C:\Documents and Settings\huangsh\桌面\PC-3000\修改\08

CREATIVE MEDICAL
PC-3000 Multi-Parameter Monitor
USER INSTRUCTION MANUAL
Version 1.0 PROACT
Shenzhen Creative Industry Co. Ltd
I
CREATIVE PC-3000
Multi-Parameter Monitor
This Manual is written and compiled in accordance with the IEC 60601-1(Medical electrical equipment Part1: General
requirements for safety） , and MDD 93/42/EEC. It complies with both international and enterprise standards and
is also approved by State Technological Supervision Bureau.
The Manual is written for the current PC-3000 Multi-parameter Monitor. In case of modifications and/or software
upgrades, you will be advised in due time with a Modification Notice.
The Manual describes, in accordance with the PC-3000 Monitor’s features and requirements, main structure,
functions, specifications, correct methods for transportation, installation, usage, operation, repair, maintenance
and storage, etc. as well as the safety procedures to protect both the user and equipment. Refer to the respective
chapters for details.
The Manual is published in English and we have the ultimate rights to content within the Manual. No part of this
manual may be photocopied, reproduced or translated into another language without the prior written consent.
We reserve the right to improve and amend it at any time without prior notice. Amendments will however be
published in a new edition of this manual.
Version of This Manual:
Revised Date:
Ver1.0 PROACT UK
July 7th 2014
All rights Reserved.
Marks in the Manual:
Warning: must be followed to avoid endangering the operator and the patient.
Note:containssome important informationandtipsaboutoperationsandapplication.
Attention: must be followed to avoid causing damage to the monitor.
II
Instructions to User
Dear Users,
Firstly, thank you for purchasing our product. We wish you to have a very good and productive experience with
your Creative Monitor and your local Creative Dealer will offer all support and assistance possible to make this
happen. We must ask you to please read the following very carefully before using this equipment.
These instructions describe the operating procedures to be followed strictly, Failure to follow these instructions
can cause monitoring abnormality, equipment damage and personal injury.
The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring
abnormality, personal injury and equipment damage due to user’s negligence. The manufacturer’s warranty
does not cover negligence.
WARNING - PACEMAKER PATIENTS. Rate meters may continue to count the pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep
pacemaker patients under close surveillance. See this manual for disclosure of the pacemaker pulse rejection
capability of this instrument.
Monitor a single person at a time.
The monitor is defibrillator proof. Verify that the accessories can function safely and normally and the monitor is
grounded properly before conducting defibrillation.
Do not use with MRI Scanners.
If you have any doubt to the grounding layout and its performance, you must use the built-in battery to power
the monitor.
All combinations of equipment must be in compliance with standard of IEC 60601-1-1 for medical and
electric system requirements.
Check SpO2 probe application site periodically (every 30 minutes) to determine circulation, positioning and
skin sensitivity.
The SpO2 measurement in this monitor may not work for all SpO2 Laboratory testers. If stable readings
cannot be obtained at any time, discontinue testing and contact the distributor for recommended testing
equipment.
Do not immerse the monitor or its accessories in liquid to clean.
Donotuseaccessoriesotherthanthoseprovided/recommendedbythemanufacturer.
Each time the monitor is used, check the alarm limits to ensure they are correct for the individual patient.
The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with
other clinical signs and symptoms.
When NIBP is used on paediatric or neonate’s (less than 10 years old), do NOT operate in the adult mode.
The high inflation pressure may cause lesion or even body putrescence.
The monitor is not to be used on patients who have severe hemorrhagic tendency or have sickle cell
abnormality.
DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or intubations or has
skin lesions.
Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with microcirculatory
problems. It is recommended that the sensor should NOT be applied to the same place for over two hours,
change the measuring site periodically if necessary.
Do NOT install the SpO2 sensor on the finger with oedema or vulnerable tissue.
III
To prevent the risk of a short circuit and to ensure the ECG signal quality, the equipment
must be properly grounded through the Power Cord or external ground point.
Although biocompatibility tests have been performed on all the applied parts, some exceptional allergic
patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis.
All the connecting cables and rubber tubes of the applied parts should be kept away from the patient’ s
neck to prevent possible of suffocation.
If any part of the monitor should fail or break it must only be repaired by trained authorised technicians with the
correct official spare parts and accessories from the manufacturer. Failure to do so may result in serious
malfunction, operation outside of specifications and other possible negative effects concerning safety and
biocompatibility etc.
DO NOT stare at the infrared light of SpO2 sensor when switched on, as the infrared light may damage the eye.
If the monitor is dropped accidentally, please do NOT operate before its integrity, safety and technical
indexes have been tested and found to be within specification.
Do not reuse, disassembly, clean, or disinfect any accessories or sensor labelled for Single Patient Use. This
especially applies to the single patient use CO2 cannula kits and in-airway adapters. Performance is not
guaranteed if an item labelled as single patient use is reused.
Electrical Shock Hazard: Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to have
been damaged. Refer servicing to qualified service personnel.
ElectricalShockHazard;Nouserserviceable partsinsidethe CO2 Sensor.
After the life cycle of the Single Patient Use Side Stream CO2 Sensing Sample Line and/or and its
accessories has been met they should be disposed of following national and/or local requirements.
IV
Table of Contents
Chapter 1 Overview............................................................................................................................................................ 1
1.1 Features................................................................................................................................................................... 1
1.2 Product Name and Model....................................................................................................................................... 3
1.3 Applications and Scope........................................................................................................................................... 3
1.4 Operating Environment.......................................................................................................................................... 3
1.5 Impact on Environment and Resources................................................................................................................ 3
1.6 Safety........................................................................................................................................................................ 3
Chapter 2 Working Theories of the Main Unit.............................................................................................................. 4
2.1 Overall Structure and Working Theories.............................................................................................................. 4
2.2 Composition............................................................................................................................................................. 4
Chapter 3 Installation and Connection........................................................................................................................... 5
3.1 Introduce to Panels................................................................................................................................................. 5
3.1.1 Front Panel.................................................................................................................................................... 5
3.1.2 Left and Right Panel..................................................................................................................................... 7
3.1.3 Rear Panel..................................................................................................................................................... 8
3.2 Installation............................................................................................................................................................... 9
3.2.1 Opening the Box........................................................................................................................................... 9
3.2.2 Power Supply................................................................................................................................................ 9
3.2.3 Switching ON the Monitor........................................................................................................................... 9
3.3 Connection............................................................................................................................................................. 10
3.3.1 ECG Connection – This is an optional fitment.......................................................................................... 10
3.3.2 Blood Pressure Cuff Connection............................................................................................................... 12
3.3.3 To connect the SpO2 Sensor Probe........................................................................................................... 14
3.3.4 Printer connection..................................................................................................................................... 16
3.3.5 Loading printing paper.............................................................................................................................. 16
3.3.6 Battery Installation.................................................................................................................................... 17
3.3.7 Bed Rail Hook / Handle Installation......................................................................................................... 17
Chapter 4 Monitoring Screen and ECG Activation...................................................................................................... 18
4.1 Date And Time....................................................................................................................................................... 18
4.2 Main Screen........................................................................................................................................................... 18
4.3 Display 2 Screen.................................................................................................................................................... 21
4.3.1 Observing Screen....................................................................................................................................... 21
4.3.2 NIBP screen................................................................................................................................................ 22
4.3.3 Seven ECG Waveforms on the Same Screen............................................................................................. 23
4.3.4 Five Channels Real‐time Waveforms and Trends on the Same Screen................................................. 24
4.3.5 Parameter screen....................................................................................................................................... 25
4.4 Freeze and S‐T Analysis Screen........................................................................................................................... 26
4.4.1 Screen Description..................................................................................................................................... 26
4.4.2 How to Analyze the S‐T Segment on ECG Waveform.............................................................................. 27
4.5 ECG Activation.................................................................................................................................................. 27
Chapter 5 Operating Instructions for System Menu.................................................................................................. 28
5.1 System Menu Screen............................................................................................................................................. 28
5.1.1 How to Select the Menu Item................................................................................................................... 28
5.2 SpO2 Data List Screen........................................................................................................................................... 28
5.2.1 Screen Description..................................................................................................................................... 29
5.2.2 Operating Instructions............................................................................................................................. 29
5.3 NIBP Data List Screen........................................................................................................................................... 29
5.3.1 Screen Description..................................................................................................................................... 29
5.3.2 Operating Instructions............................................................................................................................... 29
5.4 Graphic Trend Screen........................................................................................................................................... 30
5.4.1 How to View the Graphic Trend................................................................................................................ 30
5.4.2 Operation Instructions.............................................................................................................................. 32
5.5 Recall Screen.......................................................................................................................................................... 32
V
5.5.1 Operation Instructions.............................................................................................................................. 33
5.6 Arrhythmia Screen................................................................................................................................................ 34
5.6.1 Operation Instructions.............................................................................................................................. 34
5.7 System Setup Screen............................................................................................................................................. 35
5.7.1 How to Select the System Setup Item....................................................................................................... 35
5.7.2 Parameter Settings..................................................................................................................................... 35
5.8 Colour Settings...................................................................................................................................................... 40
5.8.1 How to Change the Parameter Colour...................................................................................................... 40
5.9 File Management Screen....................................................................................................................................... 40
5.9.1 How to Add a New Patient......................................................................................................................... 40
5.10 oxyCRG Screen.................................................................................................................................................... 41
5.10.1 Operation Instructions............................................................................................................................ 41
5.11 Event List Screen................................................................................................................................................. 41
5.11.1 Screen Description................................................................................................................................... 41
5.11.2 Operating Instructions............................................................................................................................ 41
5.12 Tourniquet Function........................................................................................................................................... 41
5.12.1 Operation Instructions............................................................................................................................ 42
Chapter 6 Optional CO2 Monitoring.............................................................................................................................. 43
6.1 CO2 Parameter Settings........................................................................................................................................ 43
6.2 CO2 Sensor Connection......................................................................................................................................... 45
6.2.1 Side stream CO2 Sensor Connection......................................................................................................... 45
6.2.2 Mainstream CO2 Sensor Connection Demonstration for Mainstream CO2 Sensor Connection........... 46
6.3 CO2 Monitoring Screen.......................................................................................................................................... 48
6.3.1 CO2 Graphic Trend..................................................................................................................................... 49
Chapter 7 Vital Signs Model(VSM)................................................................................................................................ 50
7.1 NIBP screen........................................................................................................................................................... 50
7.2 Starting the Monitor.............................................................................................................................................. 50
7.3 Blood Pressure Cuff Connection.......................................................................................................................... 51
7.3 To connect the SpO2............................................................................................................................................. 53
7.4 Printer connection............................................................................................................................................... 55
7.5 Loading printing paper......................................................................................................................................... 55
7.6 Battery Installation.............................................................................................................................................. 56
7.7 Alarm modes.......................................................................................................................................................... 56
7.7.1 Alarm Silence.............................................................................................................................................. 57
7.7.2 Alarm Settings............................................................................................................................................ 57
7.7.4 Operational Instructions........................................................................................................................... 57
7.8 NIBP Data List Screen........................................................................................................................................... 58
7.8.1 How to Select the System Setup Item....................................................................................................... 58
7.8.2 Parameter Settings..................................................................................................................................... 58
Chapter 8 Alarm................................................................................................................................................................ 59
8.1 Alarm Priority........................................................................................................................................................ 59
8.2 Alarm modes.......................................................................................................................................................... 59
8.3 Alarm Silence......................................................................................................................................................... 60
8.4 Alarm Settings....................................................................................................................................................... 60
8.5 Verify adjustable alarm function......................................................................................................................... 60
Chapter 9 Maintenance and Service.............................................................................................................................. 61
9.1 Technical Maintenances....................................................................................................................................... 61
9.1.1 Daily Examination...................................................................................................................................... 61
9.1.2 Routine Maintenance................................................................................................................................. 61
9.1.3 Battery Maintenance.................................................................................................................................. 61
9.2 Cleaning and Disinfection..................................................................................................................................... 62
9.3 Cleaning and Disinfection of Accessories............................................................................................................ 62
9.4 Storage................................................................................................................................................................... 62
9.5 Transportation...................................................................................................................................................... 62
9.6 Recycling monitor components........................................................................................................................... 62
VI
Chapter 10 Troubleshooting.......................................................................................................................................... 63
10.1 No Display on the Screen.................................................................................................................................... 63
10.2 Excessive ECG Signal Interference or Too Thick Baseline............................................................................... 63
10.3 No Blood Pressure and Pulse Oximetry Readings............................................................................................ 63
10.4 System Alarm...................................................................................................................................................... 63
Chapter 11 Technical Specifications............................................................................................................................. 64
11.1 ECG Monitoring................................................................................................................................................... 64
11.2 RESP Monitoring................................................................................................................................................. 65
11.3 TEMP Monitoring................................................................................................................................................ 65
11.4 NIBP Monitoring................................................................................................................................................. 65
11.5 SpO2 Monitoring.................................................................................................................................................. 65
11.6 Pulse Rate Monitoring........................................................................................................................................ 65
11.7 CO2 Monitoring.................................................................................................................................................... 66
11.8 Data Recording.................................................................................................................................................... 66
11.9 Other Technical Specifications........................................................................................................................... 66
11.10 Classification..................................................................................................................................................... 66
11.11 Guidance and manufacturer’s declaration‐Electromagnetic compatibility................................................. 67
Chapter 12 Monitoring Parameter................................................................................................................................ 71
12.1 ECG Monitoring................................................................................................................................................... 71
12.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value........................................................ 71
12.1.2 Factors affecting ECG signal.................................................................................................................... 71
12.2 Respiration Monitoring...................................................................................................................................... 72
12.2.1 Measuring Principle................................................................................................................................. 72
12.2.2 Factors affecting respiration monitoring............................................................................................... 72
12.3 SpO2 Monitoring.................................................................................................................................................. 72
12.3.1 Measuring Principle................................................................................................................................. 72
12.3.2 SpO2 Measurement Restrictions (interference reason)........................................................................ 72
12.3.3 Low SpO2 measuring value caused by pathology.................................................................................. 73
12.3.4 Clinical Limitations.................................................................................................................................. 73
12.3.5 Points to be noted in SpO2 and Pulse Measuring................................................................................... 73
12.3 Temperature Monitoring................................................................................................................................... 74
12.4 CO2 Monitoring.................................................................................................................................................... 74
12.4.1 Measuring Principle................................................................................................................................. 74
12.4.2 Mainstream vs. Side stream Sampling................................................................................................... 74
12.5 NIBP Monitoring................................................................................................................................................. 75
12.5.1 Measuring Principle................................................................................................................................. 75
12.5.2 Factors affecting NIBP measuring.......................................................................................................... 76
12.5.3 Clinical Limitations.................................................................................................................................. 76
Chapter 13 Appendix....................................................................................................................................................... 77
13.1 Alarm Information.............................................................................................................................................. 77
13.2 Default Alarming Values and Setup Range........................................................................................................ 78
13.3 Abbreviation of Arrhythmia............................................................................................................................... 80
13.4 Status/Error during NIBP Monitoring.............................................................................................................. 80
13.5 Status/Error during CO2 Monitoring................................................................................................................. 81
13.6 Typical Pressures and CO2 Readings at Altitudes............................................................................................ 82
Chapter 14 Packaging and Accessories........................................................................................................................ 82
14.1 Packaging............................................................................................................................................................. 82
14.2 Accessories Supplied with your Monitor.......................................................................................................... 83
14.3 Spares & Supplementary Accessories........................................................................................................................................83
Chapter 15 Instructions for SpO2Probe................................................................................................................................85
VII
Chapter 1 Overview
1.1 Features
This monitoring system may be used to monitor patient’s physiological parameters: ECG, respiratory rate, body
temperature, non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), and pulse rate.
Note: If CO2 module is added, the monitoring will not have these two functions: central networking and body
temperature (temperature connector doesn't exist)
It is compact, lightweight, easy to carry and very simple to operate;
7″ high-resolution (800 ×480 pixel) colour TFT to display patient’s ECG waveform, respiratory waveform and
SpO2 waveform;
3 Versions available:- Vital Sign Monitor (VSM) – NO ECG Fitted and defaults to Large Digit Ward Type Display;
This VSM Version is field retro-fittable and upgradeable to include 3/5 Lead ECG at a later date if
required;
- Multi-parameter Monitor – With 3/5 Lead ECG Fitted and defaults to Waveform Type Display
- Multi-parameter Monitor with ECG and Side Stream EtCO2 – does not have Temp or Networking.
User-friendly and intuitivedisplay interface,multiple configuration ofECG waveform display:
Main monitoring screen view: displays the information of all the waveforms and parameters visually;
Observing screen view: heart rate value and SpO2 value display in big fonts, and displays one channel ECG
waveform;
Seven lead waveforms on one screen view: displays the information of 7 ECG lead waveforms and different
monitoring parameters on one screen;
Five channel real-time waveforms and two hours’ trends screen view: intuitionist knowing the physiological
status of patient;
oxyCRG screen: displays heart rate trend, SpO2 trend, respiration trend or waveform simultaneously on
oxyCRG screen, to know the instantaneous the change of physiological parameters of respiration;
The cuff can be also used as a tourniquet, which is convenient and practical in use as an additional function,
and different cuff pressure can be set according to patient’s condition;
Up to 20 types of arrhythmia can be analyzed automatically; waveform freezing is available and automatic S-T
segment measurement and manual analysis;
Up to 1000 hours trend data of ECG, S-T, TEMP, CO2, SpO2, RESP and NIBP trends;
Up to 2000 groups of arrhythmia events’ can be stored, as well as the corresponding HR,
TEMP, CO2,SpO2, and RR;
Up to12000groups of NIBP measurement can be stored, as well as the corresponding,
CO2, TEMP, RR SpO2 and PR while the blood pressure measurement is taken, it can be recalled by list table
or graphic trend;
Up to 60 hours of ECG waveform storage (non-volatile) and can be reviewed;
Accurate NIBP measurement with over-pressure protection;
Unique Creative LFC PulseOximetry technology achieves accurate SpO2 and PR measurement;
1
Visual and audible alarm,recall of alarm events;
Flexible high and low alarm limits setting function;
Real-time monitoring of battery capacity, when the battery power is insufficient, low battery voltage alarm
indication will display on LCD screen.
Easy to colour-code and change the colour of the font, background and waveforms if need;
Protectionagainst defibrillatordischarge andresistance againstthe interferencefrom electrosurgical unit;
Pacemaker pulse detection and inhibition functions are available;
Patient type can beselected among “Adult”,“Pediatric”and “Neonate” insetup menu;
CO2 measuring functions optional;
Built-in printer to output waveforms and text.
Networking with the central station as a part of the Creative Central Network.
2
1.2 Product Name and Model
Name: Multi-parameter Monitor
Model:PC-3000
1.3 Applications and Scope
This Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult, paediatric and
neonate patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, noninvasive blood pressure, functional oxygen saturation, respiration rate, EtCO2, body temperature and so on, it allows
comprehensive analysis of patient’s physiological conditions.
This instrument is applicable for use in hospitals, clinical institutions and Transport/EMS. This equipment must only be
operated by suitably trained & qualified Staff.
1.4 Operating Environment
1.
Ambient temperature range: 5℃~40℃ Relative humidity: 30%~80% Atmospheric pressure: 70kPa~106kPa Power
supply: 100~240VAC
Power frequency: 50/60Hz
2.
This device should be situated in a place protected against direct sunlight, so as to prevent internal overheating.
3.
The device should be stored and used within specified temperature, humidity and atmospheric pressure range, or
it may cause damage to the device or inaccurate measurement result.
4.
Do not use this device in an environment with toxic or inflammable gas.
5.
If the device gets wet, the operator should NOT power up immediately until it has been air-dried to avoid any
damage. The device should be used with a suitable EMS Showerproof Case as necessary.
6.
This device should be fixed on a stand or other suitable surface so as to prevent possible electric shock.
7.
Do not use with any equipment other than those expressly permitted in these instructions.
8.
The monitor is defibrillator discharge-proof and has certain immunity to interference from electrosurgical devices.
When used on the patient with pacemaker or used with electrosurgical equipment, the qualified user should keep
the patient under close surveillance. Refer to the following function description for specific protective measures
or notes.
9.
Make sure that the equal-potential grounding terminal is grounded correctly as required.
10.
Do not use mobile phones near to this monitor so as to avoid strong radiant field interference.
1.5 Impact on Environment and Resources
Low
1.6 Safety
a)
This device conforms to IEC60601-1, electrical safety classification: Class I, with Type BF and CF applied
parts.
b)
This device can resist against the discharge of defibrillator and the interference of electrosurgical
unit.
c)
This device can monitor patients who are fitted with a pacemaker.
d)
DO NOT use this device while the patient is under MRI scanning. This device is not MRI Compatible or
Conditional.
3
Chapter 2 Working Theories of the Main Unit
2.1 Overall Structure and Working Theories
Figure 2.1
This Monitor is a product of modular design. It performs its measurement of the physiological parameter through
different modules. There are five functional modules for the monitor: ECG/RESP/TEMP module, NIBP module,
SpO2 module, CO2 module and Central Processing Unit (CPU) module.
1.
2.
3.
4.
5.
ECG/RESP/TEMP module collects data for heart rate and ECG waveform, respiration waveforms through the
ECG leads and electrodes. It also collects temperature data from the temperature probes.
SpO2 module collects data for pulse rate, pulse oxygen saturation (SpO2) and SpO2 volume waveform via the
SpO2 probe.
NIBP module collects data for blood pressures, including the diastolic, systolic and mean arterial pressure
through the NIBP cuff. The cuffs are sized for adult, paediatric and neonate. NIBP measure has three modes:
adult, paediatric and neonate.
CPU module consists of main board, multi-function board, and the keyboard. The multi-function
board performs the data communication between the main board, ECG/RESP/TEMP module, SpO2 module, NIBP
module and CO2 module.
The CO2 module collects data for respiration rate, EtCO2, InsCO2 through the side stream sampling tube.
2.2 Composition
1.
2.
3.
4.
The monitor consists of the main unit and the corresponding functional components (Non-invasive blood
pressure cuff, SpO2 probe, and temperature transducer. ECG Leads and CO2 accessories may also be
specified.
The monitor has 4 measurement channels: ECG and Respiration channel, NIBP channel, SpO2 and Pulse
channel and TEMP or CO2channel.
The monitor has an output channel: Ethernet networking communication port.
Basic parameters include: heart rate, respiration rate, NIBP, SpO2, pulse rate and EtCO2, TEMP
4
Chapter 3 Installation and Connection
3.1 Introduction to Panels
3.1.1 Front Panel
Figure 3.1 Front Panels
Power switch: Press it for 3 seconds to start the monitor or turn off the monitor.
1.
2.
3.
~
AC power indicator: Illuminates Green to indicates when AC power supply is available
Built-in DC power indicator:
When both AC and DC indicators are on, it means that AC power supply is available,
and the battery is being recharged. If only the DC indicator is on, it means that the battery
is being used and no AC Mains power is available.
4.
ECG lead: Click it to shift the ECG monitoring circulatory among leadⅠ, Ⅱ, Ⅲ, aVR, aVL, aVF and V.
When the option of Print in the System Menu is ON, the ECG lead Key will be changed
into Print. Press this key to print waveform.
In the Initial Screen, press this key to print Lead II ECG waveform and Waveform 2 that can be
selected in the System Menu.
In the Data List Screen, press this key to print NIBP data list.
In the Observing Screen, press this key to print Lead II ECG waveform and Waveform 2.
In the 7 leads on the Same Screen, press this key to print Lead II ECG waveform and Waveform 2.
In the SpO2 Data List Screen, press this key to print SpO2 data list.
In the Graphic Trend Screen, press this key to print trend graph.
In the System Parameter Setting Screen, press this key to print the system parameter setup.
In the Recall Screen, press this key to print recalled data list or current ECG waveform and arrhythmia
waveform.
In the Arrhythmia Screen, press this key to print arrhythmia list or current ECG waveform and
arrhythmia waveform.
5
5.
6.
AUDIOAlarm Silence: Press
key to set or activate the system alarm audio silence. In either monitoring
screen, press “Alarm Silence” to set the alarm timer. There are four options of Alarm silent time: 2
minutes, 5 minutes, 10 minutes and 20 minutes. The time shows up on the upper left corner of the
screen. When the Audible Alarm silence timer is activated, the system begins to count down. If an alarm
occurs during that period, the Visual System Alarm will still be activated automatically and the monitor will
give Visual Alarms ONLY. If there is no alarm during that period, when the set time has passed, the
Audible System Alarm will be re-activated as well.
key to suspend the Audible Alarm and set the alarm silence
When the monitor alarms, press
Time if required and safe to do so.
WARNING: DO NOT silence the audible alarm or decrease its volume in any situation if patient
safety could be compromised by doing so.
Freeze: Press the key to freeze/unfreeze ECG waveform or the waveforms of ECG, SpO2 and RESP
according to the system setting, and enter into S-T segment measurement screen for analysis (on
Observing Screen).
7.
NIBP: Press to start or stop a Manual NIBP measurement.
8.
DISPLAY : Click it to shift the display modes or return to the Default set screen from other screens.
Press it to shift between Main Waveform Screen and VSM Display 2 Screen, either of which can be set
as a start-up Default in System Menu screen.
9.
Navigation Knob: This is the major operating key of the system, which can be used to select
functions or parameters, navigate menus and select/adjust parameters. Short Press and release it to
bring up Parameter Menus for Alarm and Functional settings. When in Main Waveform Screen mode a
LONG press (over 3 Seconds) will bring up the Monitor System Menu for setting Monitor Defaults,
Colours, Operating modes etc. The Monitor will provide screen and operating tips in the lower
information bar.
10 . Alarm indicator:
Indicator Colour
Alarm Level
Alarm Event
Red flashing
High priority alarm
Exceeding the Alarm Limits, Lack of
pulse or Apnoea detected. Also if critical
low battery voltage detected.
Yellow flashing
Middle priority alarm
Leads and probe off, VE RONT and SVE
RONT.
Yellow light
Low priority alarm
Other arrhythmia phenomenon and advisory
alarms
Green light
Normal
6
3.1.2 Left and Right Panel
Figure 3.2 the right side panel
Figure 3.3 the left side panel
Different ports are located in different positions of the monitor for operating convenience. The cable and
transducer ports are at the left side panel, shown in Figure 3.3.
1.
SpO2: SpO2probe connector
2.
NIBP: NIBP hose connector
3.
TEMP: TEMP probe connector (or CO2 : CO2 probe connector)
4.
ECG/RESP: ECG cable connector
5.
Symbol definition
With type BF applied parts
With type CF applied part and applicable when the defibrillator is in use.
SYMBOL
Caution. Please read the manual for details.
The power supply socket and ports are at the right panel, shown in Figure 3.2.
Top
Middle
Bottom
：Power supply socket(DC input)
：Serial communication port which is used to network with central monitoring system.
：USB port (reserved for future use);
7
3.1.3 Rear Panel
Figure 3.4 Rear panel
The following are at the rear panel of the monitor.
(1)
S/N: Serial Number
(2)
Power supply socket: 100-240VAC
(3)
Nameplate
CE mark
Serial number
Date of manufacture
Authorised representative in the European community
Manufacturer (including address and date)
Disposal of this device according to WEEE regulations
(4)
Battery lid. Remove the battery lid to install or change the rechargeable
battery. Battery specifications: Li‐ion14.8V/2200mAh rechargeable battery pack.
To avoid battery damage, remove battery(s) before shipping or storage.
Caution: Burn hazard (the built-in Li-ion Battery) Do not disassemble, incinerate or expose to high
temperature (> 60℃/140℉). Refer to instruction manual.
8
3.2 Installation
3.2.1 Opening the Box
1. Open the packaging, take out the monitor accessories carefully, place them on a safe stable surface.
2. Open the users’ manual to sort the accessories according to the packing list.
Inspecttheaccessoriesforanymechanicaldamage
Checkalltheexposedleadsandinsertedaccessories
You can customize the module configuration by choosing necessary modules to meet
your own needs. Therefore, your monitor may not have all the monitoring functions and
accessories. Please contact your local dealer or our company in case of any problems.
3.2.2 Power Supply
1. When powered by AC mains power supply:
Make sure that theAC power supply is 100-240VAC, 50/60Hz.
Use the power cord prepared by the manufacturer. Insert one end of it to the power port of the
monitor and the other end to the grounded three-pin power jack.
To eliminate potential differences, the monitor has a separate connection to the equipotential
grounding system. If necessary, connect one end of the provided ground cable
to equipotential grounding port on the rear of the monitor, and connect the other end to one point
of the equipotential grounding system.
Caution: ensure that the monitor is grounded correctly.
Attention After the supply mains has been interrupted when power switch remains in the “on” position and is
restored after a period of time that is longer than 30 seconds, the monitor will run by the last settings
when restarting the monitor.
2. When powered by built-in battery
The provided battery of the monitor must be recharged after transportation or storage.
If the monitor is switched on without being connected to the AC power socket, it may not
operate if there is insufficient battery power.
The internal battery will fully charge after 3 hours when the monitor is off and 7-8 hours when
the monitor is being used.
3. When powered by 12V DC Vehicle Cigarette Lighter Socket using the official 12VDC Vehicle Power Cable
The provided Vehicle Power Cable will power the monitor and recharge the monitor at a rate
which is approximately 3 x slower than the Mains Power Supply. It is recommended that
the Battery be fully charged to start if being used with the Vehicle Power Cable.
If the monitor is switched on without being connected to the Vehicle Power Socket , it may not
operate if the internal battery has insufficient battery power.
Using the Vehicle Power Cable, The internal battery will fully charge after approx.9 hours
when the monitor is off and 16-18 hours when the monitor is being used.
3.2.3 Switching ON the Monitor
The system performs self-detection and enters the set default display after switching on the monitor, and the yellow
alarm indicator blinks to inform that the user can begin operating it.
Checkalltheapplicablefunctionstomakesurethatthemonitorworksnormally.
If the built-in battery is to be solely used please fully recharge it before and after using the
monitor to ensure sufficient battery power storage. It will take minimal 7-8 hours to charge
battery from depletion to 90% charge using the AC Mains adapter.
Do not use the monitor to monitor the patient if there are indications of damage or reminders of error.
Please contact the local dealer or our company.
Start the monitor again 1 minute after it is switched off.
9
3.3 Connection
3.3.1 ECG Connection – This is an optional fitment
ECG measurement is to collect ECG data via the ECG electrodes. Electrode connects the patient and the lead cable. The
lead cable connects to the monitor. The locations of the electrodes are very important for obtaining correct and clean
ECG signals.
1.
2.
3.
4.
Connect the lead cable to the right-panel connector marked with the ECG icon.
Select electrodes to be used. Use only one type of electrode on the same patient to avoid diversity of
electrode impedance. For ECG monitoring, it is strongly recommended to use silver / silver-chloride
electrodes. When dissimilar metals are used for different electrodes, the electrodes may be subject to
cause large offset potentials due to polarization. Using dissimilar metals may also increase recovery time
after defibrillation.
Prepare the electrode sites according to the electrode manufacturer’s instructions.
Skin clean
Clean and dry-abrade skin to ensure low sensor impedance. Mild soap and water is recommended
asaskincleanser.
Alcohol is not recommended as a skin cleanser; it leaves a film layer that may cause high sensor
impedance.If alcoholisused,ensure 30-second dry time.
Dry-abrading the skin gently with a dry wash cloth, gauze, or skin preparation product is helpful to remove
thenon-conductiveskinlayer.
The symbol indicates that the cable and accessories are designed to have special protection against electric shocks,
and is defibrillator proof.
The locations of the electrode are in the following Figure:
Figure 3.5 Electrode Location
Note: If skin rash or other unusual symptoms develop, remove electrodes from patient.
After starting the monitor, if the electrodes become loose or disconnected during monitoring,
The system will display “LEAD OFF” on the screen to alarm the operator.
Use either 3 wires or 5 wires of lead cable as required to give the required ECG wave.
3 or 5 Lead is user selected in the ECG Setup Menu
10
5.
The name of ECG electrodes and their corresponding locations are as follows
Symbol
Position
RA
The intersection between the centreline of the right clavicle and Rib 2
LA
The intersection between the centreline of the left clavicle and Rib 2
LL
Left part of the upper abdomen
RL
Right part of the upper abdomen
C1 (V1)
C (V)
C2 (V2)
C3 (V3)
Chest
C4 (V4)
electrode C5 (V5)
If the electrodes are placed in different places, the lead forms will display
differently.
C6 (V6)
Safety Instructions for ECG Monitoring
This Monitor can only be used with ECG lead cable provided by Creative Medical; using ECG lead cable
supplied by other companies may cause improper performance or poor protection while using defibrillator.
Electric parts of electrodes, leads and cable must not contact any other conductive parts (including
ground).
This Monitor is resistant against defibrillator and electrosurgical unit use. However readings may be inaccurate
for a short time after or during use of defibrillator or electrosurgical unit.
Transients may caused by cable circuitry connection blocks while monitoring may be similar to the real heartbeat
waveform, and as a result resistance / heart rate alarm may sound. Proper electrode and cable placement
according to this manual’s instructions and the instructions for using the electrode will minimise the chance of
this transient occurring.
IF THE PATIENT IS FITTED WITH A PACE MAKER: This device has been designed to provide
inhibition to pacemaker pulse signal, generally the pacemaker pulse is not counted in heart rate measurement
and calculation, but when the width of pacemaker pulse is over 2ms, it may be counted. In order to reduce this
possibility, observe the ECG waveforms on the screen carefully and do NOT rely entirely on the heart rate
display and alarm system of this monitor when monitoring this kind of patient. Keep Pacemaker Patients under
extra close surveillance.
The improper connection of an electrosurgical unit may cause burns, the monitor may be damaged or cause
deviations of measurement. You can take some steps to avoid this situation, such as do NOT use small ECG
electrodes, choosing the position which is as far away as possible from the estimated Hertzian waves route,
using larger electrosurgical return electrodes and connecting with the patient properly.
No predictable hazard will be caused by the summation of leakage currents when several items of monitor are
interconnected.
ECG lead cable may be damaged while using defibrillator. If the lead cable is used again, please do the functional
check first.
When the monitor is inoperable due to an overload or saturation of any part of the ECG amplifier, it will prompt,
“Lead off” to alert the operator.
11
3.3.2 Blood Pressure Cuff Connection
6. Connect the air hose to the right-panel connector marked with the NIBP icon.
7. Remove packaging and wrap the cuff around patient’s upper arm.
Requirements of the cuff:
1)
Appropriate cuff should be selected according to the age of the subject. Its width should be 2/3 of the
length of the upper arm. The cuff inflation part should be long enough to permit wrapping 50-80% of the
limb concerned. See the table below for the dimensions:
Note: The size of the cuff selected should suit the subjects while measuring. This is only a general guide.
2)
3)
4)
5)
6)
Cuff Model
Limb Circumference
Cuff Width
Neonate Cuff
6.0cm~9.5cm
3cm
Small-sized Paediatric Cuff
6cm～11cm
4.5cm
Middle-sized Paediatric Cuff
10cm～19cm
8cm
Large-sized Paediatric Cuff
18cm～26cm
10.6cm
Adult Cuff
25cm～35cm
14cm
Extra Large Adult Cuff
35.0 ~ 46.0cm
18cm
Thigh Cuff
45.0 ~ 56.5cm
25cm
Remove packaging prior to fitting on the cuff, and wrap the Cuff around the upper arm evenly to
appropriate tightness.
Remember to empty the residual air in the cuff before the measurement is commenced.
Locate the cuff in such a way that the “φ” mark is at a location where the clearest pulsation of brachial artery
is observed.
The cuff should be tightened to a degree where insertion of one finger is allowed.
The lower end of the cuff should be 2cm above the elbow joint.
Figure 3.6 Cuff Position
Safety Instructions for NIBP Monitoring
When taking an infant or child’s (less than 10 years old) blood pressure measurement, ensure that the correct NIBP
mode is selected prior to starting any measurement. Do NOT operate in the adult mode for Child or Infants. The high
inflation pressure may cause lesion or tissue damage.
It is recommended to take the blood pressure measurement manually. Automatic or continuous measurement
should be used in the presence of a doctor/nurse if possible.
NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease, or
partial bleeding will appear.
Do NOT bind NIBP cuff on limbs with transfusion tube or IV Lines, Monitoring Sensors etc or skin lesion
area, otherwise, damage may be caused to the limbs or Monitoring may be effected.
Pay attention to the colour and sensitivity of the limb when measuring NIBP; make sure the blood circulation
is not blocked. If blocked, the limb will discolour. Stop measuring or move the cuff to another position and
inform a doctor.
If the time of the automatic pattern non-invasive blood pressure measurement takes too long, the patient could
possibly have purpura, lack blood or neuralgia. When checking the patient, you must inspect the colour, the
warmth and the sensitivity of the body frequently. Once you observe any exception to normal patterns,
immediately stop the blood pressure measurement.
12
The subject should sit or lie on their back so that the cuff and the heart are in the same horizontal plane and
the most accurate measurement is taken. Other postures may lead to inaccurate measurement.
Do not speak or move before or during the measurement. Care should be taken so that the cuff will not be hit or
be touched by other objects.
The measurements should be taken at appropriate intervals. Continuous measurement at too short intervals may
lead to a compressed arm, reduced blood flow and lower blood pressure, resulting in inaccurate measurement of
blood pressure. It is recommended the measure be taken at intervals of more than two minutes.
When an adult subject is monitored, the machine may fail in giving the blood pressure measure if the infant mode
is selected. Ensure the appropriate Patient Size Mode is selected prior to taking a reading.
Prior to use, empty the cuff until there is no residual air inside it to ensure accurate measurement.
Do NOT twist the cuff tube or put heavy things on it.
When unplugging the cuff, hold the head of the connector and pull it out.
The symbol indicates that the cable and accessories are designed to have special protection against
electric shocks, and is defibrillator proof.
Pressure Accuracy Verification
Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP module
inside the device. A qualified Technician should do pressure accuracy verification every 6 -12 months in order to
check if the pressure measurement still conforms to the product performance specification. If the deviation is beyond
the declared specification, t h e M o n i t o r s h o u l d b e returned to the Distributor for repair or calibration. Before
verification, please connect the monitor to a standard calibrated pressure meter 0-300 + mmHg.
Figure 3.7 Connection of Pressure calibration
13
Mode 1: the Monitor can activate the inflation so the pressure will increase automatically until it
exceeds the limit value specified in table A. This pressure limit value depends on the patient type
selections shown in table A:
Adult
240mmHg
Child
200mmHg
Neonate
120mmHg
Table A
During inflation, the Monitor will close the deflating valve, and the pressure value will be shown during the process.
If there is no manual deflation operation, the pressure will remain until deflation by manual operation, so it is
necessary to use a manual valve for doing adequate deflation in several steps to verify the pressure accuracy in the
full scale of measurement range.
Mode 2: No automatic inflation by Monitor during the pressure accuracy verification.
Increase the pressure manually by the pumping a hand held pressure bulb, and applying different pressure
values manually to carry out the verification. If the increased pressure exceeds the given limit as shown in table B,
the Monitor will deflate automatically because of over-pressure protection. These values should also be verified
as part of the testing.
Adult
300mmHg
Child
240mmHg
Neonate
140mmHg
Table B
After the verification, press the button again to return to normal working mode, then continue
other operation, or the NIBP key will be invalid.
Doctors or nurses are not allowed to do the verification; This is dangerous especially when the
pressure cuff is still on the patient.
Air Leakage Check
In order to avoid significant error in blood pressure measurement or even no measurement result caused by air
leakage in the pneumatic system, including the cuff during measuring, it is recommended to check if there is leak
in the pneumatic system as well.
Ensure the cuff is removed from the patient while performing the leakage check.
3.3.3 To connect the SpO2 Sensor Probe
The SpO2 Sensor is a delicate piece of accessory. Please follow the steps and procedures for using it. Failure to
use it correctly may effect accuracy of readings and may can cause damage to the SpO2 Sensor.
User procedure:
8. Connect the SpO2 probe to the right panel’s jack labelled “SpO2”. When unplugging the probe, be sure to
hold the head of the connector and pull it out.
9. Insert one finger into the probe (index finger, middle finger or ring finger with proper nail length)
according to the finger mark on the probe, shown as below.
14
Figure 8 Demonstration for SpO2 probe
When selecting a sensor, consider the patient’s category, adequacy of perfusion, availability of probe site and
anticipated monitoring duration. Use only SpO2 probes provided by the Manufacturer with this monitor. Read the
following table for SpO2 probe information. Refer to Chapter 13.8 or Individual Sensor IFU’s for the detailed
instructions of each SpO2 probe.
Use of Pulse Oximetry:
High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent
lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. To prevent
interference from ambient light, ensure that the sensor is properly applied, and, if necessary, cover the sensor site
with opaque material. Failure to take this action in high ambient light conditions may result in inaccurate measurements.
If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor to a less
active site if possible; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh
adhesive backing. For reusable sensors, follow the sensor directions for use for cleaning and re-use. For single-patient
use sensors, use a new sensor for each patient. Do not sterilize any sensor by irradiation, steam, or ethylene oxide.
Safety Introductions for SpO2 Monitoring
Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with microcirculatory
problem. It is recommended that the sensor should NOT be applied to the same place for over two hours.
Change the measuring site periodically if necessary.
Themeasuringsiteisgenerallychangedevery 2-3hours.Themeasuringsiteshouldbeinspected
to ensure no abnormity every 1~2 hours. If abnormity occurs, change the measuring site periodically.
Whentheambient temperatureisover35℃,pleasechangethemeasuringsiteeverytwohours if necessary.
Burn hazard: When the ambient temperature is over 37℃, take special care.
SpO2 measuringpositionmustbeexaminedmorecarefullyforsomespecialpatients.
Do NOT install the SpO2 sensor on a finger with oedema or fragile tissue.
Do NOT put the SpO2 sensor and pressure cuff on the same limb, otherwise the NIBP
measuring will affect SpO2 measuring and cause an alarm error.
If sterile packaging of SpO2 sensor is damaged, do not use it .
Check the SpO2 sensor and cable before use. Do NOT use a damaged SpO2 sensor.
If the temperature of SpO2 sensor is abnormal, do not use it any more
Please do not use nail polish or other cosmetic product on the nail.
The finger nail should be of normal length.
Please do not allow the cable to be twisted, bent, impacted, cut or clamped.
The SpO2 sensor cannot be immerged completely into water, liquor or cleanser, because the sensor is not waterproof.
15
3.3.4 Printer connection
1.
PRINTER：USB port; connect the monitor to the provided USB cable.
Figure 3.9 rear panel of printer
3.3.5 Loading printing paper
Step 1:
Step 2:
Step 3:
Step 4:
Open the cover of the printer
Install the paper to the printer properly
Pull the paper out of the printer for 2 or 3 cm
Close the printer cover
The ERROR indicator on the top right corner of the printer will be on when the printing paper runs out.
Figure 3.10 front panel
16
3.3.6 Battery Installation
10.
11.
12.
13.
14.
Make sure that monitor is not connected to mains power supply.
Unfasten the screw on the battery lid with a screwdriver and open the battery cover.
Insert the battery connecting wire into the battery receptacle (Do not insert the plug in reverse).
Insert it into the battery compartment
Close the battery lid and fasten it with the screw.
Please remove the battery from battery compartment if it won’t be used for a long time.
Battery connecting wire
Battery receptacle
Battery label
Figure 3.11 Battery Installation
3.3.7 Bed Rail Hook / Handle Installation
15.
16.
Take out the handle / bed rail subassembly if necessary.
Fix the handle subassembly on the rear panel with two screws, see Figure 3.12.
Figure 3.12 Handle Installation
17
Chapter 4 Monitoring Screen and ECG Activation
4.1 Date And Time
Shows the date and Time Setup screen immediately after the monitor is started, shown in Figure 4.1:
Figure 4.1 Time Setup
The system will stay on this screen for 3 seconds. If you do not rotate the navigation knob within this period, the
screen will enter into the Main Screen.
Follow the steps below to set date and time.
Step 1: Rotate Navigation Knob, move the grey cursor to “Edit”.
Step 2: Press the knob, and then “Edit” turns into “Save”. The grey cursor stays on the Year of the date. Press the
knob again and the grey cursor becomes highlighted. Rotate the knob left or right to increase or decrease
the year value.
Step 3: When the Year is set, press the knob to move the grey cursor to the Month. Step 4: Repeat Step 2 and
Step 3 to adjust the Year, Month, Date, Hour and Minute. Step 5: If you have finished adjusting the date
and time, press the knob and rotate it to move the cursor to “Save”. Press it to save the settings and exit
the date and Time Setup screen. Meanwhile enter into the Main Screen shown in Figure 4.2. If you press
“Exit”, the settings will not be saved.
The system is initialized and enters into Main Screen where monitoring and system operation are performed (as
shown in Figure 4.2).
4.2 Main Screen
Figure 4.2 Main screen
18
Border area
“Alarm ”:
Audible alarm status, green “
” indicates the audible alarm is enabled, yellow “ ” indicates the
alarm sound is silent. The audible alarm will be activated again automatically after the end of given count down or
when a new type of alarm event occurs. Red “ ” indicates the audible alarm is disabled, that means the alarm
sound is fully off, this is also normal situation when the alarm sound volume is set to “0” in system parameter
settings.
“ADUL”:The type of the monitor subject. There are two modes available: “Adult” and “Infant”.
“MON”: ECG Filter type. There are three types: “Diagnosis”, “Monitor” and “Operation”. The option can be set
in the System Menu.
Battery Power indicator; When the indicator is yellow and displays only one “grid”, it means there
is a little battery power left. When the indicator turns red and blinks, as well as less than one “grid” displays, the
system alarm will be on to remind of battery shortage. Please connect the device to the mains power supply in
time to ensure the normal use of monitor, and the battery will be recharged. When the battery power is full,
battery power indicator displays full grid of white cells.. During recharging, the grids in the battery indicator are
rolling circularly.
“2011-03-02 13:57:25”:Current calendar time and date. The system time and date can be set during the system
start-up when the screen displays the time and date setups. The current figure shows the time and date is March
2nd, 13:57:25, 2011.
“Push knob for System Menu”: System prompt or description for the current status.
“ID”: The patient ID. The patient ID can be entered or changed in the archive management window.
Waveform area
1st trace: The first trace is ECG waveform for lead II. The left side of the ECG shows the sign I, which indicates the
ECG scale. The scale sign changes its length according to the ECG gains. All ECG waveforms have their own
scale. When the third trace changes to lead II, the first trace will automatically change to lead I.
2nd trace: The second trace is for the ECG waveform of lead III. When the third trace displays the ECG for the
lead III, this trace automatically changes to the ECG for lead I.
3rd trace: Its lead can be adjusted and will not repeat the 1st and 2nd traces.
4th trace: SpO2 plethysmograph.
5th trace: Respiration waveform.
Data area:
Figure 4.3 Heart rate area
“HR”: The currently displayed heart rate. The 61 on the right side is the heart rate measured.
“bpm”: The heart rate unit. bpm = beat per minute.
“ ”: The heart beating symbol. Its flashing corresponds to the R wave of the ECG waveform.
The speed is the same with the heart rate.
“ST+0.09mv”: the measured mili-volts value of automatic S-T measurement.
19
“X1”:ECGwaveformgain(amplification),6optionsavailable:
“Auto” Automatic scaled waveform.
“×1/4” Waveform scaled with 1/4 of the base gain.
“×1/2” Waveform scaled with half of the base gain.
“×1” Waveform scaled with base gain.
“×2” Waveform scaled with twice of the base gain.
“×4” Waveform scaled with four times of the base gain
Figure 4.4 Blood pressure data area
“NIBP”: Thebloodpressuretypelabelsandthemeasuredvalue.
“mmHg”: NIBP unit
“12:56”: The time of NIBP measuring
“Manu”: The NIBP measurement mode.
Figure 4.5 TEMP data area
“TEMP”:Temperaturelabel.Thevalue isthetemperaturevalue.
“℃”: Body temperature unit.℃ is Celsius, and °F is Fahrenheit.
Figure 4.6 SpO2, pulse rate, and respiration data area
“SpO2”:SpO2 label. The “98” on the right side is the current SpO2 value measured.
“PR”: Pulse rate label. The value “62” on the lower left shows the pulse rate value.
“ ”: SpO2 strength bar.
“RR”: Respiration Rate: The rpm is the unit of the respiration.
“16”: Respiration rate.
20
“X2”:
“×1/2”
“×1”
“×2”
“×4”
Respirationgain(amplification)
Waveform scaled with half of the base gain.
Waveform scaled with base gain.
Waveform scaled with twice of the base gain.
Waveform scaled with four times of the base gain
Operation Instructions:
ECG lead: press it to shift the ECG monitoring circulatory among leadⅠ, Ⅱ, Ⅲ, aVR, aVL, aVF and V.
Alarm silence: press it to set or activate the alarm silence.
Freeze: press it to freeze ECG waveform or the waveforms of ECG, SpO2 and RESP according to the
system setting.
NIBP: press it to start or stop NIBP measurement.
DISP: press it to shift the display to Display 2 Screen.
Navigation Knob:
1. Press the navigation knob for about 3 seconds, enter system menu screen.
2. Rotate the knob to move the grey cursor to the corresponding item, and press it for 1 second to
enter
4.3 Display 2 Screen
4.3.1 Observing Screen
Press the DISP key to shift screen to Observing Screen when setting Disp2 as “Obsev” in System Setup screen,
as shown in Figure 4.7.
Figure 4.7 Observing Screen
21
Operation Instructions:
ECG lead: press it to shift the ECG monitoring circulatory among leadⅠ, Ⅱ, and Ⅲ, aVR, aVL, aVF and V.
Alarm silence: press it to set or activate the alarm silence.
Freeze: press it to freeze the ECG waveform and perform manual S-T segment analysis. Double press this
key within 2 seconds to lock or unlock the operation of all other buttons (except power switch) on
the front panel.
NIBP: press it to start or stop NIBP measurement.
DISP: press it to shift the display to the Main Screen.
Navigation Knob: No action. When pressing the “Freeze” key, this key is used for S-T segment analysis.
4.3.2 NIBP screen
Figure 4.8 NIBP Screen
Press the DISP key to shift the Main Screen to NIBP screen , as shown in Figure, when setting Disp 2 as “NIBP” in
“system menu → system setup → Disp2”. In NIBP screen, PR from SpO2 is shown prior to PR from NIBP.
Operation Instructions:
EGG lead:
No action. When the printer is on, it serves as the printing key.
Alarm silence:
Press it to set or activate the alarm silence.
Freeze:
No action.
NIBP:
Shift:
Navigation knob:
Press it to start or stop NIBP measurement.
Press it to shift the display to the Main Screen.
No action.
22
4.3.3 Seven ECG Waveforms on the Same Screen
Press the DISP key to shift screen to 7 ECG Waveform Screen when setting Disp2 as “7 ECG” in System Setup
screen. In this screen, the operator can simultaneously view the ECG waveform for 7 leads: I, II, III, aVR, aVL, aVF and
V, as shown in Figure 4.9.
Figure 4.9 7 Leads on the Same Screen
Operation Instructions:
ECG lead:
No action. When the printer is on, it serves as the printing key.
Alarm silence: press it to set or activate the alarm silence.
Freeze:
press it to freeze all 7 ECG waveforms. Double press this key within 2 seconds to lock
or unlock the operation of all other buttons (except power switch) on the front panel.
NIBP:
press it to start or stop NIBP measurement.
DISP:
press it to shift the display to the Main Screen.
Navigation Knob:
rotate the knob to adjust the gain for all 7 ECG waveforms. The ECG gain includes
6 options :“Auto”, “X1/4” “X1/2”, “X1”, “X2”, “X4”.
23
4.3.4 Five Traces of Real-time Waveforms with Short Trends on the Same Screen
When the Disp2 option is “Trend” on System Menu screen, press the DISP key on the Main Screen, the system will
enter the trend screen, as shown in Figure 4.10. Five traces of real-time waveforms and short trend graph can be
viewed on this screen.
Figure 4.10 Five Channel Real-time Waveforms and Two Hours Trends
On this screen, the first trace is ECG waveform of Lead II; the second (CAS) one is the continued ECG for the first
trace of waveform; the third one is ECG waveform of Lead I; the fourth one is SpO2 plethysmogram; the last trace is
respiration waveform. On the right of waveform area, from top to down, respectively is heart rate, temperature, SpO2,
and RR trend graph, the abscissa of trend graph (-2h-0) means various trends of every parameter value from now
on to two hours before. Trend curve in trend graph shifts from right to left.
Operation Instructions:
ECG lead: press it to shift the ECG monitoring circulatory among leadⅠ, Ⅱ, and Ⅲ, aVR, aVL, aVF and V.
Alarm silence: press it to set or activate the alarm silence.
Freeze: press it to freeze ECG waveform or the waveforms of ECG, SpO2 and RESP according to the system
setting. Double press this key within 2 seconds to lock or unlock the operation of all other buttons (except power
switch) on the front panel.
NIBP: press it to start or stop NIBP measurement.
DISP: press it to shift the display to the Main Screen.
Navigation Knob: no action.
24
4.3.5 Parameter screen
Press the DISP key to shift screen to Parameter Screen when setting Disp2 as “Parameter” in System Setup screen, as
shown in Figure 4.11
Figure 4.11 Parameter screen
Operation Instructions:
ECG lead: when the printer is on, it serves as the printing key.
Alarm silence: press it to set or activate the alarm silence.
Freeze: no action. Double press this key within 2 seconds to lock or unlock the operation of all other buttons
(except power switch) on the front panel.
NIBP: press it to start or stop NIBP measurement.
DISP: press it to shift the display to the Initial Screen.
Navigation Knob: no action.
25
4.4 Freeze and S-T Measurement Screen
During the process of monitoring, the ECG waveform can be frozen to perform detailed analysis in the observing
screen, as shown in Figure 4.12.
Figure 4.12 Frozen and S-T Measurement Screen
4.4.1 Screen Description
Freezing, S-T segment measurement screen is similar to the observing screen, except the waveform is frozen.
For example, the Figure 4.13 is a portion of the frozen waveform. The symbols on the screen described briefly on the
screen.
Figure 4.13 Frozen waveform
26
4.4.2 How to Measure the Level of S-T Segment on ECG Waveform
The operator can use the “Navigation Knob” to measure the level of S-T segment on the waveform, i.e. measuring
the voltage difference between the S-T segment and the reference level (base line). The value is displayed after the
measurement on “S-T + 0.000 mV”. The operation is carried out in 4 steps.
Step 1:
rotate the “Navigation Knob” to move the base point (the red cross) horizontally to base line point
(the base line is between the Q wave and the P wave). At this point, the frozen screen shows “ST+0.xxx mV, Set Base, Dirc Hor”
Step 2:
press the “Navigation Knob”. The screen shows “S-T+0.xxx mV, Set Base, Dirc Ver”.
Then rotate the knob to move the base point vertically to the base line point.
Step 3:
press the “Navigation Knob” again. The screen shows “S-T+0.xxx mV, Set ST, Dirc Hor”. Rotate the
knob to move the S-T point (the yellow cross) horizontally to the point to be measured on the S-T
segment.
Step 4:
press the “Navigation Knob” again. The screen shows “S-T+0.xxx mV, Set ST, Dirc Ver”. Rotate the
knob to move the S-T point vertically to the point to be measured on the S-T segment.
Only the observing screen allows pressing the freeze key to enter the S-T segment measurement screen.
NOTE: The S-T segment is a time interval in ECG waveform, which starts from the end of QRS complex (a
junction called J point) to the beginning of T wave. S-T segment represents the beginning of ventricular
repolarisation, it is normally isoelectric.
Operation Instructions:
ECG lead: press it to shift the ECG monitoring circulatory among leadⅠ, Ⅱ, and Ⅲ, aVR, aVL, aVF and V.
Alarm silence: press it to set or activate the alarm silence.
Freeze: press it to unfreeze ECG waveform.
NIBP: press it to start or stop NIBP measurement.
DISP: press it to shift the display to the Main Screen.
Navigation Knob: m e a s u r e the level of S-T segment
4.5
ECG Activation
This is a Dealer only Feature. Please contact your Dealer to arrange this upgrade which can
be done on site.
27
Chapter 5 Operating Instructions for System Menu
5.1 System Menu Screen
Hold down the “Navigation Knob” for 3 seconds in the Main Waveform Screen as shown in Figure 4.2, the System Menu screen
will display in the lower left area on the screen, as shown in Figure 5.1.
Figure 5.1 System Menu Screen
5.1.1 How to Select the Menu Item
Step 1:
Step 2:
Pressing “
rotate the knob to move the grey cursor to the corresponding item.
press the knob to enter the corresponding screen: SpO2 Data List Screen, NIBP Data List Screen,
Graphic Trend Screen, Recall Screen, Arrhythmia Screen, System Setup Screen, Colour Settings,
File/Archive Management Screen, oxyCRG Screen, Event List Screen, Tourniquet Function Screen.
The following chapters will describe each one respectively.
” key to return to the Main Screen.
5.2 SpO2 Data List Screen
Figure 5.2 SpO2 Data Listing Screen
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5.2.1 Screen Description
When monitoring, the newest data will be displayed on the top of list including “Time, HR, RR, TEMP, SpO2, PR”. The
time shows the time when the SpO2 measurement was taken. Up to 6 groups of SpO2 data can be displayed on one
screen. There is a record taken every 4 seconds.
5.2.2 Operating Instructions
Up to 400 groups of SpO2 data can be memorized. Using the Navigation Knob allows the user to scroll the list up
and down to view SpO2 data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 6, the Navigation Knob
cannot be used to scroll up or down the listing.
Pressing “
” key to return to the Main Screen.
5.3 NIBP Data List Screen
Figure 5.3 NIBP Data List screen
5.3.1 Screen Description
When monitoring, the newest data will be displayed on the top of list including “Time, NIBP, PR, HR, RR, TEMP”. The
time shows the time when the NIBP measurement was taken. Up to 6 groups of NIBP data can be displayed on one
screen. There is only one record every time when the NIBP measurement was taken.
5.3.2 Operating Instructions
Up to 12000 groups of NIBP data can be memorized. Using the Navigation Knob allows the user to scroll the list up
and down to view NIBP data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 6, the Navigation Knob
cannot be used to scroll up or down the listing. Pressing “
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”key to return to the Main Screen.
5.4 Graphic Trend Screen
Figure 5.4 HR Trend
5.4.1 How to View the Graphic Trend
Figure 5.4 is the HR trend graph. There are 3 options on the right of the graph, as described below. “HR” indicates the
current trend graph is HR trend graph. If you want to enter other trend graphs, the procedures are: move cursor to “HR”
and rotate the “Navigation Knob” to choose the trend graph from “HR”, “S-T”, “Temperature”, “NIBP”, “PR”, “RR” and
“SpO2” trend graphs, next press the knob to confirm. Their screens are described in the following figures.
After choosing “Cursor”, the trend graph displays a triangle and a vertical line, a moving ruler mark that can be moved
by rotating the knob. As shown in the figure, when you move the mark to a specific point, the data area below the graph
will display the time and its corresponding heart rate, respiration rate, SpO2, temperature. When rotating the
“Navigation Knob” key to move the mark, the moving interval is a changing value. The rule is that the initial step is
5sec, after moving it towards the same direction once, the interval becomes 30 sec, and with more steps the interval
becomes 1min, 10min and 30min. Therefore, it is very easy to find the time you are looking for.
The “5 sec” on the top shows the interval time. Move the cursor to the trend time, press the knob and rotate it, and the
trend graph time will change to 30 sec, 1 min, 10 min, 30 min, which changes the horizontal axis to be 30 min, 3 hour,
6 hours, 60 hours, 180 hours. For example, the monitoring can record 360 times data continuously when setting to “5
sec” within 30 minutes. Changing the interval time of 30 seconds, it can record 360 times data within 3 hours. Other
changes are similar to that situation.
The Trend graph shows the parameter value of the current time. For example, in the “5 sec” trend graph, the
monitoring can record the current data with the interval of 5 seconds. Once the monitor is out of power, the data can be
stored automatically and you can scan the history record when turning on the monitor next time. This ensures the screen
always display the current data continuously. Other trend graph follows the same rule.
Please note that the maximum value on the vertical axis of HR is 150, not the value of HR upper limit 300. The
graph is scaled down for better viewing of the trend curve. When HR value exceeds 150, the vertical axis’s maximum
value will automatically change to 300. That is to say, the vertical axis value 0-75-150 will change to 0-150-300
automatically if HR value exceeds 150. When the system is reset or the patient ID is changed, the vertical axis will
return to its original value of 0-75-150. Other changes of vertical axis value in other trend graph are similar to that of HR.
The respiration rate, body temperature and other trend graphs are similar to that of the HR’s and we will not cover
them in detail again. Please note that for those trend graphs, the horizontal axis is the number of times the blood
pressure is measured instead of time.
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NIBP graphic trend is a little different from the other graphic trends. Rotate the knob to move the cursor to
“
”, then press the knob for activating this item. Next, rotate the knob left or right for viewing another 400
groups’ graphic trend.
Figure 5.5 S-T Graphic Trend
Figure 5.6 Body Temperature Graphic Trend
Figure 5.7 EtCO2 Graphic Trend
Figure 5.9 PR Graphic Trend
Figure 5.10 Respiration Graphic Trend
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5.4.2 Operation Instructions
Rotate the Navigation Knob to choose the parameter and press the knob to review the trend graph. Pressing “
key to return to the Main Screen.
”
5.5 Recall Screen
Figure 5.11 Waveform Recall Screen
It shows the monitoring can recall the history data continuously. If you change the patients’ ID or the monitor is out of
power, the measuring data will not be a new single record, but will connect to the last record you have measured. It is
a continuous loop recording.
The ECG lead, gain and other parameters will not change during recall.
Shown in Figure 5.12, it is different from the Main Screen in its 3rd trace of waveform area and the operation area. This
is explained in detail below.
Figure 5.12 Recall Listing
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5.5.1 Operation Instructions
Rotate the “Navigation Knob” and choose “Recall”, “HIST”, “Delete” or “Exit”. We explain the functions of each button below.
Recall:
Press the Recall and the first record in recall list becomes green. Rotate the knob
to choose a record, and press the knob to recall it. The recalled waveform is displayed on the
3rd trace of the waveform area, as shown in Figure 5.13.
Figure 5.13 Recalled Waveform
Rotate the “Navigation Knob” to move forward or backward to review the waveform. Press the “Navigation
Knob” to exit the waveform recall and return to the initial waveform recall screen. During waveform recall, the
system not only displays the current recalled waveform, but also displays the lead status, gain and filter type of
the waveform and time.
HIST:
Press the key to shift between the History key and Current key. Press HIST and the recall list
on the left displays the history data list. Press the Current; the recall list on the left side
displays the current one. When entering the recall screen, the system defaults to the current
one.
Delete:
Press this key, and the selected record in the recall list becomes green. Rotate the “Navigation
Knob” to choose the reviewed record that is to be detected, press it, release it 2 seconds later,
and then the record is deleted. The current record cannot be deleted, or system will exit Delete
screen.
Exit:
Press this key to return to the System Menu screen.
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5.6 Arrhythmia Screen
Figure 5.14 Arrhythmia Screen
5.6.1 Operation Instructions
The structure is similar to the recall screen. We will cover each function key below.
This button is used to start and end the system Arrhythmia detection. The default is OFF. When the
Arrhythmia is not ON, the “Learn” key is disabled. Press this key and the system enters learning mode. The
Start changes to End. Press it again to end the learning. When “Learn” key changes to yellow from grey, it
indicates the learning has finished. After the Arrhythmia detection begins, the system will automatically
detect the Arrhythmia waveforms. If Arrhythmia is detected, the Arrhythmia waveform will be displayed in
the 3rd trace of ECG waveform, shown in Figure 5.14. When the system is reset or the patient has
changed, the Arrhythmia needs to be re- learned.
Learn: Because the Arrhythmia detection is based on the normal ECG waveform at the same speed and same
amplitude, when the patient changes, or the Arrhythmia detection is incorrect, the Arrhythmia needs to relearn. To make better use of the learn function, it is recommended to use a good ECG waveform to learn
during monitoring.
View: Press this key, and the selected record in the Arrhythmia list, which is to be reviewed, becomes green.
Rotate the “Navigation Knob” to choose the record and display the corresponding waveform in the 3rd
ECG channel. Press the knob again to exit.
Exit:
press this key to exit the Arrhythmia detection screen and return to the System Menu screen.
Start:
During monitoring, if Arrhythmia is detected, the system will alarm. The Arrhythmia alarm is system default and does
not need setup. During Arrhythmia detection, incorrect detection might occur if the non-ECG waveforms (e.g.; square
wave and triangle wave) appear. Before starting 1mV testing, please turn off the Arrhythmia detection. During
Arrhythmia detection, the template of normal ECG waveform is very important, the system requires a group of stable ECG
waveforms to build up the template. If the system detects the Arrhythmia incorrectly, please re-learn t h e t e m p l a t e by
pressing “Learn” button and capture correct ECG waveform.
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5.7 System Setup Screen
Figure 5.15 System Setup
5.7.1 How to Select the System Setup Item
Step 1:
Step 2:
Press “
rotate the knob to move the grey cursor to the corresponding item.
press the knob to enter the corresponding setting screen: System Setup, Printer Setup, ECG Setup,
TEMP setup, CO2 Setup, NIBP Setup, SpO2 Setup, RESP Setup or resuming Default setting. The
following contents will be described each one respectively.
” key to return to the Main Screen or “Exit” button to return to the System Menu screen.
Note: If you disabled Hi and Lo limit alarm function of parameter monitoring, all the alarms
related to its parameter monitoring will be disabled as well.
5.7.2 Parameter Settings
Step 1: rotate the knob to move the grey cursor to the setting item and press the knob to confirm your selection.
Step 2: rotate the knob to change the setting or modify the setting value.
Step 3:press the knob again to change and repress it to save the setting.
Press “
” key to return to the Main Screen
SYSTEM PARAMETER SETTINGS
Figure 5.16 System Setup
Type: The object being monitored, this can be selected between Adult and Infant.
Adult: the subject is Adult. Infant: the subject is Paediatric.
Neon: the subject is Neonatal. The default is “Adult”
When changing the patient type, the system will perform the alarm settings, NIBP settings initializations.
Please pay special attention to the patient ‘type’ before monitoring begins. It is forbidden to use ‘Adult
type’ on a Paediatric or Neonatal patient, as it can cause serious injury.
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Mode: Monitor System Menu. The “Real Time” shows the real time waveform, i.e. normal monitoring state. The
“Demo” shows the demo waveforms. In the demo state, all the signals and data are generated from the
Monitor for demo, training and testing purpose. The default is “Real Time”.
LANG: The current language used, which can be selected by the user. There is no default for this setting.
However, the setting can be saved.
When the fill setting is ON, the display fills the volume for the SpO2 and Respiration.
When it is OFF, the system displays the line graph. The default is OFF.
Froze: Press the key to freeze the selected waveform. The options are “All” and “ECG”. When ECG is selected,
the system only freezes the ECG waveform. When “All” is selected, the
system freezes all the waveforms including ECG, SpO2, and Respiration. The factory default is “ECG”
Disp2: The Display 2. Two options: Obsev (Observation) and 7 ECG (7 ECG lead) can be selected. The
factorydefaultisObservation.
AlmVol: The alarm sound volume. The maximum volume is 7 and minimum is 0, i.e. no sound. When the
Fill:
setting is “0”, the icon “ ” will be displayed on screen to remind user that the alarm sound is off and
Alarm Silence function is disabled. The default is 5.
Beep: If the setting is ON, pressing the button will generate a keystroke sound. The factory
default is ON.
Exit:
return to the System Setup screen.
PRINTER SETUP
Printer: For switch on or off the printer.
Timer: If printer is ON, rotate navigation knob to set on the Timer to enable timed print, and set the value of
printing intervals in the cycle category. When the time is reached, the system
will automatically take the record. The interval is 1,2,3…….to 240 minutes.
Wav2: When printer is selected, you can choose SpO2, respiration, ECG lead I, III, aVR, aVL, aVF or V to be printed
with ECG lead II waveform. The default is SpO2
ARR: Arrhythmia trigging print. “ON” means the printer will trig once arrhythmia occurs and
record the arrhythmia waveform information. The initial setting is “OFF” means closing the arrhythmia
trigging record.
Exit:
return to the System Setup screen.
Printer is optional function. If the purchased machine has printer, please refer to above Printer
Setup.
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ECG PARAMETER SETTINGS
Figure 5.17 ECG Setup
Lead: Can choose from I, II, III, aVR, aVL, aVF, V (V1-V6). The default is I.
Gain: The ECG gain, 6 options x1/4, x1/2, x1, x2, x4 andAuto.Auto is for automatic gain control.
The factory default is x1
HR Hi: High limit of heart rate alarm
Lo: Low limit of heart rate alarm
The adjustable range and the factory default value can be found in chapter 12.2.
Speed: ECG waveform sweeping speed. 4 options: 6.25, 12.5, 25, 50 mm/s. The factory default is 25 mm/s
Mode: ECG filter mode. Three options: MON, DIA, and OPE
MON: Monitoring mode. Moderate filtering, it can filter out interference and present good ECG waveforms.
DIA:
Diagnosis mode. No filtering, represent the true ECG waveform without filtering.
OPE:
Operation mode. Deep filtering, it can filter out strong interference.
The factory default is MON.
1mV: Generating the 1mV signal. This signal is used to test the function of the machine. It is not used during
normal operation. Factory default is OFF
Notch: power line frequency filter. Different hardware configuration may make its options various. One is “ON”/
“OFF” (The factory default is ON.), and it means turn on or turn off the
50Hz frequency filter. The other option is “OFF”/ “50Hz”/ “60Hz”, please choose “50Hz” or “60Hz”
frequency filter according to your power supply frequency.
The factory default is “50Hz”.
Pace: Cardiac pacemaker pulse detection. When Pace is “ON”, a mark will be displayed on the ECG waveform if
a cardiac pacemaker pulse is detected. The factory default is OFF.
Grid:
Exit:
The grid on the background for Observing Screen and Frozen & S-T Measurement Screen.
Factory default is OFF.
return to the System Setup screen.
Limits setup: Move the grey cursor to the High or Low limits of the alarm settings, and press the “Alarm silence”
key to turn ON or OFF the alarm for the setting. Yellow colour shows ON status, and grey colour shows the
OFF status.
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TEMPERATURE PARAMETER SETTINGS
Figure 5.18 T e m p e r a t u r e Setup
TEMP Hi: High limit of temperature alarm
Lo:Low limit of temperature alarm
NIBP PARAMETER SETTINGS
Figure 5.20 NIBP Setup
The pressure unit, and mmHg and kPa can be selected. The factory default is mmHg.
Mode: The cuff inflation mode, manual or automatic. The factory default is manual. The operator needs to press the
NIBP button to perform NIBP measurement. If the Auto mode is
chosen, the operator needs to set an interval cycle as well.
Cycle: The inflation interval when the NIBP measurement is set to Auto. The options are STAT, 1 min, 2 min…240
min. Press NIBP and the system begins to count down. It takes blood
pressure measurement automatically after finishing counting down If STAT is selected, press NIBP to
take 5 minutes’ measurement.
WARNING: STAT can only be used for Adult. Using this mode to Infant patient can cause serious injury.
NIBP Cali: It is used to check the accuracy of pressure measuring system within NIBP module, which should be
conducted by technicians in test house or service department. There
are three options: “Mode 1”, “Mode 2” and “OFF” available. After the verification, it is necessary to make
sure it is in “OFF” status again, or other operations can’t be carried out and NIBP key will be inactivated.
Factory default status is “OFF”.
GasLeak: itis used by technicians toperform a leakage inspection for NIBPpneumatic system.
SYS Hi/Lo: High and Low limits of systolic pressure alarm
DIA Hi/Lo: High and Low limits of diastolic pressure alarm
MAP Hi/Lo:High and Low limits of MAP alarm
PR Hi/Lo: High and Low limits of PR alarm
Initial inflation pressure setting: Cuff pressure to be inflated initially, its options are different depending on
patienttype.
For neonate: initial inflation pressure can be: 60, 70, 80mmHg, default setting: 70 mmHg;
For infant: initial inflation pressure can be: 80, 100, 120, 140 mmHg, default setting: 100 mmHg;
For adult: initial inflation pressure can be: 80, 100, 120, 140, 160, 180, 200mmHg, default Setting: 150 mmHg.
Exit:
return to the System Setup screen.
Unit:
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SPO2 PARAMETER SETTINGS
Figure 5.21 SpO2 Setup
SpO2 Hi/Lo: High and Low limits of SpO2 alarm.
Pulse Hi/Lo: High and Low limits of pulse rate alarm.
Exit: return to the System Setup screen.
RESPIRATION PARAMETER SETTINGS
Figure 5.22 Respiration Setup
Gain:
Speed:
Respiration amplification/gain, 4 options, x1/2, x1, x2, and x4. The default is x2 Respiration
display speed, 2 options 6.25mm/s and 12.5 mm/s.
Apnea:
The default is 12.5 mm/s
The apnea alarm time (in seconds). When the patient stops breathing for longer than
the set period, the Respiration display channel displays warning “Apnea xxx second”.
Type:
RR
Hi:
Lo:
Exit:
Respiration impedance
High limit of respiratory rate alarm
Low limit of respiratory rate alarm
return to the System Setup screen.
RESUME DEFAULT
In the System setup screen as shown in Figure 6.15, rotate knob to choose “DEF” and then press the knob, clear
the check action box and all the value of parameters will resume default setting.
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5.8
Colour Settings
Figure 5.23 Colour Setup
5.8.1 How to Change the Parameter Colour
Step 1:
Step 2:
Step 3:
Press “
rotate the knob to move the grey cursor to the setting item and press the knob to confirm your
selection.
rotate the knob to choose the colour.
press the knob again to confirm the chosen colour.
” key to return to the Main Screen or “Exit” button to return to the System Menu screen.
5.9 File Management Screen
Figure 5.24 Document management screen
5.9.1 How to Add a New Patient
The document/archive management screen can be used to manage information about the patient. In the screen, the
operator can enter and modify the patient ID, Name, Bed number, Sex, and Age. The operator can also choose to save
the patient data in the permanent storage. The screen is shown in Figure 5.24.
Or Patient ID. To enter patient ID, choose the patient ID field by using the “Navigation Knob”.
Press it to enter the text entry box. Rotate the knob to choose the letter and press the knob to enter it. To
delete the letter, move the cursor to the letter and rotate the knob to enter spaces (after the H). Use the
spaces to replace the letters. After entering the patient ID, choose “Exit” button and press the knob to exit
the text entry. The patient ID is the unique identifier for the patient. When the patient ID changes, the system
considers the patient has changed.
Name: Enter the patient’s name.
Bed:
Enter the bed number.
Sex:
Choose between M and F for male and female.
ID:
Age:
Choose the age field and use the “Navigation Knob” to select an age.
Save: The operator can choose how much of the data needs to be saved. The unit is hour. Once the time is chosen,
the system starts to save data from the current time. If OFF is selected, it means that the data will not be
saved. The system will determine the time range according to the available disk space. If no disk space
available, SAVE will be displayed as OFF. When the user intends to save the current ECG waveform
permanently, please delete the history files. Refer to Chapter 5.1.1 for deletion methods.
Exit:
Press this key to return to the System Menu screen.
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5.10 oxyCRG Screen
Figure 5.25
oxyCRG Screen
This screen displays the trend curve of HR, SpO2, and RESP waveform or RR trend in selected time.
5.10.1 Operation Instructions
Step 1:
Step 2:
Step 3:
Press “
rotate the knob to move the grey cursor to the button “
” or “
” and press the
knob to confirm your selection.
rotate the knob to choose the setting. The time can be set as 1 minute, 2 minutes or 4 minutes. The
third trace of curve display can be set as RWAVE (Respiration waveform) or RR (RR trend curve).
press the knob to confirm your setting.
” key to return to the Main Screen.
5.11 Event List Screen
Figure 5.26 Event List
5.11.1 Screen Description
The Event List displays the time, event type; the value detected and high and low alarm limits. The time shows the
time when the event occurred. Up to 5 groups of event data a be displayed on one screen.
5.11.2 Operating Instructions
Up to 2000 groups of event data can be memorized. Using the Navigation Knob allows the user to scroll the list up
and down to view event data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 5, the Navigation Knob cannot
be used to scroll up or down the listing.
Press “
” key to return to the Main Screen.
5.12 Tourniquet Function
Figure 5.29 Cuff
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s
“Pressure”: when you use Tourniquet function, you need to preset a cuff pressure for haemostasis.
The pressure is adjustable, and its adjusting limit is different depending on patient type:
For neonate: preset range: 70~100 mmHg, default value: “90” mmHg;
For infant: preset range: 80~130 mmHg, default value: “110” mmHg;
For adult: preset range: 80~180mmHg, default value: “140” mmHg.
+
If the pressure drops down slowly under 10mmHg compared with the preset value due to a small air leakage in the
pneumatic system, the monitor will re-inflate to maintain the cuff pressure close to the preset pressure value.
Note: the unit of cuff pressure is the same as the NIBP unit in NIBP Setup.
s
s
s
“Duration”:
“Alarm”:
“Start”:
After presetting the cuff pressure, you need to set the time period for maintaining the preset pressure
after inflation. “5, 6, 7,…120” minutes adjustable. The default
value is “40” minutes.
If the set value is “xx” minutes, the monitor will count down from “xx” minutes
automatically when starting cuff inflation. When time is up, it will deflate
automatically.
the alert time is for reminding user that the preset operation of tourniquet is going
to end. It can be chosen from 1 to 60 minutes, and the default value is “5” minutes.
If the set value is “xx” minutes and when counting down time reaches “xx”
minutes, the monitor will give off alarm sound until deflation ends. The alarm type
is high priority alarm? (For example: if the duration is 40 minutes and the alert time
is 5 minutes, the alarm will ring to prompt when the duration counts down to 5
minutes. The Prompt Info area starts to prompt: TOUR C-D 300 seconds. )
shift cursor to “Start” and press “■” key, “Start” becomes “Stop” and meanwhile the
blood pressure cuff starts to inflate; Pressing “Stop” button will stop this
function. After deflation, it will change to “Start” again.
5.12.1 Operation Instructions
Step 1: rotate the knob to move the grey cursor to the setting item and press the knob to confirm your selection.
Step 2: rotate the knob to change the setting or modify the setting value.
Step 3: press the knob again to change and repress it to save the setting.
Press “
” key to return to the Main Screen or “Exit” button to return to the System Menu screen.
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Chapter 6 Optional CO2 Monitoring
If your monitor has CO2 monitoring function, please follow the instructions in this chapter to perform CO2 monitoring on
patient. The parameter setting menu and monitoring menu differ from different models, please refer to the monitor on
hand. Please note that Temp is not fitted where CO2 Monitoring has been chosen.
6.1 CO2 Parameter Settings
1.
On Main Screen, press the Nav knob to enter System Menu Screen. The choose “SETUP
CO2”to enter CO2 Parameter Settings screen.
Figure 6.1 CO2 Parameter Settings (1)
CO2 Parameter Settings (2)
NOTE: CO2 parameter setting screen will be displayed in two pages. Focus the gray cursor on
”, then press the navigation knob to enter the second page where the operator can set some other
“
parameters of CO2 (As shown in above figures).
Switch: choosing the mode of CO2. It is recommended that the switch be turned on only when there is a need to
monitor CO2 parameters. This can not only reduce the power consumption but also extend the life of the CO2
module.
In order to maximise the monitors battery life, please set CO2 switch at OFF state in system setup
when the CO2 function is not used.
Gain: theCO2 waveformgain.
Unit: Choosing the EtCO2 and the minimum InsCO2. It can be set up as kPa, mmHg, and %.
Baro (Barometric pressure): set ambient atmospheric pressure. It can be determined by barometer or the
ambient altitude. Altitude can be used to determine the typical barometric pressure if a barometer is not
available, refer to Appendix Typical Pressures and CO2 Readings at Altitudes for details.
Zero: The method to calibrate CO2: Zero calibration. The CO2 module must have warmed up fully over 5 minutes
continuous operation to ensure an accurate calibration. Use a large well ventilated room so that no
CO2build up can be possible.
Flow (CO2 flow): It is flow rate of the CO2 sampling. Its value is 50ml/min.
The information promoted for Zero calibration is as follows:
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Please apply the reference air with 0% CO2, the air in the well ventilated room usually can be regarded as the air
with 0% CO2. Press “OK”, and the result will be displayed on the screen several seconds later.
Apnea: display time of the respiration rate value in data area when the previous respiration has been detected
while the next one is not, meanwhile, the device will prompt apnea information. The setting range is
10s~60s, the default is 20s. For example, if 20 seconds is set here, it means the respiration rate value will
disappear after it has been shown for 20 seconds in the data area if no respiration is detected during this
period.
Period: setting the calculation cycle of EtCO2 value, there are three selectable options: “1b”, “10s” and “20s”.
“1b”: means the EtCO2 value will be calculated once every respiration cycle; “10s”: means the EtCO2 value
will be calculated once every 10s, and the maximum EtCO2 value measured during this 10s will be
displayed on data area; “20s”: means the EtCO2 value will be calculated once every 20s, and the maximum
EtCO2 value measured during this 20s will be displayed on data area
TEMP: setting the temperature value of the current measured airflow. For instance, the temperature is usually
set as 37℃ while measuring the patient’s respiration by airflow. However, if the airflow to be measured is the
reference gas, the temperature is set as 25℃. The setting range: 0~50; Unit: ℃; Default value: 35.0.
O2 Compen:adjusting the concentration of compensating gas in patient’s respiration airflow.
Generally, the compensating gas is oxygen, so it can be called oxygen compensation concentration. The
unit: %; Setting range: 0%~100%; Default value: 16.
Balance: setting the balance gas in patient’s respiration airf low. There are three kinds of selectable balance gas:
“Air”, “N2O” and “He”, namely: air, nitrous oxide and helium. If no specific balance gas is given; the balance
gas can be set as “Air”.
Agent: setting whether adding the anaesthetic agent gas to patient’s respiration airflow and the
concentration of anaesthetic gas. The setting range is 0.0%~20.0%, the default status is:
not adding anaesthetic gas, that is to say, the concentration is 0.0%.
Respiration Rate
High:
Low:
Setting the upper alarm limit of CO2 respiration rate. Setting
the lower alarm limit of CO2 respiration rate.
EtCO2
High:
Low:
Setting the upper alarm limit of EtCO2.
Setting the lower alarm limit of EtCO2.
InsCO2
High:
Low:
Setting the upper alarm limit of InsCO2.
Setting the lower alarm limit of InsCO2.
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6.2 CO2 Sensor Connection
6.2.1 Side stream CO2 Sensor Connection
Demonstration for Side stream CO2 Sensor Connection
1. Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labelled “CO2” on the connector panel of
the monitor;
2. The sample cell of the sampling cannula must be inserted into the sample cell receptacle of the CO2 Sensor. A “click” will
be heard when the sample cell is properly inserted. Then connect to airway tube. After finishing sensor connection, and
making sure that the air input end is exposed to room air and away from all sources of CO2, including the ventilator, the
patient’s breath and your own. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2 minutes for the sensor
warm-up.
3. Default Tubing Configuration
Adapter and Sampling tube (Single patient use)
Extending airway tube for connecting to sampling tube (Single patient use)
Wye Connector
45
4. Optional sampling cannula kits
(1) T connector sampling cannula kits
On-Air Connector
On-air Connector
Adapter
(2) Nasal Side stream Cannula Kits
(3) Oral Side stream Cannula Kits
6.2.2 Mainstream CO2 Sensor Connection Demonstration for Mainstream CO2 Sensor Connection
Sensor Cable
Adapter
CO2 Sensor
1 Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labelled “CO2” on the
connector panel of the monitor.
2 Snap the CO2 sensor onto the airway adapter as shown in Figure 6.9. A “click” will be heard when the
airway adapter is properly inserted.
3 Position the airway adapter in the patient’s respiratory circuit (as close to the patient as possible) between the
endotracheal tube and the ventilator circuit. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2
minutes for the sensor warm-up.
46
Safety Introductions for CO2 Monitoring
CO2 Sensor is a precision measuring part, please use it correctly and store it properly;
Precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other
equipment.
Failure of Operation: If the CO2 Sensor fails to respond as described in this user manual; DO NOT use it until
approved for use by qualified personnel.
DO NOT position the sensor cables or tubing in any manner that may cause entanglement or strangulation.
Support the airway adapter to prevent stress on the ET tube.
Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2 airway adapters may
compromise functionality and system performance leading to a user or patient
hazard. Performance is not guaranteed if an item labelled as single patient use is reused.
Inspect the side stream on-airway adapters and side stream sampling kits for damage prior to use. DO NOT
use the side stream on-airway adapters and side stream sampling kits if they
appear to be damaged or broken.
IftheCO2 waveform(Capnogram)appearsabnormal,inspecttheCO2 airwayadaptersand replace if needed.
PeriodicallychecktheCO2 /Flowsensorandtubingforexcessivemoistureorsecretionbuild-up.
Do not use them if there is excessive moisture or exterior condensation.
ElectricShockHazard:TheCO2 Sensorcontainsnouserserviceableparts.
Referservice to qualified servicepersonnel. Donot openthe sensorcabinet atwill,aselectric
shock hazard may occur.
Place the exhaust vent of the CO2 Sensor in drafty ambience and do not let anything block the exhaust vent.
Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to have been damaged. Refer
servicing to qualified service personnel.
DO NOT sterilize or immerse the CO2 Sensor in liquids.
Replacetheside streamon-airwayadaptersandside streamsamplingkitsifexcessive
secretions are observed.
Do not operate the CO2 Sensor when it is wet or has exterior condensation.
MonitortheCO2 waveform(Capnogram).Ifyouseechangesorabnormalappearance,check
the patient and the sampling line. Replace line if needed.
DO NOT use device on patients who can not tolerate the withdrawal of 50 ml/min +/- 10 ml/min from the airway or
patients that can not tolerate the added dead space to the airway.
Do not apply excessive tension to any sensor cable or pneumatic tubing.
ExplosionHazard:DONOTuseinthepresenceofflammableanaestheticsorotherflammable
gasses. Use of the CO2 Sensor in such environments may present an explosion hazard.
47
The power voltage over monitor working voltage may cause damage to CO2 sensor. Likewise, too low power
voltage may affect the CO2 measuring accuracy or even make the CO2 sensor not work.
When changing sampling tube, it is suggested choosing the default sampling tube with dehumidifying
function. The sampling tube without dehumidifying function may be easily
blocked by excessive moisture. (Use life: ordinary sampling tube: 6~12 hours; the sampling tube with
dehumidifying function: about 120 hours.)
Ifthe measurementappears abnormalcaused bysampling tube block,pleasereplace it.
The total length of the sampling tube and extending airway tube shouldn’t be longer than 3 meters, too long
may cause measurement abnormity. If using T connector sampling cannula
kits, insert the sampling tube with the tubes upward to avoid the effects of excessive moisture;
Altitudes are different in different areas, so set the Barometric Pressure setting value as the ambient
barometric pressure.
Use only our company approved accessories.
While using the CO2 sensor, a system leak which may be caused by an uncuffed endotracheal tube or a damaged
CO2 sensor, may significantly affect flow-related readings. These include
flow, volume, pressure and other respiratory parameters.
WhenstoppingCO2 monitor,pleasedisconnectedtheCO2 sensorfromthemonitor.
Disposal of the CO2 Sensor and its accessories should comply with national and/or local requirements.
In the presence of electromagnetic devices (i.e., electro diathermy), patient monitoring may be interrupted due
toelectromagneticinterference.Electromagneticfieldsupto20V/mwillnot
adversely affect system performance.
Nitrous oxide, elevated levels of oxygen, helium and halogenated hydrocarbons can influence the CO2
measurement.
Excessive moisture in the CO2 may affect the accuracy of the flow measurement.
6.3 CO2 Monitoring Screen
Figure 6.2 CO2 Monitoring Screen
48
Waveform area
5th trace CO2 waveform. Itcan be respiration waveform orCO2 waveform.
Data area
Figure 6.3 RR, EtCO2, and Ins Data Area
“RR”: Respiration Rate:
The rpm after that is the unit of the respiration, i.e., respiration per min.
“EtCO2 39.0”:
The label and the value will become grey when CO2is turned off.
Ins:
“16”:
The label of the minimal inhalational CO2, the label and the value
will become grey when CO2 is turned off.
Respiration rate. It will display the respiration rate of CO2, when the
switch is turned on.
“X1”:
“×1/2”
“×1”
“×2”
“×4”
Respiration gain（amplification）：
Waveform scaled with half of the base gain.
Waveform scaled with base gain.
Waveform scaled with twice of the base gain.
Waveform scaled with our times of the base gain
Observing Screen, 7 Leads on the Same Screen and other display screen will display CO2 monitoring
data as well as the Main Screen.
Note: only when the setting item “System Menu→SETUP→CO2→Switch”is set as “ON”, CO2 monitoring
function is available.
6.3.1 CO2 Graphic Trend
On Graphic Trend screen, rotate the knob and move the cursor to “CO2”, then press the knob to enter EtCO2 Graphic
Trend. Refer to Chapter 6.4 Graphic Trend Screen for detailed instructions and
operations.
Figure 6.4 EtCO2 Graphic Trends
49
Chapter 7 Vital Signs Model(VSM)
If the Monitor is purchased without ECG then it is referred to as the VSM Model. The VSM Model will have the
user selectable Default Screen showing the Large Numbers Ward type Display of the NIBP Screen as below.
All references to ECG will be disabled in all screens.
7.1 NIBP screen
Figure 4.8 NIBP Screen
VSM Activation; Start as usual via on/off button, using navigation Knob for quick set parameters press select and set
parameter.
Operation Instructions:
EGG lead:
No action. When the printer is on, it serves as the printing key.
Alarm silence:
Press it to set or activate alarm silence.
Freeze:
No action.
NIBP:
Shift:
Navigation knob:
Press it to start or stop NIBP measurement.
Press it to shift the display to the Main Screen.
No action.
7.2 Starting the Monitor
The system performs self-detection and enters initial display after switching on the monitor, and the yellow alarm
indicator blinks to inform that the user can begin operating it.
Check all the applicable functions to make sure that the monitor works normally.
If the built-in battery is applied please recharge it after using the monitor to ensure sufficient power storage. It will take
minimal 8 hours to charge battery from depletion to 90% charge.
Do not use the monitor to monitor the patient if there are indications of damage or
reminders of error. Please contact the local dealer or our company.
Start the monitor again 1 minute after it is switched off.
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7.3 Blood Pressure Cuff Connection
Connect the cable to the right-panel connector marked with the NIBP icon.
Remove packaging and wrap the cuff around patient’s upper arm.
7.2.1
7.2.2
Requirements of the cuff:
1)
2)
3)
4)
5)
6)
Appropriate cuff should be selected according to the age of the subject. Its width should be 2/3 of the
length of the upper arm. The cuff inflation part should be long enough to permit wrapping 50-80% of the
limb concerned. See the table below for the dimensions: Note: The size of the cuff selected should suit
the subjects while measuring.
Cuff Model
Arm Circumference
Cuff Width
Neonate Cuff
6.0cm~9.5cm
3cm
Small-sized Paediatric Cuff
6cm～11cm
4.5cm
Middle-sized Paediatric Cuff
10cm～19cm
8cm
Large-sized Paediatric Cuff
18cm～26cm
10.6cm
Adult Cuff
25cm～35cm
14cm
When putting on the cuff, remove packaging and wrap it around the upper arm evenly to appropriate
tightness.
Remember to empty the residual air in the cuff before the measurement is commenced.
Locate the cuff in such a way that the “φ” mark is at a location where the clearest pulsation of brachial artery
is observed.
The cuff should be tightened to a degree where insertion of one finger is allowed.
The lower end of the cuff should be 2cm above the elbow joint.
Figure 3.6 Cuff Position
Safety Instructions for NIBP Monitoring
When taking the measure of an infant’s (less than 10 years old) blood pressure, do NOT operate in the adult mode.
The high inflation pressure may cause lesion or even body putrescence.
It is recommended to take the blood pressure measurement manually. Automatic or continuous measurement
should be used in the presence of a doctor/nurse.
NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease, or
partial bleeding will appear.
Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area, otherwise,
damage may be caused to the limbs.
Pay attention to the colour and sensitivity of the limb when measuring NIBP; make sure the blood circulation is
not blocked. If blocked, the limb will discolour. Stop measuring or move the cuff to other positions and inform a
doctor.
If the time of the automatic pattern non-invasive blood pressure measurement takes too long, the patient could
possibly have purpura, lack blood or neuralgia.
51
When checking the patient, you must inspect the colour, the warmth and the sensitivity of the body frequently.
Once you observe any exception to normal patterns, immediately stop the blood pressure measurement.
The subject should lie on their back so that the cuff and the heart are in a horizontal position and the most
accurate measurement is taken. Other postures may lead to inaccurate measurement.
Do not speak or move before or during the measurement. Care should be taken so that the cuff will not be hit or
be touched by other objects.
The measurements should be taken at appropriate intervals. Continuous measurement at too short intervals may
lead to pressed arm, reduced blood flow and lower blood pressure, resulting in inaccurate measurement of blood
pressure. It is recommended the measure be taken at intervals of more than two minutes.
When an adult subject is monitored, the machine may fail in giving the blood pressure measure if the infant mode
is selected.
Prior to use, empty the cuff until there is no residual air inside it to ensure accurate measurement.
Do NOT twist the cuff tube or put heavy things on it.
The symbol indicates that the cable and accessories are designed to have special protection against
electric shocks, and is defibrillator proof.
Pressure Accuracy Verification
Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP module
inside the device. Technician or equipment manager should do pressure accuracy verification every half year or
year in order to check if the pressure measurement still conforms to the requirement of product performance. If the
deviation is beyond the declared specification, it is permitted to return it to factory for repair or calibration. Before
verification, please connect the monitor to a standard pressure meter as the reference equipment like a mercury
pressure meter.
Figure 3.7 Connection of Pressure Verification Fixture
52
Mode 1: The inflation can be activated by Monitor so the pressure will increase automatically until it
exceeds the limit value specified in table A. This pressure limit value depends on the patient type
selection as shown in table A:
Adult
240mmHg
Child
200mmHg
Neonate
120mmHg
Table A
During inflation, the Monitor will close the deflating valve, and the pressure value will be shown during the process.
If there is no manual deflation operation, the pressure will remain until deflation by manual operation, so it is
necessary to use a manual valve for doing adequate deflation in several steps to verify the pressure accuracy in the
full scale of measurement range.
Mode 2: No automatic inflation by Monitor during the pressure accuracy verification.
Increase the pressure manually by the pumping balloon, and the verification can be done by applying different
pressure value manually. If the increased pressure exceeds the given limit as shown in table B, the Monitor will
deflate automatically because of over-pressure protection.
Adult
300mmHg
Child
240mmHg
Neonate
140mmHg
Table B
After the verification, press the button again to return to normal working mode, then continue
other operation, or the NIBP key will be invalid.
Pressure accuracy verification must be operated by technician or equipment manager.
Doctors or nurses are not allowed to do the verification, it is very dangerous especially when the
pressure cuff is still on patients.
Air Leakage Check
In order to avoid significant error in blood pressure measurement or even no measurement result caused by air
leakage in the pneumatic system, including the cuff during measuring, it is recommended to check if there is leak
in the pneumatic system as well.
Please remove the cuff from patient while performing the leakage check.
7.3 To connect the SpO2
SpO2 probe is very delicate accessory. Please follow the steps and procedures in operating it. Failure to operate it
correctly can cause damage to the SpO2 probe.
Operation procedure:
1. Connect the SpO2 probe to the right panel’s jack labelled “SpO2”. When unplugging the probe, be sure to hold the
head of the connector and pull it out.
2. Insert one finger into the probe (index finger, middle finger or ring finger with proper nail length) according to the
finger mark on the probe, shown as below.
53
Figure 3.8 Demonstration for SpO2 probe
When selecting a sensor, consider the patient’s category, adequacy of perfusion, availability of probe site and
anticipated monitoring duration. Use only SpO2 probes provided by our company with this monitor. Read the
following table for SpO2 probe information. Refer to Chapter 13.8 for the detailed instructions of each SpO2 probe.
SpO2 Probe
Patient Category
SpO2 Finger clip Sensor (reusable)
Paediatric
SpO2 Finger rubber Sensor(reusable)
Adult
SpO2 Finger clip Sensor(reusable)
Adult
High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent
lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. To prevent
interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque
material.
Failure to take this action in high ambient light conditions may result in inaccurate measurements. If patient movement
presents a problem, verify that the sensor is properly and securely applied; move the sensor to a less active site; use an
adhesive sensor that tolerates some patient motion; or use a new sensor with fresh adhesive backing.
For reusable sensors, follow the sensor directions for use for cleaning and reuse. For single-patient use sensors, use a
new sensor for each patient. Do not sterilize any sensor by irradiation, steam, or ethylene oxide.
Safety Introductions for SpO2 Monitoring
Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with microcirculatory
problem. It is recommended that the sensor should NOT be applied to the same place for over two hours. Change
the measuring site periodically if necessary.
Themeasuringsiteisgenerallychangedevery3hours.Themeasuringsiteshouldbeinspected
to ensure no abnormity every 1~2 hours. If abnormity occurs, change the measuring site periodically if necessary.
Whentheambienttemperatureisover35℃,pleasechangethemeasuringsiteeverytwohours if necessary.
Burn hazard: When the ambient temperature is over 37℃, do not use the SpO2 sensor for a long time.
SpO2 measuringpositionmustbeexaminedmorecarefullyforsomespecialpatients.
Do NOT install the SpO2 sensor on the finger with oedema or fragile tissue.
Do NOT put the SpO2 sensor and pressure cuff on the same limb, otherwise the NIBP
measuring will affect SpO2 measuring and cause an alarm error.
54
If sterile packaging of SpO2 sensor is damaged, do not use it any more.
Check the SpO2 sensor and cable before use. Do NOT use the damaged SpO2 sensor.
When the temperature of SpO2 sensor is abnormal, do not use it any more.
Please do not allow the cable to be twisted or bent.
Please do not use nail polish or other cosmetic product on the nail.
The finger nail should be of normal length.
The SpO2 sensor cannot be immerged completely into water, liquor or cleanser, because the sensor has no
capability to resist the harmful ingress of water.
7.4 Printer connection
1. PRINTER：USB port; connect the monitor to the provided USB cable.
2. DC12V：DC power supply port. Power indicator on the front panel will be on after the
adapter is connected to power supply.
Rear panel of printer
7.5 Loading printing paper
Step 1:
Step 2:
Step 3:
Open the cover of the printer
Install the paper to the printer properly
Pull the paper out of the printer for 2 or 3 cm Step 4:
Close the printer cover
The ERROR indicator on the top right corner of the printer will be on when the printing paper runs out.
front panel
55
7.6 Battery Installation
Make sure that monitor doesn’t connect to mains power supply.
Unfasten the screw on the battery lid with a screwdriver and open the battery cover.
Insert the battery connecting wire into the battery receptacle (Do not insert the plug in reverse).
Insert it into the battery compartment.
Close the battery lid and fasten it with the screw.
Please remove the battery from battery compartment if it won’t be used for a long time.
Battery connecting wire
Battery receptacle
Battery label
Battery Installation
Handle Installation
Take out the handle subassembly if necessary.
Fix the handle subassembly on the rear panel with two screws.
7.7 Alarm modes
When an alarm occurs, the monitor responds with visual alarm indications (which are shown by two ways: alarm
indicator and alarm message description) and audible alarm indications.
Visual Alarm Indicators
The flashing rates for the three categories of alarms are shown in the table below.
Indicator Colour
Alarm Category
Flashing Rate
Red flashing
High priority alarm
2 Hz
56
Orange flashing
Medium priority alarm
0.5 Hz
Orange light
Low priority alarm
Constant (on)(non-flashing)
Audible Alarm Indications
The audible alarm has different tone pitch and on-off beep patterns for each priority category. These are summarized in
the Table below.
Alarm Category
Tone Pitch
Beep Rate
High priority alarm
~500Hz
2 beeps per 7 sec.
Medium priority alarm
~700Hz
4 beeps per 9 sec.
Low priority alarm
~600Hz
20 beeps per 13 sec.
Normal
~300Hz
Continuous
Note: Visual alarm indicators cannot be suspended or removed. Audible alarms may be decreased in
volume or silenced.
7.7.1 Alarm Silence
Press
key to set or activate the alarm silence. In the monitoring screen, press “Alarm” to set the alarm silence
timer. There are four options of alarm silent time: 2 minutes, 5 minutes, 10 minutes and 20 minutes. The time shows
up on the upper left corner of the screen. When the alarm timer is activated, the system begins to count down. If alarm
occurs during that period, the system alarm will be activated automatically and the monitor will give alarm. If there is no
alarm during that period, when the set time has passed the audible alarm will be activated as well.
key to suspend the alarm sound and set the alarm silence time.
When the monitor alarms, press
7.7.2 Alarm Settings
l DO NOT silence the audible alarm or decrease its volume if patient safety could be compromised.
In the System menu screen, move the cursor to the “SETUP”, and press it to enter System Setup screen.
Limits setup: Move the grey cursor to the High or Low limits of the alarm settings, and press the “Alarm” key to
turn ON or OFF the alarm for the setting. Yellow colour shows ON status, and grey colour shows the OFF status.
Refer to Chapter 13.2 for detailed Default Alarming Values of All Parameters and Setup Range.
Whenever the monitor is used, check the alarm limits to ensure that they are appropriate for the
patient being monitored.
7.7.3 Verify adjustable alarm function
To verify adjustable alarm function, select “Demo” for the item of Mode in system parameter settings menu and adjust
alarm limits or change alarm setting, then pay close attention to the alarm. If the alarm is sent out according to your
setting, it means the alarm function is ok.
7.7.4 Operational Instructions
Up to 400 groups of SpO2 data can be memorized. Using the Navigation Knob allows the user to scroll the list up
and down to view SpO2 data. When rotating the knob anti-clockwise, the list scrolls upward. When rotating knob
clockwise, the list scrolls down. Please note that when the groups of data are less than 6, the Navigation Knob
cannot be used to scroll up or down the listing.
Pressing “
” key to return to the Main Screen.
57
7.8 NIBP Data List Screen
NIBP Data List screen
7.8.1 How to Select the System Setup Item
Step 1 rotate the knob to move the grey cursor to the corresponding item.
Step 2 press the knob to enter the corresponding setting screen: System Setup, Printer Setup, ECG Setup, TEMP setup,
CO2 Setup, NIBP Setup, SpO2 Setup, RESP Setup or resuming Default setting. The following contents will be described
each one respectively.
Press “
” key to return to the Main Screen or “Exit” button to return to the System Menu screen.
Note: If you disabled Hi and Lo limit alarm function of parameter monitoring, all the alarms related to its parameter
monitoring will be disabled as well.
7.8.2 Parameter Settings
Step 1:
Step 2:
Step 3:
Press “
rotate the knob to move the grey cursor to the setting item and press the knob to confirm your selection.
rotate the knob to change the setting or modify the setting value.
press the knob again to change and repress it to save the setting.
” key to return to the Main Screen
SYSTEM PARAMETER SETTINGS
System Setup
58
Chapter 8 Alarm
8.1 Alarm Priority
High Priority:
Over HR limit
Over TEMP limit
Over RR limit
Over SpO2 limit
Over PR limit
Over NIBP SYS limit
Over NIBP DIA limit
Over NIBP MAP limit
the battery capacity will exhaust
Unable to detect SpO2
Unable to detect HR
ECG VPCEST
Over NIBP PR limit
Over ST limit
Over InsCO2 limit
Over EtCO2 limit
Medium Priority:
VE RONT
SVE RONT
Lead Off
CO2 Out of Range
Probe Off
Low Priority:
Other arrhythmia phenomenon（Except ECG VPCEST, VE RONT and SVE RONT, refer to 13.3
Abbreviation of arrhythmia for details.）
8.2 Alarm modes
When an alarm occurs, the monitor responds with visual alarm indications (which are shown by two ways: alarm
indicator and alarm message description) and audible alarm indications.
Visual Alarm Indicators
The flashing rates for the three categories of alarms are shown in the table below.
Indicator Colour
Alarm Category
Flashing Rate
Red flashing
High priority alarm
2 Hz
Orange flashing
Medium priority alarm
0.5 Hz
Orange light
Low priority alarm
Constant (on)(non-flashing)
Table 8.1
Refer to Chapter 13.1 Alarm Information for detailed alarm message descriptions.
Audible Alarm Indications
The audible alarm has different tone pitch and on-off beep patterns for each priority category. These are summarized in
the Table below.
Alarm Category
Tone Pitch
Beep Rate
High priority alarm
~500Hz
2 beeps per 7 sec.
Medium priority alarm
~700Hz
4 beeps per 9 sec.
Low priority alarm
~600Hz
20 beeps per 13 sec.
Normal
~300Hz
Continuous
Table 8.2
Note: Visual alarm indicators cannot be suspended or removed. Audible alarms may be decreased in
volume or silenced as described in Chapter 6.
59
8.3 Alarm Silence
Press
key to set or activate the alarm silence. In the monitoring screen, press “Alarm” to set the alarm silence
timer. There are four options of alarm silent time: 2 minutes, 5 minutes, 10 minutes and 20 minutes. The time
shows up on the upper left corner of the screen. When the alarm timer is activated, the system begins to count
down. If alarm occurs during that period, the system alarm will be activated automatically and the monitor will
give alarm. If there is no alarm during that period, when the set time has passed the system alarm will be
activated as well.
key to suspend the alarm sound and set the alarm silence time.
When the monitor alarms, press
8.4 Alarm Settings
l DO NOT silence the audible alarm or decrease its volume if patient safety could be compromised.
In the System menu screen, move the cursor to the “SETUP”, and press it to enter System Setup screen.
Limits setup: Move the grey cursor to the High or Low limits of the alarm settings, and press the “Alarm” key
to turn ON or OFF the alarm for the setting. Yellow colour shows ON status, and grey colour shows the OFF status.
Refer to Chapter 13.2 for detailed Default Alarming Values of All Parameters and Setup Range.
Whenever the monitor is used, check the alarm limits to ensure that they are appropriate for the
patient being monitored.
8.5 Verify adjustable alarm function
To verify adjustable alarm function, select “Demo” for the item of Mode in system parameter settings menu and adjust
alarm limits or change alarm setting, then pay close attention to the alarm. If the alarm is is not activated according to
your setting, it means the alarm function is ok.
60
Chapter 9 Maintenance and Service
PC-3000 Multi-parameter Monitor should be properly maintained to ensure its maximum performance and long service
life. In addition to the warranty period of TWO years, the company also offers long-term service for each customer. It is
important that the users read and follow the operating instructions, important information and maintenance measures.
9.1 Technical Maintenances
9.1.1 Daily Examination
Before using the monitor, the checks below should be carried out:
Check the monitor for any mechanical damage;
Check that the Battery is charged sufficiently and is charging correctly.
Inspect the exposed parts and the inserted parts of all the leads, and the accessories;
Examine all the functions of the monitor that are likely to be used for patient monitoring, and ensure that it is in
good working condition;
Pay close attention to the fluctuation of the local power supply voltage.
If any damage or malfunction is found DO NOT use the monitor until it has been fully checked by qualified trained
technical staff. If in doubt please contact the monitor supplier who will be pleased to assist.
9.1.2 Routine Maintenance
After each maintenance or the yearly maintenance, the monitor can be thoroughly inspected by qualified personnel,
including function and safety examinations. The design life of this monitor is minimum 5 years. In order to ensure its long
service life, please pay attention to the maintenance.
If the hospital fails to carry out a satisfactory maintenance programme on the monitor, the monitor may not perform
accurately or correctly and harm the patient’s safety and health.
In case of ECG leads becoming damaged or aging, please replace the leads immediately and DO NOT USE.
The adjustable Modules in the monitor such as potentiometers are ONLY to be adjusted by approved
Trained and Qualified Staff to ensure correct operation.
It is recommended to use the battery once a month to ensure its strong power supply capacity and long service
life, and recharge it immediately should it become fully discharged.
9.1.3 Battery Maintenance
Please pay attention to the polarity of battery, do NOT insert it into battery compartment with reversed polarities;
Do NOT use the batteries manufactured by other companies as these may damage the device;
In order to avoid damaging the battery, do NOT use anyother power supply device to charge the battery;
If the battery fails, do NOT throw the battery into fire to avoid explosion risk.
Do not hit or strike it with force;
Do not use this battery on other devices;
Do not use this battery below -20℃ or above 60℃;
In order to maintain battery supply time and prolong battery lifetime, please charge the battery periodically.
Generally, charge the battery every 3~6 months and 2~5hours each time. When the battery power is full, battery
power indicator displays full grid. Before storage, please discharge the battery until 80% power remains.
Whether the monitor is on or off, the built-in battery will be charged as long as the monitor is connected to an AC
outlet. When the battery is full, it will stop charging for protecting from damage. If the monitor is connected to an AC
outlet and turned on, it will use AC power, but when AC power is cut off, the DC power will be used. Priority of using
AC power and power shift between AC and DC are automatically and uninterrupted.
If the battery is damaged, please change it. The model and specifications of the new battery should be the same
as the original battery and should be purchased from your local Creative Distributor.. This will ensure that the
battery meets all applicable safety codes.
61
9.2 Cleaning and Disinfection
1.
Switch off the monitor and disconnect the power code before cleaning.
2.
Keep the monitor free from dust.
3.
It is recommended to clean the outer shell and screen of the monitor.
4.
Do not immerse in fluid of any kind.
5.
Wipe the monitor with a slightly dampened cloth (no running drips) with warm water and a mild non- corrosive
detergent or an alcohol impregnated wipe, dry with a clean wipe or simply air dry.
6.
The monitor can be disinfected. Please clean the monitor first.
7.
Do not let any cleaning fluid flow into the connector jack or the shell of the monitor.
8.
Do not let the cleanser and disinfectant stay on its surface.
9.
Do not perform high-pressure sterilization or autoclave on this monitor.
10.
NIPB Hose: Wipe with a damp cloth moistened in a mild detergent solution.
11.
NIBP Cuff: See manufacturers instructions with the Cuff
12.
Sp02 Sensor: see manufacturers instructions with the Sensor
13.
Do not use this monitor if it has accidentally been wetted or fluid poured over it. Contact a qualified service
technician or contact the supplier to have it fully checked and repaired if necessary before being returned to service.
9.3 Cleaning and Disinfection of Accessories
It is recommended to clean the manufacturer’s accessories (including sensor, leads and plugs) with 75% Alcohol wipes
or 70% Ispropanol (Isopropyl) before using.
Make sure all Accessories are dry and no cleaning agent remains before use.
Donotusedamagedaccessories.
Do not attempt any other type of disinfection other than that indicated.
9.4 Storage
For maximum monitor life and optimum performance, store the monitor at room temperature in a dry environment.
For prolonged storage, keep the monitor in the original container or in dust free container.
Storage environment:
Ambient temperature:
Relative humidity:
atmospheric pressure:
-20~60°C
10%~90%
53kPa~106kPa
9.5 Transportation
The monitor can be transported via road rail or air in accordance with the manufacturer’s guidelines. Do not
drop or throw the monitor in its packaging.
9.6 Recycling monitor components
Within the EU: Do not dispose of this product as “unsorted municipal waste”, Prepare it for reuse or separate
collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European
Union on Waste Electronic and Electrical Equipment (WEEE)
Note: If the monitor or the battery is contaminated, this directive does not apply
62
Chapter 10 Troubleshooting
Note: In case of problems with this machine when in use, follow the instructions below to eliminate the problem first
or contact your local Creative Dealer.
WARNING
DO NOT open the monitor case unless an approved trained Technician.
10.1 No Display on the Screen
Shut down the machine and unplug the power cable. Use a universal meter to check if the outlet has proper voltage, if
the power cable is in good condition, and if the power cable is properly connected with the monitor and outlet.
Remove the fuse from the Mains AC Plug and make sure it is in good condition.
10.2 Excessive ECG Signal Interference or Too Thick Baseline
1.
2.
Check if the plate electrodes are properly located, and if valid plate electrodes are used.
Check whether the lead wires are properly inserted. If no ECG curve displayed, check if the ECG lead wires are
broken.
10.3 No Blood Pressure and Pulse Oximetry Readings
1.
Check if the blood pressure cuff is properly wrapped around the arm according to the operating instructions, if the
cuff leaks, and if the inlet is correctly connected with the NIBP jack on the side panel. Check if the indicator of the
pulse oxygen sensor flashes and if the pulse oxygen probe is properly connected to the SpO2 jack on the side
panel.
2.
Ensure that the SpO2 Sensor probe is not fitted to the same arm as the NIBP
3.
If the problems still persists, please contact your local Creative Dealer for advice.
10.4 System Alarm
1.
When the parameter value is higher or lower than the alarm limits, the alarm will activate. Please check
whether the alarm limit values are correctly set or if the condition of the patient is actually causing alarms!
2.
Leads off. Please check the connection of the leads.
3.
Probe off Please check the connection of the probes.
63
Chapter 11 Technical Specifications
11.1 ECG Monitoring
1.
2.
3.
4.
5.
6.
7.
8.
9.
Input signals range in amplitude: ± (0.5 mVp ~ 5 mVp)
Heart rate display range: 15 bpm ~ 350 bpm
Heart rate display accuracy: ± 1% or ± 2 bpm, whichever is greater.
Heart rate averaging: Averages the recent eight beats having RR intervals falling within the acceptable limits.
Heart rate alarm delay time: ≤ 10s
Response time to change in heart rate:
Change from 80 bpm to 120 bpm: < 8 sec
Change from 80 bpm to 40 bpm: < 8 sec
Tall T-wave rejection: Rejects all T-wave less than or equal to 120% of 1mV QRS.
Pacemaker pulse rejection:
Rejectsall pulses of amplitude ± 2mV to ± 700mV and duration 0.1 to 2 ms without overshoot; Rejects all pulses
of amplitude ± 2mV to ± 400mV and duration 0.1 to 2 ms with overshoot.
Sensitivity selection:
AUTO, Automatic scaled waveform
×1/4, 2.5mm/mV tolerance: ± 5%
×1/2, 5mm/mV
tolerance: ± 5%
X 1 10mm/mV tolerance ± 5%
X 2 20mm/mV tolerance ± 5%
X 4 40mm/mV tolerance ± 5%
10.
11.
12.
13.
14.
Sweeping speed: 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s tolerance: ±10%
ECG noise level: ≤ 30μVp-p.
ECG input loop current: ≤ 0.1μA
Differential input impedance: ≥ 10MΩ
Common-mode rejection ratio (CMRR):
Diagnostic mode: ≥ 90dB
Operation, monitoring mode: ≥ 105dB
15. Time constant:
Monitoring mode: ≥ 0.3s
Diagnostic Mode: ≥ 3.2s
16. Frequency response:
Monitoring mode:
0.67 Hz～40 Hz (+0.4dB – 3.0dB)
Diagnostic mode:
0.05 Hz～150 Hz (+0.4dB – 3.0dB)
Additional declarations to conform to the particular standard of IEC 60601-2-27 “Medical electrical
equipment – Part 2-27: Particular requirements for the safety, including essential performance, of
electrocardiographic monitoring equipment”
Direct current for respiration,
leads-off sensing, and active
noise suppression
Applied current less than 0.1 microamperes.
Response to irregular rhythm
A1 Ventricular bigeminy-80BPM
A2 Slow alternating ventricular bigeminy-60BPM A3
Rapid alternating ventricular bigeminy-120BPM A4
Bidirectional systoles-90BPM
Time to ALARM for tachycardia
Waveform B1, Amplitude
0.5 mV
1 mV
2mV
Waveform B2, Amplitude
1mV
2mV
4mV
64
Average Time to Alarm
<8 sec
<8 sec
<8 sec
Average Time to Alarm
<8 sec
<8 sec
<8 sec
11.2 RESP Monitoring
1.
2.
3.
4.
RESP rate measuring range: 0rpm~120rpm
RESP rate accuracy: ±5% or ±2 rpm, whichever is greater
RESP rate alarm limit setting range: 0rpm~120rpm.
Alarm tolerance: ±5% or ±2 rpm, whichever is greater
11.3 TEMP Monitoring
1.
2.
3.
TEMP measuring range: 25.0℃~45.0℃
TEMP measuring accuracy: ±0.2℃
TEMP responding time: ≤150s
11.4 NIBP Monitoring
1.
2.
3.
4.
5.
6.
7.
Measuring method: Oscillometric Technique
Pneumatic pressure measuring range: 0 mmHg~300mmHg
Accuracy of pressure measurement: ±3 mmHg
Cuff inflation time: <10 seconds (typical adult cuff)
Measurement time on the average: < 90 seconds
Air release time while the measurement is cancelled: <2 seconds (typical adult cuff)
Initial cuff inflation pressure
Adult: 175mmHg Paediatric: 135mmHg Neonate: 65mmHg
8. Over Pressure Protection Limit
Adult: ≤ 300 mmHg
Paediatric: ≤ 240mmHg
Neonate: ≤ 150 mm
9.
NIBP Measurement Ranges
Adult
Press（unit）
Infant
Neonate
SYS
mmHg
40~275
40~200
40~135
MAP
mmHg
20~230
20~165
20~110
DIA
mmHg
10~210
10~150
10~95
10. NIBP accuracy:
Maximal mean deviation: ±5 mmHg Maximal
standard deviation: 8 mmHg
11. Measurement modes: Manual, Auto, STAT
11.5 SpO2 Monitoring
1.
2.
3.
4.
Transducer: dual-wavelength LED Uses Creative Patented LFC Technology
Wavelength: Red light: 660 nm, Infrared light: 905 nm.
Maximal optical output powerless than 2mW maximum average
SpO2 measuring range: 35%~100%
Low perfusion performance: the declared accuracy is attained when the pulse amplitude modulation ratio is as
low as 0.4%
SpO2 measuring accuracy: not greater than 2% for SpO2 range from 70% to 100%
*NOTE: accuracy defined as root-mean-square value of deviation according to ISO 9919
11.6 Pulse Rate Monitoring
1.
2.
Pulse rate measuring range: 30bpm~240bpm
Pulse rate measuring accuracy: ±2bpm or ±2%, whichever is greater.
65
11.7 CO2 Monitoring
1.
2.
3.
Technology: Infrared absorption method.
Mode of Sampling: Side stream or Mainstream
4.
5.
CO2 Response Time:
Side stream: <3seconds (including transport time and rise time).
Mainstream: <60ms (rise time)
Warm-up Time: Not less than two minutes
CO2 measurement range: 0~150mmHg
6.
CO2 Accuracy:
*NOTE:
7.
0~40mmHg
±2mmHg
41~70mmHg
±5% of reading
71~100mmHg
±8% of reading
101~150mmHg
±10% of reading
Gas temperature at 25°C for Side stream;
Gas temperature at 35°C for Mainstream.
Flow rate: 50ml/min ±10 ml/min (Side stream)
11.8 Data Recording
1.
2.
3.
4.
5.
Sensitivity selection tolerance: ±5%
Recording speed: 25mm/s
Recording speed accuracy: ±10%
Hysteresis: ≤0.5mm
Frequency response:
Monitoring mode:
0.5~40Hz Diagnostic mode: 0.05~75Hz
6.
Time constant:
Monitoring mode:
≥0.3s
Diagnostic mode: ≥3.2s
11.9 Other Technical Specifications
1.
2.
3.
4.
5.
6.
Power supply:
100~240VAC, 50/60Hz
Power consumption: see the nameplate on the monitor
Rechargeable Li-ion battery specification:14.8V 2200mAh
Display mode: 7 inches TFT colour LCD Resolution: 800×480pixel
Alarming mode: Audible & visible alarm
Communication: Serial/Net port
11.10 Classification
Safety standard:
IEC 60601-1
The type of protection against electric shock
Class I equipment.
The degree of protection against electric shock
Type BF and CF applied parts
Electro-Magnetic Compatibility:
Group I, Class A
The degree of protection against harmful ingress
of water
Ordinary equipment without protection
against ingress of water.
The safety degree of flammable gas
Not suitable to use in the environment where
flammable gas exists.
THE PC-3000 IS NOT MRI CONDITIONAL OR COMPATIBLE.
66
11.11 Guidance and manufacturer’s declaration-Electromagnetic compatibility
Table 1
Guidance and manufacturer’s declaration-electromagnetic emission- for all EQUIPMENT
AND SYSTEMS
PC-3000 Multi-parameter Monitor is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment or system should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions CISPR 11
Group 1
PC-3000 Monitor uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
PC-3000 Monitor is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
RF emissions CISPR 11
Harmonic emissions IEC610003-2
Voltage fluctuations/flicker
emissions
IEC61000-3-3
Class A
Complies
67
Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity
for all EQUIPMENT AND SYSTEMS
PC-3000 Multi-parameter Monitor is intended for use in the electromagnetic environment specified below. The customer
or the user of the equipment or system should ensure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC61000-4-2
Electrical fast
transient/burst
IEC61000-4-4
Surge
IEC 61000-4-5
IEC60601 test level
Compliance level
±6 kV contact
±8kV air
±6 kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile. if
floors are covered with
synthetic material, the
relative humidity should be
at least 30%
±2kV for power
Supply lines
±1 kV for
input/output lines
±2kV for power
Supply lines
±1 kV for
input/output lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
±1kV line (s) to line(s) ±1kV differential mode Mains power quality should
±2kV line(s) to earth ±2kV common mode
be that of a typical
commercial or hospital
environment.
Voltage dips, short interruptions and
voltage variations on power supply
input lines
IEC61000-4-11
Power frequency(50Hz/60Hz)
magnetic field
IEC61000-4-8
Electromagnetic
environment -guidance
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of the
equipment or system requires
continued operation during
power mains interruptions, it
is recommended that the
equipment or system be
powered from an
uninterruptible power supply
or a battery.
3A/m
3A/m
NOTE: UT is the a.c. mains voltage prior to application of the test level.
68
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunityfor EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
PC-3000 Multi-parameter Monitor is intended for use in the electromagnetic environment specified below. The customer
or the user of PC-3000 Monitor should ensure that it is used in such an electromagnetic environment.
IMMUNITY test
IEC 60601 test level
Compliance level Electromagnetic environment
- guidance
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of
PC-3000 Monitor, including cables,
other than the recommended
separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation
distance
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in metres (m). b Field
strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a
should be less than the compliance
level in each frequency range .b
Interference may occur in the
vicinity of equipment marked with
the following symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a:
b:
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey
should be considered. If the measured field strength in the location in which PC-3000 Monitor is used exceeds the
applicable RF compliance level above, PC-3000 Monitor should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating PC-3000
Monitor.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
69
Table 4
Recommended separation distances between portable and mobile RF communications equipment and
The equipment or systemfor EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
PC-3000 Multi-parameter Monitor is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the equipment or system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the equipment or system as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power of
transmitter
W
150kHz to 80MHz
80MHz to 800MHz
80MHz to 2,5GHz
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be determined using the equation applicable to the frequency of the transmitter, where p is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people
70
Chapter 12 Monitoring Parameter
12.1 ECG Monitoring
12.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value
The electrocardiogram (ECG or EKG) is primarily a tool for evaluating the electrical events within the heart. The action
potentials of cardiac-muscle cells can be viewed as batteries that cause charge to move throughout the body fluids.
These currents represent the sum of the action potentials occurring simultaneously in many individual cells and can be
detected by recording electrodes at the surface of the skin. The figure below shows the system of the heart.
A common ECG plate electrode used together with this monitor has short shelf life. Generally, the shelf life is only
one month after the package is opened. When outdated plate electrode is used, due to skin’s contact impedance and
big electrode potential, the chance of interference will be increased, and the ECG baseline will have an unstable
inclination. Therefore, always use valid plate electrodes.
12.1.2 Factors affecting ECG signal
Interference from Electrosurgical Unit;
Doesn’t filter the interference waveform;
Poor grounding;
Electrodesarenotplacedproperly;
Use expired electrode or use disposable electrode repeatedly;
The skin where the electrod is placed is unclean or has poor contract caused by grease/hair etc;
Electrode has dried out or been used for too long.
71
12.2 Respiration Monitoring
12.2.1 Measuring Principle
The air will be filled into alveolus or be expelled during respiration, and the chest’s volume changes with this process.
Because the conductivity of air is lower than body tissues, the chest’s impedance will be changed by the inflation.
With this specialisation, the respiration can be monitored through putting safe current into body and measuring the
change of voltage between the electrodes. The product will transmit the high-frequency current whose frequency is
much higher than ECG frequency (but with the safe current limit) to the ECG electrodes (placed at the both sides of
chest), which can be detect ECG signal and chest’s impedance at the same time, and the respiratory rate will be
measured through impedance method by the software. So the additional electrodes for respiratory measurement are
unnecessary.
12.2.2 Factors affecting respiration monitoring
Place the white (RA) and red (LL) electrodes on the cross, if the line between two electrodes in liver area or heart
area, the artificial error may occur.
Respiration monitoring doesn’tsupport monitoring patients who move too much, or may lead to the wrong alarm
being given.
12.3 SpO2 Monitoring
12.3.1 Measuring Principle
Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with its density or
concentration. When the light with certain wavelength emits on human tissue, the measured intensity of light after
absorption, reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes.
Because oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (Hb) have different absorption characters in
the spectrum range from red to infrared light (600nm~1000nm wavelength), by using these characteristics, SpO2
can be determined. SpO2 measured by this monitor is the functional oxygen saturation -- a percentage of the
haemoglobin that can transport oxygen. In contrast, hemoximeters report fractional oxygen saturation – a percentage
of all measured haemoglobin, including dysfunctional haemoglobin, such as carboxyhemoglobin or
metahemoglobin.
12.3.2 SpO2 Measurement Restrictions (interference reason)
Intravascular dyes such as indocyanine green ormethylene blue
Exposuretoexcessiveillumination,suchassurgicallamps,bili rubinlamps,fluorescentlights, infraredheating
lamps,ordirectsunlight.
Vascular dyes or external used colour-up product such as nail enamel or colour skin care
Excessive patient movement
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line
Exposuretothe chamberwithhighpressure oxygen
There is an arterial occlusion proximal to the sensor
Blood vesselcontractioncaused by peripheralvesselhyperkinesiasorbody temperature decreasing
72
12.3.3 Low SpO2 measuring value caused by pathology
Hypoxemiadisease,functionallackofHbO2
Pigmentation or abnormal oxyhemoglobin level
Abnormal oxyhemoglobin variation
Methemoglobin disease
Sulfhemoglobinemia or arterial occlusion exists near sensor
Obvious venous pulsations
Peripheral arterial pulsation becomes weak
Peripheralbloodsupply isnotenough
12.3.4 Clinical Limitations
As the measure is taken on the basis of arteriole pulse, substantial pulsating blood stream of subject is required.
For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular
contracting drug, the SpO2 waveform (PLETH) will decrease.
In this case, the measurement will be more sensitive to interference.
For those with a substantial amount of staining dilution drug (such as ethylene blue, indigo green and acid indigo
blue), or carbon monoxide haemoglobin (COHb), or methionine (Me+Hb)
or thiosalicylic haemoglobin, and some with icterus problem, the SpO2 determination by this monitor may be
inaccurate.
Thedrugssuchasdopamine,procaine,prilocaine,lidocaineandbutacainemayalsobeamajor
factor blamed for serious error of SpO2 measurements.
As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia,
The measurement result of some patients with serious anaemia may also present as good SpO2 value.
12.3.5 Points to be noted in SpO2 and Pulse Measuring
Thefinger should beproperly placed (see the attached illustration ofthis instruction manual),or elseitmaycause
inaccuratemeasurementresult.
Make sure that capillary arterial vessel beneath the finger is penetrated through by red and infrared lights.
TheSpO2sensor should notbe used ata location or limb tied with arterial orblood pressure cuff or receiving
intravenous injection.
Do not fix the SpO2 sensor with adhesive tape, or else it may result in venous pulsation and consequential
inaccurate measurement result of SpO2.
Make sure the optical path is free from any optical obstacles like adhesive tape.
Excessiveambient lightmay affectthe measuring result. Itincludes fluorescentlamp,dualruby light,infrared
heater,and direct sunlightetc.
Strenuousaction ofthe subjectorextremeelectrosurgical interferencemayalsoaffectthe accuracy.
Please do not use the SpO2 sensor when having the MRI, or burn may be caused by faradism.
Alwaysobservetheplethysmogram(waveform),whichisauto-scaledwithintherangeof100.
The SpO2 reading may be unlikely true when the waveform is not smooth or irregular. If in doubt, rely on your clinical
judgment, rather than the monitor readout.
Afunctional tester can not be used to assess the accuracy of the pulse oximeter monitor or a
SpO2 sensor. However, a functional tester, such as SpO2 simulator can be used to check how accurately a
particular pulse oximeter is reproducing the given calibration curve. Before testing
the oximeter by a functional tester, please firstly ask the manufacturer which calibration curve is used, if necessary,
request the manufacturer for its dedicated calibration curve and download it into the tester.
73
12.3 Temperature Monitoring
The sensor is thermo-resistor type (25℃ 5kΩ) and is supplied with constant micro current. Calculating the temperature
of measured part through measuring the voltage. There is a period responding time, so the accurate temperature value
display after a while. The temperature monitoring can be divided into two measuring method: measure through body
surface temperature and through the temperature inside the body cavity (placed in mouth or anus).
Normal value: body surface: 36.5℃~37℃; inside body cavity: 36.5℃~37.7℃.
Notes:
When attaching the TEMP transducer to the patient, make sure the transducer is attached correctly as this
could affect TEMP reading.
Take special care and time with attaching to paediatric patients.
12.4 CO2 Monitoring
12.4.1 Measuring Principle
The principle is based on the fact that CO2 molecules absorb infrared light energy of specific wavelengths, with
the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed
through a gas sample containing CO2, the electronic signal from a photodetector (which measures the remaining light
energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to accurately
reflect CO2 concentration in the sample. When calibrated, the photo-detector’s response to a known concentration of CO2
is stored in the monitor’s memory.
The monitor determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these
gases.EtCO2 is displayed as a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In
addition, a CO2 waveform (capnogram) may be displayed which is a valuable clinical tool that can be used to assess
patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the
time interval between detected breaths.
12.4.2 Mainstream vs. Side stream Sampling
Mainstream CO2 sensors are placed at the airway of an intubated patient, allowing the inspired and expired gas to
pass directly across the IR light path. The major advantages of mainstream sensors are fast response time and
elimination of water traps.
Side stream CO2 sensors are located away from the airway, requiring a gas sample to be continuously aspirated from the
breathing circuit and transported to the sensor by means of a pump. This type of system is needed for non-intubated
patients.
When using mainstream CO2 sensors, check the window for secretions as pooled secretions may affect the accuracy
of the measurement or even prevent the sensor from working.
When using side stream CO2 sensors, there is a water trap or a part of the sampling tube with dehumidifying
function. Please periodically check the flow sensor and tubing for excessive moisture or secretion build-up.
74
12.5 NIBP Monitoring
12.5.1 Measuring Principle
Blood pressure may be measured in an invasive way (whereby the sensor will be inserted into blood vessel directly) or
a non-invasive way. The non-invasive way includes several methodologies, such as the Korotkoff Sound Method and
oscillating method. The Korotkoff Sound Method is used as a conventional way, whereby stethoscope is used to
measure the blood pressure. By the oscillating method, an inflation pump will fill the air, and release it slowly. A
computer will record change of the cuff pressure when the air is released. With this record, the blood pressure value will
be determined. First of all, make sure the signal quality judgment by computer meets the requirements of accurate
calculation (such as sudden limb movement or cuff being hit during the measurement). If the answer is negative, give
up the calculation. If the answer is positive, proceed with calculation of the blood pressure value.
As change of the blood pressure is recorded by electric sensor, which sensitivity is much higher than that of human ears,
the oscillating method uses different definitions for measurement of diastolic pressure, mean arterial pressure and
systolic pressure from the Korotkoff Sound Method. When the oscillating method is used, the circuit in the measuring
apparatus will separate the amplitude of the cuff pressure from its change with pulsation. With the oscillating method,
the blood pressure at the maximum amplitude of cuff pressure is defined as the mean arterial pressure. The blood
pressure at amplitude of cuff pressure forward reduced according to proper proportion is defined as systolic
pressure, while the blood pressure at amplitude of cuff pressure backward reduced according to proper proportion
is defined as diastolic pressure. The maximum change of pulse pressure occurs at these two points. They are equivalent
to the point with pulse sound and the point without pulse sound respectively in the Korotkoff Sound Method.
When the risk of invasive monitoring method outweighs its advantage of accuracy, non-invasive monitoring method
shall be used.
Comparison between blood pressure measuring methods
To overcome the effect of human hearing variation and air release speed on measurement accuracy when the
conventional Korotkoff Sound Method is used to take measure of blood pressure, people have been dedicated to study
of automatic measurement of blood pressure. By now, automatic blood pressure measuring system based on the
principle of oscillating method is mature. In practice, however, various problems are encountered, such as why
the measures taken by the oscillating method is lower or higher than those taken by Korotkoff Sound Method?
Why the measures are inclined to decline? Why, in some cases, no result is obtained in spite of the inflation actions?
Why the measure values have big discreteness and even abnormal data in some cases? Why the SpO2
waveforms may disappear suddenly? ...and so on. The following explanations are devised to give
the answers.
The Oscillating method vs. the Korotkoff Sound Method
Blood pressure measurement by the oscillating method and Korotkoff Sound Method has good correlation with
the invasive measurement. Notwithstanding, any of the non-invasive blood pressure measurements has its onesidedness when it is compared to the invasive measurement. The oscillating method has its advantages over the
Korotkoff Sound Method in less error, higher reliability and stability. Their differences may be reflected in the following
aspects.
The measures by the Korotkoff Sound Method are liable to affect human factors. For example, different people may have
different sound judging ability, or different reactivity when listening to heart sound and reading mercury meter. The air
release speed and subjectivity may also affect the judgment. By the oscillating method, the computation is accomplished
by the computer, thus relieving the possibility of effect due to human factor.
With the Korotkoff Sound Method, the measure is taken on the basis of appearance and disappearance of heart sound.
The air release speed and heart rate may have direct effect on the measurement accuracy. It also has the disadvantages
of rapid air release and poor accuracy. In the contrast, with the oscillating method, the determination is calculated on the
basis of cuff pressure oscillatory waveform envelope, and the air release speed and heart rate has little effect on the
measurement accuracy.
75
Statistics show that, when measuring the hypertension, the measure taken by the oscillating method is likely to be lower
than that taken by the Korotkoff Sound Method. When measuring the hypotension, the measure taken by the oscillating
method is likely to be higher than that by the Korotkoff Sound Method. But, it doesn’t mean the advantages or
disadvantages between the oscillating method and the Korotkoff Sound Method. Comparison with the results taken by
more accurate method, let’s say comparison of the invasive pressure result with the output value by the blood pressure
measuring simulator, will show which method has more accurate results. In addition, higher or lower value should be a
statistical concept. It is recommended those used to adopt the Korotkoff Sound Method use different physiological
calibration for values determined by the oscillating method.
The studies have shown that the Korotkoff Sound Method has the worst accuracy when it comes to measurement of
hypotension, while the oscillating method has worse accuracy when it comes to measurement of controlled hypertension
relief.
12.5.2 Factors affecting NIBP measuring
Select a cuff of appropriate size according to the age of the subject.
Its width should be 2/3 of the length of the upper arm. The cuff inflation part should be long enough to permit
wrapping 50-80% of the limb concerned.
Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate measurement.
Make the cuff mark φ in the position where artery pulsates obviously, the effect will be best. The lower part of cuff
shall 2cm above the elbow joint.
Do not wrap the cuff on too thick clothes (especially forcotton-padded clothes and sweater ) to take measurement;
The tester should lie in bed or sit in chair, make the cuff and heart at the same level, for most accurate results,
other postures may have inaccurate result.
During measuring, do not move your arm or the cuff.
Themeasuring interval should be longer than 2 minutes, in continuous measurement, too short intervalmaycause
armextrusion,bloodquantityincreases,thencausebloodpressureincreases.
Keep the patient still and stop talking before and during measuring.
Thepatient’smood alsocanaffectthe measuringresult,whenexcited,theblood pressuregoes up.
The measuring result is also affected by time, lower in the morning and higher in the evening.
12.5.3 Clinical Limitations
1.
2.
3.
4.
5.
6.
Serious angiospasm, vasoconstriction, or too weak pulse.
When extremely low or high heart rate or serious arrhythmia of the subject occurs. Especially auricular
fibrillation will lead to unreliable or impossible measurement.
Do not take the measurement when the subject is connected with an artificial heart-lung machine.
Do not take the measurement when the subject uses diuresis or vasodilator.
When the subject is suffering from major haemorrhage, hypovolemic shock and other conditions with rapid blood
pressure change or when the subject has too low body temperature, the reading will not be reliable, for reduced
peripheral blood flow will lead to reduce arterial pulsation.
Subject with hyperadiposis; In addition, statistics show that 37% people report blood pressure difference of no
less than 0.80kPa(6mmHg) between the left and right arms, and 13% people report difference of no less than
1.47kPa (11mmHg).
Note: Some practitioners may report big discrepancies or abnormal values of the blood pressure measures when
the oscillating method is used. As a matter of fact, the so-called “big discrepancy” must be a term in the sense of
statistical significance of mass data. Abnormal data may be observed in some individual cases. It is normal in the scientific
experiments. It may be caused by an apparent reason, or by an unknown factor in some cases. Such individual doubtful
experimental data may be identified and eliminated using the special statistical technique. It is not a part of this manual.
The practitioner may eliminate the apparently unreasonable data according to the experience
76
Chapter 13 Appendix
13.1 Alarm Information
Alarm Information
Descriptions
Over HR limit
Over TEMP limit
Over RR limit
Over SpO2 limit
Over PR limit
Over NIBP SYS limit
The related parameter value exceeds the preset high/low alarm
limit.
Over NIBP DIA limit
Over NIBP MAP limit
Over ST limit
Over NIBP PR limit
Unable to detect HR
ECG cable and leads are connected to monitor and patient well, but
HR is unable to be detected. It may caused by inconformity HR signal.
Unable to detect SpO2
SpO2 probe is connected to monitor and patient well, but SpO2 is
unable to be detected. It may be caused by inconformity SpO2
signal.
The battery capacity will exhaust
Low battery voltage
Lead Off
The ECG electrodes or cable fell off
Probe Off
SpO2 probe fell off
77
13.2 Default Alarming Values and Setup Range
The default alarming value:
Mode
Heart Rate
Parameter
High limit
Low limit
Respiration
Adult
Infant
Neonate
180 bpm
40 bpm
200 bpm
50 bpm
220 bpm
50 bpm
High limit
40 rpm
50 rpm
60 rpm
Low limit
10 rpm
10 rpm
10 rpm
High limit
39℃
39℃
39℃
Low limit
High limit
35℃
180 mmHg
35℃
130 mmHg
35℃
110 mmHg
Low limit
60 mmHg
50 mmHg
50 mmHg
High limit
120 mmHg
90 mmHg
90 mmHg
Low limit
50 mmHg
40 mmHg
30 mmHg
High limit
160 mmHg
110 mmHg
100 mmHg
Low limit
50 mmHg
40 mmHg
30 mmHg
High limit
100%
100%
100%
Low limit
90%
85%
85%
High limit
180 bpm
200 bpm
220 bpm
Low limit
40 bpm
50 bpm
50 bpm
High Limit
+1.00mV
+1.00mV
+1.00mV
Low Limit
-1.00mV
-1.00mV
-1.00mV
Temperature Difference
Range
Arterial
Pressure
High limit
2℃
200mmHg
2℃
160mmHg
2℃
140mmHg
Low limit
10mmHg
10mmHg
10mmHg
DIA
High limit
200mmHg
160mmHg
140mmHg
MAP
Low limit
High limit
10mmHg
200mmHg
10mmHg
160mmHg
10mmHg
140mmHg
Low limit
10mmHg
10mmHg
10mmHg
SYS
High limit
120mmHg
100mmHg
90mmHg
DIA
Low limit
High limit
10mmHg
120mmHg
10mmHg
100mmHg
10mmHg
90mmHg
Low limit
10mmHg
10mmHg
10mmHg
High limit
120mmHg
100mmHg
90mmHg
Low limit
10mmHg
10mmHg
10mmHg
SYS
High limit
30mmHg
30mmHg
30mmHg
DIA
Low limit
High limit
0mmHg
30mmHg
0mmHg
30mmHg
0mmHg
30mmHg
Low limit
0mmHg
0mmHg
0mmHg
High limit
30mmHg
30mmHg
30mmHg
Low limit
0mmHg
0mmHg
0mmHg
Respiration
Rate
High limit
40 rpm
50 rpm
60 rpm
Low limit
10 rpm
10 rpm
10 rpm
EtCO2
High limit
70 mmHg
70 mmHg
70 mmHg
Low limit
10 mmHg
10 mmHg
10 mmHg
High limit
Low limit
10 mmHg
0 mmHg
10 mmHg
0 mmHg
10 mmHg
0 mmHg
Temperature
Systolic
NIBP
Diastolic
MAP
SpO2
Pulse Rate
ST Segment
Pulmonary
Artery
Pressure
SYS
MAP
Central
Venous
Pressure
MAP
CO2
InsCO2
78
The high and low limits setting range:
Mode
Parameter
Heart Rate
1~350bpm
1~350bpm
Low limit
0~349bpm
0~349bpm
0~349bpm
High limit
1~120rpm
1~150rpm
1~150rpm
Low limit
0~119rpm
0~149rpm
0~149rpm
High limit
0.1~60°C
0.1~60°C
0.1~60°C
Low limit
0~59. 9°C
0~59. 9°C
0~59. 9°C
High limit
31~280 mmHg
31~200 mmHg
31~135 mmHg
Low limit
30~279 mmHg
30~199 mmHg
30~134 mmHg
High limit
11~232 mmHg
11~150 mmHg
11~100 mmHg
Low limit
10~231 mmHg
10~149 mmHg
10~99 mmHg
High limit
21~242 mmHg
21~165 mmHg
21~110 mmHg
Low limit
20~241 mmHg
20~164 mmHg
20~109 mmHg
High limit
1~100%
1~100%
1~100%
Low limit
0~99%
0~99%
0~99%
High limit
1~300bpm
1~350bpm
1~350bpm
Low limit
0~299bpm
0~349bpm
0~349bpm
High Limit
-2.49Mv~+2.49mV
-2.49mV~+2.49mV
-2.49mV~+2.49mV
Low Limit
-2.49mV~+2.49mV
-2.49mV~+2.49mV
-2.49mV~+2.49mV
0.0~5.0℃
0.0~5.0℃
(1~250)mmHg
0.0~5.0℃
(1~250)mmHg
Low limit li mit（0~249）mmHg
High limit
（1~250）mmHg
(0~249)mmHg
(0~249)mmHg
(1~250)mmHg
(1~250)mmHg
Low limit
（0~249）mmHg
(0~249)mmHg
(0~249)mmHg
High limit
（1~250）mmHg
(1~250)mmHg
(1~250)mmHg
Low limit
（0~249）mmHg
(0~249)mmHg
(0~249)mmHg
High limit
（1~120）mmHg
(1~120)mmHg
(1~120)mmHg
Low limit
（0~119）mmHg
(0~119)mmHg
(0~119)mmHg
High limit
(1~120)mmHg
(1~120)mmHg
Low limit
（1~120）mmHg
（0~119）mmHg
(0~119)mmHg
(0~119)mmHg
High limit
（1~120）mmHg
(1~120)mmHg
(1~120)mmHg
Low limit
（0~119）mmHg
(0~119)mmHg
(0~119)mmHg
High limit
（-9~40）mmHg
(-9~40)mmHg
(-9~40)mmHg
Low limit
（-10~39）mmHg
(-10~39)mmHg
(-10~39)mmHg
High limit
（-9~40）mmHg
(-9~40)mmHg
(-9~40)mmHg
Low limit
（-10~39）mmHg
(-10~39)mmHg
(-10~39)mmHg
High limit
（-9~40）mmHg
(-9~40)mmHg
(-9~40)mmHg
Low limit
（-10~39）mmHg
(-10~39)mmHg
(-10~39)mmHg
Respiration
High limit
（1~120）rpm
(1~150)rpm
(1~150)rpm
Rate
Low limit
（0~119）rpm
(0~149)rpm
(0~149)rpm
High limit
（1~100）mmHg
(1~100) mmHg
(1~100) mmHg
Low limit
（0~99）mmHg
(0~99) mmHg
(0~99) mmHg
High limit
（1~30）mmHg
(1~30) mmHg
(1~30) mmHg
Low limit
（0~29）mmHg
(0~29) mmHg
(0~29) mmHg
Systolic
Diastolic
Mean
SpO2
Pulse Rate
ST Segment
Temperature Difference
Systolic
Diastolic
Mean
Systolic
Diastolic
Mean
Central
Venous
Pressure
Systolic
Diastolic
Mean
CO2
Neonate
1~350bpm
Temperature
Pulmonary
Artery
Pressure
Infant
High limit
Respiration
Arterial
Pressure
Adult
EtCO2
InsCO2
High limit
（1~250）mmHg
79
13.3 Abbreviation of Arrhythmia
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
ECG TACHY
ECG BRADY
ECG VPCEST
MISS BEAT
VE EARLY
SVE EARLY
VE COUPLET
SVE COUPLET
VE RUN
SVE RUN
VE SHORT RUN
SVE SHORT RUN
VE BIGEMINY
SVE BIGEMINY
VE TRIGEMINY
SVE TRIGEMINY
VE INSERT
SVE INSERT
VE RONT
SVE RONT
13.4 Status/Error during NIBP Monitoring
“Cuff error”
“Air leak”
“Signal weak”
“Over extent”
“Over motion”
“Signal overflow”
“Leak in gas run”
“System error”
“Adult”
“Infant”
“PROBE OFF”
“LEADS OFF”
“LEARNING”
“DEMO”
— cuff is not wrapped correctly, or is not connected
— Air moving part, tube or the cuff air leak. “Pressure error”
— Unstable cuff pressure or tangled cuff tubing
— Very weak signal because of the cuff, or the patient has very weak pulse
— The measurement range exceeds 255 mmHg (Infant patient over 135 mmHg)
— The repeated measurement due to moving, excessive noise during the
stepping inflation and measuring pressure and pulse, e.g. during patient shaking motion
— Blood pressure amplifier overflow due to excessive movement
— Leaking during the pneumatic device testing
— Abnormal condition of CPU, such as register overflow, divided by zero
— The blood pressure measuring now is in adult mode. In this case, it is not allowed to
monitor infant patient. Otherwise, there may be serious danger to the infant monitored.
— The blood pressure module is now worked in infant measuring mode.
— SpO2 probe fell off
— The ECG electrodes or cable fell off
—Learning arrhythmia for 15 seconds
— The monitor is displaying the demo waveforms, which are generated by the monitor itself.
80
13.5 Status/Error during CO2 Monitoring
Suggested Message/Response
Description
“Sensor Over Temp”
Make sure sensor is not exposed to extreme heat
(heat lamp, etc.). If error persists, return sensor to
factory for servicing.
The sensor temperature is greater than 40 °C
“Sensor Faulty”
Check that the sensor is properly plugged in.
Reinsert or reset the sensor if necessary.
If error persists, return sensor to factory for
servicing
One of the following conditions exist:
Source Current Failure,
EEPROM Checksum Faulty,
Hardware Error
No Parameter Message
The host must set the Barometric Pressure
compensations to clear this error; no user
intervention should be required.
Barometric Pressure and/or gas
compensations have not been set since power and
on. For CO2 to be calculated with the stated
accuracy, these values should be set
whenever the sensor is plugged in.
“Module in Sleep Mode”
This bit is set when sensor has been placed in
sleep mode.
“Zero In Progress “
A Module Zero is currently in progress.
“Sensor Warm Up”
This error condition is normal at start-up. This error
clear when the warm up is complete.
One of the following conditions exist: should
Sensor under temperature, Temperature not
stable or Source Current unstable
“Check Sampling Line”
Check that the sampling line is not occluded or kinked.
This error occurs whenever the pneumatic
pressure is outside the expected range.
“Zero Required”
To clear, check airway adapter and clean if
necessary. If this does not correct the error,
perform an adapter zero. If you must zero adapter
more than once, a possible hardware error may
exist.
One of the following conditions exist:
Zero Required;
Zero Required: Zero Error
“CO2 Out of Range”
If error persists, perform a zero.
The value being calculated is greater than the
upper CO2 limit (150 mmHg, 20.0 kPa, or 19.7%).
The maximum value output is the upper CO2 limit.
“Check Airway Adapter”
To clear, clean airway adapter if mucus or
moisture is seen. If the adapter is clean, perform
Capnostat zero.
Usually caused when the airway adapter is
removed from the sensor or when there is an a
optical blockage on the windows of the airway
adapter. May also be caused by failure to perform
sensor zero to when adapter type is changed.
The Sensor
not Ready
This is prompted if the CO2 sensor is not ready
for a Capnostat Zero.
If the “Zero Required” and this massage both prompt
message both promp one or more of the following
conditions may exist:
• Breaths detected
• Temperature is not stable
• Source Current unstable
• In sleep mode.
Zero already in progress
Normal zero calibration is already in progress.
Zero Fault and Breaths Detected
Zero attempted and breaths have been detected in
the last 20 seconds.
Zero Ok
Zero calibration is successful
81
13.6 Typical Pressures and CO2 Readings at Altitudes
Altitude
Barometric
Pressure(mmHg)
EtCO2 Reading
(%）
5
（mmHg）
38.0
0m
760
70m
754
5
37.7
100m
751
5
37.5
200m
743
5
37.1
1500m
641
5
32.0
3000m
537
5
26.8
5000m
420
5
21.0
Chapter 14 Packaging and Accessories
14.1 Packaging
The product is packed in high quality corrugated cartons with foam inside to protect the equipment against damage in
the shipping and handling process.
Gross Weight: Details see the indication on the outer Package
Dimension: 355(L) ×245(W) ×245(H) mm
14.2 Accessories Supplied with your Monitor
(1)
ECG lead 3/5 Lead (optional – not fitted to VSM)
One set
(2)
(3)
(4)
Adult NIBP cuff Reusable Single Tube Male Bayonet
Adult Silicone Rubber SpO2 probe
Reusable temperature transducer Trunk Cable for
YSi400 Disposable Temp Transducers with
Sample 12fr and 9fr Sterile Disposable Temperature
Sensors – available separately from your Dealer
One piece
One piece
One piece
(6)
AC power adapter with UK and Euro Power Cables
One piece
(8)
(9)
(10)
(11)
(12)
(13)
Li-ion re-chargeable battery
Bed Rail Hook / Handle sub-assembly
(Optional) Starter Pack Disposable ECG electrodes
User Manual
Dust Cover
CO2 accessories (optional)
One piece
One set
Ten pieces
One copy
One piece
For Mainstream
Mainstream sensor
( CAPNOSTAT 5 )
Airway adapter
For Side stream
One set
Side stream Sensor
(LoFlo C5)
One set
One piece
Sampling Line Kit
One set
Note: The accessories are subject to change. Detailed items and quantity see the Packing List.
82
14.3 Spares & Supplementary Accessories
Part No.
Part Name
Remark
ECG Cables and Spares
CR15010513
ECG cable 3/5 Lead One Piece Reusable - Pop On
connectors
Standard Supply for
Monitors with ECG
SpO2 Sensors
CR15040040
CR15044074
Creative SpO2 Sensor (Round Connector),
Silicone, Adult (2.5m Cable)
Creative SpO2Sensor (Round Connector),
Finger Clip, Adult (2.5m Cable)
Standard Supply
Optional
CR15040034
Creative SpO2 Sensor (Round Connector),
Silicone, Paediatric (2.5m Cable)
Optional
CR15040021
Creative SpO2 Sensor (Round Connector),
Finger Clip, Paediatric (2.5m Cable)
Optional
CR15044040
Creative SpO2 Sensor (Round Connector),
Foam Wrap, Neonate (Limited Reuse)
Optional
CR15040019
Creative SpO2 Sensor (Round Connector),
Y Type with Silicone Wrap (2.5m Cable)
Optional
For compatible Nellcor and Masimo SpO2 sensors
please contact your Dealer for full options.
Reusable BP Cuffs - Single Tube with Bayonet Fitting
X1TL-3600SHP
Trimline Reusable Cuff, Thigh
Single
X1TL-3602SHP
Trimline Reusable Cuff, Large Adult
Single
X1TL-3602XLSHP
Trimline Reusable Cuff, Large Adult XL
Single
X1TL-3603SHP
Trimline Reusable Cuff, Adult
Single
X1TL-3603XLSHP
Trimline Reusable Cuff, Adult XL
Single
X1TL-3604SHP
Trimline Reusable Cuff, Small Adult
Single
X1TL-3605SHP
Trimline Reusable Cuff, Child
Single
X1TL-3606SHP
Trimline Reusable Cuff, Infant
Single
Disposable BP Cuffs - Single Tube with Bayonet
TL-39015
Trimline Disposable Soft Cuff, Thigh
Box of 20
TL-39230
Trimline Disposable Soft Cuff, Large Adult
Box of 20
TL-39060
Trimline Disposable Soft Cuff, Large Adult XL
Box of 20
TL-39048
Trimline Disposable Soft Cuff, Adult
Box of 20
TL-39019
Trimline Disposable Soft Cuff, Adult XL
Box of 20
TL-39085
Trimline Disposable Soft Cuff, Small Adult
Box of 20
TL-39100
Trimline Disposable Soft Cuff, Child
Box of 20
TL-39045
Trimline Disposable Soft Cuff, Infant
Box of 20
83
Temperature Measurement Spares and Consumables
Call Dealer
YSI 400 compatible Creative Temp Trunk Cable Reusable
Single
EV-TSS119095S
Bridge Temperature Probes, Skin Contact, 5mm STERILE Disposable YSI 400 Fitting
Pack of 25
EV-TSM119095S
Bridge Temperature Probes, Skin Contact, 7mm STERILE Disposable YSI 400 Fitting
Pack of 25
EV-TSL119095S
Bridge Temperature Probes, Skin Contact, 9mm STERILE Disposable YSI 400 Fitting
Pack of 25
EV-TVL119175S
Bridge Temperature Probes, General Purpose, 12Fr –
STERILE Disposable YSI 400 Fitting
Pack of 50
EV-TVM119175S
Bridge Temperature Probes, General Purpose, 09Fr –
STERILE Disposable YSI 400 Fitting
Pack of 50
OTHER KEY ACCESSORIES AND SPARES
CR-PROSTAND1
Rolling PROStand for Creative PC-3000 Monitor
Each
CR2203-0500003
USB Printer for Creative PC-3000 Monitor
Each
Call Dealer
Printer Paper
CR2600-2600041
Wall Mount for PC-3000 Monitor
Each
CR2600-2600043
Pole Mount Clamp for PC-3000 Monitor
Each
CR2507-1700010
Bed Rail Hook /Handle sub-assembly
Each
CR2301-1005055
220-240 VAC Power Adapter for PC-3000 Monitors
Each
Call Dealer
230/240 VAC Power cord with UK or Euro Plug
Each
CR-12VDC3
12 DC Vehicle Cigar Lighter Power Cable, 2 metres
Each
Please contact your Dealer for all
CO2 Sampling line and adapter option details
For more information regarding the accessories, please contact your local Creative Dealer.
84
Chapter 15 Instructions for SpO2 Probes
Instructions for Paediatric SpO2 Finger Clip Sensor
Intended Use
When used with a compatible Multi-parameter Monitor or a pulse oximeter device, the sensor is intended to be used
for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for paediatric
patients weighing between 10~40kg.
Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.
Instructions for Use
1) With the upper and lower jaws open, place an index finger evenly on the base of the clip. Push the fingertip
against the stop so that it is over the sensor window (A). If an index finger cannot be positioned correctly, or is not
available, other fingers can be used.
2) Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood
pressure cuff, or intravascular infusion line.
3) Spread open the rear tabs of the
sensor to provide even force over
the length of the pads (B).
4)
5)
6)
7)
The sensor should be
oriented in such a way that the cable is positioned along the top of the hand (C).
Plug the sensor into the oximeter and verify proper operation as described in the user manual.
Inspect the monitoring site every 1~2 hours for skin integrity.
Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Warnings
1) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient motion,
fingernail polish, use of intravascular dyes, excessive light, poor blood perfusion in the finger, extreme finger sizes
or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover the
sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 3 hours. Because individual skin condition affects the ability of
the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently with some
patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate
saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by
NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears damaged.
85
Instructions for Adult SpO2 Finger Rubber Sensor
Intended Use
When used with a compatible Multi-parameter Monitor or a pulse oximeter device, this SpO2 sensor is intended to be used
for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for patients
weighing greater than 50kg.
Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.
Instructions for Use
1)
2)
3)
4)
Hold the sensor with its opening towards the patient’s index finger (A). The sensor should be orientated in
such a way that the sensor side with a finger
tip sign is positioned on the top.
Insert the patient’s index finger into the sensor until the fingernail tip rests against the stop at the end of the sensor.
Adjust the finger to be placed evenly on the middle base of the sensor. Direct the cable along the top of the
patient’s hand. Apply adhesive tape to secure the cable (B). If an index finger cannot be positioned correctly, or is
not available, other fingers can be used.
Plug the sensor into the oximeter and verify proper operation as described in the user manual.
Inspect the monitoring site every 1~2 hours for skin integrity.
Cleaning & Disinfection
Unplug the sensor before cleaning or disinfecting. Surface-clean sensor and cable with a soft gauze pad by saturating it
with a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Warnings
1) This sensor is for use only with compatible Monitors or pulse oximeter devices. Use of this sensor with
instruments other than compatibles may result in improper performance.
2) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger
sizes or improper placement of the sensor.
3) The sensor site must be checked for skin integrity at least every 1~2 hours. Because individual skin condition
affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor to another
finger.
4) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by
NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse. Do not use the sensor during
MRI scanning.
5) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
6) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
7) Do not use the sensor if the sensor or the sensor cable appears damaged.
86
Instructions for Adult SpO2 Finger Clip Sensor
Intended Use
When used with a compatible patient Multi-parameter Monitor or a pulse oximeter device, the sensor is intended to be
used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for patients
weighing greater than 40kg.
Contraindications
This sensor is contraindicated for use on very active patients or for prolonged use.
Instructions for Use
1)
2)
3)
4)
5)
6)
7)
With the upper and lower jaws open, place an index finger evenly on the base of the clip. Push the fingertip
against the stop so that it is over the sensor window (A). If an index finger cannot be positioned correctly, or is not
available, other fingers can be used.
Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood
pressure cuff, or intravascular infusion line.
Spread open the rear tabs of the sensor to provide even force over the length of the pads (B).
The sensor should be oriented
in such a way that the cable is positioned along the top of the hand (C).
Plug the sensor into the oximeter and verify proper operation as described in the user manual.
Inspect the monitoring site every 1~2 hours for skin integrity.
Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Warnings
1)
Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger
sizes or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover the
sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 3 hours. Because individual skin condition affects the ability of
the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently with some
patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate
saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by
NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears damaged.
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