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PM-6000
Portable Multi-parameter
Patient Monitor
Operation Manual
Copyright
SHENZHEN MINDRAY®BIO-MEDICAL ELECTRONICS CO., LTD. 2002
Version:
2.2
Issued date: 2004/08/08
Serial No:
PM-6000
Statement
SHENZHEN MINDRAY® BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns all rights to this unpublished work and intends to maintain this work as
confidential. Mindray may also seek to maintain this work as an unpublished copyright. This
publication is to be used solely for the purposes of reference, operation, maintenance, or
repair of Mindray equipment. No part of this can be disseminated for other purposes.
In the event of inadvertent or deliberate publication, Mindray intends to enforce its rights to
this work under copyright laws as a published work. Those having access to this work may
not copy, use, or disclose the information in this work unless expressly authorized by Mindray
to do so.
Mindray shall not be liable for errors contained herein nor for incidental or consequential
damages in connection with the furnishing, performance, or use of this material. This
publication may refer to information and protected by copyrights or patents and does not
convey any license under the patent rights of Mindray, nor the rights of others. Mindray does
not assume any liability arising out of any infringements of patents or other rights of third
parties.
Content of this manual is subject to changes without prior notice.
PROPERTY OF
SHENZHEN MINDRAY®BIO-MEDICAL ELECTRONICS CO., LTD.
ALL RIGHTS RESERVED
Responsibility on the manufacturer party
Mindray is responsible for safety, reliability and performance of this equipment only in the
condition that:
• all installation, expansion, change, modification and repair of this equipment are conducted
by Mindray qualified personnel; and,
• applied electrical appliance is in compliance with relevant National Standards; and,
• the monitor is operated under strict observance of this manual.
Patient Monitor user’s manual (V 2.2)
I
Note
This equipment is not intended for family usage.
Warning
Failure to follow this message may result in death or serious injury to the patient or
operator, or may cause damage to the equipment.
Warning
To use this equipment safely, the user must observe all special application instructions
or precautions in this operation manual. However, these special instructions or
precautions cannot replace the medical procedures executed presently.
Do not solely rely on the audible alarming system to monitor a patient. Setting a
very low volume or completely turning off the volume may cause catastrophe to
the patient. The most reliable method to monitor the patient is to at the same time
of using the monitoring equipment, the physician should himself closely observe
the situation of the patient.
This equipment is designed to be used only by trained health care personnel in
health care institution.
To reduce the risk of electrical shock, do not open any casing of the equipment.
Service can be performed only by qualified personnel.
This equipment may interfere with the ultrasound imaging system. If there is
interference, interference signals may appear on the screen of the ultrasound
imaging system. To eliminate the interference, the distance between this
equipment and the ultrasound imaging system should be as far as possible.
It is dangerous to subject the electric contact and the connector to normal saline,
other liquid or conductive adhesive. The electric contact and the connector such
as cable connector, power and parameter module plug-in connector, and frame
connector must be kept clean and dry. Once being wetted, they must be
thoroughly dried before use. If to decontaminate the electric contact or the
connector, please contact biomedical department or Mindray company.
Warning
This monitor is not a device for treatment purpose.
It is important for the hospital or organization that employs this equipment to carry out a
reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury
of human health.
II
Patient Monitor user’s manual (V 2.2)
Warranty
Workmanship & Materials
Mindray guarantees new equipment other than accessories to be free from defects in
workmanship and materials for a period of 18 months (six months for multi-site probes and
SpO2 sensor) from date of shipment under normal use and service. Mindray's obligation
under this warranty is limited to repairing, at Mindray’s option, any part which upon Mindray's
examination proves defective.
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the substitution upon it of parts or
accessories not approved by Mindray or repaired by anyone other than a Mindray authorized
representative.
This warranty shall not extend to any instrument which has been subjected to misuse,
negligence or accident; any instrument from which Mindray's original serial number tag or
product identification markings have been altered or removed, or any product of any other
manufacturer.
Safety, Reliability and Performance
Mindray is not responsible for the effects on safety, reliability and performance of the
PM-6000 Modular Patient Monitor if:
■
assembly operations, extensions, re-adjusts, modifications or repairs are carried out by
persons other than those authorized by Mindray.
■
the Patient Monitor is not used in accordance with the instructions for use, or the
electrical installation of the relevant room does not comply with NFPA 70: National
Electric Code or NFPA 99: Standard for Health Care Facilities (Outside the United States,
the relevant room must comply with all electrical installation regulations mandated by the
local and regional bodies of government).
Patient Monitor user’s manual (V 2.2)
III
Return Policy
Return Procedure
In the event that it becomes necessary to return a unit to Mindray, the following procedure
should be followed:
1.
Obtain return authorization. Contact the Mindray Service Department and obtain a
Customer Service Authorization (Mindray) number. The Mindray number must appear on
the outside of the shipping container. Return shipments will not be accepted if the
Mindray number is not clearly visible. Please provide the model number, serial number,
and a brief description of the reason for return.
2.
Freight policy. The customer is responsible for freight charges when equipment is
shipped to Mindray for service (this includes customs charges).
Company Contact
Address:
Mindray Building, Keji 12th Road South, Hi-tech
Industrial Park, Nanshan, Shenzhen, P. R. China
518057,
Phone:
+86 755 2658 2888
Fax:
+86 755 2658 2680
Free hot line: +86 800 830 3312
EC Representative
IV
Name:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestrasse 80 D-20537 Hamburg Germany
Phone:
+49 40 2513174
Fax:
+49 40 255726
Patient Monitor user’s manual (V 2.2)
Preface
This manual gives detailed description to PM-6000 Modular Patient Monitor concerning its
performance, operation, and other safety information. Reading through this manual is the first
step for the user to get familiar with the equipment and make the best out of it.
Following symbols indicates some important facts that you have to pay special attention to:
Warning
Caution
Note
Points to be noted to avoid injury to the patient and the operator.
Points to be noted to avoid damage to the equipment.
Points to be noted.
This manual is intended for persons who are trained in the use of this field and have adequate
experience in operation of monitoring equipment.
Patient Monitor user’s manual (V 2.2)
V
Content
Content
Chapter 1
Introduction................................................................................................... 1-1
1.1 General Information................................................................................................... 1-3
1.2 Screen Display .......................................................................................................... 1-7
1.3 Button Functions ..................................................................................................... 1-10
1.4 Interfaces................................................................................................................. 1-13
1.5 Spefication ............................................................................................................... 1-14
Chapter 2
Getting Started .............................................................................................. 2-1
2.1 Open the Package and Check .................................................................................. 2-1
2.2 Connect the Power Cables........................................................................................ 2-1
2.3 Power on the Monitor ................................................................................................ 2-2
2.4 Connect Patient Sensors........................................................................................... 2-2
2.5 Check the Recorder .................................................................................................. 2-2
Chapter 3
System Menu.................................................................................................. 3-1
3.1 Patient Information Setup.......................................................................................... 3-1
3.2 Default Setup............................................................................................................. 3-3
3.3 Review....................................................................................................................... 3-4
3.4 System Setup ............................................................................................................ 3-4
3.5 Selection Setup ....................................................................................................... 3-11
3.6 Monitor Version........................................................................................................ 3-12
3.7 Drug Calculation ...................................................................................................... 3-13
3.8 Maintenance ............................................................................................................ 3-13
3.9 DEMO Function ....................................................................................................... 3-16
Chapter 4
Face Select ..................................................................................................... 4-1
4.1 Select Operating Screen ........................................................................................... 4-1
4.2 Standard Screen........................................................................................................ 4-1
4.3 Trend Screen ............................................................................................................. 4-2
4.4 oxyCRG Screen......................................................................................................... 4-3
4.5 Viewbed Screen ........................................................................................................ 4-4
Chapter 5
Alarm............................................................................................................... 5-1
5.1 Alarm Modes.............................................................................................................. 5-1
5.2 Alarm verification during power on ............................................................................ 5-4
5.3 Alarm Cause .............................................................................................................. 5-4
5.4 SILENCE and PAUSE ............................................................................................... 5-5
5.5 Parameter Alarm........................................................................................................ 5-6
5.6 When an Alarm Occurs ............................................................................................. 5-6
Chapter 6
Freeze............................................................................................................. 6-1
6.1 General...................................................................................................................... 6-1
6.2 Enter/Exit Freeze Status............................................................................................ 6-1
6.3 Frozen Menu ............................................................................................................. 6-2
Patient Monitor user’s manual (V 2.2)
1
Content
6.4 Reviewing Frozen Waveform .................................................................................... 6-3
6.5 Recording Frozen Waveform..................................................................................... 6-3
Chapter 7
Recording ...................................................................................................... 7-1
7.1 General Information on Recording ............................................................................ 7-1
7.2 Recording Type ......................................................................................................... 7-1
7.3 Recording Startup...................................................................................................... 7-4
7.4 Recorder Operations and Status Messages ............................................................. 7-5
Chapter 8
Trend and Event............................................................................................ 8-1
8.1 Trend Graph .............................................................................................................. 8-1
8.2 Trend Table................................................................................................................ 8-3
8.3 NIBP Recall ............................................................................................................... 8-4
8.4 Alarm Event Recall .................................................................................................... 8-5
8.5 Power-off data storage(Optional) .............................................................................. 8-7
Chapter 9
Drug Calculation and Titration Table ........................................................... 9-1
9.1 Drug Calculation ........................................................................................................ 9-1
9.2 Titration Table ............................................................................................................ 9-3
Chapter 10
Patient Safety.............................................................................................. 10-1
Chapter 11
Care / Cleaning............................................................................................ 11-1
11.1 System Check........................................................................................................ 11-1
11.2 General Cleaning................................................................................................... 11-1
11.3 Cleaning Agents..................................................................................................... 11-2
11.4 Sterilization ............................................................................................................ 11-3
11.5 Disinfection ............................................................................................................ 11-3
Chapter 12
ECG/RESP Monitoring ............................................................................... 12-1
12.1 What Is ECG Monitoring........................................................................................ 12-1
12.2 ECG/RESP Module ............................................................................................... 12-1
12.3 Precautions during ECG Monitoring...................................................................... 12-3
12.4 Monitoring Procedure ............................................................................................ 12-3
12.5 ECG Screen Hot Keys........................................................................................... 12-8
12.6 ECG Menu............................................................................................................. 12-9
12.7 ECG Alarm Information and Prompt.................................................................... 12-14
12.8 ST Segment Monitoring (optional)....................................................................... 12-15
12.9 Arr. Monitoring (optional) ..................................................................................... 12-19
12.10 Measuring RESP............................................................................................... 12-24
12.11 Maintenance and Cleaning................................................................................ 12-28
Chapter 13
SpO2 Monitoring .......................................................................................... 13-1
13.1 PART 1 (MASIMO SpO2 board configuration) ...................................................... 13-1
13.1.1 Precautions......................................................................................................... 13-3
13.1.2 Monitoring Procedure ......................................................................................... 13-5
13.1.3 Sensors and Accessories: .................................................................................. 13-9
13.1.4 Alarm Description and Prompt.......................................................................... 13-12
13.1.5 Masimo Information.......................................................................................... 13-14
13.2 PART 2 (MINDRAY SpO2 board configuration) .................................................. 13-15
13.2.1 SpO2 Module.................................................................................................... 13-15
2
Patient Monitor user’s manual (V 2.2)
Content
13.2.2 Precautions during SpO2/Pulse Monitoring ..................................................... 13-17
13.2.3 Monitoring Procedure ....................................................................................... 13-18
13.2.4 Limitations for Measurement ............................................................................ 13-20
13.2.5 SpO2 Menu ...................................................................................................... 13-20
13.2.6 Alarm Description and Prompt.......................................................................... 13-22
13.2.7 Maintenance and Cleaning............................................................................... 13-24
Chapter 14
NIBP Monitoring........................................................................................... 14-1
14.1 Introduction............................................................................................................ 14-1
14.2 NIBP Module ......................................................................................................... 14-2
14.3 NIBP Monitoring .................................................................................................... 14-3
14.4 NIBP SETUP menu ............................................................................................... 14-7
14.5 NIBP Alarm Message .......................................................................................... 14-11
14.6 Maintenance and Cleaning.................................................................................. 14-13
Chapter 15
TEMP Monitoring ......................................................................................... 15-1
15.1 TEMP Monitoring................................................................................................... 15-1
15.2 TEMP Module........................................................................................................ 15-2
15.3 TEMP SETUP Menu.............................................................................................. 15-3
15.4 TEMP Alarm message........................................................................................... 15-4
15.5 Care and Cleaning ................................................................................................ 15-5
Chapter 16 IBP Monitoring .............................................................................................. 16-1
16.1 General.................................................................................................................. 16-1
16.2 IBP Module ............................................................................................................ 16-1
16.3 Precautions during IBP Monitoring........................................................................ 16-2
16.4 Monitoring Procedure ............................................................................................ 16-3
16.5 IBP Menu............................................................................................................... 16-4
16.6 Alarm Information and Prompts........................................................................... 16-12
16.7 Maintenance and Cleaning.................................................................................. 16-14
16.8 ICP Transducer ICT/B(Optional Accessory) ................................................... 16-15
Chapter 17
CO Measuring............................................................................................... 17-1
17.1 General.................................................................................................................. 17-1
17.2 CO Module ............................................................................................................ 17-1
17.3 Monitoring Procedure ............................................................................................ 17-3
17.4 CO SETUP Menu .................................................................................................. 17-7
17.5 Hemodynamic Calculation..................................................................................... 17-9
17.6 Alarm Information and Prompt............................................................................. 17-10
17.7 Maintenance and Cleaning.................................................................................. 17-11
Chapter 18
CO2 Measuring............................................................................................. 18-1
18.1 General.................................................................................................................. 18-1
18.2 CO2 Module .......................................................................................................... 18-2
18.3 Monitoring Procedure ............................................................................................ 18-3
18.4 CO2 Menu ............................................................................................................. 18-5
18.5 Alarm Information and Prompt............................................................................. 18-10
18.6 Maintenance and Cleaning.................................................................................. 18-12
Chapter 19 AG Measuring ............................................................................................... 19-1
Patient Monitor user’s manual (V 2.2)
3
Content
19.1 General ......................................................................................................... 19-1
19.2 AG Module .................................................................................................... 19-2
19.3 Measuring principle and operating process................................................... 19-4
19.4 Menus ........................................................................................................... 19-6
19.5 Alarm information and prompts ................................................................... 19-12
19.6 Technical specifications............................................................................... 19-15
19.7 Anesthetic Gas Accessories ........................................................................ 19-17
19.8 Maintenance and cleaning ................................................................................ 19-17
Chapter 20 Accessories and Ordering Information ..................................................... 20-1
20.1 ECG Accessories .................................................................................................. 20-1
20.2 SpO2 Accessories ................................................................................................. 20-2
20.3 NIBP Accessories .................................................................................................. 20-2
20.4 TEMP Accessories ................................................................................................ 20-3
20.5 IBP Accessories..................................................................................................... 20-3
20.6 CO Accessories ..................................................................................................... 20-4
20.7 CO2 Accessories................................................................................................... 20-4
20.8 AG Accessories ..................................................................................................... 20-4
Appendix I EC Declaration of Conformance ......................................................................... 1
Appendix II Product Specification ......................................................................................... 1
Appendix III EMC ..................................................................................................................... 1
Appendix IV System Alarm Prompt ....................................................................................... 1
4
Patient Monitor user’s manual (V 2.2)
Chapter 1 Instruction
For the overall information about the monitor, refer to General
For the knowledge about the various displayed information on the screen, refer to
Screen Display
For the operating method, refer to Button Function and Basic Operation
For the position of the various interface, refer to External Interface
For the specifications of the monitor, refer to Specifications
For safety precautions of the monitor, please refer to Patient Safety.
Warning
PM-6200 is intended for clinical monitoring application with operation only granted to
appropriate medical staff.
Warning
Monitor can only monitoring one patient at a time.
Warning
There could be hazard of electrical shock by opening the monitor casing. All servicing
and future upgrading to this equipment must be carried out by personnel trained and
authorized by Mindray.
Warning
Possible explosion hazard if used in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or
nitrous oxide.
Warning
You must verify if the device and accessories can function safely and normally before
use.
Warning
You must customize the alarm setups according to individual patient situation and
make sure that alarm sound can be activated when alarm occurs.
Warning
Do not use cellular phone in the vicinity of this device. High level electromagnetic
radiation emitted from such devices may greatly affect the monitor performance.
Warning
Patient Monitor user’s manual (V 2.2)
1-1
Introduction
Do not touch the patient, table, or the device during defibrillation.
Warning
Devices connected to the monitor shall form an equipotential system (protectively
earthed).
Warning
When used with Electro-surgery equipment, you (doctor or nurse) must give top
priority to the patient safety.
Warning
Do not place the monitor or external power supply in any position that might cause it
to fall on the patient. Do not lift the monitor by the power supply cord or patient cable,
use only the handle on the monitor.
Warning
Consult IEC-601-1-1 for system interconnection guidance. The specific requirements
for system interconnection are dependent upon the device connected to the monitor
and the relative locations of each device from the patient, and the relative location of
the connected device to the medically used room containing the monitor. In all
circumstance the monitor must be connected to a grounded AC power supply. The
monitor is referred to as an IEC 601/F device in the summary of situations table
contained in IEC 601-1-1.
Warning
Dispose of the packaging material, observing the applicable waste control regulations
and keeping it out of children’s reach.
Warning
This equipment is accord with the standard CISPR11(EN55011) class A.
Warning
Grounding:
Connect the oximeter only to a three-wire, grounded, hospital-grade receptacle. The
three-conductor plug must be inserted into a properly wired three-wire receptacle; if a
three-wire receptacle is not available, a qualified electrician must install one in
accordance with the governing electrical code.
Do not under any circumstances remove the grounding conductor from the power
plug.
Do not use extension cords or adapters of any type. The power cord and plug must be
intact and undamaged.
If there is any doubt about the integrity of the protective earth conductor arrangement,
operate the oximeter on internal battery power until the AC power supply protective
conductor is fully functional.
1-2
Patient Monitor user’s manual (V 2.2)
Instruction
Note
The software was developed per IEC601-1-4. The possibility of hazards arising from
errors in the software program is minimized.
Caution
At the end of its service life, the product described in this manual, as well as its
accessories, must be disposed of in compliance with the guidelines regulation the
disposal of such products. If you have questions concerning disposal of the product,
please contact MINDRAY or its representatives.
Caution
If you have any doubt to the grounding layout and its performance, you must use the
built-in battery to power the monitor.
1.1
General
PM-6000 is a modular multi-parameter patient monitor that has abundant monitoring functions
and is used for the clinical monitoring of adult, pediatric and neonate.
The user may increase the parameter and functional module at any time according to different
requirements. In addition, the system also supports the module exchange between inside and
outside of the hospital and the transmission of parameter alarm setup.
PM-6000 can be connected to the central monitoring system via the Mindray network so as to
form a network monitoring system.
PM-6000 Modular Patient Monitor is year 2000 compliant.
The Patient Monitor (Figure 1-1) can monitor vital physiological signals as ECG, Respiratory
Rate, SpO2, NIBP, Dual-TEMP, fourfold-IBP, CO, CO2 and AG.
Heart Rate (HR)
2-channel ECG waveforms
ECG
Arrhythmia and S-T segment analysis(optional),Pace
Respiratory Rate (RR)
RESP
Respiration Waveform
Oxygen Saturation (SpO2), Pulse Rate (PR)
SpO2
SpO2 Plethysmogram
Systolic Pressure (NS), Diastolic Pressure (ND), Mean Pressure
NIBP
(NM)
Channel-1 Temperature (T1), Channel-2 Temperature (T2),
TEMP
Temperature Difference between two channels (TD)
Channel-1 SYS, DIA, MAP
Channel-2 SYS, DIA, MAP
IBP
Channel-3 SYS, DIA, MAP
Channel-4 SYS, DIA, MAP
fourfold-IBP waveforms
Blood Temperature (TB)
CO
Cardiac Output (CO)
End Tidal CO2 (EtCO2)
CO2
Inspired Minimum CO2 (InsCO2)
Air Way Respiration Rate (AwRR)
Inhale and exhale CO2 (FiCO2, EtCO2)
AG
Patient Monitor user’s manual (V 2.2)
1-3
Introduction
Inhale and exhale N2O (FiN2O, EtN2O)
Inhale and Exhale O2 (FiO2, EtO2)
Inhale and exhale anesthetic agent (FIAA, ETAA, Note: AA refers
to one of anesthetic agents listed below:
HAL (Halothance)
ISO (Isoflurance)
ENF (Enflurance)
SEV (Sevoflurance)
DES (Desflurance)
Airway Respiration Rate (respiratory times per minute, unit: rpm)
AwRR
MAC(Minimum alveolar concentration)
Waveforms of four anesthetic gases including CO2, N2O, O2, AA
System Construction:
This Monitor has three independent parts:
■ Display: 12.1’’ color LCD or CRT
■ Module Box: allows horizontal or vertical placement.
■ Module: includes parameter module and function module.
The display can be placed independently as a separate system or placed together with
the module box forming a compact system.
③
④
②
⑤
①
Figure 1-1
System Construction
The visible LED are CLASS 1 LED PRODUCT according EN 60825-1 A11 Oct 1996.
The power switch “POWER” of the monitor lies at the right side of the module box(①). The
three lamps (②) on the right side of the module box are used to indicate the power situation.
After powering on the monitor, these three lamps light on. When the monitor is in function and
there is alarm occurring, both the alarm lamp on the screen (③) and the ALARM lamp on the
button module (④) light on or flash in a specific way. The socket for each sensor is on the
front panel of corresponding module. The output end of the recorder is on the front panel of
the recorder module (⑤). The battery door is on the rear panel of the monitor. The analog
interface, VGA interface, TFT interface are all on the right side of the rear panel of the monitor.
The power socket is on the left side of the rear panel, refer to “1.4 Rear Panel”
Display:
■ The system may use either the 12.1’’ color LCD provided by Mindray or the ordinary
purchased display.
■ The color LCD provided by Mindray has 6 system buttons and a rotary knob used for
1-4
Patient Monitor user’s manual (V 2.2)
Instruction
direct operation performed by the user.
■ The display provided by the Mindray possesses the device used for visual and audio
alarm.
■ The ordinary purchased display does not have system buttons and alarm device.
Therefore, the user should buy the button module to realize the direct operation by
the user and visual and audio alarm function.
Module box
■ The module box can maximally hold 8 standard modules at the same time.
■ The module box can be placed either horizontally or vertically.
Modules:
The modules currently provided by the system include:
■ 0# module: blank module (used for decoration, standard module)
■ 1# module: button/alarm module (standard module)
■ 2# module: ECG/RESP+TEMP(2 channel, standard module)
■ 3# module: SPO2 module (standard module)
■ 4# module: NIBP module (standard module)
■ 5# module: IBP(1,2 channel)module (standard module)
■ 6# module: CO module (standard module)
■ 7# module: EtCO2 module (standard module)
■ 8# module: Anaesthetic gas module (occupies a space of three slots)
■ 9# module: Recorder module(occupies a space of two slots)
■ 11# module:IBP(3, 4 channel)module (standard module)
1# module
5# module
2# module
6# module
Figure 1-2
3# module
7# module
4# module
9# module
module
Patient Monitor user’s manual (V 2.2)
1-5
Introduction
These modules are independent from each other, hence easy for the expansion of the new
parameter module.
Note
The manufacturer will not inform each customer of the appearance of the new module.
Method to load/unload the module:
(1) Step 1 unload the module
(2) step 2 unload the module
(3) Step 3 unload the module
Figure 1-3
(4) load the module
methods to load/unload the module
Unload the module: as per the Figure 1-3 (1)-(3), first use one hand to hold the
module to be unloaded, then use the other hand to press down the plate under the
module, and finally take out the module carefully.
Load the module: Align the module to be loaded with the empty slot, and then push
the module into the slot as per the method shown in the Figure 1-3 (4). When the
sound “click” is heard, it indicates the module has been successfully loaded.
Note
You can load/unload a module when the monitor is operating. After loading/unloading a
module, the system will refresh the screen and display parameters and waveforms
according to the module newly loaded. For a module that has been unloaded, its
measured data will be still stored in the system. You can view these data by using
Trend Graph, Trend Table and NIBP Recall menus.
Warning
If the user does not load/unload the module as per the method illustrated above, when
the top rake of the device is large, the module may slide out from the slot. In this case,
the user may be injured and the module may be damaged.
1-6
Patient Monitor user’s manual (V 2.2)
Instruction
1.2
Screen Display
The display of PM-6000 modular multi-parameter monitor is a color LCD, which can display
the collected patient parameters, waveforms, alarm information as well as bed number, time
and monitor status, etc.
The operating screen of the PM-6000 is the standard monitoring screen.
Main system screen:
■ Standard monitoring screen
①
②
③
Figure 1-4
standard monitoring screen
In the standard monitoring screen, the screen has three areas: information area( ① ),
waveform/menu area(②), and parameter area(③).
Information area(①):
Information area lies on the top part of the screen, which is used to display the current status
of the monitor and the patient. The information area contains following data:
Bed No.: used to indicate the bed number of the patient being monitored. This information
is displayed all the time.
Adult: used to indicate the patient type. This information is displayed all the time.
2000-01-01: used to indicate the date. “21:09:12” is the time. This information is
displayed all the time.
Patient name: displayed to the right side of the data. When the operator is entering the
patient name, the name is displayed in this position. When the operator does not enter the
patient name, the position displays blank.
Patient sex: displayed to the right side of the patient name.
Other information displayed in the information area appears or disappears together with the
status being reported, which is divided into following parts based on the contents:
Patient Monitor user’s manual (V 2.2)
1-7
Introduction
■
Monitor Prompt Information: informing the status of monitor or sensor, which always
appears to the right side of the time. When this information appears, it will cover the patient
sex and name.
■
flag for alarm PAUSE. Press “SILENCE” button once (less than 1 second) to mute all
alarm sounds are muted for the time being and the flag appears at the same time. Press the
button again to terminate the PAUSE status. The duration for PAUSE status can be 1 minute,
2 minutes or 3 minutes.
■
flag for alarm SILENCE. Press “SILENCE” button once (more than 1 second) to
manually mute the alarm sound and this flag appears at the same time. The SILENCE status
terminates when you discharge the status or new alarm occurs.
■
flag for Alarm Volume Off. It appears indicating that you have closed the alarm
sound permanently. This status terminates when you discharges the status.
Note
If
symbol appears, the system will no longer give audible alarm sound. You
must be very careful in using this function. Two ways can be used to discharge
this status. One is set the alarm volume to an option other than OFF in the USER
MAINTAIN menu. The other method is to press SILENCE button to make the flag
turn to
. And then press SILENCE again and the system will restore the normal
alarm status.
■
Patient parameter alarm information: this information is fixedly displayed in the extreme
right side of the screen.
■When the waveform on the screen is frozen, the corresponding prompt “FROZEN” window
appears on the lower part of the screen.
■There is a status bar on the bottom of the screen. Some status information will be displayed
in it. For example, “Loading XX module”, “Module unloaded”, “The recorder does not exit”,
and the information such as the lead system detected by the hardware is different from the
current user setup.
Waveform/menu area(②):
The waveform area can maximally display 8 waveforms. The displaying order of the
waveforms on the screen can be adjusted. For the maximum configuration, the waveforms
provided by the system for selection are: 2 ECG waveforms, SpO2 waveform, 4 IBP
waveforms, RESP waveform, CO2 waveform, O2 waveform and anaesthetic gas waveform.
All the waveforms in the system are listed out in the “
TRACE SETUP” menu. The user
may select the waveform to be displayed and adjust their displaying positions. The specific
method is illustrated in the part: SYSTEM MENU.
The name of the waveform is displayed on the upper left part of the waveform. The user may
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Instruction
choose ECG lead based on the requirements. The gain of the channel and the filter way are
also displayed on each ECG waveform. A 1mV scale bar is also displayed to the right side of
ECG waveform. The IBP waveform scale can also be selected according to the actual
requirement. Its range is described in the part: IBP MONITORING. In the IBP waveform area,
the waveform scale is displayed. The three dotted lines for each IBP waveform form up to
down represent respectively the upper limit scale, reference scale and lower limit scale. The
values of these three scales can be set. The specific method is given in the part: IBP
MONITORING.
When menu is wanted during screen operation, the menu always occupies the fixed position
in the middle part of the waveform area, therefore part of waveform can not be viewed
temporarily. After exiting the menu, the system will restores the original screen.
The user may set up the rate to refresh the waveform. The method to adjust the refreshing
rate of each waveform is discussed in the setup description of each parameter.
Parameter area(③):
The parameter area lies to the right side of the waveform area, whose position basically
corresponds to the waveform. The parameters displayed in the parameter area include:
ECG
— heart rate or pulse rate (unit: beats/minute)
— The ST analyzing result of channel 1 and 2: ST1, ST2 (unit: mV)
— PVCs(unit: times/minute)
NIBP
— From left to right, there are Systolic pressure, Mean pressure and Diastolic
pressure(unit: mmHg or kPa)
SpO2
— SpO2(unit: %)
— Pulse Rate(unit: beats/minute)(When “BOTH” item is selected)
CO
─ CO(unit: liter/minute);
─ TB(unit: ℃ or ℉)
IBP
— The blood pressure of channel 1, 2, 3 and 4. From left to right, there are
Systolic pressure, Mean pressure and Diastolic pressure(unit: mmHg or
kPa).
RESP
— Respiration Rate(unit: times/minute)
CO2
— EtCO2(unit: mmHg or kPa)
— INS CO2 (unit: mmHg or kPa)
— AwRR (times/minute)
TEMP
— Temperature of channel 1 and 2: T1, T2 and the difference between them
TD. (unit: ℃ or ℉)
AG
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Introduction
─ AwRR (times/minute)
─ MAC
Alarm lamp and alarm status:
In normal status: the alarm lamp is not on.
When alarm exists, the alarm lamp flashes or lights on. The color of the lamp
corresponds to the alarm level. Refer to related chapter: Alarm.
For the details of alarm information and prompt information, refer to the related content of
each parameter in related chapter.
1.3
Button Function and Basic Operation
This section discusses the following information:
Button functions of PM-6000
The method to use the rotary knob to realize the operation on the screen
Index for basic operation
Button function of PM-6000:
Two types of buttons are available on PM-6000: hard buttons and soft buttons.
Hard buttons include system button panel and module button panel. The system button panel
is on the screen or on the button module. The module button is on each module.
Soft buttons are on the screen, which have to be selected by the operator through using the
rotary knob.
Figure 1-5
module button panel and screen button panel
System buttons:
SILENCE
Push this button to suspend alarm for maximum 3 minutes (with 1 minute, 2 minutes
and 3 minutes selectable). In Alarm PAUSE status, a
symbol appears in the
Message Area. Push this button to mute all kinds of sounds (including alarm sound,
heart beat, pulse tone, key sound). At the same time, a
symbol appears in
the Message Area. Push this button again to restore all kinds of sounds and the
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Instruction
symbol disappears from the screen.
Note
If new alarm occurs in Alarm Pause/Silence status, the system will discharge
Pause/Silence status automatically. For specific rules, see Chapter Alarm.
Note
The system will begin to give alarm information again once there exist
alarm-triggering event.
Nevertheless, remember pushing SILENCE button can
permanently shut off audible alarm sound of ECG LEAD OFF and SPO2 SENSOR
OFF alarms.
PAUSE
Press this button, the system accesses the Alarm Pause status. All the alarm sounds
are muted. However, other sounds such as heart beat, button sound and pulse sound
will still exist. At this time, the “ALARM PAUSE xx s” appears in the parameter alarm
information area. Press this button again or when the pause time runs out, the system
terminates the alarm pause status and returns to the normal monitoring status, then the
alarm sound resumes and the prompt “ALARM PAUSE xx s” disappears from the
screen.
Note
After the end of Alarm Pause status, whether the alarm sound is restored depends
on whether the alarm exists. However, the technical alarms such as lead off will
not be restored. That is to say the user may also close the technical alarms such
as lead off through accessing and then exiting the Alarm Pause status.
ALARM SETUP
Press this button to let the system rapidly access the sub-menu of ALARM SETUP. In
this menu, the user may set up all the information about the alarms.
MAIN
Whatever level of menu the system is in, press the button and the system will always
return to the main screen.
FREEZE
Press this button and the system will access the FREEZE status. In this status the user
may review the waveform of 40 seconds. Also, the frozen waveform can be printed out. In
the FREEZE status, press this button again to discharge the FREEZE status. For detailed
information, refer to related chapter: Freeze.
MENU
Press this button to call up the SYSTEM MENU, in which the user may set up system
information and perform review operation. For detailed information, refer to related
chapter: System Menu and related chapter: Trend and Event.
Rotary knob
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Introduction
The user may use the rotary knob to select the menu item and modify the setup. It can
be rotated clockwise or counter-clockwise and pressed like other buttons. The user may
use the knob to realize the operations on the screen and in the system menu and
parameter menu.
Method to use the knob to operate on the screen:
The rectangular mark on the screen that moves with the rotation of the knob is called
“cursor”. Operation can be performed at any position at which the cursor can stay.
When the cursor is in the waveform area, the user may immediately modify the current
setup. When the cursor is in the parameter area, the user may open the setup menu of
the corresponding parameter module so as to set up the menu items of the module.
Operating method:
■ Move the cursor to the item where the operation is wanted
■ Press the knob
■ One of the following four situations may appear:
1.The cursor with background color may become into the frame without
background color, which implies that the content in the frame can change with
the rotation of the knob.
2.Menu or measuring window may appear on the screen, or the original menu is
replaced by the new menu.
3.A check mark “√” appears at the position, indicating that the item is confirmed.
4.The system immediately executes a certain function.
Module buttons:
ECG module:
SETUP: setup button of ECG/RESP, TEMP
: blank button
SPO2 module:
SETUP: SPO2setup button
: blank button
NIBP module:
SETUP: NIBP setup button
START/STOP: button to start/stop measurement
IBP(1, 2) module:
SETUP:IBP setup button
ZERO :IBP zero button
CAL
:IBP calibrate button
CO module:
SETUP: CO setup button
MEASURE: button used to access the CO MEASURMENT window
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CO2 module:
SETUP: CO2 setup button
STANDBY/START: Standby/Measure button
Recorder module:
REC/STOP: button to start/stop recording
IBP(3, 4)module:
SETUP: IBP setup button
ZERO: IBP zero button
CAL
: IBP calibrate button
Note
When using the color LCD provided by Mindray, the system buttons and alarm
function are integrated on the screen. The user may operate the buttons on the
display directly to realize the functions of the monitor.
When using the ordinary purchased display, the user should buy the button
module to realize the functions of the monitor.
The monitor supports the use of both hard buttons on the screen and the button module.
All the operations of the system can be realized through the combined operation of the
buttons and the rotary knob.
1.4
Rear panel
⑦
①
⑥
②
⑤
Figure 1-6
⑧
rear panel
③
④
① FUSE: Standard-T 3.0A
② Power supply: 100/250 (VAC), 50/60 (Hz)
③ Analog output: used to output the analog signals, able to be connected to
oscillometer and pen recorder.
④ VGA MONITOR: able to be connected to the external VGA monitor.
⑤ LVDS MONITOR: able to be connected to the display provided by Mindray.
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Introduction
⑥ Network interface: connected to the Mindray Hypervisor III via a standard RJ45
Socket.
⑦ EXTEND: used to connect to an external device.
⑧ Equipotential grounding terminal: able to be connected to the hospital’s grounding
system.
This symbol means “BE CAREFUL". Refer to the manual (this manual).
Note
Monitor must be connected with specific network equipment such as Harb during
using net function.
Warning
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (e.g. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the system standard IEC 60601-1-1. Everybody
who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies
with the requirements of the valid version of the system standard IEC 60601-1-1. If in
doubt, consult the technical service department or your local representative.
1.5
Specifications
1.5.1
Products classification
Anti-electroshock type
Class I equipment
EMC type
Class A
Anti-electroshock degree
ECG (RESP), SpO2, NIBP, IBP, TEMP, CO,CO2
CF
Harmful liquid proof degree
Ordinary equipment (sealed equipment without liquid
proof)
Working system
1.5.2
Continuous running equipment
Specifications
■ Applicable patient type:
Adult, pediatric and neonate
■ Parameters monitored by PM-6000:
ECG, RESP, NIBP, SpO2, PR (pulse rate), Dual-TEMP, 4 IBP, CO, TB (blood temperature),
CO2, ANAESTHETIC GAS, etc.
■ Display
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Instruction
12.1”TFT
■ Analog output
1 channel, signal amplitude: 1V/mV, amplitude error <5%, output impedance: 100ohm,
signal delay <20ms.
■ Power supply:
Operate on AC power.
AC power: 100~250VAC, 50/60Hz, Pmax=110VA.
1.5.3
Environmental requirements
■ Working environment:
PM-6000 can only be used in the hospital or by the trained physician during transporting
the patient into or out of the hospital.
This device can not be used at home.
The operating environment must satisfy following conditions:
Surrounding temperature:
0℃ ∼ 40℃
Humidity:
15% - 85%
-500 ∼ 4600 meters
Altitude:
■ Conditions for transportation and storage:
Without specific description, the transportation and storage of PM-6000 must satisfy
following conditions:
Surrounding temperature:
-20℃ ∼ 60℃
Humidity:
10% - 93%, relative humidity
Altitude:
-500 ∼ 13100 meters
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1-15
Chapter 2 Getting Started
■
Open the package and check
■
Connect the power cables
■
Power on the monitor
■
Connect patient sensors
■
Check the recorder
Note
To ensure that the monitor works properly, please read Chapter Patient safety, and
follow the steps before using the monitor.
2.1 Open the Package and Check
Open the package and take out the monitor and accessories carefully. Keep the package for
possible future transportation or storage. Check the components according to the packing list.
■
Check for any mechanical damage.
■
Check all the cables, modules and accessories.
If there is any problem, contact the distributor immediately.
2.2 Connect the Power Cables
Connection procedure of the AC power line:
Make sure the AC power supply complies with following specification: 100~250 VAC,
50/60 Hz.
Apply the power line provided with the monitor. Plug the power line to INPUT interface of
the monitor(Socket ③ in Figure 1-7).. Connect the other end of the power line to a
grounded 3-phase power output.
Note
Connect the power line to the jack special for hospital usage.
Note
Mindray does not provide MULTIPLE PORTABLE SOCKET-OUTLETS. IF use it, please
do not place it on the floor. Mindray advises that every one monitor uses one
MULTIPLE PORTABLE SOCKET-OUTLETS.
Connect to the ground line if necessary. Refer to Chapter Patient Safety for details.
Patient Monitor user’s manual (V 2.2)
2-1
Getting Started
2.3 Power on the Monitor
Press POWER(① in Figure 1-1) to power on the monitor. Then a beep will be heard and at
the same time the indicator will flash twice in yellow and red. After 10 seconds or so, the
system will enter monitoring screen after self-test, and you can perform normal monitoring
now.
During self-test, the software version will display.
Warning
If any sign of damage is detected, or the monitor displays some error messages, do
not use it on any patient. Contact biomedical engineer in the hospital or Mindray
Customer Service Center immediately.
Note
If the monitor finds any fatal error during self-test, it will alarm.
Note
Check all the functions that may be used to monitor and make sure that the monitor is
in good status.
Note
The battery must be recharged to the full electricity after each use to ensure adequate
electricity reserve.
Note
The interval between twice press of POWER should be more than 1 minute.
2.4 Connect Patient Sensors
Connect all the necessary patient sensors between the monitor and the patient.
Note
For information on correct connection, refer to Chapter 12~19.
2.5 Check the Recorder
If your monitor is equipped with a recorder, open the recorder door to check if paper is
properly installed in the output slot. If no paper present, refer to Chapter Recording for
details.
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Chapter 3 System Menu
■
New patient enrolment
■
Recording
■
Trend Graph/Table and Alarm Review
■
System Setup
■
Drug Calculation
■
Maintenance
The Patient Monitor features flexible configurations. You can configure various aspects of the
monitor, including the parameters to be monitored, sweeping speed of the waveforms, audio
signal volume, and printout text.
Press the “MENU” button on the Button Module or the display panel to call up “SYSTEM
MENU”. The configuration is realized through operations on the SYSTEM MENU, as shown
below.
Figure 3-1
SYSTEM MENU
Trend graph/table review, NIBP review and alarm review are discussed in Chapter: Trend and
Event.
3.1 Patient Information Setup
Note
To clear current patient data, refer to New Patient for details.
Pick the [PATIENT SETUP] item in the “SYSTEM MENU” to call up the following menu.
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3-1
System Menu
Figure 3-2
PATIENT SETUP
You can setup following patient information:
DEPT.
Department in which the patient receives treatment.
PAT NO
Patient No.
BED NO
Patient bed number (Range: 1-100)
DOCTOR
Name of the doctor.
NAME
Patient name (Valid characters: A-Z, 0-9 and space bar; Max. length: 12
characters)
SEX
Patient gender (Available options: "F" for Female, "M" for Male)
PAT TYPE
Patient type (Available options: ADU, PED, and NEO)
ADMIT
Hospitalization starting date (format: year\month\ day)
BIRTH
Patient date of birth (format: year\month\day)
HT. (cm/inch )
Patient height (turning the knob with the increase/decrease of 0.5 cm/inch
each time)The other HT. unit in the other menus accord with the unit which
you choosed here.
WT. (kg/Ib)
Patient weight (turning the knob with the increase/decrease of 0.5 kg/Ib
each time)The other WT. unit in the other menus accord with the unit which
you choosed here.
BLOOD
Patient blood type (Pick A, B, O, AB, or N. "N" represents unknown blood
type)
NEW PATIENT Admission of new patient
Also in this menu, you may select the [NEW PATIENT] item to access the “CONFIRM TO
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UPDATE PATIENT” dialog box as shown below, in which you can decide whether to monitor a
new patient.
Figure 3-3
Confirm To Update Patient Menu
Pick [YES] to delete all information of the patient being currently monitored and exit the menu.
Pick [NO] to give up updating the patient and the system will keep the information of the
current patient and exit the menu.
Note
If you select [YES], the system will delete all information of the patient being currently
monitored.
3.2
Default Setup
Note
After selecting any item in this sub-menu, the selected item will replace the current
setup of the system and accordingly become the system default configuration.
Figure 3-4
DEFAULT Menu
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3-3
System Menu
In this sub-menu, you can select both the factory default and the user-defined default. Also in
this sub-menu, you can save the current system configuration as the user-defined default
configuration. But at this time, the system will automatically save all the setups in the
parameter menu, ECG gain and filter way as the user-defined default configuration according
to the patient type. Also, the dialog box as shown below will pop up.
Figure 3-5
CONFIRM DEFAULT CONFIG
Note
After selecting any item in the DEFAULT menu and exiting the box, the “CONFIRM
DEFAULT CONFIG” Dialog box will pop up, in which you can select [YES] to confirm
your selection or [NO] to give up your selection.
Warning
All configurations in the system will be replaced by “default configurations”.
3.3
Trend Review, Measurement Review and Alarm
Event Review
In the “SYSTEM MENU”, there are [TREND GRAPH], [TREND TABLE], [NIBP RECALL] and
[ALARM RECALL] items. Please refer to Chapter 7: Trend and Event for detailed information.
3.4
System Setup
Select the [system setup] item in the [system menu]:
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Patient Monitor user’s manual (V 2.2)
System Menu
Figure 3-6 System setup
In the [System setup] menu , users can setup the following items.
3.4.1 Face select
Select “FACE SELECT” item in “SYSTEM SETUP” menu to access “FACE SELECT” dialog
box as shown below, in which four selections are available: STANDARD SCREEN, TREND
SCREEN, oxyCRG SCREEN and VIEWBED SCREEN. Only one selection can be chosen for
each time.
Figure 3-7
FACE SELECT
3.4.2 Alarm setup
The system provides three levels of alarm volume. You can select any of them as per the
clinical requirement. The procedures are:
Select the [ALARM SETUP] item in the “SYSTEM SETUP” sub-menu of the “SYSTEM
SETUP” menu. The menu as shown below will pop up, in which you can set up the alarm
volume and other alarm information. For detailed information, refer to Chapter Alarm.
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3-5
System Menu
Figure 3-8 Alarm Setup
You can highlight the [ALARM VOL] item and then turn the knob to set up the alarm volume.
There are three options: LOW, MED and HIGH.
3.4.3 Time Setup
Select the [TIME SETUP] item in the “SYSTEM SETUP” menu. The menu as shown below
will pop up. System time is in the format of year, month, day, hour, minute and second. Use
cursor to highlight the item that you want to modify and turn the knob to select time. Then
select [EXIT].
Note
You shall set up the system time upon turning on the monitor (if you need to set up the
system time); otherwise, when you review the content with time information, the
system may not display the correct time.
Figure 3-9 System Time Setup
When this monitor is linked to the Central Station, its system time will keep consistent with
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System Menu
that of the Central Station. Method to adjust time:Once link is successfully established, the
Central Station will send its current time to the monitor. The monitor will automatically adjust
its system time accordingly. Besides, the Central Station will keep on sending its current time
to the monitor once per hour to maintain consistent time between them. However, the monitor
will not adjust its time if it is different from the Central Station only in second. Please note that
if you are setting up the system time when link is just established successfully, the monitor will
immediately close the setup menu of system time. The setup button of system time in the
system setup menu is disabled when the monitor is linked to the Central Station. That means
you cannot open the setup menu of system time.(If the Central Station has no this function,
you can skip over this paragraph.)
3.4.3 Recorder setup
Select the [RECORD] in the “SYSTEM SETUP” menu to call up the following menu:
Figure 3-10 Record Setup
In this menu, the user can set up to output two waveforms. The waveforms that can be
selected include:
ECG1The first to the seventh ECG waveform on the screen (there are seven ECG
ECG6
waveforms in full leads display)(If no ECG waveform is currently displayed on
the screen, this item cannot be picked).
SPO2
SpO2 Plethysmogram.
IBP1
IBP2
Displayed waveform of Generated by IBP(1,2) module on the screen (If no IBP
IBP3
IBP4
Displayed waveform of Generated by IBP(3,4) module on the screen (If no IBP
waveform is currently displayed on the screen, this item cannot be picked).
waveform is currently displayed on the screen, this item cannot be picked).
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3-7
System Menu
RESP
RESP waveform (If no RESP waveform is currently displayed on the screen,
this item cannot be picked).
CO2
Displayed waveform either of anesthetic gas or generated by CO2 module.
N2O
Displayed waveform of anesthetic gas.
O2
Displayed waveform of anesthetic gas.
AA
Refers to displayed waveform anesthetic agent.
OFF
No display for this waveform.
RT REC TIME this item has two options, CONTINUAL and 8s. “CONTINUAL” means
once pushing the “REC/STOP” button on the recorder panel or the monitor panel, the
recorder will continuously print out the waveform or parameter until this button is pushed
again.
TIMING REC TIME OFF used to set up the time interval between two recordings. 10
selections are available: “OFF, 10min, 20min, 30min, 40min, 50min, 1hour, 2hours,
3hours and 4hours”. The system will start the recording process according to the selected
time interval. The recording time is always 8 seconds.
Note
RT REC TIME takes priority over TIMING REC TIME OFF.
REC RATE: this item has two options, 25.0 and 50.0 mm/s.
REC GRID: used to decide output format: OFF is without grid, and ON is with grid.
CLEAR REC TASK: used to clear the alarm event that has been generated and is waiting
for recording out.
Note
If two same waveforms are selected, the system will automatically change one of the
waveform to a different one.
3.4.4 Module Setup
Select the [MODULE SETUP] item in the “SYSTEM SETUP” menu to call up the following
menu:
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System Menu
Figure 3-11 Module Setup
You can choose the parameters to be monitored in this menu. This can avoid the interference
from the parameters that need not attention.
3.4.5 Analog output setup
The monitor can output an analog waveform, whose time delay is less than 30ms. The output
terminal is on the rear panel.
Select “ANALOG” item in “SYSTEM SETUP” menu to call up the ANALOG menu. The first
item is for setting up On/Off of the switch of the analog output. The second item is for
selecting the waveform name to be output.
Select “EXIT” item to return to the previous menu.
Figure 3-12
Analog
3.4.6 Tracing Waveforms Selection
Select the [TRACE SETUP] in the “SYSTEM SETUP” menu to call up the following menu.
Patient Monitor user’s manual (V 2.2)
3-9
System Menu
Figure 3-13 Tracing Waveforms Selection
You can choose the waveform to be displayed in this menu.
3.4.7 Event Setup
The monitor has four types of events. You can specify their representations by yourself.
Select the [MARK EVENT] item in the “SYSTEM SETUP” to call up the following menu:
Figure 3-14
MARK EVENT Menu
How to mark the event: Use the rotary knob to select one from event A, B, C and D. The @
symbol will appear in the frame of the event being selected. Once making a wrong selection,
you can push the knob on the event again to give up the selection. Select [EXIT] to exit the
menu and consequently the selection will come into effect.
Event function has following significance:
To classify the records into different categories, such as those having influence on patients
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System Menu
and those having influence on parameter monitoring including dose taking, injection, therapy
status. Event will be displayed on the trend graph/table in order to assist the analysis on the
patient parameters when the event happens.
3.5
Selection Setup
Select the [SELECTION] item in the “SYSTEM SETUP” to call up the following menu.
Figure 3-15 Selection Setup
Key Volume:
Select the [KEY VOL] item in the “SELECTION” menu. Turn the knob to select the volume.
There are four selections available, which are “OFF, LOW, MED, HIGH”.
Help Function:
The system provides On-line Help to menu operations. You can choose any help information
as per your need. The method is:
Select the [SELECTION] item in the “SYSTEM MENU” to access the “SELECTION”
sub-menu, in which you can highlight the [HELP] item and turn the knob to select “ON” or
“OFF”. When it is “ON”, you can browse the on-line help information. When it is “OFF”, the
system will turn off the on-line help function.
Scan type:
The system can display all waveforms about monitored patient on the screen either in
“Refresh” or “Scroll” way. The method is:
Select “SELECTION” item in “SYSTEM MENU” to access “SELECTION” sub-menu, in which
there is the item “SCAN TYPE”. The user may decide the way to display the waveform by
choosing either “REFRESH” or “SCROLL”.
Alarm Limits:
The system can display the alarm limits. You can choose this function as per your need. The
method is:
Patient Monitor user’s manual (V 2.2)
3-11
System Menu
Select the [SELECTION] in the “SYSTEM MENU” to call up the “SELECTION” menu. You can
set the “ALM LIMIT” switch to “ON” or “OFF”.
Night Mode
You can use the “NIGHT” item to set On/Off of night mode. When “ON” is picked, the monitor
will silence the beep and pulse volume in order to ensure comfortable environment for the
patient.
Select the “SELECTION” item in “SYSTEM SETUP” MENU, “SELECT” menu pops up, in
which the user may set up the “NIGHT” to “ON” or “OFF”. When it is “ON”, the system
automatically adjusts the screen brightness to the “DARK” level (when the system has
brightness adjustment function), and turns off the volume of heart beat and pulse to help
patient sleep. When the system is alarming, the user can not select “NIGHT” mode.
If any parameter alarm is triggered or any operation is executed under the NIGHT mode, night
mode will be automatically shut off.
Brightness
You can user the “BRIGHTNESS” item to select the screen brightness. There are totally 8
options to select.
3.6
Monitor Version
Select the [VERSION] item in the “SYSTEM MENU” to know the software version of the
monitor.
Figure 3-16 Monitor Version
Select the [DEVICE CONFIG LIST] to know the configuration of the monitor.
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System Menu
Figure 3-17 Device Configuration List
3.7
Drug Calculation
You can use the drug calculation and titration table function of PM-6000 to calculate the
concentration of 15 kinds of drugs. Refer to Chapter: Drug Calculation and Titration Table for
detailed information.
3.8
Maintenance
Select the [MAINTAIN] item in the “SYSTEM MENU” to call up the “ENTER MAINTAIN
PASSWORD” dialog box as shown below, in which you can enter password and then
customize maintenance settings. You cannot execute factory maintenance function, which is
only available for the service engineers of MINDRAY company.
Figure 3-18 Enter Maintain Password
Patient Monitor user’s manual (V 2.2)
3-13
System Menu
Input the password into the “ENTER MAINTAIN PASSWORD” box and press [CONFIRM], the
“USER MAINTAIN” menu will pop up, in which you can set up following items.
Figure 3-19 User Maintain
For the [LANGUAGE] language, you can set the screen language to “Chinese” or
“English”.
For the [LEAD NAMING] item, you can select “AHA” or “EURO”. To know the difference
between these two styles, refer to Chapter: ECG/RESP Monitoring.
For the [ALM SOUND] item, you can set the alarm volume to “ON” or “OFF”.
For the [NET TYPE] item, two selections are available: HYPER III and CMS.
For the [LOCAL NET NO] item, it refers to the net No.
SYSTEM KEY SETUP: press this item to access “SYSTEM KEY SETUP” submenu, in
which the user may define the functions of the six extension keys (F1~F6) on the external
keyboard.
The user can define that the extension key has the same function as the button on any of
the modules including the button module (except rotary knob). Pressing this extension is
the same as pressing the corresponding button on the module. All the buttons on all the
modules (not including rotary knob on the button module) are given as the selections for
the extension function, which are not related to whether the corresponding module is
loaded or not.
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Patient Monitor user’s manual (V 2.2)
System Menu
Figure 3-20
SYSTEM KEY SETUP
Warning
When the alarm volume is set to “OFF”, you will not hear the alarm sound if new alarm
occurs. Therefore, you must be very careful in using this selection.
If setting the alarm volume to “OFF” when the system is in Silence or Pause status, the
system will automatically discharge Silence or Pause status.
If you select “Silence” or “Pause” when the alarm volume is set to “OFF”, the system
will restore the alarm volume before the alarm volume is set to “OFF” and enter Silence
or Pause status.
Note
After the alarm volume is set to OFF, a
symbol will appear in the Technical Alarm
Area.
Note
Setting Alarm Volume to “OFF” is valid only when the monitor is turned on for this time.
After turning on the monitor next time, this setup will restore its value of the previous
time when the system is turned on.
COLOR SELF-DEFINE: is used by the user to define the color of the waveform displayed
on the screen. Five colors can be chosen from: green, cyan, red, yellow and white.
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System Menu
Figure 3-21 Color Self-define
3.9
DEMO function
Select the [DEMO] item in the “SYSTEM MENU” to call up the “ENTER DEMO PASSWORD”.
After entering the password, the system enters DEMO status.
The purpose of waveform demonstration is only to demonstrate the machine performance,
and for training purpose. In clinical application, this function is not forbidden because the
DEMO will mislead the medical staff to treat the DEMO waveform and parameter as the
actual data of the patient, which may result in the delay of treatment or mistreatment.
Therefore before entering this menu, you shall enter password.
Figure 3-22 Input Demo Key
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Patient Monitor user’s manual (V 2.2)
Chapter 4
Face Select
This monitor has four different operating screens, which are “Standard Screen”, “Trend
Screen”, “oxyCRG Screen”, and “Viewbed Screen”. When required, you can select
different operating screens for necessary information. Let’s probe into these four
operating screens one by one.
4.1
Select Operating Screen
In the “SYSTEM MENU”, select the “FACE SELECT” option in the “SYSTEM SETUP”
menu to call up the dialog box as shown in the figure below. There are four options in
this dialog, which are “STANDARD SCREEN”, “TREND SCREEN”, “oxyCRG
SCREEN” and “VIEWBED SCREEN”. Only one item can be selected at one time.
Figure 4-1
4.2
FACE SELECT
Standard Screen
In the “FACE SELECT” menu, Select the “STANDARD SCREEN” option to enter the
Standard Screen. The Standard Screen displays to us the parameters in the Parameter
area and the waveforms being monitored. This screen is the basic operating screen of
the monitor.
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4-1
Face Select
Figure 4-2
4.3
STANDARD SCREEN
Trend Screen
Enter TREND SCREEN
In the “FACE SELECT” menu, select the“TREND SCREEN”option to enter the Trend
Screen.
Figure 4-3
TREND SCREEN
Position of trend graph
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Face Select
Trend graph is located to the right of the corresponding waveform in the Waveform
area. Its color is the same as that of the corresponding parameter.
Trend length
Dynamic trend length is 2 hours. On the trend graph, the scale of the right end of the
X-axis is 0 hour while the left end is 2-hour.
Select trend parameter
If multiple parameters are located at the same position on the trend graph, by selecting
the corresponding hot key of a parameter on the trend graph, you can have the trend
graph of this parameter displayed on the screen. For example, in ECG trend graph,
you can select hot keys such as HR, ST or PVCs, then the system will display their
corresponding trend graphs respectively.
Close trend screen
In the “FACE SELECT” menu, select options of other operating screens to close the
Trend Screen.
4.4
oxyCRG Screen
Enter oxyCRG screen
In the “FACE SELECT” menu, select the “oxyCRG SCREEN” to enter the oxyCRG
Screen.
Figure 4-4
oxyCRG SCREEN
Trend graph of oxyCRG screen
Located at the lower part of the screen, oxyCRG screen consists of three trends: HR
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Face Select
Trend, SpO2 Trend and RR Trend or Compressed Resp. Waveform.
Select OxyCRG trend length
Three are three hot keys at the bottom part of the oxyCRG Screen, which are
4MIN/2MIN/1MIN, RR/RESP WAVE, and REC.
By using hot keys for trend time, you may select to display trend graphs of three
different lengths, i.e., 1 min, 2 min and 4 min.
Select RR trend or Compressed Resp. Waveform
By using the hot keys for RR/RESP WAVE, you may select either RR trend graph or
compressed Resp. Wave. They occupy the same position. Therefore, if select “RR”,
the position displays the dynamic trend of RR. If select “RESP WAVE”, the position
displays the compressed Resp. Wave.
Record
Select the “REC” hot key in the “OxyCRG Screen”, you may use the recorder to output
the three waveforms in the oxyCRG at the same time.
Close OxyCRG
In the FACE SELECT menu, select options of other operating screens to close the
OxyCRG Screen.
4.5
Viewbed Screen
If another monitor is connected on the same LAN of this monitor, you can use this
monitor to view any measured waveform and information about all measured
parameters from another monitor.
Enter Viewbed Screen
Select the “VIEWBED SCREEN” option in the “FACE SELECT” menu. Viewbed
Screen window occupies the space of the bottom four waveforms.
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Face Select
Figure 4-5 VIEWBED SCREEN
Hot key of Viewbed
There are two hot keys in the Viewbed Screen: Select Bed Number and Select
Waveform.
The hot key of Select Bed Number displays the bed numbers and patient names of
other monitors currently connected on the LAN. You can select a monitor to be
monitored according to the patient name and bed number. If at this time no other
monitors are connected on the same LAN of this monitor, the hot key of Bed Number
will therefore display “N/A”. After you use this hot key to select a monitor to be viewed,
the system will toggle to the display of the selected monitor for your view. The selected
waveform is one of those listed in the hot key of Select Waveform.
The hot key of Select Waveform is used to select a waveform generated by the
monitor being viewed. If the hot key of Select Waveform displays “N/A”, it indicates that
the bedside monitor being viewed has no waveforms. You can use this hot key to
select and therefore view different waveforms of the monitor being viewed.
Alarm indicator of Viewbed
On the upper right side of the Viewbed Screen, there is an Alarm Indicator used to tell
the alarm status of the monitor being viewed. The activity of this alarm indicator is
identical with that of the alarm lamp on the panel of the monitor being viewed. That is
to say, if the monitor being viewed occurs medium/low level alarm, this alarm indicator
illuminates yellow; if it occurs high level alarm, this alarm indicator illuminates red. If
the monitor being viewed has no alarm or the alarm is screened, the icon for this alarm
indicator will not be displayed.
Parameter area of Viewbed Screen
Under the hot key of Select Bed Number is the Parameter area, in which parameters
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Face Select
of all monitors being viewed are displayed.
Waveform area of Viewbed Screen
Under the hot key of Select Waveform is the Waveform area. The Sweep manner
(refreshing or scrolling) of the waveform is identical with that of this monitor. The
feature description of the displayed waveform is given above the waveform. Sweep
speed is also identical with that set up for the same waveform on this monitor.
Technical Information area
Technical Information area is to the right of patient name in Viewbed Screen. This area
displays related technical information to Viewbed, such as due to network failure or
network too busy, Viewbed is disabled.
Close Viewbed Screen
In the FACE SELECT menu, select options of other operating screens to close the
Viewbed Screen.
Rules for automatically selecting monitor to be viewed and waveform
When you turn on the monitor or enter Viewbed Screen, the system will automatically
select a networked bedside monitor and a waveform of this monitor for you to view. If
the monitor being currently viewed is disconnected, the viewed monitor will
automatically close, clear displays of all alarms, parameters and waveforms. However
in this situation, the Viewbed Screen still displays. If you want to view another monitor,
you must select again through using hot keys.
If a measure module of the viewed monitor is plugged out or closed, its corresponding
waveform will disappear and the waveform in the Waveform area will not be refreshed.
Instead this Waveform area will display empty. At this time, if you want to view other
waveforms of this monitor, you need to select again.
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Chapter 5 Alarm
This chapter gives general information about the alarm and corresponding remedies.
Alarm setup and prompt messages are provided in respective parameter setup sections.
Warning
When the monitor is powered on, the system may verify the audio and visual alarm
function.
Upon turning on the monitor, a “Dang” will be heard and at the same time the indicator
will flash twice in yellow and red. This is used to verify the audio and visual alarm
function of the system. Therefore, the user should be carefully observe the status. If
the audio and visual alarm function is not normal, it indicates that the monitor cannot
be used to monitor a patient. Please contact Mindray company or service center.
5.1 Alarm Modes
5.1.1
Alarm Level
Each alarm, either technical or physiological, has its own level. For alarm of higher level,
when it occurs, the system will give prompt in a more alert way. Some alarm’s level can be set
by the user via software. Others can not by changed once defined by the system. Alarms in
The monitor are divided into three levels, that is, high, medium and low.
High-level alarm indicates the patient’s life is in danger or the monitor under using has serious
problem in technical respect. It is the most serious alarm.
Medium-level alarm means serious warning.
Low-level alarm is a general warning.
Alarms are classified into three categories, which are physiological alarm, technical alarm and
general alarm. Physiological alarm refer to those alarms triggered by patient’s physiological
situation which could be considered dangerous to his or her life, such as heart rate (HR)
exceeding alarm limit (parameter alarms). Technical alarm refer to system failure which can
make certain monitoring process technically impossible or make monitoring result
unbelievable. Technical alarm is also called System Error Message. General alarm belongs to
those situations that can not be categorized into these two cases but still need to pay some
attention.
The monitor has preset the alarm level for the parameters. You can also modify the alarm
level using the method described in this chapter.
Alarm level of the System Error Message (technical alarm) is pre-set in the system.
All technical alarm level and general alarm level, some of the physiological alarm level are
pre-set in the system and can not be changed by user.
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5-1
Alarm
5.1.2
Alarm Modes
When alarm occurs, The monitor may raise the user’s attention in at least three ways, which
are audio prompt, visual prompt and description. Audio and visual prompt is given by the
button module or TFT display device, the speaker on the module (or on the display device)
and the alarm indicator. Description is displayed on the screen. Physiological alarm is
displayed in the Physiological Alarm area. Most of technical alarms are displayed in the
Technical Alarm area. Technical alarms related to NIBP measurement are displayed in the
NIBP Technical Alarm area at the bottom of NIBP parameter area.
Note
The Physiological Alarm area is on the upper right part of the screen. The Technical
Alarm area is to the left side of the Physiological Alarm area.
Note
If the monitor is connected to the external alarm prompt system (e.g. the alarm speaker
and indicator connected onto the rear panel of the monitor), when alarm occurs, the
external alarm prompt system responds in the same way as the button module of the
monitor.
Note
The concrete presentation of each alarm prompt is related to the alarm level.
Alarm prompt of the parameter exceeding the alarm limit.
When physiological alarm of the monitored parameter exceeds the alarm limit, besides using
the above-mentioned three ways to give the alarm prompt, the monitor also gives alarm by
making the monitored parameter flash in the frequency of 1Hz. If at this time the upper and
lower limits of the parameter are displayed, they will flash in the same frequency (1Hz).
Screen Display
When an alarm occurs, the parameter triggering the alarm flashes. “*” signal appears on the
screen indicating the occurrence of alarm. Red “***” indicates high-level alarm, yellow “**”
indicates medium-level alarm, and yellow “*” indicates low-level alarm. Technical alarm will not
prompts “*” signal.
Lamp light
The high/medium/low-level alarms are indicated by the system in following different visual
ways:
Alarm level
High
Medium
Low
Visual prompt
Alarm indicator flashes in red with high frequency.
Alarm indicator flashes in yellow with low frequency.
Alarm indicator lights on in yellow.
Alarm Sound
The high/medium/low-level alarms are indicated by the system in following different audio
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Patient Monitor user’s manual (V 2.2)
Alarm
ways:
Alarm level
High
Medium
Low
Audio prompt
Mode is “DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”, which is
triggered once every 8 seconds.
Mode is “DO-DO-DO”, which is triggered once every 24 seconds.
Mode is “DO-”, which is triggered once every 24 seconds.
Note
When alarms of different levels occur at the same time, the monitor prompts the one of
the highest level.
5.1.3
Alarm Setup
The setup of the alarms can be realized in the alarm menu.
Press the “ALARM SETUP” button on the button module to call up “ALARM SETUP” menu
(default menu) as shown below. In the “ALM SEL” item, the user may set up the information
about common alarm setup (represented by “COMMON ALM SETUP”) and the alarm setup of
each parameter.
Figure 5-1
ALARM SETUP
COMMON ALM SETUP
Select “COMMON ALM SETUP” selection in “ALM SEL” item. This operation may call up the
dialog box as the default one.
ALARM VOL: which has three selections: OFF, LOW, MED and HIGH.
ALM REC TIME: which has three selections: 8S, 16S, 32S.
ALM STOP TIME: refers to the alarm suspension time span, which has three selections:
1MIN, 2MIN, 3MIN.
PARA ALM TYPE: which has two selections: LATCH, UNLATCH. LATCH refers to the
situation once alarm occurs, the system will alarm always until the intervention of the
operator (press PAUSE or SILENCE on the button module). UNLATCH refers to the
situation that once the alarm condition is discharged, the alarm will disappear
automatically.
Alarm setup of each parameter
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5-3
Alarm
In “ALARM SETUP” menu select “ALM SEL” item to set up the alarm information of following
parameters. They are HR, ST, PVC, SPO2, NIBP, IBP (1, 2), RESP, TEMP. For example:
Method to set up alarm information of HR:
Step 1: Select “HR ALM SETUP” in “ALM SEL” item to call up the dialog box “ALARM
SETUP” for HR only.
Step 2: Five items are available for the user to set up, which are HR ALM (on/off of the alarm
switch), ALM LEV(alarm level), ALM REC(alarm recording switch), ALM HI (higher limit of HR
alarm), ALM LO (lower limit of HR alarm). When use the knob to select each item and press
the knob, a pull-down list appears for the user to choose his desired selection.
The method for setting the alarm information of other parameters is the same as HR.
5.2 Alarm verification during power on
During the monitor power on, audible and visual alarm capability will be tested by the system.
Every time when the monitor powers on, alarm beeps “DANG-”, and the LED indicator on
button module or on the display device flashes yellow and red once. If no beeps heard or no
alarm indicator flashing viewed, do not use this device to monitor any patient, and notify
Customer Service Center.
Warning
Always verify the audible and visual alarms when the monitor powers on.
5.3 Alarm Cause
Alarm occurs when:
1.Physiological alarm is evoked;
2. Alarm for error of the system (technical alarm) is evoked;
3. General alert occurs.
Conditions that activate the parameter alarms:
When the measurement value exceeds the alarm limit and the alarm is set “ON”. Alarm will
not activate if the alarm is set “OFF”.
Conditions that activate the system alarms (technical alarm):
Upon the system error, the monitor prompts alarm immediately and proceeds corresponding
remedy, stops all monitoring and eliminates the final results in order to avoid faulted treatment.
If more than one error occur, they will be displayed by turns.
General alert
In some circumstances, alerts will behave as physiological alarm but in normal sense, we
don’t regard them as real patient health related items.
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Alarm
5.4 SILENCE and PAUSE
SILENCE/CLOSE
Push the SILENCE button on the panel for more than 1 second, the system will shut off all
sounds. Push the SILENCE button again, the system can exit the SILENCE status and
accordingly suspend the alarm as per the previously defined time duration. When the system
is in the SILENCE status, any new alarm will terminate the SILENCE status and make the
system restore the normal alarm status.
Note
When the
symbol appears indicating the alarm sound is shut off and
accordingly the system will not give alarm sound. Therefore, you must be very careful
in using this function. There are two methods to terminate this status. One is to set the
alarm volume to “ON” in the MAINTAIN menu. The second method is to push the
PAUSE button shortly to make the
symbol become
; push the PAUSE button
again and the system will restore the normal alarm status again. The third method is to
twice push the PAUSE button , the system will restore the normal alarm status again.
PAUSE
Push the PAUSE button on the panel shortly, the system will shut off all alarm sound and
visual prompt as well as description of physiological alarm, and enter the PAUSE status. The
countdown of PAUSE status is displayed in the Physiological Alarm area, in which area the
symbol is also displayed.
The time duration of the PAUSE status can be set to 1min, 2min or 3min. You can select in
the [ALM PAUSE TIME] item in the “SYSTEM MENU\MAINTAIN”.
After pushing the PAUSE button again, the system will restore the normal status. Besides, the
occurrence of any new technical alarm will also terminate the PAUSE status and let the
system restore the normal status. The
symbol disappears, too.
Note
After the system goes back to the normal status, the existence of alarm depends on
whether the alarm condition is complied with. After pushing the SILENCE button, the
system will permanently shut off the alarm sound for LEAD OFF/SENSOR OFF alarm.
5.5 Parameter Alarm
The setup for parameter alarms is in their menus. In the menu for a specific parameter, you
can check and set the alarm limit, alarm status. The setup is isolated from each other.
When a parameter alarm is off, a symbol “
” displays near the parameter. If the alarms
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5-5
Alarm
are turned off individually, they must be turned on individually.
For the parameters whose alarm is set to ON, the alarm will be triggered when at least one of
them exceeds alarm limit. The following actions take place:
1.
Alarm message displays on the screen as described in alarm mode;
2.
The monitor beeps in its corresponding alarm class and volume;
3.
Alarm lamp flashes;
4.
Store all parameter values during the alarm and 4,8 or 16 second waveform prior to and
after alarm.
5.
If alarm recording is on, the recorder starts alarm recording. For further information on
alarm recording, please refer to Chapter Recording.
5.6 When an Alarm Occurs
Note
When an alarm occurs, you should always check the patient's condition first.
The alarm message appears at the top of the screen on the right side. It is needed to identify
the alarm and act appropriately, according to the cause of the alarm.
1.
Check the patient's condition.
2.
Identify the module in alarm.
3.
Identify the cause of the alarm.
4.
Silence the alarm, if necessary.
5.
When cause of alarm has been over, check that the alarm is working properly.
You will find the alarm messages for the individual parameter in Chapter 12~19 of this
manual.
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Patient Monitor user’s manual (V 2.2)
Chapter 6
Freeze
General
Freeze & Unfreeze
Review & Record Frozen Waveforms
6.1
General
When monitoring a patient, you may freeze the waveforms of interest so as to view
them carefully. Generally you can review maximally 40 seconds of a frozen waveform.
If required, you may also use recorder to print out a frozen waveform. The Freeze
function of this monitor has following features:
Freeze status can be activated on any operating screen;
At the same time of entering the Freeze status, the system exits all other operating
menus. Besides, the system freezes all waveforms in the Waveform area of the Basic
Screen, or Full-lead ECG waveforms and the extra waveform (if available) on the
Full-lead ECG screen. Nevertheless the Parameter area refreshes normally.
In the Freeze status, it does not affect the display and refresh of the Trend Graph
area on the trend screen, the display and refresh of oxyCRG on the Dynamic Refresh
screen, or the display and refresh of the Viewbed window on the Viewbed screen.
The frozen waveforms can be reviewed or recorded.
6.2
Enter/Exit Freeze Status
Enter Freeze Status
In the Non-Freeze status, press the “FREEZE” button on the button module of the
monitor to let the system exit the Menu being currently displayed (if available), then
enter the Freeze status and display the popup “FROZEN” menu. In the Freeze status,
except Viewbed waveforms, all other waveforms are frozen. In other words, the system
will no longer refresh all other waveforms.
Exit Freeze Status
In the Freeze status, executing any of the following operations will command the
system to exit the Freeze status:
Select the “EXIT” option on the “FROZEN” menu;
Press the “FREEZE” button on the button module again;
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Freeze
Press the non-immediate-to-execute button (such as a button once pressed, a
menu will pop up for you to further select an option )on the module and system
buttons of MAIN and MENU;
Plug in/out the module;
Execute any operation that may trigger the adjustment of the screen or display of
a new menu.
After exiting the Freeze status, the system will discharge the Freeze status, clear
screen waveforms and resume to display real-time waveforms. In the Screen Refresh
mode, the system begins scanning waveforms from the extreme left one. In the Screen
Scroll mode, the system begins displaying and scrolling waveforms from the extreme
right one.
6.3
FROZEN Menu
Press the “FREEZE” button on the button module, the FROZEN menu will appear on
the bottom part of the screen. At the same time, the system enters the Freeze status.
Figure 6-1
WAVE 1:
FROZEN menu
used to select the first frozen waveform to record. The
pull-down list of this item gives you the names of all frozen waveforms
displayed on the screen.
WAVE 2:
used to select the second frozen waveform to record. The
pull-down list of this item gives you the names of all waveforms displayed
on the screen.
RECALL:used to review frozen waveforms.
REC: after selected, the system begins recording the frozen waveforms
selected in“WAVE 1” and“WAVE 2”.
EXIT: after pressed, the system closes the FROZEN menu and exits
the Freeze status。
Note
Pressing the “FREEZE” button repeatedly in short time period may result in
discontinuous waveforms on the screen.
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Freeze
6.4
Reviewing Frozen Waveform
By moving the waveform, you may review a waveform of 40 seconds before the
moment when it is frozen. For a waveform less than 40 seconds, the remaining part is
displayed as a straight line. Use the rotary snob on the button module to move the
cursor to the “RECALL” option on the FROZEN menu. Press the knob, the option
displays “L-RIGHT”. By turning the knob left or right, frozen waveforms on the screen
will move left or right correspondingly. There is an arrow indicating upward under the
right side of the last waveform. There is also a time scale beside the arrow. “0S” is
used to mark the moment when waveforms are frozen. With waveforms moving right,
this time mark will in turn change into -1S, -2S, -3S… These time marks are applied to
all waveforms on the screen.
6.5
Recording Frozen Waveform
In the Freeze status, you may output displayed frozen waveforms via the recorder.
Maximum 2 waveforms can be output at one time. On the FROZEN menu, the
pull-down lists of both “WAVE 1” and “WAVE 2” give you all names of frozen
waveforms on the screen, from which you may select two. Select the “REC” option on
the FROZEN menu to output parameters generated upon the freezing moment and the
two selected frozen waveforms. If one of the two selected waveforms is closed or not
available, only parameters and the other waveform are recorded. If these two selected
waveforms are all closed or not available, only parameters are recorded. As for the
function of recording frozen waveforms, you can only record the waveforms displayed
upon the freezing moment. The recording time length is the same as the length of the
waveform displayed on the screen. For example, if the speed of a waveform is
relatively fast, then it needs shorter time to record it. When recording frozen
waveforms, the system is still in the Freeze status. After completion of recording, if
required, you may select once more the waveform to be output and select “REC”
option again to record the whole selected waveforms. You may also record frozen
waveforms by pressing the “REC/STOP” button on the recorder module. If the recorder
does not exist, selecting the “REC” option can only call out the prompt “Recorder does
not exist” in the STATUS bar. For more detailed information about recording, please
refer to the chapter of “Recording”.
Patient Monitor user’s manual (V 2.2)
6-3
Chapter 7 Recording
General information on recording
Instructions for configuring and recording
Recording messages
7.1
General Information on Recording
A thermal dot matrices recorder with 48mm wide printout paper is used for PM-6000 Modular
Patient Monitor.
Performance of the Recorder
Waveform record is printed out at a rate of 25 or 50 mm/s.
It can record up to 2 waveforms.
Output with grid selectable.
English / Chinese printout.
The real time recording time and waveform are user-configurable.
Auto recording interval is set by the user, the waveform is in accordance with the real
time recording.
The alarm recording waveform is automatically selected by the monitor.
7.2
Recording Type
The monitor provides several stripe recording types:
Continuous real-time recording
8 second real-time recording
Auto 8 second recording
Alarm recording
Waveform freeze recording
Trend graph/table recording
ARR events review recording
Alarm event recording
NIBP review recording
CO2 Measurement review recording
AG Measurement review recording
CO Measurement curve recording
Hemodynamic Calculation result recording
Drug Calculation and titration table recording
Monitor information recording
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7-1
Recording
OxyCRG review recording
Real-time Recording
Real-time recording starts as you press the REC/STOP button on the recorder module.
The waveforms for continuous real-time recording and continuous 8 second recording are
automatically set by the monitor (usually the first two waveforms displayed on the screen).
You can also configure it through the menu. Refer to related section for details.
In RECORD menu, the user can choose two waveforms to be printed out. The User can setup
one waveform off. Thus, the real time record will print out one waveform. If two waveforms are
off, the real time record will print out measure parameters only.
Note
If certain recording is in process, and another parameter demands alarm recording, it
will only be executed after the earlier recording is finished.
Auto recording
The monitor starts the recorder for 8 seconds according to interval time set in the “TIMING
REC TIME” of the “RECORDER SETUP” menu. Refer to Charter Recorder Setup for details.
Alarm Recording
1
Parameter Alarm
The monitor records waveforms 4, 8, or 16 seconds prior to and after the alarm (totally 8, 16
or 32 seconds) (which can be selected in System Menu). All parameter values during the
alarm will also be recorded.。
When parameter alarm occurs, two recorded waveforms can be printed out.
In order to avoid repeated printout of alarm waveforms:
■If more than two parameter alarms are switched on and triggered simultaneously, the
recorder will print out those of the highest level. If of the same alarm level, the latest alarm
will be printed out.
■If an alarm occurs during the alarm of another parameter, it will be printed out after the
current recording is finished.
■If many alarms occur at the same time, some of waveforms will be stored for printout in
turn.
2.
ST Segment Alarm
The monitor records 2-channel ECG waveforms 4, 8, or 16 seconds prior to and after the
alarm (totally 8, 16, or 32 seconds) (which can be selected in the ECG SETUP menu). All
parameter values during the alarm will also be recorded.
3.
Arrhythmia Alarm
The monitor records 2-channel ECG waveforms 4 seconds prior to and after the alarm (totally
7-2
Patient Monitor user’s manual (V 2.2)
Recording
8 seconds). All measurement results during the alarm will also be recorded.
Freeze Waveform Recording
The monitor prints out the selected waveforms under the FREEZE mode. In this way you can
snap the abnormal waveforms on the screen and record it.
Trend Graph / Table Recording
The monitor can print out the trend graph and table in the current TREND GRAPH or TREND
TABLE window.
Arrhythmia Review Recording
The monitor can print out the alarm Arrhythmia event in the current ARR RECALL window.
Alarm Review Recording
The monitor can print out the alarm events include waves and parameters in the current
ALARM RECALL window.
NIBP Review Recording
The monitor can print out all the NIBP review events in NIBP RECALL window.
CO Measurement Curve Recording
The monitor can print out CO Measurement curve in WINDOWS FOR CO MEASUREMENT.
Hemodynamic Calculation result recording
The monitor can print out parameters and results in HEMOD WINDOWS.
Monitor Information
The monitor can print out messages in the current STATUS window.
Titration Table
The monitor can print out the messages in the current TITRATION window.
Notes on Recording
Recording texts:
Real time Report
Periodic Report
Para Alarm Report: XXX (name of the alarm parameter)
Arrhythmia Report: XXX (Arrhythmia type)
Freeze Wave Report
Trend Graph
Trend Table
Para Alarm Review
NIBP Test Review
CO Test Curve
HEMOCAL PARAMETERS
Patient Monitor user’s manual (V 2.2)
7-3
Recording
Status Report
Titration Table
Alarm parameters, alarm time and freeze time
Patient bed number, name, sex, height, weight, date of birth, admission date
Parameter name and value
Recording time
Waveform name
Waveform scale (for ECG waveform)
ECG lead, scale, filter mode, (if having ECG waveforms, it will be printed out within the
first second or when changing the lead, gain and filter mode during real-time recording. )
IBP scale (the first second of IBP waveform)
CO2 scale (the first second of CO2 waveform)
Date and time
Company name
7.3
Recording Startup
You can start the recording in the following ways:
Continuous real-time recording Press REC/STOP to start/stop the recording.
8 second real-time recording
Press REC/STOP to start recording. It will automatically
stop in 8 seconds.
Auto recording
Record the two waveforms selected in RECORD menu
according to the setup time interval in RECORD menu.
When alarm recording is set ON, it automatically starts
when alarm occurs.
Alarm recording
Frozen waveform recording
Trend graph recording
---After accessing FREEZE menu, use knob to select two
waveforms to be output. Then press REC button in the
menu to print out the waveforms.
If two waveforms are off, the measure parameters in frozen
are printed out only.
Pick ”REC” button in the “TREND GRAPH” menu when
viewing the trend graph to print out the currently displayed
trend graph.
Trend table recording
Pick ”REC” button in the “TREND TABLE” menu when
viewing the trend table to printout the currently displayed
trend table.
Arrhythmia review recording
Access ARR RECALL window from ARR ANALYSIS of ECG
SETUP menu and Pick ”WAVE” button to access “ARR
WAVE RECALL” menu. Then press “REC” button to output
7-4
Patient Monitor user’s manual (V 2.2)
Recording
the Arr. waveform and related information currently
displayed on the screen.
Access the “ALARM RECALL” window from “ALARM
RECALL CONDITION” menu from “SYSTEM MENU” and
pick “REC” button to print out the alarm review waveform
and related information currently displayed in the “ALARM
RECALL” window.
Alarm review recording
NIBP review recording
Access the “NIBP RECALL” window from “SYSTEM MENU”
and pick “REC” button to print out the NIBP information
currently displayed in the window.
CO measurement curve record
Press the MEASURE button on the CO module to call up
the “WINDOWS FOR CO MEASUREMENT” window.
Pick ”REC” button to print out the CO value and
measurement curve.
Access the MEASURE button on the CO module to call up
the “WINDOWS FOR CO MEASUREMENT” window. Pick
the “EDIT” button in the window to call up the “WINDOWS
FOR C.O. EDIT” window, in which pick the “HEMO
CALCULATE” button to access the “HEMOD WINDOW”
window. Then pick the “REC” button to print out the
calculated result.
Access the “ENTER MAINTAIN PASSWORD” menu from
the “MAINTAIN” menu. Then pick the “STATUS” button to
access the ‘’STATUS” window. Pick “REC” button to print
out the status monitor information currently displayed in the
window.
Hemodynamic
result recording
Calculation
Monitor information recording
Titration table recording
Access the “DRUG CALC” menu from the “SYSTEM
MENU” menu. Pick the “TITRATION” button in the menu to
access the “TITRATION” window. Pick the “REC” button to
print out the titration currently displayed in the window.
OxyCRG recording
In oxyCRG screen, pick the “REC” button to print out the
oxyCRG currently displayed in the window.
Note
You can press REC/STOP button on the recorder module to stop the current recording
process.
Access the “RECORD” menu from the “SYSTEM SETUP” menu. Then pick the “CLEAR REC
TASK” button to stop all recording tasks.
7.4
Recorder Operations and Status Messages
Record Paper Requirement
Only standard 50 (+0/-1) mm thermosensitive record paper can be used, otherwise the
recorder may not function, the recording quality may be poor, and the thermosensitive
printhead may be damaged.
Patient Monitor user’s manual (V 2.2)
7-5
Recording
Function Properly
■
When the recorder is working, the record paper goes out steadily. Do not pull the paper,
or the recorder will be damaged.
■
Do not operate the recorder without record paper.
Paper Out
When "RECORDER OUT OF PAPER" alarm is displayed, the recorder cannot start. Please
insert record paper properly.
Inserting Paper
■
Open the recorder catch.
■
Pull down the switch on the left axis of the recorder.
■
Insert a new roll of paper into the paper cassette, printing side facing the thermosensitive
printhead.
■
When the paper can be seen from the other side, pull it out. Ensure proper position and
tidy margin.
■
Pull back the switch on the left axis of the recorder.
■
Give out the paper from the recorder outlet.
■
Close the recorder catch.
Note
Be careful when inserting paper. Avoid damaging the thermosensitive printhead.
Unless when inserting paper or shooting troubles, do not leave the recorder catch
open.
Removing Paper Jam
When the recorder functions or sounds improperly, open the recorder catch to check for a
paper jam. Removing the paper jam in the following way:
■
Cut the record paper from the feeding edge.
■
Pull up the switch on the left axis of the recorder.
■
Pull the paper from below.
■
Re-insert the paper.
Recorder Status Message (Technical Alarms)
Message
RECORDER
HOT
Cause
HEAD
REC HEAD IN
WRONG POS.
RECORDER OUT OF
PAPER
7-6
Alarm
Level
Remedy
The thermal terminal is
too hot.
low
The thermal head is not
in recording place.
low
Push down the switch on
the left axis of the
recorder.
low
Insert a new
record paper.
Record paper runs out.
Patient Monitor user’s manual (V 2.2)
Stop operation
roll
of
Recording
RECORDER COMM
ERR
RECORDER PAPER
JAM
RECORDER
INITIALIZING
Operating status error
low
Recording continuously for
more than 30m
The recorder is
initialization process.
in
low
Reset the recorder.
Re-insert paper.
low
Wait for the completion
of initialization
TOO MANY REC
TASKS
Too many alarm events
take place simultaneously.
Low
Send recording
after a while.
RECORDER PAPER
W.P.
The paper is in wrong
position.
low
Insert the record paper
again.
low
Wait for the completion
of printing out
Low
Gives recording order
after
the
recorder
restores to the normal
status or the failure is
removed.
Low
Stop recording until the
recorder restores normal
status.
Low
Stop recording until the
recorder restores normal
status.
Shut down the monitor
and re-start it again.
RECORDER BUSY
In the status of printing out
Recorder stops working.
REC NOT AVAILABLE
The voltage of
recorder is too high.
the
The voltage of
recorder is too low.
the
RECORDER VLT LOW
RECORDER S. COMM
ERR
Unrecoverable serial port
communication error.
Low
RECORDER
SELFTEST ERR
Possibly caused by the
RAM, ROM, CPU or
WATCHDOG.
Low
RECORDER VLT
HIGH
RECORDER INIT ERR
Error
occurs
initialization
during
RECORDER INIT
ERR1
Error
occurs
initialization
during
RECORDER INIT
ERR2
Error
occurs
initialization
during
RECORDER INIT
ERR3
Error
occurs
initialization
during
RECORDER INIT
ERR4
Error
occurs
initialization
during
RECORDER INIT
ERR7
Error
occurs
initialization
during
RECORDER INIT
ERR8
Error
occurs
initialization
during
order
Reset the recorder.
low
low
low
low
low
low
low
Shutdown and re-start
Shutdown and re-start
Shutdown and re-start
Shutdown and re-start
Shutdown and re-start
Shutdown and re-start
Shutdown and re-start
If after shutdown and re-start, error still exists, contact out service engineers.
Patient Monitor user’s manual (V 2.2)
7-7
Chapter 8
Trend and Event
The monitor provides 72-hour trend data of all parameters, storage of 400 NIBP measurement
results and 60 alarm events. This chapter gives detailed instruction for review of all data.
8.1
Trend Graph
■
The latest 1-hour trend is displayed every 1 or 5 seconds;
■
The latest 72-hour trend is displayed every 1, 5 or 10 minutes;
Pick "TREND GRAPH" in the SYSTEM MENU to call up the following menu:
Figure 8-1
TREND GRAPH Menu
The uppermost part is the name of the parameter, in which y-axis stands for value and x-axis
time. "
" Indicates the value of the parameter, which it points to, is below the x-axis, with
corresponding time displayed beyond the trend graph. Other trends except NIBP trend are
displayed as continuous curves. In NIBP trend graph, "σ" indicates systolic value, "τ" indicates
diastolic value, and "*" indicates mean value.
To select trend graph of a specific parameter:
Pick PARA SELECT item (the first selection of the upper line) and select a requested
parameter name by turning the knob.
To select 1-hour or 72-hour trend graph:
Pick RESOLUTION item (the latter selection of the upper line), choose 1 or 5 sec for 1-hour
trend graph and 1, 5 or 10 min for 72-hour trend graph.
Patient Monitor user’s manual (V 2.2)
8-1
Trend and Event
To view other trend curves:
When "
" appears on the right part of the screen, pick "L-RIGHT" (the button at the
extreme left of the lower line), turn the knob clockwise to view later trend curves. When "
" appears on the left part of the screen, pick the same item, turn the knob counterclockwise to
view earlier trend curve.
To change the display scale
Pick the “ZOOM” button in the lower line to adjust the y-axis scale and thus change the trend
curve in proportion. The value beyond maximum value will be represented by the maximum
value.
To obtain trend data of a specific time
The time to which the cursor points will change as the knob is turned. Parameter at this time
is displayed below the x-axis. When "
" appears on the right part of the screen, the trend
graph pages down for later trend curve as the cursor moves here. When "
" appears on
the left part of the screen, the trend graph pages up for earlier trend curve as the cursor
moves here.
To print out the trend curve
Press REC button to print out the trend curve of current selected parameter.
Mark event
If an event is marked A, B, C, or D, then the corresponding event type will display on the axis
time of the trend graph. The event sign (A, B, C or D) is displayed in a frame.
Operation example
To view the NIBP trend graph of the last 1 hour:
Press the MENU button on the button module.
Pick TREND GRAPH item.
Pick the first item and switch to NIBP by turning the knob.
Adjust the second item to be 1 or 5 sec.
Pick the ZOOM button and turn the knob to view changes of the trend graph time and
trend curve.
Stop at requested trend time section for careful review. Pick the ZOOM button to adjust
the display scale if necessary.
For measurement result of a specific time, pick CURSOR to move the cursor to the point,
corresponding time and value will display on above and below respectively.
For printout of trend graph, pick REC to start report printing of NIBP trend of this hour.
Pick EXIT to return to trend graph display.
8-2
Patient Monitor user’s manual (V 2.2)
Trend and Event
8.2
Trend Table
The latest 72-trend table data can be displayed at every 1, 5, 10, 30, or 60 minutes.
Pick TREND TABLE in the SYSTEM MENU to call up the following menu:
Figure 8-2
TREND_TABLE Menu
Time in response to each group of trend data is displayed at the leftmost list with date in
bracket. Marked event corresponds to marking time. Trend data of each parameter is divided
into 9 groups.
HR, RR, PVC
ST1, ST2
TEMP1, TEMP2, TEMPD
SPO2, PR
NIBP NS/ND (NM)
IBP1 (S/D/M), IBP2 (S/D/M)
IBP3 (S/D/M), IBP4 (S/D/M)
CO2, INS, AwRR
TB
NIBP trend data presents different specificity. A certain NIBP measuring time is displayed
below the TEST AT item, as well as the measurement value. For more than one measurement
in one time, it can display only one group, and mark a "*" on the MORE to indicate two and
above measurement results.
To choose trend table of different resolution
Pick the leftmost item and change the time interval of trend data.
Patient Monitor user’s manual (V 2.2)
8-3
Trend and Event
To view other trend data:
When "
" appears on the upper part of the screen, pick UP-DOWN button and turn the
knob clockwise to view later trend data. When "
" appears on the lower part of the screen,
pick the same item and turn the knob counterclockwise to view earlier trend data.
To obtain trend data of different parameter
Pick L-RIGHT to select one from the 9 groups of parameters. A ">" by the rightmost item
indicates following page available. And "<" by the leftmost item indicated previous page
available.
To print out the trend data
Pick REC to print out the trend data of current displayed parameter.
Mark event
If an event is marked A, B, C, or D, the corresponding event type will display on the axis time
of the trend table.
Operation example
To view a NIBP trend table:
■
Press MENU button on the button module to access “SYSTEM MENU”.
■
Pick TREND TABLE.
Pick L-RIGHT and switch to NIBP by turning the knob.
Pick the first item from the left and select requested time interval.
Pick UP-DOWN and turn the knob to view NIBP trend data of different time.
For printout of trend table, pick REC to start report printing of all trend data including
NIBP of this time span.
■
Pick EXIT to return to SYSTEM MENU.
8.3
NIBP Recall
The monitor can review the latest 400 NIBP measurement data.
Pick NIBP RECALL in the SYSTEM MENU to invoke the result and time of the latest 10
measurements, as shown in the figure below.
8-4
Patient Monitor user’s manual (V 2.2)
Trend and Event
Figure 8-3
NIBP RECALL
Data is listed chronologically from the latest to the earliest. 10 measurements can be
displayed in one screen. Pick UP-DOWN to view other trend curve up to 400 results. Pick
REC to print out all measurement data of NIBP RECALL.
8.4
Alarm Event Recall
PM-6000 can display the latest 60 alarm events.
Select “ALARM RECALL” in the SYSTEM MENU to access ALARM RECALL
CONDITION menu as shown below.
Figure 8-4
ALARM RECALL CONDITION Menu
In this menu, the user may select the conditions for alarm review, including:
Patient Monitor user’s manual (V 2.2)
8-5
Trend and Event
1.
Start and End time of review:
The user may select the start time of review in the item of START.
Then the user may select the end time of review. Two selections are available: current
time and the user-defined time.
For user-defined end time, the user can use the knob to select.
2.
ALARM RECALL EVENT
In the pull-down list of ALARM RECALL EVENT, the user can select the parameter
whose alarm events he wants to review. The selections include ALL(alarm events of all
parameters), ECG, REST, SPO2, NIBP, IBP, TEMP, CO2, CO, HR_H>180(the value of
HR is higher than the upper alarm limit), HR_L<60(the value of HR is below the lower
alarm limit), SPO2<90%, IBP_H>200mmHg, IBP_L<40mmHg, RR_H>40, RR_L<10,
TEMP_H>40℃, TEMP_L<34℃.
After setting up all the review conditions, press the “ALARM RECALL” button to access
“ALARM RECALL” window.
ALARM RECALL
The ALARM RECALL window is as shown below, in which following data are displayed:
① Time span (Format: month-day-year hour: minute- month-day-year hour: minute).
② Event type.
③ Serial number (Format: NO. xx of XX ).
④ The value at the time of alarm. NIBP result is with time.
⑤ Two 8/16/32-second waveforms.
①
②
③
④
⑤
Figure 8-5
ALARM RECALL Menu
To view all waveforms during the alarming process
Pick L-RIGHT and turn the knob to view all 8/16/32-second waveforms stored.
8-6
Patient Monitor user’s manual (V 2.2)
Trend and Event
To view other alarm events
Events of up to 60 are listed chronologically from the latest to the earliest. Pick UP-DOWN
button and turn the knob to view later or earlier events.
Recording
Pick REC to print our all data and waveform of this event.
8.5
Power-off data storage (optional)
PM-6000 has the function to store the data after power-off. Once power-off accident happens,
the PM-6000 can save the 72-hour trend data, the latest 400 NIBP data, the latest 60 alarm
events and latest 60 Arr. events. That means even power-off accident takes place, these data
can be safely saved. And after the monitor is turned on next time, the user can view all saved
data via menus including Trend Graph, Trend Table, NIBP Recall, Alarm Recall, and Arr.
Recall, etc.
Note
If the user executes New Patient operation, all measured data and trends will be
cleared.
Warning
When monitoring a new patient, the new measured data will be saved together with the
measured data of the previous patient. To save appropriate data, please execute New
Patient operation.
Patient Monitor user’s manual (V 2.2)
8-7
Chapter 9 Drug
Titration Table
Calculation
and
PM-6000 Modular Patient Monitor provides Drug calculation and titration table display
functions for fifteen drugs and outputs the content of titration table on the recorder.
9.1 Drug Calculation
The drug calculations that can be performed by the system are AMINOPHYLLINE,
DOBUTAMINE, DOPAMINE, EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE,
NITROGLYCERIN and PITOCIN. Besides DRUG A, DRUG B, DRUG C, DRUG D and DRUG
E are also provided to flexibly replace any of the drugs.
Select “DRUG CALC” in SYSTEM MENU, the following “DRUG CALC” display appears:
Figure 9-1
DRUG CALC
The following formulas are applied for dose calculation:
Concentrat
= Amount / Volume
INF Rate
=DOSE/Concentrat
Duration
Dose
= Amount / Dose
= Rate × Concentrat
Operating method:
In the Drug Calculation window, the operator should first select the name of the drug to be
Patient Monitor user’s manual (V 2.2)
9-1
Drug Calculation and Titration Table
calculated, and then confirm the patient weight. Afterwards, the operator should also enter
other known values.
Turn the knob to select the value of the item to be calculated. Turn the knob to change the
value. When it is the required value, press the knob to view the calculation result. Each item
has its calculation range. If the result exceeds the range, display “---.--”
Note
For the drug calculation, the prerequisite is that the operator must first of all enter the
patient weight and drug name. The system first gives a group of random initial values,
which cannot be used by the operator as the calculation reference. Instead, he should
enter a new group of values at the doctor’s instruction.
Note
Each drug has its fixed unit or unit series. Operator must select the proper unit at the
doctor’s instruction. If the result exceeds the system-defined range, it will display “---”.
Note
After entering a value, a conspicuous prompt will appear in the menu warning the
operator to confirm the correctness of the entered value. The correct value is the
guarantee for the reliability and safety of the calculated results.
Note
In neonate mode, Drip Rate and Drop Size items are disabled.
Note
For each entered value, the system will always give a dialog box asking for the user’s
confirmation. You must be careful when answering each box. The calculated result is
reliable only after the entered value is confirmed to be correct.
Select the drug name:
Turn the knob to pick the DRUG NAME item in DRUG CALC menu. The user may select the
drug name in the pull-down list, including AMINOPHYLLINE、DOBUTAMINE、DOPAMINE、
EPINEPHRINE、HEPARIN、ISUPREL、LIDOCAINE、NIPRIDE、NITROGLYCERIN、PITOCIN、
Drug A、Drug B、Drug C、Drug D and Drug E. Calculation for only one type can be generated
each time.
NOTE: A、B、C、D、E are only codes for drugs instead of their real names. The units for these
five drugs are fixed. The operator may select the appropriate units according to the
convention of using these drugs. The rules for expressing the units are:
“mg” series units are fixedly used for drug A, B and C: g, mg, mcg.
“unit” series units are fixedly used for drug D: unit, k unit, m unit.
“mEq” is fixedly used for drug E.
9-2
Patient Monitor user’s manual (V 2.2)
Drug Calculation and Titration Table
Patient weight:
After accessing the DRUG CALC window, the operator should enter the patient weight into
the first or the second item. The entered weight will be used as the independent data only for
the calculation of drug concentration.
Note
This drug calculation function acts only as a calculator. That means the patient weight
in Drug Calculation menu and the patient weight in Patient Information menu are
independent from each other. Therefore if the Weight in Drug Calculation changes, the
Weight in Patient Information does not change. In this way, we can say, the Drug
Calculation menu is independent from other menus in the system. Any change of it will
not affect other information about the patient being currently monitored.
9.2 Titration Table
Access titration table:
Select TITRATION item in DRUG CALC menu to enter titration table display.
Titration table display for drug is as following:
Figure 9-2
TITRATION
Method to operate the titration table:
1.
In the TITRATION table, turn the knob to pick BASIC item. Press and turn the knob to
select either FLOW RATE or DOSE or DROP RATE.
2.
Then turn the knob to pick STEP item. Press and turn the knob to select step. 1 ~ 10 are
available for selection with the increment being 1.
Patient Monitor user’s manual (V 2.2)
9-3
Drug Calculation and Titration Table
3.
Turn the knob to pick DOSE TYPE item. Press and turn the knob to select the unit in the
pull-down list.
4.
Use UP-DOWN item in the table to view the data in previous or following pages.
5.
Turn the knob to pick REC item. After pressing the knob, the recorder prints out the data
displayed in the current titration table.
6.
Turn the knob to pick EXIT to return to DRUG CALC menu.
Total amount, dose, volume, flow-rate, drop rate and patient weight and drug name are
displayed on the top of the titration table. Meaning of each English identifier is:
AMOUNT:drug amount
VOLUME:liquid volume
DOSE/min:drug dose
FLOW RATE:flow rate
DROP RATE:drop rate
WEIGHT:patient weight
9-4
Patient Monitor user’s manual (V 2.2)
Chapter 10 Patient Safety
The PM-6000 Modular Patient Monitor is designed to comply with the International National
Safety requirements for medical electrical equipment. This device has floating inputs and is
protected against the effects of defibrillation and electrosurgery. If the correct electrodes are
used and applied in accordance with the manufacturer instructions, the screen display will
recover within 10 seconds after defibrillation.
This symbol indicates that the instrument is IEC60601-1 Type CF equipment. The unit
displaying this symbol contains an F-Type isolated (floating) patient applied part providing a
high degree of protection against shock, and is suitable for use during defibrillation.
Warning
Do not touch the patient, bed or instrument during defibrillation.
Environment
Follow the instructions below to ensure a completely safe electrical installation. The
environment where the PM-6000 Modular Patient Monitor will be used should be reasonably
free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and
so on. For a cabinet mounted installation, allow sufficient room at the front for operation and
sufficient room at the rear for servicing with the cabinet access door open.
The PM-6000 Modular Patient Monitor operates within specifications at ambient temperatures
between 0℃ and 40℃, approximately 15 minutes after switch on. Ambient temperatures that
exceed these limits could affect the accuracy of the instrument and cause damage to the
modules and circuits. Allow at least 2 inches (5cms) clearance around the instrument for
proper air circulation.
Power Source Requirements
Refer to Appendix Ⅱ Production Specification.
Grounding the PM-6000 Modular Patient Monitor
To protect the patient and hospital personnel, the cabinet of the PM-6000 Modular Patient
Monitor must be grounded. Accordingly, the PM-6000 Modular Patient Monitor is equipped
with a detachable 3-wire cable which grounds the instrument to the power line ground
(protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is
not available, consult the hospital electrician. If completeness of the protective grounding wire
Patient Monitor user’s manual (V 2.2)
10-1
Patient Safety
is in doubt, the equipment must be operated with internal power supply.
Warning
Do not use a 3-wire to 2-wire adapter with this instrument.
Connect the grounding wire to the equipotential grounding terminal on the main system. If it is
not evident from the instrument specifications whether a particular instrument combination is
hazardous or not, for example due to summation of leakage currents, the user should consult
the manufacturers concerned or else an expert in the field, to ensure that the necessary
safety of all instruments concerned will not be impaired by the proposed combination.
Equipotential Grounding
Protection class 1 instruments are already included in the protective grounding (protective
earth) system of the room by way of grounding contacts in the power plug. For internal
examinations on the heart or the brain, the PM-6000 Modular Patient Monitor must have a
separate connection to the equipotential grounding system. One end of the equipotential
grounding cable (potential equalization conductor) is connected to the equipotential grounding
terminal on the instrument rear panel and the other end to one point of the equipotential
grounding system. The equipotential grounding system assumes the safety function of the
protective grounding conductor if ever there is a break in the protective grounding system.
Examinations in or on the heart (or brain) should only be carried out in medically used rooms
incorporating an equipotential grounding system. Check each time before use that the
instrument is in perfect working order. The cable connecting the patient to the instrument must
be free of electrolyte.
Warning
If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by inner power only.
Condensation
Make sure that during operation, the instrument is free of condensation. Condensation can
form when equipment is moved from one building to another, thus being exposed to moisture
and differences in temperature.
Warning
Possible explosion hazard if used in the presence of flammable anesthetics.
Explanation of Symbols in the Monitor
This symbol means 'BE CAREFUL '. Refer to the manual..
10-2
Patient Monitor user’s manual (V 2.2)
Patient Safety
This symbol indicates that the instrument is IEC60601-1 Type CF equipment. The unit
displaying this symbol contains an F-Type isolated (floating) patient applied part providing a
high degree of protection against shock, and is suitable for use during defibrillation.
Equipotential grounding system.
Protective earth ground.
Power on
Power off
This item is compliant with Medical Device Directive 93/42/EEC of 14 June 1993, a directive
of the European Economic Community.
Patient Monitor user’s manual (V 2.2)
10-3
Chapter 11 Care / Cleaning
11.1 System Check
Before using the monitor, do the following:
■
check if there is any mechanical damage;
■
check all the outer cables, inserted modules and accessories;
■
check all the functions of the monitor to make sure that the monitor is in good condition.
If you find any damage on the monitor, stop using the monitor on patient, and contact the
biomedical engineer of the hospital or Mindray Customer Service immediately.
The overall check of the monitor, including the safety check, should be performed only by
qualified personnel once every 6 to 12 month, and each time after fix up.
You should check the synchronism of the defibrillator in the frequency described in the
hospital regulations. At least every 3 months, it should be checked by a qualified customer
service technician.
All the checks that need to open the monitor should be performed by qualified customer
service technician. The safety and maintenance check can be conducted by persons from
Mindray. You can obtain the material about the customer service contract from the local
Mindray office.
Warning
If the hospital or agency that is responding to using the monitor does not follow a
satisfactory maintenance schedule, the monitor may become invalid, and the human
health may be endangered.
Note
To ensure maximum battery life, it is recommended that, at least once a month, the
monitor be run on battery until it turns itself off and then recharged.
Warning
Refer the battery replacement only to Mindray service technician.
11.2 General Cleaning
Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched
off and disconnected from the power line.
Patient Monitor user’s manual (V 2.2)
11-1
Care / Cleaning
The PM-6000 Modular Monitor must be kept dust-free.
Regular cleaning of the monitor shell and the screen is strongly recommended. Use only
non-caustic detergents such as soap and water to clean the monitor shell.
Note
Please pay special attention to the following items:
1.
Avoid using ammonia-based or acetone-based cleaners such as acetone.
2.
Most cleaning agents must be diluted before use. Follow the manufacturer's
directions carefully to avoid damaging the monitor.
3.
Don't use the grinding material, such as steel wool etc.
4.
Don't let the cleaning agent enter into the chassis of the system.
5.
Don't leave the cleaning agents at any part of the equipment.
11.3 Cleaning Agents
Examples of disinfectants that can be used on the instrument casing are listed below:
■
Diluted Ammonia Water
■
Diluted Sodium Hyoichlo (Bleaching agent).
Note
The diluted sodium hyoichlo from 500ppm(1:100 diluted bleaching agent) to 5000ppm
(1:10 bleaching agents) is very effective. The concentration of the diluted sodium
hyocihlo depends on how many organisms (blood, mucus) on the surface of the
chassis to be cleaned.
■
Diluted Formaldehyde 35% -- 37%
■
Hydrogen Peroxide 3%
■
Alcohol
■
Isopropanol
Note
PM-6000 monitor and sensor surface can be cleaned with hospital-grade ethanol and
dried in air or with crisp and clean cloth.
Note
Mindray has no responsibility for the effectiveness of controlling infectious disease
using these chemical agents. Please contact infectious disease experts in your
hospital for details.
11-2
Patient Monitor user’s manual (V 2.2)
Care / Cleaning
11.4 Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when
stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities should
be cleaned first.
Recommended sterilization material: Ethylate, and Acetaldehyde.
Appropriate sterilization materials for ECG lead, blood pressure cuff are introduced in
Chapter ECG/RESP Monitoring, Chapter NIBP Monitoring respectively.
Caution
Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest
possible density.
Do not let liquid enter the monitor.
No part of this monitor can be subjected to immersion in liquid.
Do not pour liquid onto the monitor during sterilization.
Use a moistened cloth to wipe up any agent remained on the monitor.
11.5 Disinfection
To avoid extended damage to the equipment, disinfection is only recommended when
stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities should
be cleaned first.
Appropriate disinfection materials for ECG lead, SpO2 sensor, blood pressure cuff, TEMP
probe, IBP sensor and CO cable are introduced in Chapters 12~17 respectively.
Caution
Do not use EtO gas or formaldehyde to disinfect the monitor.
Patient Monitor user’s manual (V 2.2)
11-3
Chapter 12 ECG/RESP Monitoring
12.1 What Is ECG Monitoring
Monitoring the ECG produces a continuous waveform of the patient's cardiac electric activity
to enable an accurate assessment of his current physiological state. Only proper connection
of the ECG cables can ensure satisfactory measurement. On the Normal Display, PM-6000
provides display of 2-channel ECG waveforms.
■
The patient cable consists of 2 parts ;
The cable that connects to the monitor;
The lead set that connects to the patient.
■
Using a 5-lead set, the ECG can derive up to two waveforms from two different leads.
For requested lead, you may choose from the left side of ECG waveform.
■
The monitor displays the Heart Rate (HR), ST segment and Arrhythmia analysis.
■
All of the parameters above can be set as alarm parameters.
Note
In the default settings of PM-6000, the ECG waveforms are the first two waveforms
from top in the Waveform Area.
12.2 ECG/TEMP Module
ECG/TEMP module is a standard module incorporating functions of ECG, RESP and TEMP
monitoring. For TEMP monitoring, refer to Chapter 15.
①
③
②
④
⑤
⑦
⑥
Figure 12-1
ECG/TEMP module
Patient Monitor user’s manual (V 2.2)
12-1
ECG/RESP Monitoring
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the module
communicates with the host system triumphantly. If the indicator is still flashing, it
means that the ECG/TEMP module or the slot has failure. In this case, the operator
should re-load the module. If the failure still exists, please contact the Mindray service
engineer for repair.
② SETUP:the button used to set up the related items of ECG/REST/TEMP. Press SETUP
button, the ECG/RESP/TEMP SETUP menu appears on the screen. The user may modify
any item in the menu through using the rotary knob on the control panel.
③ Blank Button
④ Two sockets for TEMP sensor: Before monitoring the patient, the user should first safely
insert the TEMP sensor cable into this socket.
⑤ A socket for ECG :Befor monitoring the patient, the user should first safely insert the ECG
lead cable into this socket.
means “BE CAREFUL“. Refer to the attached document (this manual) of the
⑥
monitor.
means that the ECG/TEMP module is IEC 60601-1 Type CF equipment.
⑦
Note
When not using the ECG/TEMP module to monitor the patient, the user may unload the
module, which however must be stored in a clean and dry environment, otherwise the
life cycle of the module will be unfavorably affected.
Press “SETUP” button, the ECG/RESP/TEMP SETUP appears on the screen. Then the user
may access the setup menu respectively for ECG, RESP or TEMP through using the rotary
knob on the control panel.
Figure 12-2
12-2
ECG/RESP/TEMP SETUP menu
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
12.3 Precautions during ECG Monitoring
Warning
Do not touch the patient, table nearby, or the equipment during defibrillation.
Warning
Use only the original PM-6000 ECG cable for monitoring.
Warning
When connecting the cables and electrodes, make sure no conductive part is in
contact with the ground. Verify that all ECG electrodes, including neutral electrodes,
are securely attached to the patient.
Warning
When apply the ECG cable with no resistances to Mindray patient monitor or other
patient monitors which themselves with no current limit resistance, it can’t be applied
to defibrillation.
Note
Interference from a non-grounded instrument near the patient and ESU interference
can cause inaccuracy of the waveform.
12.4 Monitoring Procedure
12.4.1
1.
Preparation
Prepare the patient's skin prior to placing the electrodes.
■
The skin is a poor conductor of electricity, therefore preparation of the patient's skin
is important to facilitate good electrode contact to skin.
■
Shave hair from sites, if necessary.
■
Wash sites thoroughly with soap and water. (Never use ether or pure alcohol,
because this increases skin impedance).
■
Rub the skin briskly to increase capillary blood flow in the tissues and remove skin
scurf and grease.
2.
Attach clip or snap to electrodes prior to placement.
3.
Put the electrodes on the patient. Before attaching, apply some conductive jelly on the
electrodes if the electrodes are not electrolyte self-supplied.
4.
Connect the electrode lead to the patient's cable.
5.
Make sure the monitor is ready with power supply.
Warning
Patient Monitor user’s manual (V 2.2)
12-3
ECG/RESP Monitoring
Check everyday whether there is skin irritation resulted from the ECG electrodes. If so,
replace electrodes every 24 hours or change their sites.
Note
For protecting environment, the electrodes must be recycled or disposed of properly.
Warning
Verify lead fault detection prior to the start of monitoring phase. Unplug the ECG cable
from the socket, the screen will display the error message “ECG LEAD OFF” and the
audible alarm is activated.
12.4.2
Installing ECG lead
Placing the Electrodes for ECG Monitoring
Electrode placement for 5-lead set (Figure 12-3)
■
Red (R) electrode - Be placed near the right shoulder, directly below the clavicle.
■
Yellow (L) electrode - Be placed near the left shoulder, directly below the clavicle.
■
Black (N) electrode - Be placed on the right hypogastrium.
■
Green (F) electrode - Be placed on the left hypogastrium.
■
White (C) electrode - Be placed on the chest as illustrated in the F Figure 12-4
Note: the following table gives the corresponding lead names used in Europe and America
respectively. (Lead names are represented by R, L, N, F and C respectively in Europe, whose
corresponding lead names in America are RA, LA, RL, LL and V.)
America
12-4
Euro
Lead names
color
Lead names
color
RA
White
R
Red
LA
Black
L
Yellow
LL
Red
F
Green
RL
Green
N
Black
V
brown
C
White
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
Figure 12-3
Electrode placement for 5-lead set
Note
To ensure patient safety, all leads must be attached to the patient.
For 12-lead set, attach the C-electrode to one of the indicated positions as below (Figure
12-4):
■
V1
On the 4th intercostal space at the right sterna margin.
■
V2
On the 4th intercostal space at the left sterna margin.
■
V3
Midway between V2 and V4 electrodes.
■
V4
On the 5th intercostal space at the left clavicular line.
■
V5
On the left anterior axillary line, horizontal with V4 electrode.
■
V6
On the left middle axillary line, horizontal with V4 electrode.
■
V3R-V7R
On the right side of the chest in positions corresponding to those on the
left.
■
VE
Over the xiphoid position.
■
V7
On the 5th intercostal space at the left posterior axillary line of back.
■
V7R
On the 5th intercostal space at the right posterior axillary line of back.
Patient Monitor user’s manual (V 2.2)
12-5
ECG/RESP Monitoring
Figure 12-4
C-electrode placement for 5-lead set
Recommended ECG Lead Placement for Surgical Patients
Warning
When using Electrosurgery equipment, leads should be placed in a position in equal
distance from Electrosurgery electrotome and the grounding plate to avoid cautery.
Electrosurgery equipment wire and ECG cable must not be tangled up.
The placing of the ECG leads will depend on the type of surgery that is being performed. For
example, with open chest surgery the electrodes may be placed laterally on the chest or on
the back. In the operating room, artifacts can sometimes affect the ECG waveform due to the
use of ES (Electrosurgery) equipment. To help reduce this you can place the electrodes on
the right and left shoulders, the right and left sides near the stomach, and the chest lead on
the left side at mid-chest. Avoid placing the electrodes on the upper arms, otherwise the ECG
waveform will be too small.
Warning
When using Electrosurgery equipment, never place an electrode near the grounding
plate of the Electrosurgery device, otherwise there will be a great deal of interference
with the ECG signal.
■
Using 5-lead ECG set
The default setting is ECG CH1 corresponding to Channel II, and ECG CH2 to Channel I,
you can modify the setting to meet your needs. You can set them to correspond to any
two from I, II, III, AVR, AVL, AVF and V. If you set both to the same value, one of them will
be adjusted to another option automatically. (Figure 12-5)
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Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
Figure 12-5
ECG lead
Note
If a ECG waveform is not accurate, while the electrodes are tightly attached, try to
change the lead.
Note
Interference from a non-grounded instrument near the patient and ESU interference
can cause inaccuracy of the waveform.
Normal QRS complex should be:
Tall and narrow with no notches.
With tall R-wave completely above or below the baseline.
With pacer spike no higher than R-wave height.
With T-wave less than one-third of the R-wave height.
With P-wave much smaller than the T-wave.
For getting 1 mv calibrated ECG wave, choose ECG CAL button in ECG SETUP -> OTHER
SETUP menu. A message "when CAL, can't monitor! " prompts on the screen.
R
T
P
Q
Figure 12-6
S
Standard ECG Waveform
Patient Monitor user’s manual (V 2.2)
12-7
ECG/RESP Monitoring
Warning
Do not touch the patient, table nearby, or the equipment during defibrillation.
12.5 ECG Screen Hot Keys
① ② ③
④
⑤
Figure 12-7
the hot key for ECG
① Leads of channel 1:
1) The selectable leads are I, II, III, aVR, aVL, aVF, V.
2) When the ECG is 5-lead, the selectable leads are: I, II, III, aVR, aVL, aVF, V; when
ECG is 3-lead, the selectable leads are: I,II,III.
3) Leads on the ECG wave must not have the same name. Otherwise, the system will
automatically change the ECG waveform name that has the same name as the waveform
being currently adjusted to another name.
② Waveform gain of channel 1: used to adjust the size of ECG waveforms
Select gain value for each channel from ×0.25,×0.5,×1,×2, and auto. Under "auto" mode,
the monitor chooses an appropriate level automatically. A 1mv scale displays on each ECG
channel's right side. The height of 1mV bar is directly proportional to the waveform amplitude.
Note
When the input signals are too large, the peak of the waveform may be not able to be
displayed. In this case the user may manually change the setup method of ECG
waveform according to the actual waveform so as to avoid the occurrence of the
unfavorable phenomena.
③ Filter method: used for displaying clearer and more detailed waveform
There are three filter modes for selection. DIAGNOSTI, MONITOR and SURGERY modes
may reduce perturbance and interference from Electrosurgery equipment. The filter method is
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Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
the item applicable for both channels, which is always displayed at the waveform place of the
channel 1 ECG waveform.
Note
Only in Diagnosis mode, the system can provide non-processed real signals. In
Monitor or Sugery mode, ECG waveforms may have distortion of different extent. In
either of the latter two modes, the system can only show the basic ECG and the results
of ST analysis may also be greatly affected. In Surgery mode, results of ARR analysis
may be somewhat affected. Therefore, it is suggested that in the environment having
relative small interference, you’d better monitor a patient in Diagnosis mode.
④ Leads of channel 2: refer to ① for detailed information.
⑤ Waveform gain of channel 2: refer to ② for detailed information.
Note
Pacemaking signal detected is marked by a "|" above the ECG waveform.
12.6 ECG Menu
ECG SETUP Menu
There are two ways for the user to access the ECG SETUP menu.
Pick the SETUP button on the ECG/TEMP module to call up the ECG/RESP/TEMP
SETUP menu.
Then select ECG SETUP item to access the ECG SETUP menu as shown below.
Turn the rotary knob on the control panel to move the cursor on the screen to the ECG
hot key in the parameter area and then press the knob to directly access the ECG
SETUP menu.
Patient Monitor user’s manual (V 2.2)
12-9
ECG/RESP Monitoring
Figure 12-8
ECG SETUP menu
ECG alarm setting
• HR ALM: pick "ON" to enable prompt message and data record during the ECG alarm;
pick "OFF" to disable the alarm function, and there will be a
beside “ECG”.
• ALM LEV: selectable from HIGH, MED, LOW. Level HIGH represents the most serious
case.
• ALM REC: pick "ON" to enable report printing upon ECG alarm.
• ALM HI: used to set up the upper limit of ECG alarm.
• ALM LO: used to set up the lower limit of ECG alarm.
ECG alarm is activated when the heart beat exceeds set ALM HI value or falls below
ALM LO value.
ECG alarm limits:
Max. ALM HI
Min. ALM LO
Step
HR ADU
300
15
1
HR PED
350
15
1
HR NEO
350
15
1
Note
Please set the alarm limits according to clinical condition of individual patient. The
upper limit shall not exceed 20 beat/min higher than the patient's heart rate.
HR FROM
■
ECG, SpO2, AUTO and BOTH may detect heart rate. AUTO distinguishes heart rate
source according to the quality of signal. By picking ECG, the monitor prompts HR and
activates HR beep. By picking SpO2, the monitor prompts PULSE and activates pulse
beep. BOTH mode displays HR and PR simultaneously, when this item is picked, PR
12-10
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
parameter is displayed to the right side of SpO2. As for the sound of HR or PR in BOTH
mode, HR is given the priority, i.e., if HR is available, whose sound will be sent out, but if
HR is not available, then the sound will be for PR.
■
HR CHANNEL
"CH1"
to count the heart rate by CH 1 waveform
"CH2"
to count the heart rate by CH 2 waveform
"AUTO" the monitor selects a channel automatically
■
LEAD TYPE: used to select either 5 LEADS or 3 LEADS.
■
SWEEP
Available options for ECG SWEEP are 12.5, 25.0, and 50.0 mm/s.
■
ST ANALYSIS
Pick this item to access ST ANALYSIS menu, the detailed information about the menu is
to be discussed in the following section.
■
ARR ANALYSIS
Pick this item to access ARR ANALYSIS menu, the detailed information about the menu
is to be discussed in the following section.
■
OTHER SETUP
Pick this item to access ECG SETUP menu as shown below:
Figure 12-9
ECG SETUP menu
In the sub-menu, following functions are available:
ECG DISPLAY: Select NORMAL DISPLAY to display 2 ECG waveforms for 5-lead (for
3-lead, only 1 ECG waveform is displayed.). Select MULTI-LEADS DISPLAY, the
waveform area on the screen displays 6 ECG waveforms. Select HALF-SCAN
MULTI-LEADS, there are 4 ECG waveforms are displayed on the screen.
Note: If 3 LEADS is selected in the ECG SETUP menu, only NORMAL DISPLAY can be
selected for ECG DISPLAY item in the sub-menu.
BEAT VOL
Four selections are available: OFF, LOW, MED, HIGH. HIGH indicates maximum volume.
OFF indicates no sound.
PACE
Patient Monitor user’s manual (V 2.2)
12-11
ECG/RESP Monitoring
"ON"
detected signal will be marked by a "|" above the ECG waveform
"OFF"
for non-pacemaking patient
Note
If monitoring a patient with the pacemaker, set “PACE” to On. If monitoring a patient
without pacemaker, set “PACE” to Off.
If “PACE” is on, the system will not perform some types of ARR analysis. For detailed
information, please refer to the section: ARR ALARM. In the table, the ARR type marked
by All types applies to the analysis in all situations, marked by Non-paced applies only
to the analysis in the situation when the patient does not use pacemaker.
CASCADE: switch for ECG cascade. CASCADE: wave of each channel is displayed in
two lines. This function effects only when NORMAL DISPLAY is selected for ECG
DISPLAY.
ECG CAL: pick this item to start calibrating ECG. The method to end CAL: re-select the
CAL key in the menu or re-select the lead name on the screen.
ADJUST WAVE POS: used to adjust the position of the waveform on the screen. Pick to
access ADJUST WAVE POS dialog box. The user may use CH NAME item to select the
channel to be adjusted, UP-DOWN to adjust the position of the selected channel on the
screen, BACK TO DEFAULT to let the wave go back to the default position on the
screen.
Figure 12-10 ADJUST WAVE POS menu
SETUP TRANSFER: used to access the sub-menu of ECG SETUP TRANSFER, in
which the user may set up following information.
12-12
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
Figure 12-11 ECG SETUP TRANSFER
Refers to real-time transfer. two selections are available:
1. OFF: when choose the OFF selection, the system will not automatically save the
modifications to the ECG/TEMP module into the ECG/TEMP module.
2. ON: when choose the ON selection, the system first saves all the setups into the
ECG/TEMP module and then saves the modifications to the module into the
ECG/TEMP module immediately. For the newly loaded ECG/TEMP module, default is
OFF
◆ SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
◆ LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the module are loaded into the system.
When using this function, the warning “Menu item will adopt the value from the
module. Yes?” will be appearing on the screen. And the system will execute the
operation after the confirmation of the user.
DEFAULT: pick this item to access the ECG DEFAULT CONFIG dialog box, in which the
user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation.
Warning
For pacemaker patient, the pacing impulse analysis function must be switched on,
otherwise, the pacing impulse may be counted as normal QRS complex, which results
in failure of “ECG LOST” error detection.
■
For monitor with ST segment & Arrhythmia analysis software, refer to ST Segment
Monitoring and Arrhythmia Analysis for details.
Note
When Pacer Switch is On, the Arrhythmia events related to PVCs will not be monitored.
Patient Monitor user’s manual (V 2.2)
12-13
ECG/RESP Monitoring
At the same time, the ST analysis will not be performed either.
12.7 ECG Alarm Information and Prompt
Alarm Message
Alarms occurring in the process of ECG measurement contain two types: physiological alarm
and technical alarm. Prompt message may also appear in the mean time. For the audio and
visual features during the appearance of these alarms and prompt messages in the process
of ECG measurement, please refer to the related description in Chapter Alarm. In the screen,
physiological alarm messages and the prompt messages able to trigger alarms (general alerts)
all displayed in the alarm area of the monitor while technical alarms and prompt messages
unable to trigger alarms are then displayed in the information area of the monitor. This section
does not describe the content about Arr. and ST analysis.
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe respectively the possible various alarms those may occur during the
measurement.
Physiological alarms:
Message
ECG LOST
HR TOO HIGH
HR TOO LOW
Cause
No ECG signal of the patient is detected.
HR measuring value is above the upper alarm limit
HR measuring value is below the lower alarm limit
Alarm level
HIGH
User-selectable
User-selectable
Technical alarms:
Message
Alarm
level
Remedy
ECG electrodes fall off
the skin or ECG cables fall
off the monitor.
LOW
Make sure that all
electrodes, leads and
patient
cables
are
properly connected.
ECG module failure
HIGH
Cause
ECG LEAD OFF
ECG V LEAD OFF or
ECG C LEAD OFF
ECG LL LEAD OFF or
ECG F LEAD OFF
ECG LA LEAD OFF or
ECG L LEAD OFF
ECG RA LEAD OFF or
ECG R LEAD OFF
ECG INIT ERR
ECG INIT ERR1
ECG INIT ERR2
12-14
Patient Monitor user’s manual (V 2.2)
Stop using measuring
function provided by
ECG module, notifies
biomedical engineer
ECG/RESP Monitoring
or Mindray
staff.
ECG INIT ERR3
service
ECG INIT ERR4
ECG INIT ERR5
ECG INIT ERR6
ECG INIT ERR7
ECG INIT ERR8
ECG COMM STOP
Occasional communication
failure
ECG COMM ERR
Occasional communication
failure
HR ALM LMT ERR
ECG NOISE
Functional safety failure
ECG measuring signal is
greatly interfered.
HIGH
If failure persists,
notify
biomedical
engineer or Mindray
service staff.
HIGH
If failure persists,
notify
biomedical
engineer or Mindray
service staff.
HIGH
Stop using HR alarm
function,
notify
biomedical engineer
or Mindray service
staff.
LOW
Make sure the patient
is
quiet,
the
electrodes
are
properly
connected
and AC power system
is well grounded.
Prompt messages (include general alerts):
Message
Cause
Alarm Level
HR EXCEED
HR measuring value exceeds
the measurement range.
HIGH
12.8 ST Segment Monitoring (optional)
ST Segment Monitoring (Optional)
■
ST segment monitoring function is shutoff by default. You can switch it to ON when
necessary.
NOTE: When setting ST ANALYSIS on, the monitor will automatically switch to
“DIAGNOSTIC” mode. You can set it to “MONITOR” mode or “OPERATE” mode as
required. However at this time ST value has been severely distorted.
■
It is available to measure the variance of ST segment with ST analysis at the waveform
tracks for selected lead. The corresponding ST measurement result displays numerically
at ST1 and ST2 in the Parameter Area. The trend can be viewed with table or graphic
form.
■
Measurement unit of ST segment: mv.
■
Measurement symbol of ST segment: "+" = elevating, "-" = depressing.
Patient Monitor user’s manual (V 2.2)
12-15
ECG/RESP Monitoring
■
Measurement range of ST segment: -2.0 mv, ~ + 2.0 mv.
Pick the ST ANALYSIS item in the ECG SETUP menu to access the ST ANALYSIS sub-menu
as shown below.
ST ANALYSIS menu
Figure 12-12 ST ANALYSIS menu
ST analysis alarm setting
ν
ST ANAL: the switch for ST analysis. Set it to ON to activate the ST analysis or OFF to
disable the ST analysis.
ν
ST ALM: pick "ON" to enable prompt message and data record during the ST analysis
alarm; pick "OFF" to disable the alarm function, and there will be a
beside ST. ST
alarm is activated when the result exceeds set ST HI value or falls below ST LO value.
ν
ALM LEV: used to set up the ST alarm level. There are three selections: HIGH, MED and
LOW.
ν
ALM REC: pick "ON" to enable report printing upon ST analysis alarm.
ν
ALM HI: used to set up the upper limit of ST alarm. The max. higher limit is 2.0. The
minimum higher limit is 0.2 larger than the set lower limit.
ν
ALM LOW: used to set up the lower limit of ST alarm. The minimum lower limit is –2.0.
The max. lower limit is 0.2 lower than the set higher limit.
ST analysis alarm limits:
ST
■
Max. ST HI
Min. ST LO
Step
2.0 mv
-2.0 mv
0.1
DEF POINT pick this item to access the DEF POINT window, in which the position of ISO
and ST point can be set up.
12-16
ISO
Base point. Default is 78 ms.
ST
Measurement point.
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
Figure 12-13 DEF POINT window
The operator can adjust the position of both ISO and ST measurement points.
The reference point is the position where the peak of R-wave locates (see Figure 12-14).
R Wave
T
P
}
Q
ISO
-78 ms
ST Value
S
ST
+109 ms
Figure 12-14 DEF Point
The ST measurement for each beat complex is the vertical difference between the two
measurement points.
Note
the ST measurement point should be adjusted if the patient's HR or ECG morphology
changes significantly.
Patient Monitor user’s manual (V 2.2)
12-17
ECG/RESP Monitoring
Adjusting ISO, ST
These two points can be adjusted turning the knob.
When adjusting ST measurement point, the system will show the ST Measurement Point
Window. The QRS complex template displays in the window (If the template is not established,
a horizontal line will display. If the channel is not at ON position, a horizontal line will also
display). It is adjustable of the highlight bar in the window. You may select ISO or ST, then
switch the knob left or right to move the cursor line. When the cursor is at the required
position, you may select the base point or the measurement point.
Note
Abnormal QRS complex is not considered in ST segment analysis.
ST Alarm Message
Note: The alarm limits for two ST measurements are identical. No setting of alarm limits can
be made only for one channel.
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages during ST measurement.
Physiological alarms:
Message
Cause
Alarm Level
ST1 TOO HIGH
ST measuring value of channel 1 is
above the upper alarm limit.
User-selectable
STI TOO LOW
ST measuring value of channel 1 is
below the lower alarm limit.
User-selectable
ST2 TOO HIGH
ST measuring value of channel 2 is
above the upper alarm limit.
User-selectable
ST2 TOO LOW
ST measuring value of channel 2 is
below the lower alarm limit.
User-selectable
Technical alarms:
Message
ST ALM LMT ERR
Cause
Functional safety failure
Alarm Level
Remedy
HIGH
Stop using ST alarming
function, notify biomedical
engineer
or
Mindray
service staff.
Prompt messages (include general alerts):
Message
12-18
Cause
Patient Monitor user’s manual (V 2.2)
Alarm Level
ECG/RESP Monitoring
ST measuring value of channel 1 exceeds the
measurement range.
ST measuring value of channel 2 exceeds the
measurement range.
ST1 EXCEED
ST2 EXCEED
HIGH
HIGH
12.9 Arr. Monitoring (optional)
Arrhythmia Analysis
The arrhythmia algorithm is used to monitor ECG of neonate and adult patient in clinical,
detect the changing of heart rate and ventricular rhythm, and also save arrhythmia events and
generate alarming information. Arrhythmia algorithm can monitor paced and non-paced
patients. Qualified personnel can use arrhythmia analysis to evaluate patient’s condition (such
as heart rate, PVCs frequency, rhythm and ectopic beat) and decide the treatment. Besides
detecting changing of ECG, arrhythmia algorithm can also monitor patients and give proper
alarm for arrhythmia.
■
The arrhythmia monitoring is shutoff by default. You can enable it when necessary.
■
This function can call up the doctor's attention to the patient's heart rate by measuring
and classifying the arrhythmia and abnormal heart beat and triggering the alarm.
■
The monitor can conduct up to 13 different arrhythmia analyses.
■
The monitor can store the latest 60 alarm events when taking arrhythmia analysis to a
peculiar buffer. The operator can edit these arrhythmia events through the menu below.
Pick the item ARR ANALYSIS in ECG SETUP menu to access the ARR ANALYSIS sub-menu.
ARR ANALYSIS Menu
Figure 12-15
ARR ANALYSIS Menu
■
ARR ANAL:
Pick "ON" during monitoring. Default set is "OFF".
■
PVCs ALM: pick "ON" to enable prompt message and data record when alarm occurs;
pick "OFF" to disable the alarm function, and there will be a
■
beside “PVCs”.
ALM LEV: selectable from HIGH, MED, LOW. Level HIGH represents the most serious
case.
Patient Monitor user’s manual (V 2.2)
12-19
ECG/RESP Monitoring
ALM REC: pick "ON" to enable report printing upon PVCs alarm.
■
• PVCs alarm is activated when the PVCs exceeds set PVCs ALM HI value.
PVCs alarm upper limits:
PVCs
Max
Min
Step
10
1
1
PVCs alarm and prompt message:
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during pvcs measurement.
Physiological alarms:
Message
Cause
Alarm Level
PVCs TOO HIGH
PVCs measuring value is above upper alarm
limit.
User-selectable
Technical alarms:
Message
PVCs ALM LMT ERR
Cause
Functional
failure
safety
Alarm Level
Remedy
HIGH
Stop using PVCs alarming
function, notify biomedical
engineer or Mindray service
staff.
■
ARR RELEARN
Pick this item to start a learning procedure.
■
ARR ALARM
Pick this item to access the ARR ALARM dialog box to set
arrhythmia alarm parameters.
Set ALM to ON/OFF to enable/disable the alarm function; Set REC to ON/OFF to
enable/disable alarm record function, turn the knob under LEV column to set alarm level
to HIGH, MED or LOW.
12-20
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
Figure 12-16
ARR ALARM Menu
You can pick ALL ALM ON to enable alarm function of all arrhythmia types and pick ALL ALM
OFF to disable this function. Likewise, you can pick ALL REC ON to enable recording function
for all arrhythmia types and pick ALL REC OFF to disable this function. Changing the ALM
LEV can reset alarm level of all arrhythmia types to the same value.
■
ARR RECALL
Pick this item to review and edit the ARR analysis result.
Figure 12-17
ARR RECALL Menu
The latest arrhythmia events (up to 60) are displayed.
UP-DOWN
Observe other event lists of other page.
CURSOR
Select the Arr. event, whose name is displayed in a protruding frame.
Patient Monitor user’s manual (V 2.2)
12-21
ECG/RESP Monitoring
DELETE
Delete the selected Arr. event.
RENAME
Rename the selected Arr. event, whose name is displayed in a
sunken frame.
Switch the knob until the name you want appears.
WAVE
To display the Arrhythmia waveform, time and parameter value.
UP-DOWN
To observe waveforms of other Arrhythmia events.
L_RIGHT
To observe 8-second waveform of Arrhythmia events.
REC
To print out displayed Arrhythmia event.
EXIT
To return to ARR RECALL menu of Arrhythmia event.
Figure 12-18
ARR WAVE RECALL Menu
Note
If there are more than 60 Arrhythmia events, the latest will be retained. For a monitor
having the function of power-off data storage, the system can save the latest 60 Arr.
Events once power-off accident happens.
ARR ALARM
The alarm is triggered when an Arrhythmia occurs. If the ALM is ON, the alarm sounds and
the alarm indicator flashes. If the REC is ON, the alarm record will be printed out (4 seconds
prior to and after the alarm, with the ECG waveforms of analysis channel).
Physiological alarms:
Prompt
ASYSTOLE
12-22
Applicable
Patient Type
All patients
Occurring Condition
Alarm Level
No QRS is detected for 4 consecutive
seconds
User-selectable
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
VFIB /VTAC
VT>2
COUPLET
Without
pacemaker
Without
pacemaker
Without
pacemaker
BIGEMINY
Without
pacemaker
Without
TRIGEMINY
pacemaker
R ON T
Without
pacemaker
PVC
Without
pacemaker
TACHY
All patients
BRADY
All patients
MISSED
BEATS
Without
pacemaker
PNP
With
pacemaker
PNC
With
pacemaker
Fibrillatory wave for
consecutive 4
seconds; or
The number of continuous Vent beats is
larger than the upper limit of cluster
Vent beats (>5).
The RR interval is less than 600ms.
3 < the number of cluster PVCs < 5
2 consecutive PVCs
User-selectable
User-selectable
User-selectable
Vent Bigeminy
User-selectable
Vent Trigeminy
User-selectable
A type of single PVC under the
condition that HR<100,R-R interval is
less than 1/3 the average interval,
followed by a compensating pause of
1.25X the average R-R interval(the next
R wave advances onto the previous T
wave).
Single PVCs not belonging to the type
of above mentioned PVCs.
5 consecutive QRS complex , RR
interval is less than 500ms.
5 consecutive QRS complex, RR
interval is longer than 1.5s.
When HR is less than 100 beats/min.,
no heart beat is tested during the
period 1.75 times of the average RR
interval; or
When HR is larger than 100 beats/min.,
no beat is tested with 1 second.
No QRS complex and pacing pulse are
availabe during the period 1.75 times
of the average R-R interval (only
considering patients with pacemaker.)
When pacing pulse is available, no
QRS exists during the period 1.75 times
of the average RR interval (only
considering patients with pacemaker.)
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
Patient type:
All patients: refers to perform Arr.analysis on patients either with pacemakers or without
pacemakers.
Without pacemaker: refers to perform Arr. Analysis only on the patients without pacemakers.
With pacemaker: refers to perform Arr. Analysis only on the patients with pacemakers.
Prompt message:
Message
Cause
Alarm Level
ARR LEARNING
The QRS template building
required for Arr. Analysis is in
process.
No alarm
Patient Monitor user’s manual (V 2.2)
12-23
ECG/RESP Monitoring
Note
Arrhythmia name displays in the Alarm Message Area.
12.10 Measuring RESP
12.10.1
How to measure RESP?
The monitor measures respiration from the amount of thoracic impedance between two ECG
electrodes. The change of impedance between the two electrodes, (due to the thoracic
movement), produces a respiratory waveform on the screen.
12.10.2
Setting Up RESP measurement
For RESP monitoring, it is not necessary for additional electrodes, however, the placing of
electrodes is important.
Some patients, due to their clinical condition, expand their chest laterally, causing a negative
intrathoracic pressure. In these cases it is better to place the two RESP electrodes laterally in
the right axillary and left lateral chest areas at the maximum point of breathing movement to
optimize the respiratory waveform.
Note
The RESP monitoring is not recommended to be used on patients who are very active,
as this can cause false alarms.
Checklist for RESP Monitoring
1.
Prepare the patient's skin prior to placing the electrodes.
2.
Attach snap or clip to the electrodes and attach the electrodes to the patient as described
below.
3.
12-24
Switch on the monitor.
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
12.10.3
Installing electrode for RESP measurement
Placing the Electrodes for Respiratory Monitoring
Figure 12-19
Electrodes placement (5-lead)
Note
Place the red and green electrodes diagonally to optimize the respiration waveform.
Avoid the liver area and the ventricles of the heart in the line between the RESP
electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow. This is
particularly important for neonates.
12.10.4
RESP menu
RESP SETUP Menu
There are two ways for the user to access the RESP SETUP menu.
Pick the SETUP button on the ECG/TEMP module to call up the ECG/RESP/TEMP
SETUP menu. Then pick the RESP SETUP item to call up the following menu:
Turn the rotary knob on the control panel to move the cursor on the screen to the RESP
hot key in the parameter area and then press the knob to directly access the RESP
SETUP menu.
Patient Monitor user’s manual (V 2.2)
12-25
ECG/RESP Monitoring
Figure 12-20
RESP SETUP Menu
RESP alarm setting
• ALM: pick "ON" to enable prompt message and data record during the RESP alarm; pick
"OFF" to disable the alarm function, and there will be a
beside “RESP”.
• ALM REC: pick "ON" to enable report printing upon RESP alarm.
• ALM LEV: selectable from HIGH, MED and LOW. Level HIGH represents the most serious
case.
• ALM HI: used to set up the upper alarm limit.
• ALM LO: used to set up the lower alarm limit.
RESP alarm is activated when the respiration rate exceeds set ALM HI value or falls below
ALM LO value.
RESP alarm limits:
Max. RR HI
Min. RR LO
Step
RESP ADU
120
0
1
RESP NEO/PED
150
0
1
• APNEA ALM: to set the standard of judging an apnea case. It ranges from 10 to 40
seconds, increases / decreases by 5.
• SWEEP: Available options for RESP SWEEP are 6.25, 12.5 and 25.0 mm/s.
• WAVE AMP: The user may set up the displaying amplitude of the RESP waveform. The
selections are 0.25, 0.5, 1, 2, 3, 4, 5.
• HOLD TYPE: AUTO/MANUAL adjustable. When it is AUTO mode, HOLD HI and HOLD LO
menus cannot be used and the monitor automatically calculates the RESP RATE. When it
is MANUAL mode, the user can adjust the two dashed lines in the RESP WAVEFORM area
respectively by using HOLD HI and HOLD LO menus. The position of the dashed lines will
be used to calculate the upper and lower limits of RESP RATE by the monitor.
• HOLD HI and HOLD LO: When the HOLD TYPE is MANUAL, the user can use the knob to
pick either HOLD HI or HOLD LO and turn the knob to adjust the two dashed lines in the
RESP WAVEFORM area respectively. The positions of the dashed lines will be used to
12-26
Patient Monitor user’s manual (V 2.2)
ECG/RESP Monitoring
calculate the upper and lower limits of RESP RATE by the monitor.
• SETUP TRANSFER: used to access the sub-menu of ECG SETUP TRANSFER, in which
the user may set up following information.
▲ RT TRANSFER
Refers to real-time transfer. Three selections are available:
1. OFF: when choose the OFF selection, the system will not automatically save the
modifications to the ECG/TEMP module.
2. ON: when choose the ON selection, the system first saves all the setups into the
ECG/TEMP module and then saves the modifications to the ECG/TEMP module into
the ECG/TEMP module immediately. For the newly loaded ECG/TEMP module,
default is OFF
▲ SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
▲ LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON, this
function is unnecessary), the setups in the module are loaded into the system. When
using this function, the warning “Menu item will adopt the value from the module. Yes?”
will be appearing on the screen. And the system will execute the operation after the
confirmation of the user.
• DEFAULT: pick this item to access the RESP DEFAULT CONFIG dialog box, in which the
user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation
RESP Alarm Message
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during RESP measurement.
Physiological alarms:
Message
RR TOO HIGH
RR TOO LOW
RESP APNEA
Cause
Alarm Level
RESP measuring value is above upper alarm limit.
RESP measuring value is below lower alarm limit.
RESP can not be measured within specific time
interval.
User-selectable
User-selectable
HIGH
Technical alarms:
Message
Cause
Alarm Level
Patient Monitor user’s manual (V 2.2)
Remedy
12-27
ECG/RESP Monitoring
RESP
ERR
ALM
LMT
Functional
failure
safety
HIGH
Stop using RESP
alarming
function,
notify
biomedical
engineer or Mindray
service staff.
Prompt message (general alerts):
Message
Cause
Alarm Level
RR EXCEED
RR measuring value exceeds
the measure range.
HIGH
12.11 Maintenance and Cleaning
Care and Cleaning
Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched
off and disconnected from the power line.
If there is any sign that the ECG cable may be damaged or deteriorated, replace it with a new
one instead of continuing its application on the patient.
■
Cleaning:
Use fine-hair cloth moistened in mild soap liquid or cleaning agent containing 70%
ethanol to clean the equipment.
■
Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when
stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities
should be cleaned first.
Recommended sterilization material:
Ethylate: 70% alcohol, 70% isopropanol
Acetaldehyde
■
Disinfection
To avoid extended damage to the equipment, disinfection is only recommended when
stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities
should be cleaned first.
12-28
Patient Monitor user’s manual (V 2.2)
Chapter 13
SpO2 Monitoring
13.1 PART 1 (MASIMO SpO2 board configuration)
General description
SpO2 is a non-invasive measurement of the functional oxygen saturation.
The measurement is taken by placing a sensor on a patient , usually on the fingertip for adults,
and the hand or foot for neonates. The sensor is connected to the patient monitor with pulse
oximetry measurement module (Masimo Set, which is called MS-7). The monitor displays the
calculated data from MS-7 in three ways: 1)as a percent value for arterial oxygen saturation
(SpO2) ; 2)as a pulse rate (PR) and 3)as a plethysmographic waveform on the screen.
Principles of Operation
This MS-7 is based on three principles:
Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared
light(spectrophotometry).
The volume of arterial blood in tissue and the light absorbed by the blood changes during
the pulse(plethysmography)
Arterio-venous shunting is highly variable and that fluctuating absorbance by venous
blood is a major component of noise during the pulse.
This MS-7 determines SpO2 by passing red and infrared light into a capillary bed and
measuring changes in light absorption during the pulsatile cycle. Red and infrared
light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, a photodiode
serves as the photodetector.
Traditional pulse oximeter assumes that all pulsations in the light absorbance signal are
caused by oscillations in the arterial blood volume. This assumes that the blood flow in the
region of the sensor passes entirely through the capillary bed rather than through any
arterio-venous shunts. The traditional pulse oximeter calculates the ratio of pulsatile
absorbance (AC) to the mean absorbance (DC) at each of two wavelengths, 660 nm and 940
nm:
S(660) = AC(660)/DC(660)
Patient Monitor user’s manual (V 2.2)
13-1
SpO2 Monitoring
S(940) = AC(940)/DC(940)
This traditional instrument then calculates the ratio of these two arterial pulse-added
absorbance signals:
R = S(660)/S(940)
This value of R is used to find the saturation SpO2 in a look-up table built into the instrument’s
software. The values in the look-up table are based upon human blood studies against a
laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.
This MS-7 assumes that arterio-venous shunting is highly variable and that fluctuating
absorbance by venous blood is the major component of noise during the pulse. The MS-7
decomposes S(660) and S(940) into an arterial signal plus a noise component and calculates
the ratio of the arterial signals without the noise:
S(660) = S1 + N1
S(940) = S2 + N2
R = S1/S2
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to
find the saturation SpO2 in an empirically derived equation into the software. The values in the
empirically derived equation are based upon human blood studies against a laboratory
co-oximeter on healthy adult volunteers in induced hypoxia studies.
The above equations are combined and a noise reference (N’) is determined:
N’ = S(660) - S(940) x R
If there is no noise N’ = 0: then S(660) = S(940) x R which is the same relationship for the
traditional pulse oximeter.
The equation for the noise reference is based on the value of R, the value being seeked to
determine the SpO2. This instrument’s software sweeps through possible values of R that
correspond to SpO2 values between 1% and 100% and generates an N’ value for each of
these R values. The S(660) and S(940) signals are processed with each possible N’ noise
reference through an adaptive correlation canceler (ACC) which yields an output power for
each possible value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete
Saturation Transform (DST™) plot of relative output power versus possible SpO2 value as
shown in the following figure where R corresponds to SpO2 = 97%:
13-2
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
Discrete Saturation Transform
DST
Relative Correlation Canceler
Energy Output
TM
65
70
75
80
85
90
95
97 100
%SpO2
The DST plot has two peaks: the peak corresponding to the higher saturation is selected as
the SpO2 value. This entire sequence is repeated once every two seconds on the most recent
four seconds of raw data. The SpO2 value therefore corresponds to a running average of
arterial hemoglobin saturation that is updated every two seconds.
13.1.1 Precautions
Warning
This pulse wave from M-7 should NOT be used as an apnea monitoring.
Warning
This monitor with M-7 should be considered an early warning device for SpO2. As a
trend towards patient deoxygenation is indicated, blood samples should be analyzed
by a laboratory co-oximeter to completely understand the patient’s condition.
Warning
If an alarm condition (other than exceptions listed herein) occurs while the alarm
silence period is set to off, the only alarm indications will be visual displays and
symbols related to the alarm condition.
Warning
Patient Monitor user’s manual (V 2.2)
13-3
SpO2 Monitoring
Measure the monitor’s leakage current whenever an external device is connected to
the serial port. Leakage current must not exceed 100 microamperes.
Warning
To ensure patient electrical isolation, connect only to other equipment with
electronically isolated circuits.
Warning
Do not connect to an electrical outlet controlled by a wall switch or dimmer.
Warning
As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.
Warning
Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The
level of increase is approximately equal to the amount of carboxyhemoglobin present.
Dyes, or any substance containing dyes, that change usual arterial pigmentation may
cause erroneous readings.
Warning
Do not use this instrument and the sensors during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns. The monitor may affect the
MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.
Warning
Pulse oximetry can overestimate the SpO2 value in the presence of Hb-CO, Met-Hb or
dye dilution chemicals.
Warning
Verify sensor cable fault detection before beginning of monitoring phase. Unplug the
SpO2 sensor cable from the socket, the screen will display the error message “SpO2
SENSOR OFF” and the audible alarm is activated.
Warning
Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is
13-4
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
damaged and return them to the vendor.
Warning
Prolonged and continuous monitoring may increase jeopardy of unexpected change of
dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive
putrescence, and so on. It is especially important to check the sensor placement of
neonate and patient of poor perfusion or immature dermogram by light collimation and
proper attaching strictly according to changes of the skin. Check per 2~3 hours the
sensor placement and move it when the skin deteriorates. More frequent examinations
may be required for different patients.
Note
Do not perform SpO2 measuring and NIBP measuring in same arm at one time, because
obstruction of blood flow during NIBP measuring may adversely affect the reading of
SpO2 value.
Note
Make sure the nail covers the light window;
The wire should be on the backside of the hand.
Note
SpO2 value always displays at the same position. Pulse Rate will display when HR
FROM is set at "SpO2", “BOTH” in the ECG SETUP menu.
Note
SpO2 waveform is not proportional to the pulse volume.
13.1.2 Monitoring Procedure
SpO2 Module:
Patient Monitor user’s manual (V 2.2)
13-5
SpO2 Monitoring
①
②
③
④
⑤
⑥
Figure 13-1
SPO2 module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the module
communicates with the host system triumphantly. If the indicator is still flashing, it
means that the SpO2 module or the slot has failure. In this case, the operator should
re-load the module. If the failure still exists, please contact the Mindray service
engineer for repair.
② SETUP:the button used to set up the related items of SpO2. Press SETUP button, the
SPO2 SETUP menu appears on the screen. The user may modify any item in the menu
through using the rotary knob on the control panel.
③ Blank Button
④ A socket for SpO2 sensor: Before monitoring the patient, the user should first safely insert
the watertrap into this socket.
⑤
means “BE CAREFUL“. Refer to the attached document (this manual) of the
monitor.
⑥
means that the SpO2 module is IEC 60601-1 Type CF equipment.
Note
When not using the SpO2 module to monitor the patient, the user may unload the
module, which however must be stored in a clean and dry environment, otherwise the
13-6
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
life cycle of the module will be unfavorably affected.
Note
This monitor with MS-7 is intended for continuous noninvasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured
by an SpO2 sensor) for adult, pediatric, and neonatal patients in a hospital and mobile
environment.
Limitations for Measurement
If the accuracy of any measurement does not seem reasonable, first check the patient’s vital
signs by alternate means and the check the instrument for proper functioning.
Inaccurate measurements may be caused by:
•
•
incorrect sensor application or use
significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or
methemoglobin)
•
intravascular dyes such as indocyanine green or methylene blue.
•
exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessive illumination can be corrected by covering the
sensor with a dark or opaque material)
•
excessive patient movement
•
venous pulsations
•
placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line
the monitor can be used during defibrillation, but the readings may be inaccurate for a
short time.
Loss of pulse signal can occur in any of the following situation:
the sensor is too tight
•
•
there is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight
•
a blood pressure cuff is inflated on the same extremity as the one with a SpO2
sensor attached.
•
the patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia
•
•
there is arterial occlusion proximal to the sensor
the patient is in cardiac arrest or is in shock
SpO2 plethysmogram measurement: (MASIMO SETTM ONLY)
1. Switch on the monitor.
2. Attach the sensor to the appropriate site of the patient finger.
3. Plug the connector of the sensor extension cable into the SpO2 socket on the PM-9000.
Patient Monitor user’s manual (V 2.2)
13-7
SpO2 Monitoring
Figure 13-2
mounting of the sensor
SpO2 SETUP Menu
Pick the SpO2 hot key on the screen to call up the SpO2 SETUP menu as shown below.
Figure 13-3 SpO2 SETUP menu
Warning
Setting the SpO2 upper alarm limit to 100% is equivalent to switching off the alarm on
upper limit. High oxygen levels may predispose a premature infant to retrolental
fibroplasia. Therefore, the upper alarm limit for oxygen saturation must be carefully
selected in accordance with commonly accepted clinical practices.
SpO2 alarm setting
• ALM: pick "ON" to enable prompt message and data record during the SpO2 alarm;
pick "OFF" to disable the alarm function, and there will be a
beside “SpO2”.
• ALM REC: pick "ON" to enable report printing upon SpO2 alarm.
• ALM LEV: used to set up alarm level, selectable from HIGH, MED and LOW. HIGH
represents the most serious case.
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Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
• SpO2 ALM HI and SpO2 ALM LO:SpO2 alarm is activated when the result exceeds set
SpO2 ALM HI value or falls below SpO2 ALM LO value. Use the knob to pick the SpO2
ALM HI or SpO2 ALM LO item and turn the knob to select the desired alarm limit.
• PR ALM HI and PR ALM LO: PR alarm is activated when the pulse rate exceeds set
PR ALM HI value or falls below PR ALM LO value. Use the knob to pick the PR ALM
HI or PR ALM LO item and turn the knob to select the desired alarm limit.
Warning
Check alarm limits each time the monitor is used to ensure that they are
appropriate for the patient being monitored.
SpO2 and PR alarm limits:
Max. Upper Limit
Min. Lower Limit
Step
SpO2
100
0
1
PR
254
0
1
■
SWEEP
Available options are 12.5, 25.0 mm/s.
■
PR SOUND
Pulse beep volume. Options are OFF, HIGH, MED, LOW.
■
AVG TIME
2~4S,4~6S, 8S,10S,12S,14S, 16S represent times that SpO2 average value is counted.
■
SENSITIVITY MODE
Available options are normal and high.
■
DEFAULT:
Pick this item to access the SpO2 DEFAULT CONFIG dialog box, in which the user may
select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG is to
be used. After selecting any of the items and exiting the dialog box, the system will pop
up the dialog box asking for the user’s confirmation.
13.1.3 Sensors and Accessories:
Before use, carefully read the LNOP sensor Directions for Use.
Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers or
sensors may cause improper Radical Pulse Oximeter performance.
Tissue damage can be caused by incorrect application or use of an LNOP sensor, for
example by wrapping the sensor too tightly. Inspect the sensor site as directed in he sensor
Directions for Use to ensure skin integrity and correct positioning and adhesion of he sensor.
Caution
Do not use the damaged sensors. Do not use a sensor with exposed optical
Patient Monitor user’s manual (V 2.2)
13-9
SpO2 Monitoring
components. Do not immerse the sensor in water, solvents, or cleaning solutions
(the sensors and connectors are not waterproof ). Do not sterilize by irradiation,
steam, or ethylene oxide.
Caution
Do not use damaged patient cables. Do not immerse the patient cables in water,
solvents, or cleaning solutions (the sensors and connectors are not waterproof ).
Do not sterilize by irradiation, steam, or ethylene oxide.
Selecting a Masimo sensor:
When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the
available sensor sites, and the duration of monitoring. For more information refer to the
following table or contact Masimo. Use only Masimo sensors and sensor cables. Select an
appropriate sensor, apply it as directed, and observe all warnings and cautions presented in
the directions for use accompanying the sensor.
High ambient light sources such as surgical lights(especially those with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with
the performance of an SpO2 sensor. To prevent interference from ambient light, ensure that
the sensor is properly applied, and cover the sensor site with opaque material, if required.
Failure to take this precaution in high ambient light conditions may result in inaccurate
measurements.
SENSOR
LNOP ADT
LNOP PDT
LNOP NEO
LNOP NEO PT
LNOP DCI
LNOP DCIP
LNOP DCSC
LNOP Ear sensor
LNOP YI Multi-site
USAGE
SINGLE USE
SINGLE USE
SINGLE USE
SINGLE USE
REUSABLE
REUSABLE
REUSABLE
REUSABLE
REUSABLE
PATIENT WEIGHT
ADULTS > 30 kg
Adults >10 kg and <50 kg
Neonate <10 kg
Neonate <1 kg,or with poor skin integrity
Adults and Pediatrics >30 kg
Pediatrics >10 kg and <50 kg
Adult and Pediatrics >30 kg,for spot check applications
Adult/Pediatric >30 kg
Adult/Pediatric/Infant/Neonatal > 1 kg
Cleaning and reuse of Masimo LNOP sensors
Reusable sensors can be cleaned per the following procedure:
Remove the sensor from the patient.
Disconnect the sensor from the monitor.
Wipe the entire sensor clean with a 70%isopropyl alcohol pad.
Allow the sensor to air dry before returning it to operation.
Reattachment of single use adhesive sensors
LNOP single use sensors may be reapplied to the same patient if the emitter and
13-10
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
detector windows are clear and the adhesive still adheres to the skin.
The adhesive can be partially rejuvenated by wiping with a 70%isopropyl alcohol wipe
and allowing the sensor to thoroughly air dry prior to replacement on the patient.
Warning
To avoid cross contamination only use Masimo LNOP single use sensors on the same
patient.
Note
If the sensor fails to track the pulse consistently, the sensors may be incorrectly
positioned. Reposition the sensor or choose a different monitoring site.
Caution
Do not reprocess any LNOP single use sensors.
MASIMO SET PATIENT CABLES:
Reusable patient cables of various lengths are available. All cables that display the Masimo
SET logo are designed to work with any Masimo LNOP sensor and with any pulse oximeter or
multiparameter instrument displaying the Masimo SET logo.
Only use Masimo oximetry patient cables for SpO2 measurements. Other patient cables may
cause improper Radical pulse oximeter performance.
Caution
Carefully route patient cables to reduce the possibility of patient entanglement or
strangulation.
Caution
Do not soak or immerse patient cables in any liquid solution. Do not sterilize patient
cables by irradiation steam or ethylene oxide see the cleaning instructions in the
directions for use for reusable Masimo patient cables.
Maintenance
Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched
off and disconnected from the power line.
For cleaning:
Use a cotton ball or a soft mull moistened with hospital-grade ethanol to wipe the
Patient Monitor user’s manual (V 2.2)
13-11
SpO2 Monitoring
surface of the sensor, and then dry it with a cloth. This cleaning method can also be
applied to the luminotron and receiving unit.
The cable can be cleaned with 3% hydrogen dioxide, 7% isopropanol, or other
active reagent. However, connector of the sensor shall not be subjected to such solution.
13.1.4 Alarm Description and Prompt
SpO2 Alarm Message
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
TABLES BELOW DESCRIBE THE POSSIBLE PHYSIOLOGICAL ALARMS,
TECHNICAL ALARMS AND PROMPT MESSAGES OCCURRING DURING SPO2
MEASUREMENT.
Physiological alarm:
Message
Cause
Alarm Level
SPO2TOO HIGH
SpO2 measuring value is above upper alarm limit.
User-selectable
SpO2 TOO LOW
SpO2 measuring value is below lower alarm limit.
User-selectable
PR TOO HIGH
PR measuring value is above upper alarm limit.
User-selectable
PR TOO LOW
PR measuring value is below lower alarm limit.
User-selectable
Technical alarms:
Message
SpO2 NO
Possible Cause(s)
Sensor not fully inserted
into the connector.
Alarm
Level
Recommendation
LOW
May be an incorrect sensor,
or a defective sensor or
cable. Insert sensor into the
connector. Disconnect and
reconnect sensor. Refer to
the instructions for the sensor
being used.
SENSOR
Sensor
inserted
upside down.
SpO2 SENSOR
OFF
SpO2
SENSOR
FAULT
13-12
SpO2 sensor may be
disconnected from the
patient or the monitor.
This message appears
when the sensor is faulty
LOW
LOW
Disconnect and reconnect he
sensor
with
the
logos
matching.
Disconnect
the sensor.
and
reconnect
Reattach sensor.
HIGH
Patient Monitor user’s manual (V 2.2)
Stop using the measuring
function of SpO2 module,
notify biomedical engineer or
our service staff.
SpO2 Monitoring
SpO2
UNRECOGNIZED
SENSOR
Masimo board does not
recognize the sensor.
LOW
Make sure that the monitor
and the patient are in correct
connection with the cables.
SpO2
INCOMPATIBLE
SENSOR
This
message
is
displayed
when
the
masimo sensor is finding
incompatible sensor.
LOW
Make sure that the monitor
use incompatible sensor.
SpO2
INTERFERENCE
Outside signal or energy
preventing reading.
LOW
Remove outside interference.
SpO2 PULSE
SEARCH
Unit is searching for the
patients pulse.
LOW
If values are not displayed
within
30
seconds,
disconnect and reconnect
sensor. If pulse search
continues, remove sensor
and replace on a better
perfused site.
SpO2
LOW
PERFUSION
Signal too small.
LOW
Move sensor
perfused site.
Too much light on
patient(sensor).
Inadequate
tissue
covering
sensor
detector.
LOW
Remove or reduce lighting.
Cover sensor from light.
Reposition sensor.
Low signal quality.
LOW
Ensure
proper
sensor
application. Mover sensor to
a better perfused site.
HIGH
Stop using the measuring
function of SpO2 module,
notify biomedical engineer or
our service staff.
HIGH
Stop using the measuring
function of SpO2 module,
notify biomedical engineer or
our service staff.
HIGH
Stop using the measuring
function of SpO2 module,
notify biomedical engineer or
our service staff.
HIGH
Stop using the measuring
function of SpO2 module,
notify biomedical engineer or
our service staff.
SpO2 TOO
MUCH LIGHT
SpO2 LOW
SIGNAL IQ
SpO2
BOARD FAULT
This message appears
when the Masimo Set
board malfunctions.
SpO2
COMMUNICATION
ERROR
This
message
is
displayed when the front
end module is having
problems communicating
( ie: framing errors or bad
checksums)
with
the
Masimo board.
SpO2
COMMUNICATION
STOP
This
message
is
displayed when the host
can not receive the data
from Masimo board for 5
seconds
SpO2 INIT ERR
This
message
is
displayed when the SpO2
module initialization error
happened.
Patient Monitor user’s manual (V 2.2)
to
better
13-13
SpO2 Monitoring
Prompt message (include general alerts):
Message
Cause
SpO2 EXCEED
PR EXCEED
Alarm Level
SpO2 measuring value exceeds the range.
HIGH
PR measuring value exceeds the range.
HIGH
13.1.5 Masimo Information
The MASIMO SET® Product
®
Masimo Patents
This device is covered under one or more the following U.S. Patents: 5,482,036; 5,490,505;
5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830,
6,157,850 and international equivalents. U.S.A. and international patents pending.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use
the device with replacement parts which would, alone, or in combination with this device, fall
within the scope of one or more of the patents relating to this device.
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Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
13.2 PART 2 (MINDRAY SpO2 board configuration)
What is SpO2 Monitoring
SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of
hemoglobin in the arterial blood. If, for example, 97% hemoglobin molecules in the red blood
cells of the arterial blood combine with oxygen, then the blood has a SpO2 oxygen saturation
of 97%. The SpO2 numeric on the monitor will read 97% .The SpO2 numeric shows the
percentage of hemoglobin molecules which have combined with oxygen molecules to form
oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse rate signal and a
plethysmogram wave.
13.2.1 SpO2 Module
①
②
③
④
⑤
⑥
Figure 13-2
SPO2 module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the module
communicates with the host system triumphantly. If the indicator is still flashing, it
means that the SpO2 module or the slot has failure. In this case, the operator should
re-load the module. If the failure still exists, please contact the Mindray service
engineer for repair.
② SETUP:the button used to set up the related items of SpO2. Press SETUP button, the
Patient Monitor user’s manual (V 2.2)
13-15
SpO2 Monitoring
SPO2 SETUP menu appears on the screen. The user may modify any item in the menu
through using the rotary knob on the control panel.
③ Blank Button
④ A socket for SpO2 sensor: Before monitoring the patient, the user should first safely insert
the watertrap into this socket.
⑤
means “BE CAREFUL“. Refer to the attached document (this manual) of the
monitor.
⑥
means that the SpO2 module is IEC 60601-1 Type CF equipment.
Note
When not using the SpO2 module to monitor the patient, the user may unload the
module, which however must be stored in a clean and dry environment, otherwise the
life cycle of the module will be unfavorably affected.
How the SpO2 / PLETH Parameter Works
■
Arterial oxygen saturation is measured by a method called pulse oximetry. It is a
continuous, non-invasive method based on the different absorption spectra of reduced
hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on
one side of the sensor, is transmitted through patient tissue (such as a finger or an ear),
to a receiver on the other side.
The sensor measurement wavelengths are nominally 660nm for the Red LED and
940nm for Infrared LED. Maximum optical power output for LED is 4 mW.
■
The amount of light transmitted depends on many factors, most of which are constant.
However, one of these factors, the blood flow in the arteries, varies with time, because it
is pulsating. By measuring the light absorption during a pulsation, it is possible to derive
the oxygen saturation of the arterial blood. Detecting the pulsation gives a PLETH
waveform and pulse rate signal.
■
The SpO2 value and the PLETH waveform can be displayed on the main screen.
Warning
Pulse oximetry can overestimate the SpO2 value in the presence of Hb-CO, Met-Hb or
dye dilution chemicals.
SpO2 / Pulse Monitoring
Warning
ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up.
13-16
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
Warning
Do not put the sensor on extremities with arterial catheter or venous syringe.
Note
Do not perform SpO2 measuring and NIBP measuring in same arm at one time, because
obstruction of blood flow during NIBP measuring may adversely affect the reading of
SpO2 value.
13.2.2 Precautions during SpO2/Pulse Monitoring
Note
Make sure the nail covers the light window;
The wire should be on the backside of the hand.
Note
SpO2 value always displays at the same position. Pulse Rate will display when HR
FROM is set at "SPO2", “BOTH” in the ECG SETUP menu.
Note
SpO2 waveform is not proportional to the pulse volume.
Warning
Verify sensor cable fault detection before beginning of monitoring phase. Unplug the
SpO2 sensor cable from the socket, the screen will display the error message
“SENSOR OFF” and the audible alarm is activated.
Warning
Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is
damaged and return them to the vendor.
Warning
Prolonged and continuous monitoring may increase jeopardy of unexpected change of
dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive
putrescence, and so on. It is especially important to check the sensor placement of
neonate and patient of poor perfusion or immature dermogram by light collimation and
proper attaching strictly according to changes of the skin. Check per 2~3 hours the
Patient Monitor user’s manual (V 2.2)
13-17
SpO2 Monitoring
sensor placement and move it when the skin deteriorates. More frequent examinations
may be required for different patients.
13.2.3 Monitoring Procedure
Adult SpO2 plethysmogram measurement
4. Switch on the monitor.
5. Attach the sensor to the appropriate site of the patient finger.
6. Plug the connector of the sensor extension cable into the SpO2 socket on the SpO2 module.
Figure 13-3
mounting of the adult sensor
Neonate SpO2 plethysmogram measurement
The process of neonate SpO2 plethysmogram measurement is the same as for adult. The
neonate SpO2 sensor and install method will be introduced.
1. Neonate SpO2 sensor
Neonate SpO2 sensor consists of Y-form SpO2 sensor and its sheath. Insert the LED and PD
ends of the Y-form SpO2 sensor respectively into the upper and lower grooves on the sheath
(figure 13-3). Figure 13-4 shows us the neonate SpO2 sensor after insertion.
Y-form SpO2 sensor
Neonate SpO2 sensor sheath
Figure 13-4
13-18
Neonate SpO2 sensor (1)
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
Figure 13-5
neonate SpO2 sensor (2)
2. Mounting of the neonate SpO2 sensor
Wind the SpO2 sensor around a hand or foot. Hold the sensor, pull the belt and fit one of its
sides with “V” edge into the “V” groove on the corresponding side of the sheath. Appropriately
elongate the belt (about 20mm) and fit the “V” edge of the other side of the belt into the “V”
groove of the other side of the sheath and then loosen the belt. After the “V” edges of the two
sides of the belt fit well into the “V” grooves on the two sides of the sheath, put the belt into
the first lock bar to fasten the belt. See figure 13-5. If the belt is too much long, you may put it
into the second lock bar. You must position the SpO2 sensor in this way so as to make the
photoelectric component face the correct position. In the mean time, note not to elongate the
belt too much, which may cause venous pulsation and therefore result in inaccurate
measurement and also blocking the blood circulation severely.
Figure 13-6
mounting of the neonate sensor
Note
If the sensor can not be positioned accurately to the part to be measured, it may result
in inaccurate SpO2 reading, or even that the SpO2 cannot be measured because no
pulse is detected. If this is true, you must position the sensor again.
The excessive patient movement may result in inaccurate reading. In this situation, you
must keep the patient quiet or change the part for monitoring to reduce the adverse
influence of excessive movement.
Warning
In the process of extended and continuous monitoring, you should check the
Patient Monitor user’s manual (V 2.2)
13-19
SpO2 Monitoring
peripheral circulation and the skin every 2 hours. If any unfavorable changes take
place, you should change the measured position in time.
In the process of extended and continuous monitoring, you should periodically check
the position of the sensor. In case that the position of the sensor moves during
monitoring, the measurement accuracy may be affected.
13.2.4 Limitations for Measurement
Measurement Limitations
In operation, the accuracy of oximetry readings can be affected by:
High-frequency electrical noise, including noise created by the host system, or noise
from external sources, such as electrosurgical apparatus, which is admitted by the host
system.
Do not use oximeters and oximetry sensors during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns.
Intravascular dye injections
Excessive patient movement
Improper sensor application
Sensor temperature (maintain between 28°C and 42°C for best operation )
Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter,
or intravascular line
Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and
methemoglobin
External illumination more than 5,000 lumens/square meter (typical office lighting)
Venous pulsations
It is recommended to use SpO2 sensors described in chapter Accessories and Ordering
Information.
Shock, anemia, low temperature and the use of vasoconstrictive drug can cause the
blood flow in the artery to reduce to a value exceeding the measurement range.
Measurement is also dependent on the properties of HbO2 and deoxyhemoglobin to
absorb lights of special wavelengths. If there are materials that can absorb the lights of
the same wavelengths, false or low SpO2 value may be resulted. These materials
include COHb, MetHb, indigo carmine, etc.
13.2.5 SpO2 Menu
SPO2 SETUP Menu
There are two ways to access the SPO2 SETUP menu:
Pick the SETUP button on the SpO2 module to access the SPO2 SETUP menu as shown
below.
Turn the rotary knob on the control panel to move the cursor on the screen to the SPO2
hot key in the parameter area and then press the knob to directly access the SPO2
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Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
SETUP menu.
Figure 13-7
SPO2 SETUP menu
Warning
Setting the SpO2 upper alarm limit to 100% is equivalent to switching off the alarm on
upper limit. High oxygen levels may predispose a premature infant to retrolental
fibroplasia. Therefore, the upper alarm limit for oxygen saturation must be carefully
selected in accordance with commonly accepted clinical practices.
SpO2 alarm setting
• ALM: pick "ON" to enable prompt message and data record during the SpO2 alarm;
pick "OFF" to disable the alarm function, and there will be a
beside “SpO2”.
• ALM REC: pick "ON" to enable report printing upon SpO2 alarm.
• ALM LEV: used to set up alarm level, selectable from HIGH, MED and LOW. HIGH
represents the most serious case.
• SpO2 alarm is activated when the result exceeds set SPO2 ALM HI value or falls below
SPO2 ALM LO value. Use the knob to pick the SPO2 ALM HI or SPO2 ALM LOW item
and turn the knob to select the desired alarm limit.
• PR alarm is activated when the pulse rate exceeds set PR ALM HI value or falls below
PR ALM LO value. Use the knob to pick the PR ALM HI or PR ALM LOW item and turn
the knob to select the desired alarm limit.
SpO2 and PR alarm limits:
Max. Upper Limit
Min. Lower Limit
Step
SpO2
100
0
1
PR
254
0
1
■
SWEEP
Available options for SPO2 SWEEP are 12.5, 25.0 mm/s.
Patient Monitor user’s manual (V 2.2)
13-21
SpO2 Monitoring
■
PR SOUND
Pulse beep volume. Options are OFF, HIGH, MED, LOW.
■
AVG TIME
4S, 8S,16S represent times that SpO2 average value is counted.
■
SETUP TRANSFER
Pick this item to access SPO2 SETUP TRANSFER dialog box
Figure 13-8
SPO2 SETUP Transfer menu
Whose functions are:
RT TRANSFER
Refers to real-time transfer. Three selections are available:
1. OFF: when choose the OFF selection, the system will not automatically save the
modifications to the SpO2 module into the SpO2 module.
2. ON: when choose the ON selection, the system first saves all the setups into the
SpO2 module and then saves the modifications to the module into the SpO2 module
immediately. For the newly loaded SpO2 module, default is OFF
SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the module are loaded into the system.
When using this function, the warning “Menu item will adopt the value from the
module. Yes?” will be appearing on the screen. And the system will execute the
operation after the confirmation of the user.
■ DEFAULT: pick this item to access the SPO2 DEFAULT CONFIG dialog box, in which
the user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation.
13.2.6 Alarm Description and Prompt
SpO2 Alarm Message
Among physiological alarms, those belonging to the type that the parameter has exceeded
13-22
Patient Monitor user’s manual (V 2.2)
SpO2 Monitoring
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
TABLES BELOW DESCRIBE THE POSSIBLE PHYSIOLOGICAL ALARMS,
TECHNICAL ALARMS AND PROMPT MESSAGES OCCURRING DURING SPO2
MEASUREMENT.
Physiological
alarm Message
SPO2 TOO HIGH
SpO2 TOO LOW
PR TOO HIGH
PR TOO LOW
Cause
Alarm Level
SpO2 measuring value is above upper alarm
limit.
User-selectable
SpO2 measuring value is below lower alarm limit.
PR measuring value is above upper alarm limit.
PR measuring value is below lower alarm limit.
Technical
alarmsMessage
SPO2 SENSOR OFF
SPO2 INIT ERR
Cause
SpO2 sensor may
be
disconnected
from the patient or
the monitor.
SpO2
failure
module
SPO2 COMM STOP
SpO2
module
failure
or
communication
error
SPO2 COMM ERR
SpO2
module
failure
or
communication
error
SPO2 ALM LMT ERR
Functional
failure
safety
PR ALM LMT ERR
Functional
safety
User-selectable
User-selectable
User-selectable
Alarm
Level
Remedy
LOW
Make sure that the
monitor and the patient
are in correct connection
with the cables.
HIGH
HIGH
HIGH
HIGH
HIGH
Patient Monitor user’s manual (V 2.2)
Stop
using
the
measuring function of
SpO2 module, notify
biomedical engineer or
Mindray service staff.
Stop
using
the
measuring function of
SpO2 module, notify
biomedical engineer or
Mindray service staff.
Stop
using
the
measuring function of
SpO2 module, notify
biomedical engineer or
Mindray service staff.
Stop
using
the
measuring function of
SpO2 module, notify
biomedical engineer or
Mindray service staff.
Stop
using
the
13-23
SpO2 Monitoring
failure
measuring function of
SpO2 module, notify
biomedical engineer or
Mindray service staff.
Prompt message (include general alerts):
Message
Cause
Alarm Level
SPO2 EXCEED
SpO2 measuring value exceeds the range.
HIGH
PR EXCEED
PR measuring value exceeds the range.
HIGH
SEARCH PULSE
SpO2 module is searching for pulse.
NO PULSE
SpO2 module cannot detect SpO2 signal for a
long time.
No alarm
HIGH
13.2.7 Maintenance and Cleaning
Care and Cleaning
Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched
off and disconnected from the power line.
Warning
Do not subject the sensor to autoclaving.
Do not immerse the sensor into any liquid.
Do not use any sensor or cable that may be damaged or deteriorated.
For cleaning:
Use a cotton ball or a soft mull moistened with hospital-grade ethanol to wipe the surface
of the sensor, and then dry it with a cloth. This cleaning method can also be applied to
the luminotron and receiving unit.
The cable can be cleaned with 3% hydrogen dioxide, 70% isopropanol, or other active
reagent. However, connector of the sensor shall not be subjected to such solution.
13-24
Patient Monitor user’s manual (V 2.2)
Chapter 14 NIBP Monitoring
14.1 Introduction
■
Reference to the European standard EN 1060-1: Specification for Non-invasive
sphygmomanometers Part 1, General requirements.
■
The Non-invasive Blood Pressure (NIBP) module measures the blood pressure using the
oscillometric method.
■
It is applicable for adult, pediatric, and neonatal usage.
■
There are three modes of measurement available: manual, automatic and continuous.
Each mode displays the diastolic, systolic and mean blood pressure.
In the MANUAL mode, only one measurement is conducted for each time.
In the AUTO mode, the measurement is cycled; you can set the interval time to
1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes.
In the continuous mode, the monitor measures the blood pressure as many times as
possible in five minutes.
Warning
1. You must not perform NIBP measurements on patients with sickle-cell disease or
under any condition which the skin is damaged or expected to be damaged.
2. For a thrombasthemia patient, it is important to determine whether measurement of
the blood pressure shall be done automatically. The determination should be based
on the clinical evaluation.
3. Ensure that the correct setting is selected when performing measurements on
children. It may be dangerous for the children to use an over pressure level.
Patient Monitor user’s manual (V 2.2)
14-1
NIBP Monitoring
14.2 NIBP Module
①
③
②
④
⑥
⑤
Figure 14-1
NIBP module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the module
communicates with the host system triumphantly. If the indicator is still flashing, it
means that the NIBP module or the slot has failure. In this case, the operator should
re-load the module. If the failure still exists, please contact the Mindray service
engineer for repair.
② SETUP:the button used to set up the related items of NIBP. Press SETUP button, the
NIBP menu appears on the screen. The user may modify any item in the menu through
using the rotary knob on the control panel.
③ START/STOP: the button is used to start/stop the NIBP measurement.
④ A socket for NIBP: a socket for NIBP air hose. Before monitoring the patient, the user
should first safely insert the NIBP air hose into this socket.
⑤
means “BE CAREFUL“. Refer to the attached document (this manual) of the
monitor.
⑥
means that the NIBP module is IEC 60601-1 Type CF equipment.
Note
When not using the NIBP module to monitor the patient, the user may unload the
module, which however must be stored in a clean and dry environment, otherwise the
life cycle of the module will be unfavorably affected.
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NIBP Monitoring
14.3 NIBP Monitoring
14.3.1
NIBP Measuring
Warning
■
Before starting a measurement, verify that you have selected a setting appropriate
for your patient (adult, pediatric or neonate.)
■
Do not apply the cuff to a limb that has an intravenous infusion or catheter in
place. This could cause tissue damage around the catheter when infusion is
slowed or blocked during cuff inflation.
Warning
Make sure that the air conduit connecting the blood pressure cuff and the monitor is
neither blocked nor tangled.
1.
Plug in the air hose and switch on the system.
2.
Apply the blood pressure cuff to the patient's arm or leg following the instructions below
(Figure 14-2).
■
Ensure that the cuff is completely deflated.
■
Apply the appropriate size cuff to the patient, and make sure that the symbol "Φ" is over
the appropriate artery. Ensure that the cuff is not wrapped too tightly around the limb.
Excessive tightness may cause discoloration and eventual ischemia of the extremities.
Figure 14-2
Applying Cuff
Note
The width of the cuff should be either 40% of the limb circumference (50% for neonates)
or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to
encircle 50-80% of the limb. The wrong size of cuff can cause erroneous readings. If
the cuff size is in question, then use a larger cuff.
Patient Monitor user’s manual (V 2.2)
14-3
NIBP Monitoring
Size of reusable cuff for neonate/children/adult
Patient Type
Limb perimeter
Cuff width
Hose
Infant
10 ~19 cm
8 cm
Child
18 ~ 26 cm
10.6 cm
1.5 m
Adult
25 ~ 35 cm
14 cm
or
Large Adult
33 ~ 47 cm
17 cm
3m
Thigh
46 ~ 66 cm
21 cm
Size of disposable cuff for neonate/children/adult
Size No.
■
Limb perimeter
Cuff width
1
3.1 ~ 5.7 cm
2.5 cm
2
4.3 ~ 8.0 cm
3.2 cm
3
5.8 ~ 10.9 cm
4.3 cm
4
7.1 ~ 13.1 cm
5.1 cm
Hose
1.5 m
or
3m
Make sure that the cuff edge falls within the range of mark <->. If it does not, use a larger
or smaller cuff that fits better.
3.
Connect the cuff to the air hose. The limb chosen for taking the measurement should be
placed at the same level as the patient's heart. If this is not possible you should apply the
following corrections to the measured values:
■
If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa) for each cm of
difference.
■
If it is placed lower than the heart level, deduct 0.75 mmHg (0.10 kPa) for each cm of
difference.
4.
Check whether the patient mode is appropriately selected. Access PATIENT SETUP
menu from SYSTEM MENU and pick PAT TYPE item and turn the knob to select the
required patient type.
5.
Press the SETUP button on the NIBP module to call up the NIBP SETUP menu.
6.
Press the START/STOP button on the NIBP module to start a measurement.
Operation Hints
1.
To start auto measuring:
Access NIBP SETUP menu and pick the INTERVAL item, in which the user may choose
the selections other than MANUAL to set up the time interval for auto measurement. After
that, press START/STOP button on the NIBP module to start the auto measuring
according to the selected time interval.
Warning
Prolonged non-invasive blood pressure measurements in Auto mode may be
14-4
Patient Monitor user’s manual (V 2.2)
NIBP Monitoring
associated with purport, ischemia and neuropathy in the limb wearing the cuff. When
monitoring a patient, examine the extremities of the limb frequently for normal color,
warmth and sensitivity. If any abnormality is observed, stop the blood pressure
measurements.
2.
To stop auto measuring:
During auto measuring press START/STOP button on the NIBP module at any time to
stop auto measurement.
3.
To start a manual measuring:
Access NIBP SETUP menu and pick the INTERVAL item. Select the MANUAL
selection. Then press the START/STOP button on the NIBP module to start a
manual measurement.
During the idle period of auto measuring process, press the START/STOP button on
the NIBP module at any time to start a manual measurement. Then press the
START/STOP button on the NIBP module to stop manual measurement and the
system continues executes auto-measuring program according to selected time
interval.
4.
To start a manual measuring during the AUTO mode:
Press START/STOP button on the NIBP module.
5.
To stop a manual measuring
Repress the START/STOP button on the NIBP module again.
6.
To perform continuous measuring:
Access NIBP SETUP menu and pick the CONTINUAL item to start the continuous
measurement. The monitor will measure as many times of NIBP as possible within 5
minutes.
Warning
Prolonged non-invasive blood pressure measurements in continual mode may be
associated with purport, ischemia and neuropathy in the limb wearing the cuff. When
monitoring a patient, examine the extremities of the limb frequently for normal color,
warmth and sensitivity. If any abnormality is observed, stop the blood pressure
measurements.
7.
To stop continuous measuring:
During continuous measuring press START/STOP button on the NIBP module at any
time to stop continuous measurement.
Note
If you are in doubt about the accuracy of any reading(s), check the patient's vital signs
by an alternative method before checking the functioning of the monitor.
Warning
Patient Monitor user’s manual (V 2.2)
14-5
NIBP Monitoring
If liquid is inadvertently splashed on the equipment or its accessories, or may enter the
conduit or inside the monitor, contact local Customer Service Center.
Measurement Limitations
To different patient conditions, the oscillometric measurement has certain limitations. The
measurement is in search of regular arterial pressure pulse. In those circumstances when the
patient's condition makes it difficult to detect, the measurement becomes unreliable and
measuring time increases. The user should be aware that the following conditions could
interfere with the measurement, making the measurement unreliable or longer to derive. In
some cases, the patient's condition will make a measurement impossible.
Patient Movement
Measurements will be unreliable or may not be possible if the patient is moving, shivering or
having convulsions. These motions may interfere with the detection of the arterial pressure
pulses. In addition, the measurement time will be prolonged.
Cardiac Arrhythmia's
Measurements will be unreliable and may not be possible if the patient's cardiac arrhythmia
has caused an irregular heartbeat. The measuring time thus will be prolonged.
Heart-lung Machine
Measurements will not be possible if the patient is connected to a heart-lung machine.
Pressure Changes
Measurements will be unreliable and may not be possible if the patient's blood pressure is
changing rapidly over the period of time during which the arterial pressure pulses are being
analyzed to obtain the measurement.
Severe Shock
If the patient is in severe shock or hypothermia, measurements will be unreliable since
reduced blood flow to the peripheries will cause reduced pulsation of the arteries.
Heart Rate Extremes
Measurements can not be made at a heart rate of less than 40 bpm and greater than 240
bpm.
Fatty patient
The thick fat layer around the extremity may prevent the oscillation in the artery from coming
to the cuff, which therefore leads to decreased accuracy.
14.3.2
NIBP monitoring screen
NIBP measurement result and corresponding message are displayed as follows:
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Patient Monitor user’s manual (V 2.2)
NIBP Monitoring
Time of measurement
Measurement value
Measurement mode
Message
NIBP
16: 50
108
84
mmHg
BP unit
70
NS Alarm limit
MANUAL
Current cuff pressure
Manual measure ……
CUFF:100
14.4 NIBP SETUP menu
There are two ways for the users to access the NIBP SETUP menu:
Pick the SETUP button on the NIBP module to access the NIBP SETUP menu as shown
below.
Turn the rotary knob on the control panel to move the curse on the screen to the NIBP
hot key in the parameter area and then press the rotary knob to directly access the NIBP
SETUP menu.
Figure 14-3
ν
NIBP SETUP Menu
NIBP alarm setting
• ALM: pick "ON" to enable prompt message and data record during the NIBP alarm;
pick "OFF" to disable the alarm function, and there will be a
beside “NIBP”.
• ALM LEV: selectable from HIGH, MED to LOW. HIGH represents the most serious
case.
• ALM REC: pick "ON" to enable report printing upon NIBP alarm.
• SYS ALM HI, SYS ALM LOW, MEAN ALM HI, MEAN ALM LO, DIA ALM HI, DIA ALM
LO are for the user to set up the alarm limit for each type of pressure. NIBP alarm is
activated when the pressure exceeds set upper alarm limits or falls below lower alarm
limits.
Patient Monitor user’s manual (V 2.2)
14-7
NIBP Monitoring
NIBP alarm limits:
Adult Mode
SYS
40-270 mmHg
DIA
10-215 mmHg
Mean
20-230 mmHg
Pediatric Mode
SYS
40-200 mmHg
DIA
10-150 mmHg
Mean
20-165 mmHg
Neonatal Mode
■
SYS
40-135 mmHg
DIA
10-100 mmHg
Mean
20-105 mmHg
RESET
Restore measurement status.
Pick this item to restore initial settings of the pressure pump.
When the pressure does not work properly and the system fails to give message for the
problem, pick this item to activate self-test procedure, thus restore the system from
abnormal performance.
■
CONTINUAL
Start continuous measuring.
When this item is picked, the menu will disappear automatically.
■
INTERVAL
Interval
time
for
automatic
measuring.
Available
selections:
1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes. Press START/STOP button on the
NIBP module to start the first auto measuring.
Pick MANUAL selection in INTERVAL item to set up the measuring mode to MANUAL.
■
UNIT
Pick this item to set measurement unit. (Option: mmHg or kPa)
■
CALIBRATE
Calibrate the cuff pressure reading with a calibrated reference manometer. Pick the
CALIBRATE item to start the calibration and the item will change into STOP CAL, which if
picked, the system will stop calibration.
Warning
The calibration of the NIBP measurement is necessary for every two years (or as
frequently as dictated by your Hospital Procedures Policy). The performance should be
checked according to the following details.
Procedure of the Pressure Transducer Calibration:
Replace the cuff of the device with a rigid metal vessel with a capacity of 500 ml ± 5%.
14-8
Patient Monitor user’s manual (V 2.2)
NIBP Monitoring
Connect a calibrated reference manometer with an error less than 0.8 mmHg and a ball pump
by means of a T-piece connector and hoses to the pneumatic system. Set the monitor in
CALIBRATE mode. Inflate the pneumatic system to 0, 50 and 200 mmHg by ball pump
separately. The difference between the indicated pressure of the reference manometer and
the indicated pressure of the monitor will not exceed 3 mmHg. Otherwise, please contact our
customer service.
Figure 14-4
■
Diagram of NIBP calibration
PNEUMATIC
This item is used for air leakage test. Turn the knob to pick the item to start the air
leakage test. Then the item will change into STOP PENUM, which if picked, the system
will stop air leakage test.
Warning
This pneumatic test other than being specified in the EN 1060-1 standard is to be used
by the user to simply determine whether there are air leaks in the NIBP airway. If at the
end of the test the system gives the prompt that the NIBP airway has air leaks, please
contact the manufacturer for repair.
Procedure of the air leakage test:
1) Connect the cuff securely with the socket for NIBP air hole.
2) Wrap the cuff around the cylinder of an appropriate size.
3) Access the NIBP SETUP menu.
4) Turn the knob to the PNEUMATIC item and press the knob. Then the prompt “Pneum
testing…” will appear on the bottom of the NIBP parameter area indicating that the
system has started performing pneumatic test.
5) Inflate the pneumatic system to about 180mmHg automatically.
6) After 20 seconds or so, the system will automatically open the deflating valve, which
marks the completion of a pneumatic measurement.
7) If no prompt appears on the bottom of the NIBP parameter area, it indicates that the
airway is in good situation and no air leaks exist. However if the prompt “PNEUMATIC
LEAK” appears in the place, it indicates that the airway may have air leaks. In this case,
the user should check for loose connection. After confirming secure connections, the
Patient Monitor user’s manual (V 2.2)
14-9
NIBP Monitoring
user should re-perform the pneumatic test. If the failure prompt still appears, please
contact the manufacturer for repair.
Figure 14-5
■
Diagram of NIBP air leakage test
SETUP TRANSFER
Pick this item to access NIBP SETUP TRANSFER dialog box.
Figure 14-6
NIBP SETUP menu
Whose functions are:
RT TRANSFER
Refers to real-time transfer. Three selections are available:
1. OFF: when choose the OFF selection, the system will not automatically save the
modifications to the NIBP module into the NIBP module.
2. ON: when choose the ON selection, the system first saves all the setups into the
NIBP module and then saves the modifications to the module into the NIBP module
immediately. For the newly loaded NIBP module, default is OFF
SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the module are loaded into the system.
When using this function, the warning “Menu item will adopt the value from the
module. Yes?” will be appearing on the screen. And the system will execute the
operation after the confirmation of the user.
■
DEFAULT: pick this item to access the NIBP DEFAULT CONFIG dialog box, in which the
user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation.
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NIBP Monitoring
14.5 NIBP Alarm Message
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during NIBP measurement.
Physiological alarms:
Message
Cause
Alarm Level
NIBP SYS measuring value is
upper alarm limit.
NIBP SYS measuring value is
NS TOO LOW
lower alarm limit.
NIBP DIA measuring value is
ND TOO HIGH
upper alarm limit.
NIBP DIA measuring value is
ND TOO LOW
lower alarm limit.
NIBP MAP measuring value is
NM TOO HIGN
upper alarm limit.
NIBP MAP measuring value is
NM TOO LOW
lower alarm limit.
Technical alarms 1: (display in information area)
Alarm
Message
Cause
Level
NS TOO HIGH
above
below
above
below
above
below
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
Remedy
Stop using alarming functions of
NIBP module and notify biomedical
engineer or Mindray service staff.
Stop using alarming functions of
Functional safety
NM ALM LMT ERR
HIGH NIBP module and notify biomedical
failure
engineer or Mindray service staff.
Stop using alarming functions of
Functional safety
ND ALM LMT ERR
HIGH NIBP module and notify biomedical
failure
engineer or Mindray service staff.
Technical alarms 2: (display in the area below the NIBP value)
Alarm
Remedy
Message
Cause
Level
Sensor
or
other
Stop using measuring function of
NIBP SELF TEST
hardware of NIBP HIGH NIBP module, notify biomedical
ERR
module is incorrect.
engineer or Mindray service staff.
If failure persists, stop using
measuring function of NIBP module,
Communication with
HIGH
NIBP COMM ERR
notify
biomedical
engineer
or
NIBP module is failed.
Mindray service staff.
Cuff is no properly
LOOSE CUFF
wrapped or no cuff LOW Properly wrap the cuff
exists.
Cuff,
hose
or
Check and replace the leaking parts,
AIR LEAK
connector
is LOW if
required,
notify
biomedical
damaged.
engineer or Mindray service staff.
Stable pressure value
Check if the hoses are tangled, if
AIR PRESSURE
is not available. e.g. LOW failure persists, notify biomedical
ERROR
hoses are tangled.
engineer or Mindray service staff.
NS ALM LMT ERR
Functional safety
failure
HIGH
Patient Monitor user’s manual (V 2.2)
14-11
NIBP Monitoring
WEAK SIGNAL
Cuff is too loose or
patient pulse is too
weak.
RANGE
EXCEEDED
Measuring
range
exceeds the specified
upper limit.
EXCESSIVE
MOTION
OVER PRESSURE
SIGNAL
STURATED
PNEUMATIC LEAK
LOW
Use other method to measure blood
pressure.
HIGH
Reset NIBP module, if failure
persists, stop using measuring
function of NIBP module, notify
biomedical engineer or Mindray
service staff.
LOW
Make sure that the patient under
monitoring is motionless.
HIGH
Measure again, if failure persists,
stop using measuring function of
NIBP module and notify biomedical
engineer or Mindray service staff.
Excessive motion
LOW
Stop the patient from moving.
During
pneumatic
test, leak is detected.
LOW
Affected
by
arm
motion, signal noise is
too large or pulse rate
is not regular.
Pressure
has
exceeded
the
specified upper safety
limit.
Check and replace the leaking parts,
if
required,
notify
biomedical
engineer or Mindray service staff.
Stop using measuring function of
NIBP module, notify biomedical
engineer or Mindray service staff.
Operation of blood
pressure
pump HIGH
system is failed.
Cuff type does not
CUFF TYPE ERR
comply
with
the LOW Select appropriate cuff type
patient type.
Measuring time has
exceeded
120
Measure again or use other
NIBP TIME OUT
HIGH
seconds (adult) or 90
measuring method.
seconds (neonatal).
NIBP ILLEGALLY
Abnormal
module
HIGH Reset again
RESET
reset
Problem
happens
when measuring the
Check the cuff. Make sure that the
curve. The system
MEASURE FAIL
cannot
perform HIGH patient
under
monitoring
is
measurement,
motionless. Measure again.
analysis
or
calculation.
Prompt message: (display in the prompt area below NIBP value)
NIBP SYSTEM
FAILURE
Message
Manual measure…
During manual measuring mode.
Cont measuring…
During continuous measuring mode.
Auto measuring…
During automatic measuring mode.
Please start
Measurement over
Calibrating…
14-12
Cause
After
selecting
interval
between
measurements in MENU
Press
START/STOP
key
during
measuring to stop measurement
During calibrating
Calibration over
Calibration over
Pneum testing…
During pneumatic test
Pneum test over
pneumatic test over
Patient Monitor user’s manual (V 2.2)
Alarm Level
No alarm
NIBP Monitoring
Resetting...
NIBP module in resetting
Reset failed
NIBP module reset failed
14.6 Maintenance and Cleaning
Warning
■
Do not squeeze the rubber tube on the cuff.
■
Do not allow liquid to enter the connector socket at the front of the monitor.
■
Do not wipe the inner part of the connector socket when cleaning the monitor.
■
When the reusable cuff is not connected with the monitor, or being cleaned,
always place the cover on the rubber tube to avoid liquid permeation.
Reusable Blood Pressure Cuff
The cuff can be sterilized by means of conventional autoclaving, gas, or radiation sterilization
in hot air ovens or disinfected by immersion in decontamination solutions, but remember to
remove the rubber bag if you use this method. The cuff should not be dry-cleaned.
The cuff can also be machine-washed or hand-washed, the latter method may prolong the
service life of the cuff. Before washing, remove the latex rubber bag, and for
machine-washing, close the Velcro fastening. Allow the cuff to dry thoroughly after washing,
then reinsert the rubber bag.
Figure 14-7
Replace Rubber Bag in Cuff
Patient Monitor user’s manual (V 2.2)
14-13
NIBP Monitoring
To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the rubber
tubes line up with the large opening on the long side of the cuff. Now roll the bag lengthwise
and insert it into the opening on the long side of the cuff. Hold the tubes and the cuff and
shake the complete cuff until the bag is in position. Thread the rubber tubes from inside the
cuff, and out through the small hole under the internal flap.
Disposable Blood Pressure Cuffs
Disposable cuffs are intended for one-patient use only. Do not use the same cuff on any other
patient. Do not sterilize or use autoclave on disposable cuffs. Disposable cuffs can be cleaned
using soap solution to prevent infection.
Note
For protecting environment, the disposable blood pressure cuffs must be recycled or
disposed of properly.
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Patient Monitor user’s manual (V 2.2)
Chapter 15 TEMP Monitoring
15.1 TEMP Monitoring
TEMP monitoring setup
If you are using disposable TEMP probes you need to plug the TEMP cable into the
monitor and then connect the probe to the cable. With a reusable TEMP probe you can
plug the probe directly into the monitor.
Apply the TEMP probe(s) securely to the patient.
Switch on the system.
Warning
Verify probe cables fault detection before beginning of monitoring phase. Unplug the
temperature probe cable of the channel 1 from the socket, the screen will display the
error message “T1 SENSOR OFF” and the audible alarm is activated. The other
channel is the same.
Warning
Handle the TEMP probes with due care. The probe and cable should be rolled up to a
loose loop when not in use. Over straining will result in mechanical damage of the
probes.
Warning
The calibration of the temperature measurement is necessary for every two years (or
as frequently as dictated by your Hospital Procedures Policy). When you need calibrate
the temperature measurement, contact the manufacture please.
Warning
If use two TEMP probes, them must be made by the same manufacture.
Note
Disposable TEMP probe can only be used once for one patient.
Note
Patient Monitor user’s manual (V 2.2)
15-1
TEMP Monitoring
Disposable TEMP probe can only be used once for one patient.
The self-test of the temperature measurement is performed automatically once per
hour during the monitoring. The test procedure lasts about 2 seconds and does not
affect the normal measurement of the temperature monitoring.
15.2 TEMP Module
TEMP module refers also to the ECG/TEMP module. It is a standard module incorporating
functions of ECG, RESP and TEMP monitoring. For ECG, RESP monitoring, refer to Chapter
12.
Figure 15-1
TEMP module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the module
communicates with the host system triumphantly. If the indicator is still flashing, it
means that the ECG/TEMP module or the slot has failure. In this case, the operator
should re-load the module. If the failure still exists, please contact the Mindray service
engineer for repair.
② SETUP:the button used to set up the related items of ECG/REST/TEMP. Press SETUP
button, the ECG/RESP/TEMP SETUP menu appears on the screen. The user may modify
any item in the menu through using the rotary knob on the control panel.
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Patient Monitor user’s manual (V 2.2)
TEMP Monitoring
③ Blank Button
④ Two sockets for TEMP sensor: Before monitoring the patient, the user should first safely
insert the TEMP sensor cable into this socket.
⑤ A socket for ECG
⑥
means “BE CAREFUL“. Refer to the attached document (this manual) of the
monitor.
⑦
means that the ECG/TEMP module is IEC 60601-1 Type CF equipment.
Note
When not using the ECG/TEMP module to monitor the patient, the user may unload the
module, which however must be stored in a clean and dry environment, otherwise the
life cycle of the module will be unfavorably affected.
15.3 TEMP SETUP Menu
There are two ways to access the TEMP SETUP menu:
Press the SETUP button on the ECG/TEMP module to access the ECG/RESP/TEMP
SETUP menu. Pick the TEMP SETUP to call up the TEMP SETUP menu as shown
below.
Turn the rotary knob on the control panel to move the cursor on the screen to the TEMP
hot key in the parameter area and then press the knob to directly access the TEMP
SETUP menu.
Figure 15-2
TEMP SETUP Menu
TEMP alarm setting
• ALM: pick "ON" to enable prompt message and data record during the TEMP alarm; pick
"OFF" to disable the alarm function, and prompt the
symbol beside TEMP numeric.
Patient Monitor user’s manual (V 2.2)
15-3
TEMP Monitoring
• ALM LEV: used to set up the alarm level, selectable from HIGH, MED or LOW.
• ALM REC: used to start/stop recording TEMP alarms. Pick "ON" to enable report printing
upon TEMP alarm.
• Alarm for T1, T2 and TD occurs when the measured temperature exceeds set alarm high
limit or falls below alarm low limit.
T1 is Channel-1 temperature, T2 is Channel-2 temperature, TD is the temperature
difference between the above two.
TEMP alarm limits:
Max. TEMP HI
Min. TEMP LO
Step
50
0
0.1
50
0
To set temperature unit (ºC or ºF).
0.1
T1, T2
TD
■ UNIT
■
SETUP TRANSFER
see
chapter
ECG/RESP
Monitoring
for
ECG
SETUP
TRANSFER.
■
DEFAULT
see chapter ECG/RESP Monitoring for ECG DEFAULT CONFIG.
15.4 TEMP Alarm message
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during TEMP measurement.
Physiological alarms:
Message
T1 TOO HIGH
TI TOO LOW
T2 TOO HIGH
T2 TOO LOW
TD TOO HIGH
Cause
Alarm Level
Measuring value of channel 1 is above
upper alarm limit.
Measuring value of channel 1 is below
lower alarm limit.
Measuring value of channel 2 is above
upper alarm limit.
Measuring value of channel 2 is below
lower alarm limit.
Difference between two channels is
larger than upper limit.
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
Technical alarms:
Alarm Message
T1 SENSOR OFF
15-4
Cause
Temperature
cable of channel
1
may
be
disconnected
from the monitor.
Alarm
Level
Remedy
LOW
Make sure that the cable is
properly connected.
Patient Monitor user’s manual (V 2.2)
TEMP Monitoring
T2 SENSOR OFF
Temperature cable
of channel 2 may be
disconnected from
the monitor.
T1 ALM LMT ERR
Functional
failure
safety
T2 ALM LMT ERR
Functional
failure
safety
TD ALM LMT ERR
Functional
failure
safety
LOW
Make sure that the cable is
properly connected.
HIGH
Stop using alarming function
of TEMP module, notify
biomedical
engineer
or
Mindray service staff.
HIGH
Stop using alarming function
of TEMP module, notify
biomedical
engineer
or
Mindray service staff.
HIGH
Stop using alarming function
of TEMP module, notify
biomedical
engineer
or
Mindray service staff.
Prompt message:
Message
T1 EXCEED
T2 EXCEED
Cause
Alarm Level
Measuring value of channel 1 is beyond
measuring range.
Measuring value of channel 2 is beyond
measuring range.
HIGH
HIGH
15.5 Care and Cleaning
Warning
Before cleaning the monitor or the probe, make sure that the equipment is switched off
and disconnected from the power line.
Reusable TEMP Probes
1
The TEMP probe should not be heated above 100℃ (212℉). It should only be
subjected briefly to temperatures between 80℃ (176℉) and 100℃ (212℉).
2
The probe must not be sterilized in steam.
3
Only detergents containing no alcohol can be used for disaffection.
4
The rectal probes should be used, if possible, in conjunction with a protective rubber
cover.
5
To clean the probe, hold the tip with one hand and with the other hand rubbing the
probe down in the direction of the connector using a moist lint-free cloth.
Note
Disposable TEMP probe must not be re-sterilized or reused.
Note
Patient Monitor user’s manual (V 2.2)
15-5
TEMP Monitoring
For protecting environment, the disposable TEMP probe must be recycled or disposed
of properly.
15-6
Patient Monitor user’s manual (V 2.2)
Chapter 16 IBP Monitoring
16.1
General
This chapter introduces IBP measurement, maintenance and cleaning of relevant
accessories.
This chapter mainly describes the information about IBP module, including the specifications
of the module, the method to use the module to measure some indexes of invasive blood
pressure. Also information about how to maintain and clean the module is briefed in the
chapter. Using the PM-6000, the user may simultaneously monitor maximum 4-channel IBP of
2 modules, i.e., one module has IBP1 and IBP2, the other module has IBP3 and IBP4.
16.2
IBP Module
Figure 16-1
IBP module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the
module communicates with the host system triumphantly. If the indicator is still
flashing, it means that the IBP module or the slot has failure. In this case, the
operator should re-load the module. If the failure still exists, please contact the
Mindray service engineer for repair.
Patient Monitor user’s manual (V 2.2)
16-1
IBP Monitoring
② SETUP:the button used to set up the related items of IBP. Press SETUP button, the
IBP(1,2) SETUP menu appears on the screen. The user may modify any item in the menu
through using the rotary knob on the control panel.
③ ZERO: used to zero the IBP module.
④ CAL: used to calibrate the IBP module.
⑤ Two sockets for IBP: socket for IBP sensor. Before monitoring the patient, the user should
first safely insert the IBP sensor cable into this socket.
⑥
means “BE CAREFUL“. Refer to the attached document (this manual) of the monitor.
⑦
means that the IBP module is IEC-601-1 Type CF equipment.
Note
When not using the IBP module to monitor the patient, the user may unload the module,
which however must be stored in a clean and dry environment, otherwise the life cycle
of the module will be unfavorably affected.
PM-6000 Modular Patient Monitor measures direct blood pressure (SYS, DIA and MAP) of
one selected blood vessel through two channels, and displays two BP waveforms.
The available pressure labels are:
Label
Definition
ART:
Arterial Blood Pressure
PA:
Pulmonary Arterial Pressure
CVP:
Center Venous Pressure
RAP:
Right Atrial Pressure
LAP:
Left Atrial Pressure
ICP:
Intracranial Pressure(ICT/B Transducer information Refer to 16.8)
P1-P4
Expand Pressure
16.3
Precautions during IBP Monitoring
Warning
Parts and accessories used must meet the safety requirements of the medical
electrical equipment standards.
Warning
Do not contact the metal part connected to the electrical appliance when connecting or
using the accessory.
16-2
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
Warning
When the monitor is used with HF surgical equipment, do not let the transducer and
cable contact the HF surgical equipment to prevent the patient from burning caused by
leakage current.
Warning
Disposable IBP transducer or domes should not be reused.
Note
Use only the pressure transducer specified in this operation manual.
The specified transducer(except for ICT/B transducer) has the function of protecting against
the electric shock (especially the leakage current) and the influence of cardiac defibrillator. It
can be used in surgical operation. When the patient is in the defibrillation, the pressure
waveform may become temporarily distorted. However the monitor will work normally after
defibrillation with the operation mode and user configuration being not affected.
Warning
Inspect the transducer cable is in normal condition before monitoring. Unplug the
transducer of the channel 1, the monitor should display the error message “IBP:
SENSOR 1 OFF” and trigger audible alarm. The other channel should act the same.
Note
Periodically calibrate the transducer either new or used according to the Hospital
Regulation.
Warning
If any kind of liquid, other than the solution to be infused in the pressure line or
transducer, is splashed on the equipment or its accessories, especially enters the
transducer or the monitor, contact the Service Center of the Hospital immediately.
16.4
Monitoring Procedure
Preparation before IBP measurement:
1.Plug the pressure cable into corresponding socket and check that the monitor is switched
on.
2.Any entrapped air should be removed from the pressure system (pressure line and
transducer) by filling with normal saline.
Patient Monitor user’s manual (V 2.2)
16-3
IBP Monitoring
3.Connect the arterial catheter to the pressure line, ensure any entrapped air removed.
Warning
If any entrapped air in pressure system, re-fill system with normal saline.
4.Position the transducer at the same level of the patient’s heart, approximately mid-axillary
line.
5.Ensure the correct label name has been selected, Refer to the next section for details.
6.Zero the transducer. Refer to the next section for details.
Figure 16-2
16.5
IBP Monitoring
IBP Menu
There are two ways to access the IBP (1,2) SETUP menu.
z
Pick the SETUP button on the IBP module to call up the IBP (1,2) SETUP menu as
shown below.
z
Turn the rotary knob on the control panel to move the cursor on the screen to the IBP hot
key in the parameter area and then press the knob to directly access the IBP (1,2)
SELECT menu. And then pick the IBP SETUP button to access the IBP (1,2) SETUP
menu.
16-4
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
Figure 16-3
IBP SETUP Menu
Options that could be set up are:
■
■
ALM: Select “ON” to enable alarm and data storage during IBP alarm. Select
“OFF” to disable physiological alarm and display the
symbol beside “IBP”
numeric.
■ ALM LEV: Set up the alarm level. Three levels are available: HIGH, MED, LOW.
■
ALM REC: Select “ON” to enable recording once IBP alarm occurs. Select ”OFF” to
disable recording function.
■ AMP ADJUST: adjust waveform amplitude. Two selections are available: MANUAL,
AUTO. Set it to AUTO, the pressure names of IBP become P1 and P2, and the IBP
scale is adjusted by system automatically. Set it to MANUAL, the pressure names
of IBP can choose one of ART, PA, CVP, RAP, LAP, ICP, P1, P2, and the IBP scale
is adjusted by the user via SCALE ADJUST item.
■ SWEEP: Select the scanning speed of the IBP wave. Two selections are available:
12.5 mm/s or 25 mm/s.
■ UNIT: Select the pressure unit (mmHg or kPa).
■
FILTER: Select filtering mode of system. Three selections are available: NORMAL
(filter the waveform at the frequency of 16Hz), SMOOTH (filter the waveform at the
frequency of 8Hz) and NO FILTER (display the original waveform). The default is
NO FILTER.
■
ALM LIMIT SETUP: Access the sub-menu of IBP ALM LIMIT SETUP, in which user
may set up the upper and lower alarm limit of systolic pressure, diastolic pressure
and mean pressure respectively for channel 1 and channel 2.
■ SCALE ADJUST: Access the sub-menu of IBP SCALE ADJUST, in which user
may adjust the position of the high, reference and low scales for the two waveforms
displayed on the screen.
■
EXPAND PRESSURE: Access the sub-menu of IBP EXPAND PRESSURE, user
could select the pressure type to be represented by P1 and P2.
■
SETUP TRANSFER: used to access the sub-menu of IBP (1,2) SETUP
TRANSFER as shown below.
■ DEFAULT: Access the IBP DEFAULT CONFIG dialog, in which user could select
Patient Monitor user’s manual (V 2.2)
16-5
IBP Monitoring
FACTORY DEFAULT CONFIG or USER DEFAULT CONFIG. After selecting an
option and exiting the dialog, the system will pop up a dialog asking for
confirmation.
■ EXIT: Exit the menu and return to the upper menu
Figure 16-4
IBP(1,2) SETUP TRANSFER
in which the user may set up following information.
z
RT TRANSFER
Refers to real-time transfer. Three selections are available:
1.
OFF: when choose the OFF selection, the system will not automatically save
the modifications to the IBP module into the IBP module.
2.
ON: when choose the ON selection, the system first saves all the setups into
the IBP module and then saves the modifications to the module into the IBP module
immediately. For the newly loaded IBP module, default is OFF
z
SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
z
LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the module are loaded into the system.
When using this function, the warning “Menu item will adopt the value from the
module. Yes?” will be appearing on the screen. And the system will execute the
operation after the confirmation of the user.
„
DEFAULT: pick this item to access the IBP(1, 2) DEFAULT CONFIG dialog box, in which
the user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation.
„
EXIT: used to exit the menu and return to the main screen.
Warning
Before setting the alarm limits, confirm to choose the correct label.
16-6
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
Figure 16-5
IBP ALM LIMIT SETUP
When the value exceeds the alarm limits, an alarm will occur.
IBP alarm limits:
ART
Max. Alarm High
(mmHg)
300
Min. Alarm Low
(mmHg)
0
Step
(mmHg)
1
PA
120
-6
1
CVP
40
-10
1
RAP
40
-10
1
LAP
40
-10
1
ICP
40
-10
1
P1
300
-50
1
P2
300
-50
1
Pressure Label
IBP Zeroing
„
Press the ZERO button on the IBP module to call up IBP PRESSURE ZERO menu as
shown below:
Figure 16-6 IBP PRESSURE ZERO
Patient Monitor user’s manual (V 2.2)
16-7
IBP Monitoring
Note
User should ensure that the transducer has been zeroed before measurement;
otherwise the device does not have valid zero value, which may result in
inaccurate measuring data.
Zero Transducer
Select “CH1 ZERO”, IBP1 is zeroed, Select “CH2 ZERO”, IBP2 is zeroed
Cautions:
„ Close the transducer stopcock to the patient before zeroing.
„ Open the venting stopcock to atmosphere.
„ The transducer should be placed at the same level of the patient’s heart, approximately
mid-axillary line.
„ Zero procedure should be performed before starting the monitoring or at least once a day
(or each time after connecting/disconnecting the cable).
Information related to zero; (For this example, CH1 is used)
■ “SUCCESSFUL ZERO”
Indicate the zero procedure has finished, open the transducer stopcock to the patient
and close the venting stopcock to atmosphere.
■ “SENSOR OFF, FAIL”
Verify that the transducer for CH1 does not fall off, then execute zeroing. If problem
still exists, contact the serviceman.
■ “IN DEMO FAIL”
Ensure that the monitor is not in DEMO mode. Contact the serviceman if necessary.
■ “PRESSURE OVER RANGE, FALL”
Ensure that the venting stopcock is opened to atmosphere, then execute zeroing. If
the problem still exists, replace the transducer and contact the serviceman.
■ “PULSATILE PRESSURE, FALL”
Ensure that the transducer is not opened to the patient and the stopcock is vented to
atmosphere. Then execute zeroing. If the problem still exists, contact the serviceman.
IBP Calibration
Pick IBP PRESSURE CALIBRATE in the IBP (1,2) SELECT menu to popup IBP PRESSURE
CALIBRATE menu as shown below:
16-8
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
Figure 16-7
IBP Calibration Menu
Calibrate the transducer:
Turn the knob to select the item CH1 CAL VALUE, press and turn the knob to select the
pressure value to be calibrated for channel 1. Then turn the knob to select CALIBRATE to
start calibrating channel 1.
Turn the knob to select the item CH2 CAL VALUE, press and turn the knob to select the
pressure value to be calibrated for channel 2. Then turn the knob to select CALIBRATE to
start calibrating channel 2.
The pressure calibration of PM-6000
Figure 16-8
IBP Calibration
Caution:
„
Mercury calibration should be performed by the biomedical engineering department
either whenever a new transducer is used or as periodically as requested by your
Patient Monitor user’s manual (V 2.2)
16-9
IBP Monitoring
Hospital regulation.
„
The purpose of the calibration is to ensure that the system gives you accurate
measurements.
„
Before starting a mercury calibration, a zero procedure must be performed.
„
If you need to perform this procedure yourself you will need the following pieces of
equipment:
• Standard sphygmomanometer
• 3-way stopcock
• Tubing approximately 25 cm long
The Calibration Procedure: (SEE Figure 16-8)
Warning
You must never perform this procedure while patient is being monitored.
1.
Disconnect transducer with patient.(when patient is monitored)
2.
By using of tube, one end of T-type connector links to 3-way stopcock of transducer,
another end links to inflation orb and the third end links to sphygmomanometer.
3.
Vent the stopcock of transducer to atmosphere and run zeroing procedure. Open the
stopcock to the sphygmomanometer side after successful zeroing.
4.
Select the calibrated channel in “IBP calibration” menu and preset the calibration
pressure of this channel.
5.
Inflate sphygmomanometer and obtain the value of pressure to preset value in menu.
6.
Repeatedly adjust the calibrating pressure value in the menu or the pressure value of
sphygmomanometer until they are equal.
7.
Push CALIBRATION button, the monitor starts calibrating process.
8.
9.
Wait for the result of calibration; determine the action according to the prompt message.
After calibration, disconnect the tube of sphygmomanometer and the T-type connector;
then connect the transducer to the patient by following specified steps.
Related information to calibration(for this example,CH1 is used)
• “SUCCESSFUL CALIBRATION”
CH1 work properly, User could perform IBP monitoring via CH1.
• “SENSOR OFF , FALL”
Check the connection of CH1 transducer, Ensure no “SENSOR OFF, FALL” message
prompts, and Execute calibration. If problem still exists, contact serviceman.
• “IN DEMO, FAIL”
Ensure that the monitor is not in DEMO mode, Execute calibration. If problem still
exists, contact serviceman.
• “PRESSURE OVER RANGE, FAIL”
Make sure that you have selected transducer value in IBP CAL, then proceed
calibration.
• “PULSATILE PRESSURE, FALL”
16-10
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
Ensure that the pressure value of the sphygmomanometer is constant. Execute
calibration. If problem still exists, contact serviceman.
Changing the Label
„
IBP SCALE ADJUST submenu:
Figure 16-9
IBP SCALE ADJUST Menu
The waveform and corresponding scale appears in the IBP Waveform Area with 3 dotted lines
representing Higher Scale, Reference Scale, and Lower Scale from the top to the bottom.
Values of the three scales can be set according to the instruction given below.
■ IBP label: Selectable from ART, PA, CVP, RAP, LAP, ICP, P1, P2;
■ HI: IBP value of Higher scale , the range of which is the measurable range of current
pressure.
Note
The HI value must be higher than the LO value.
■ LO: IBP value of Lower scale , the range of which is the measurable range of current
pressure.
Note
The LO value must be lower than the HI value.
■ VAL: IBP value of Reference scale (between HI and LO).
.
Note
HI scale, LO scale, Reference scale and IBP waveform are displayed simultaneously on
the screen, user could obviously view the change of the waveform after the scale has
been adjusted.
Patient Monitor user’s manual (V 2.2)
16-11
IBP Monitoring
16.6
Alarm Information and Prompts
Alarm Messages
Physiological alarm, caused by the parameter value exceeds the limits, will activate the
recorder to automatically outputting the parameters and related measuring waveforms once
the alarm occur while ALARM REC in related menu switch ON.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during IBP measurement.
Physiological alarms:
Message
IS1 TOO HIGH
IS1 TOO LOW
ID1 TOO HIGH
ID1 TOO LOW
IM1 TOO HIGH
IM1 TOO LOW
IS2 TOO HIGH
IS2 TOO LOW
ID2 TOO HIGH
ID2 TOO LOW
IM2 TOO HIGH
IM2 TOO LOW
Cause
Alarm Level
SYS measuring value of channel 1
above upper alarm limit.
SYS measuring value of channel 1
below lower alarm limit.
DIA measuring value of channel 1
above upper alarm limit.
DIA measuring value of channel 1
below lower alarm limit.
MAP measuring value of channel 1
above upper alarm limit.
MAP measuring value of channel 1
below lower alarm limit.
SYS measuring value of channel 2
above upper alarm limit.
SYS measuring value of channel 2
below lower alarm limit.
DIA measuring value of channel 2
above upper alarm limit.
DIA measuring value of channel 2
below lower alarm limit.
MAP measuring value of channel 2
above upper alarm limit.
MAP measuring value of channel 2
below lower alarm limit.
is
is
is
is
is
is
is
is
is
is
is
is
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
Technical alarms:
Message
IBP1 SENSOR OFF
IBP2 SENSOR OFF
IBP(1,2) INIT ERR
16-12
Alarm
Level
Remedy
of channel
off from
LOW
Make sure that cable is properly
connected.
of channel
off from
LOW
Make sure that cable is properly
connected.
HIGH
Stop using measuring function of
Cause
IBP cable
1 falls
monitor.
IBP cable
2 falls
monitor.
IBP module failure
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
IBP module, notify biomedical
engineer or Mindray service staff.
IBP(1,2) INIT ERR1
IBP(1,2) INIT ERR2
IBP(1,2) INIT ERR3
IBP(1,2) INIT ERR4
IBP(1,2) INIT ERR5
IBP(1,2) INIT ERR6
IBP(1,2) INIT ERR7
IBP(1,2) INIT ERR8
IBP(1,2) COMM
STOP
IBP(1,2)
module
failure
or
communication
failure
HIGH
IBP(1,2) COMM ERR
IBP(1,2)
communication error
HIGH
IBP1 ALM LMT ERR
Functional
failure
safety
HIGH
IBP2 ALM LMT ERR
Functional
failure
safety
HIGH
Stop using ALARM function of IBP
module, notify biomedical engineer
or Our service staff.
Stop using ALARM function of IBP
module, notify biomedical engineer
or Our service staff.
Stop using ALARM function of
IBP module, notify biomedical
engineer or Our service staff.
Stop using ALARM function of
IBP module, notify biomedical
engineer or Our service staff.
Prompt message:
Message
IBP1 SYS EXCEED
IBP1 DIA EXCEED
IBP1 MEAN EXCEED
IBP2 SYS EXCEED
IBP2 DIA EXCEED
IBP2 MEAN EXCEED
Cause
Systolic value of channel 1 is beyond
measurement range.
Diastolic measuring value of channel 1 is
beyond measurement range.
Mean measuring value of channel 1 is
beyond measurement range.
Systolic value of channel 2 is beyond
measurement range.
Diastolic measuring value of channel 2 is
beyond measurement range.
Mean measuring value of channel 2 is
beyond measurement range.
Alarm
Level
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
IBP1 NEED ZERO-CAL
IBP channel 1 has not been zeroed.
LOW
IBP2 NEED ZERO-CAL
IBP channel 2 has not been zeroed.
LOW
Patient Monitor user’s manual (V 2.2)
16-13
IBP Monitoring
16.7
Maintenance and Cleaning
16.7.1
Care and cleaning
Warning
Before cleaning the monitor or the transducer, turn off the power and disconnect
from power line.
Cleaning of IBP Transducer (Reusable)
After the IBP monitoring operation is completed, remove the tubing and the dome from the
transducer and wipe the transducer diaphragm with water. To clean the transducer and the
cable, soak or wipe them by using soap or the detergents listed below:
Cetylcide
Wavicide-01
Wescodyne
Cidex
Lysol
Vesphene
Do not immerse the connector in any liquid. After cleaning, dry the transducer thoroughly
before storing. Slight discoloration or temporary increase of surface stickiness of the cable
should not be considered abnormal If adhesive tape residue must be removed from the
transducer cable, double seal tape remover is effective and will cause a minimum of damage
to the cable if used sparingly. Acetone, Alcohol, Ammonia and Chloroform, or other strong
solvents are not recommended because over time the vinyl cabling will be damaged by these
agents.
Note
The disposable transducers or domes must not be re-sterilized or re-used.
Note
For protecting environment, the disposable transducers or domes must be reclaimed
or disposed properly
Sterilization
■
Chemical solution Sterilization
Remove obvious contamination by using the cleaning procedure described previously.
Select a sterilant that has been found effective to your hospital or institution for chemical
solution sterilization of operating room equipment. Buffered glutaraldehyde (e.g. Cidex or
Hospisept) has been found to be effective. Do not use quaternary cationic detergents
16-14
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
such as zephiran chloride. If the whole unit is to be sterilized, immerse the transducer but
not the electrical connector into the sterilant for the recommended sterilizing period.
Ensure that the dome has been removed. Then rinse all transducer parts except the
electrical connector with sterilized water or saline. The transducer must be thoroughly
dried before storing.
■ Gas Sterilization
For more complete asepsis, use gas sterilization.
Remove obvious contamination by using the cleaning procedure described previously. To
inhibit the formation of ethylene glycol when ethylene oxide gas is used as the
disinfectant, the transducer should be completely dry.
Follow the operating instructions provided by the manufacturer of the gas disinfectant.
Warning
The sterilize temperature must not exceed 70°C (158°F). Plastics in the pressure
transducer may deform or melt above this temperature.
16.8
ICP Transducer ICT/B (Optional Accessory)
16.8.1
Introduction
The ICT/B is one of catheter tip transducers manufactured by Gaeltec. It is designed for
measuring intracranial pressure by the epidural method. There are many advantages of
catheter tip measurement including simplicity of use and excellent frequency response
without artefacts.
The ICT/B has an atmospheric reference pressure channel that connects the back of the
sensing area to the ambient air pressure via the luer fitting on the connector. All
measurements are differential with respect to ambient air pressure.
Measured
pressure
Calibration
sleeve
Luer fitting for
zero check by
balloon inflation
sensor
Reference channel to
ambient air pressure
Extension
cable
Temperature compensation and
bridge balance network
Figure 16-10
Transducer drive
Output signal
ICT/B transducer
A significant feature of the ICT/B is the ability to check the zero drift of the ICT/B and pressure
Patient Monitor user’s manual (V 2.2)
16-15
IBP Monitoring
monitor in-vivo. Not only does this allow for accurate measurements, but also allow moving
the patient with the ICT/B in the epidural space and reconnection to another monitor quickly
and easily.
There is a flat silicone rubber membrane, or balloon, covering the pressure sensing
diaphragm. Two internal tubes connect the two sides of the diaphragm to a female luer fitting
on the connector shell. By introducing approximately 0.2 to 0.3ml of air from a 1ml syringe the
pressure in these tubes will be greater than the ICP being measured. The exact amount of air
is not critical, subject to the permitted maximum. When this air is injected, the pressure will
cause the balloon to be lifted from the surface of the sensor and the same pressure will be
applied to the back of the sensor. The strain gauge senses equal pressure above and below
which is equivalent to having zero pressure applied. Thus by injecting a small volume of air,
one undeflects the pressure sensor and checks the zero of the transducer and amplifier.
16.8.2
Cautions
Note
Gaeltec catheter tip pressure transducers are designed for use by trained physicians
practicing a specialized branch of medicine. Use of the transducers should be
restricted to those trained to perform the procedures.
Note
All pressure transducers must be used with patient monitors which meet the current
safety standards for the country in which they are used and which are intended for use
with strain gauge pressure transducers. The PATIENT MONITOR must provide
electrical isolation between the transducer and any mains powered equipment to which
the monitor is connected.
Warning
Disconnect the catheter from the monitor before defibrillation or electrosurgery.
Warning
Do not plug the female luer on the proximal end of the catheter during ethylene oxide
sterilization or damage to the transducer may result.
Warning
Do not immerse or soak the electrical connector end in any kind of fluid or liquid.
Warning
The total volume of air injected to check the zero or baseline must not exceed 0.5ml or
the membrane over the sensor may be ruptured.
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Patient Monitor user’s manual (V 2.2)
IBP Monitoring
Warning
Do not press with thumb and forefinger on the tip of the ICT/B. Enormous pressures
will be generated this way and the device will be subject to possible damage. To see if
the ICT/B is operating, gently touch the sensor tip.
Note
Carefully check for cuts on the silicone of the catheter and sensor tip before use.
z
PLACING THE ICT/B
Note
Burr hole edges must be rounded where the catheter makes an ''S'' bend into the
epidural space. Evacuate all bone chips.
Note
The catheter should be protected by suitable means where sutures are placed. This will
prevent damage to the catheter when pulling sutures tight.
Warning
Do not use haemostats or forceps as these will damage the device.
Note
When removing the catheter, care should be taken not to nick the device while cutting
sutures. Pull slowly on the catheter to remove the ICT/B.
16.8.3
Connection to the pressure monitor
Note
Although the catheter tip pressure transducer sensor is electrically isolated from the
patient, it is recommended that pressure monitors with patient isolation be used for
safety. Consult the manufacturer of the monitoring equipment for questions relating to
monitor safety.
z
Calibration
The ICT/B is supplied with minimal zero offset and the sensitivity is set at 5 uV/V/mmHg. In
order to set up the amplifier and recorder accurately the controls should be zeroed at ambient
pressure and then a known pressure applied, for instance using the calibration tube, syringe
and manometer, or immersion to a known depth in a water column. The gain of the system is
Patient Monitor user’s manual (V 2.2)
16-17
IBP Monitoring
then set to the required level. The procedure should be repeated to check that the zero
baseline has not changed due to the change in gain.
Figure 16-11
ICT/B calibration
Tightening the collet on calibration tube over the sliding calibration sleeve will seal around the
ICT/B catheter. Using the male luer fitting a connection can be made to a reference pressure,
such as a syringe and manometer. The output of the transducer and amplifier system can be
reliably and quickly confirmed.
z
Zeroing
„
Checking the Zero when the ICT/B is in the Epidural Space
Using a 1ml syringe, inject approximately 0.3cc of air into the female luer connector on the
proximal end of the ICT/B. Leave the syringe attached and note the value on the pressure
monitor or scope. The ICP will decrease to zero or a value very close to it. If the
monitor/transducer combination has drifted from zero, reset the zero control to zero value on
the meter. Remove the syringe and the monitor will immediately begin to measure intracranial
pressure.
Warning
The total volume of air injected from a 1ml syringe to check the zero must not exceed
0.5ml or the membrane over the sensor may be ruptured.
„
Connecting to a new monitor when the ICT/B is in the Epidural Space
9 Set correct pressure range on monitor.
9 Inject 0.3cc of air from a 1ml syringe.
9 Adjust the monitor for zero reading.
9 With the air still injected, set the calibration number on the monitor, if applicable.
16-18
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
9 Remove the syringe and the ICP will be displayed immediately.
Note
Always leave the luer fitting open to ambient pressure during measurement.
Warning
Disconnect the catheter from the monitor before defibrillation or electrosurgery.
16.8.4
Practicing with the ICT/B
It is a good idea to obtain experience using the ICT/B and monitor combination before actually
using the device with a patient.
Set up the monitor and the ICT/B as already described. Use either a water column or the
calibration tube to apply a known pressure of from 10 to 25mmHg to the ICT/B. Recall that
13.6cm of water is about equal to 10mmHg.
With the known pressure applied to the ICT/B, inject approximately 0.3cc of air into the female
luer using a 1ml syringe and note that the monitor does indeed immediately go to zero. Also
note that if the ICT/B is moved rapidly up and down in a column of water pressure waves of
high fidelity are seen. The ICT/B has a very high frequency response and you will observe
excellent pressure waves in actual practice. It can also be confirmed that the exact amount of
air injected to check the zero is not important.
16.8.5 Note to the neurosuregeon
The ICT/B is intended for the measurement of epidural pressures. Use of the transducer for
the measurement of intraventricular pressures is not recommended. The ICT/B is designed
for the measurement of positive pressures only.
Note
Catheter Tip Pressure Transducers must be used under the supervision of a suitably
qualified Physician.
z
Method of Application of the ICT/B
The application of the ICT/B may be accomplished through a variety of surgical techniques.
Therefore, the surgeon is best advised to use the method which his own practice and
discretion dictate to be best for the patient. The following are some general guidelines.
The ICT/B may be inserted during surgery or through a burr hole. When in place, the catheter
tip transducer should have its pressure sensing surface facing against the dura, under the
cranium. There are 2.5cm marks on the back of the catheter and these are visible when the
sensor is facing in the proper direction.
The site of placement should be away from any craniotomy flap, preferably via a contralateral
burr hole.
The dura mater should be carefully stripped at least 2cm under the skull and 180° in arc
Patient Monitor user’s manual (V 2.2)
16-19
IBP Monitoring
before insertion. Failure to do this will result in wedging of the pressure sensor and inaccurate
readings.
Protect the catheter :Use thick sutures and put tape around the catheter before
suturing. Remove all bone chips. Use bone wax.
Use of a tunnel is recommended. A short length
of a large bore catheter can be passed first to act
Note that both edges are smoothed.
as a guide for the sensor tip. Remove the guide
This will help to prevent damage to
from the burr hole end after the ICT/B has been
the catheter.
passed to the burr hole from the tunnel entrance.
Strip the dura at least 2 cm under the inner table
of the skull. Strip in an arc of at least 180°
Figure 16-12
ICT/B application
Reseat the transducer tip after a few days since the dura may rapidly tighten and change its
physical characteristics.
If possible, round the bone at the point where the catheter makes its first bend into the burr
hole and round the bone where the catheter makes the second bend under the cranium. This
will help to prevent tearing the catheter or tip during insertion or removal. A tear will require
the device to be returned for repair, an inconvenience that may be avoided by smoothing
areas of bone in contact with the catheter transducer.
The catheter is led out through the wound in the manner of a drain. It may make sharp bends
without disturbing the operation of the ICT/B. Care should be taken though, not to pinch the
catheter by bending onto itself at acute angles for this will seal and possibly damage the
internal lumens required for proper operation.
The catheter should be restrained from moving once the tip is in place. It may be fixed to the
scalp by encircling sutures or with a silicone rubber suture collar available from manufacturers
of such items as peritoneal shunt systems. The latter method is preferred as it will help
prevent damage to the catheter by sutures or during removal of sutures.
Another method is by first approaching the burr hole through a tunnel under the skin (entering
the tunnel from a point distal to the burr hole by making a small incision in the skin). The
ICT/B can be guided in the tunnel by using a disposable tube removable from the burr hole
side.
This latter method is to be preferred from both a mechanical stability point of view and from
16-20
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
the reported low incidence of infection. The catheter can then be led out in the manner of a
drain and the burr hole incision sutured.
The physician is urged to examine the ICT/B for physical damage to the silicone rubber
covering anywhere on the tip or catheter before use. If damage is suspected, do not use the
catheter and return it to Manufactory for repair.
Proper function before insertion into the epidural space should be confirmed by gently
touching the tip of the transducer and observing a deflection on the operating room pressure
monitor.
Once the ICT/B has been inserted into the epidural space, the physician should check the
proper function again, by injecting 0.3cc of air to check the zero of the ICT/B. The monitor
should respond correctly as previously described.
z
Review of techniques to prevent damage to the catheter.
1. In preparing the burr hole, it is imperative that the hole be rounded at the edges where
the catheter makes an "S" bend into the epidural space.
2. Evacuate all bone chips.
3. A small pledgelet of woven bandage should be placed around the catheter where
sutures will be placed. This will prevent damage to the catheter when pulling sutures
tight. Otherwise you may cut the catheter.
4. Use some bone wax on the edges of bone where the catheter and tip make contact
with bone.
5. When removing the catheter, care should be taken not to cut the device while cutting
sutures. Remove the ICT/B by pulling slowly on the catheter.
6. The dura mater should be stripped sufficiently so that the tip of the sensor is not forced
or wedged into place.
7. Do not use haemostats or forceps, they will damage the device. Do not squeeze the
sensor between thumb and forefinger.
16.8.6
Cleaning and sterilization
Warning
Do not autoclave
Warning
Do not use radiation sterilization
Warning
Do not use ultrasonic cleaning
Warning
Do not use chlorinated hydrocarbons
Warning
Patient Monitor user’s manual (V 2.2)
16-21
IBP Monitoring
Do not use toluene
Warning
Do not use sodium hypochlorite solution
Note
The ICT/B is supplied non-sterile. It must be cleaned and sterilised before each use.
Inspect for cuts or damage to silicone coating before immersing in any liquid. Be careful not to
get liquid on the connector pins or inside the connector via the luer fitting
Wash the catheter with soap solution being careful not to poke the sensing area. Do not use
synthetic detergents or oil based soaps as this may result in a foreign body reaction.
Transducers may be cleaned gently with alcohol wipes. Do not soak in alcohol.
Sterilisation is by means of cold aqueous solutions of detergicide (e.g. Cidex), formalin or by
ethylene oxide gas.
Warning
Do not use the sterilizing cap during ETO gas sterilizing.
Note
Immediately after removal of the catheter from the patient, Checking for cuts in the
silicone rubber.
Use a 1ml syringe to inject 0.5cc of air into the luer and immerse the catheter in water. If small
bubbles are seen from any part of the catheter or tip, wipe dry and sterilize. Return to
Manufactory for repair.
Note
It is recommended that each institution establish the efficacy of its sterilization
procedure by a method which includes the sterilization of an intentionally
contaminated product.
Note
There are only two chemical sterilization techniques recognized by the U.S.
Department of Agriculture as effective and truly sporicidal, gas sterilization by ethylene
oxide and liquid sterilization by a glutaraldehyde.
z
Ethylene oxide (ETO) Procedure
Unplug the female luer on the proximal connector before the ETO sterilization cycle. Failure to
do this will result in damage to the ICT/B and render it unusable. The luer must be open to
allow free passage of ETO gas both internally and externally.
„ Package the ICT/B in a coil in disposable ETO packaging. Include an approved
16-22
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
sterilization indicator.
„ Sterilize - "Normal Cycle" in an accepted commercially available hospital sterilizer. Follow
the manufacturer's instructions for the sterilizer.
Use the following as a guide only. In an actual hospital sterilization facility, the following
parameters were found to provide acceptable sterilization via ETO:
z
Sterilizer make and model
- AMSCO Eagle 2000
Prevacuum
- 15 minutes, 24 inches Hg
Relative humidity
- 40%
Temperature
- 140°F
ETO mix
- 12:88
Gas pressure
- 8 psi
Exposure time
- 1 hour 45 minutes
Post Vacuum
- 15 minutes, 24 inches Hg
Aeration Cycle
- 12 hours
Calculated ETO Concentration
- 600 mg/l
Liquid Sterilization Procedure
Prevent liquids from entering the female luer on the electrical connector. A male plug may be
used to do this. This plug must be removed during normal use and ETO sterilization.
1.
Rinse and cold soak the catheter transducer in a solution of glutaraldehyde such as
Cidex, following the chemical manufacturer's instructions. Note that disinfecting does not
equal sterilisation and the strength of the glutaraldehyde must be confirmed by the
chemical manufacturer's instructions.
2.
After sterilisation of the catheter and just before use, rinse the device with pyrogen-free,
sterile distilled water or saline solution as recommended by the manufacturer of the
sterilising agent.
z
Care of the ICT/B
The metal sensor is very robust and can withstand severe shocks and vibrations. It can be
irreversibly damaged by contact with sharp objects or overpressure, for instance by squeezing
the tip between finger and thumb.
The silicone coating on the sensing area allows a small amount of water absorption. During
this process, which may take an hour or more, the baseline may drift a few mmHg. The device
should be allowed to stabilize in water or saline before use for a few hours.
Liquids entering the back of the sensor will cause damage to the sensor. Cuts to the outer
coating should be avoided and repaired immediately if any are found. Return to manufactory
or apply a temporary repair using a suitable silicone sealant to the damage.
The most common reason for failure of the ICT/B pressure transducer is physical damage to
the device's silicone catheter and/or tip. The cuts are usually caused by sharp bone segments
and are not always visible to the naked eye. If such damage remains undetected fluids may
enter the device and damage the sensing element. Check for damage as described in the
Cleaning section of this manual.
Patient Monitor user’s manual (V 2.2)
16-23
IBP Monitoring
16.8.7
SOME COMMONLY ASKED QUESTIONS
QUESTION
Is the ICT/B a single use device?
If it is damaged, what shall we do?
Does the air used for checking the zero get
into the patient?
What happens if we autoclave the ICT/B?
We inject air to check the zero but the
baseline on the scope always returns to ICP
even if we leave the syringe attached. What
is wrong?
Readings were taken with the syringe left
attached until we noticed it. Can we rely on
these readings?
Someone new on the staff began injecting
water into the luer but we caught it just as a
little went into the ICT/B. Is the device
ruined?
Why will the ICT/B be damaged if we ETO
sterilize it with the luer plugged?
16.8.8
ANSWER
No, it is designed to be reused many times.
Sterilize first. Then, obtain a purchase order
for repair and send it back to Manufactory for
repair.
No. Air used for checking the zero stays in
the fine lumens and tip of the ICT/B until the
syringe is removed.
It will have to be returned to Manufactory for
repair.
There is a leak in the catheter or sensor tip.
Remove, wipe clean with alcohol and then
sterilize. Return the device to Manufactory for
repair.
No. They are incorrect. All pressure readings
must be made with the proximal female luer
open to atmosphere.
Probably not. Return to Manufactory for
repair.
When you plug the luer you are sealing the
internal lumens at normal atmospheric
pressure. Part of the ETO cycle is a partial
vacuum. Thus, the trapped air at atmospheric
pressure will expand and rupture the balloon.
TROUBLE-SHOOTING
TROUBLE
CAUSE
REMEDY
You inject air to
check the zero and
cal
but
the
baseline reappears
with the waveform
showing.
The catheter or tip is cut and
cannot hold zero long enough.
Readings cannot be trusted.
Remove the ICT/B and use a spare.
The waveforms will be accurate if
that is all you need.
The
monitor
indicates
‘damaged gauge’
or ‘over range’ and
if you inject air or
not, you cannot
see the waveform.
Either the tip is ‘wedged’ or the
tip sensor was overpressured
against
the
dura
during
insertion. Therefore the monitor
is seeing a transducer that has
a very high initial zero and finds
this zero out of its range.
If the tip is wedged, pull back a few
millimeters to free it. This will allow
the monitor to be zeroed. If this
does not help, the transducer has
been strained and must come out
and be returned for repair.
Everything
was
alright for several
hours and then the
Although overpressured or
wedged, the sensor zero must
have been just within the range
Try raising the pressure scale to 90,
120 or 300mmHg and then setting
16-24
Sometimes raising the scale on the
monitor will allow it to manage a
transducer with a high zero offset.
Try raising the pressure scale to 90,
120 or 300mmHg and then setting
zero. If this works, the only thing
that you will sacrifice is the
waveform resolution. Return the
catheter for repair when the
measurement is finished.
Patient Monitor user’s manual (V 2.2)
IBP Monitoring
‘damaged gauge’
or
‘over-range’
light came on.
of the monitor. As conditions
changed, the total pressure
(=zero amount+ICP), pushed
the
monitor
beyond
its
capabilities.
zero.
The
transducer
can be zeroed and
we
have
good
pressure
waves
but the ICP reads
constantly
near
zero mmHg.
The sensor face must be flat
(planar) against the dura. If its
facing the inner table of the
skull for example, then you will
get pressure waves and be able
to zero it but not obtain actual
ICP readings.
It is important that the transducer
face be placed against an intact
section of dura.
If required, use a contralateral burr
hole.
If indeed placed properly, the
brain may have moved away
from the skull substantially
enough so that there is poor
contact between the skull,
transducer and the dura. This
may happen soon after the
transducer is placed but may
correct itself in a short time.
We read negative
ICP but get good
waveforms on the
monitor
Not proper zeroing.
The ICT/B cannot read negative
pressure. Rezero the monitor
/transducer combination. Make sure
that you are not plugging the female
luer during readings.
The waveform on
the monitor makes
large
cyclical
swings
If you are using a respirator or
some device that applies
pressure even indirectly it may
affect ICP. The transducer is
responding
normally
by
showing this accurately.
/
Patient Monitor user’s manual (V 2.2)
16-25
Chapter 17 CO Measuring
17.1 General
„
The Cardiac Output(CO) measurement is performed by using the rmodilution method.
„
The PM-6000 Modular Patient Monitor can determine blood temperature, measure
cardiac output, and perform hemodynamic calculations.
„
You can have iced injectate using either the flow through system or individual syringes of
injectate.
„
You can perform up to six measurements before editing the average cardiac output (C.O.)
and cardiac index (C.I.).
„
Prompt message on the screen will tell you when to inject.
17.2 CO Module
①
③
②
④
⑤
⑥
Figure 17-1
CO module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the
module communicates with the host system triumphantly. If the indicator is still
flashing, it means that the CO module or the slot has failure. In this case, the
Patient Monitor user’s manual (V 2.2)
17-1
CO Measuring
operator should re-load the module. If the failure still exists, please contact the
Mindray service engineer for repair.
② SETUP:the button used to set up the related items of CO. Press SETUP button, the CO
SETUP menu appears on the screen. The user may modify any item in the menu through
using the rotary knob on the control panel.
③ MEASURE: press the MEASURE button to activate CO measuring program.
④ A socket for CO sensor: Used to connect CO sensor. Before monitoring the patient, the
user should first safely insert the CO sensor cable into this socket.
⑤
means “BE CAREFUL“. Refer to the attached document (this manual) of the
monitor.
⑥
means that the CO module is IEC 60601-1 Type CF equipment.
Note
When not using the CO module to monitor the patient, the user may unload the module,
which however must be stored in a clean and dry environment, otherwise the life cycle
of the module will be unfavorably affected.
17.3 Monitoring Procedure
17.3.1
C.O. Measurement Procedure
1.
Plug the C.O. interface cable into the C.O. socket on the CO module.
2.
Attach the injectate probe connector and catheter thermistor connector to the appropriate
parts of the cardiac output interface cable. (Figure 17-2).
3.
Pick C.O SELECT Menu and if necessary change the computation constant to the one
appropriate to the catheter and volume of fluid used.
Note
If to replace the Catheter thermistor, please enter the catheter computation coefficient
into the CO .CONST item according to the instruction.
4.
Pick the MEASURE button on the CO module to access the WINDOW FOR CO
MEASUREMENT.
Note
You should appropriately set the injectate switch, because the CO calculation will be
according to the ON or OFF of the injectate switch at the completion of measurement.
No change shall be made after the switch is set off.
17-2
Patient Monitor user’s manual (V 2.2)
CO Measuring
Figure 17-2
CO sensor connection
5.
You can perform more than one measurement as required.
6.
After completion of the measurement(s), access the WINDOW FOR CO EDIT window to
edit measured data.
The procedure in detail is described in the following pages.
Warning
Make sure that the computational constant for the measurement is appropriate to the
catheter used.
Patient Monitor user’s manual (V 2.2)
17-3
CO Measuring
Note
The blood temperature alarm will not function during CO measurement. It will resume
automatically when the measurement is over.
17.3.2
CO Measuring
Warning
Make sure that appurtenance applied is in conformity with relevant Medical Device
Safety Requirements.
Warning
Appurtenance should be avoided from contact with conductive metal body when being
connected or applied.
CO Measurement Window
Press the MEASURE button on the CO module to access WINDOWS FOR CO
MEASUREMENT window. If CO transducer is not connected, the monitor will prompt “No
Sensor, unable to measure CO” in the window.
④
⑤
①
⑥
⑦
⑧
②
③
⑨
Figure 17-3
„
Contents in CO Measurement Window
Contents displayed in the CO Window:
① Measurement curve
② Prompt message
③ Start time of the measurement
④ CO: Cardiac Output
⑤ CI: Cardiac Index
⑥ BSA: Body Surface Area
17-4
Patient Monitor user’s manual (V 2.2)
CO Measuring
⑦ TB: Blood Temperature
⑧ TI: Injectate Temperature. If necessary, change can be performed in the “SETUP”
menu.
⑨ Function keys:
„
START
Start a measurement.
STOP
If the blood temperature cannot resume in a considerably long time,
the measurement could not stop automatically. Use this button to
stop the measurement and display the C.O. C.I. calculation result.
CANCEL
Cancel the processing measurement or cancel the result after
measurement.
REC
Print out the curve.
Scale Y
Change the scale Y (temperature) value. Three modes are
available: 0 - 0.5℃, 0 - 1.0℃, and 0 - 2.0℃. Adjust the scale by the
temperature differences. A smaller scale results in a larger curve.
Scale X
Change the scale X (time) value. Two modes are available: 0 - 30s
and 0 - 60s. If you start measurement in the 0 - 30s mode, it will be
switched to 0 - 60s mode automatically if the measurement can not
finish within 30 seconds. After the switch, no further adjustment can
be made to the Scale X.
EDIT
Enter the WINDOW FOR CO EDIT.
EXIT
Press to exit the WINDOWS FOR CO MEASUREMENT.
Measuring CO
Measurement should be taken when the message “Ready for new measurement” appears on
the screen (② in the Figure 17-3). Press the START button, and then start injection. The
thermodilution curve, current blood temperature and the injectate temperature are displayed
during the measurement. Curve drawing will stop automatically when the measurement
completes, and then the C.O. (Cardiac output) and the C.I. (Cardiac Index) (④ and ⑤ in the
Figure 17-3) will be calculated and displayed on the screen. The monitor will also display the
CO in the Parameter Area, as well as the remaining time to the next measurement (② in the
Figure 17-3).
To ensure the accuracy of the measurement, it is suggested that a reasonable interval should
take place between two consecutive measurements. The length of the interval can be set in
the CO SETUP menu (Time unit: second). The interval time counter (② in the Figure 17-3) is
displayed on the screen. The next measurement can not be performed until the time reduces
to zero and a prompt message “Ready for new measurement” appears.
Note
It is strongly recommended that the user must push the injector within four seconds
after pressing the START button.
Patient Monitor user’s manual (V 2.2)
17-5
CO Measuring
Note
It is strongly recommended that you wait at least 1 minute (or longer depending on the
patient’s clinical condition) before starting the next measurement.
Continue to repeat this procedure until you have completed the measurements you want to
perform.
You can perform a maximum of 6 measurements before editing. If you perform additional
measurements the oldest measurement each time will be deleted. If any of the curves in the
editing window is not selected for calculation (excluded from the averaging calculations), the
place will be taken by the new measurement.
„
Editing the CO measurement
Pick “EDIT” to access the WINDOW FOR C.O. EDIT window:
①
②
④
③
Figure 17-4
z
CO Edit Windows
Contents displayed in the window:
①Six curves of the six measurements and C.O. value
②Average value of cardiac output
③Average value of cardiac index
④Function button in the edit window
z
Editing operation:
Values of selected measurements can be averaged and stored in the CO item in the
HEMOD menu as the basis for Hemodynamic calculations.
When first enter the EDIT Window, curves and CO values of valid measurements
are highlighted, indicating these values are to be averaged. You can move the
cursor to the curve of questionable measurements and press the rotary knob,
dis-highlighted waveforms and CO values will be excluded from the averaging
calculation.
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Patient Monitor user’s manual (V 2.2)
CO Measuring
Note
Dis-highlighted curves can be picked and included into the averaging calculation.
17.3.3
„
Blood Temperature Monitoring
Blood temperature monitoring can function when C.O. measurement is not taken. The
blood temperature is measured by the thermistor situated in the distal end of the flotation
catheter in the pulmonary artery. (See the Figure 17-5).
„
The blood temperature alarm function will not work during the C.O. measurement. When
the measurement ends, the function will automatically resume.
„
The current blood temperature is displayed in the CO Parameter Area.
Thermodilutio
Cathetern
Pulmonary
Artery
Balloon
Thermister
Right Atrium
Right Ventricle
Figure 17-5
Thermodilutio Cathetern Site
17.4 CO SETUP Menu
„
CO Setup and Adjustment
There are two ways for the user to access the CO SETUP menu.
z
Pick the SETUP button on the CO module to call up the CO SETUP menu as shown
below.
z
Turn the rotary knob on the control panel to move the cursor on the screen to the CO hot
key in the parameter area and then press the knob to call up the C.O. SELECT menu,
pick the C.O. SETUP button to access the C.O. SETUP menu.
Patient Monitor user’s manual (V 2.2)
17-7
CO Measuring
Figure 17-6
„
CO Setup Menu
TB Alarm setup
z
ALM: Select “ON” to enable alarm prompt and data storage during TB alarm. Select
“OFF” to disable audio alarm and prompt the
symbol beside TB numeric.
Warning
During the cardiac output measurement procedure the blood temperature alarms will
be inactive.
z
ALM REC: Select “ON” to enable recording during the TB alarm.
z
ALM LEV: selectable from level HIGH, level MED to level LOW. Level HIGH
represents the most serious case.
z
TB ALM HI and TB ALM LO: used to set up the upper and lower alarm limit for TB.
Alarm occurs when the measured TB exceeds set alarm high limit or falls below
alarm low limit.
TB alarm limits:
TB
„
Max. Alarm High
43℃
Min. Alarm Low
23℃
Step
0.1℃
CO.CONST
It represents the computation constant related to the catheter and injectate volume. After
replacing the catheter, you should adjust this constant according to the instruction.
Warning
Make sure that the computational constant for the measurement is appropriate to the
catheter used.
„
INT TIME(s): It refers to the minimum time interval between two measurements. It is in
second unit. The adjustment range is 5 to 300 seconds with the increment being 5
17-8
Patient Monitor user’s manual (V 2.2)
CO Measuring
seconds
„
INJ. TEMP FROM: Pick “ON” or “OFF” to select from two ways of obtaining the injectate
temperature.
ON: the system obtains the injectate temperature through sampling.
OFF: directly display the injectate temperature obtains from the INJ.TEMP item.
„
INJ. TEMP: When the INJ. TEMP FROM is OFF, the user can set the injectate
temperature between 0 – 27℃ with the increment being 0.1℃.
„
„
TEMP UNIT: “C” for Celsius degree, “F” for Fahrenheit degree.
SETUP TRANSFER: used to access the sub-menu of CO SETUP TRANSFER, in which
the user may set up following information.
z
RT TRANSFER
Refers to real-time transfer. Three selections are available:
1. OFF: when choose the OFF selection, the system will not automatically save the
modifications to the CO module into the CO moduel.
2. ON: when choose the ON selection, the system first saves all the setups into the CO
module and then saves the modifications to the module into the CO module
immediately. For the newly loaded CO module, default is OFF
z
SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
z
LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the module is loaded into the system.
When using this function, the warning “Menu item will adopt the value from the
module. Yes?” will be appearing on the screen. And the system will execute the
operation after the confirmation of the user.
„
DEFAULT: pick this item to access the CO DEFAULT CONFIG dialog box, in which the
user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation.
„
EXIT: used to exit the menu and return to the main screen.
17.5 Hemodynamic Calculation
„
Hemocalculation
Pick HEMO CALCULATE item in the WINDOWS FOR C.O. EDIT to call up the HEMOD
WINDOWS that displays input parameter value and lists calculation results.
Patient Monitor user’s manual (V 2.2)
17-9
CO Measuring
Figure 17-7
HEMOD Windows
Turn the rotary knob, you can change the value of the selected parameter. Pick
“CALCULATE” after all parameter values being input, the calculation results will be
displayed in the window. Pick “REC” can print out all the calculation results.
Input parameter value:
„
PAWP:
Pulmonary Artery Wedge Pressure
„
CVP:
Central Venous Pressure
„
CO:
Cardiac Output
„
HR:
Heart Rate
„
AP MAP:
Mean Artery Pressure
„
LV_D:
Left Ventricular Diameter
„
PA MAP:
Mean Pulmonary Artery Pressure
„
HT:
Height
„
WT:
Weight
17.6 Alarm Information and Prompt
CO Alarm Message
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during co measurement.
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Patient Monitor user’s manual (V 2.2)
CO Measuring
Physiological alarms:
Message
TB TOO HIGH
TB TOO LOW
Cause
Alarm Level
TB measuring value is above upper alarm
limit.
TB measuring value is below lower alarm
limit.
User-selectable
User-selectable
Technical alarms:
Message
Cause
Alarm
Level
Remedy
TB SENSOR OFF
TB measuring cable
falls off the monitor.
LOW
Make sure that cable is properly
connected.
CO module failure
HIGH
Stop using measuring function of
CO module, notify biomedical
engineer or Mindray service staff.
CO INIT ERR
CO INIT ERR1
CO INIT ERR2
CO INIT ERR3
CO INIT ERR4
CO INIT ERR5
CO INIT ERR6
CO INIT ERR7
CO INIT ERR8
CO COMM STOP
CO COMM ERR
TB ALM LMT ERR
CO module failure or
communication
failure
CO module failure or
communication
failure
Functional
failure
safety
HIGH
HIGH
HIGH
Stop using measuring function of
CO module, notify biomedical
engineer or Mindray service staff.
Stop using measuring function of
CO module, notify biomedical
engineer or Mindray service staff.
Stop using TB alarming function,
notify biomedical engineer or
Mindray service staff.
Prompt message (general alerts):
Message
TB EXCEED
Cause
TB measuring value
beyond measuring range.
Alarm Level
is
HIGH
17.7 Maintenance and Cleaning
Care and Maintenance
Warning
Before cleaning the monitor or the transducer, make sure that the equipment is
Patient Monitor user’s manual (V 2.2)
17-11
CO Measuring
switched off and disconnected from the power line.
CO Cable Cleaning
1.
If adhesive tape residue must be removed from the transducer cable, double seal tape
remover is effective and will cause a minimum of damage to the cable if used sparingly.
Acetone, Alcohol, Ammonia, Chloroform, or other strong solvents are not recommended
because they will eventually damage the vinyl cabling.
2.
Sponge the cable with warm water and soap, or another suitable cleaning solution, and
dry. Do not immerse them in water.
3.
Check each cable for corrosion, cracks and deterioration.
Gas Sterilization
For more complete asepsis, use gas sterilization.
…
Remove obvious contamination by using the cleaning procedure described
previously. To inhibit the formation of ethylene glycol when ethylene oxide gas is
used as the disinfectant, the transducer should be completely dry.
…
Follow the operating instructions provided by the manufacturer of the gas
disinfectant.
Warning
Do not autoclave the cable or heat it above 75℃ (167℉). The cable should be stored in
an environmental temperature between -20℃ to 75 ℃ (-68℉ to 167℉). It should be
hung up or laid flat to prevent damage to the cable.
17-12
Patient Monitor user’s manual (V 2.2)
Chapter 18 CO2 Measuring
18.1 General
This chapter offers some relevant data concerning CO2 monitoring.
PM-6000 provides two kinds of CO2 measuring methods as per the requirements of users,
which are MainStream and SideStream.
This module can be applied in operation room, monitor units etc, it can measure the CO2
partial pressure or concentration of patient Air Way, obtain EtCO2, Inspired Maximum CO2
(InsCO2), Air Way Respiration Rate (AwRR), and display CO2 concentration waveforms. The
parameter symbols displayed on the screen are defined as following:
CO2:EtCO2
INS: InsCO2。
AWRR: Air Way Respiration (AwRR)(Resp. times/MIN)。
Warning
Do not perform CO2 sidestream measurement in the presence of flammable
anaesthetic agent.
Do not measure CO2 in the presence of foggy drug.
Use the specified gas sampling tube. Mindray Company shall not be responsible for
any damage caused by other than specified sampling tube.
The device can only be operated by personnel having taken professional training and
familiar with this manual.
Warning
CO2 module shall be avoided from crash and vibration.
Patient Monitor user’s manual (V 2.2)
18-1
CO2 Measuring
18.2 CO2 Module
①
③
②
④
⑥
⑤
Figure 18-1
CO2 module
① Indicator: the indicator that indicates the working status of the module. When the module
is working, this indicator is on.
Note
When loading the module, this indicator is on at all times, indicating that the module
communicates with the host system triumphantly. If the indicator is still flashing, it
means that the CO2 module or the slot has failure. In this case, the operator should
re-load the module. If the failure still exists, please contact the Mindray service
engineer for repair.
② SETUP:the button used to set up the related items of CO2. Press SETUP button, the
CO2 SETUP menu appears on the screen. The user may modify any item in the menu
through using the rotary knob on the control panel.
③ STANDBY/START:Standby/Measure button.
④ A socket for CO2 watertrap: Before monitoring the patient, the user should first safely
insert the watertrap into this socket.
⑤
means “BE CAREFUL“. Refer to the attached document (this manual) of the
monitor.
⑥
means that the CO2 module is IEC 60601-1 Type CF equipment.
Note
When not using the CO2 module to monitor the patient, the user may unload the
18-2
Patient Monitor user’s manual (V 2.2)
CO2 Measuring
module, which however must be stored in a clean and dry environment, otherwise the
life cycle of the module will be unfavorably affected.
18.3 Monitoring Procedure
Principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb
4.3um infrared ray. Absorption intensity is proportional to CO2 concentration of patient sample,
the CO2 concentration will compute from the detecting CO2 absorption intensity of patient
sample. The relation between partial pressure and percentage of CO2 concentration is given
below : P(mmHg) = Percentage(%) * Pamp(ambient pressure)
Of CO2 MainStream and CO2 SideStream modules, whichever is selected by the user,
Autorun measuring mode is adopted. Rate for waveform sampling is 31 msec/time. The
operating series for the two modules are respectively:
MainStream work sequence: After the system is powered on, CO2 module automatically
begins warming-up for about 45S to 90S. Then the sensor motor is activated. After 5S to 10S,
the light source of infrared ray is opened. After 10S, the system enters the normal measuring
status.
SideStream work sequence: Except the procedures that after being powered on, the system
needs not warming-up and the air pump should be activated, other procedures are the same
as those in MainStream sequence.
CO2 measurement setups:
1. Verify the type of the configured CO2 module (MainStream or SideStream);
2. For MainStream, connect the sensor to the receptacle of CO2 module. For SideStream,
plug the water trap onto its fixing chassis. Add a permanently used nafion tube between the
sampling line and the watertrap to further remove the influence of water vapor.
3. After CO2 module is activated and enters the normal status, for MainStream, “MAIN” is
displayed following CO2 waveform identifier, and for SideStream, “SIDE” is displayed
following the identifier of CO2 waveform.
Patient Monitor user’s manual (V 2.2)
18-3
CO2 Measuring
Figure 18-2
Sidestream Connectio
Figure 18-3
Mainstram Connection
1. Do not use the supplied CO2 Water trap set (for side stream including water trap and
sample line and cannula) and Air adapter (for main stream) if the packaging or the
sensor is damaged and return them to the vendor.
2. “CO2 WARM UP” or “CO2 SENSOR START UP” displayed on the screen indicates
that the sensor is in warm-up or starting-up. After the information disappears from the
screen, the standard measurement can then be generated.
3. For MainStream, if the sensor is not connected, it will display “CO2 SENSOR OFF” on
the screen. If connect the sensor, the information will disappear and the information
“CO2 WARM UP” will be on the screen. For SideStream, if water trap is not inserted,
“CO2 WaterTrap Off” is displayed on the screen. If connect water trap, the information
will disappear.
4. Monitor has water trap beside it, which is used to prevent the moisture or water drops
produced by patient’s respiration from entering the module. The sample line and the water
trap are one-off consumables that can not be repeatedly used by different patients.
Warning
For mainstream measurement, the sensor and the airway connector must be braced to
avoid oppressing the endotracheal sleeve.
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Patient Monitor user’s manual (V 2.2)
CO2 Measuring
18.4 CO2 Menu
18.4.1
Parameter Setup and Adjustment
There are two ways to access the CO2 SETUP menu:
Pick the SETUP button on the CO2 module to call up the CO2 SETUP menu as shown
below.
Turn the rotary knob on the control panel to move the cursor on the screen to the CO2
hot key in the parameter area and then press the knob to directly access the CO2
SETUP menu.
Figure 18-4
CO2 Setup Menu
Following functions can be realized via CO2 SETUP menu.
ALM: select “ON” to enable and store alarm prompt when CO2 parameters have alarms.
Select “OFF” to disable alarm and display
beside CO2. The default is “ON”.
ALM REC: select “ON” to generate output from the recorder ever since CO2 parameter
alarm occurs. The default is “OFF”.
ALM LEV: select from HIGH, MED and LOW. Level HIGH represents the most serious
alarm, followed by Level MED and Level LOW with a decrease of seriousness. Change in
“ALM LEV” can only affect the physiological alarm levels of CO2 parameters including
EtCO2 upper limit, EtCO2 lower limit, InsCO2 upper limit, AwRR upper limit and AwRR
lower limit. The default alarm level is “MED”.
CO2 ALM HI: to adjust the upper alarm limit of EtCO2. If the measuring value is larger
than CO2 upper alarm limit, “CO2 TOO HIGH” appears on the screen.
After the
measuring value returns to the normal one, the information disappears.
CO2 ALM LO: to adjust the lower alarm limit of EtCO2. If the measuring value is smaller
than CO2 lower alarm limit, “CO2 TOO LOW” appears on the screen. After the measuring
value returns to the normal one, the information disappears.
Patient Monitor user’s manual (V 2.2)
18-5
CO2 Measuring
INS ALM HI: to adjust the upper alarm limit of InsCO2. If the measuring value is larger
than InsCO2 upper alarm limit, “INS TOO HIGH” appears on the screen. After the
measuring value returns to the normal one, the information disappears.
AWRR ALM HI: to adjust the upper alarm limit of AwRR. If the measuring value is larger
than the upper alarm limit of AwRR, “AWRR TOO HIGH” appears on the screen. After the
measuring value returns to the normal one, the information disappears.
AWRR ALM LO: to adjust the lower alarm limit of AwRR. If the measuring value is smaller
than the lower alarm limit of AwRR, “AWRR TOO LOW” appears on the screen. After the
measuring value returns to the normal one, the information disappears.
UNIT: to change the display units of CO2 and InsCO2 parameters. “mmHg” and “kPa” are
available for selection.
APNEA ALM: After selecting the alarm time for APNEA alarm (having 7 options, which are
10S, 15S, 20S, 25S, 30S, 35S, and 40S), the “CO2 APNEA” information will appear on
the screen after the corresponding selected time. The alarm level is HIGH.
SWEEP: to adjust the display rate of CO2 waveforms with “6.25 mm/s”, “12.5 mm/s”, or
“25.0 mm/s” selectable.
Exit: to close CO2 SETUP menu.
Note
“APNEA ALM” cannot be closed.
When various alarms occur simultaneously, the alarm information of highest level will be
displayed on the screen.
OTHER SETUP: pick this item in the menu to call up CO2 more setup sub-menu.
Figure 18-5
CO2 More Setups Menu
Now we introduce you to the functions of each item in CO2 SETUP submenu.
WAVE SCALE: to adjust full scale size of CO2 waveform display area with “LOW” or
“HIGH” selectable. The default value is “LOW”.
PUMP RATE: to adjust the pump rate of the air pump of CO2 module with “100ml/min”,
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Patient Monitor user’s manual (V 2.2)
CO2 Measuring
“150ml/min”, or “200ml/min” selectable. The default value is “100ml/min”.
This item only functions to “SideStream”.
WORK MODE: to change the work mode of CO2 with “MEASURE” mode or “STANDBY”
mode selectable. The default is “STANDBY” mode. When it is required to monitor CO2,
select “MEASURE” mode. “STANDBY” mode disables the air pump in SideStream module,
the sensor and the IR (infrared ray) source in MainStream module, thus decreases the
power consumption and extends the life cycles of IR source and the whole CO2 module.
Note
When not using CO2 monitoring function, it is suggested not to connect MainStream
sensor or SideStream water trap and to adjust to “STANDBY” mode.
COMPENSATE: to perform different compensate operations as per the selection of the
user. The selections are GENERAL, O2, N2O/DESand ALL. Work conditions for
calculating compensate are shown in following table. Here is the operation method. First,
select the gas compensates to be used, including general compensate, O2 compensate,
Desf compensate and full compensates. Then, determine whether to make VA
compensate and BTPS compensate.
Work Conditions for CO2 Calculation Compensate:
Calculation
Compensate Method
General
O2
O2
Modification
Desflurance
OFF
ON
OFF
N2O/Desflurane
Modification
OFF
OFF
ON
Full
ON
ON
Work Conditions
O2≤60%,no N2O
O2>50%,no N2O
O2≤60%,&N2O 或
Desflurane≥12%
O2>60%,& N2O
WATERVAPOR: determine whether to make watervapor compensate.
Water vapor compensation accounts for the effect of water vapor on the CO2
IR(Infra-Red) absorption characteristics. It is used in both mainstream and sidestream
measurement modes. The user may disable this compensation under certain situations.
During normal sidestream operation, CO2 measurements are adjusted mathematically to
compensation for this effect.
The host may choose to disable this compensation when performing dry gas
meaasurements in which the gas does not contain water vapor.Dry gas procedures may
include
steady
state
measurements
and
calibration
procedures.Steady
state
measurements are performed only when background CO2,or CO2 present in the
immediate environment,is measured. An example of a steady state measurement is
measuring the CO2 content inside an incubator. Calibration procedures use calibrated
gas which is free of water vapor,or dry,as well.
The water vapor compensation is ON by default and may be enabled or disabled via a
host system command.
BTPS:The end user may want choose whether to correct values for gas that is at body
temperature, ambient pressure and is saturated with water vapor (BTPS) or has that is at
Patient Monitor user’s manual (V 2.2)
18-7
CO2 Measuring
ambient temperature and pressure and is dry (ATPD). BTPS compensation (Body
Temperature and Pressure, Saturated) is a user selectable compensation that accounts
for the differences between the airway sample and “deep lung” CO2. Since the intent is to
report “deep lung” CO2, where the sample is at 37 ℃ and fully saturated, BTPS
compensates for the variance of water vapor content due to temperature. The BTPS
compensation of CO2 module is on by default.
Note
1. If Compensate item is not correctly set as per the operation conditions, the result
will be far from the actual value, thus leading to severe misdiagnosis.
2. The default of Water Vapor Compensate is on. Turn it off when measuring dry gas,
such as when performing regular maintenance or measurement validation by using dry
calibrated gas.
3. The default of BTPS is on. Turn it on when measuring the VA saturated “damp” gas
under the body temperature and ambient pressure and turn it off when measuring the
“dry” gas under the ambient temperature and pressure.
4. Operate by strictly observing the Compensate operation method.
SETUP TRANSFER:used to access the sub-menu of CO2 SETUP TRANSFER, in which
the user may set up following information.
RT TRANSFER
Refers to real-time transfer. Three selections are available:
1. OFF: when choose the OFF selection, the system will not automatically save the
modifications to the CO2 module into the CO2 module.
2. ON: when choose the ON selection, the system first saves all the setups into the CO2
module and then saves the modifications to the module into the CO2 module
immediately. For the newly loaded CO2 module, default is OFF
SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is
ON, this function is unnecessary), the setups in the system are transferred into the
module.
LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the module are loaded into the system.
When using this function, the warning “Menu item will adopt the value from the
module. Yes?” will be appearing on the screen. And the system will execute the
operation after the confirmation of the user.
DEFAULT: pick this item to access the CO2 DEFAULT CONFIG dialog box, in which the
user may select whether the FACTORY DEFAULT CONFIG or the USER DEFAULT
CONFIG is to be used. After selecting any of the items and exiting the dialog box, the
system will pop up the dialog box asking for the user’s confirmation.
EtCO2 upper alarm limit: when parameter value exceeds this limit, there will be alarm for
exceeding the upper limit.
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Patient Monitor user’s manual (V 2.2)
CO2 Measuring
Default:
Adult:
50 mmHg
Pediatric: 50 mmHg
Neonatal: 45 mmHg
EtCO2 lower alarm limit: when parameter value is smaller than the lower limit, there will be
alarm for exceeding lower limit.
Default:
Adult:
15 mmHg
Pediatric: 20 mmHg
Neonatal: 30 mmHg
InsCO2 upper alarm limit: when parameter value exceeds this limit, there will be alarm for
exceeding upper limit.
Default:
Adult:
4 mmHg
Pediatric: 4 mmHg
Neonatal: 4 mmHg
AwRR upper alarm limit: when parameter value exceeds this limit, there will be alarm for
exceeding upper limit.
Default:
Adult:
30 rpm
Pediatric: 30 rpm
Neonatal: 100 rpm
AwRR lower alarm limit: when parameter value is smaller than the limit, there will be alarm for
exceeding lower limit.
Default:
Adult:
8 rpm
Pediatric: 8 rpm
Neonatal: 30 rpm
APNEA Time: Selections are 10S to 40S,
Default: 20S.
Work Mode: MainStream: Standby, Measurement;
SideStream: Standby, Measurement.
Default: Measurement
Compensate Method:
MainStream: General /O2 /N2O/DES/ALL
SideStream: General /O2 /N2O/DES/ALL
Default Methods: General
Pump Rate: 100 – 200 ml/min.
Default: 100 ml/min
Unit: mmHg/kPa.
Default: mmHg
Waveform Sweep: 25.0/12.5/6.25 (mm/s)
Patient Monitor user’s manual (V 2.2)
18-9
CO2 Measuring
Default: 25.0 mm/s
Waveform Scale: LOW/HIGH
Default: LOW
Besides, for alarm function of CO2 module, refer to Chapter Alarm, for its recording function,
refer to Chapter Recording, and for information about alarm event review, graphic and tabular
trend of CO2 parameters, refer to Chapter Trend and Event.
18.5 Alarm Information and Prompt
Among physiological alarms, those belonging to the type that the parameter has exceeded
the limits may activate the recorder to automatically output the parameters and related
measured waveforms when the alarms occur on the condition that the alarm record switch in
the related menu is On.
Tables below describe the possible physiological alarms, technical alarms and prompt
messages occurring during CO2 measurement.
Physiological alarms:
Message
CO2 TOO HIGH
CO2 TOO LOW
INS TOO HIGH
AWRR TOO HIGH
AWRR TOO LOW
CO2 APNEA
Cause
Alarm Level
EtCO2 measuring value is above upper
alarm limit.
EtCO2 measuring value is below lower
alarm limit.
InsCO2 measuring value is above alarm
limits.
AwRR measuring value is above upper
alarm limit.
AwRR measuring value is below lower alarm
limit.
In specific time interval, no RESP can be
detected using CO2 module.
User-selectable
User-selectable
User-selectable
User-selectable
User-selectable
HIGH
Technical alarms:
Message
CO2 SENSOR OFF
CO2 NO
WATERTRAP
Alarm
Level
Cause
Mainstream sensor is not
properly connected or has
fallen off.
Sidestream water trap is not
properly connected or has
fallen off.
CO2 WATERTRAP
OCCLUDE
Sidestream
occluded.
CO2 SIGNAL LOW
Measuring module technical
failure
CO2 SIGNAL TOO
LOW
CO2 BAROMTRC
TOO LARGE
CO2 PNEUMATIC
LEAK
18-10
water
trap
is
LOW
LOW
LOW
LOW
LOW
MED
MED
Patient Monitor user’s manual (V 2.2)
Remedy
Make
sure
that
mainstream sensor is
properly connected.
Make
sure
that
sidestream water trap
is soundly connected.
Make
sure
that
sidestream water trap
functions smoothly.
If necessary, re-start
the monitor. If failure
persists, stop using
measuring function of
CO2 module, notify
biomedical engineer
or Mindray service
staff.
CO2 Measuring
CO2 SIGNAL NOISY
LOW
CO2 SIGNAL
SATURATE
CO2 CALCULATION
ERR
staff.
LOW
HIGH
CO2 SENSOR FAULT
HIGH
CO2 SENSOR TEMP
HIGH
CO2 SENSOR TEMP
LOW
CO2 WATCHDOG
TIMEOUT
HIGH
HIGH
HIGH
CO2 INT COMM ERR
HIGH
CO2 SYSTEM ROM
ERR
CO2 FLASH CRC
ERR
HIGH
HIGH
CO2 INT RAM ERR
HIGH
CO2 FLASH CHECK
ERR
HIGH
CO2 EXT RAM ERR
HIGH
CO2 STACK OVER
HIGH
CO2 PUMP FAULT
HIGH
CO2 REVERSE
FLOW
CO2 FORWARD
FLOW
HIGH
HIGH
CO2 MALFUNCTION
HIGH
CO2 BAROMETRIC
HIGH
CO2 BAROMETRIC
LOW
HIGH
HIGH
CO2 COMM ERR
CO2 module communication
failure
HIGH
CO2 INIT ERR
CO2 module is not properly
connected or failed.
HIGH
CO2 COMM STOP
Measuring module failure or
communication failure.
HIGH
CO2 ALM LMT ERR
Functional safety failure
HIGH
INS ALM LMT ERR
Functional safety failure
HIGH
AWRR ALM LMT ERR
Functional safety failure
HIGH
Stop using measuring
function
of
CO2
module,
notify
biomedical engineer
or Mindray service
staff.
Stop using measuring
function
of
CO2
module,
notify
biomedical engineer
or Mindray service
staff.
Stop using measuring
function
of
CO2
module,
notify
biomedical engineer
or Mindray service
staff.
Prompt message:
Patient Monitor user’s manual (V 2.2)
18-11
CO2 Measuring
Message
CO2 STANDBY STATUS
CO2 WARM UP
CO2 SENSOR START UP
Cause
Turn from measuring mode to
standby mode, making the module
in energy-saving status.
Shows that the sensor is in
warming-up stage.
Shows that the sensor has just
entering start-up stage.
Alarm Level
No alarm
No alarm
No alarm
18.6 Maintenance and Cleaning
Care and Maintenance
1. Sample line is for one-off use in SideStream module. Do not sterilize or clean for reuse on
another patient.
2. Airway adapter is for one-off use in MainStream module. Do not sterilize or clean for reuse
on another patient.
3. When the sample system of Sidestream module occurring occlusion, first check kinks for
sampling line. If no kinks are found, then check water trap after disconnecting sample line
from the Watertrap. If the occlusion message on the screen disappears, the sampling line
must be replaced. If the occlusion message on the screen remains, the Watertrap must be
replaced.
4. No routine calibration required in both Mainstream and Sidestream CO2 module.
18-12
Patient Monitor user’s manual (V 2.2)
Chapter 19 Anesthetic Gas
Measurement
19.1 General
AG module is used to measure respiratory and anesthetic gases of a patient during
anesthesia. This module provides et (end tidal) values and inspired values of various
gases listed below.
z
--- here it represents the measured EtCO2 value (maximum expired
CO2
gas value---maximum expired gas value tested during expiring period)
z
N2O ---
z
O2
z
AwRR
---
nitrous oxide
optional function
---
respiring time per minute
The system can simultaneously display the waveforms of 4 anesthetic gases: CO2, N2O,
O2 and an anesthetic waveform. The default is to display CO2 waveform.
Parameters that can be displayed simultaneously are CO2, N2O, O2 and AA (it refers to
anesthetic: DES, ISO, ENF, SEV, HAL). In addition, inspired and expired values are
displayed at the same time plus MAC (Minimal Alveolar Concentration) or BAL (Balance
gas) and AwRR.
Definitions of parameter:
CO2
: carbon dioxide
N2O
: nitrous oxide
O2
: oxygen
AwRR
: air way respiration rate (respiring time per minute)
Halothame : HAL
Isoflurane
: ISO
Enflurane
: ENF
Sevoflurane
: SEV
Desflurane : DES
Patient Monitor user’s manual (V 2.2)
19-1
Anesthetic Gas Measurement
AwRR
AG value
MAC
Figure 19-1
AG measurement display
Note
The system can only display the waveform and value of one anesthetic agent at
one time.
19.2 AG Module
19.2.1
AG module
The outlook of AG module is as shown in the figure below:
①
③
②
⑤
④
⑥
Figure 19-2
19-2
AG module
Patient Monitor user’s manual (V 2.2)
Anesthetic Gas Measurement
① Indicator: used to indicate the working status of the module. It lights on when the module
is operating.
Note
When AG module is being loaded, this indicator should always light on indicating that
the module is communicating with the master system. If the indicator flashes, it
indicates that either the AG module or the communication port has failure. In this
situation, you should load the module once again. If the failure persists, you should
contact Mindray service engineer.
② SETUP: used to set up anesthetic-related items. Press SETUP key to call out the popup
“AG SETUP” menu.
③ MEASURE/STANDBY: press this key to make the module either access the standby
status or start a measurement.
④ Watertrap socket: prior to monitoring a patient, you should first of all safely plug the
watertrap into this socket.
⑤ EXHAUST OUTLET: Exhaust Line to Scavenging System.
⑥
ATTENTION: consult accompanying documents (this operation manual).
When not using this AG module, you may plug out it and preserve it in a clean and dry
place so as to ensure its intended life cycle.
19.2.2
Plug in/out AG module
This AG module has relatively big volume and heavy weight. It occupies a space of three
slots. The method of plugging in/out the AG module is different from that of plugging
in/out other modules. The detailed procedures are:
(1)
(2)
(3)
(4)
Figure 19-3
Plug in/out AG module
Patient Monitor user’s manual (V 2.2)
19-3
Anesthetic Gas Measurement
„
Unload AG module: according to figure (1), (2) and (3). Use one hand to hold the AG
module and another hand to press down the press plates at the left and right sides of the
bottom of the module. And then press down the press plate on the middle bottom of the
module. After the module comes out, use two hands to safely hold the module and put it
out gently.
„
Load AG module: place the AG module into empty slots (totally three slots), push the
module into slots in the way as shown in figure (4). You should push the module for
consecutive two times. The sound of “Ka” “Ka” indicates the completion of loading the
AG module.
Note
When loading AG module, if CO2 module works normally, the system will
automatically unload CO2 module. When loading CO2 module, if AG module works
normally, the system will automatically unload AG module. AG module and CO2
module cannot work at the same time.
19.3 Measuring principle and operating process
Principle for measuring anesthetic gas:
Anesthetic gas can absorb infrared ray. By using this principle, we can measure the
concentration of anesthetic gas.
Gases that can be measured using “AG module” are all able to absorb infrared ray.
Besides, each gas has it own absorption characteristic. First the gas to be measured is
driven into a sample cell. Then optic infrared filter selects the infrared ray with special
wavelength to penetrate this gas. For a given volume, the higher the gas concentration
is, the more infrared rays are absorbed. This means that the higher the concentration of
the absorbed infrared is, the fewer infrared rays there are to have penetrated the gas.
We may first measure the quantity of the infrared rays that have penetrated the gas and
then calculate the gas concentration via specialized formula. If you desire to measure
multiple gases, you should install various infrared filters in the AG module.
19-4
Patient Monitor user’s manual (V 2.2)
Anesthetic Gas Measurement
Principle for measuring oxygen:
Within the range of wavelengths mentioned above, oxygen does not absorb infrared rays.
Therefore we have to measure oxygen concentration by taking advantage of its
paramagnetic characteristic. Inside the sensor of the oxygen module, there are two glass
balls filled up with Nitrogen. These two glass balls are suspended into symmetric
non-uniform magnetic field, pointing into the direction away from the most intensive part
of the field. This device is surrounded by oxygen having paramagnetic characteristic. By
this means, this device is actually further pushed out of the field by the oxygen having
relatively more intensive paramagnetic characteristic. The force moment acted on this
device is proportional to the paramagnetic intensity of the surrounding gas, and therefore
also proportional to oxygen concentration.
Figure 19-4 connection diagram for measuring AG gas
Warning
Ensure tight connection when installing the filter. Any leakage in the system will
result in incorrect reading because this leakage will make the surrounding
environmental air mix up with patient gas.
Warning
To protect the module against contamination, always use bacteria filter because
without it, bacteria and liquid may directly enter the AG module and lead to system
contamination, clog or incorrect reading. In order to prevent clog, dispose the filter
each time after it is used on a patient. Do not try to disinfect or clean a used filter.
Only use the sample line recommended especially for the system. Using other sample
line may reduce the performance and reliability of the AG module.
If the sample line is tangled up, do not use it because the line in this condition may
have clog or leakage.
Patient Monitor user’s manual (V 2.2)
19-5
Anesthetic Gas Measurement
19.4 Menus
19.4.1
AG SETUP menu
There are two ways to enter the AG SETUP menu:
1. Use the rotary knob to select the “GAS” hot key in the Parameter area to call out the
“AG SETUP” menu.
2. Press the “SETUP” button on the AG module to call out the “AG SETUP” menu.
Figure 19-5
AG SETUP menu
Detailed information about each item in the AG SETUP menu is:
„ AGENT: used to select the name of the anesthetic to be monitored.
„ CO2 UNIT: used to select the display unit of CO2.
„ O2 UNIT: used to select the display unit of O2.
„ N2O UNIT: used to select the display unit of N2O.
„ AA UNIT: used to select the display unit of anesthetic.
„ PUMP RATE: used to select the appropriate pump rate.
„ O2 COMPEN: O2 compensation switch. When the O2 concentration is larger than
60% and O2 is not being monitored, turn on this switch.
„ SWEEP: used to select the speed to scan the screen waveforms.
„ WORK MODE: to monitor the anesthetic gas, select the “MEASURE” option.
Otherwise, select the “STANDBY” option.
19-6
Patient Monitor user’s manual (V 2.2)
Anesthetic Gas Measurement
„ ALARM SETUP>>: used to enter the ALARM SETUP submenu.
„ CALIBRATE>>: used to enter the CALIBRATE submenu.
„ O2 calibrate>>: used to enter the “O2 CALIBRATE” submenu.
„ ADJUST WAVE AMP>>: used to enter the “ADJUST WAVE AMP” submenu, in which
you may select the appropriate waveform amplitude for display.
„ SETUP TRANSFER>>: used to enter the “AG SETUP TRANSFER” submenu.
„ DEFAULT>>: used to enter the “AG DEFAULT CONFIG” submenu. You can use the
information in this submenu to initialize all menus.
19.4.2
ALARM SETUP menu
In the ALARM SETUP menu, select the “ALARM” item to pop up the “ALARM SETUP”
menu.
Figure 19-6
ALARM SETUP menu
„ ALM: when this switch is “ON”, if anesthetic gas has alarm, the system will give alarm
prompt and save the alarm information. When this switch is “OFF”, the system will
beside GAS in the Parameter area.
not trigger alarm. Instead it will display
„ ALM LEV: there are three options: “HIGH”, “MED” and “LOW”. “HIGH” refers to the
most serious alarm, followed by “MED” and “LOW” in the order of descending
seriousness. The default alarm level is “MED”.
„ ALM REC: if it is “ON”, when anesthetic gas parameter has alarm, the recorder will
output the alarm information. The default is “OFF”.
„ EtCO2 ALM HI: used to adjust the upper alarm limit of EtCO2. When the measured
value is larger than EtCO2 upper alarm limit, the “EtCO2 HIGH” message is
Patient Monitor user’s manual (V 2.2)
19-7
Anesthetic Gas Measurement
displayed on the screen. In the UNLATCH mode, this message disappears when the
measured value is below the upper alarm limit.
„ EtCO2 ALM LO: used to adjust the lower alarm limit of EtCO2. When the measured
value is smaller than EtCO2 lower alarm limit, the “EtCO2 LOW” message is
displayed on the screen. In the UNLATCH mode, this message disappears when the
measured value is above the lower alarm limit.
„ FiCO2 ALM HI: used to adjust the upper alarm limit of FiCO2. When the measured
value is larger than FiCO2 upper alarm limit, the “FiCO2 HIGH” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is below the upper alarm limit.
„ FiCO2 ALM LO: used to adjust the lower alarm limit of FiCO2. When the measured
value is smaller than FiCO2 lower alarm limit, the “FiCO2 LOW” message is
displayed on the screen. In the UNLATCH mode, this message disappears when the
measured value is above the lower alarm limit.
„ EtO2 ALM HI: used to adjust the upper alarm limit of EtO2. When the measured
value is larger than EtO2 upper alarm limit, the “EtO2 HIGH” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is below the upper alarm limit.
„ EtO2 ALM LO: used to adjust the lower alarm limit of EtO2. When the measured
value is smaller than EtO2 lower alarm limit, the “EtO2 LOW” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is above the lower alarm limit.
„ FiO2 ALM HI: used to adjust the upper alarm limit of FiO2. When the measured value
is larger than FiO2 upper alarm limit, the “FiO2 HIGH” message is displayed on the
screen. In the UNLATCH mode, this message disappears when the measured value
is below the upper alarm limit.
„ FiCO2 ALM LO: used to adjust the lower alarm limit of FiO2. When the measured
value is smaller than EiO2 lower alarm limit, the “FiO2 LOW” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is above the lower alarm limit.
„ AwRR ALM HI: used to adjust the upper alarm limit of AwRR. When the measured
value is larger than AwRR upper alarm limit, the “AwRR HIGH” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is below the upper alarm limit.
„ AwRR ALM LO: used to adjust the lower alarm limit of AwRR. When the measured
value is smaller than AwRR lower alarm limit, the “AwRR LOW” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is above the lower alarm limit.
„ OTHER SETUP>>: used to enter the other ALARM SETUP menus.
„ EXIT: used to close this “ALARM SETUP” menu.
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Anesthetic Gas Measurement
After selecting “OTHER SETUP>>” item in the ALARM SETUP menu, the following
ALARM SETUP menu pops up.
Figure 19-7
ALARM SETUP menu for other parameters
„ EtN2O ALM HI: used to adjust the upper alarm limit of EtN2O. When the measured
value is larger than EtN2O upper alarm limit, the “EtN2O HIGH” message is
displayed on the screen. In the UNLATCH mode, this message disappears when the
measured value is below the upper alarm limit.
„ EtN2O ALM LO: used to adjust the lower alarm limit of EtN2O. When the measured
value is smaller than EtN2O lower alarm limit, the “EtN2O LOW” message is
displayed on the screen. In the UNLATCH mode, this message disappears when the
measured value is above the lower alarm limit.
„ FiN2O ALM HI: used to adjust the upper alarm limit of FiN2O. When the measured
value is larger than FiN2O upper alarm limit, the “FiN2O HIGH” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is below the upper alarm limit.
„ FiN2O ALM LO: used to adjust the lower alarm limit of FiN2O. When the measured
value is smaller than FiN2O lower alarm limit, the “FiN2O LOW” message is
displayed on the screen. In the UNLATCH mode, this message disappears when the
measured value is above the lower alarm limit.
„ EtAA ALM HI: used to adjust the upper alarm limit of EtAA. When the measured value
is larger than EtAA upper alarm limit, the “EtAA HIGH” message is displayed on the
screen. In the UNLATCH mode, this message disappears when the measured value
is below the upper alarm limit.
„ EtAA ALM LO: used to adjust the lower alarm limit of EtAA. When the measured
value is smaller than EtAA lower alarm limit, the “EtAA LOW” message is displayed
on the screen. In the UNLATCH mode, this message disappears when the measured
value is above the lower alarm limit.
„ FiAA ALM HI: used to adjust the upper alarm limit of FiAA. When the measured value
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19-9
Anesthetic Gas Measurement
is larger than FiAA upper alarm limit, the “FiAA HIGH” message is displayed on the
screen. In the UNLATCH mode, this message disappears when the measured value
is below the upper alarm limit.
„ FiAA ALM LO: used to adjust the lower alarm limit of FiAA. When the measured value
is smaller than FiAA lower alarm limit, the “FiAA LOW” message is displayed on the
screen. In the UNLATCH mode, this message disappears when the measured value
is above the lower alarm limit.
„ APNEA ALM: used to set up the apnea alarm time.
Note
Never turn off APNEA alarm.
When various alarms happen together, the screen only displays the alarm
message of the highest alarm level.
19.4.3
ADJUST WAVE AMP menu
In the “AG SETUP” menu, select the “ADJUST WAVE AMP>>” item to pop up the
“ADJUST WAVE AMP” menu as shown in the figure below:
Figure 19-8
ADJUST WAVE AMP menu
„ CO2 WAVE AMP: used to adjust the display amplitude of CO2 waveform.
„ N2O WAVE AMP: used to adjust the display amplitude of N2O waveform.
„ O2 WAVE AMP: used to adjust the display amplitude of O2 waveform.
„ AA WAVE AMP: used to adjust the display amplitude of anesthetic waveform.
„ EXIT: used to exit this menu.
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Anesthetic Gas Measurement
19.4.4
SETUP TRANSFER menu
In the “AG SETUP” menu, select the “TSETUP RANSFER” item to pop up the “AG
SETUP TRANSFER” menu.
Figure 19-9
„
AG SETUP TRANSFER menu
Refers to RT TRANSFER, there are two selections are available:
OFF: when choose the OFF selection, the system will not automatically save the
modifications to the AG module into the AG module.
ON : when choose the ON selection, the system first saves all the setups into the AG
module and then saves the modifications to the module into the AG module immediately.
For the newly loaded AG module, default is OFF.
SAVE SETUP INTO MODULE: means that when the RT TRANSFER is off (when it is ON,
this function is unnecessary), the setups in the system are transferred into the module.
LOAD MODULE SETUP: means that when the RT TRANSFER is off (when it is ON, this
function is unnecessary), the setups in the module are loaded into the system. When
using this function, the warning “Menu items will adopt the value from the module, Yes?”
will be appearing on the screen. And the system will execute the operation after the
confirmation of the user.
19.4.5
DEFAULT menu
In the “AG SETUP” menu, select the “DEFAULT” item to pop up the “AG DEFAULT
CONFIG” menu as shown in the figure below:
Patient Monitor user’s manual (V 2.2)
19-11
Anesthetic Gas Measurement
Figure 19-10
„
AG DEFAULT CONFIG
FACTORY DEFAULT CONFIG: use the factory default configuration to initialize menu
items.
„
USER DEFAULT CONFIG: use the user default configuration to initialize menu items.
„
EXIT: used to exit this menu.
19.5 Alarm information and prompts
When the alarm record switch in a related menu is on, those physiological alarms
caused by the parameter value exceeding the alarm limits will trigger the recorder to
automatically output this parameter value and its related measured waveforms.
Physiological and technical alarms and prompts that may appear during AG monitoring
are listed in following tables:
Physiological alarms:
Message
Cause
Alarm level
FiCO2 HIGH
value
The
measured
FiCO2
exceeds the setup upper alarm
limit.
User selectable
FiCO2 LOW
The measured FiCO2 value is below
the setup lower alarm limit.
User selectable
EtCO2 HIGH
value
The
measured
EtCO2
exceeds the setup upper alarm
limit.
User selectable
EtCO2 LOW
The measured EtCO2 value is
below the setup lower alarm limit.
User selectable
FiO2 HIGH
The measured FiO2 value exceeds
the setup upper alarm limit.
User selectable
FiO2 LOW
The measured FiO2 value is below
the setup lower alarm limit.
User selectable
EtO2 HIGH
value
The
measured
EtCO2
exceeds the setup upper alarm
limit.
User selectable
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Anesthetic Gas Measurement
EtO2 LOW
The measured EtCO2 value is
below the setup lower alarm limit.
User selectable
FiN2O HIGH
value
The
measured
FiN2O
exceeds the setup upper alarm
limit.
User selectable
FiN2O LOW
The measured FiN2O value is below
the setup lower alarm limit.
User selectable
EtN2O HIGH
value
The
measured
EtN2O
exceeds the setup upper alarm
limit.
User selectable
EtN2O LOW
The measured EtN2O value is
below the setup lower alarm limit.
User selectable
FiDES HIGH
The
measured
FiDES
value
exceeds the setup upper alarm
limit.
User selectable
FiDES LOW
The measured FiDES value is
below the setup lower alarm limit.
User selectable
EtDES HIGH
The measured EtDES value
exceeds the setup upper alarm
limit.
User selectable
EtDES LOW
The measured EtDES value is
below the setup lower alarm limit.
User selectable
FiHAL HIGH
The
measured
FiHAL
value
exceeds the setup upper alarm
limit.
User selectable
FiHAL LOW
The measured FiHAL value is below
the setup lower alarm limit.
User selectable
EtHAL HIGH
The
measured
EtHAL value
exceeds the setup upper alarm
limit.
User selectable
EtHAL LOW
The measured EtHAL value is
below the setup lower alarm limit.
User selectable
FiISO HIGH
The measured FiISO value exceeds
the setup upper alarm limit.
User selectable
FiISO LOW
The measured FiISO value is below
the setup lower alarm limit.
User selectable
EtISO HIGH
The
measured
EtISO
value
exceeds the setup upper alarm
limit.
User selectable
EtISO LOW
The measured EtISO value is below
the setup lower alarm limit.
User selectable
FiSEV HIGH
The
measured
FiSEV
value
exceeds the setup upper alarm
limit.
User selectable
FiSEV LOW
The measured FiSEV value is
below the setup lower alarm limit.
User selectable
EtSEV HIGH
The
measured
EtSEV
value
exceeds the setup upper alarm
limit.
User selectable
Patient Monitor user’s manual (V 2.2)
19-13
Anesthetic Gas Measurement
EtSEV LOW
The measured EtSEV value is
below the setup lower alarm limit.
User selectable
FiENF HIGH
The
measured
FiENF
value
exceeds the setup upper alarm
limit.
User selectable
FiENF LOW
The measured FiENF value is
below the setup lower alarm limit.
User selectable
EtENF HIGH
The
measured
EtENF
value
exceeds the setup upper alarm
limit.
User selectable
EtENF LOW
The measured EtENF value is
below the setup lower alarm limit.
User selectable
AwRR HIGH
The
measured
AwRR
value
exceeds the setup upper alarm
limit.
User selectable
AwRR LOW
The measured AwRR value is
below the setup lower alarm limit.
User selectable
GAS APNEA ALM
Respiration cannot be detected
during specified time interval.
HIGH
Technical alarms:
Cause
Alarm
Level
The AG watertrap falls off from the
monitor.
Medium
Replace the AG watertrap
Medium
AG WATERTRAP TYPE
WRONG
The type of the AG watertrap being
used is not suitable.
Medium
AG INIT FAIL
AG module has failure.
High
AG COMM STOP
AG module failure or communication
failure
High
AG OCCLUSION
The actual PUMP rate of the AG
module is <20ml/min, which exceeds 1
second.
High
AG COMM ERROR
AG module has communication failure.
High
AG HARDWARE ERROR
AG module has hardware failure.
High
AG DATA LIMIT ERROR
AG module failure
High
AG USA ERROR
AG module failure
High
AG ZREF FAIL
AG module fails to zero.
High
AG CAL FAIL
AG module fails to calibrate.
High
FiCO2 ALM LMT ERR
Functional safety failure
High
EtCO2 ALM LMT ERR
Functional safety failure
High
FiO2 ALM LMT ERR
Functional safety failure
High
EtO2 ALM LMT ERR
Functional safety failure
High
Message
AG NO WATERTRAP
CHANGE
WATERTRAP
19-14
AG
Patient Monitor user’s manual (V 2.2)
Anesthetic Gas Measurement
FiN2O ALM LMT ERR
Functional safety failure
High
EtN2O ALM LMT ERR
Functional safety failure
High
FiAA ALM LMT ERR
Functional safety failure
High
EtAA ALM LMT ERR
Functional safety failure
High
AwRR ALM LMT ERR
Functional safety failure
High
Prompt:
Message
Cause
Alarm
level
AG IS STARTING
Loading the AG module
No alarm
AG WARM UP
AG module is operating in the Warm-up
status.
No alarm
AG STANDBY
The AG module is operating in the
Standby status.
No alarm
19.6 Technical specifications
Method
infrared absorption characteristic
Patient mode:
Adult/Pediatric, Neonate
Flow rate:
Adult/Pediatric: High:
200 ml/min
Medium: 150 ml/min
Neonate:
Low:
120 ml/min
High:
120 ml/min
Medium: 90 ml/min
Low:
70 ml/min
Measure range:
CO2
0-76 mmHg
O2
0-100%
N2O
0-100%
AwRR
0-100 rmp
Halothame
0-5%
Isoflurane
0-5%
Enflurane
0-5%
Sevoflurane
Desflurane
0-8%
0-18%
Patient Monitor user’s manual (V 2.2)
19-15
Anesthetic Gas Measurement
Gas
CO2
Concentration[%REL]
Inaccuracy[%ABS]
0-1
±0.1
1-5
±0.2
5-7
±0.3
7-10
±0.5
>10
Unspecified
0-20
±2
20-100
±3
0-25
±1
25-80
±2
80-100
±3
0-1
±0.15
1-5
±0.2
>5
Unspecified
0-1
±0.15
1-5
±0.2
5-8
±0.4
>8
Unspecified
0-1
±0.15
1-5
±0.2
5-10
±0.4
10-15
±0.6
15-18
±1
>18
Unspecified
N2O
O2
HAL,EN
F,
ISO
SEV
DES
Updating frequency:
once per second
Start time:
≤40 seconds
Calibrate:
Test gas measurement once per year. Refer to the “Service Manual” for
the method.
Responding time:
Delay time:
≤350ms (10% - 90 %)
Sampling rate is 200ml/min for adult/pediatric and 120ml/min for
neonate. When using Artema watertrap and sampling tube, the delay time is ≤4
seconds.
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Anesthetic Gas Measurement
19.7 Anesthetic Gas Accessories
„
Sampling elbow
PRYON P/N: 000.91400
„
Airway adapter for Adult
PRYON P/N: 000.91060
„
DRYLINE Water Trap Adult
ARTEMA P/N:60-13100-00
„
DRYLINE Water Trap Neonate
ARTEMA P/N:60-13200-00
„
DRYLINE Sample Line Adult 1.5m
ARTEMA P/N:60-15100-00
„
DRYLINE Sample Line Adult 2.5m
ARTEMA P/N:60-15200-00
„
DRYLINE Sample Line Neonate 2.5m
ARTEMA P/N:60-15300-00
19.8 Maintenance and cleaning
„
AG module
For detailed cleaning information about “AG Module”, refer to the chapter of
“Maintenance and Cleaning” in this operation manual.
„
Bacteria filter
The bacteria filter is one-off type, i.e., one bacteria filter can only be used by one patient.
„
Sample line
The sample line is one-off type.
„
Gas exhaust outlet
The gas exhaust outlet is reusable. You need to replace it only when it is damaged or
becomes loosely connected. This tube can be cleaned and disinfected.
Cleaning: use cloth moistened with warm soap water to clean the tube. Do not immerse
the tube into the liquid.
Disinfection: use cloth moistened with cool chemical disinfector (ramification mainly
containing aldehyde, ethanol or ramification mainly containing ethanol) to clean the tube.
Do not immerse the tube into the liquid. After cleaning, use wet cloth to wipe off the
disinfector and then use dry cloth to wipe the tube.
„
Watertrap
Replace the watertrap periodically every month or when prompt message appears
requiring the maintenance.
„
Occlusion handling
If the AG module passage is occluded, the screen will display the message “AG
OCCLUSION”. Following are a few examples of occlusion, which you may remove one
by one until this message disappears.
Patient Monitor user’s manual (V 2.2)
19-17
Anesthetic Gas Measurement
Entrance Occlusion
If the part at the entrance such as filter, sample line or airway connector is occluded by
condensed water, the screen will display the message telling that the airway is occluded.
The optimal method to remove clogs of this kind is:
check for clogs in entrance parts:
a. replace the bacteria filter at the entrance;
b. check the sample pipe for clogs and/or entangle. If necessary, replace it.
c. Check the airway connector for water. If necessary, drain off the water and
install the connector again.
Internal Occlusion
If the interior of the AG module is contaminated by condensed water, the screen will also
display the message telling that the airway is occluded.
The optimal method to remove clogs of this kind is:
Step 1: as usual, check the entrance or the exit for clogs and remove them.
Step 2: if occlusion still persist after step 1, you should consider the existence of interior
occlusion. In this situation, contact Mindray service engineer.
„
Calibrate the reading accuracy
Check the module once per year and confirm if it is necessary to calibrate the reading
accuracy. Please consult the biomedical engineer in your hospital or Mindray service
engineer for related information.
Note
Calibration of the reading accuracy of the AG module must be performed by
trained and qualified personnel.
19-18
Patient Monitor user’s manual (V 2.2)
Chapter 20 Accessories and Ordering
Information
This chapter lists the recommendation accessories used in this device.
Warning
The accessories list below are specified to be used in this device of Shenzhen Mindray
Bio-Medical Electronics Co., Ltd. The device will be possibly damaged or lead some
harm if any other accessories are used.
20.1 ECG Accessories
„
Cables
12PIN 5-lead ECG cable and lead wires assembly, AHA(Mindray)
P/N:0010-30-12248
12PIN 5-lead ECG cable and lead wires assembly, IEC(Mindray)
P/N:0010-30-12249
12PIN 3-lead ECG cable and lead wires assembly, AHA(Mindray)
P/N:0010-30-12250
12PIN 3-lead ECG cable and lead wires assembly, IEC(Mindray)
P/N:0010-30-12251
12PIN 5-lead ECG cable and lead wires assembly, Deffibrilation,
AHA(Mindray)
P/N:0010-30-12252
12PIN 5-lead ECG cable and lead wires assembly, Deffibrilation,
IEC(Mindray)
P/N:0010-30-12253
12PIN 3-lead ECG cable and lead wires assembly, Deffibrilation,
AHA(Mindray)
P/N:0010-30-12254
12PIN 3-lead ECG cable and lead wires assembly, Deffibrilation,
IEC(Mindray)
P/N:0010-30-12255
12PIN separable ECG trunk cable assembly,white(Mindray)
P/N:0010-30-12258
12PIN separable ECG trunk cable assembly,green(Mindray)
P/N:0010-30-12259
12PIN separable ECG trunk cable assembly, Deffibrilation,
white(Mindray)
P/N:0010-30-12260
12PIN separable ECG trunk cable assembly, Deffibrilation,
green(Mindray)
P/N:0010-30-12261
„
Lead wires
3-lead ECG lead wire LL-22363
P/N:9000-10-07445
EURO 5-lead ECG lead wire (KENDALL)
P/N:9000-30-07338
3-lead ECG lead wire, EURO (KENDALL)
P/N:9000-30-07470
Patient Monitor user’s manual (V 2.2)
20-1
Accessories and Ordering Information
5-lead separable ECG lead wire, AHA, PINCH (Mindray)
P/N:0010-30-12262
3-lead separable ECG lead wire, AHA, PINCH (Mindray)
P/N:0010-30-12263
5-lead separable ECG lead wire, IEC, PINCH (Mindray)
P/N:0010-30-12264
3-lead separable ECG lead wire, IEC, PINCH (Mindray)
P/N:0010-30-12265
5-lead separable ECG lead wire, AHA, SNAP (Mindray)
P/N:0010-30-12266
3-lead separable ECG lead wire, AHA, SNAP (Mindray)
P/N:0010-30-12267
5-lead separable ECG lead wire, IEC, SNAP (Mindray)
P/N:0010-30-12268
3-lead separable ECG lead wire, IEC, SNAP (Mindray)
P/N:0010-30-12269
„
Electrodes
ECG electrode (Medi-Trace 230)
P/N:0010-10-12080
ECG electrode (Medi-Trace 210’KENDALL’)
P/N:0010-10-12304
ECG electrode (2249 3M)
P/N:0509-10-00094
Pediatric ECG electrode (2248 3M)
P/N:900E-10-04879
Pediatric electrode (2258-3 3M)
P/N:900E-10-04880
20.2 SpO2 Accessories
„
MASIMO ACCESSORIES:
1269 LNOP-DCI ADULT SENSOR(KIT)
P/N:0010-10-12274
1269 LNOP-DCI ADULT REUSABLE SENSOR
P/N:0010-10-12101
12PIN SPO2 cable
P/N:6200-30-11692
„
NELLCO ACCESSORIES:
DS-100A finger sensor
P/N:9000-10-05161
OXI-P/I pediatric sensor
P/N:9000-10-07308
NELLCO Adult/Neonate wrapping SPO2 sensor (OXI-A/N)
P/N:9000-10-07336
„
MINDRAY ACCESSORIES:
512B finger SPO2 sensor
P/N:512B-30-90134
Finger SPO2 sensor
P/N:512D-30-90200
518A multi-function SPO2 sensor
P/N:518A-30-90226
12PIN SPO2 sensor trunk cable,ver E
P/N:0010-21-11957
20.3 NIBP Accessories
„
20-2
Reusable cuff
Patient Monitor user’s manual (V 2.2)
Accessories and Ordering Information
„
Patient Type
Limb perimeter
PN
Factory PN
Infant
10-19 cm
0010-30-12157
CM1201
Child
18-26 cm
0010-30-12158
CM1202
Adult
25-35 cm
0010-30-12159
CM1203
Large Adult
33-47 cm
0010-30-12160
CM1204
Thigh
46-66 cm
0010-30-12161
CM1205
Adult
25-35 cm
0010-30-12059
W.A.BAUM
Child
18-26 cm
0010-30-12060
W.A.BAUM
Infant
10-19 cm
0010-30-12061
W.A.BAUM
Pediatric
6-11 cm
0010-30-12067
W.A.BAUM
Adult
25-35 cm
509B-30-08845
CM1203-1
Disposable cuff
Size No.
Limb perimeter
PN
Factory PN.
1
3.1~5.7 cm
900E-10-04876
Pediatric PHILIPS M1866A
2
4.3 ~ 8.0 cm
900E-10-04875
Pediatric PHILIPS M1868A
3
5.8 ~ 10.9 cm
900E-10-04874
Pediatric PHILIPS M1870A
4
7.1 ~ 13.1 cm
900E-10-04873
Pediatric PHILIPS M1872A
20.4 TEMP Accessories
NAME
Temperature Probe
YSI PN
YSI 401
PN
0509-10-00095
Temperature Probe
YSI 402
6000-10-01969
Skin TEMP probe
(Adult)
Skin TEMP probe
(Pediatric)
YSI 409B
900E-10-04881
YSI-427
0010-10-12124
Application
Adult esophageal and rectal
temperature measurements
Pediatric esophageal and rectal
temperature measurements
Can easily be taped to the skin to
give surface temperature readings
Can easily be taped to the skin to
give surface temperature readings
20.5 IBP Accessories
ICP encephalic pressure transducer ICT/B’’GADTEC”
P/N:0010-10-12151
12PIN ICP cable assembly
P/N:0010-21-12206
12PIN IBP cable assembly PX1800/896019021EDWARDS,ver A
P/N:0010-21-12180
Disposable IBP transducer DT-4812'OHMEDA' or 'BD'
P/N:6000-10-02107
Reusable IBP transducer P23XL`OHMEDA`
P/N:900E-10-04882
Disposable IBP pressure transducer PX260/EDWARDS
P/N:0010-10-12176
Edwards two disposable IBP pressure transducer PX2X2
P/N:0010-10-12208
Patient Monitor user’s manual (V 2.2)
20-3
Accessories and Ordering Information
20.6 CO Accessories
IT sensor OHMEDA P /N: SP4042 'BD'
P/N:6000-10-02079
IT sensor cap OHMEDA P/N: SP5045 'BD'
P/N:6000-10-02080
anti-pressure three-circles injector 12CC
P/N:6000-10-02081
12PIN CO cable assembly
P/N:6200-30-09744
20.7 CO2 Accessories
008-0781-00/EtCO2 DryerSample Line with TEE(HH)
P/N:0010-10-12082
008-0784-00/EtCO2 DryerSample Line (HH)(No TEE)
P/N:0010-10-12083
008-0780-00/EtCO2 DryerSample Line with TEE(LH)
P/N:0010-10-12084
008-0782-00/EtCO2 Dryer
P/N:0010-10-12085
008-0789-00/Adult Nasal Sampling Line (soft)
P/N:0010-10-12086
008-0786-00/Adult O2 Delivery Sampling Line
P/N:0010-10-12087
008-0790-00/Pediatric Nasal Sampling Line,Soft
P/N:0010-10-12088
008-0785-00/Pediatric O2 Deliver Nasal SampleLine
P/N:0010-10-12089
008-0788-00/Infant EtCO2 Nasal Sampling Line,Soft
P/N:0010-10-12090
008-0783-00/Infant O2 Deliver Nasal SampleLine
P/N:0010-10-12091
2.5mm,008-0766-00/InfantConnecter with Sideport
P/N:0010-10-12092
008-0779-00/Adult/Pediatric Sampling TEE
P/N:0010-10-12093
Sampling LineNeonate2.5m purchase No:60-15300-00
P/N:9200-10-10555
Sampling ELBOW (BOX OF 50) (P/N 000.91167)
P/N:9000-10-07297
Sampling SATRAIGHT CTEE connector
P/N:9200-10-10593
DRYLINE WATER TRAP NEONATER(60-13200-00)
P/N:9200-10-10574
MAINSTREAM SENSOR II (P/N 000.59000)
P/N:9000-10-07299
AIRWAY ADAPTER,ADULT (BOX OF 10)(P/N 000.91060)
P/N:9000-10-07301
AIRWAY ADAPTER,LDS(BOX OF 10)(P/N 000.91070)
P/N:9000-10-07302
20.8 Anesthetic Gas Accessories
DRYLINE Airway Adapter,Straight P/N:60-14100-00
P/N:9000-10-07486
DRYLINE Airway Adapter,Elbow P/N:60-14200-00
P/N:9000-10-07487
Aion DRYLINE Water Trap,Adult, purchase No:60-13100-00
P/N:9200-10-10530
20-4
Patient Monitor user’s manual (V 2.2)
Accessories and Ordering Information
Sampling Line,Adult 2.5m, Adult, purchase No:60-15200-00
Patient Monitor user’s manual (V 2.2)
P/N:9200-10-10533
20-5
Appendix I
EC Declaration of Conformance
Manufacturer
Shenzhen Mindray Bio-Medical Electronics
Co., Ltd.
Address
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, 518057, P. R. China.
European
Shanghai International Holding Corp. GmbH (Europe)
Representative
Eiffestrasse 80 D-20537 Hamburg Germany
Product
Patient Monitor
Model Code
PM-6000
Standard Configuration including:
ECG/RESP/Temp, NIBP, SpO2
Options:
1. Thermal Recorder
2. 4-channel IBP
3. Cardiac Output
4. EtCO2(Sidestream)
5. EtCO2(Mainstream)
6. Anaesthetic Gases
Classification (MDD, Annex IX): IIb
We herewith declare that the above mentioned products meet the provisions of the
following EC Council Directives and Standards. All supporting documentations are
retained under the premises of the manufacturer and the notified body.
Patient Monitor user’s manual (V 2.2)
1
EC Declaration of Conformance
DIRECTIVES
General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
medical devices (MDD 93/42/EEC).
Standards:
Harmonized Standards (published in the Official Journal of the European Communities)
applicable to this product are:
ISO14971:2000+A1:2003,
EN1041:1998,
ISO1000:1992+A1:1998,
ISO10993-1:2003,
EN980:2003,
IEC60878:2003,
ISO3744:1994,
EN540:1993,
EN60601-1:1990+A1:1993+A2:1995+A13:1996, EN60601-1-1:2001, EN60601-1-2:2001,
EN60601-1-4:2000,
EN475:1995,
EN60601-2-27:1994,
EN865:1997,
EN60601-2-30:2000,
EN864:1996,
EN60601-2-34:2000,
EN12470-4:2000,
EN1060-1:1995,
EN1060-3:1997, IEC60601-2-49:2001, ANSI/AAMI SP-10:1996.
Notified Body:
TÜV Product Service GmbH, Ridlerstrasse 65 D- 80339 Münich,
Germany.
2
Patient Monitor user’s manual (V 2.2)
Appendix II
Product Specification
1 Classification
Anti-electroshock type
Class I equipment with internal power supply
Anti-electroshock degree
ECG(RESP), SpO2, NIBP, IBP, TEMP, CO, CO2 CF
AG
BF
EMC
Class A
Harmful liquid proof degree
Ordinary equipment (sealed equipment without liquid proof)
Disinfection/sterilizing method
Refer to Operation manual for details.
Working system
Continuous running equipment
2 Specifications
2.1 Size and Weight
Size
Weight
Main box
340 x 120 x 250 mm (W*H*D)
Single module
40 x 100 x 155 mm (W*H*D)
Main box
7.3 (kg)
2.2 Environment
Temperature
Working
0 ~ 40 (°C)
Welch Allyn Sidestream CO2
+5ºC ~ +35ºC
Welch Allyn Mainstream CO2
+10ºC ~ +40ºC
Artema AION Anesthesia Gases +10ºC ~ +40ºC
Storage
-20 ~ 60 (°C)
Humidiity
Working
15% - 85 %(noncondensing)
Storage
10% - 93 % (noncondensing)
Patient Monitor user’s manual (V 2.2)
1
Product Specification
Altitude
Working
-500 to 4,600m
Transport and Storage -500 to 13,100m
Power Supply
100~250 (V) AC, 50/60 (Hz)
Pmax = 110VA
FUSE T 1.6A
2.3 Display
Device
12.1 (in.) Color TFT, 800 x 600 Resolution, 3 LED
Messages
8 Waveforms Maximum
1 Alarm LED (Yellow/Red)
1 Power LED (Green)
3 Sound Mode corresponding Alarm Mode
2.4 Signal Interface
External Display
Standard VGA
ECG Output
BNC
Amplitude
1 V/mV
Accuracy
<5%
Impedance
100 (ohm)
Signal Delay
< 20 (ms)
2.5 Recorder
Record Width
48 (mm)
Paper Speed
25/50(mm/s)
Trace
2
Recording types:
Continuous real-time recording
8 second real-time recording
Auto 8 second recording
Parameter alarm recording
Waveform freeze recording
Trend graph/table recording
ARR events review recording
Alarm event review recording
NIBP review recording
CO2 Measurement review recording
2
Patient Monitor user’s manual (V 2.2)
Product Specification
AG Measurement review recording
CO Measurement curve recording
Hemodynamic Calculation result recording
Drug Calculation and titration table recording
Monitor information recording
OxyCRG review recording
2.6 Recall
Trend Recall
Short
1 hour, 1 second or 5 second Resolution
Long
72 (hrs), 1 min, 5min or 10 min Resolution
Alarm Event Recall
60 alarm events of all parameters and 8, 16 or 32
seconds of corresponding waveform.
NIBP Measurement Recall
400 NIBP measurement data.
2.7 ECG
Lead Mode
5 Leads ( R, L, F, N, C or RA, LA, LL, RL, V )
Lead selection
I, II, III, avR, avL, avF, V, CAL
Waveform
2 ch
Lead mode
3 Leads ( R, L, F or RA, LA, LL)
Lead selection
I, II, III, CAL
Waveform
1 ch
Gain
×0.25, ×0.5, ×1, ×2, auto
HR and Alarm
Range
Adult
15 ~ 300 (bpm)
Neo/Ped
15 ~ 350 (bpm)
Accuracy
± 1% or ± 1bpm, use the greater
Resolution
1 (bpm)
Sensitivity
> 200 (uV) P-P
Differential Input Impedance
> 5 (Mohm)
CMRR
Monitor
> 105 dB
Surgery
> 105 dB
Diagnostic
> 90 dB
Electrode offset potential
±300mV
Leakage Current
< 10 (uA)
Baseline Recovery
< 3 (S) After Defi.
ECG Signal Range
± 8 (mV) p-p
Bandwidth
Surgery
1 ~ 15 Hz
Patient Monitor user’s manual (V 2.2)
3
Product Specification
Monitor
0.5 ~ 35 Hz
Diagnostic
0.05 ~ 100 Hz
1 (mV) p-p, ±5% Accuracy
Calibration Signal
ST Segment Monitoring Range
Measure and Alarm
-2.0 ~ +2.0 (mV)
ARR Detecting
Type
ASYSTOLE, VFIB/VTAC, COUPLET, BIGEMINY,
TRIGEMINY, R ON T, VT>2, PVC, TACHY, BRADY,
MISSED BEATS, PNP, PNC
Alarm
Available
Review
Available
2.8 RESPARATION
Method
Impedance between RA-LL
Differential input Impedance:
>2.5 MOhm
Measuring Impedance Range:
0.3~5.0Ω
Base line Impedance Range:
200- 2500Ω(use 1kΩ of ECG cable)
Bandwidth
0.2 ~ 2 Hz(-3db)
Resp.Rate
Measuring and Alarm Range
Adult
0 ~ 120 (rpm)
Neo/Ped
0 ~ 150 (rpm)
Resolution
1 (rpm)
Accuracy
±2 (rpm)
Apean Alarm
10 ~ 40 (s)
2.9 NIBP
Method
Oscillometric
Mode
Manual, Auto, STAT
Measuring Interval in AUTO Mode
1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180, 240, 480 min
Measuring Period in STAT Mode 5 (Min)
Pulse Rate Range
40 ~ 240 (bpm)
Alarm
Type
SYS, DIA, MEAN
Measuring and alarm range
Adult Mode
SYS
40 ~ 270 mmHg
DIA
10 ~ 215 mmHg
MEAN
20 ~ 230 mmHg
Pediatric Mode
4
Patient Monitor user’s manual (V 2.2)
Product Specification
SYS
40 ~ 200 mmHg
DIA
10 ~ 150 mmHg
MEAN
20 ~ 165 mmHg
Neonatal Mode
SYS
40 ~ 135 mmHg
DIA
10 ~ 100 mmHg
MEAN
20 ~ 105 mmHg
Resolution
Pressure
1mmHg
Cuff pressure accuracy
± 3mmHg
Accuracy
Pressure
Maximum Mean error
±5mmHg
Maximum Standard deviation
8mmHg
Overpressure Protection
dult Mode
297±3 mmHg
Pediatric Mode
240±3 mmHg
Neonatal Mode
147±3 mmHg
2.10 SPO2
Measuring Range
0 ~ 100 %
Alarm Range
0 ~ 100 %
Resolution
1%
Accuracy
70% ~ 100% ±2 %
0% ~ 69% unspecified
Actualization interval
about 1(Sec.)
Alarm Delay
10 (Sec.)
Pulse Rate
Measuring and Alarm Range
0~254bpm
Resolution
1bpm
Accuracy
±2bpm or ±2%, use the greater
MASIMO Specification:
Range
Saturation(%SpO2)
Pulse Rate(bmp)
1%~100%
25~240
Accuracy
Saturation(%SpO2) - During No Motion Conditions
Adults/pediatric
70%~100%±2%
0%~69% unspecified
Neonates
70%~100%±3%
Patient Monitor user’s manual (V 2.2)
5
Product Specification
0%~69% unspecified
Saturation(%SpO2) - During Motion Conditions
Adults/ pediatric/ Neonates
70%~100%±3%
0%~69% unspecified
Pulse(bpm) - During No Motion Condition
25 to 240 ± 3BPM
Pulse(bpm) - During Motion Condition
25 to 240 ± 5BPM
Resolution
Saturation(%SpO2)
1%
Pulse Rate(bpm)
1
2.11 TEMPERATURE
Channel
2
Measuring and Alarm Range
0 ~ 50 °C
Resolution
0.1°C
Accuracy
±0.1°C (0°C~50°C ,exclusive of probe errors)
Actualization interval
about 1(Sec.)
Average Time Constant
< 10 (Sec.)
2.12
IBP
Channel
2
Label
ART, PA, CVP, RAP, LAP, ICP, P1, P2
Measuring and alarm range
ART
0 ~ 300 (mmHg)
PA
-6 ~ 120 (mmHg)
CVP/RAP/LAP/ICP
-10 ~ 40 mmHg
P1/P2
-50 ~ 300 mmHg
Press Sensor
Sensitivity
5 (uV/V/mmHg)
Impedance
300 ~ 3000 (Ohm)
Resolution
1 (mmHg)
Accuracy
±2% or ±1mmHg, use the greater
Actualization interval
about 1(Sec.)
2.13
CO
Method
Thermodilution Technique
Measuring range
6
CO
0.1 ~ 20 (L/min)
TB
23 ~ 43 (°C)
TI
0 ~ 27 (°C)
Patient Monitor user’s manual (V 2.2)
Product Specification
Resolution
CO
0.1 (L/min)
TB
0.01 (°C)
TI
0.1 (°C)
Accuracy
CO
±2% or ± 0.1L/min
TB
±0.1 (°C)
TI
±0.1 (°C)
Calculation
CO, Hemodynamic Calculation
Alarm Range
23-43 (°C)
2.14 CO2
Method
Infra-red Absorbation Technique
Measuring mode
Sidestream or Mainstream (optional)
Side-stream mode sampling gas flow rate
100, 150, 200 ml/min (option)
Measuring range
CO2
0~99 mmHg
INS CO2
0-99 mmHg
AwRR
0~150 bpm
CO2
1 mmHg
Resolution
INS CO2
1mmHg
AwRR
1 rpm
CO2
±2 mmHg,
0 ~ 40 mmHg
±5% of reading,
41 ~ 76 mmHg
Accuracy
±10% of reading,
77 ~ 99 mmHg
±2 rpm
AwRR
Actualization interval
about 1(Sec.)
Start-up Time:
< 30 sec typical in sidestream mode
< 80 seconds in mainstream mode from 25°C ambient, 5W supplied to
sensor heater (Mainstream sensor temperature controlled to 42°C)
Mainstream Response Time
100 msec (10% to 90 %)
Sidestream Rise Time
240 msec (10% to 90 %)
Sidestream Delay Time
1.12 seconds maximum with 7-feet long sampling line
and ID 0.055 inch ,Sample rate is 175 ml/min
Alarm range
CO2
Ins CO2
AwRR
0 – 99 mmHg
0 – 99 mmHg
0 – 150 rpm
Patient Monitor user’s manual (V 2.2)
7
Product Specification
Suffocation Alarm Delay
AwRR
2.15
10 ~ 40 Sec.
AG
Method
Infrared Absorption Technique
Measuring mode
Side-stream
Warm-up time
30 Sec
Iso accuracy mode
10 Min
Full accuracy mode
Side-stream mode sampling gas flow rate
Adult:
120,150,250 ml/min (option)
Neonate:
70,90,120 ml/min (option)
Gas Sort
CO2, N2O, O2 (Option), Des. , Iso., Enf., Sev., Hal.
Measuring range
CO2
0- 10% ( 0-76 mmHg)
N2O
0-100%
Des
0- 18%
Sev
0- 8%
Enf, Iso, Hal
0- 5%
O2
0- 100%(Option)
awRR
2-100 rpm
Resolution
CO2
1 mmHg
awRR
1 rpm
Accuracy
CO2
N2O
Des
Sev
Enf, Iso, Hal
8
Accuracy
range
±0.1%
0 – 1%
±0.2%
1 – 5%
±0.3
5 – 7%
±0.4
7 – 10%
Unspecified
> 10%
±2%
0 - 20%
±3%
20 - 100%
±0.15%
0 – 1%
±0.2%
1- 5%
±0.4%
5 - 10%
±0.6%
10 - 18%
Unspecified
>18%
±0.15%
0 – 1%
±0.2%
1- 5%
±0.4%
5 - 8%
Unspecified
> 8%
±0.15%
0-1%
Patient Monitor user’s manual (V 2.2)
Product Specification
O2 (Option)
awRR
±0.2%
1-5%
Unspecified
>5%
±1%
0- 25%
±2%
25-80%
±3%
80-100%
±1 rpm
Alarm range
CO2
0-10% (0-76 mmHg)
awRR
2-100 rpm
Suffocation Alarm Delay
awRR
Updating frequency:
:
20-40 Sec.
once per second
no specified calibrate regulations
AG calibrate stability
after being used for consecutive 12 months, the
deviation from precision is < 1%
Descending time:
240ms (10% - 90 %)
Delay time
1.12 seconds maximum with 7-feet long sampling
line and ID 0.055 inch ,Sample rate is 175 ml/min
Patient Monitor user’s manual (V 2.2)
9
Appendix III
EMC
The monitor meets the requirements of EN 60601-1-2:2001
Note
The monitor needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided below.
Note
Portable and mobile RF communications equipment can affect this monitor. See tables
1,2,3, and 4 below.
TABLE 1
Guidance and manufacturer’s declaration — electromagnetic emmissions
The monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitor should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
CISPR 11
Group1
RF emissions
CISPR 11
Class A
Harmonic
Emissions IEC
Voltage
Fluctuations/
Flicker
Emissions IEC
61000-3-3
Class A
Electromagnetic environment — guidance
The MONITOR uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
The MONITOR is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes
Class A
TABLE 2
Guidance and manufacturer’s declaration — electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitor should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
Electromagnetic
Test level
environment — guidance
Patient Monitor user’s manual (V 2.2)
1
EMC
± 2KV, ± 4KV,
±6KV contact
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical
fast
Transient/burst
IEC 61000-4-4
± 2kV, ± 4KV,
± 6KV, ± 8KV
air
±2kV, ±4KV, ±
6KV, ±8KV air
±2 kV for power
supply lines
±2 kV
±
1
kV
differential mode
±2 kV common
mode
<5% UT (>95%
dip in UT ) for 0.5
cycle
Surge
IEC 61000-4-5
Voltage dips, Short
interruptions and
voltage
variation
on power supply
input lines
IEC 61000-4-11
40% UT (60% dip
in UT ) for 5 cycle
70% UT (30% dip
in UT ) for 25
cycle
<5% UT (>95%
dip in UT ) for 5
sec
Power frequency
(50/60
HZ)
magnetic field IEC
61000-4-8
±2KV, ±4KV, ±
6KV contact
3 A/m
±1 kV
Mains power quality should be
that of a typical commercial or
hospital environment.
±2 kV
<5% UT (>95% dip
in UT ) for 0.5
cycle
40% UT (60% dip
in UT ) for 5 cycle
70% UT (30% dip
in UT ) for 25 cycle
<5% UT (>95% dip
in UT ) for 5 sec
3 A/m
Floors
should
be
wood,
concrete or ceramic tile. If
floors
are
covered
with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the monitor requires
continued operation during
power mains interruptions, it is
recommended that the monitor
be
powered
from
an
uninterruptible power supply or
a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
of hospital environment.
NOTE — UT is the a.c. mains voltage prior to application of the test level.
TABLE 3
Guidance and manufacturer’s declaration — electromagnetic immunity
Portable and mobile RF communications equipment should be used no closer to any part of the monitor,
including cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
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.
The monitor is intended for use in the electromagnetic environment specified below. The customer or
the user of the monitor should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Conducted RF
IEC 61000-4-6
3 Vrms 150kHz
to 80MHz
2
Compliance
level
3 Vrms
Electromagnetic environment —
guidance
Recommended separation distance:
d = 1.2 x P
Patient Monitor user’s manual (V 2.2)
EMC
Radiated
RF
IEC 61000-4-3
3 V/m 80MHz
to 2.5 GHz
3 V/m
Recommended separation distance:
d = 1.2 x P 80MHz to 800MHz
d = 2.3 x P 800MHz to 2.5GHz
Where P is the maximum output power
rating of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following symbol:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the monitor is used exceeds the applicable RF compliance level above, the monitor
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the monitor.
b
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3V/m.
TABLE 4
Recommended separation distances between portable and mobile RF
communications equipment and the monitor
The monitor is intended for user in an electromagnetic environment in which radiated RF disturbance
are controlled. The customer or the user of the monitor can help prevent electromagnetic interference
by maintain a minimum distance between portable and mobile RF communication equipment
(transmitters) and the monitor as recommended below, according to the maximum output power of the
communication equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
800 MHz to 2.5
150 kHz to 80 MHz 80 MHz to 800 MHz
GHz
d = 1.2 x P
d = 1.2 x P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
d = 2.3 x
P
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 distanced d in meters (m) can be estimated 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.
Patient Monitor user’s manual (V 2.2)
3
Appendix IV
System Alarm Prompt
PROMPT
CAUSE
MEASURE
"SLOT
X
LOADING
MODULE CONFLICT"
Already
load
another
module of the same type.
Do not load more than one
module of the same parameter.
X represents the numerical code of 1-8 slots.
"XX TOO HIGH"
XX value exceeds
higher alarm limit.
the
"XX TOO LOW"
XX value is below the lower
alarm limit.
Check if the alarm limits are
appropriate and the current
situation of the patient.
XX represents the value of parameter such as HR, ST1, ST2, RR, SpO2, IBP, NIBP, etc in the system.
"ECG WEAK SIGNAL"
“NO PULSE”
"RESP APNEA"
"CO2 APNEA"
The ECG signal of the
patient is too small so that
the system can not perform
ECG analysis.
The pulse signal of the
patient is too small so that
the system can not perform
pulse analysis.
The respiration signal of the
patient is too small so that
the system cannot perform
RESP analysis.
The respiration signal of the
patient is too small so that
the system cannot perform
RESP analysis.
"ASYSTOLE"
Patient suffers from Arr. Of
ASYSTOLE.
"VFIB/VTAC"
Patient suffers from Arr. of
VFIB/VTAC.
"COUPLET"
Patient suffers from Arr. of
COUPLET.
"BIGEMINY"
Patient suffers from Arr. Of
BIGEMINY.
"TRIGEMINY"
Patient suffers from Arr. of
TRIGEMINY.
"R ON T"
Patient suffers from Arr. of
R ON T.
Check if the electrodes and lead
wires are connected correctly
and the current situation of the
patient.
Check the connection of the
sensor and the current situation
of the patient.
Check the connection of the
linking wire and the current
situation of the patient.
Check the connection of CO2
sensor and the current situation
of the patient.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
Patient Monitor user’s manual (V 2.2)
1
System Alarm Prompt
"PVC"
Patient suffers from Arr. of
PVC.
"TACHY"
Patient suffers from TACHY.
" BRADY"
Patient
BRADY.
"VT>2"
Patient suffers from Arr. of
VT>2.
“MISSED BEATS”
Patient suffers from Arr. of
MISSED BEATS.
"PNP"
The pacemaker
paced.
"PNC"
No pacemaker signal is
captured.
"ECG LEAD OFF"
"ECG V LEAD OFF";
"ECG LL LEAD OFF";
"ECG LA LEAD OFF";
"ECG RA LEAD OFF";
"ECG C LEAD OFF";
"ECG F LEAD OFF";
"ECG L LEAD OFF";
"ECG R LEAD OFF";
suffers
from
is
not
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the current situation of the
patient. Check the connection of
the electrodes and lead wires.
Check the connection of the
pacemaker.
Check
the
connection
of
electrodes and lead wires. Check
the current situation of the
patient.
Check the connection of the
pacemaker.
Check
the
connection
of
electrodes and lead wires. Check
the current situation of the
patient.
ECG lead is not connected
correctly.
The V lead wire of ECG is
not connected correctly.
The LL lead wire of ECG is
not connected correctly.
The LA lead wire of ECG is
not connected correctly.
The RA lead wire of ECG is
not connected correctly.
Check the connection of ECG
lead wire.
Check the connection of V lead
wire.
Check the connection of LL lead
wire.
Check the connection of LA lead
wire.
Check the connection of RA lead
wire.
The C lead wire of ECG
not connected correctly.
The F lead wire of ECG
not connected correctly.
The L lead wire of ECG
not connected correctly.
The R lead wire of ECG
not connected correctly.
Check
wire.
Check
wire.
Check
wire.
Check
wire.
is
is
is
is
the connection of C lead
the connection of F lead
the connection of L lead
the connection of R lead
SPO2 SENSOR OFF
SpO2 sensor may be
disconnected from the
patient or the monitor.
Make sure that the monitor and
the patient are in correct
connection with the cables.
SPO2 INIT ERR
SpO2 module failure
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or Mindray
service staff.
SPO2 INIT ERR 1
SPO2 INIT ERR 2
SPO2 INIT ERR 3
2
Patient Monitor user’s manual (V 2.2)
System Alarm Prompt
SPO2 INIT ERR 4
SPO2 INIT ERR 5
SPO2 INIT ERR 6
SPO2 INIT ERR 7
SPO2 INIT ERR 8
SPO2 COMM STOP
SpO2 module failure or
communication error
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or Mindray
service staff.
SPO2 COMM ERR
SpO2 module failure or
communication error
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or Mindray
service staff.
Functional safety failure
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or Mindray
service staff.
Functional safety failure
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or Mindray
service staff.
Sensor not fully inserted
into the connector.
May be an incorrect sensor, or a
defective sensor or cable. Insert
sensor into the connector.
Disconnect
and
reconnect
sensor. Refer to the instructions
for the sensor being used.
Sensor
down.
Disconnect and reconnect he
sensor with the logos matching.
SPO2 ALM LMT ERR
PR ALM LMT ERR
MASIMO Alarm information:
SpO2 NO SENSOR
SpO2 SENSOR
OFF
inserted
upside
SpO2 sensor may
disconnected
from
patient or the monitor.
be
the
Disconnect and reconnect the
sensor.
Reattach sensor.
This message appears
when the sensor is faulty
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
SpO2
UNRECOGNIZED
SENSOR
Masimo board does not
recognize the sensor.
Make sure that the monitor and
the patient are in correct
connection with the cables.
SpO2
INCOMPATIBLE
SENSOR
This message is displayed
when the masimo sensor is
finding incompatible sensor.
Make sure that the monitor use
incompatible sensor.
SpO2
INTERFERENCE
Outside signal or energy
preventing reading.
Remove outside interference.
SpO2
SEARCH
Unit is searching for the
patients pulse.
If values are not displayed within
30 seconds, disconnect and
reconnect sensor. If pulse search
SpO2
FAULT
SENSOR
PULSE
Patient Monitor user’s manual (V 2.2)
3
System Alarm Prompt
continues, remove sensor and
replace on a better perfused site.
SpO2
LOW
PERFUSTION
SpO2 TOO
MUCH LIGHT
Move sensor to better perfused
site.
Signal too small.
Too
much
light
on
patient(sensor). Inadequate
tissue
covering
sensor
detector.
Remove or reduce lighting. Cover
sensor from light.
Reposition sensor.
Ensure
proper
sensor
application. Mover sensor to a
better perfused site.
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
SpO2 LOW
SIGNAL IQ
Low signal quality.
SpO2
BOARD FAULT
This message appears
when the Masimo Set
board malfunctions.
SpO2 COMMUNICATION
ERROR
This message is displayed
when the front end module
is
having
problems
communicating ( ie: framing
errors or bad checksums)
with the Masimo board.
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
SpO2 COMMUNICATION
STOP
This message is displayed
when the host can not
receive the data from
Masimo
board
for
5
seconds
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
SpO2 INIT ERR
This message is displayed
when the SpO2 module
initialization
error
happened.
Stop using the measuring
function of SpO2 module, notify
biomedical engineer or our
service staff.
TEMP1 sensor is
connected correctly.
TEMP2 sensor is
connected correctly.
Check the connection of TEMP1
sensor.
Check the connection of TEMP2
sensor.
"TEMP1 SENSOR OFF"
"TEMP2 SENSOR OFF"
"IBP1 LEAD OFF"
"IBP2 LEAD OFF"
"IBP3 LEAD OFF"
"IBP4 LEAD OFF"
"IBP1 NEED ZERO-CAL"
"IBP2 NEED ZERO-CAL"
"IBP3 NEED ZERO-CAL"
"IBP4 NEED ZERO-CAL"
4
not
not
IBP1
sensor
is
not
connected correctly.
IBP2
sensor
is
not
connected correctly.
IBP3
sensor
is
not
connected correctly.
IBP4
sensor
is
not
connected correctly.
Zero calibrating must be
done before measuring in
IBP1
Zero calibrating must be
done before measuring in
IBP2
Zero calibrating must be
done before measuring in
IBP3
Zero calibrating must be
done before measuring in
Check
sensor.
Check
sensor.
Check
sensor.
Check
sensor.
the connection of IBP1
the connection of IBP2
the connection of IBP3
the connection of IBP4
Do zero calibrating for IBP1
Do zero calibrating for IBP2
Do zero calibrating for IBP3
Do zero calibrating for IBP4
Patient Monitor user’s manual (V 2.2)
System Alarm Prompt
IBP4
TB sensor is not connected
correctly.
CO2
sensor
is
not
connected correctly.
Check the connection of TB
sensor.
Check the connection of CO2
sensor.
"ECG NOISE"
Rather large interference
signals appear in the ECG
signals.
Check the connection of ECG
lead wire. Check the current
situation of the patient. Check if
the patient moves a lot.
"XX INIT ERR X"
XX has error X during
initialization.
"XX COMM STOP"
XX cannot communicate
with the host.
"XX COMM ERR"
XX cannot communicate
normally with the host.
"TB SENSOR OFF"
"CO2 SENSOR OFF"
Re-start up the monitor or re-plug
in/out the module. If the error still
exists, contact the manufacturer.
XX represents all the parameter modules in the system such as ECG, NIBP, SpO2, IBP, CO module, etc.
"XX ALM LMT ERR"
"XX RANGE EXCEEDED"
The alarm limit of XX
parameter is modified by
chance.
The measured value of XX
parameter has exceeded
the measuring range of the
system.
Contact
repair.
the
manufacturer
for
Contact
repair.
the
manufacturer
for
XX represents the parameter name in the system such as HR, ST1, ST2, RR, SpO2, IBP, NIBP, etc.
"CO2 NO WATERTRAP"
CO2 watertrap is
connected correctly.
"CO2
WATERTRAP
OCCLUDE"
CO2 watertrap is clogged.
"CO2 SIGNAL LOW"
CO2 signals are poor.
"CO2 SIGNAL TOO LOW"
CO2 signals are too poor.
"CO2 BAROMETRIC TOO
LARGE"
"CO2 PNEUMATIC LEAK"
"CO2 SIGNAL NOISY"
"CO2
SIGNAL
SATURATE"
"CO2
CALCULATION
ERR"
"CO2 PUMP FAULT"
"CO2REVERSE FLOW"
"CO2 FORWARD FLOW"
"CO2 MALNUFUNCTION"
"CO2
BAROMETRIC
HIGH"
"CO2
BAROMETRIC
LOW"
not
CO2 modules has failure.
Check the connection of CO2
watertrap.
Replace the filter net or CO2 air
hose. Check if the water in the
CO2 watertrap is too much.
Check for leaks in the airway.
Check if the airway is clogged.
Check if the watertrap is too old.
After excluding the above
problems, replace another CO2
air hose or watertrap. If it still
cannot work normally, contact the
manufacturer for repair.
Contact the manufacturer for
repair.
Patient Monitor user’s manual (V 2.2)
5
System Alarm Prompt
"CO2
WATCHDOG
ERROR"
"CO2 INT COMM ERR"
“CO2
SYSTEM
ROM
ERR”
“CO2 FLASH CRC ERR”
“CO2 EXT RAM ERR”
“CO2 INT RAM ERR”
“CO2 FLASH CHECK
ERR”
“CO2 STACK OVER”
"CO2 SENSOR FAULT"
"CO2 SENSOR TEMP
HIGH"
"CO2 SENSOR TEMP
LOW"
"REAL
NEEDSET"
"REAL
EXIST"
CLOCK
CLOCK
NOT
"SYSTEM WD FAILURE"
"SYSTEM
SOFTWARE
ERR"
"SYSTEM CMOS FULL"
"SYSTEM CMOS ERR"
"SYSTEM
EPGA
FAILURE"
"SYSTEM FAILURE2"
"SYSTEM FAILURE3"
"SYSTEM FAILURE4"
"SYSTEM FAILURE5"
"SYSTEM FAILURE6"
"SYSTEM FAILURE7"
"SYSTEM FAILURE8"
"SYSTEM FAILURE9"
"SYSTEM FAILURE10"
"SYSTEM FAILURE11"
"SYSTEM FAILURE12"
"KEYBOARD
AVAILABLE";
NOT
"KEYBOARD
COMM
ERR";
"KEBOARD ERROR";
"KEYBOARD ERR1";
"KEYBOARD ERR2";
6
When the system displays
2000-1-1, the system gives
this prompt reminding the
user that the current system
time is not right.
Re-set up the system time. It is
better to set up the time just after
the start-up and prior to
monitoring the patient. After
modifying the time, the user had
better re-start up the monitor to
avoid storing error time.
The system has no cell
battery or the battery has
run out of the capacity.
Install
or
replace
rechargeable battery.
The system has serious
error.
Re-start up the system. If the
failure still exists, contact the
manufacturer.
The keys on the keyboard
cannot be used.
Check the keys to see whether it
is pressed manually or by other
object. If the key is not pressed
abnormally,
contact
the
manufacturer for repair.
The keyboard has failure,
which cannot be used.
Contact
repair.
Patient Monitor user’s manual (V 2.2)
the
manufacturer
the
for
System Alarm Prompt
"NET INIT ERR(G.)"
"NET INIT ERR(Ram)"
"NET INIT ERR(Reg)"
"NET INIT ERR(Mii)"
"NET INIT ERR(Loop)"
"NET ERR(Run1)"
"NET ERR(Run2)"
"NET ERR(Run3)"
"5V TOO HIGH"
"5V TOO LOW"
"POWER ERR3"
"POWER ERR4"
"12V TOO HIGH"
"12V TOO LOW"
"POWER ERR7"
"POWER ERR8"
"3.3V TOO HIGH"
"3.3V TOO LOW"
"CELL BAT TOO HIGH"
"CELL BAT TOO LOW"
The network part in the
system has failure. The
system cannot be linked to
the net.
Contact
repair.
The power part of
system has failure.
If the prompt appears repeatedly,
contact the manufacturer for
repair.
the
Cell battery has problem.
The cell battery has low
capacity or the cell battery
is not installed or the
connection is loose.
Place the paper into the recorder.
The paper in the recorder is
jammed.
Place the recorder correctly and
try again.
Re-load the module or in the
recorder setup menu, execute
the function of clearing record
task. The function can make the
host and the recorder connect
again. If the failure still exists,
contact the manufacturer for
repair.
The recorder module has
voltage failure.
"RECORDER HEAD HOT"
The continuous recording
time may be too long.
"RECORDER
W.P."
COMM
PAPER
"REC NOT AVAILABLE"
Replace the battery. If the failure
still
exists,
contact
the
manufacturer.
No paper is in the recorder.
"RECORDER VLT HIGH"
"RECORDER VLT LOW"
"RECORDER S. COMM
ERR"
for
The handle for pressing the
paper is not pressed down.
During the selftest, the
system fails connecting with
the recorder module.
"RECORDER
ERR"
manufacturer
Execute ‘Clear Record Task’
function in the recorder setup
menu to re-connect the host and
the recorder. If the failure still
exists, contact the manufacturer
for repair.
Contact the manufacturer for
repair.
After the recorder becomes cool,
use the recorder for output again.
If the failure still exists, contact
the manufacturer for repair.
Press down the recorder handle
for pressing the paper.
"RECORDER SELFTEST
ERR"
"REC HEAD IN WRONG
POSITION"
"RECORDER OUT OF
PAPER"
"RECORDER
PAPER
JAM"
the
The communication of the
recorder is abnormal.
The paper roll of the
recorder is not placed in the
correction position.
Place the paper roll in the correct
position.
Cannot communicate with
the recorder.
Re-load the module or in the
recorder setup menu, execute
the function of clearing record
task. The function can make the
host and the recorder connect
Patient Monitor user’s manual (V 2.2)
7
System Alarm Prompt
again. If the failure still exists,
contact the manufacturer for
repair.
Execute the reset program in the
NIBP menu. If the failure still
exists, contact the manufacturer
for repair.
"NIBP INIT ERR"
NIBP initialization error
"NIBP SELFTEST ERR"
"NIBP
RESET"
ILLEGALLY
During NIBP measurement,
illegal reset occurs.
Check the airway of NIBP to see
if there are clogs. Then measure
again, if the failure still exists,
contact the manufacturer for
repair.
Execute the reset program in the
NIBP menu. If the failure still
exists, contact the manufacturer
for repair.
"NIBP COMM ERR"
The NIBP communication
part has problem.
"LOOSE CUFF"
The NIBP cuff is
connected correctly.
"AIR LEAK"
The NIBP cuff is not
connected correctly or there
are leaks in the airway.
Check the connection of each
part or replace with a new cuff. If
the failure still exists, contact the
manufacturer for repair.
"AIR
ERROR"
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
Check the connection of each
part or replace with a new cuff. If
the failure still exists, contact the
manufacturer for repair.
"WEAK SIGNAL"
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
Check if the setup of patient type
is correct. Check the connection
of each part or replace with a
new cuff. If the failure still exists,
contact the manufacturer for
repair
"RANGE EXCEEDED"
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
Check the connection of each
part or replace with a new cuff. If
the failure still exists, contact the
manufacturer for repair.
PRESSURE
not
"EXCESSIVE MOTION"
The patient arm moves.
"OVER PRESSURE"
Perhaps folds exist in the
airway.
"SIGNAL SATURATED"
"NIBP TIME OUT"
8
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
Re-connect the NIBP cuff.
Check the connection of each
part and the patient situation.
Measure again, if the failure still
exists, contact the manufacturer
for repair.
Check for the smoothness in the
airway and patient situation.
Measure again, if the failure still
exists, contact the manufacturer
for repair.
Check the connection of each
part and the patient situation.
Measure again, if the failure still
exists, contact the manufacturer
for repair.
Check the connection of each
part and the patient situation.
Measure again, if the failure still
exists, contact the manufacturer
for repair.
Patient Monitor user’s manual (V 2.2)
System Alarm Prompt
"CUFF TYPE ERR"
Perhaps the used cuff does
not fit the setup patient
type.
"PNEUMATIC LEAK"
NIBP airway has leaks.
"MEASURE FAIL"
"NIBP SYSTEM FAILURE"
Check the connection
The AG watertrap falls off
watertrap sensor.
from the monitor.
AG NO WATERTRAP
CHANGE
WATERTRAP
AG WATERTRAP
WRONG
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
Problem happens when
measuring the curve. The
system cannot perform
measurement, analysis or
calculation.
AG
TYPE
AG COMM STOP
AG module failure or
communication failure
AG COMM ERROR
AG HARDWARE ERROR
AG DATA LIMIT ERROR
AG USA ERROR
AG ZREF FAIL
FiCO2 ALM LMT ERR
EtCO2 ALM LMT ERR
FiO2 ALM LMT ERR
EtO2 ALM LMT ERR
FiN2O ALM LMT ERR
EtN2O ALM LMT ERR
FiAA ALM LMT ERR
EtAA ALM LMT ERR
AwRR ALM LMT ERR
AG
Check if the watertrap type is
correct. Check the connection of
each part or replace with a new
The type of the AG watertrap. If the failure still exists,
watertrap being used is contact the manufacturer for
repair.
not suitable.
AG module has failure.
AG OCCLUSION
of
Replace the AG watertrap
AG INIT FAIL
AG CAL FAIL
Check if the patient type is set up
correctly. Check the connection
of each part or replace with a
new cuff. If the failure still exists,
contact the manufacturer for
repair.
Check the connection of each
part or replace with a new cuff. If
the failure still exists, contact the
manufacturer for repair.
Check the connection of each
part and the patient situation.
Measure again, if the failure still
exists, contact the manufacturer
for repair.
Check the connection of each
part and the patient situation.
Measure again, if the failure still
exists, contact the manufacturer
for repair.
The actual PUMP rate of
the
AG
module
is
<20ml/min,
which
exceeds 1 second.
AG
module
has
communication failure.
AG module has hardware
failure.
AG module failure
AG module failure
AG module fails to zero.
AG module fails to
calibrate.
Functional safety failure
Functional safety failure
Functional safety failure
Functional safety failure
Functional safety failure
Functional safety failure
Functional safety failure
Functional safety failure
Functional safety failure
Check the connection of each part
and the patient situation. Measure
again, if the failure still exists,
contact the manufacturer for
repair.
Refer
to
the
chapter
of
“Maintenance and Cleaning” of the
“Anesthetic Gas Measurement” in
this operation manual.
Check the connection of each part
and the patient situation. Measure
again, if the failure still exists,
contact the manufacturer for
repair.
Patient Monitor user’s manual (V 2.2)
9
P/N: 6200-20-09733
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