Henry Schein MD300K2 User manual

1
®
HANDHELD PULSE
OXIMETER
• Instructions for use
HENRY SCHEIN®900-8275
Pulsooxímetro de mano • Instrucciones de uso
ymtre de pouls de poche • ode demploi
S-inhandpulsoimeter • ebrauchsaneisun
Pulsossimetro a mano • Istruioni per luso
Pulsoxímetro portátil • Instrues de utiliaão
3x1.5V AA
Rev.2019/07
ade in China
-20°C
70°C
IPX1

2
Copyright
Our company owns all rights of this unpublished work and intends to maintain it as a
confidential work. We may also seek to maintain this work as an unpublished copyright. This
publication is to be used solely for the purpose of reference or operation of our software
system. No part of this work can be disseminated for other purposes.
In the event of inadvertent or deliberate publication, we intend to enforce its right to this
work
under copyright laws as a published work. Those having access to this work may not copy,
use, or disclose the information in this work unless expressly authorized by our company.
All information contained in this publication is believed to be correct. We shall not be liable
for
errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this material. The information this publication refers to is
protected by copyrights or patents and does not convey any license under the patent rights
of our company, nor the rights of others. We do not assume any liability arising out of any
infringements of patents or other rights of third parties.
Content of the manual is subject to change without prior notice.
Model: MD300K2
Version: Ver 4.0K2
Revised Date: July 24, 2019

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CONTENT
1 INTRODUCTION 4
1.1 Brief Introduction 4
1.2 Intended Use 4
1.3 Measurement Principle 4
1.4 Safety Information 4
1.5 Electromagnetism Interference 6
1.6 Explanation of Symbols 7
1.7 Product Features 7
1.8 Contraindication 7
2 GENERAL DESCRIPTION 8
2.1 Appearance 8
2.2 Power Supply 9
3 TIME AND DATE SETTINGS 10
4 TAKE A MEASUREMENT 10
4.1 Install the Probe 10
4.2 Measurement Screens 11
5 SETTINGS 13
5.1 System Setting 13
5.2 Alarm Setting 13
6 DATA MANAGEMENT 15
6.1 Data Review 15
6.2 SpO Trend 15
6.3 PR Trend 16
6.4 Delete all data 16
7 ALARM 17
8 MAINTENANCE AND REPAIR 18
8.1 Maintenance 18
8.2 Safety Checks 18
8.3 Troubleshooting 20
8.4 Warranty and Repair 20
APPENDIX A SPECIFICATIONS 23
APPENDIX B CLINICAL STUDY SUMMARY 26
APPENDIX B DECALARATION 28
English

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1 INTRODUCTION
1.1 Brief Introduction
Thank you for purchasing the MD300K2 pulse oximeter. The main functions of the device include SpO, PR
and PI (Perfusion Index) measurements, visual and audible indication, probe o and finger out indicarion,
data storage, transmitting and review etc. Please read this manual carefully before using the device.
Notes:
• The illustrations applied in the manual may dier slightly from the actual device.
• The device is designed of handheld structure, please be sure not to turn upside down when using it.
1.2 Intended Use
The MD300K2 Pulse Oximeter is intended for continuous monitoring, spot-checking of oxygen saturation
(SpO), pulse rate (PR) and PI (Perfusion Index) of single adult, adolescent, child and infant patients in
hospitals and clinics.
1.3 Measurement Principle
Principle of the oximeter is as follows: A mathematical formula is established making use of Lambert Beer
Law according to Spectrum Absorption Characteristics of Reductive hemoglobin(RHb) and Oxyhemoglobin
(HbO) in red and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin
Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology,
so that two beams of dierent wavelength of lights (660nm red and 905nm near infrared light) can be
focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a
photosensitive element, will be shown on the oximeter’s display through process in electronic circuits and
microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
1.4 Safety Information
Conception of Warning, Caution and Note
The Warning, caution and Note at this document are special information in favor of users operation.
Warning - Information concerning something that could possibly hurt the patient or operator.
Caution - Reminds the user to pay close attention to device operation, failure of which may cause abnormal
function of the instrument.
Note - Informs the user of other important information by suggestion, requirement and supplement.
Warnings!
1. Before use, carefully read the manual. This device is intended for use by persons trained in professional
health care. Our company will assume no warranty for using this equipment improperly.
2. Operation of the handheld pulse oximeter may be aected by the use of an electrosurgical unit (ESU).

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3. Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death, so pay close
attention to the sensor and inspect it often.
4. Do not use the handheld pulse oximeter in an MRI or CT environment.
5. Although the pulse oximeter has alarms, it is not suggested for long time continuous monitoring.
6. Do not use the handheld pulse oximeter in an explosive atmosphere.
7. The handheld pulse oximeter is intended only as an adjunct in patient assessment. It must be used in
conjunction with other methods of assessing clinical signs and symptoms.
8. Check the pulse oximeter sensor application site every half an hour to determine the positioning of the
sensor and circulation and skin sensitivity of the patient.
9. When begin to gauge associated body features please follow the doctor’s counseling.
10. When link this equipment to other peripherals, make sure you are sophisticated operator to handle this
device. Any peripherals should be in the light of protocol of IEC 60950 or IEC 60601-1. Any input/output
device should be following the protocol of IEC 60601-1.
11. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid.
The device is not intended for sterilization.
12. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and
device components, including batteries.
13. This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical elec-
trical equipment and/or systems. However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise in healthcare and other environments, it is possible
that high levels of such interference due to close proximity or strength of a source might disrupt the
performance of this device.
14. You should operate the equipment according to the EMC information provided in the accompanying
documents.
15.
16. This equipment should not be used adjacent to or stacked with other equipment.
17. This equipment is not intended for use during patient transport outside the healthcare facility
18. When connecting this device to other peripherals, make sure that you are qualified to
operate this device. Any peripheral must be certified according to the protocol of IEC 60601-1.
Any input/output device should follow the protocol of IEC 60601-1.
19. When using the equipment, the voice of the environment is not greater than 45 db.
Rx only: “Caution: Federal law restricts this device to sale by or on the order of a physician.”
Cautions:
1. The pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2 measurement.
Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement.
2. Worn-out data cables may also cause inaccurate data, so if the data is used as a reference to treat a
patient, pay special attention to data cable and check it more frequently.
3.

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4. Single use accessories should never be re-used.
5. Only use SpO sensors specified by the manufacturer. Other SpO sensors may cause improper perfor-
mance.
6. Unplug the sensor from the monitor before cleaning or disinfecting to prevent sensor or monitor from
being damaged, and to prevent user under safety situation.
7. Alarm must be set up according to dierent situation of individual patient. Make sure that audio sound
can be activated when alarm occurs.
Notes:
1. Optical cross talk can occur when two or more sensors are located in adjoining areas. It can be eliminated
by covering each site with opaque material. Optical cross talk may adversely aect the accuracy of the
SpO readings.
2. Obstructions or dirt on the sensor’s red light or detector may cause a sensor failure. Make sure there are
no obstructions and the sensor is clean.
3. For routine equipment maintenance, please refer to the service procedures at the associated section as
indicated in the manual.
4. As to the other concerns for attention, please carefully look through the specific chapter in this instruction.
Inaccurate measurements may be caused by:
1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin);
2. Intravascular dyes such as indocyanine green or methylene blue;
3. High ambient light. Shield the sensor area if necessary;
4. Excessive patient movement;
5. High-frequency electrosurgical interference and defibrillators;
6. Venous pulsations;
7. Placement of a sensor on an extremity with a blood pressure cu, arterial catheter, or intravascular line;
8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia;
9. The patient is in cardiac arrest or is in shock;
10. Fingernail polish or artificial fingernails;
11. Weak pulse quality (low perfusion);
12. Low hemoglobin;
1.5 Electromagnetism Interference
This oximeter is designed and tested in compliance with the EMC standard, complying with the international
standard for the EMC of the electronic medical device – IEC 60601-1-2. However, because of the prolifera-
tion of radio frequency transmitting equipment and other sources of electrical noise in the health-care and
home environments (e.g. cellular phones, mobile two-way radios, electrical appliances) it is possible that
high levels of such interference due to close proximity or strength of a source, may result in disruption of
performance of this device.

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This apparatus complies with the IEC 60601-1-2 international standard. The requirements of this internati-
onal standard are: CISPR11, GROP1, and CLASS B.
1.6 Explanation of Symbols
1.7 Product Features
• Compact, light in weight and simple to use.
• TFT displaying screen with adjustable backlight.
• Up to 127 user ID and 72-hour records storage.
• Visual and three-level audible alarms, low battery alarm.
• Data transfer to PC by USB cable.
• Powered by three AA alkaline batteries or power adapter (optional).
1.8 Contraindication
None
Symbol Explanation Symbol Explanation
Type BF applied part Protected against dripping
water
Caution Prevent from rain
Date of Manufacture Manufacturer’s information
Serial number User ID
Audio alarm inhibition Battery power indication
Storage temperature and
relative humidity
Follow instructions for use
Pulse rate Hemoglobin Oxygen
Saturation
USB cable is connected Battery cover unlock / lock
European union approval Authorized representative in
the European community
Do not discard the device
and other components
Class II equipment
Waste electrical and
electronic equipment
Beep silence
Indicate the signal is not
stable
IPX1
-20°C
70°C
RH≤93%
non-condensing
ID
PULSE OXIMETER
MD300K2
- 4 -
t h i s i n t e r n a t i o n a l s t a n d a r d a r e : C I S P R 11, G R O P 1, and C L A S S B .
1.6 Explanation of Symbols
Symbol Explanation Symbol Explanation
T y p e B F a p p l i e d p a r t IPX1 P r o t e c t e d a g a i n s t d r i p p i n g w a t e r
C a u t i o n Pr e v e n t f r o m r a i n
D a t e o f Ma n u f a c t u r e Ma n u f a c t u r e r ’ s i n f o r m a t i o n
SN Se r i a l n u m b e r Us e r I D
Au d i o a l a r m i n h i b i t i o n B a t t e r y p o w e r i n d i c a t i o n
S t o r a g e t e m p e r a t u r e a n d
r e l a t i v e h u m i d i t y Fo l l o w i n s t r u c t i o n s f o r u s e
bpm P u l s e r a t e SpO2H em oglobin O x y gen S a t u r a t i o n
US B c able i s c o n n e c t e d B a t t e r y c o v e r u n l o ck / l o ck
European union approval A u t h o r i z e d r e p r e s e n t a t i v e i n t h e
Eu r o p e a n c o m m u n i t y
D o n o t d i s c a r d t h e d e vi c e
and o t hercom ponents C l a s s I I equipm ent
W a s t e e l e c t r i c a l a n d
e l e c t r o n i c e q u i p m e n t Beep s i l e n c e
Al a r m i n h i b i t ?In d i c a t e t h e s i g n a l i s n o t s t a b l e
1.7 Product Features
•C o m p a c t , lig h t i n w e i g h t a n d s i m p l e t o u s e .
•T F T d i s p l a y i n g s c r e e n w i t h a d j u s t a b l e b a c k l i g h t .
•Up t o 127 u s e r I D a n d 72- h o u r r e c o r d s st orage.
•V i s u a l a n d t h r e e - l e v e l a u d i b l e a l a r m s, l o w b a t t e r y a l a r m .
•D a t a t r a n s f e r t o P C b y US B c a b l e .
•P o w e r e d b y t h r e e A A a l k a l i n e b a t t e r i e s o r pow eradapter(optional).
1.8 Contraindication
None
PULSE OXIMETER
MD300K2
- 4 -
t h i s i n t e r n a t i o n a l s t a n d a r d a r e : C I S P R 11, G R O P 1, and C L A S S B .
1.6 Explanation of Symbols
Symbol Explanation Symbol Explanation
T y p e B F a p p l i e d p a r t IPX1 P r o t e c t e d a g a i n s t d r i p p i n g w a t e r
C a u t i o n Pr e v e n t f r o m r a i n
D a t e o f Ma n u f a c t u r e Ma n u f a c t u r e r ’ s i n f o r m a t i o n
SN Se r i a l n u m b e r Us e r I D
Au d i o a l a r m i n h i b i t i o n B a t t e r y p o w e r i n d i c a t i o n
S t o r a g e t e m p e r a t u r e a n d
r e l a t i v e h u m i d i t y Fo l l o w i n s t r u c t i o n s f o r u s e
bpm P u l s e r a t e SpO2H e m o g l o b i n O x y g e n S a t u r a t i o n
US B c able i s c o n n e c t e d B a t t e r y c o v e r u n l o ck / l o c k
European union approval A u t h o r i z e d r e p r e s e n t a t i v e i n t h e
Eu r o p e a n c o m m u n i t y
D o n o t d i s c a r d t h e d e v i c e
and o t hercom ponents C l a s s I I equipm ent
W a s t e e l e c t r i c a l a n d
e l e c t r o n i c e q u i p m e n t Beep s i l e n c e
Al a r m i n h i b i t ?Indi c a t e t h e s i g n a l i s n o t s t a b l e
1.7 Product Features
•C o m p a c t , lig h t i n w e i g h t a n d s i m p l e t o u s e .
•T F T d i s p l a y i n g s c r e e n w i t h a d j u s t a b l e b a c k l i g h t .
•Up t o 127 u s e r I D a n d 72- h o u r r e c o r d s s t o r a g e .
•V i s u a l a n d t h r e e - l e v e l a u d i b l e a l a r m s, l o w b a t t e r y a l a r m .
•D a t a t r a n s f e r t o P C b y US B c a b l e .
•P o w e r e d b y t h r e e A A a l k a l i n e b a t t e r i e s o r pow eradapter(optional).
1.8 Contraindication
None

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2 GENERAL DESCRIPTION
2.1 Appearance
Description of Fig.2-1:
1.
transmission.
2. Alarm indicator: it will flash with yellow when alarms occur.
3. Displaying screen.
4. Navigation buttons (UP, DOWN, LEFT, RIGHT): the function of the left button is confirming the items that
you choose; the function of the right button is back to the previous or menu interface. In the measuring
interface, press the right button to shift between digital mode and wave mode.
5. Menu button: short press to enter the main menu; long press it to silence the audio alarm, the device will
be appear the audio alarm indicator icon covered with “X” and countdown, long press it again, the device
will recover the audio alarm.
6. Power button: Press and hold the button for 3 seconds to power the device on, and for about 4 seconds
7. Connector for adapter.
8. USB interface: Used for update the software, only serves engineers;
9. Side UP/DOWN button: Short press it to increase/decrease the volume of alarm; Press it for extended time
to increase/decrease the brightness of the backlight.
NOTE: In the measuring interface, press the menu button for extended time, the alarm pause will be turn on;
Fig.2-1
MENU
1
2
3
4
6
7
9
8
5

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Fig.2-2
2.2 Power Supply
The device can be powered by 3 AA alkaline batteries.
Batteries Installation:
1) Open the battery cover: Slide the fixing screw slightly in the rear panel to the position which is marked
with “ ” and then open the cover.
2) Batteries installation: Install 3 AA alkaline batteries or rechargeable batteries lightly as indicated by the
polarity signs as shown in Fig.2-2.
3) Close the battery cover: Close the battery cover and slide the screw to the position. It means that
the battery cover is locked.
Battery life and replacement
When the battery voltage is lower, the battery indicator will become empty and its frame shows in red,
which means few of battery capacity remains. You should replace the batteries with new ones in time.
Warnings!
• If battery fluid should get into your eyes, immediately rinse with plenty of clean water. Consult a doctor
immediately.
• Be sure to insert the batteries in the correct polarities, as indicated by polarity markings inside the battery
compartment.
Cautions!
• Do not use batteries not specified for this unit.
• Do not dispose of batteries in fire.
• Remove the batteries from this unit when you are not going to use it for a long period.
• Do not use batteries of dierent types together.
• Do not use new and used batteries together.
• Do not use the broken battery.
• Dispose of batteries in accordance with the local ordinances and regulations.

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AC Power Supply
The device can be supplied by AC power through connecting the device to AC adapter.
Note: Use the AC power supply, make sure put the device in the safety and proper place and convenient
to power o.
Warnings!
• Be sure to use the adapter that specified for this device.
• Plug and unplug the adapter cautiously to avoid injuries caused to your body.
• If the device suddenly power o, please take out your finger at once, and then connect power or install
the batteries.
3 TIME AND DATE SETTINGS
Set the correct time according to the following steps:
1) Press the power switch for 3 seconds to power on the oximeter and then press the menu
button to enter the main menu, refer to the Fig.3.1.
Fig.3.1 Fig.3.2
2) Press the Navigation button to select “Date and Time” item, and then press the OK button to enter the
time setup screen, refer to Fig.3.2. Press the Navigation button adjust the value, and then press the OK
button to confirm thevalue. The date is displayed as the order of Year-Month-Day and Time of Hour-Mi-
nute (time show: 24-hour).
4 TAKE A MEASUREMENT
4.1 Install the Probe
1. Before use, check the pulse oximeter
for mechanical damage.

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2. Insert the SpO probe into the probe socket (refer to Fig.4.1).
If the SpO probe is disconnected from the unit, a prompt
“Probe O” will be shown in the status bar in the top left of
the display screen.
Note: The probes that specified for this device conform to the
ISO80601-2-61 standard. The connector is also applied to
uploading data to MedView software for reviewing. For detailed
information, refer to the instruction manual of MedView soft-
ware.
After finishing the time setting, plug your finger into the sensor as shown in the following illustration.
Fig.4.2 Placement of the sensor
Select the suitable sensor in terms of type and dimension.
4.2 Measurement Screens
There are two display modes as shown in the following pictures.
Fig.4.3 (Digital Mode) Fig.4.4 (Wave Mode)
Description of measurement screens:
1. Measuring: The pulse oximeter is in the status of measuring.
❚ It shows “Finger o” when there is no finger inserted or no signal is detected.
❚ It shows “Probe o”when the sensor/probe is not connected to the pulse oximeter.
2. SpO%: SpO area of display
❚
It shows the oxygen saturation level of functional hemoglobin during normal measurement.
❚ The color of the SpO2 value will become red when the SpO2 is beyond the alarm limits.
❚ It shows two dashes throughout probe o and finger out conditions.
3. 100: SpO high alarm limit; 90: SpO low alarm limit.
- 9 -
CHAPTER 4 Take a Measurement
4.1 Install The Probe
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

Note:   

   



IN STRUCTION MA N UA L MD300K2
Fig.4.1
- 9 -
CHAPTER 4 Take a Measurement
4.1 Install The Probe



probe is


Note:   

   



IN STRUCTION MA N UA L MD300K2

12
4. : Pulse bar
5. 100: PR high alarm limit; 060: PR low alarm limit.
6. PR: PR area of display
❚It shows the pulse rate in beats per minute during normal measurement.
❚The color of the PR value will become red when the PR is beyond the alarm limits.
❚It shows three dashes throughout probe o and finger out conditions.
7. ID: 001, the ID number of the current patient is 001.
8. 12:00: The current time.
9. PI%: Perfusion Index indicator display area.
Warnings!
❚Use only SpO probes provided by manufacturer. Other SpO probes may cause improper performance.
❚Do not use an SpO probe with exposed optical components.
❚Excessive patient movement may cause inaccurate measurements.
❚Tissue damage can be caused by incorrect operation or misusing probe; for example, by wrapping the
probe too tight. Inspect the probe site to ensure the skin’s integrity and the adhesion position of the probe
is correct. More frequent inspection should be taken if necessary.
❚Loss of pulse signal can occur in any of the following situations:
a) The probe is too tight;
b) There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight;
Pulse sensor should obviate the light source, e.g. radial lamp or infrared lamp.
c) A blood pressure cu is inflated on the same extremity as the one to which an SpO sensor is attached.
• After measurement, please take o your finger and press and hold the power button to turn o the device.
- 10 -
4.2 Measurement Screens

Description of measurement screens:




SpO2% : area of display


is beyond the


 100: 

100: 
PR: 




ID: 
09 : 06: 
2010-03-10: 
Data-base 100% : 
 
PULSE OXIMETER
MD300K2

13
5 SETTINGS
5.1 System Setting
Pick and enter the [System Setting] interface from the main menu. And then press the Navigation buttons
to select dierent item to set.
Fig.5.1 Fig.5.2
Alarm Volume: you can adjust the value of alarm volume, there are 7 levels, and the default level is 3
Alarm Pause: there are two modes, 60s and 120s, and the default mode is 120s. The device audibly alarm
upon new alarm conditions.
Beep Tone: the level is from 0 to 7, and the default level is 3.
Backlight Setting: the level of brightness is from 1 to 7, and the default level is 3.
Language: English, French, German, Spanish, Italian, Japanese, Russian and Chinese.
Screen Sleep Mode: 1minute, 10 minutes, 30 minutes, screen always on, and the default is 1 minutes
Charging management: Charging activated, Charging stop.
ID setup: ➀ press OK button, ➁ press Navigation button to change the number, ➂ press OK button to
confirm.
Factory Default: recover to factory reset.
Note:
1. Every time enter into the Alarm Volume and Alarm Pause, you should input the password, refer to Alarm
Setting.
2. The ID range is 1~127.
5.2 Alarm Setting
Pick the [Alarm Setting] interface from the main menu. Before setting, please enter password (1234) to set
the parameter. Or you can direct access to check the parameter but not to change.

14
How do you input passwords?
1. Press the Navigation button to change the numbers.
2. Press the OK button to confirm the number.
3. Press the Navigation button switch to the next numbers.
4. Press the OK button to confirm your selection.
5. Repeat the step one.
How to change the passwords?
In the measuring interface, hole and press the menu button for 5s
to change the passwords.
The first time, enter the old passwords.
The second time, enter the new passwords.
Then you can change the passwords.
Notes:
1. The read-only password is 0000. Under this password, you can only check the parameter but not change.
2. The make-changes password is 1234, enter this password, you can set the parameters.
3. You can change the password. If you forget the password, Please choose “Factory Default” in System
Setting, the password will Recover to factory password (1234) .
4. Every time enter into the Alarm Setting in the main menu, Alarm Volume and Alarm Pause in the System
Setting, you should input the password.
Enter the [Alarm Setting] interface.
You can select the Alarm on or o.
High limit SpO range is 71~100, Low Limit SpO range is 70~99
High Limit PR range is 31~250, Low Limit PR range is 30~249
Fig.5.3
Fig.5.4

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Fig.5.3
6 DATA MANAGEMENT
Pick and enter the [Data Management] interface from the main menu. You can choose continuous measu-
rement or not.
6.1 Data Review
Pick and enter the “Data review” interface as shown in Fig.6.1. By pressing the UP / DOWN button, the user
can turn to the earlier/later item page.
The pulse oximeter can record the alarming parameter marked with red color. Press the MENU button, it will
return to the main menu interface.
6.2 SpO Trend
Pick and enter the “SpO Trend” interface as shown in Fig.6.3. Press the Left / Right button; you can turn
to the earlier or later item page. Press the Up button, the pulse oximeter returns to the previous interface.
Press the MENU button, the pulse oximeter returns to the main menu interface.
Fig.6.1
Fig.6.2

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On the above of the trend, the date and time of the first item are displayed, with month/day; hour: minute:
second.
6.3 PR Trend
Pick and enter the “PR Trend” interface as shown in Fig.6.4. Press the Left / Right button; you can turn to the
earlier or later item page. Press the Up button, the pulse oximeter returns to the previous interface. Press
the MENU button, the pulse oximeter returns to the main menu interface.
6.4 Delete all data
Pick and enter the “Delete all data” interface as shown in Fig.6.5. You can select “Yes” or “No” by pressing
the up or down button, and by pressing the OK button to confirm your selection.
Note:
1. Please take caution to the deletion of data; you will never get the data back once deleted.
2. Data is unable to be deleted during measurement.
Fig.6.3
Fig.6.4

17
Fig.6.5
7 ALARM
ALARM PRIORITY:
There are two-level priorities for selection.
High priority: the highest level alarm, indicates the patient is in the very dangerous situation.
Low priority: indicate the technical alarm caused by the device itself.
Alarms of the oximeter include technical and physiological alarms. All the two priorities
divided by built-in module and cannot be changed by user.
Assignment of priority:
Notes:
1. The alarm will appear if the measurement value out of range.
2. The alarm sound will go on until alarm disappears or is turned o.
3. After silencing the alarm, the corresponding indicator will indicate this.
4. The power low alarm: the corresponding indication lamp will be flashing with a red frame.
High Low
Paramter SpO/PR /
Value Red /
Alarm lamp Flashing /
Lamp Frequency 1.5Hz /
Audiblesound Di- Di – Di ----- Di - Di Di
Alarm cycle 3 s 20 s
Alarm info SpO too high/low, PR too high/low, Battery
power low
Probe o/Finger o

18
Warnings!
When the alarm occurs, check patients’ conditions immediately.
• When the alarm occurs, check patients’ conditions immediately.
• Check which parameter is alarming or which alarm is going on.
• Check patient’s condition.
• Search for the source of alarm.
• Make the alarm mute if necessary.
• Check the alarm when no warning.
Alarm delay
The alarm condition delay and alarm signal generation delay: less than 1s.
Note:
1. The pulse rate correspondence with the user’s pulse rate. It based on the user’s actual pulse rate.
2. Use the alarm setting in dierent areas will be brings the potential dangerous.
3. The alarm setting can recover if the power-break time less than 30s.
4. Set the high parameter value with simulator to test the eciency of the alarm system.
5. Do not set the parameter value out of the range, or the alarm system will failure.
6. The device can reserve alarm setting if it power break.
8 MAINTENANCE AND REPAIR
Warnings!
• The advanced circuit inside the oximeter does not require periodic calibration and maintenance, except
replacing the batteries.
• Don’t open the cover of oximeter or repair electronic circuits. Its open will cause the damage of the device
and the annulment of the guarantee.
8.1 Maintenance
Use only the substances approved by us and methods listed in this chapter to clean or disinfect your equip-
ment. Warranty does not cover damage caused by unapproved substances or methods.
We make no claims regarding the ecacy of the listed chemicals or methods as a means for controlling
infection. For the method to control infection, consult your hospital’s Infection Control Ocer or Epidemiolo-
gist. Keep your 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 into liquid.

19
• 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).
Caution: If you spill liquid on the equipment or accessories, contact us or your service personnel.
Note: To clean or disinfect reusable accessories, refer to the instructions delivered with the accessories.
8.2 Safety Checks
Before every use, or after your pulse oximeter has been used for 6 to 12 months, 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.
• 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.
Cleaning
Please use medical alcohol to clean the silicone touching the finger inside of SpO probe with a soft cloth
dampened with 70% isopropyl alcohol. Also clean the being tested finger using alcohol before and after
each test. To clean your equipment, follow these rules:
1. Shut down the pulse oximeter and take the batteries out of the battery wharf.
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 o all the cleaning solution with a dry cloth after cleaning if necessary.
5. Dry your equipment in a ventilated, cool place.
Disinfecting
The applied parts touching the patients’ body are required to be disinfected once after each use. The recom-
mended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehydetype 2% liquid disinfectants.
Disinfection may cause damage to the equipment and is therefore not recommended for this pulse oxi-
meter unless otherwise indicated in your hospital’s servicing schedule. Clean the pulse oximeter before
disinfecting it.
Caution: Never use EtO or formaldehyde for disinfection.
"dudu" voice should be heard.

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8.3 Troubleshooting
8.4 Warranty and Repair
8.4.1 Maintenance Method
Repair response time: AM9:00 to PM17:30 on Monday to Friday except legal holiday.
Repair time: AM9:00 to PM17:30 on Monday to Friday except legal holiday.
8.4.2 Exempt and limitation
a) Our company isn’t responsible for such damage caused by force nature. For example: fire, thunder flash,
flood, cyclone, hail, earthquake, house collapse, commotion, plane failing and trac accident, deliberate
damage, lack of fuel or water, labor and capital bother, strike and stop-working etc.
b) No-service oer
• The cost and insurance charge of disassembling, refurbishing, repackaging and conveying of the oximeter
or the part of it.
• Damage or loss sustained due to inspected or repaired by other institute that is notcertified.
• The damage and failure caused by user or its representative who doesn’t use the device according to
the operator’s manual
Malfunction Reason Solution
SpO or PR is
shown unstably
1. Finger might not be
plugged deep enough.
2. Finger is trembling or pa-
tient’s body is in movement
status.
1. Retry by plugging the
finger.
2. Try not to move.
The Oximeter
cannot be powered on
1. Power of batteries might
be inadequate or not be
there at all.
2. Batteries might be instal-
led incorrectly.
3. The Oximeter might be
damaged.
1.Please replace batteries
2.Please reinstall the
batteries
3. Please contact with local
customer service centre.
Indication lamps are
suddenly o
1.The product is automati-
cally powered o when no
signal is detected longer
than 8 seconds
2. Lower power
1.Normal
2.Replace the batteries
Others Please contact with local
customer service centre.