Mindray DPM 1 Operator`s manual

Mindray DPM 1 Operator`s manual
DPM 3 Vital Signs Monitor
Operator’s Manual
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject
to change without prior notice.
Revision number:
5.0
Release time:
2011-12
© Copyright 2008-2011 Mindray DS USA, Inc. All rights reserved.
WARNING
Federal Law (USA) restricts this device to sale by or on the order of a physician.
I
Intellectual Property Statement
Mindray DS USA, Inc. (hereinafter called Mindray DS) owns the intellectual property rights
to this product and this manual. This manual may refer to information protected by
copyrights or patents and does not convey any license under the copyright and the patent
rights of Mindray DS, nor the rights of others.
Mindray DS intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray DS is strictly forbidden. Release, amendment, reproduction,
distribution, rental, adaption and translation of this manual in any manner whatsoever without
the written permission of Mindray DS is strictly forbidden.
is a trademark or a registered trademark of Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. All third-party trademarks that appear in this manual are used solely for
editorial purposes and are the property of their respective owners.
Contents of this manual are subject to changes without prior notice.
© 2008-2011 Mindray DS USA, Inc. All rights reserved.
II
Manufacturer’s Responsibility
All information contained in this manual is believed to be correct. Mindray DS shall not be
liable for errors contained herein nor for incidental or consequential damages in connection
with the furnishing or use of this manual.
Mindray will not be liable for the effects on safety, reliability and performance of this product
if:
all installation operations, expansions, changes, modifications and repairs of this product
are not conducted by Mindray DS authorized personnel; and
the electrical installation of the relevant room does not comply with the applicable
national and local requirements; and
the product is not used in accordance with the instructions for use.
Warranty
This warranty is exclusive and is in lieu of all other warranties, expressed or implied,
including warranties of merchantability or fitness for any particular purpose.
Exemptions
Mindray DS'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 use of parts or accessories not
approved by Mindray DS or repairs by people other than Mindray DS authorized personnel.
This warranty shall not extend to
Any Mindray DS product which has been subjected to misuse, negligence or accident;
or
Any Mindray DS product from which Mindray DS's original serial number tag or
product identification markings have been altered or removed; or
Any product of any other manufacturer.
III
Return Policy
In the event that it becomes necessary to return a unit to Mindray DS, follow the instructions
below.
1.
Return authorization.
Contact the Customer Service Department and obtain a Customer Service Authorization
number. This number must appear on the outside of the shipping container. Returned
shipments will not be accepted if the number is not clearly visible. Please provide the model
number, serial number, and a brief description of the reason for return.
2.
Freight policy
The customer is responsible for freight charges when this product is shipped to Mindray DS
for service (this includes customs charges).
3.
Return address
Please send the part(s) or equipment to the address offered by the Customer Service
Department.
Contact Information
Manufacturer:
Address:
Tel:
Website:
Mindray DS USA, Inc.
800 MacArthur Blvd.Mahwah, New Jersey 07430 USA
1.800.288.2121, 1.201.995.8000
www.mindray.com
IV
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. Observance of this manual is a prerequisite for
proper product performance and correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not
apply to your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment
so that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working
knowledge of medical procedures, practices and terminology as required for monitoring of
critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the
setup or data displayed on your patient monitor.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
The terms warning, and caution are used throughout this manual to point out hazards
and to designate a degree or level of severity.
→ is used to indicate operational procedures.
1
FOR YOUR NOTES
2
Contents
1 Safety................................................................................................................................. 1-1
1.1 Safety Information .......................................................................................................... 1-1
1.1.1 Warnings............................................................................................................. 1-2
1.1.2 Cautions ............................................................................................................. 1-3
1.1.3 Notes .................................................................................................................. 1-4
1.2 Equipment Symbols ........................................................................................................ 1-4
2 The Basics ......................................................................................................................... 2-1
2.1 Monitor Description ........................................................................................................ 2-1
2.1.1 Intended Use....................................................................................................... 2-1
2.1.2 Contraindications ............................................................................................... 2-1
2.1.3 Components........................................................................................................ 2-2
2.1.4 Functions............................................................................................................ 2-2
2.2 Appearance...................................................................................................................... 2-3
2.2.1 Front Panel ......................................................................................................... 2-3
2.2.2 Rear Panel .......................................................................................................... 2-7
2.2.3 Recorder ............................................................................................................. 2-8
2.3 Display ............................................................................................................................ 2-9
2.3.1 Cursor................................................................................................................. 2-9
2.4 Battery........................................................................................................................... 2-10
2.4.1 Battery Maintenance .........................................................................................2-11
2.4.2 Battery Recycling............................................................................................. 2-12
3 Installation and Maintenance.......................................................................................... 3-1
3.1 Installation....................................................................................................................... 3-1
3.1.1 Unpacking and Checking ................................................................................... 3-1
3.1.2 Environmental Requirements............................................................................. 3-2
3.1.3 Power Supply Requirements .............................................................................. 3-2
3.1.4 Bracket Mounting............................................................................................... 3-2
3.1.5 Installation Method ............................................................................................ 3-3
3.1.6 Powering on the Monitor.................................................................................... 3-7
3.1.7 Powering off the Monitor................................................................................... 3-7
3.2 Maintenance .................................................................................................................... 3-7
3.2.1 Inspection ........................................................................................................... 3-8
3.2.2 Cleaning ............................................................................................................. 3-8
3.2.3 Disinfection ...................................................................................................... 3-10
4 Menus and Screens........................................................................................................... 4-1
4.1 Patient Information.......................................................................................................... 4-1
4.2 System Setup................................................................................................................... 4-2
1
4.2.1 Common Setup................................................................................................... 4-2
4.2.2 Network Setup.................................................................................................... 4-3
4.2.3 Time Setup ......................................................................................................... 4-4
4.2.4 User Maintenance............................................................................................... 4-4
4.2.5 Nurse Call Setup ................................................................................................ 4-5
4.2.6 Version................................................................................................................ 4-6
4.2.7 Configuration ..................................................................................................... 4-6
4.2.8 Exporting Data ................................................................................................... 4-7
4.3 Normal Screen................................................................................................................. 4-7
4.4 Trend Screen ................................................................................................................... 4-8
4.5 Standby State................................................................................................................... 4-9
4.5.1 Entering the Standby State ................................................................................. 4-9
4.5.2 Exiting the Standby State ................................................................................... 4-9
4.6 Patient Review System Software .................................................................................. 4-10
5 Alarms ............................................................................................................................... 5-1
5.1 Overview......................................................................................................................... 5-1
5.1.1 Alarm Categories................................................................................................ 5-1
5.1.2 Alarm Levels ...................................................................................................... 5-2
5.2 Alarm Indications ............................................................................................................ 5-2
5.2.1 Alarm Lamp ....................................................................................................... 5-3
5.2.2 Audible Alarms................................................................................................... 5-3
5.2.3 Alarm Messages ................................................................................................. 5-3
5.3 Alarm Status .................................................................................................................... 5-4
5.3.1 Audio Off ........................................................................................................... 5-4
5.3.2 Physiological Alarm Off..................................................................................... 5-5
5.3.3 Alarms Paused.................................................................................................... 5-5
5.3.4 Alarm Silenced ................................................................................................... 5-6
5.3.5 Status Switchover............................................................................................... 5-6
5.4 Clearing Alarm Indications ............................................................................................. 5-7
5.5 Setting Alarms................................................................................................................. 5-7
5.6 SpO2 Sensor Off Alarm ................................................................................................... 5-8
5.7 When an Alarm Occurs ................................................................................................... 5-8
6 Recording.......................................................................................................................... 6-1
6.1 Overview......................................................................................................................... 6-1
6.2 Using the Recorder.......................................................................................................... 6-1
6.2.1 Printing Real-time PLETH waveform................................................................ 6-1
6.2.2 Printing Currently Displayed Trend Data........................................................... 6-1
6.2.3 Printing All Trend Data of the Current Patient................................................... 6-1
6.3 Loading Paper ................................................................................................................. 6-2
6.4 Removing Paper Jam....................................................................................................... 6-3
7 SpO2 Monitoring .............................................................................................................. 7-1
2
7.1 Introduction..................................................................................................................... 7-1
7.2 Safety .............................................................................................................................. 7-2
7.3 Monitoring Procedure ..................................................................................................... 7-3
7.4 Measurement Limitations................................................................................................ 7-3
7.5 Masimo Information........................................................................................................ 7-4
7.6 Nellcor Information......................................................................................................... 7-4
8 NIBP Monitoring.............................................................................................................. 8-1
8.1 Overview......................................................................................................................... 8-1
8.2 Monitoring Procedure ..................................................................................................... 8-2
8.2.1 Cuff Selection and Placement ............................................................................ 8-2
8.2.2 Operation Guides ............................................................................................... 8-3
8.3 Measurement Limitations................................................................................................ 8-4
8.4 Setting Initial Cuff Inflation Pressure, NIBP Reset, Calibration and Test for Air Leakage
............................................................................................................................................... 8-5
8.4.1 Setting Initial Cuff Inflation Pressure ................................................................ 8-5
8.4.2 Resetting NIBP................................................................................................... 8-5
8.4.3 Calibrating NIBP................................................................................................ 8-6
8.4.4 NIBP Leakage Test............................................................................................. 8-7
9 TEMP Monitoring............................................................................................................ 9-1
9.1 Overview......................................................................................................................... 9-1
9.2 Temperature Setup........................................................................................................... 9-2
9.3 Monitoring Procedure ..................................................................................................... 9-2
9.3.1 TEMP position ................................................................................................... 9-2
9.3.2 Oral Temperature Measurement ......................................................................... 9-3
9.3.3 Axillary Temperature Measurement ................................................................... 9-3
9.3.4 Measuring Rectal Temperature .......................................................................... 9-4
9.3.5 Temperature Measurement in MONITOR Mode ............................................... 9-5
9.4 Decontamination of the SmarTemp™ TEMP Probe....................................................... 9-5
9.5 Precautions ...................................................................................................................... 9-6
10 Accessories .................................................................................................................... 10-1
10.1 SpO2 Accessories ........................................................................................................ 10-1
10.2 NIBP Accessories........................................................................................................ 10-3
10.3 TEMP Accessories ...................................................................................................... 10-4
10.4 Others.......................................................................................................................... 10-4
A Product Specifications.................................................................................................... A-1
A.1 Safety Specifications ..................................................................................................... A-1
A.2 Environmental Specifications........................................................................................ A-1
A.3 Power Requirements ..................................................................................................... A-2
A.4 Hardware Specification ................................................................................................. A-3
A.5 Signal Output ................................................................................................................ A-4
3
A.6 SpO2 Specification ........................................................................................................ A-4
A.6.1 Mindray DS SpO2 Specification....................................................................... A-4
A.6.2 Masimo SpO2 Specification ............................................................................. A-5
A.6.3 Nellcor SpO2 Specification .............................................................................. A-6
A.7 NIBP Specification........................................................................................................ A-6
A.8 TEMP Specification ...................................................................................................... A-7
B EMC..................................................................................................................................B-1
C Alarm Messages and Prompt Information................................................................... C-1
C.1 Physiological Alarm Messages.......................................................................................C-1
C.2 Technical Alarm Messages .............................................................................................C-1
C.2.1 General Alarm Messages of Parameter Modules...............................................C-2
C.2.2 NIBP Module Alarm Messages .........................................................................C-2
C.2.3 Mindray DS SpO2 Module Alarm Messages .....................................................C-4
C.2.4 Masimo SpO2 Module Alarm Messages............................................................C-5
C.2.5 Nellcor SpO2 Module Alarm Messages.............................................................C-7
C.2.6 SmarTemp™ TEMP Module Alarm Messages..................................................C-8
C.2.7 Recorder Module Alarm Messages....................................................................C-9
C.2.8 System Alarm Messages..................................................................................C-11
C.3 Prompt Messages..........................................................................................................C-12
D Factory Defaults ............................................................................................................. D-1
D.1 Patient Information........................................................................................................ D-1
D.2 System Setup ................................................................................................................. D-2
D.3 Alarm Limit................................................................................................................... D-3
E Symbols and Abbreviation..............................................................................................E-1
E.1 Units ............................................................................................................................... E-1
E.2 Symbols .......................................................................................................................... E-2
E.3 Abbreviations.................................................................................................................. E-3
4
1 Safety
1.1 Safety Information
The safety statements presented in this chapter refer to the basic safety information that the
operator shall pay attention to and abide by. There are additional safety statements in other
chapters or sections, which may be the same as or similar to the followings, or specific to
the operations.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the
most from your product.
1-1
1.1.1 Warnings
WARNING
This monitor is not applicable for prolonged and continuous SpO2 monitoring,
which may increase the risks of irritation and burns at the site of the sensor.
This monitor is not applicable for prolonged and continuous temperature
monitoring for more than 5 minutes.
This monitor is intended for use by qualified clinical physicians or well-trained
nurses in the specified places.
It is your responsibility to verify the device and accessories can function safely
and normally before use
The disposable accessories should be disposed of in accordance with the hospital
regulations.
A possible fire or explosion hazard exists when used in the presence of
flammable anesthetics or other flammable or explosive substances in
combination with air, oxygen-enriched environments, or nitrous oxide.
Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level or off may result in a hazard to the
patient. Remember that alarm settings should be customized according to
different patient situations and always keeping the patient under close
surveillance is the most reliable way for safe patient monitoring.
Opening the monitor housing presents a risk of hazard due to electrical shock.
All servicing and future upgrades to this equipment must be carried out by
personnel trained and authorized by Mindray DS only.
Do not touch the patient or equipment connected to the patient during
defibrillation. A risk of serious injury or death is present.
When using the equipment with electrosurgical units (ESU), make sure the
patient is safe.
Dispose of the package material according to the applicable waste control
regulations and keep it out of children’s reach.
The device must be connected to a properly installed power outlet with
protective earth contacts only. If the installation does not provide for a
protective earth conductor, disconnect the monitor from the power line and
operate it on battery power, if possible.
1-2
1.1.2 Cautions
CAUTION
To ensure patient safety, use only parts and accessories specified in this manual.
Remove the battery from the monitor if it will not be used or not be connected to
the power line for a long period.
Carefully route patient cabling to reduce the possibility of patient entanglement
or strangulation.
Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
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 regulating the
disposal of such products. If you have any questions concerning disposal of the
products, please contact with us.
Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason make sure that all external devices
operated in the vicinity of the monitor comply with the relevant EMC
requirements. Mobile phone, X-ray equipment or MRI devices are a possible
source of interference as they may emit higher levels of electromagnetic
radiation.
Before connecting this monitor to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the label
or in this manual.
Install or carry the monitor properly to avoid damages caused by drop, impact,
strong vibration or other mechanical force.
If you spill liquid on the equipment or accessories, contact us or your service
personnel.
1-3
1.1.3 Notes
NOTES
Put the equipment in a location where you can easily see the screen and access
the operating controls.
This monitor complies with the requirements of CISPR11 (EN55011) class A.
The software was developed per IEC60601-1-4. The possibility of hazards
arising from program errors is minimized.
Put the monitor in a location where you can easily see the screen and access the
operating controls.
The instructions of this manual are based on the maximum configuration. Some
of them may not apply to your monitor.
Devices connected the RS232 port shall be Mindray DS -specified only.
1.2 Equipment Symbols
Caution: Consult
accompanying documents
(this manual).
Up
Power ON/OFF
Selection
Alternating current (AC)
Down
Battery indicator
Pulse Rate (PR)
Defibrillation-proof type CF
applied part
Neonate
NIBP
Pediatric/Child
PATIENT INFO.
Adult
MENU
Equipotential grounding
1-4
SET ALARMS
NurseCall output
DISPLAY
RS-232 connector
INTERVAL
Date of manufacture
European community
representative
Manufacturer
RECORD
Serial number
Alarm Silenced
Network connector
Classified by Underwriters Laboratories Inc. with respect to electric shock, fire
and mechanical hazards, only in accordance with UL 60601-1,
CAN/CSA C22.2 NO.601-1, IEC 60601-1-1, IEC 60601-2-30,
IEC 60601-2-49.
The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household
waste. By ensuring that this product is disposed of correctly, you will help
prevent bringing potential negative consequences to the environment and
human health. For more detailed information with regard to returning and
recycling this product, please consult the distributor from whom you purchased
it.
* For system products, this label may be attached to the main unit only.
1-5
FOR YOUR NOTES
1-6
2 The Basics
2.1 Monitor Description
2.1.1 Intended Use
This device is to monitor physiologic parameters, including SpO2, PR, NIBP and TEMP, on
adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or
appropriate medical staff under the direction of physicians. It is not intended for transport.
WARNING
This device is to be operated by clinical physicians or appropriate medical staffs
under the direction of physicians. The operator of the monitor must be well
tranined. Any operation by unauthorized or non-tranined personnel is forbidden.
The physiological parameters and the alarm information displayed by the monitor
are only for the reference of physicians, but cannot be used directly to determine
the clinical treatment.
CAUTION
The environment and power supply of this monitor must meet the requirements
specified in A Product Specifications.
2.1.2 Contraindications
None
2-1
2.1.3 Components
This monitor is composed of a main unit, NIBP cuff, SpO2 sensor and TEMP probe. Note
that some of the mentioned parts are optional and may not be found in your monitor.
2.1.4 Functions
This monitor has the following functions and features:
SpO2 measurement: pulse oxygen saturation (SpO2), pulse rate (PR), and SpO2
plethysmogram.
NIBP measurement: systolic pressure (S), diastolic pressure (D), mean pressure (M),
and pulse rate (PR).
TEMP measurement: temperature (TEMP).
Alarm: support visual/audible alarms and prompt messages.
Record: support the function of recording NIBP trend data and PLETH waveform.
Patient ID input by bar code scanning.
Nurse call.
Storage of trend data: support the function of storing up to 1200 groups of measured
results.
Powerful system menu.
Large LED digit display.
Adjustable LCD brightness and contrast.
Network communication: support the function of being connected to the CMS or PC
for data output or upgrade.
Rechargeable lead-acid battery or lithium battery.
2-2
2.2 Appearance
2.2.1 Front Panel
1
2
4
3
14
15
16
5
17
6
18
19
7
20
21
22
8
23
24
25
9
10
26
11
27
28
29
12
13
Figure 2-1 Front Panel
2-3
1.
Alarm indicator
The alarm indicator of this monitor is in compliance with the requirement of
EN60825-1 A11 Class 1 for LED. The LED indicator varies its flash color and
frequency to indicate different alarm levels. For details, refer to 5.2.1 Alarm Lamp.
2.
SYS
This LED displays the systolic pressure reading in the NIBP measurement.
3.
DIA
This LED displays the diastolic pressure reading in the NIBP measurement. At the
right side of the NIBP reading, it is the NIBP unit: kPa or mmHg. The illuminating one
is the unit selected. NIBP unit can be set in the system setup menu
4.
MAP
This LED displays the mean pressure reading in the NIBP measurement.
5.
PR
This LED displays the PR value in the NIBP measurement or SpO2 measurement, with
the unit (bpm) on the right.
6.
SpO2
This LED displays the SpO2 value, with the unit (%) on the right.
7.
TEMP
This LED displays the temperature reading. At the right side of the TEMP reading, it is
the TEMP unit: ℃ or ℉. The one illuminates is the unit selected. TEMP unit can be
set in the system setup menu.
8.
LCD
The LCD displays menus, trend data and PLETH waveforms, etc.
9.
PATIENT INFO.
Press this key to set patient information.
10. MENU
Press this key to switch between the SYSTEM SETUP menu and the Normal screen.
11. Power On/Off, standby, working status indicator
Press this key to power on/off the monitor and to enter/exit the standby state. To power
off the monitor, press and hold this key for more than 2 seconds.
Inside this key is a working status indicator:
ON: It indicates that the monitor is powered on;
OFF: It indicates that the monitor is powered off.
2-4
12. Battery indicator
It indicates the status of the battery. For details, refer to 2.4 Battery.
13. AC power indicator
ON: It indicates that the AC power is applied to the monitor;
OFF: It indicates that the monitor is not applied to the monitor.
14. Patient type indicator
It indicates the patient types: respectively adult, pediatric and neonate from left to
right.
15. Temperature site and mode indicator
It indicates the temperature measurement site and monitoring mode: respectively oral,
axillary, rectal and monitor.
16. Pulse strength indicator
It indicates the pulse strength of a patient.
17. RECORD
Press this key to start or stop the recording.
18. NIBP status indicator
ON: It indicates that the monitor is performing the NIBP measurement;
OFF: It indicates that the monitor is not performing the NIBP measurement.
19. NIBP
Press this key to start an NIBP measurement, or press this key during measurement to
stop it.
20. SILENCE
Shortly pressing this key pauses the current alarm for 2 minutes. Pressing and holding
this key for more than 2 seconds disables audible alarms, thus entering the alarm
silenced mode. During alarm silenced, the system will return to the normal status when
a new alarm occurs.
21. Silence indicator
OFF: normal status; in this status, when an alarm occurs, the system can give an
audible alarm according to the alarm level;
ON: alarm silenced status; in this status, the system cannot give audible alarm.
FLASH: alarm paused status; in this status, the system cannot give the audible
and visual alarm.
22. Up
Press this key to move the cursor upward.
2-5
23. OK
Press this key to select the highlighted option. In the trend view, pressing this key pops
up the REVIEW SETUP menu.
24. Down
Press this key to move the cursor down.
25. INTERVAL
Press this key to switch between the INTERVAL menu and the Normal screen.
Changes the NIBP measuring mode and interval by cycling through the modes and
intervals displayed in the NIBP Interval indicator (25), as follows:
MANUAL, 1min, 2min, 3min, 4min, 5min, 10min, 15min, 30min, 60min, 90min,
120min, 240min, 480min
Pressing and holding the INTERVAL key for 3 seconds directly goes to MANUAL, i.e.
the manual mode.
26. DISPLAY
Press this key to switch between the normal screen and trend view.
27. NIBP cuff connector
This connector is used to connect the NIBP cuff to the monitor.
28. SpO2 sensor connector
This connector is used to connect the SpO2 sensor to the monitor.
29. SET ALARMS
Press this key to switch between the SET ALARMS menu and the Normal screen.
2-6
2.2.2 Rear Panel
1
2
3
4
6
5
7
Figure 2-2 Rear Panel
1.
TEMP probe sheath
2.
TEMP probe connector
3.
RS-232 connector:: used to connect the bar code scanner.
4.
Nurse call connector: used to connect the monitor to the hospital’s nurse call system.
5.
Network connector: used to connect the monitor to the CMS or PC.
6.
Equipotential grounding connector: connects the equipotential grounding connectors of
other devices.
7.
AC power input connector: used to connect the monitor to the AC power through a
3-core power cable.
2-7
2.2.3 Recorder
The recorder is on the left side of the monitor. See the following figure.
Power indicator
Paper outlet
Recorder door
Figure 2-3 Recorder
For details about the recorder, refer to 6 Recording
.
2-8
2.3 Display
1
2
3
Figure 2-4 Display
This monitor adopts the LCD display. It is able to display the following three parts:
1.
Patient information area
This area displays patient ID, patient category and alarm status symbol.
2.
PLETH wave/NIBP timing area
This area displays the PLETH wave and/or NIBP timing.
3.
Alarm information area
On the left of this area is the technical alarm message or prompt message. If there are
multiple messages, they will be displayed circularly.
On the right of this area are the physiological alarm message and the current system time.
2.3.1 Cursor
In menus or trend data view, when the cursor moves to an option or a data, the background
of the option or the data becomes black and the texts turn white. You can press
to move the cursor, and press
to confirm the selection.
NOTE
and
are used to move the cursor, and
selection.
2-9
is used for
or
2.4 Battery
Rechargeable batteries can be used to supply power to the monitor where AC mains is
unavailable or whenever the power supply is interrupted. The battery is charged
automatically when the monitor is connected to AC mains till it is full. If the power supply
is lost during monitoring, the monitor can run on internal battery.
The battery indicator indicates the status of the battery.
ON: The battery is being charged or the battery is fully charged.
OFF: The battery is removed from the monitor, or the monitor is equipped with battery
but is not connected to AC mains and not turned on.
Flashes: The monitor is powered by the internal battery.
The capacity of the internal battery is limited. When the battery capacity is too low, a high
level alarm is triggered and the “Battery too low” message is given in the technical alarms
area. At this moment, the AC mains shall be applied to the monitor; otherwise the monitor
will power off automatically before the battery is depleted.
For details about installation of the battery, refer to 3.1.5 Installation Method:Installing the
battery.
WARNING
Keep the battery out of the reach of children.
Use only the battery specified by the manufacturer.
NOTE
Remove the battery before transport, or if the monitor is not likely to be used
for an extended period of time.
2-10
2.4.1 Battery Maintenance
2.4.1.1 Conditioning a Battery
A battery needs at least two conditioning cycles when it is used for the first time. A battery
conditioning cycle is one uninterrupted charge of the battery, followed by an uninterrupted
discharge of the battery. Batteries should be conditioned regularly to maintain their useful
life. Condition a battery once when it is used or stored for two months, or when its run time
becomes noticeably shorter.
To condition a battery, follow this procedure:
1.
Disconnect the monitor from the patient and stop all monitoring or measuring.
2.
Insert the battery in need of conditioning in the battery compartment of the monitor.
3.
Apply AC power to the monitor and allow the battery to charge uninterruptedly for 10
hours.
4.
Remove AC power and allow the monitor to run on the battery until it shuts off.
5.
Apply AC power again to the monitor and allow the battery to charge uninterruptedly
for 10 hours.
This battery is now conditioned and the monitor can be returned to service.
2.4.1.2 Checking a Battery
The performance of a rechargeable battery may deteriorate over time. To check the
performance of a battery, follow this procedure:
1.
Disconnect the monitor from the patient and stop all monitoring or measuring.
2.
Apply AC power to the monitor and allow the battery to charge uninterruptedly for 10
hours.
3.
Remove AC power and allow the monitor to run on the battery until it shuts off.
4.
The operating time of battery reflects its performance directly.
If the oprating time of the battery is noticeable shorter than that stated in the specifications,
replace it or contact your service personnel,
2-11
NOTE
Life expectancy of a battery depends on how frequent and how long it is used.
For a properly maintained and stored lead-acid or lithium ion battery, its life
expectancy is about 2 or 3 years respectively. For more aggressive use models,
life expectancy can be less. We recommend replacing lead acid batteries every 2
years and lithium ion batteries every 3 years.
The operating time depends on the configuration and operation. For example,
measuring NIBP more frequently will also shorten the operating time.
2.4.2 Battery Recycling
When a battery has visual signs of damage, or no longer holds a charge, it should be
replaced. Remove the old battery from the monitor and recycle it properly. To dispose of the
batteries, follow local laws for proper disposal.
WARNING
Do not disassemble batteries, or dispose of them in fire, or cause them to short
circuit. They may ignite, explode, leak or heat up, causing personal injury.
2-12
3 Installation and Maintenance
3.1 Installation
WARNING
The installation of the monitor must be carried out by personnel we authorize.
The software copyright of the monitor is solely owned by our company. Any
action to change, copy or exchange the software by any organization or person is
regarded as copyright infringement and is not allowed.
3.1.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is
detected, contact the carrier or our company.
If the packing case is intact, open the package and remove the instrument and accessories
carefully. Check all materials against the packing list and check for any mechanical damage.
Contact our Customer Service Department for any problem.
NOTE
Please save the packing case and packaging material for future transport and
storage.
WARNING
Dispose of the packaging material accordint to applicable waste control
regulations and keep it out of children’s reach.
The equipment might be contaminated in storage, transport or when used.
Verify the package and the single use accessories are intact. In case of any
damage, do not apply it to patients.
3-1
3.1.2 Environmental Requirements
The operating environment of the monitor must meet the requirements specified in the
section A.2 Environmental Specifications
The environment where this monitor is to be used should be free from noise, vibration, dust,
and corrosive or explosive and inflammable substances. For a cabinet mounted installation,
allow sufficient room at the front and the rear of the cabinet for operation, maintenance and
servicing. Besides, allow at least 2 inches clearance around the instrument for proper air
circulation.
Condensation can form when the monitor is moved from one location to another, and being
exposed to differences in humidity or temperature. Make sure that during operation the
instrument is free from condensation.
3.1.3 Power Supply Requirements
The power applied to the monitor must meet the requirements specified in Section A.3
Power Requirements
WARNING
Make sure that the operating environment and the power applied to the monitor
comply with the specified requirements. Otherwise its performance might not
meet the specifications claimed in AProduct Specifications, and unexpected
results, such as damages to the monitor, may be incurred.
The monitor shall be powered according to the requirement for the system
power voltage. Otherwise, serious damage might be caused to the system.
3.1.4 Bracket Mounting
For details, please refer to the corresponding instructions for use of bracket mounting
3-2
3.1.5 Installation Method
WARNING
Equipments connected to this monitor must be certified according to the
respective IEC standards (e.g. IEC 60950 for information technology equipment
and IEC 60601-1 for medical electrical equipment). Furthermore all
configurations shall comply with the valid version of IEC 60601-1-1. Any person
who connects additional equipment to the signal input or signal output is
responsible to ensure the system complies with the requirements of the valid
version of IEC 60601-1-1. If in doubt, contact our company or customer service.
If the monitor is connected to another electrical instrument and the instrument
specifications cannot tell whether the instrument combination is hazardous (e.g.
due to summation of leakage currents), you should consult us or experts in the
field to ensure the required safety of all instruments concerned.
NOTE
The following operations are not all required. User-customized installation by
authorized personnel is provided.
3.1.5.1 Connecting to AC mains
1.
Use the original 3-core power cable.
2.
Connect the power cable to the AC mains input connector on the rear panel of the
monitor.
3.
Connect the other end of the power cable to a compatible 3-prong hospital grade AC
power outlet.
The 3-prong power outlet must be grounded. In case of any doubt, contact related personnel
of the hospital.
WARNING
Do not use three-wire to two-wire adapter with this instrument.
To avoid unexpected power interruption, do no use power outlet with a
wall-mounted switch control.
3-3
3.1.5.2 Installing the battery
The battery compartment is located at the bottom of the patient monitor. Follow the steps
given below to install the battery.
1.
Push the compartment door in the marked direction to open the door.
2.
Flip the battery stopper to the left, as Figure 3-1 shows.
3.
Follow the marked polarity to insert the battery into the compartment, as Figure 3-2
shows.
4.
Push the battery to the bottom and flip the stopper back to the original position, as
Figure 3-3 shows.
5.
Close the battery door.
Figure 3-1
Figure 3-2
3-4
Figure 3-3
NOTE
Be sure to charge the battery after a long-term storage or when you find the
battery energy is low. A low-energy battery may not provide enough power to
start the patient monitor.
To charge the battery, connect the AC power to the monitor. The battery will be
charged regardless the monitor is on or off.
3.1.5.3 Equipotential Grounding
When other equipment is used together with the monitor, a grounding cable should be used
to connect the equipotential grounding connectors of the monitor and other equipment. This
helps to eliminate the potential differences between different equipment, and ensure the
safety of the operator and patient.
WARNING
If the grounding system is in doubt, the monitor shall run on its internal battery.
3.1.5.4 Connecting the accessories
Connect the necessary accessories to the monitor. For details, see the chapters for specific
parameter monitoring in the following pages, or corresponding instructions for the
accessories.
3-5
3.1.5.5 Connecting the network cable
The network connector of the monitor is a standard RJ45 connector. It connects the monitor
with the specified central monitoring system, or with a PC for software upgrade and data
export. To connect the monitor with CMS or PC,
1.
Connect one end of the network cable to the network connector of the monitor.
2.
Connect the other end of the network cable to the hub of the central monitoring system,
or to the network connector of a PC.
WARNING
Upgrading the system through network is only to be executed by personnel we
authorize.
3.1.5.6 Nurse call connector
The nurse call connector is used for the nurse call function. If connected to the hospital’s
nurse call system through a special nurse call cable, the monitor can generate nurse call
signals when an alarm occurs. The output end of the nurse call cable consists of two free
cords that is neutral. The nurse call system shall be installed by the maintenance engineer
from the manufacturer or the engineer of the hospital.
3.1.5.7 Connecting the Bar Code Scanner
The bar code scanner shall be connected to the RS232 connector. Use only bar code
scanners supplied by us.
3-6
3.1.6 Powering on the Monitor
After installing the monitor, please power on it in the following procedure:
1.
Before using the monitor, please carry out corresponding safety inspection in
accordance with Section 3.2.1Inspection.
2.
Press the Power Switch on the control panel. A beep will be heard.
3.
The system starts self-test and the start-up screen will be displayed.
4.
Several seconds later, the system finishes the self-test and displays the Normal screen.
5.
Then you can operate the monitor through the control panel.
When AC mains is connected, the battery will be charged regardless the monitor is on or
off.
3.1.7 Powering off the Monitor
To power off the monitor, please follow the procedures below:
1.
Confirm the patient monitoring is to be finished.
2.
Disconnect the cables and sensors between the monitor and the patient.
3.
Confirm whether to store or clear the patient monitoring data.
4.
Press the Power switch and hold it for more than 2 seconds to power off the monitor.
3.2 Maintenance
WARNING
Failure to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
The safety inspection before equipment disassembly or the servicing of the
equipment must be performed by professional servicing personnel. Otherwise,
equipment failure and possible health hazard may be caused.
3-7
3.2.1 Inspection
Make sure the qualified service personnel have implemented a complete inspection before
putting the monitor into operation, after monitor servicing or system upgrading, or after the
monitor has been used for 6-12 consecutive months. This is to ensure the normal operation
of the system.
Check that
The environment and the power supply meet the specified requirements.
The monitor surface is free from stains.
The monitor surface, keys, connectors and accessories have no signs of physical
damage.
The power cords are not worn and the insulation is in good performance.
The grounding cables are properly connected.
Only specified accessories are applied.
The monitor clock is correct.
The audible and visual alarms are normal.
The recorder functions normally and the recorder paper meets the requirement.
The monitoring functions of the system are in good performance.
In case of any damage or exception, do not use the monitor. Contact the biomedical
engineers of the hospital or our Customer Service immediately.
3.2.2 Cleaning
WARNING
Be sure to shut down the system and disconnect all power cords from the outlet
before cleaning the equipment.
Your equipment should be cleaned regularly. If there is heavy pollution or lots of dust and
sand in your place, the equipment should be cleaned more frequently. Before cleaning the
equipment, consult your hospital’s regulations for cleaning, disinfecting and sterilizing
equipment.
3-8
The exterior surfaces of the equipment may be cleaned with a clean and soft cloth, sponge
or cotton ball, dampened with a non-erosive cleaning solution. Drying off excess cleaning
solution before cleaning the equipment is recommended. Following are examples of
cleaning solutions:
Diluted soap water
Diluted ammonia water
Diluted sodium hypochlorite (bleaching agent)
Diluted formaldehyde (35 to 37%)
Hydrogen peroxide (3%)
Ethanol (70%), or Isopropanol (70%)
NOTE
The sodium hypochlorite of the concentration ranging from 500ppm (1:100
diluted bleaching agent for home use) to 5000ppm (1:10 diluted bleaching agent
for home use) is effective. The required concentration depends on the quantity
of the organic substances (such as blood, mucus) on the equipment surface.
To avoid damage to the equipment, please follow these rules:
ALWAYS dilute the solutions according to the manufacturer’s suggestions.
ALWAYS wipe off all the excess cleaning solution with a dry cloth after cleaning.
NEVER submerge the equipment into water or any cleaning solution, or pour or spray
water or any cleaning solution on the equipment.
NEVER permit fluids run into the casing, switches, connectors, or any ventilation
openings in the equipment.
NEVER use abrasive or erosive cleaners of any kind as well as cleaners containing
acetone.
CAUTION
Failure to follow these rules may erode or fray the casing, or blur lettering on
the labels, or cause equipment failures.
For cleaning information of accessories, please refer to the chapters for specific patient
parameters and the instructions for use of the accessories.
3-9
3.2.3 Disinfection
WARNING
Disinfection may cause damage to the equipment; therefore, when preparing to
disinfect the equipment, consult your hospital’s infection controllers or
professionals.
The cleaning solutions above can only be used for general cleaning. If you use
them to control infections, we shall assume no responsibility for the
effectiveness.
Disinfection may cause damage to the equipment. We recommend the sterilization and
disinfection are contained in the hospital’s servicing schedule only when necessary. The
equipment should be cleaned prior to sterilization and disinfection.
Recommended sterilization material: Alcohol based (Ethanol 70%, Isopropanol 70%), and
aldehyde based.
CAUTION
ALWAYS dilute the solutions according to the manufacturer’s suggestions and
adopt lower concentration if possible.
NEVER submerge the equipment into water or any solution, or pour water or
any solution on the equipment.
ALWAYS wipe off all the excess liquids on the equipment surface and accessory
surface with a dry cloth.
NEVER use EtO and undiluted formaldehyde to disinfect the equipment.
Never permit high-pressure and high-temperature disinfection of the equipment
and accessories.
3-10
4 Menus and Screens
4.1 Patient Information
The figure shows the PATIENT INFORMATION menu.
Figure 4-1
In the PATIENT INFORMATION menu, you can set:
PATIENT ID: The system automatically creates a patient ID each time the monitor is
turned on. You can also:
Input a patient ID by scanning the bar code:
In the event BARCODE POWER is switched on, you can scan the bar code
information using a bar code scanner. The PATIENT INFORMATION menu pops up
if the bar code is sucessfully identified. You can admit the patient using the current bar
code by selecting OK. You can also keep the original patient ID by selecting
CANCEL.
Input a patient ID by pressing the PATIENT INFO button:
In the event QUICK ADMIT is switched on, pressing
opens the PATIENT
INFORMATION menu. The system creates a patient ID according to the current time
and admits the patient using this patient ID. You can also keep the original patient ID
by selecting CANCEL.
To switch on/off QUICK ADMIT, select SYSTEM SETUP→MAINTAIN.
Keep patient ID unchanged:
If patient ID is not input by bar code scanning or by pressing PATIENT INFO button,
or the bar code scanner fails to identify the bar code, the system will keep original
patient ID unchanged.
PATIENT TYPE: You can set patient type to ADU, PED or NEO.
4-1
NOTE
The system automatically creates a patient ID each time the monitor is turned
on.
Select appropriate patient type each time a patient is admitted.
If you need to change patient type after the patient has been admitted, switch off
QUICK ADMIT; press
and then change PATIENT TYPE in the pop-up
PATIENT INFORMATION menu.
If you need to admit a patient in the event both BARCODE POWER and
QUICK ADMIT are set to OFF, switch either of them on.
By holding and pressing
for at least one second when the PATIENT
INFORMATION menu is not opened, you can quickly switch the patient type.
In this case the patient ID will not be changed.
4.2 System Setup
By pressing
on the front panel of the monitor, you can open the SYSTEM SETUP
menu as shown in Figure 4-2.
Figure 4-2
4.2.1 Common Setup
In the SYSTEM SETUP menu, select COMMON SETUP. In the COMMON SETUP menu,
you can set the following items.
ALARM VOL
MIN ALARM VOL to 10
4-2
In the following circumstance, the setting of ALARM VOL may be lower than the
setting of MIN ALARM VOL. In this case, ALARM VOL is automatically adjusted
according to MIN ALARM VOL.
Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required
password; and then change MIN ALARM VOL in the pop-up menu.
Select SYSTEM SETUP→DEFAULT; and then select LOAD FACTORY
CONFIG or LOAD USER CONFIG in the pop-up menu;
Restart the monitor after turning it off for more than 120s;
Change patient ID;
Change patient type.
KEY VOL
0 to 10
PULSE VOL
0 to 10
LCD BRIGHT
1 to 10
LCD CONTRAST 1 to 10
NIBP UNIT
mmHg, kPa
When the key volume or pulse volume is set to 0, it indicates that the key tone or pulse tone
is disabled.
4.2.2 Network Setup
In the SYSTEM SETUP menu, select NET SETUP. In the NET SETUP menu, you can set
the following items.
NET TYPE:
LOCAL NET NO.:It indicates the bed number of a monitor in the monitoring network.
If the NET TYPE is CMS, the LOCAL NET NO can be set between 1 and 64; if the
NET TYPE is CMS+, it can not be set.
IP ADDRESS SETUP: When the monitor is connected with the central monitoring
system, and the NET TYPE is CMS+, you can set the IP address for your monitor .
CMS, CMS+
The network type and local net No. are related to the central monitoring system (CMS) to
which the monitor is connected. Contact the CMS technical personnel for any doubt.
WARNING
This monitor is intended for use only by clinical professionals or under their
guidance. It must only be used by persons who have received adequate training
in its use. Anyone unauthorized or untrained must not perform any operation
on it.
4-3
4.2.3 Time Setup
In the SYSTEM SETUP menu, select TIME SETUP. In the TIME SETUP menu, you can
set the following items.
1.
2.
DATE FORMAT: You can set DATE FORMAT to any of the following formats:
YY-MM-DD
MM-DD-YY
DD-MM-YY
System time: you can set the year, month, day, hour and minute respectively as
required.
4.2.4 User Maintenance
Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password. You
can set the following items in the pop-up menu:
MIN ALARM VOL:
BARCODE POWER: You can toggle BARCODE POWER between ON and OFF.
You can set it to OFF if bar code scanner is not used for a prolonged time.
SPO2 SENSOR OFF:
MED, LOW or OFF.
AUDIO OFF PROMPT: You can toggle AUDIO OFF PROMPT between ON and
OFF. If you switch it on, the monitor clanks at an interval of one minute. The volume
level of prompt tone is 2.
LANGUAGE:
SAVE USER CONFIG: You can save the current configuration as user configuration.
SELECT CONFIG:
You can select LAST CONFIG, USER CONFIG or
FACTORY CONFIG as desired.
0 to 10
You can set the alarm level of SPO2 SENSOR OFF to HIGH,
You can select a desired language for user interface.
4-4
4.2.5 Nurse Call Setup
Select SYSTEM SETUP→MAINTAIN→NURSE CALL. You can set the following items
in the pop-up menu:
SIGNAL DURATION
1.
CONTINUUM
It indicates that the nurse call signal duration is the same with the alarm duration,
namely, the nurse call signal lasts from the beginning of the alarm to the end of the
alarm.
2.
PULSE
It indicates that the nurse call signal is a pulse signal whose duration is 1s. When
multiple alarms occur, the monitor outputs only one pulse signal; if another alarm
occurs before the current alarm is cleared, the monitor will output another pulse signal.
SIGNAL TYPE
1.
NORMAL CLOSE: set the signal type to NORMAL CLOSE when the nurse call
system of the hospital is set to normally-closed;
2.
NORMAL OPEN: set the signal type to NORMAL OPEN when the nurse call system
of the hospital is set to normally-open.
NORMAL CLOSE and NORMAL OPEN are technical terms which describe the type of
relay in nurse call system. The hospitals should select the right signal type consistent with
their nurse call system.
ALM LEV: HIGH, MED, LOW; check box
ALM TYPE: TECH, PHYS; check box.
The system will send the nurse call signal according to the selected alarm level and alarm
type. If neither alarm level nor alarm type is selected, the system will not send any nurse
call signal when alarms occur.
The Nurse Call function doesn't distinguish among ALM LEV and ALM TYPE. As long as
any type is checked and when the alarmable event occurs, the monitor will send the same
signal to the interface of the Nurse Call System.
NOTE
The medical/nursing staff are not expected to take the nurse call function as the
major alarm notification. The patient conditions should be determined based on
the audible/visual alarm of the monitor and the clinical symptoms of the patient.
In the Alarm Paused or Standby State, the nurse call function will be disabled.
4-5
WARNING
Then nurse call settings shall not be changed by non-medical staff.
4.2.6 Version
Select SYSTEM SETUP→MAINTAIN→VERSION, you can view information on the
monitor’s hardware version and software version.
4.2.7 Configuration
4.2.7.1 Presetting Configuration
If the monitor is turned off for less than 60 seconds, last configuration will be loaded
automatically when it is restarted. If it has been turned off for more than 120 seconds,
different configuration will be loaded according to the setting when it is restarted, or when
patient type or patient ID is changed.
1.
Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password
to enter the USER MAINTAIN menu.
2.
Select SELECT CONFIG.
3.
Select LAST CONFIG, USER CONFIG or FACTORY CONFIG as desired.
4.
Select OK.
NOTE
When the monitor is restarted after being turned off for 60 to 120 seconds, the
configuration loaded may be last configuration, user configuration or factory
configuration
4.2.7.2 Saving User Configuration
1.
Make sure the modification you make is appropriate and correct.
2.
Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password
to enter the USER MAINTAIN menu.
3.
Select SAVE USER CONFIG.
4-6
4.2.7.3 Resuming Default Configuration
In actual applications, the operator may change some settings. However, these changes may
not always be appropriate or correct, particularly for a newly admitted patient. The monitor
has the function of loading factory configuration so that you can resume the factory default
configuration as desired. You can also load the saved user configuration.
1.
In the SYSTEM SETUP menu, select DEFAULT.
2.
Select LOAD FACTORY CONFIG or LOAD USER CONFIG.
3.
Select OK in the pop-up menu.
4.2.8 Exporting Data
To export data to a PC,
1.
Ensure that the monitor is connected to a PC; run the Patient Review System software
on the PC.
2.
In the SYSTEM SETUP menu of the monitor, select DATA OUT.
3.
If the connection is available, the data (including patient ID, patient type and trend data
of all the patients) will be export to the PC. For more information, please refer to the
help information of the Patient Review System software.
4.3 Normal Screen
You can enter the Normal screen by pressing
.
Time to next
measurement
NIBP interval
NIBP icon
PLETH wave
Figure 4-3
4-7
4.4 Trend Screen
The Trend screen displays systolic pressure (S), diastolic pressure (D) and mean pressure
(M), SpO2, PR and TEMP, as shown in the figure below. Up to 1200 groups of data can be
stored.
The monitor stores trend data in either of the following modes:
For SpO2 and TEMP values in monitor mode, the trend data is sampled value. The time
interval of sampling is 30 seconds. Additionally, the last value obtained before the
“SENSOR OFF” or “TEMP SENSOR OFF” alarm occurs will also be stored.
For NIBP and TEMP values obtained in predict mode, the trend data is the actual value
measured when the data is sampled.
NOTE
If the difference between the time when two storage modes happen is less than
one second, the trends displayed may be of the same time, but SpO2 trends
and/or TEMP trends in monitor mode may be different.
Figure 4-4
Press
to enter the REVIEW SETUP menu where you can change:
REVIEW ID:
REVIEW MODE: You can set REVIEW MODE to ALL, NIBP EVENTS or TEMP
EVENTS. If you select ALL, all the trend data of the selected
patient will be displayed. If you select NIBP EVENTS, the trend
data which includes all NIBP measurements of the selected patient
will be displayed. If you select TEMP EVENTS, the trend data
which includes all TEMP measurements of the selected patient
will be displayed.
Select the patient ID you want to review.
4-8
DELETE:
By selecting DELETE, you can toggle between CURRENT ITEM,
ITEMS OF CURRENT ID, or ITEMS OF ALL ID. Then select
OK to respectively delete the current trend data, all trend data of
current ID, or data of all ID.
4.5 Standby State
4.5.1 Entering the Standby State
To enter the Standby state, press
for less than 2 seconds and then select OK in the
CONFIRM STANDBY STATE dialog box.
4.5.2 Exiting the Standby State
In the Standby state, press any key on the front panel of the monitor. The EXIT STANDBY
dialog box appears. Select YES to exit the Standby state. If no operation is done within 30
seconds, the monitor will automatically select NO, this dialog box will disappear, and the
monitor will keep in the Standby state.
In the following circumstance,
The monitor presents a prompt to ask if you want to exit the Standby mode when a
button is pressed.
The monitor exits the Standby mode when a bar code scanner is used to identify
patient ID.
The monitor exits the Standby mode automatically after continuously receiving SpO2
signal for 5 seconds.
The monitor exits the Standby mode automatically when the TEMP probe is
withdrawn from the probe sheath.
In the case that the monitor runs on internal battery, the monitor exits the Standby
mode and presents an alarm “BAT. VOLTAGE LOW” when the battery power is low.
4-9
4.6 Patient Review System Software
The monitor can be configured with the optional patient review system software (hereafter
called PrsView software ) to implement the following functions:
Exporting data;
Viewing exported data;
Editing patient information; and
Printing data.
Refer to PrsView software instructions for installation and help information for detailed
software instructions for use.
4-10
5 Alarms
5.1 Overview
The monitor gives audible or visual alarms to indicate the medical staff when a vital sign of
the patient appears abnormal, or mechanical or electrical problems occur to the monitor.
WARNING
A potential hazard can exist if different alarm presets are used for the same or
similar equipment in any single area, e.g. an intensive care unit or cardiac operating
room.
NOTE
For details about alarm setup of this monitor, please refer to 5.5 Setting Alarms.
5.1.1 Alarm Categories
By nature, the alarms are divided into three categories: physiological alarms, technical
alarms and prompt information.
1.
Physiological alarms
A physiological alarm either indicates that a monitored physiological parameter goes
beyond specified limits or indicates an abnormal patient condition. For example, no pulse is
detected.
2.
Technical alarms
A technical alarm indicates that the monitor or parts of the monitor is not capable of
accurately monitoring the patient’s condition due to improper operation or system failure.
Technical alarms are also referred to as system error messages. For example, an error occurs
during module initialization.
3.
Prompt information
As a matter of fact, prompt messages are not alarm messages. They are usually information
relating to the system status, but not concerning vital signs of patients. For example, the
monitor prompts “REC INITIALIZING”.
5-1
5.1.2 Alarm Levels
By severity, the alarms of this monitor are divided into three priority levels: high level
alarms, medium level alarms and low level alarms.
1.
High level alarms
The patient is in danger and requires emergency treatment, or
A serious technical problem occurs to the monitor, such as an error in the NIBP
module self-test.
2.
Medium level alarms
The patient’s vital signs appears abnormal and an immediate treatment is required, or
A specific technical problem occurs to the monitor, such as the leakage in the NIBP
hose.
3.
Low level alarms
A specific technical problem occurs to the monitor, for example, the SpO2 signal is too
weak during the measurement.
The levels of some technical and physiological alarms are predefined before the monitor
leaves the factory and cannot be changed.
For all physiological alarms, technical alarms and prompt information, refer to C Alarm
Messages and Prompt Information.
5.2 Alarm Indications
When an alarm occurs, the monitor indicates it to the user through the following audible or
visual indications:
Visual alarms
Audible alarms
Alarm messages
The alarm indications are presented in different ways to match the alarm levels.
5-2
5.2.1 Alarm Lamp
When an alarm occurs, the alarm lamp on the front panel of the monitor flashes in different
color and frequency to match the alarm levels as follows:
High level alarms:
the lamp quickly flashes red.
Medium level alarms:
the lamp slowly flashes yellow.
Low level alarms:
the lamp turns yellow without flashing.
5.2.2 Audible Alarms
The monitor uses different alarm tone patterns to indicate different alarm levels.
High level alarm:
“DO-DO-DO--DO-DO---DO-DO-DO--DO-DO”.
Medium level alarm:
“DO-DO-DO”.
Low level alarm:
“DO”.
Different intervals correspond to different alarm levels: High level alarm phonates once
every 6.2 or 11 seconds. Medium level alarm phonates once every 15 or 25 seconds. Low
level alarm phonates once every 25 seconds.
5.2.3 Alarm Messages
When alarms occur, the alarm messages are displayed in the physiological or technical
alarm area in black. Asterisks before the alarm messages matches the alarm level as follows:
High level alarms:
triple asterisks “***”
Medium level alarms:
dual asterisks “**”
Low level alarms:
single asterisk “*”
5-3
5.3 Alarm Status
Apart from the aforementioned alarm indicators, the patient monitor still uses symbols to
indicate the alarm status: You can set alarms to the following status as desired:
Audio off:
is displayed at the right side of patient information area and a
prompt message “AUDIO ALARM OFF” appears at the right side of the alarm
information area.
Physiological Alarm off:
is displayed at the right side of patient information area
and a prompt message “ALARM OFF” appears at the right side of the alarm
information area.
Alarm paused:
is displayed at the right side of patient information area ; a
prompt message “ALARM PAUSE” and remaining alarm pause time appear at the
right side of the alarm information area.
Alarm silenced:
is displayed at the right side of patient information area.
5.3.1 Audio Off
To switch off alarm tones, follow this procedure:
1.
Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password
and set MIN ALARM VOL to 0 in the pop-up menu.
2.
Select SYSTEM SETUP→COMMON SETUP; set ALMAR VOL to 0 in the pop-up
menu. Thus alarm tones are switched off.
If AUDIO OFF PROMPT in the USER MAINTAIN menu is set to ON, the monitor clanks
at an interval of one minute. The volume level of prompt tone is 2.
The monitor automatically exit the audio off status when:
ALARM VOL is manually changed to a level other than 0;
The monitor is restarted after being turned off for more than 120s, or when patient ID
or patient type is changed in the case it is preset to load factory configuration or user
configuration at startup.
LOAD FACTORY CONFIG or LOAD USER CONFIG is selected in the DEFAULT
menu.
5-4
WARNING
If alarm tones are switched off, the monitor does not give audible alarm signal
even if new alarms occur. So take care when you switch off alarm tones.
5.3.2 Physiological Alarm Off
If alarms related to a parameter are switched off, the monitor does not generate alarms even
if the measured parameter values exceed the alarm limit. This status is called Alarms Off.
To disable the alarms of a parameter, you need to open SET ALARMS menu .Take NIBP
(Non-Invasive Blood Pressure) as an example.
1.
Press
2.
Move the cursor to the pane to the right of SYS ALM.
3.
Select OFF and the NIBP alarms are disabled.
to open the SET ALARMS menu.
NOTE
Within 30s after the NIBP, SPO2 and TEMP modules are loaded, physiological
and technical alarms related to these modules are switched off automatically.
5.3.3 Alarms Paused
Shortly pressing
for less than 2 seconds can pause all alarms for 2 minutes. When
alarms are paused,
Alarm lamp flashing and alarm tones are suspended.
For a physiological alarm, alarm message is not displayed.
For a technical alarm, alarm message is displayed if Alarm lamp flashing and alarm
tones can be cleared.
For a technical alarm, alarm message is not displayed if all alarm indications can be
cleared completely.
The remaining alarm pause time is shown at the right side fo alarm information area.
5-5
In the alarm paused status,
All alarm indications are disabled when a new physiological alarm occurs.
Alarm lamp flashing and alarm tone are disabled and only alarm message is displayed
when a new technical alarm occurs.
The monitor automatically exits the alarm paused status when the alarm pause time expires.
You can also press
to manually leave the larm paused status.
5.3.4 Alarm Silenced
You can silence alarms by press and hold
for more than 2 seconds. In the alarm
silenced status, alarm indications except alarm tones operate properly. The monitor
automatically exits the alarm silenced status if a new technical or physiological alarm
occurs.
5.3.5 Status Switchover
1.
In the normal status,
Press
for less than 2 seconds to switch the monitor to the Alarms Paused
status, or
Press
for 2 seconds or more to switch the monitor to the Alarms silenced
status.
2.
In the alarm paused status,
Press
for less than 2 seconds to switch the monitor to the normal status, or
Press
for 2 seconds or more to switch the monitor to the Alarms silenced
status.
3.
In the alarm silenced status,
Press
for less than 2 seconds to switch the monitor to the Alarms Paused
status, or
Press
for 2 seconds or more to switch the monitor to the normal status.
5-6
5.4 Clearing Alarm Indications
1.
Clearing alarm light flashing and alarm tones
For some technical alarms, the alarm lamp flashing and alarm tones are cleared and the
alarm messages change to prompt messages during and after the alarm paused period if
is pressed for less than 2 seconds. If the technical alarm is triggered again after the
monitor restores to the normal status, the monitor will give alarm indications as normal. For
technical alarms whose alarm light flashing and alarm tones can be cleared, refer to C
Alarm Messages and Prompt Information.
2.
Clearing all alarm indications
For some other technical alarms, all alarm indications are cleared during and after the alarm
paused period if
is pressed for less than 2 seconds. If the technical alarm is
triggered again after the monitor restores to the normal status, the monitor will give alarm
indications as normal.
5.5 Setting Alarms
By pressing
, you can enter the SET ALARMS menu to set NIBP and SpO2 alarm
switches and change alarm limits.
You can switch on or off NIBP-related physiological alarms by selecting the pane to the
right of SYS ALM and toggling between ON and OFF. You can switch on or off
physiological alarms related to SpO2 and PR by selecting the pane to the right of SPO2
ALM and toggling between ON and OFF.
To adjust alarm limits, move the cursor respectively to HI and LO and select a desired value
by pressing
,
and
.
When any of the pressure values exceeds the alarm limits, an alarm will be triggered. The
ranges of NIBP limits is listed below:
Patient type
Adult
Pediatric
Neonate
Sys
40 to 270 mmHg
40 to 200 mmHg
40 to 135 mmHg
Map
20 to 230 mmHg
20 to 165 mmHg
20 to 110 mmHg
Dia
10 to 210 mmHg
10 to 150 mmHg
10 to 100 mmHg
5-7
When any of the SpO2 or PR values exceeds the alarm limits, an alarm will be triggered.
The ranges of SpO2 and PR limits are listed below:
SpO2 module
SpO2
PR
Mindray DS SpO2
0 to 100%
0 to 254 bpm
Masimo SpO2
0 to 100%
25 to 240 bpm
Nellcor SpO2
0 to 100%
20 to 250 bpm
5.6 SpO2 Sensor Off Alarm
Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password
and set SPO2 SENSOR OFF to HIGH, MED, LOW or OFF in the pop-up menu. When the
alarm level of SPO2 SENSOR OFF is set to OFF, all alarm indications related to this alarm
is disabled.
5.7 When an Alarm Occurs
WARNING
When an alarm occurs, always check the patient’s condition first.
When an alarm occurs to the monitor, refer to the following steps and take action properly.
1.
Check the patient’s condition.
2.
Identify the alarming parameter and the alarm category.
3.
Identify the cause of the alarm.
4.
Take proper action to eliminate the alarm condition.
5.
Make sure the alarm condition is corrected.
NOTE
For details about how to deal with specific alarms, refer to C Alarm Messages
and Prompt Information.
5-8
6 Recording
6.1 Overview
A thermal recorder can be installed on the left side panel of the monitor to print:
Real-time PLETH waveform.
Currently displayed trend data.
All trend data of the current patient.
6.2 Using the Recorder
6.2.1 Printing Real-time PLETH waveform
1.
Press
to enter the PLETH screen.
2.
Press
for less than 2 seconds to print the currently displayed PLETH
waveform.
6.2.2 Printing Currently Displayed Trend Data
1.
Enter the Trend screen.
2.
Press
for less than 2 seconds to print the currently displayed trend data.
6.2.3 Printing All Trend Data of the Current Patient
1.
Enter the Trend screen.
2.
Press
for 2 seconds or more to print all trend data of the current patient.
NOTE
You can stop printing at any time by pressing
For information on recorder status and corresponding handling measures, refer
to C Alarm Messages and Prompt Information.
6-1
.
6.3 Loading Paper
1.
Press the latch at the upper right of the recorder door to open the door.
2.
Lift the roller lever located at the upper left of the recorder as shown in the following
figure.
3.
Install a new roll of paper into the compartment as shown below. The roller scrolls
automatically to send the paper out of the compartment.
4.
Push down the roller lever.
5.
Close the recorder door.
Paper roll
Figure 6-1 Installing Recording Paper
CAUTION
Use only specified thermal paper. Otherwise, it may cause damage to the
recorder’s printhead, the recorder may be unable to print, or poor print quality
may result.
Never pull the recorder paper with force when the printing is in process.
Otherwise, it may cause damage to the recorder.
Do not leave the recorder door open except when you are replacing the paper or
removing a fault.
6-2
6.4 Removing Paper Jam
If the recorder works improperly or produces unusual sound, check whether there is a paper
jam. If yes, remove it following this procedure:
1.
Open the recorder door.
2.
Take out the jammed paper and tear off the draped part.
3.
Lift the lever on the upper left of the recorder.
4.
Draw out the paper from the paper inlet.
5.
Reload the paper and close the recorder door.
6-3
FOR YOUR NOTES
6-4
7 SpO Monitoring
2
This monitor can be equipped with any of the following SpO2 modules:
Mindray DS SpO2 module
Masimo SpO2 module
Nellcor SpO2 module.
A monitor, equipped with a Masimo or Nellcor SpO2 module, is marked by “Masimo SET”
or “Nellcor” at the lower left corner of the front panel. The following pages respectively
gives introduction to the above three SpO2 modules. Please read this chapter according to
your monitor configuration before operation.
7.1 Introduction
SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated
haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light.
The light generated in the probe passes through the tissue and is converted into electrical
signals by the photodetector in the probe. The SpO2 module processes the electrical signal
and displays a waveform and digital values for SpO2 and pulse rate.
This device is calibrated to display functional oxygen saturation. It provides four
measurements:
1.
PLETH waveform (PLETH): visual indication of patient’s pulse. The waveform is
normalized.
2.
Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin in
relation to the sum of oxyhemoglobin and deoxyhemoglobin.
3.
Perfusion indicator: the pulsatile portion of the measured signal caused by arterial
pulsation.
4.
Pulse rate (derived from pleth wave): detected pulsations per minute.
7-1
7.2 Safety
WARNING
Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s
instructions for use and adhere to all warnings and cautions.
When a trend toward patient deoxygenation is indicated, blood samples should be
analyzed by a co-oximeter to completely understand the patient’s condition.
Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced
current could potentially cause burns. The sensor may affect the MRI image, and
the MRI unit may affect the accuracy of the oximetry measurements.
Prolonged continuous monitoring may increase the risk of undesirable changes in
skin characteristics, such as irritation, reddening, blistering or burns. Inspect the
sensor site every two hours and move the sensor if the skin quality changes. For
neonates, or patients with poor peripheral blood circulation or sensitive skin,
inspect the sensor site more frequently.
Check if the sensor is in normal condition before monitoring. Do not use the SpO2
sensor once the package or the sensor is found damaged.
After unplugging the SpO2 sensor cable from the connector of the monitor, the
system shall display the alarm message "SPO2 SENSOR OFF" and give the
audible alarm.
ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up.
Do not apply the sensor on a limb with an intravenous infusion or arterial catheter
in place.
Do not perform SpO2 monitoring and NIBP measurements on the same limb
simultaneously. Obstruction of blood flow during NIBP measurements may
adversely affect the SpO2 reading.
Measure the monitor’s leakage current whenever an external device is connected to
the serial port. Leakage current must not exceed 100 mA.
To ensure patient electrical isolation, connect only to other equipment with
electronically isolated circuits.
Do not connect the monitor to a mains outlet with a wall switch or dimmer.
Interfering Substances, such as carboxyhemoglobin, may erroneously increase
SpO2 readings. The level of increase is approximately equal to the amount of
carboxyhemoglobin. Dyes, or any substance containing dyes, that change usual
arterial pigmentation may also cause the increase of SpO2 readings.
7-2
NOTE
Place the SpO2 sensor cable along the backside of patient’s hand. Make sure the
fingernail is just opposite to the light emitted from the sensor.
SpO2 waveform amplitude is not proportional to the pulse strength.
SpO2 value is not proportional to the pulse rate.
7.3 Monitoring Procedure
1.
Power on the monitor.
2.
Remove colored nail polish from the application site.
3.
Apply the sensor to the patient.
4.
Plug the connector of the sensor extension cable into the SpO2 connector on the
monitor.
7.4 Measurement Limitations
If you doubt the measured SpO2, check patient vital signs first. Then check the patient
monitor and SpO2 sensor. The following factors may influence the accuracy of
measurement:
Ambient light
Physical movement (patient and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin
(MetHb)
Presence of certain dyes, such as methylene and indigo carmine
Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor
Drop of arterial blood flow to immeaurable level caused by shock, anemia, low
temperature or vasoconstrictor.
The absorption of oxyhemoglobin (HbO2) and deoxyhemoglobin to the light of special
wavelength may also affect the accuracy of the SpO2 measurement. In the presence of other
substances (such as carbon hemoglobin, methemoglobin, methylene blue and indigo
carmine) that absorb the light of the same wavelengths, false or low SpO2 readings may
result.
7-3
7.5 Masimo Information
The MASIMO SET® Product
®
Masimo Patents
This device is covered under one or more of the following U.S.A. patents: 5,758,644,
5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975, 7,469,157 and other applicable
patents listed at www.masimo.com/patents.htm.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use
the device with unauthorized sensors or cables which would, alone, or in combination with
this device, fall within the scope of one or more of the patents relating to this device.
7.6 Nellcor Information
Nellcor Patents
This device is covered under one or more the following U.S. Patents: 4,802,486; 4,869,254;
4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,485,847;5,743,263; 5,865,736; 6,035,223;
6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,791; Re.35,122 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 unauthorized 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.
7-4
8 NIBP Monitoring
8.1 Overview
The Non-invasive Blood Pressure (NIBP) module measures blood pressure using the
oscillometric method. This monitor can be applied to adult, pediatric, and neonatal patients.
Three modes of measurement are available:
Manual: Pressing
Auto:
NIBP measurement is performed automatically at a preset interval.
STAT:
NIBP measurement is performed continually over a five minute period.
starts an NIBP measurement manually.
The systolic, mean and diastolic pressure readings are displayed on the monitor. If SpO2
measurement is not performed, the PR data can be obtained from the NIBP measurement.
WARNING
Be sure to select the correct patient category setting for your patient before
measurement. Do not apply the higher adult settings for pediatric or neonatal
patients. Otherwise it may present a safety hazard.
Do not measure NIBP on patients with sickle-cell disease or any condition where
skin damage has occurred or is expected.
Use clinical judgement to determine whether to perform frequent unattended
blood pressure measurements on patients with severe blood clotting disorders
because of the risk of hematoma in the limb fitted with the cuff.
Do not use the NIBP cuff on a limb with an intravenous infusion or arterial
catheter in place. This could cause tissue damage around the catheter when the
infusion is slowed or blocked during cuff inflation.
If you doubt the NIBP readings, determines the patient’s vital signs by
alternative means and then verify that the monitor is working correctly.
8-1
8.2 Monitoring Procedure
To perform NIBP measurement on a patient, follow the procedure below.
1.
Power on the monitor.
2.
Enter the PATIENT INFORMATION menu to select correct patient type.
3.
Plug the air hose in the NIBP connector of the monitor.
4.
Apply a cuff of proper size to the upper arm or the thigh of the patient.
5.
Connect the cuff with the air hose.
6.
Press
to start the NIBP measurement.
8.2.1 Cuff Selection and Placement
1.
Determine the patient’s limb circumference.
2.
Select appropriate cuff according to limb circumference.
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 circle 50-80% of the limb. Wrong cuff size may cause
erroneous readings. If the cuff size is in question, use a larger cuff.
3.
Ensure that the cuff is completely deflated. Apply the cuff to the patient’s upper arm or
thigh and make sure the Φ marking on the cuff matches the artery location.
4.
Do not wrap the cuff too tightly around the limb. It may cause discoloration, and
ischemia of the extremities.
8-2
5.
Make sure that the cuff edge falls within the marked range. If it does not, use a larger
or smaller cuff that will fit better.
6.
The limb chosen for taking the NIBP measurement should be placed at the same level
as the patient's heart. If this is not possible, use the following method to correct the
measurement result:
If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa) to the
measured result for each centimeter of difference.
If the cuff is placed lower than the heart level, deduct 0.75 mmHg (0.10 kPa) from
the measured result for each centimeter of difference.
WARNING
Do not use the NIBP cuff on a limb with an intravenous infusion or arterial
catheter in place. This could cause tissue damage around the catheter when the
infusion is slowed or blocked during cuff inflation.
Make sure the air hose connecting the NIBP cuff and the monitor is not blocked,
twisted, or tangled.
8.2.2 Operation Guides
1.
To start a manual NIBP measurement.
Press
to enter the INTERVAL menu; set INTERVAL to MANUAL; and then
press
to start a manual NIBP measurement. In this case, a symbol “
” is
shown on the Normal screen.
Directly press
to start a manual NIBP measurement between two auto NIBP
cycles.
Quick start the manual model by holding and pressing button
2.
To start an Auto NIBP measurement.
Press
for 3 seconds.
to enter the INTERVAL menu; set INTERVAL to a desired time (e.g.5MIN);
and then press
to start the first auto NIBP measurement. The monitor will then
automatically repeat NIBP measurements at the preset time interval.
8-3
3.
To start a STAT NIBP measurement:
Press
to enter the INTERVAL menu and then select NIBP STAT to start a 5-minute
continuous NIBP measurement.
WARNING
4.
Continuous non-invasive blood pressure measurements may cause purpura,
ischemia and neuropathy in the limb with the cuff. Inspect the application site
regularly to ensure skin quality and inspect the extremity of the cuffed limb for
normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to
another site or stop the NIBP measurements immediately.
To stop an NIBP measurement
You can stop an NIBP measurement by pressing
whenever you are in Manual, Auto
or STAT mode.
NOTE
If you doubt the NIBP readings, determine the patient’s vital signs by
alternative means and then verify that the monitor is working correctly.
8.3 Measurement Limitations
Measurements are impossible with heart rate extremes of less than 40bpm or greater than
240bpm, or if the patient is on a heart-lung machine.
The measurement may be inaccurate or impossible:
If a regular arterial pressure pulse is hard to detect
With excessive and continuous patient movement such as shivering or convulsions
With cardiac arrhythmias
Rapid blood pressure changes
Severe shock or hypothermia that reduces blood flow to the peripheries
Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming
from the artery
8-4
8.4 Setting Initial Cuff Inflation Pressure, NIBP Reset,
Calibration and Test for Air Leakage
8.4.1 Setting Initial Cuff Inflation Pressure
In SYSTEM SETUP menu, select MAINTAIN→NIBP TOOLS→Initial Cuff Inflation
Pressure, and then you can set the initial cuff inflation pressure. The initial cuff inflation
pressures are listed in the following:
Adult:80、100、120、140、160、180、200、220、240 mmHg,Default is 160 mmHg
Pediatric:80、100、120、140、160、180、200 mmHg,Default is 140 mmHg
Neonate:60、80、100、120mmHg,Default is 100 mmHg
NOTE
The cuff will be inflated with the default initial cuff inflation pressure at each
time you set the measurement mode as MANUAL.
8.4.2 Resetting NIBP
If the blood pressure pump works incorrectly but the monitor does not alarm for it, you can
check the pump by resetting it. To reset the pump, select SYSTEM SETUP→MAINTAIN→
NIBP TOOLS→NIBP RESET.
8-5
8.4.3 Calibrating NIBP
In SYSTEM SETUP menu, select MAINTAIN→NIBP TOOLS→NIBP CALIBRATE to
start NIBP calibration. Then the button NIBP CALIBRATE changes to STOP CALIBRATE.
By selecting STOP CALIBRATE, you can stop the calibration.
Follow this procedure to calibrate the cuff pressure with a calibrated reference manometer
(or mercury manometer) with accuracy 1mmHg:
1.
Disconnect the NIBP cuff from the monitor and replace it with a metal vessel with
capacity 500±25ml.
2.
Connect a calibrated reference manometer (with an error less than 0.8 mmHg), a ball
pump and a hoses to the monitor, as shown in the figure below:
3.
Select NIBP CALIBRATE.
4.
Inflate the metal vessel with the ball pump until the reference manometer reads 0, then
50, and finally 200 mmHg.
5.
The difference between the indicated pressure of the reference manometer and that of
the monitor shall not exceed 3 mmHg. Otherwise, contact Our Customer Service.
Metal vessel
Figure 8-1 NIBP Calibration
NOTE
z
NIBP calibration shall be performed every two years or according to your
hospital’s protocol.
8-6
8.4.4 NIBP Leakage Test
You can test the pump for air leakage by selecting SYSTEM SETUP→MAINTAIN→NIBP
TOOLS→NIBP LEAK TEST. With the NIBP cuff connected, you can test the air way for
leakage by selecting NIBP LEAK TEST. If the NIBP leakage test is passed, no prompt will
be given; If it fails, error information will be displayed in the NIBP parameter area.
To test air leakage, follow the procedure below:
1.
Set the patient category to adult.
2.
Connect a rigid metal container or vessel with a capacity of 500 ml ± 5% to the NIBP
cuff connector of the monitor.
Monitor
Connector for
NIBP cuff
Air tubing
Metal
vessel
Figure 8-2 NIBP Leakage Test
3.
Select NIBP LEAK TEST in the M NIBP TOOLS menu, the message “Pneum
testing...” displays in the information area..
4.
The cuff automatically deflates in 20s which means NIBP leakage test is completed.
5.
If no message appears in the NIBP parameter area, it indicates the airway is in good
condition and no air leak exists. However, if the system prompts “PNEUMATIC
LEAK”, it indicates the airway may have an air leak. In this case, check for loose
connections. After confirming that all connections are secure, perform the test again.
If the problem persists, contact our Customer Service.
NOTE
z
The leakage test is intended for use to simply determine whether there are
leakages in the NIBP airway. It is not the same as that specified in the EN 1060-3
standard.
8-7
FOR YOUR NOTES
8-8
9 TEMP Monitoring
9.1 Overview
The SmarTemp™ TEMP module is intended for monitoring oral, axillary and rectal
temperature of adult and pediatric patients and axillary temperature of neonatal patients. Be
sure to set correct monitoring mode and position and to select appropriate temperature
probe before taking measurement. TEMP TYPE can be set to PREDICT or MONITOR. The
default TEMP TYPE is PREDICT.
PREDICT MODE: In PREDICT mode, the TEMP probe warms up automatically as
the probe is withdrawn from the probe sheath. Warming up takes approximately 10s at
25℃ and when it is done, the monitor gives two beeps. Final temperature is obtained
in approximately 10s to12s and the monitor gives a beep. Temperature reading remains
on the display till the probe is removed from the sheath again. In this mode, if no
accurate patient temperature is reached, or after the probe is removed from the sheath
for 60s, neither measurement is taken nor the probe is not replaced in its sheath, the
monitor automatically enters the MONITOR mode.
MONITOR MODE: In MONITOR mode, final temperature is reached in 3 to 5
minutes and the temperature reading is continuously shown. In this mode, the monitor
does not beep when the final temperature is obtained.
The TEMP reading is display above the LCD.
WARNING
The TEMP module shall only be operated under specified environment. When
the probe is removed from the probe sheath, the monitor detects the ambient
temperature. An auditory alarm will be triggered and the alarm message “ENV
TEMP OVERRANGE”
”will be displayed if the ambient temperature is over
range.
For neonatal patient, only axillary temperature can be taken.
Choose appropriate probe according to temperature position. Incorrect probe
may result in erroneous measurement.
Prolonged and continuous monitoring beyond 5 minutes is not recommended in
any mode.
In PREDICT mode, temperature probe shall be placed to the measured site as
soon as probe warmup is completed; otherwise, inaccurate temperature reading
may result.
In MONITOR mode, the monitor stops measurement after performing
measurement for five minutes later and the TEMP reading disappears.
Long-time TEMP measurement may cause patient discomfort.
9-1
9.2 Temperature Setup
In the SYSTEM SETUP menu, select TEMP SETUP, you can adjust:
TEMP TYPE: PREDICT or MONITOR. If MONTIOR is selected, The LED
indicating measuring mode on the front panel illuminates.
TEMP POSITION:: ORAL, AXILLARY or RECTAL. Corresponding indicating lamp
on the front panel illuminates if a measurement site is selected.
TEMP UNIT: ℃ or ℉.
9.3 Monitoring Procedure
9.3.1 TEMP position
The TEMP module can be configured with 2 types of TEMP probe: oral/axillary probe (blue)
and rectal probe (red). The blue oral/axillary probe shall only be used with blue probe
sheath, while the red rectal probe shall only be used with red sheath. Be sure to select
correct probe.
Oral/axillary probe: This type of probe is intended for taking oral or axillary
temperature of adult and pediatric patients, or axillary temperature of neonatal patient.
Rectal probe: This type of probe is intended for taking rectal temperature of adult and
pediatric patient.
NOTE
If the patient type is adult or pediatric, the equipment automatically selects oral
as the measurement site when the oral/axillary temperature probe is in use. You
can change the measurement site in the TEMP SETUP dialog.
If the patient type is neonatal, the equipment automatically selects axillary as
the measurement site if the oral/axillary temperature probe is in use. In this
case, you cannot change measurement site.
9-2
9.3.2 Oral Temperature Measurement
Follow the procedure below to measure oral Temperature.
1.
Make sure that the oral/axillary probe is connected to the probe connector and the
indication lamp beside the temperature unit lights to indicate that TEMP module
properly operates.
2.
Select desired temperature type (the following procedure taking predict mode as an
example) and set TEMP POSITION to ORAL.
3.
Unplug the probe from the probe sheath and insert it into a cover in the probe cover
box. Press the probe handle down firmly until the cover engages with the probe.
4.
After the probe warmingup is ready, apply it under the patient’s tongue from either
side of the mouth. Verify that the probe reaches the rear sublingual pocket. Have the
patient close his/her lips to hold the probe.
5.
Hold the probe in place. Make sure that the probe contacts with the patient’s oral tissue
throughout the measurement.
6.
The monitor will give a beep as the temperature measurement is complete. The
temperature reading displays continuously.
7.
Withdraw the probe from the patient’s mouth when accurate temperature reading is
obtained. Press firmly the ejection button on the top of the probe to eject the probe
cover. Return the probe into the sheath.
Temperature reading displays when final temperature is reached.
9.3.3 Axillary Temperature Measurement
1.
Make sure that the oral/axillary probe is connected to the probe connector and the
indication lamp beside the temperature unit lights to indicate that TEMP module
properly operates.
2.
Select desired temperature type (the following procedure taking predict mode as an
example) and set TEMP POSITION to AXILLARY.
3.
Unplug the probe from the probe sheath and insert it into a cover in the probe cover
box. Press the probe handle down firmly until the cover engages with the probe.
4.
After probe warmingup is ready, lift the patient’s arm to show the entire armpit. Apply
the probe as high as possible in the armpit. Check that the probe tip is completely
surrounded by the axillary tissue. Lower the patient’s arm so that it is tightly placed at
the patient side. Keep the patient’s arm and the probe in place throughout the
measurement.
9-3
5.
The monitor will give a beep as the temperature measurement is complete. The
temperature reading is shown continuously.
6.
Withdraw the probe from the patient’s armpit when accurate temperature reading is
obtained. Press firmly the ejection button on the top of the probe to eject the probe
cover. Return the probe into the sheath.
Temperature reading displays when final temperature is reached.
9.3.4 Measuring Rectal Temperature
1.
Make sure that the rectal probe is connected to the probe connector and the indication
lamp beside the temperature unit lights to indicate that TEMP module properly
operates.
2.
Select desired temperature type (the following procedure taking predict mode as an
example) and set TEMP POSITION to RECTAL.
3.
Unplug the probe from the probe sheath and insert it into a cover in the probe cover
box. Press the probe handle down firmly until the cover engages with the probe.
4.
After probe warmingup is ready, seperate the patient’s buttocks with one hand and
insert the probe 1.5 cm inside the rectum with the other hand. For pediatric patient,
depth of insertion shall be less. Tilt the probe so that it always contacts with patient’s
tissue. Lubricant can be used in rectal mode.
5.
The monitor will give a beep as the temperature measurement is complete. The
temperature reading is shown continuously.
6.
Withdraw the probe from the patient’s rectum when accurate temperature reading is
obtained. Press firmly the ejection button on the top of the probe to eject the probe
cover. Return the probe into the sheath.
Temperature reading displays when final temperature is reached.
9-4
9.3.5 Temperature Measurement in MONITOR Mode
Temperature measurement can be taken in MONITOR mode. The monitor automatically
enters the MONITOR mode in the following two cases:
Accurate temperature is not reached in the PREDICT mode.
Neither measurement is taken nor the probe is replaced in the probe sheath in 60s after
the probe is withdrawn from the sheath.
In MONITOR mode, temperature reading remains on the display as long as the probe is
kept at the measurement position and the patient’s temperature is within the measuring
range. Final temperature value is reached in 3 to 5 minutes, however, the monitor does not
beep in this mode.
To measure temperature in the Monitor mode,
1.
Make sure that the probe is connected to the probe connector and the indication lamp
beside the temperature unit lights to indicate that TEMP module properly operates.
2.
Set TEMP TYPE to MONITOR and select appropriate TEMP POSITION.
3.
Unplug the probe from the probe sheath and insert it into a cover in the probe cover
box. Press the probe handle down firmly until the cover engages with the probe.
4.
Apply the probe to the measuring site and take measurement according to the
instructions as described in the PREDICT mode.
5.
Remain the probe in place for 3 to 5 minutes till accurate measurement is reached.
6.
Remove the probe when accurate temperature reading is obtained. Press firmly the
ejection button on the top of the probe to eject the probe cover. Return the probe into
the sheath.
9.4 Decontamination of the SmarTemp™ TEMP Probe
Use LpH SE Germicidal detergent to decontaminate a probe that has come in contact with a
biological material. Apply a small amount of detergent to a disposable wipe (paper based)
and wipe down the outside of the probe. Discard the wipe appropriately. After waiting 10
minutes, use a clean dry wipe to dry the probe.
WARNING
Perform the decontamination or cleaning process with the unit powered down
and power cord removed.
9-5
9.5 Precautions
WARNING
Check the probe before taking temperature measurement. The prompt
information “TEMP NO PROBE” will be presented and an auditory alarm will
be triggered if the TEMP probe is disconnected from the probe connector.
Check the disposable probe cover for damage before using. Never use any probe
cover for temperature measurement in case of damage or contamination.
Be careful to avoid damaging the TEMP probe. Replace the TEMP probe in the
probe sheath if not in use.
Calibration of the TEMP module is required every two years or according to
your hospital’s policy. Please contact our Customer Service if calibration is
needed.
Only TEMP probes and probe covers supplied by our company shall be used.
The use of any other TEMP probe and probe cover may result in erroneous
temperature measurements.
Taking temperature without using probe cover or reusing the disposable probe
cover may result in cross contamination.
NOTE
TEMP TYPE automatically returns to PREDICT mode when TEMP probe is
replaced in the probe sheath.
In the PREDICT mode, please cool the TEMP probe before taking measurement
if ambient temperature is higher than 32.5℃
℃.
Patient actions may interfere with oral temperature readings. Ingesting hot or
cold liquids, eating food, chewing gum or mints, brushing teeth, smoking, or
performing strenuous activities may affect temperature readings for up to 20
minutes after the activity has ended.
Prolonged and continuous monitoring for more than 3 minutes in oral or rectum
mode or 5 minute in axillary mode is not recommended.
In the axillary mode, the probe shall directly contact with patient’s skin.
Measuring through patient’s clothes or long-term exposal of patient’s armpit to
the air may result in inaccurate temperature reading.
In the rectal mode, incorrect probe placement may result in bowel perforation.
Washing hands after temperature measurement is complete will significantly
reduce the risk of cross infection and nosocomial contamination.
9-6
10 Accessories
WARNING
Use specified accessories only. Accessories of other types may cause damage to
the monitoror not meet the claimed specifications.
Single-use accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
Check the accessories and their packages for any sign of damage. Do not use
them if any damage is detected.
10.1 SpO2 Accessories
Extension Cable
Module type
PN
Mindray DS SpO2 Module
0010-20-42594
Masimo SpO2 Module
0010-30-42625
SpO2 Sensor
The SpO2 sensor material that patients or other staff will come into contact with has
undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1.
For Mindray DS SpO2 Module
Type
Single
patient
Model
Applicable Patient
PN
520A
Adult
520A-30-64101
520P
Pediatric
520P-30-64201
520I
Infant
520I-30-64301
520N
Neonate
520N-30-64401
10-1
518B
Reusable
512E
512F
512G
512H
Adult, pediatric, neonate (Multi-sites)
518B-30-72107
512E-30-90390
Adult (Finger type)
512F-30-28263
512G-30-90607
Pediatric (Finger type)
512H-30-79061
For Masimo SpO2 Module
Type
Reusable
Single
patient use
Model
Applicable Patient
Remark
PN
\
Adult (>30 kg)
LNCS DCI
0600-00-0126
\
Pediatric (10 to 50 kg)
LNCSDCIP
0600-00-0127
\
Adult (>30 kg)
LNCS Adtx
0600-00-0121
\
Pediatric (10 to 50 kg)
LNCS Pdtx
0600-00-0122
\
Infant (3 to 20 kg)
LNCS INF-L
0600-00-0124
\
Neonate (<3 kg and > 40
kg)
LNCS NEO-L
0600-00-0158
\
Neonate Pre-term (<1kg)
LNCS NEO
PT-L
0600-00-0125
Wavelengths emitted by 512F sensor intended for Mindray DS SpO2 module are red light
660 nm and infrared light 940 nm; wavelengths emitted by other sensors for Mindray DS
SpO2 module are red light 660 nm and infrared light 905 nm;
Wavelength emitted by the sensors intended for Masimo SpO2 module are red light 660 nm
and infrared light 940 nm.
The maximum photic output consumption of the sensor is less than 18 mW.
The information about the wavelength range and maximum photic output consumption can
be especially useful to clinicians, for example, clinicians performing photodynamic therapy.
10-2
10.2 NIBP Accessories
Tubing
Type
Reusable
Applicable Patient
PN
Adult, pediatric
509B-30-06259
Neonate
509B-30-06260
Cuff
Type
Model
Limb
Bladder
Applicable Measurement
Circumference Width PN
Patient
Site
(cm)
(cm
\
Child
Reusable
9.2
0683-15-0001-01
\
Small Adult Arm
18 to 26
12.2
0683-15-0002-01
\
Adult
25 to 35
15.1
0683-15-0003-01
\
Large adult
33 to 47
18.3
0683-15-0004-01
\
Adult
46 to 66
22.5
0683-15-0005-01
\
Blood Pressure Cuff Starter
Kit (Includes one of each:
Child, Small Adult, Adult, \
Large Adult and Thigh
cuff)
Thigh
CM1500A
Single
patient
10 to 19
CM1500B
CM1500C
Neonate
Arm
CM1500D
\
Child
\
Small Adult
Disposable \
Adult
\
Large adult
\
Adult
Arm
Thigh
10-3
0020-00-0184-01
\
3.1 to 5.7
2.2
001B-30-70692
4.3 to 8.0
2.9
001B-30-70693
5.8 to 10.9
3.8
001B-30-70694
7.1 to 13.1
4.8
001B-30-70695
10 to 19
7.2
0683-14-0001-01
18 to 26
9.8
0683-14-0002-01
25 to 35
13.1
0683-14-0003-01
33 to 47
16.5
0683-14-0004-01
46 to 66
20.5
0683-14-0005-01
10.3 TEMP Accessories
Description
Measurement Site
PN
oral/axillary
6006-30-39598
rectal
6006-30-39599
oral/axillary
M09A-20-62062
rectal
M09A-20-62062-51
Disposable probe cover (20 pcs)
/
M09A-20-62124
Disposable probe cover (200 pcs)
/
M09A-30-62126
Disposable probe cover (2000 pcs)
/
M09A-30-62128
TEMP probe
Probe sheath
10.4 Others
Description
Lithium Ion Battery
PN
M05-010001-06
0146-00-0099
Data Output Software Package
6006-30-39515
Bedrail Clamp
8000-30-90170
Bar code scanner
0000-10-10767
Nurse call cable
8000-21-10361
Roll stand
0010-30-42945
Thermal Paper, one roll (50mm x 20m)
0683-00-0505-01
Wall-mounting rack
0010-30-42952
10-4
A Product Specifications
A.1 Safety Specifications
Item
Specification
Class I; internally/externally powered equipment
Type of protection against
electrical shock
When integrity of the external protection grounding or grounding
cable is doubtable, the equipment must be powered by the
internal power (battery).
Degree of protection
against electric shock
SpO2/NIBP/TEMP: CF
Degree of protection
against hazards of
explosion
Not suitable (ordinary)
Degree of protection
against harmful ingress of
water
Not suitable (ordinary)
Mode of operation
Continuous
Equipment type
Portable
A.2 Environmental Specifications
Item
Specification
Operating ambient
temperature
0 to 40 ºC
Operating relative humidity
15 to 95%, non-condensing
Atmospheric pressure at
working condition
(operating altitude)
10 to 40 ºC (50 to 104 ºF) (SmarTemp™ TEMP module)
57~107.4KPa
70 to 106 kPa(SmarTemp™ TEMP module)
Storage temperature
-20 to 60 ºC
Storage relative humidity
10 to 95%, non-condensing
atmospheric pressure in
Storage (Storage altitude)
16~107.4KPa
50~106KPa(SmarTemp™ TEMP module)
A-1
A.3 Power Requirements
Item
Specification
AC mains
Input voltage
100 to 240V
Input current
0.7 to 0.3A
Frequency
50/60Hz
Battery
Number of batteries
1
Battery type
Sealed lead-acid battery or lithium-ion battery
Time to shutdown
>5 min (after the first low-power alarm)
Sealed lead-acid battery
Nominal voltage
12VDC
Battery capacity
2.3Ah
260min
Typical operating time
Charge time
(Using a new, fully charged battery for continuous SpO2
monitoring and auto NIBP measurements at an interval of 15
minutes at 25℃ ).
A maximum of 8h with monitor operating normally or in
standby mode
Lithium-ion battery
Nominal voltage
11.1VDC
Battery capacity
4.4Ah
620min
Typical operating time
Charge time
(Using a new, fully charged battery for continuous SpO2
monitoring and auto NIBP measurements at an interval of 15
minutes at 25℃ ).
A maximum of 8h with monitor operating normally or in
standby mode
A-2
A.4 Hardware Specification
Item
Specification
Size
177×240×170mm (width × height × depth))
Weight
<3.5kg (battery included)
LCD
Type
Monochrome FSTN
Size
80.3×41.0mm
Resolution
320×160 pixels
7-segment LED Digit Displays
Groups
6
LED indicating lamp
Groups
8
Recorder
Type
Thermal dot array
Horizontal resolution
160dots/cm 25 mm/s (paper speed: 25mm/s)
Vertical resolution
80dots/cm
Paper width
50mm
Paper length
20m
Paper speed
25 mm/s
Number of waveform
channels
1
Connectors
Power supply
1 AC power connector
Nurse call
1
Network
1 standard RJ45 network connector, 100 BASE-TX
Serial port
1 standard RS-232 serial port
A-3
A.5 Signal Output
Item
Specification
Applicable standards
Meet the requirements of EC60601-1 for short-circuit
protection and leakage current
Nurse call output
Driving mode
Driven by relay
Electrical specification
≤60W, ≤2A, ≤36VDC, ≤25VAC
Isolation voltage
>1500VAC
Working mode
N/O or N/C (optional)
Sound output
Issues alarm tones (sound pressure 45 to 85 dB), key tones,
pulse tones and audible temperature done prompt, supporting
Pitch Tone and multiple volume levels. Audible alarm signals
meet the requirement of IEC60601-1-8.
Speaker
A.6 SpO2 Specification
A.6.1 Mindray DS SpO2 Specification
All SpO2 sensors for Mindray DS SpO2 Module specified in the section 10.1meets the
following specifications.
Item
Specification
Measurement validation: The SpO2 accuracy has been validated in human studies against
arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are
statistically distributed, and only about two-thirds of the measurements can be expected to fall
within the specified accuracy compared to CO-oximeter measurements.
SpO2
Measurement range
0 to 100%
Resolution
1%
Accuracy
70% to 100%:
(adult/pediatric, in non-motion conditions)
70% to 100%:
±3%(neonate, in non-motion conditions) *
0% to 69%:
Undefined
*Studies were performed to validate the accuracy of this monitor with neonatal SpO2 sensors by
contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of
22 weeks to full term were involved in this study. The statistical analysis of data of this study
shows the accuracy (Arms) is within the stated accuracy specification. Please see the following
table.
A-4
Sensor type
Totally neonates
Data
Arms
520N
122 (65 male & 57 female)
200 pairs
2.88%
518B
97 (51 male & 46 female)
200 pairs
2.38%
This monitor with neonatal SpO2 sensors was also validated on adult subjects.
Update period
1s
Averaging time
7s
PR
Measurement range
20 to 254bpm
Resolution
1bpm
Accuracy
±3 bpm (in non-motion conditions)
Update period
1s
Averaging time
7s
A.6.2 Masimo SpO2 Specification
All SpO2 sensors for Masimo SpO2 Module specified in the section 10.1meets the following
specifications.
Item
Specification
SpO2
Measurement range
1 to 100%
Resolution
1%
Accuracy
Update period
70% to 100%:
±2% (adult/pediatric, in non-motion conditions)
70 %to 100%:
±3% (neonate, in non-motion conditions)
70 %to 100%:
±3% (in motion conditions)
0 %to 69%:
Undefined
1s
PR
Measurement range
25 to 240bpm
Resolution
1bpm
Accuracy
Update period
±3 bpm (in non-motion conditions)
±5 bpm (in motion conditions)
1s
A-5
A.6.3 Nellcor SpO2 Specification
Item
SpO2 measurement range
and accuracy
Specification
Sensor
Range
Accuracy*
MAX-A, MAX-AL, MAX-N,
MAX-P, MAX-I, MAX-FAST
70% to 100%
±2%
0% to 69%
Undefined
OxiCliq A, OxiCliq N, OxiCliq
P, OxiCliq I
70 %to 100%
±2.5%
0% to 69%
Undefined
D-YS, DS-100A, OXI-A/N,
OXI-P/I
70 %to 100%
±3%
0% to 69%
Undefined
70% to 100%
±3.5%
0% to 69%
Undefined
MAX-R, D-YSE, D-YSPD
PR measurement range and
accuracy
20 to 250 bpm: ±3 bpm
Update period
1s
251 to 300 bpm: Undefined
*: When sensors are used on neonatal patients as recommended, the specified accuracy range is
increased by ±1%, to account for the theoretical effect on oximeter measurements of fetal
hemoglobin in neonatal blood.
A.7 NIBP Specification
Item
Specification
NIBP
Applicable standards
IEC 60601-2-30, EN 1060-1, EN1060-3, AAMI SP-10
Method
Oscillometry
Displayed parameters
Systolic pressure, diastolic pressure and mean pressure, pulse
rate
Mode of operation
Manual, auto and STAT
Measurement range in
normal mode
Accuracy
Adult
Pediatric
Neonate
Systolic
pressure
40 to 270
mmHg
40 to 200
mmHg
40 to 135
mmHg
Diastolic
pressure
10 to 210
mmHg
10 to 150
mmHg
10 to 100
mmHg
Mean
pressure
20 to 230
mmHg
20 to 165
mmHg
20 to 110
mmHg
Maximum average error: ±5mmHg
Maximum standard deviation: 8mmHg
A-6
Resolution
Over-pressure protection
Default initial pressure
1mmHg
Adult:
297±3 mmHg
Pediatric:
240±3 mmHg
Neonate:
147±3 mmHg
Neonate: 67±5 mmHg
PR
Measurement range
40 to 240bpm
Resolution
1bpm
Accuracy
±3 bpm
A.8 TEMP Specification
Item
Specification
Displayed parameter
TEMP
Measurement range
In MONITOR mode: 25 to 44 ºC (77 to 111.2 ºF)
In PREDICT mode: 35 to 43 ºC (95 to 109.4 ºF)
Resolution
Accuracy
Typical measurement time
In MONITOR mode: 0.1 ºC
In MONITOR mode: 25 to 32 ºC (77 to 89.6 ºF): ±0.2 ºC (±0.3
ºF) including 32 ºC (89.6 ºF)
In MONITOR mode: 32 to 44 ºC (89.6 to 111.2 ºF): ±0.1ºC
(±0.2 ºF)excluding 32 ºC (89.6 ºF)
typically 10s to 12s from the moment when temperature “----”
displays dynamically
A-7
FOR YOUR NOTES
A-8
B EMC
The device meets the requirements of IEC60601-1-2.
NOTE
Use of accessories, transducers, and cables other than those specified may result
in increased emission and/or decreased electromagnetic immunity of the patient
monitoring equipment.
The device or its components should not be used adjacent to or stacked with
other equipment. and if adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the configuration in which it
will be used.
The equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided
below.
Other devices may affect this monitor even though they meet the requirements
of CISPR.
When the inputted signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
Portable and mobile RF communications equipment may affect this equipment.
Guidance and Declaration - Electromagnetic Emissions
The device is suitable for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Emission tests
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The equipment uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic Emissions
IEC61000-3-2
Class A
Voltage
Fluctuations/Flicker
Emissions
IEC 61000-3-3
Compliance
The equipment 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.
B-1
Guidance and Declaration - Electromagnetic Immunity
The device is suitable for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Immunity tests
Electromagnetic
environment - guidance
IEC60601 test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
(EFT)
IEC 61000-4-4
±2 kV for power
cords
±1 kV for
input/output lines
(>3 m)
±2 kV for power
cords
±1 kV for
input/output lines
(>3 m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% UT (>95% dip
in UT) for 0.5 cycle
<5 % UT (>95 % dip
in UT) for 0.5 cycle
<40% UT (>60% dip
in UT) for 5 cycle
40 % UT (60 % dip
in UT) for 5 cycles
<70% UT (>30% dip
in UT) for 25 cycle
70 % UT (30 % dip
in UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 seconds
<5 % UT (>95 % dip
in UT) for 5 s
3 A/m
3 A/m
Power frequency
magnetic field
(50/60Hz)
IEC 61000-4-8
Note: UT is the A.C. mains voltage prior to application of the test level.
B-2
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of our product
requires continued
operation during power
mains interruptions, it is
recommended that our
product be powered from
an uninterruptible power
supply or a battery.
Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
Guidance and Declaration - Electromagnetic Immunity
The device is suitable for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Immunity
tests
IEC 60601
Test level
Compliance
level
Electromagnetic environment — guidance
Conduced RF
IEC61000-4-6
3 Vrms
150k to 80MHz
3 Vrms
Radiated RF
IEC61000-4-3
3V/m
80M to 2.5GHz
3V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter. Recommended separation
distance:
d = 1.2 P
d = 1.2 P 80M to 800MHz
d = 2.3 P 800M 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:
.
Note 1: From 80 MHz to 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the device is
used exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the device.
b: Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.
B-3
Recommended Separation Distances between Portable and Mobile RF, Communications
Equipment and This Equipment
The equipment is intended for use in an electromagnetic environment in which radiated RF
disturbance are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the device as recommended below, according
to the maximum output power of the communication equipment.
Separation Distance According to Frequency of Transmitter (m)
Rated Maximum
80M to 800MHz
800M to 2.5GHz
150k to 80MHz
Output power of
Transmitter Watts (W)
 3.5 
 3.5 
7 
d=  P
 3 
d=  P
 3 
d=  P
3
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.34
10
3.69
3.69
7.38
100
11.67
11.67
23.34
For transmitters at a maximum output power not listed above, the recommended separation
distanced in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note 1: From 80 MHz to 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.
B-4
C Alarm Messages and Prompt Information
C.1 Physiological Alarm Messages
Note: XX represents a parameter label, such as PR, SpO2, NIBP, etc.The “L” field indicates
the alarm level. H means high, M means medium and L means low.
Alarm message
L
Cause
Action
XX TOO HIGH
M
XX value exceeds the upper alarm
limit.
XX TOO LOW
M
XX value is lower than the lower
alarm limit..
Make sure the alarm
limits are appropriate for
the patient, and check
the patient’s condition.
NO PULSE
H
The pulse signal of the patient is so
weak that the monitor cannot
perform pulse analysis.
Check the connection of
the sensor and the
patient’s condition.
C.2 Technical Alarm Messages
Note: XX represents a parameter module such as NIBP or SpO2, or a parameter label, such
as PR and SpO2. ## stands for patient category, i.e. adult, pediatric or neonate. The “A”
field indicates whether all alarm indications can be cleared or not, and the “B” field
indicates whether all alarm indications except the alarm message can be cleared or not. The
“L” field indicates the alarm level: H means high, M means medium and L means low. “*”
means the alarm level is user-adjustable.
C-1
C.2.1 General Alarm Messages of Parameter Modules
Alarm message
A
B
L
Cause
Action
XX INIT ERR N
Yes
No
H
An error occurs to
the XX module
during initialization.
Restart the monitor. If
the problem persists,
contact our service
personnel for repair.
Note: N stands for error code.
XX COMM STOP
No
No
H
Failure in
communication
between XX module
and the main board.
XX COMM
ERROR
No
No
H
Failure in
communication
between XX module
and the main board.
XX ALM LMT
ERR
No
No
H
The alarm limit of
the XX parameter is
changed
inadvertently.
XX EXCEED
No
No
H
The measured XX
value exceeds the
measurement range.
If the problem
persists, contact our
service personnel for
repair.
C.2.2 NIBP Module Alarm Messages
Alarm message
A
B
L
Cause
Action
NIBP SELFTEST
ERR
Yes
Yes
H
An error occurs
during NIBP module
initialization.
Select NIBP RESET
in the MAINTAIN
menu. If the problem
still exists, contact
our service personnel
for repair.
NIBP INIT ERR
Yes
Yes
H
An error occurs
during NIBP module
initialization.
Restart the monitor. If
the problem still
exists, contact our
service personnel for
repair.
C-2
NIBP COMM ERR
Yes
Yes
H
Communication
between NIBP
module and the host
fails.
Restart the monitor. If
the problem still
exists, contact our
service personnel for
repair.
LOOSE CUFF
No
Yes
L
The NIBP cuff is not
properly connected.
AIR LEAK
No
Yes
L
Leak in the airway.
CUFF TYPE ERR
No
Yes
M
PNEUMATIC
LEAK
No
Yes
L
AIR PRESSURE
ERROR
No
Yes
L
Check the patient’s
condition and verify
patient type. Replace
with a appropriate
cuff and connect it
correctly. If the
problem still exists,
contact our service
personnel for repair.
NIBP WEAK
SIGNAL
No
Yes
L
SIGNAL
SATURATED
No
Yes
L
NIBP
OVERRANGE
No
Yes
M
EXCESSIVE
MOTION
No
Yes
L
Excessive motion of
the patient’s arms
OVER
PRESSURE
No
Yes
M
The airway might be
blocked.
NIBP SYSTEM
FAILURE
No
Yes
M
NIBP TIME OUT
No
Yes
M
Failures occur in the
pulse measurement.
The monitor cannot
perform
measurement,
analysis, or
calculation.
NIBP RESET
ERROR
No
Yes
M
Failures occur in the
pulse measurement.
The monitor cannot
perform
measurement,
analysis, or
calculation. 。
Illegal reset during
NIBP measurement.
C-3
Check the patient’s
condition and verify
patient type. Replace
with a appropriate
cuff and connect it
correctly. If the
problem still exists,
contact our service
personnel for repair.
Check the airway and
take measurements
again. If the problem
still exists, contact
our service personnel
for repair.
C.2.3 Mindray DS SpO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Action
SPO2 SENSOR
OFF
No
Yes
*
The sensor is
disconnected from
the patient or the
monitor.
Make sure that the
sensor is placed at an
appropriate position
and the monitor is
connected to cables
correctly.
SPO2 LOW
PERFUSION
No
No
L
The pulse signal is
too weak.
Move the sensor to a
site with better
perfusion.
SPO2 NO SENSOR
No
Yes
L
SpO2 sensor is
detached from the
patient or monitor,
or SpO2 sensor is
not properly
connected.
Disconnect SpO2
sensor and reconnect
it as per instructions
for use. If the alarm
persists, SpO2 sensor
or cable may be
damaged.
SpO2 sensor is
reversely connected
Disconnect SpO2
sensor and reconnect
it as per instructions
for use. Pay attention
to the mark on the
sensor.
C-4
C.2.4 Masimo SpO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Action
SPO2 SENSOR
OFF
No
Yes
*
The sensor is
disconnected from
the patient or the
monitor.
Make sure that the
sensor is placed at an
appropriate position
and the monitor is
connected to cables
correctly.
SPO2 PULSE
SEARCH
No
No
L
The monitor is
searching for the
patient’s pulse
signal.
If the pulse reading is
not displayed after 30
seconds, check if the
sensor is properly
connected to the
patient. Change the
sensor site for better
signals if necessary.
SPO2
INTERFERENCE
No
No
L
The pulse signals
are subject to great
external
interference.
Reduce or remove
external interference.
SPO2 LOW
PERFUSION
No
No
L
The pulse signal is
too weak.
Move the sensor to a
site with better
perfusion.
SPO2 TOO MUCH
LIGHT
No
No
L
Too much light on
the sensor.
Turn down or off the
lighting, move the
sensor to a place of
weaker light or cover
the sensor.
UNKNOWN SPO2
SENSOR
No
No
L
The monitor cannot
recognize the SpO2
sensor type.
Check whether the
type of the sensor is
correct.
SPO2 BOARD
FAULT
No
No
H
The SpO2 board
malfunctions and
might not be able to
measure the pulse
signals correctly.
Stop using the SpO2
module, and contact
biomedical engineers
or us for
maintenance.
SPO2 SENSOR
FAULT
No
No
H
The sensor is
damaged.
Stop using the sensor.
C-5
SPO2 NO SENSOR
No
Yes
L
The sensor is
disconnected from
the patient or the
monitor, or the
sensor is not
properly connected.
Disconnect and
reconnect the sensor
as directed by the
instructions. If the
alarm remains, the
sensor or the cable
might have been
damaged.
SpO2 sensor is
reversed.
Disconnect and
reconnect the sensor
as directed by the
instructions. Pay
attention to the mark
on the sensor.
SPO2 WEAK
SIGNAL
No
No
L
The pulse signals
detected by the
monitor are of poor
quality.
Move the sensor to a
site with better
signals.
WRONG SPO2
SENSOR
No
No
L
The SpO2 sensor is
incompatible to the
monitor, or is
damaged.
Stop using the sensor.
C-6
C.2.5 Nellcor SpO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Action
SPO2 SENSOR
OFF
No
Yes
*
The sensor is
disconnected from
the patient or the
monitor.
Make sure that the
sensor is placed at an
appropriate position
and the monitor is
connected to cables
correctly.
SPO2 NO SENSOR
No
Yes
L
The sensor is
disconnected from
the patient or the
monitor, or the
sensor is not
connected properly.
Disconnect and
reconnect the sensor
as directed by the
instructions. If the
alarm remains, the
sensor or the cable
might have been
damaged.
SpO2 sensor is
reversed.
Disconnect and
reconnect the sensor
as directed by the
instructions. Pay
attention to the mark
on the sensor.
SPO2
INTERFERENCE
No
No
L
The pulse signals
are subject to great
external
interference.
Reduce or remove
external interference.
SPO2 BOARD
FAULT
No
No
H
The SpO2 board
malfunctions and
might be unable to
measure the pulse
signals correctly.
Stop using the SpO2
module, and contact
biomedical engineers
or us for
maintenance.
SPO2 SENSOR
FAULT
No
No
H
The sensor is
damaged.
Stop using the sensor.
SPO2 WEAK
SIGNAL
No
No
L
The SpO2 signal is
weak.
Change the sensor
site for better signals.
SPO2 WEAK
PULSE
No
No
L
The detected pulse
signal is too weak.
C-7
C.2.6 SmarTemp™ TEMP Module Alarm Messages
Alarm message
A
B
L
Cause
Action
WARMUP TIMED
OUT
Yes
Yes
M
TEMP probe initial
temperature is too high.
Cool the TEMP
probe before taking
measurement.
WARMING
RESISTOR ERR
No
No
M
The warming resistor in
the TEMP probe fails.
Replace the TEMP
probe.
TEMP PROBE
MISPLACED
Yes
Yes
M
TEMP probe is not
placed in the sheath or
the probe sheath is not
in place.
1. Check that the
probe sheath is in
place.
2. Replace the
TEMP probe in the
sheath properly.
ENV TEMP
OVERRANGE
No
Yes
M
The ambient
temperature is beyond
the measuring range.
Take measurement
in proper working
condition.
TEMP VOLTAGE
ERR
No
Yes
M
Supply voltage is too
high or too low.
Check the power
supply.
TEMP NO PROBE
No
Yes
M
The TEMP probe is
disconnected from the
TEMP module.
Reconnect the
probe with the
TEMP module.
TEMP
PREDICTION
ERR
Yes
Yes
L
Improper temperature
measurement
Take TEMP
measurement again
correctly.
TEMP SELFTEST
ERR
No
No
H
An error occurs during
the TEMP module
initialization
Replace the TEMP
module
TEMP PROBE
OFF
No
Yes
L
TEMP probe does not
contact with the patient.
Take measurement
again after the
probe warms up.
TEMP OVER
HIGH LIMIT
No
No
H
The temperature
measured is too high or
measurement error
Lower the
measured
temperature or
replace the TEMP
module.
TEMP OVER
LOW LIMIT
No
No
H
The temperature
measured is too low or
measurement error
Raise the measured
temperature or
replace the TEMP
module.
C-8
Alarm message
A
B
L
Cause
Action
TEMP WRONG
PROBE
No
No
H
A TEMP probe not
supplied by our
company is used.
Replace with a
TEMP probe we
supply.
TEMP COMM
ERR
No
No
H
TEMP module is not
available or TEMP
module fails
Check if a TEMP
module is
available. If yes,
replace the TEMP
module.
C.2.7 Recorder Module Alarm Messages
Alarm message
A
B
L
Cause
Action
RECORDER INIT
ERR N
Yes
No
M
An error occurs
during the recorder
initialization.
Contact the hospital’s
engineers or our
Customer Service.
Note: N represents the error number.
REC SELFTEST
ERR
Yes
No
M
An error might
occur to the RAM,
ROM and CPU
watchdog.
Restart the recorder.
If the error remains,
contact our service
personnel for repair.
RECORDER VLT
HIGH
No
No
H
RECORDER VLT
LOW
No
No
H
A problem occurs to
the system’s power
supply.
If this alarm message
occurs frequently,
contact our service
personnel for repair.
RECORDER
HEAD HOT
No
No
H
The thermal head of
the recorder is too
hot.
Resume the recording
after the recorder
cools down
completely. If the
problem still exists,
contact our service
personnel for repair.
REC HEAD
WRONG POS.
Yes
Yes
L
The thermal head of
the recorder is in
wrong position.
Restore the control
lever of the recorder
to its previous
position.
REC OUT OF
PAPER
Yes
Yes
L
The recorder paper
is used up.
Replace with a new
paper roll.
C-9
Alarm message
A
B
L
Cause
Action
RECORDER
PAPER JAM
No
No
M
The recorder has
recorded data on
paper for 30m long
or more.
Place the recorder
correctly and try
again.
RECORDER
COMM ERR
Yes
No
M
Error in recorder
communication.
TOO MANY REC
TASKS
No
No
M
Too many alarm
events occur at the
same time.
Clear recording tasks
and restart the
monitor. If the
problem remains,
contact our service
personnel for repair.
RECORDER
PAPER W.P.
Yes
Yes
M
The paper roll of the
recorder is not
placed in the correct
position.
REC S. COMM
ERR
Yes
No
M
Error in recorder
communication.
REC
NOT
AVAILABLE
No
No
M
Place the paper roll
correctly.
Clear recording tasks
and restart the
Error in the recorder monitor. If the
problem remains,
work mode.
contact our service
personnel for repair.
C-10
C.2.8 System Alarm Messages
Alarm message
A
B
L
Cause
Action
REAL CLOCK
NEED SET
No
No
H
The system time is
incorrect.
Reset the system time
and then restart the
monitor.
REAL CLK NOT
EXIST
No
No
H
There is no button
battery, or the
battery power is
depleted.
Install a button
battery or replace
with a new one.
NET INIT ERR (G.)
No
No
M
NET INIT ERR
(Ram)
No
No
M
Contact our service
personnel for repair.
NET INIT ERR
(Reg)
No
No
M
The monitor cannot
be connected to the
network due to
network problem.
NET ERR (Run 1)
No
No
M
NET ERR (Run 2)
No
No
M
12V TOO HIGH
No
No
H
12V TOO LOW
No
No
H
A problem occurs to
the system’s power
supply.
If this alarm message
occurs frequently,
contact our service
personnel for repair.
BATTERY TOO
LOW
No
No
H
The battery voltage
is too low.
Connect the monitor
to AC mains to
charge the battery.
DATAOUT FAIL
Yes
Yes
M
A failure occurs in
data transmission
during the data
output.
Re-output the data.
NET ERROR
Yes
Yes
M
The monitor is not
connected to the
network
Check the network
connection.
BARCODE ID
FAILED
Yes
No
L
Bar code format
cannot be decoded.
Enter patient ID
manually or use a
decodable bar code.
C-11
C.3 Prompt Messages
Prompt message
Cause
Action
SEARCH PULSE
The SpO2 module is searching the
pulse.
Wait till the end of the search.
SPO2 MOTION
SpO2 sensor is moving.
Eliminate sensor movement.
SPO2 Alarm Disabled
SpO2 alarm is switched off.
Switch on SpO2 alarm.
RECORDER BUSY
The recorder is recording data.
Wait till the end of the recording.
Manual measure...
The NIBP module is performing a
manual measurement.
Wait till the end of the
measurement.
Cont measuring...
The NIBP module is performing a
continuous measurement.
Auto measuring...
The NIBP module is performing
an automatic measurement.
NIBP Alarm Disabled
NIBP alarm is switched off.
Switch on NIBP alarm.
Resetting…
Module is resetting.
Wait till resetting is finished.
Please start
The interval for automatic
measurement has been selected.
Press
to start the
measurement.
Calibrating...
The NIBP module is being
calibrated.
Wait till the end of the
calibration.
Calibration over
The calibration is finished.
None
Testing leak...
The NIBP module is testing for
air leakage.
Wait till the end of test.
Pneum test over
The test for air leakage is
finished.
None
Measurement over
is pressed during
None
measurement to stop NIBP
measurement.
Reset failed
The NIBP module fails to be
reset.
None
TEMP Warming Up
TEMP module is warming up.
Wait till TEMP module
completes warmup.
TEMP
Ready
TEMP module completes
warming up and predictive
measurement can be performed
now.
Perform predictive TEMP
measurement.
Prediction
C-12
TEMP Prediction
Over
TEMP predictive measurement is
finished.
Check TEMP reading.
TEMP Measure Over
TEMP monitoring is over
Remove the TEMP probe from
patient and insert it in the probe
sheath.
OUTPUTTING...
Data are being output.
None
CONNECTING...
The monitor is connecting to the
PC software.
None
OUTPUT SUCCESS!
Data output is finished.
None
Server not exist
Sever is not installed.
Install the server.
AUDIO ALARM OFF
The alarm volume is set to 0.
Exit the audio alarm off status.
ALARM OFF
The SILENCE button is shortly
pressed.
Wait till alarm pause time is
reached or shortly press the
SILENCE button again.
CONFIGURATION
RESTORED
Last configuration is loaded
successfully.
None
FACTORY ##
CONFIG LOADED
## factory configuration is loaded
sucessfully.
None
USER ## CONFIG
LOADED
## user configuration is loaded
sucessfully.
None
C-13
FOR YOUR NOTES
C-14
D Factory Defaults
This section lists the most important factory default settings. These settings are not
user-adjustable. You can restore the factory default settings if necessary.
Note: Column A indicates whether the item is affected by factory or user configuration.
“√” represents that this item is affected by the configuration and user configuration will be
loaded first when the monitor is restarted; if the user configuration is unavailable, factory
configuration will be loaded.
“×” represents that this item is not affected by the configuration; the settings changed by
the user maintain when the monitor is powered off and will be loaded when the monitor is
restarted.
D.1 Patient Information
Patient Information
A
Factory Default Settings
PATIENT TYPE
×
ADU
D-1
D.2 System Setup
System Setup
A
Factory Default Settings
ALARM VOL
√
2
KEY VOL
√
0
PULSE VOL
√
0
LCD BRIGHT
×
8
LCD CONTRAST
×
6
NIBP UNIT
√
mmHg
TEMP TYPE
×
PREDICT
TEMP POSITION
×
ORAL
TEMP UNIT
√
℃
NET TYPE
×
CMS+
LOCAL NET NO.
×
1
IP ADDRESS
×
196.16.0.1
DATE FORMAT
×
DD-MM-YYYY
System date and time
×
0:0:0, 2005-01-01
QUICK ADMIT
×
ON
SPO2 SENSOR OFF
×
LOW
AUDIO OFF PROMPT
×
ON
MIN ALARM VOL
×
2
SELECT CONFIG
×
LAST CONFIG
BARCODE POWER
×
ON
LANGUAGE
×
ENGLISH
SIGNAL DURATION
×
CONTINUUM
SIGNAL TYPE
×
NORMAL OPEN
INTERVAL
√
MANUAL
REVIEW MODE
×
ALL
DELETE
×
Unselected, current trend data.
D-2
D.3 Alarm Limit
Mindray DS SpO2
A
Adult
Pediatric
Neonate
SpO2 HI
√
100
100
95
SpO2 LO
√
90
90
90
PR HI
√
120
160
200
PR LO
√
50
75
100
Masimo SpO2
A
Adult
Pediatric
Neonate
SpO2 HI
√
100
100
95
SpO2 LO
√
90
90
90
PR HI
√
120
160
200
PR LO
√
50
75
100
Nellcor SpO2
A
Adult
Pediatric
Neonate
SpO2 HI
√
100
100
95
SpO2 LO
√
90
90
90
PR HI
√
120
160
200
PR LO
√
50
75
100
NIBP
A
Adult
Pediatric
Neonate
SYS HI
√
160
120
90
SYS LO
√
90
70
40
MEAN HI
√
110
90
70
MEAN LO
√
60
50
25
DIA HI
√
90
70
60
DIA LO
√
50
40
20
PR HI
√
120
160
200
PR LO
√
50
75
100
D-3
FOR YOUR NOTES
D-4
E Symbols and Abbreviation
E.1 Units
A
ampere
Ah
ampere hour
bpm
beats per minute
℃
centigrade
cm
centimeter
dB
decibel
℉
fahrenheit
g
gram
hr
hour
Hz
hertz
inch
inch
k
kilo
kg
kilogram
kPa
kilopascal
l
litre
lb
pound
m
meter
mg
milligrams
min
minute
ml
milliliter
mm
millimeters
mmHg
millimeters of mercury
ms
millisecond
mV
millivolt
mW
milliwatt
nm
nanometer
E-1
s
second
V
volt
VA
volt ampere
Ω
ohm
µA
microampere
µm
micron
µV
microvolt
W
watt
E.2 Symbols
-
minus
%
percent
/
per; divide; or
~
to
^
power
+
plus
=
equal to
<
less than
>
greater than
≤
less than or equal to
≥
greater than or equal to
±
plus or minus
×
multiply
©
copyright
E-2
E.3 Abbreviations
AAMI
Association for Advancement of Medical
Instrumentation
AC
alternating current
ADT
adult
ANSI
American National Standard Institute
AUX
Auxiliary output
BTPS
Body temperature and pressure, Saturated
CH
channel
CISPR
International Special Committee on Radio Interference
CMS
central monitoring system
cmos
Complementary Metal Oxide Semiconductor
CPU
central processing unit
DC
direct current
D, DIA
diastolic
EEC
European Economic Community
EMC
electromagnetic compatibility
err
error
fpga
Field Programmable Gate Array
Hb-CO
Carbonmonoxide hemoglobin
HT
height
IEC
International Electrotechnical Commission
ISO
International organization for standardization
LED
light emitting diode
Loop
loop read-write test fail
M, MAP
Mean arterial pressure
MDD
Medical Device Directive
MetHb
methemoglobin
Mii
initialize MII registers fail
E-3
MRI
magnetic resonance imaging
N/A
not applied
NIBP
noninvasive blood pressure
ND
NM
——
NS
oxyCRG
Oxygen Cardio-respirogram
P
power
PD
photodetector
PLETH
plethysmogram
PR
pulse rate
RAM
random access memory
Reg
test NE2000 registers fail
ROM
read-only memory
SpO2
arterial oxygen saturation from pulse oximetry
S, SYS
systolic pressure
TEMP
temperature
VGA
Video Graphic Array
E-4
Mindray DS USA, Inc.
800 MacArthur Blvd.
Mahwah, New Jersey 07430
USA
Tel:1.800.288.2121
Tel:1.201.995.8000
Fax:1.800.926.4275
www.mindray.com
P/N: 046-000178-00(5.0)
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