEASURE” mode or
“STANDBY” mode selectable. The default is “STANDBY” mode. When it is required to monitor CO2, select “WORK” mode. “STANDBY” mode disables the air pump in SideStream module, the sensor and the IR (infrared ray) source in MainStream module, thus decreases the power consumption and extends the life cycles of IR source and the whole CO2 module. Note When not using CO2 monitoring function, it is suggested not to connect MainStream sensor or SideStream water trap and to adjust to “STANDBY” mode. O2 COMPEN: to perform compensate operations as per the selection of the user. BALANCE GAS: ROOM AIR, N2O, HELIUM. Anaesthesia Agent: The intensity of the Anaesthesia Agent GAS TEMP: Current Temperature of the gas Barometric: Current Atmospheric Pressure ETCO2 Period: The period to calculate the ETCO2, Per breath, 10s, 20s
Figure 11- 5 CO2 More Setups Menu To perform the ZERO. The usage of the module will be display in the MENU.
Note 1. If Compensate item is not correctly set as per the operation conditions, the result will
be far from the actual value, thus leading to severe misdiagnosis. 2. The default of Water Vapor Compensate is on. Turn it off when measuring dry gas,
63

such as when performing regular maintenance or measurement validation by using dry calibrated gas. 3. The default of BTPS is on. Turn it on when measuring the VA saturated “damp” gas under the body temperature and ambient pressure and turn it off when measuring the “dry” gas under the ambient temperature and pressure. 4. Operate by strictly observing the Compensate operation method. 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. 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 exceeding 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: 4mmHg 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 APNEA Time: Selections are 10S to 40S, Default: 20S. Work Mode: MainStream: Standby, Measurement; SideStream: Standby, Measurement. Default: Measurement Compensate Method: MainStream: General/O2/N2O/DES/ALL SideStream: General/O2/N2O/DES/ALL Default Methods: General. Pump Rate: 100 ­ 200 ml/min. Default: 100 ml/minUnit: mmHg/kPa.Default: mmHg Waveform Sweep: 25.0/12.5/6.25 (mm/s) Default: 25.0 mm/s Waveform Scale: LOW/HIGH Default: LOW 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.
11.3 Alarm Information and Prompt
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.
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Tables below describe the possible physiological alarms, technical alarms and prompt messages occurring during CO2 measurement. Physiological alarms:

Message

Cause

Alarm Level

CO2 TOO HIGH OR LOW

EtCO2 measuring value is above upper alarm or below lower limit.

User-selectable

INS TOO HIGH

InsCO2 measuring value is above alarm limits.

User-selectable

AWRR TOO HIGH OR LOW
CO2 APNEA
Technical alarms:
Message
CO2 SENSOR OFF
CO2 NO WATERTRAP
CO2 WATERTRAP OCCLUDE
CO2 SIGNAL LOW OR TOO LOW CO2 BAROMTRC TOO LARGE CO2 PNEUMATIC LEAK CO2 SIGNAL NOISY OR SATURATE CO2 CALCULATION ERR CO2 SENSOR FAULT CO2 SENSOR TEMP HIGH OR LOW CO2 WATCHDOG TIMEOUT CO2 OTHER INFORMATION ERR
CO2 COMM ERR

AwRR measuring value is above upper or below lower alarm limit.
In specific time interval, no RESP can be detected using CO2 module.

User-selectable HIGH

Cause
Mainstream sensor is not properly connected or has fallen off. Sidestream water trap is not properly connected or has fallen off.
Sidestream water trap is occluded.

Alarm Level
LOW

Remedy
Make sure that mainstream sensor is properly connected.

LOW LOW LOW

Make sure that sidestream water trap is soundly connected.
Make sure that sidestream water trap functions smoothly.

MED

MED

M

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