For this Operator’s Manual, the issue date is March 2010..
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Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
called Mindray) owns the intellectual property rights to this Mindray product and this
manual. This manual may refer to information protected by copyright or patents and
does not convey any license under the patent rights or copyright of Mindray, or of
others.
Mindray 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 is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any
other derivative work of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
, and are the trademarks, registered or
otherwise, of Mindray in China and other countries. All other trademarks that appear
in this manual are used only for informational or editorial purposes. They are the
property of their respective owners.
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Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be
liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this
product, only if:
all installation operations, expansions, changes, modifications and repairs of
this product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable
national and local requirements;and
the product is used in accordance with the instructions for use.
WARNING
z It is important for the hospital or organization that employs this
equipment to carry out a reasonable service/maintenance plan. Neglect of
this may result in machine breakdown or personal injury.
NOTE
z This equipment must be operated by skilled/trained clinical professionals.
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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'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 or repairs by people other than Mindray
authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified
orunauthorized service people.
Malfunction of the instrument or part whose serial number is not legible
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
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FOR YOUR NOTES
VI
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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 pulse oximeter.
Password
Password is required to access maintenance. The password is 321.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
[ ] is used to enclose screen texts.
→ is used to indicate operational procedures.
z Indicates an imminent hazard that, if not avoided, will result in death or
serious injury.
WARNING
z Indicates a potential hazard or unsafe practice that, if not avoided, will
result in death or serious injury.
CAUTION
z Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
NOTE
z Provides application tips or other useful information to ensure that you
get the most from your product.
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1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements
may be given in the respective sections of this manual.
1.1.2 Warnings
WARNINGS
z Before putting the system into operation, verify that the equipment,
connecting cables and accessories are in correct working order and
operating condition.
z To avoid explosion hazard, do not use the equipment in the presence of
flammable anesthetics, vapors or liquids.
z Do not open the equipment housings; electric shock hazard may exist.
All servicing and future upgrades must be carried out by the personnel
trained and authorized by our company only.
z When using the equipment with electrosurgical units (ESU), make sure
the patient is safe.
z Do not come into contact with the patient during defibrillation.
Otherwise serious injury or death could result.
z 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.
z The physiological data and alarm messages displayed on the equipment
are for reference only and cannot be directly used for diagnostic
interpretation.
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z To avoid inadvertent disconnection, route all cables in a way to prevent a
stumbling hazard. Wrap and secure excess cabling to avoid risk of
entanglement or strangulation by patients or personnel.
1.1.3 Cautions
CAUTIONS
z To ensure patient safety, use only parts and accessories specified in this
manual.
z At the end of its service life, the equipment, 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 equipment, please contact us.
z Magnetic and electrical fields are capable of interfering with the proper
performance of the equipment. For this reason make sure that all
external devices operated in the vicinity of the equipment 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.
z Before connecting the equipment to the power line, check that the voltage
and frequency ratings of the power line are the same as those indicated
on the equipment’s label or in this manual.
z Always install or carry the equipment properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
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1.1.4 Notes
NOTES
z Put the equipment in a location where you can easily see the screen and
access the operating controls.
z Keep this manual in the vicinity of the equipment so that it can be
obtained conveniently when needed.
z The software was developed in compliance with IEC60601-1-4. The
possibility of hazards arising from software errors is minimized.
z This manual describes all features and options. Your equipment may not
Mark of conformity to European Medical Device Directive
93/42/EEC
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.
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2 The Basics
2.1 Introduction
2.1.1 Intended Use
The pulse oximeter is intended for continuously monitoring, spot checking, displaying,
storing and transferring oxygen saturation and pulse rate of single adult, pediatric and
neonatal patients in hospitals, emergency treatment, patient transport and home care.
WARNING
z This pulse oximeter 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.
2.1.2 Contraindications
None.
2.1.3 Components
This pulse oximeter consists of a main unit and an SpO2 sensor.
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2.2 Main Unit
2.2.1 Front View
6
5
1. Display screen
2. Power button
Press this button to turn the pulse oximeter on after the batteries are installed.
Press and hold it for 2 seconds to turn the pulse oximeter off.
3. Power indicating lamp
It is a LED that lights green and yellow. The status of the LED is specified as
follows:
4
1
8
7
2
9
3
10
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Green: when the pulse oximeter is placed in the Charger stand and the AC
mains is connected, or when the battery is fully charged if a lithium
battery is used.
Yellow: when a lithium ion battery is used and is being charged.
Off: When the AC mains is not connected.
4. Alarm indicating lamp
When an alarm occurs, this lamp will light up as defined below:
High level alarms: the lamp quickly flashes red.
Medium level alarms: the lamp slowly flashes yellow.
Low level alarms: the lamp lights yellow without flashing.
5. Press this button to pause or reactivate the alarm sound.
6. Left button
Press this button to enter the main menu or select the highlighted menu item.
7. Right button
Press this button to return to the previous menu or exit the current menu. In the
case that no menu is opened, you can press and hold this button for 2 seconds to
lock or unlock buttons except the Power button.
8. Up button
Press this button to move the cursor upwards, increase the value of selected menu
item or raise the beat volume.
9. Down button
Press this button to move the cursor downwards, decrease the value of selected
menu item or lower the beat volume.
10. Power supply connector
It is used to connect the Charger stand.
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2.2.2 Rear View and Right View
2
4
3
1. Multifunctional connector
It is used to connect an SpO
personal computer through a PC communication cable to export the trend data.
2. Speaker
3. Battery door
4. Cord hole
5. Infrared port
It is a port through which a personal computer is communicated to export data in
real time.
sensor to measure the oxygen saturation or connect a
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2.3 Display Views
The following figures show the layout of the wave screen and the normal screen.
2
3
4
5
2
6
1
Wave screen Normal screen
1. Waveform Area
This area displays Pleth waveform (Pleth). The label of this waveform is shown at
the top left corner.
2. SpO
3. Technical alarm area
This area shows the technical alarm message, prompt message and the pulse
4. Alarm status area
area
2
oximeter’s operating mode. When multiple messages come, they will be displayed
circularly.
indicates that alarm sounds are paused;
indicates that alarm sounds are turned off.
5
7
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5 PR area
6. Physiological alarm area
This area shows physiological alarm messages. When multiple alarms come, they
will be displayed circularly.
7. Information area
8. QuickKeys area
This area contains QuickKeys that give you fast access to functions.
1.3.1 SpO2 Area
1
2
3
4
1. SpO
2. SpO
3. SpO
4. SpO
label
2
unit
2
high alarm limit
2
low alarm limit
2
5. Oxygen saturation reading
6. Pleth bar
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2.3.2 PR Area
1
2
3
4
1. PR label
2. PR unit
3. PR high alarm limit
4. PR low alarm limit
5. Pulse rate reading
5
2.3.3 Information Area
1. Patient ID
2. Patient category
Patients are classified into three categories: adults, pediatrics and neonates.
3. Real-time data exporting symbol
This symbol appears when data is being exported in real-time through the infrared
port.
4. Battery symbol
5. Real-time clock
123
4
5
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FOR YOUR NOTES
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3 Getting Started
3.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any
damage is detected, contact the carrier.
If the packing case is intact, open the package and remove the equipment and
accessories carefully. Check all materials as per the packing list and check for any
mechanical damage. Contact us in case of any problem.
NOTE
z Save the packing case and packaging material as they can be used if the
equipment must be reshipped.
WARNING
z Keep the packing material out of children’s reach. Disposal of the
packaging material should observe the applicable waste control
regulations.
z The equipment might be contaminated during storage and transport.
Before use, please verify whether the packages, especially the packages of
the single use accessories, are intact. In case of any damage, do not apply
it to the patient.
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3.2 Environmental Requirements
The operating environment of the equipment must meet the requirements specified in
this manual.
When the equipment is moved from one place to another, condensation may occur as a
result of temperature or humidity difference. In this case, never start the system before
the condensation disappears.
WARNING
z Make sure that the operating environment of the equipment meets the
specific requirements. Otherwise the equipment may not meet the
specifications claimed in this manual and unexpected consequences, e.g.
damage to the equipment, could result.
3.3 Starting the Pulse oximeter
1. Before use, check the pulse oximeter for mechanical damage.
2. Install the alkaline batteries or the lithium ion battery and ensure that the batteries
have sufficient power.
3. Plug the SpO
4. Press the Power button. The alarm indicating lamp flashes, and then goes out. The
system gives a beep and displays the startup screen.
5. The startup screen disappears and the pulse oximeter enters the main screen.
extension cable into the multifunctional connector.
2
NOTE
z If the pulse oximeter has not used for a prolonged time, a technical alarm
[Clock Need Set] may occurs when the pulse oximeter is started. In this
case, set the clock. In the continuous monitoring mode, changing the
clock may clear the trend data of this mode.
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WARNING
z Do not use the pulse oximeter for patient monitoring if it is mechanically
damaged or appears abnormal. Contact your service personnel or us.
3.4 Shutting Off the Pulse oximeter
To shut off the pulse oximeter,
1. Confirm that the patient monitoring is finished.
2. Disconnect the SpO
3. Press and hold the Power button for 2 seconds.
extension cable from the pulse oximeter.
2
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FOR YOUR NOTES
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4 Basic Operations
4.1 Selecting the Work Mode
The pulse oximeter is designed to operate in the continuous monitoring and
spot-checking mode. The continuous monitoring mode is intended for long-term
monitoring. This mode is normally selected when the patient is in hospital or under
transport. The spot-checking mode is intended for short-term on-site measurement. This
mode is normally selected to check outpatient or to check inpatient when doctors make
2. Select [User Maintenance >>] and then select [Work Mode] to toggle between
[Spot-Check] and [Continuous]. Press the Right button and follow the prompt.
The work mode is shown in the technical alarm area. When other technical alarms or
prompt messages occur, the work mode and the message will be displayed circularly.
NOTE
z The trend data of the continuous monitoring mode will be cleared if you
change the continuous monitoring mode to the spot-checking mode.
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4.2 Admitting a Patient
WARNING
z Be sure to select correct patient category setting for your patient before
measurement. Wrong patient category may result in patient hazard due
to improper alarm limits.
4.2.1 Continuous Monitoring Mode
In the continuous monitoring mode, to admit a patient,
1. Select [Menu]→[Patient Info.].
2. Set up [Patient ID] and [Patient Cat.].
3. Press the Left button to confirm the settings.
If you do not change the patient ID for a new patient, the patient will not be admitted.
4.2.2 Spot-checking Mode
In the spot-checking mode, to admit a patient,
1. Select [Menu]→[Patient Info.].
2. Select [Patient Cat.] and toggle between [Adu], [Ped] and [Neo].
3. Apply the SpO
The patient ID automatically changes to 1 if the current patient ID is 0. Thus
the patient is admitted.
The patient ID flashes and automatically increases by 1 after 8 seconds if the
current patient ID is not 0. Thus the patient is admitted.
If you press the Left button when the current patient ID is flashing, the patient ID will
stop flashing and remain unchanged. The patient will not be admitted and new
measurements will be stored under the current patient ID.
sensor to the patient. After valid SpO2 signals are detected,
2
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4.3 Selecting the Screen
To select a screen to be viewed,
1. Select [Menu]→[System].
2. Select [Screen] and toggle between [Normal] and [Wave].
4.4 Adjust the Screen Brightness
To adjust the screen brightness,
1. Select [Menu]→[General Setup].
2. Adjust [Brightness]: You can set the screen brightness to a value between 1 and
10. 1 is the minimum brightness and 10 the maximum. If the pulse oximeter runs
on batteries, choose a lower level brightness to save the power.
NOTE
z If the the pulse oximeter is used outdoors or the ambient light is strong,
set the screen brightness to a higher level.
4.5 Changing the Language
To change the pulse oximeter’s operating language,
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. In the [User Maintenance >>] menu, select [Language] and then choose a desired
language.
3. Restart the pulse oximeter.
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4.6 Setting the Clock
To set the clock,
1. Select [Menu]→[System]→[Clock >>].
2. Set [Date] and [Time].
3. Select [Format >>]. In the [Format] menu,
Set [Date Format] to [yyyy-mm-dd], [mm-dd-yyyy] or [dd-mm-yyyy].
Set [Time Format] to [24 h] or [12 h].
4 Press the Right button to return to the previous menu in the spot-checking mode, or
press the Right button and follow the prompt in the continuous monitoring mode.
NOTE
z In the continuous monitoring mode, trend data of this mode may be
cleared if you change the clock.
4.7 Adjusting the Volume
4.7.1 Setting the Beat Volume
To set the beat volume,
1. Select [Menu]→[General Setup].
2. Set [Beat Vol] to a value between 0 and 10. 0 means the beat volume is turned off,
and 10 is the maximum volume. When [Beat Vol] is set to 0, the icon
shown in the PR area.
You can increase/decrease the beat volume by pressing the Up/Down button in the case
that no menu is opened.
During SpO
saturation level changes. The pitch of the tone rises as the oxygen saturation level
increases and falls as the oxygen saturation level decreases.
monitoring, the pitch of the pulse tone changes as the patient’s oxygen
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4.7.2 Setting the Key Volume
To set the key volume,
1. Select [Menu]→[General Setup].
2. Set [Key Vol] to a value between 0 and 10. 0 means the key volume is turned off,
and 10 is the maximum volume.
4.8 Entering/Exiting the Demo Mode
To enter the demo mode:
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [Demo] and follow the prompt.
In the demo mode, the message [Demo Mode] is shown in the technical alarm area. To
exit the demo mode, press the Right button to return to the screen displayed before you
enter the demo mode.
WARNING
z The Demo mode is for demonstration purpose only. To avoid that the
simulated data are mistaken for the monitored patient’s data, you should
not enter the Demo mode during a patient is being monitored. Otherwise,
improper patient monitoring and delayed treatment could result.
4.9 Checking the Version
To check the version information,
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [Version >>].
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4.10 Entering/Exiting the Standby Mode
4.10.1 Entering the Standby Mode
In the spot-checking mode, in situations where reviewing or exporting trend data is not
performed, the pulse oximeter will automatically enter the standby mode if no button
operation and SpO2 signal are detected for 1 minute and no "Battery Too Low" alarm
occurs. In the standby mode,
The backlight is turned off.
The standby screen is displayed.
Alarms excetp the “Battery too Low” alarm are disabled.
In the standby mode, if the “Battery too Low” alarm occurs, the system gives an audible
If you exit the standby mode at this time, the “Battery too Low” alarm will be given in
the form of techinical alarm.
4.10.2 Exiting the Standby Mode
In the standby mode, if the SpO2 signal is detected or any button except the Power
button is pressed, the pulse oximeter will automatically exit the standby mode and
return to the previous mode.
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4.11 Setting Auto Poweroff
In the spot-checking mode, you can select to shut off the pulse oximeter automatically:
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [User Maintenance >>], and then select [Auto Quit] to toggle between:
[Allowed]: The pulse oximeter will shut down automatically if no button
operation and SpO
[Unallowed]: The pulse oximeter will not shut down if no button operation
and SpO
signal are detected for 5 minutes in the standby mode.
2
signal are detected for 5 minutes in the standby mode.
2
4.12 Configuration
The pulse oximeter provides factory configuration and user configuration. The
configuration is loaded and saved according to the operating mode and patient category.
and PR alarm limits are subject to the patient category. The user configuration will
SpO
2
be loaded first when the pulse oximeter is started. If the user configuration is not
available, corresponding factory configuration will be loaded. Refer to C Factory Defaults.
4.12.1 Restoring the Factory Configuration
If you have changed the system’s configuration and want to restore the factory
configuration, follow this procedure:
1. Select [Menu]→[System].
2. Select [Load Conf. >>] →[Load Factory Conf.].
The factory configuration will be restored according to the current work mode and
patient category.
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4.12.2 Saving the User Configuration
You can change the pulse oximeter’s settings and save the changed settings as user
configuration.
To save the user configuration,
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [User Maintenance >>]→[Save as User Conf.].
The user configuration will be saved according to the current work mode and patient
category.
4.12.3 Loading the User Configuration
To call the saved user configuration,
1. Select [Menu]→[System].
2. Select [Load Conf. >>] →[Load User Conf.].
The system will select an appropriate user configuration according to the current work
mode and patient category. If the user configuration of this type is not available,
corresponding factory configuration will be restored.
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5 Alarms
Alarms, triggered by a vital sign that appears abnormal or by technical problems of the
pulse oximeter, are presented to the user by visual and audible alarm indications.
5.1 Alarm Categories
By nature, the pulse oximeter’s alarms can be classified into three categories:
physiological alarms, technical alarms and prompt messages.
1. Physiological alarms
Physiological alarms, also called patient status alarms, are triggered by a monitored
parameter value that violates set alarm limits or an abnormal patient condition.
Physiological alarm messages are displayed in the physiological alarm area.
2. Technical alarms
Technical alarms, also called system status alarms, are triggered by a device
malfunction or a patient data distortion due to improper operation or system
problems. Technical alarm messages are displayed in the technical alarm area.
3. Prompt messages
As a matter of fact, prompt messages are not alarm messages. Apart from the
physiological and technical alarm messages, the pulse oximeter will show some
messages telling the system status. Prompt messages are displayed in the technical
alarm area.
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5.2 Alarm Levels
By severity, the pulse oximeter’s physiological alarms can be classified into three
categories: high level alarms, medium level alarms and low level alarms.
1. High level alarms
Indicate that the patient is in a life threatening situation and an emergency
treatment is demanded.
2. Medium level alarms
Indicate that the patient’s vital signs appear abnormal and an immediate treatment
is required.
3. Low level alarms
Indicate that the patient’s vital signs appear abnormal and an immediate treatment
may be required.
The pulse oximeter’s technical alarms can be classified into three categories: high level
alarms, medium level alarms and low level alarms.
The levels for some technical alarms and physiological alarms are predefined before the
pulse oximeter leaves the factory and cannot be changed.
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5.3 Alarm Indicators
When an alarm occurs, the pulse oximeter will indicate it through the following
indications:
Alarm lamp
Alarm tone
Alarm message
For different alarm levels, the alarm lamp, alarm tone and alarm messages presented are
different.
5.3.1 Alarm Lamp
If a technical or a physiological alarm occurs, the alarm lamp will flash. The flashing
color and frequency match the alarm level 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.
5.3.2 Alarm Tones
When a technical or a physiological alarm occurs, the pulse oximeter presents different
alarm tone patterns to match the alarm level:
High level alarms: triple + double + triple + double beep
Medium level alarms: triple beep.
Low level alarms: single beep.
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5.3.3 Alarm Messages
When an alarm occurs, an alarm message will appear in the technical or physiological
alarm area.
For physiological alarms, the asterisk symbols (*) before the alarm message match the
alarm level as follows:
High level alarms: ***
Medium level alarms: **
Low level alarms: *
Additionally, the system uses different background colors for the alarm message to
match the alarm level:
High level alarms: red
Medium level alarms: yellow
Low level alarms: yellow
NOTE
z When multiple alarms of different levels occur simultaneously, the pulse
oximeter will select the alarm of the highest level and give visual and
audible alarm indications accordingly. Alarm messages will be presented
circularly.
5.3.4 Alarm Status Symbols
Apart from the aforementioned alarm indicators, the pulse oximeter still uses the
following symbols telling the alarm status:
indicates the alarm sound is paused.
indicates the alarm sound is turned off.
indicates individual measurement alarms are turned off.
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5.4 Alarm Tone Configuration
5.4.1 Setting the Minimum Alarm Volume
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [Alarm >>] and then select [Min. Alm Vol]. Choose a value between 0 and
10. in which 0 is the minimum volume and 10 the maximum.
Minimum alarm volume decides the minimum value to be set for the alarm volume,
which is not affected by user or factory default configurations. The setting of the
minimum alarm volume remains unchanged when the pulse oximeter is shut down and
restarted.
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5.4.2 Changing the Alarm Volume
1. Select [Menu]→[General Setup].
2. Select [Alm Vlm] and then select a volume between X and 10. X is the minimum
volume which depends on the setting of the minimum alarm volume, and 10 the
maximum volume.
When alarm volume is set to 0, the alarm sound is turned off and a
appears in the alarm status area. In the case that alarm sound is switched off, the alarm
lamp remains lit and alarm message remains presented. The audible alarm is reactivated
automatically when:
The pulse oximeter is shut down and restarted;
The factory configuration is loaded;
The user configuration is loaded.
When a factory or user configuration is selected, the alarm volume of the pulse oximeter
may be lower than the minimum alarm volume. In this case, the alarm volume is
automatically adjusted according to the minimum alarm volume.
WARNING
z When the alarm sound is switched off, the pulse oximeter will give no
audible alarm tones even if a new alarm occurs. Therefore the user
should be very careful about whether to switch off the alarm sound or
not.
z Do not rely exclusively on the audible alarm system for patient
monitoring. Adjusting alarm volume to a low level may result in a hazard
to the patient. Always keep the patient under close surveillance.
symbol
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5.4.3 Pausing the Alarm Tones
To pause the alarm tones, press the key. In this case,
The audible alarm is paused, but the alarm lamp remains lit and the alarm
message remains displayed;
The remaining alarm pause time is displayed in the alarm status area;
The
Audible alarm starts again automatically after the alarm pause period expires. You can
also press the
automatically when:
The pulse oximeter is shut down and restarted.
The pulse oximeter is switched to a new operating mode
The pulse oximeter enters or exits the standby mode
The pulse oximeter enters or exits the demo mode.
Alarm pause time can be adjusted and the default is 2 minute. To change the alarm
pause time,
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [Alarm >>] and then set [Audio Paused] to an appropriate time.
symbol is displayed in the alarm status area.
key to restart the audible alarm. The audible alarm is reactivated
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5.5 Setting the Alarm Level
The levels of all technical alarms except [Sensor Off] are predefined before the pulse
oximeter leaves the factory. To set the alarm level of [Sensor Off],
1. Select [Menu]→[Alarm Setup];
2. Select [Sensor Off] and choose a desired alarm level.
If you enter the demo mode after the [Sensor Off] alarm occurs, the alarm will be
presented in the form of prompt message when you exit the demo mode.
In the continuous monitoring mode, the alarm level of [Sensor Off] can be set to [High],
[Med] or [Low]. If theSpO
pulse oximeter will present [Sensor Off] in the form of prompt message.
In the spot-check mode, the alarm level of [Sensor Off] can be set to [High], [Med],
[Low] or [Off].
If the [Sensor Off] alarm is not switched off, the pulse oximeter will present
the alarm in the form of prompt message in the case that the SpO
off before an effective SpO
If the pulse oximeter enters the standby mode after the [Sensor Off] alarm
occurs, it will present the alarm in the form of prompt message when the
standby mode is exited.
sensor falls off before a valid SpO2 signal is obtained, the
2
sensor falls
2
signal is obtained.
2
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5.6 Switching On/Off the Reminder Tone
When the alarm volume is set to 0, the pulse oximeter gives a reminder tone of two
beeps every three minutes if reminder tone is switched on.
To switch on or off the reminder tone,
1. Select [Menu]→[System]→[Maintenance >>]→enter the required password.
2. Select [Alarm >>] → [Reminder Tone], and toggle between [On] and [Off].
The reminder tone is switched off by default. The setting of the reminder tone is saved
even if the pulse oximeter is turned off.
5.7 When an Alarm Occurs
When an alarm occurs, observe the following steps to take proper actions:
1. Check the patient’s condition.
2. Confirm the alarming parameter or alarm category.
3. Identify the source of the alarm.
4. Take proper action to eliminate the alarm condition.
5. Make sure the alarm condition is corrected.
For troubleshooting specific alarms, see appendix D Alarm Messages.
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FOR YOUR NOTES
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6 Measuring SpO
2
6.1 Introduction
measuring is a non-invasive technique used to measure the amount of oxygenated
SpO
2
haemoglobin and pulse rate by measuring the absorption of selected wavelengths of
light. The light emitted by a red and infrared light-emitting diodes passes through the
tissue and is converted into electrical signals by a photodiode. This device is calibrated
to display functional oxygen saturation.
2
1
The pulse oximeter provides:
1. Pleth waveform (Pleth): The waveform is normalized.
2. Oxygen saturation of arterial blood (SpO
hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin.
3. Pulse rate (PR): It is the pulsations per minute derived from the Pleth wave.
4. Pleth bar: The number of segments indicates the pulse strength.
): It is the percentage of oxygenated
2
3
4
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6.2 Safety
WARNING
z Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s
instructions for use and adhere to all warnings and cautions.
z Check the SpO
Do not use the sensor if any damage is detected.
z When a trend toward patient deoxygenation is indicated, blood samples
should be analyzed by a laboratory co-oximeter to completely understand
the patient’s condition.
z Do not use the pulse oximeter and the SpO
resonance imaging (MRI). Induced current could cause burns.
z 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. Change the application site every four hours. For
neonates or patients with poor peripheral blood circulation or sensitive
skin, inspect the sensor site more frequently.
z As with electrosurgical unit, carefully route patient cabling to avoid
entanglement.
z Do not use the SpO
arterial catheter in place.
z Do not use the SpO
may result in inaccurate SpO
cuff inflation.
z Do not apply the equipment to a patient younger than one year old if the
operating temperature is higher than 40℃. This may lead to skin burn.
sensor and its package for any sign of damage before use.
2
sensor during magnetic
2
sensor on a limb with an intravenous infusion or
2
sensor on a limb where the NIBP cuff is applied. This
2
reading due to blocked blood flow during
2
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6.3 Applying the Sensor
1. Select an appropriate SpO
2. Remove colored nail polish from the application site.
3. Apply the SpO
4. Connect the SpO
sensor to the patient.
2
2
sensor according to the patient category and weight.
2
extension cable to the pulse oximeter.
6.4 Changing SpO2 Settings
6.4.1 Switching On/Off SpO2 and PR Alarms
1. Select [Menu]→[Alarm Setup].
2. Select SpO
[On]: When an alarm limit is exceeded, the pulse oximeter will give an alarm
[Off]: When an alarm limit is exceeded, the pulse oximeter will not give an
or PR [Alarm] and toggle between:
2
according to the defined alarm level.
alarm; the audible and visible alarm as well as the alarm message will be
[On]: Alarm limits are displayed in the SpO2 and PR area.
[Off]: Alarm limits are not displayed in the SpO2 and PR area.
6.4.5 Setting SpO2 Sensitivity
The SpO2 reading is the average of data collected within a specific time. The shorter the
averaging time is, the quicker the pulse oximeter responds to the changes in the patient’s
oxygen saturation level. Contrarily, the longer the averaging time is, the slower the
pulse oximeter responds to the changes in the patient’s oxygen saturation level, but the
measurement accuracy will be improved. When a critical patient is monitored, selecting
shorter averaging time will help understanding the patient’s state.
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To set the SpO
sensitivity,
2
1. Select [Menu]→[General Setup].
2. Set [Sensitivity] to [High], [Med] or [Low], whose averaging time is respectively
7 seconds, 9 seconds and 11 seconds.
6.5 Measurement Limitations
If you doubt the SpO
pulse oximeter and SpO2 sensor. The following factors may influence the accuracy of
measurements:
Ambient light
Physical movement (patient or 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
Drop of arterial blood flow to unmeaurable level due to shock, anemia, low
temperature or vasoconstrictor.
measurements, check the patient’s vital signs first. Then check the
2
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FOR YOUR NOTES
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7 Data Management
7.6 Storing data
NOTE
z The stored data will not be cleared in case of power failure or power off.
z It's recommended to export the data before the memory is filled up.
7.6.1 Continuous Monitoring Mode
In the continuous monitoring mode, the data, including the measurement time, oxygen
saturation and pulse rate values, are stored once every 2 seconds. The pulse oximeter
can store up to 96 hours of data for a single patient.
In the continuous monitoring mode,
The initial patient ID is 1 when the pulse oximeter is used for the first time.
The range of patient ID is 1 to 99 and you have to change the patient ID
manually when a new patient is admitted.
The patient ID remains unchanged after all data is cleared in the trend
window.
The patient ID selected before the pulse oximeter is last turned off is
automatically loaded when you start the pulse oximeter.
During continuous patient monitoring,
The measurements are stored under the current patient ID as long as the
patient ID is not changed.
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If the patient ID is changed, a new patient is considered to be admitted and the
new measurements will be stored under the new patient ID. The data under
the old patient ID will be cleared.
When the memory is filled up, the oldest data will be overwitten by the new data.
7.6.2 Spot-checking Mode
In the spot-checking mode, the data are stored once every 30 seconds. The stored data
include all the average oxygen saturation and pulse rate values measured during this
period. The pulse oximeter can store up to 4000 groups of data for 99 patients.
In the spot-checking mode,
The initial patient ID is 0 when the pulse oximeter is used for the first time.
The range of the patient ID is 1 to 99.The patient ID will automatically
increase by 1 if a new patient is admitted.
As the patient ID reaches 99, the patient ID will turn to 1 if a new patient is
admitted.
In the trend window, the patient ID will be restored to 0 after all data is
cleared.
The patient ID set before the pulse oximeter is last turned off will be loaded
automatically when the pulse oximeter is started.
During spot checking,
The measurements are stored under the current patient ID as long as the
patient ID is not changed.
If the patient ID is changed, a new patient is considered to be admitted and the
new measurements will be stored under the new patient ID. Data of the old
patients will not be cleared unless the memory is filled up.
If the data are stored under multiple patient IDs, all the data under the oldest patient ID
will be cleared when the memory is filled up. If the data is stored under one patient ID,
the earliest data will be overwritten by the new one when the memory is filled up.
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7.7 Reviewing Trend Data
The patient’s history physiological data can be stored and displayed in the form of a
trend table. Reviewing the trend data helps you to understand changes in the patient
condition.
7.7.1 Continuous Monitoring Mode
In the continuous monitoring mode, you can perform patient monitoring with the trend
window opened.
To open the trend window, select [Menu]→[Trend].
In the trend window, SpO
and the blank lines indicate that the pulse oximeter is shut off during that period.
In the trend window, you can
Press the Up or Down button to page up or down, or press and hold the Up or
Down button for 1 second to speed paging up or down.
Press the Left button to enter the [Trend Setup] menu. In the [Trend Setup]
menu, you can
and PR readings beyond the alarm limits are displayed in red
2
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Adjust [Interval]: The minimum interval is 2 seconds.
Select [Start Time >>] to set the [Date] and [Time] from which you
want to review.
Select [Delete All] to delete all the trend data under the current patient
ID.
Press the Right button to exit the trend window.
7.7.2 Spot-checking Mode
In the spot-checking mode, the pulse oximeter will stop measuring the patient if you
open the trend window. A patient cannot be admitted with the trend window opened.
To open the trend window, select [Menu]→[Trend].
In the trend window, SpO
If you have changed the system time before entering the trend window, the trend data
time before the system time is changed remains unchanged.
In the trend window, you can
Press the Up or Down button to page up or down, or press and hold the Up or
Down button for 1 second to speed paging up or down.
and PR readings beyond the alarm limits are displayed in red.
2
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Press the Left button to enter the [Trend Setup] menu. In the [Trend Setup]
menu, you can
Select [Select ID] to review the history data as well as the maximum,
minimum and average measurements of the selected paitent.
Select [Delete Selected] to delete the trend data under the selected
patient ID.
Select [Delete All] to delete the trend data under all patient IDs.
Press the Right button to exit the trend window.
7.8 Data Exporting
7.8.1 Real-time Exporting
During SpO2 measuring, you can export the data in real-time through the infrared port.
To do so, follow this procedure:
1. Select [Menu]→[System].
2. Select [RT Export] and toggle between [Start] and [Stop].
When the data is being exported in real-time, the symbol
information area. You can enter the trend exporting window when data is being exported
in real-time. In this case, real-time data exporting will stop automatically. If you need to
export the real-time data again, manually adjust [RT Export] to [Start].
The real-time data transmission protocol has the following features:
The baud rate is 9600;
The data frame format is one start bit plus eight data bits plus one stop bit;
The data sending rate is 1 Hz and the packet head is F1H.
will be shown in the
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The real-time data transmission protocol has 6 bytes as listed in the table below:
Byte 1 Byte 2 Byte 3 Byte 4 Byte 5 Byte 6
Packet
head
Byte 1 is the packet head whose value is 0xF1. The structure of Byte 1 is:
The structure of Byte 2 is:
Bit 7 to 4 is the module type code; Bit 3 to 0 is the checksum which is the sum of the
last 4 bits of Byte 3, Byte 4, Byte 5 and Byte 6.
The structure of Byte 3 is:
The structure of Byte 4 is:
SP is the pulse searching label. The value of SP is 0 or 1; 1 means the system is
searching the pulse.
The structure of Byte 5 is:
Module type code and
checksum
7 6 5 4 3 2 1 0 Byte 1
1 1 1 1 0 0 0 1
7 6 5 4 3 2 1 0 Byte 2
1 0 0 1 Checksum
7 6 5 4 3 2 1 0 Byte 3
0 The last 7 bits of the pulse rate value.
7 6 5 4 3 2 1 0 Byte 4
0 The first two bits of the
pulse rate value.
7 6 5 4 3 2 1 0 Byte 5
0 The last 7 bits of SpO2 value
Data
SP For future use
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The structure of Byte 6 is:
7 6 5 4 3 2 1 0 Byte 6
0 0 For future use LP NS SO SPL
The value of LP is 1 or 0; 1 means low perfusion. The value of NS is 1 or 0; 1 means
that SpO
The value of SPL is 1 or 0; 1 means that the pulse searching time is too long.
sensor is not connected. The value of SO is 1 or 0; 1 means SpO2 sensor is off.
2
7.8.2 Exporting Trend Data
You can export trend data through the multifunctional connector. To do so, follow this
procedure:
1. Connect a personal computer to the multifunctional connector using a
communication cable.
2. Select [Menu]→[Trend] to enter the trend window.
3. Press the Left button to enter the [Trend Setup] menu.
4. Set [Export Port] to [Wire].
5. Select [Export Trend] to enter the trend exporting window.
When the trend exporting window is entered, all operations except exiting the trend
export window and turning off the pulse oximeter are disabled. To exit the trend
exporting window, press the Right button and select [OK].
Refer to the PC data management system software for detailed information on trend
data exporting.
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FOR YOUR NOTES
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8 Battery
8.1 Overview
The pulse oximeter is designed to operate on three 1.5V alkaline AA batteries or a
rechargeable lithium ion battery.
When the alkaline batteries are used, the battery icon indicates the battery status as
follows:
represents the current power level of the batteries in proportion to its
maximum power level..
Indicates that the batteries work correctly. The solid portion
replaced.
replaced immediately.
When a lithium ion battery is used, the battery icon indicates the battery status as
follows:
represents the current charge level of the battery in proportion to its maximum
charge level.
charged.
immediately.
Indicates that the batteries have low power level and need to be
Indicates that the batteries are almost depleted and need to be
Indicates that the battery works correctly. The solid portion
Indicates that the battery has low charge level and need to be
Indicates that the battery is almost depleted and need to be charged
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If the battery capacity is too low, a technical alarm will be triggered and the [Battery Too Low] message displayed. At this moment, replace the batteries if the alkaline
batteries are used, or charge the battery if a lithium ion battery is used. Otherwise, the
pulse oximeter will shut down automatically when the battery is depleted. If interrupting
patient monitoring is not allowed at this moment, you can place the pulse oximeter in
the Charger stand and connect the AC mains. In this case, the pulse oximeter will give
prompt message [Battery Type Err] if the alkaline batteries are used. You must pay
close attention to the power supply to the pulse oximeter and replace the alkaline
batteries or charge the lithium ion battery as soon as interruption of patient monitoring
is permissible.
You can charge the lithium ion battery using a Charger stand whether the pulse oximeter
is turned on or off. However, monitoring a patient while the battery is being charged is
not recommended.
NOTE
z Remove the batteries prior to shipping or if the pulse oximeter is not
likely to be used for an extended period of time.
WARNING
z Keep the batteries out of children’s reach.
z Use only batteries specified in this manual.
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8.2 Installing the Batteries
8.2.1 Opening the Battery Door
1. Remove the pulse oximeter from the Charger stand and disconnect the SpO
sensor.
2. Use the key to loose the screw that secures the battery door to the pulse oximeter.
3. Press the battery door, push it downwards and remove the battery door.
2
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8.2.2 Installing the Alkaline Batteries
1. Insert the AA alkaline batteries in the battery compartment, aligning the + on each
battery with the + shown inside the battery compartment.
2. Close the battery door and push it upwards.
3. Tighten the screw that secures the battery door to the pulse oximeter.
Caution
z Do not run the pulse oximeter using alkaline batteries of different types
or capacities at the same time.
8.2.3 Installing the Lithium Ion Battery
1. Remove the battery adjusting bracket.
2. Insert the lithium ion battery in the battery compartment, aligning the + on the
battery with the + shown inside the battery compartment.
3. Close the battery door and push it upwards.
4. Tighten the screw that secures the battery door to the pulse oximeter.
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8.3 Charging the Lithium Ion Battery
Pulse oximeter
Battery charger
To charge the lithium ion battery,
1. Place the pulse oximeter in the Charger stand.
2. Connect the power cord.
3. Plug the power cord into the AC mains.
WARNING
z Do not use the charger stand when the alkaline batteries is depleted or no
battery is installed.
z Monitoring a patient while the battery is being charged is not
recommended.
8-5
Power cord
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8.4 Conditioning the Lithium Ion Battery
A lithium ion battery needs at least two conditioning cycles when it is put into use for
the first time. A battery conditioning cycle is one complete, uninterrupted charge of the
battery, followed by a complete, uninterrupted discharge of the battery. A lithium ion
battery should be conditioned regularly to maintain its 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 lithium ion battery, follow this procedure:
1. Disconnect the pulse oximeter from the patient and stop all monitoring and
measuring procedures.
2. Place the lithium ion battery in need of conditioning into the battery compartment
of the pulse oximeter
3. Place the pulse oximeter in the Charger stand and connect the AC mains. Allow the
battery to be charged uninterruptedly for above 2 hours.
4. Remove the AC mains and allow the pulse oximeter to run from the battery until it
shuts off.
5. Replace the pulse oximeter in the Charger stand and connect the AC mains. Allow
the battery to be charged uninterruptedly for above 2 hours.
Now, the battery is conditioned and the pulse oximeter can be returned to service.
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8.5 Checking the Lithium Ion Battery
The performance of a rechargeable lithium ion battery may deteriorate over time. To
check the performance of a battery, follow this procedure:
1. Disconnect the pulse oximeter from the patient and stop all monitoring and
measuring procedures.
2. Place the pulse oximeter in the Charger stand and connect the AC mains. Allow the
battery to be charged uninterruptedly for above 2 hours.
3. Disconnect AC mains and allow the pulse oximeter to run on the battery until it
shuts off.
The operating time of a battery reflects its performance directly. If the operating time of
a lithium ion battery is noticeably shorter than that stated in the specifications, replace it
or contact your service personnel.
NOTE
z Life expectancy of a lithium ion battery depends on how frequent and
how long it is used. For a properly maintained and stored lithium ion
battery, its life expectancy is about 3 years. For more aggressive use
models, life expectancy can be less. We recommend replacing a lithium
ion battery every 3 years.
z The operating time of a lithium ion battery depends on the configuration
and operation of the pulse oximeter.
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8.6 Disposing of the Batteries
Batteries that are damaged or depleted should be replaced and discarded properly.
Dispose of used batteries according to local regulations.
WARNING
z Do not disassemble batteries, or dispose of them in fire, or cause them to
short circuit. They may ignite, explode, or leak, causing personal injury.
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9 Maintenance and Cleaning
Use only the substances approved by us and methods listed in this chapter to clean or
disinfect your equipment. Warranty does not cover damage caused by unapproved
substances or methods.
We make no claims regarding the efficacy of the listed chemicals or methods as a means
for controlling infection. For the method to control infection, consult your hospital’s
Infection Control Officer or Epidemiologist.
Keep you equipment and accessories free of dust and dirt. To avoid damage to the
equipment, follow these rules:
Always dilute according the manufacturer’s instructions or use lowest
possible concentration.
Do not immerse part of the equipment in the liquid.
Do not pour liquid onto the equipment or accessories.
Do not allow liquid to enter the case.
Never use abrasive materials (such as steel wool or silver polish), or erosive
cleaners (such as acetone or acetone-based cleaners).
WARNING
z Be sure to shut down the system and disconnect all power cables from the
outlets before cleaning the equipment.
CAUTION
z If you spill liquid onto the equipment or accessories, contact us or your
service personnel.
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NOTE
z To clean or disinfect reusable accessories, refer to the instructions
delivered with the accessories.
9.1 Safety Checks
Before first use, or at least every two years, or whenever your pulse oximeter is repaired
or upgraded, a thorough inspection should be performed by qualified service personnel
to ensure the reliability.
Follow these guidelines when inspecting the equipment:
Make sure that the environment and power supply meet the requirements.
Inspect the equipment and its accessories for mechanical damage.
Inspect all power cords for damage, and make sure that their insulation is in
good condition.
Make sure that only specified accessories are applied.
Inspect if the alarm system functions correctly.
Make sure that the batteries meet the performance requirements.
Make sure that the pulse oximeter is in good working condition.
In case of any damage or abnormity, do not use the pulse oximeter. Contact your
hospital’s biomedical engineers or your service personnel immediately.
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9.2 Cleaning
Your equipment should be cleaned on a regular basis. 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 the equipment.
1. Shut down the pulse oximeter and disconnect it from the power line.
2. Clean the display screen using a soft, clean cloth dampened with a glass cleaner.
3. Clean the exterior surface of the equipment using a soft cloth dampened with the
cleaner.
4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary.
5. Dry your equipment in a ventilated, cool place.
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9.3 Disinfecting
Disinfection may cause damage to the equipment and is therefore not recommended for
this pulse oximeter unless otherwise indicated in your hospital’s servicing schedule.
Clean the pulse oximeter before disinfecting it.
The recommended disinfectants include: ethanol 70%, isopropanol 70%,
glutaraldehyde-type 2% liquid disinfectants.
CAUTION
z Never use EtO or formaldehyde for disinfection.
9.4 Disposal
Dispose of the pulse oximeter in accordance with local environment and waste disposal
laws and regulations. For the disposal of SpO
disposal of hospital waste.
sensor, follow local regulations regarding
2
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10 Accessories
WARNING
z Use only accessories specified in this manual. Using other accessories may
cause damage to the pulse oximeter.
z Disposable accessories are designed for single-patient use only. Reuse of
them may cause a risk of contamination and affect the measurement
accuracy
z Check the accessories and their packages for any sign of damage. Do not
use them if any damage is detected.
z The SpO2 sensor mentioned in this chapter meet the bio-compatibility
requirements and complies with ISO 10993-1, ISO 10993-5 and ISO
10993-10 standards.
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SpO2 Sensor
Type Model Applicable patient Wavelength* PN
Disposable
* The maximum optical output power of SpO2 sensors is less than 18 mw. Information
on wavelength range and the maximum optical output power can be especially useful to
clinicians, for example, when performing photodynamic therapy.
Safety specifications (classified according to IEC60601-1)
Type of protection against
electrical shock
Degree of protection
against electric shock
Degree of protection
against hazards of
explosion
Degree of protection
against ingress of liquid
Equipment type Handheld
Mode of operation Continuous
Physical specifications
Width × Height × Depth 56×124×30 mm
Max. weight < 300g (full configuration, including the batteries)
Environmental
specifications
Temperature (ºC) 0 to 40 -20 to 60
Relative humidity
(non-condensing)
Atmospheric pressure
(mmHg)
Maximum recommended
ambient temperature:
II (Internally powered equipment)
Type BF – Applied part (defibrillation proof)
Ordinary equipment, not protected
IPX2
Operating conditions Storage conditions
15% to 95% 10% to 95%
425 to 809 120 to 809
35 °C for battery charging and 45 °C for battery
discharging
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Charger stand
Input voltage 100 to 240 VAC, 50/60 Hz
Output voltage 5 VDC
Output current 1.2 A
Output power 6 W
Alkaline batteries
Quantity 3
Specification 1.5 V, AA
Capacity 2000 mAh
Run time 36 hours with SpO2 monitored continuously, audio
indicators off and backlight brightness set to minimum
using new, full power batteries at ambient temperature
25℃.
Shutdown delay Max. 10 minutes after the low battery alarm first occurs.
Lithium ion battery
Quantity 1
Rated voltage 3.7V
Capacity 1800 mAh
Run time 24 hours with SpO2 monitored continuously, audio
indicators off and backlight brightness set to minimum
using a new, fully charged battery at ambient
temperature 25℃.
Charge time 2 hours to 90%
3.5 hours to 100%
Shutdown delay Max. 10 minutes after the low battery alarm first occurs.
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Hardware specifications
Display Color TFT, 2.4”, 320×240 pixel
Power indicating lamp 1, lighting green and yellow
Loudspeaker 1; Gives audible alarm (45 to 85dB) and button tone;
Supports Pitch Tone and multi-level volume;
Alarm tones meet the requirement of IEC 60601-1-8.
Alarm indicating lamp 1, lighting red and yellow
Multifunctional connector 1, 9-pin type D connector
Power supply connector 1, used to connecting the Charger stand
Infrared port 1, through which a personnel computer is communicated.
Data storage
Operating mode Continuous monitoring Spot-checking
Capacity 96 hours of data 4000 data
Resolution 2 s 30 s
Stored data Patient ID, patient category, SpO2 and PR value,
measurement time
Measurement specifications
SpO2
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.
Range 0 to 100%
Resolution 1%
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Accuracy 70 to 100%:
70 to 100%:
70 to 100%:
0% to 69%:
Refreshing rate 1 s
Averaging time 7 s (When the sensitivity is set to High)
9 s (When the sensitivity is set to Med)
11 s (When the sensitivity is set to Low)
PR
Range 18 to 300 bpm
Resolution 1 bpm
Accuracy ±3 bpm (measured without motion)
±5 bpm (measured with motion)
Refreshing rate 1 s
Averaging time 7 s (When the sensitivity is set to High)
The device meets the requirements of IEC 60601-1-2.
NOTES
z Using accessories, transducers and cables other than those specified may
result in increased electromagnetic emission or decreased
electromagnetic immunity of the patient monitoring equipment.
z The device or its components should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the device
or its components should be observed to verify normal operation in the
configuration in which it will be used.
z The device needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information
provided below.
z Other devices may affect this pulse oximeter even though they meet the
requirements of CISPR.
z When the inputted signal is below the minimum amplitude provided in
technical specifications, erroneous measurements could result.
z Portable and mobile communication equipment will have impact on the
performance of the pulse oximeter.
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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.