MedLinket AM-806 User manual

REF: AM-806
20220725 A.1
Temp-pulse oximeter
P2-24
ENGLISH
P25-47
FRANÇAIS DEUTSCH NEDERLANDS ITALIANO
P48-70 P71-93 P94-116 P117-139
0123
ESPAÑOL

Contents
4
4
5
5
5
5
5
5
6
7
8
9
10
10
10
11
11
11
12
14
15
15
18
19
19
19
21
21
21
22
23
23
23
23
23
24
24
English 2
3
Quick Start Guide
Foreword
Warning
Latex Content Statement
About This Manual
Secon1-Overview
Intended Use
About the Pulse Oximeter
Idenficaon of Front Panel, Le Panel Buons and Symbols
Equipment Symbols
Technical Specificaons
Product parts and accessories
Principle of Measurement
Contraindicaon
Aenons
Unpacking and Inspecon
Included in the package
Secon 2- Operaon
Installaon and Verificaon
General Operaon
Safety
Funcon Seng Introducon
Menu Seng
Secon 3- Troubleshoong
Secon 4- Electromagnec Environment
Electromagnec Interference Cauon
Electromagnec Environment
Secon 5- Measurement Validaon
Subject Demographics
ARMS Results
Graphs
Secon 6- Service and Maintenance
Cleaning and Disinfecng
Calibrang
Repairing and Maintenance
Disposal
Warranty
Qualified cerficate

English 3
Quick Start Guide
How to begin?
3. Make sure the sensor LED is above the fingernail
as shown below.
2. Open the clip of the pulse oximeter, insert a
finger (The preferred applicaon is middle finger
and index finger), as shown below.
1. Open baery compartment cover and insert two
new AAA alkaline baeries as indicated below to
ensure the polarity (<+> and <->) of the baeries
are correct and then close it.
+
+
-
-
2*AAA
alkaline
baery
5. Get the informaon of SpO2 directly from screen
display.
4. Turn on the pulse oximeter by pressing the
Power buon.
Scan the QR code to download the user manual or watch the
instrucon video, thanks!
User manual in PDF Instrucon video
English, Français, Español,
Deutsch, Nederlands, Italiano
Scan the QR code to watch
the instrucon video on YouTube!

English 4
Foreword
The Pulse Oximeter manual is intended to provide informaon for proper operaon
and maintenance. General knowledge of monitoring and understanding of the
features and funcons of the Pulse Oximeter are prerequisites for proper use. Please
read these instrucons carefully before using this equipment.
The manual describing the operang procedures should be followed strictly. Failure
to follow these instrucons can cause measuring abnormality, equipment damage
and personal injury. The manufacturer is NOT responsible for the safety, reliability
and performance issues and any monitoring abnormality, personal injury and
equipment damage due to user’s negligence of the operaon instrucons.
The Pulse Oximeter is a medical device, and can be used repeatedly.
Warnings are idenfied by the WARNING symbol shown above.
● Explosion hazard. Do not use the PULSE OXIMETER in the presence of flammable
anesthecs mixed with air, or with oxygen, or nitrous oxide.
● Do not spray, pour, or spill any liquid on the PULSE OXIMETER and its accessories.
● Reusable sensors must be moved to a new site at least every 4 hours. Because
individual skin condion affects the ability of the skin to tolerate sensor placement,
it may be necessary to change the sensor site more frequently with some paents. If
skin integrity changes, move the sensor to another site.
● At elevated ambient temperatures, paent skin could be severely burned aer
prolonged sensor applicaon at sites that are not well perfused. To prevent this , be
sure to check paent applicaon sites frequently. The temperature of the sensor
contacng with skin won't exceed 41℃ if the inial skin temperature doesn't exceed
35℃.
● Be aware that following removal of the sensor from the paent, it is possible that
environmental light may cause the oximeter to connue to display a waveform or
data values but these data should not be used as a basis for a clinical diagnosis.
● Portable and mobile RF communicaons equipment can affect MEDICAL ELECTRI-
CAL
EQUIPMENT.
● The waste of PULSE OXIMETER must not be disposed as unsorted municipal waste
and must be collected separately. Please contact an authorized representave of the
manufacturer for informaon concerning the disposal of your equipment.
● This device is not intended for treatment.
● The LCD panel contains toxic chemicals. Do not ingest chemicals from a broken LCD
panel.
● Do not modify this equipment without authorizaon of the manufacturer.
● Don't reuse disposable temperature probe or it may cause cross-infecon among
paents.
Warning

English 5
The PULSE OXIMETER and accessories are not made with natural rubber latex in any
locaon that may result in paent contact.
Latex Content Statement
The PULSE OXIMETER is to be operated by qualified personnel only. Before servicing
this product, read the operator's manual carefully to get a thorough understanding
of operaon.
About This Manual
Intended Use
The Pulse Oximeter is intended for spot checking in measuring and displaying
funconal arterial oxygen saturaon (SpO2), pulse rate and temperature of paents
in hospitals, physician’s office, clinical sengs and home care environment.
Target populaon: Adult, adolescent and child.
About the Pulse Oximeter
The device contains a dual light source (red LED and infrared red LED) and a photo
detector. Bone, ssue, pigmentaon and venous vessels normally absorb a constant
amount of light over me. The arteriolar bed normally pulsates and absorbs variable
amounts of light during the pulsaons. The rao of light absorbed is translated in an
oxygen saturaon measurement (SpO2). Because a measurement of SpO2 is
dependent on light from the device, excessive ambient light can interfere with this
measurement.
Idenficaon of Front Panel, Le Panel Buons and Symbols
Refer to the PULSE OXIMETER Operator’s manual for a complete descripon of all
buons, symbols, controls, displays and indicators.
Section 1- Overview

English 6
98 1
23 5
4
6 7
Figure 1: PULSE OXIMETER Front Panel and Le Panel
1—Menu buon/Power buon
2—%SpO2 Display
3—Low Baery indicator
4—Temperature Display
5—Pulse Rate Display (bpm)
6—PPG (photoplethysmograph)
7—Bar graph (The Pulse Amplitude Indicator)
8—Display mode switch
9—Accessories Port Connector
Equipment Symbols
Cauon
Non sterile Packaging
Refer to Instrucon
manual/booklet
Humidity limitaon
MR unsafe
Compliance with WEEE
Standard
Protected against vercally
falling water drops when
enclosure lted up to 15°
NON
STERILE
80%
0%
-10℃
40℃
LOT
10
Atmospheric Pressure
limitaon
Type BF (Body Floang)
Applied Part
Temperature limit
Environment-friendly
use period
Batch Code
Date of manufacture
No SpO2 Alarm
Do not re-use
MR
Medical device Unique Device Idenfier
CN
Model number

English 7
Technical Specifications
Pulse Oximeter
SpO2 Range 70% to 100%
SpO2 Resoluon 1%
SpO2 Accuracy
(under good &
low perfusion)
90% to 100% range: ±2%;
70% to 89% range: ±3%
<70%: unspecified;
Reminder Baery-low indicator
Method Dual wavelength LED
Pulse Rate Range 30 to 245 bpm
Pulse Rate Resoluon
Pulse Accuracy
(under good
& low perfusion)
±3 bpm
LED Wavelengths Red: approximately 660nm; Infrared: approximately 905nm
Less than 15mW
5min
skin surface
Oral cavity and axilla
Range, Accuracy
Measuring site
Reference body site
Shortest measurement
me recommended
77°to 113°F (25℃to 45℃): ±0.1℃
Display Resoluon ±0.1℃
1 bpm
Opcal output power
Temperature
Note:The funcon of temperature measurement works by the accessory
of temperature probe.
Power Supply Requirements
Note: The Oximeter does not include baeries.
Baeries 1.5V (AAA) alkaline baeryX2 (IEC Type LR03)
Adaptable Range 2.6V～3.6V
Only SpO2 funcon works
Less than 55mA
Only Temp funcon works Less than 40mA
SpO2 and Temp funcon
work together Less than 60mA
Display Parameters SpO2, Pulse Rate, Pulse Waveform Display, Bar Graph and
Low Baery Indicator
Data Update Period 8s
Reminder Response Time <2s
SpO2 plethysmogram,
pulse sound 50Hz
Value of Pulse and SpO21Hz

English 8
Product parts and accessories
The Pulse Oximeter is composed of instrument and accessories. The accessories
include adapter cable and temperature probe . Detail of the instrument and accesso-
ries see figure 2 and figure 3.
1. Instrument
Control buon Display
Screen
Applied
part
Baery cover
Accessories
Port Connector lanyard
Figure 2: instrument
Degree of protecon
Mode of operaon Connuous
The surface material has no harm or toxicity for
the person in contact.
Environment
Operang environment Temperature 41°~104°(5℃~40℃), humidity ≤80%
Transportaon and
Storage environment Temperature 14°~104°(-10℃~40℃), humidity ≤80%
Hyperbaric Pressure
(Storage, Transportaon
and Operang) 86kPa～106kPa
Classificaon
Medical device ClassⅡa by EU Direcve 93/42/EEC
Protecon Against Liquids IPX2
Dimension and Weighng Weight: 31.5g (Not including baeries), Size: 61*34*30.5mm
Compliance
Item Compliant with
Type of protecon Internally powered equipment (on baery power)
Type BF Applied part
Compability

English 9
Principle of Measurement
The measurement of PULSE OXIMETER uses a mul-funconal oxyhemoglobinome-
ter to transmit some narrow spectrum light bands through blood samples, and to
measure aenuaon of spectrum with different wavelengths according to the
characterisc that RHb, O2Hb, Met Hb and COHb absorb the light of different
wavelength, thereby determining O2Hb saturaon of different fracons. O2Hb
saturaon is called “fraconal” O2Hb saturaon.
Connector
Cable
2. Accessories (Separate Purchase)
2.1 mul-funconal adapter
Accessories
Port Connector
Figure 3-1: mul-funconal adapter
2.2 Probes
Applied part
Figure 3-2: Temperature probe
2.3 Adapter Cable
Cable
Connector
Yoke for connect with probe
Figure 3-3: Adapter Cable
Fractional O2Hb saturation=
Oppositely, pulse oxygen oximeter measure functional O2Hb saturation:
RHb+O2Hb+MetHb+COHb
O2Hb x100
Functional O2Hb saturation= RHb+O2Hb
O2Hb x100

English 10
● Keep the oximeter away from dust, vibraon, corrosive substances, explosive
materials, high temperature and moisture.
● If the oximeter gets wet, please stop using.
● When it is carried from cold environment to warm and humid environment,
please do not use it immediately.
● DO NOT operate keys on front panel with sharp materials.
● High temperature or high pressure steam disinfecon of the oximeter is not
permied. Refer to User’s Manual for instrucons of cleaning and disinfecon.
● Do not have the oximeter immerged in liquid. When it needs cleaning, please
wipe its surface with disinfect soluon by so material. Do not spray any liquid on
the device directly.
● When cleaning the device with water, the temperature should be less than 60℃.
● Temperature probe that is compable with pulse oximeter menoned in this IFU
include W0024E.
● The operator is responsible for checking the compability of the equipment
connected,probe cable extender and probe before use.
● Incompable components can result in degraded performance.
Aenons
Present SpO2 oximeter transmits light of two wavelengths only, red light and
infrared, to differenate HbO2 from HbR. One side of the sensor contains two LEDs,
and the other side contains a photoelectric detector. SpO2 oximeter measures HbO2
saturaon in the blood by the light plethysmograph when the pulse beats. The
result is quite precise when HbO2 saturaion is between 70% to 100%.
Regarding temperature measurement, it's based on the principle that resistance of
thermistor based on the metal conductor increases with temperature decrease, and
changes linearly with the temperature measurement characteriscs.
The device can not be used for paents with diseases or condions including blood
microcirculaon disorder, excessive staining in the blood, disorders of important
hemoglobin indicators and severe arrhythmia.
Contraindicaon
Unpacking and Inspecon
Remove the instrument of PULSE OXIMETER from the shipping carton and
examine for signs of shipping damage. Please check all materials against the
packing list. Save the invoice, bill of lading and all packing materials. These may
be required if it is necessary to process a claim with the carrier.
If anything is missing or damaged, please contact the Technical Service
Department.
You can contact by:
● Phone: [phone]
● Fax: [phone]
● Email: [e-mail]

English 11
Section 2- Operation
Descripon
PULSE OXIMETER (instrument)
PULSE OXIMETER Operator's Manual
lanyard
Temperature probe: Disposable Skin-surface
Temperature Probe, 0.9m.
Qty
1 Piece
1 Piece
1 Piece
1 Piece
Included in the package
Installaon and Verificaon
● Baery installaon
Cauon: The Pulse Oximeter does not operate with dead baeries and can not be
powered by external power source does not input outer power.
Install new baeries.
1. Unplug all accessories from the Pulse Oximeter, and press the menu bar to
access the Seng Interface, turn the PULSE OXIMETER off. See table 1.
2. Remove the baery rear cover towards the direcon indicated on the cover.
3. Insert two “AAA” size baeries, making sure the baery’s posive and
negave poles are correctly oriented in the baery compartment as shown in
Figure 4.
4. Close the baery rear cover.
● Performance Verificaon
1. Performance Tests
Power up the device to get the oximeter ready for measurement.
2. Power-On Self-Test
Before using the PULSE OXIMETER, you must verify that the PULSE OXIMETER is
working properly and is safe to use. Proper working condions are verified each me
when the PULSE OXIMETER is turned on as described in the following
procedure. The verificaon procedure (POST) takes 2 to 3 seconds to complete.
Cauon: If any indicator or display element does not light when the PULSE
OXIMETER is turned on, do not use the PULSE OXIMETER. Instead, contact
qualified service personnel, your local MED-LINKET representave, or MED-LINKET’s
Technical Services Department.
Baery rear cover
Figure 4: Installing Baeries

English 12
Note: Physiological condions, medical procedures, or external agents may
interfere with the PULSE OXIMETER’s ability to detect and show measurements,
including dysfunconal hemoglobin, arterial dyes, low perfusion, dark pigment,
and externally applied coloring agents such as nail polish, dye, or pigmented
cream.
Note: The Pulse Oximeter automacally starts the Power-On Self-Test (POST) to
ensure that its internal circuits are funconing properly.
Procedure
1) Turn on the PULSE OXIMETER by pressing the Menu buon.
2) Aer the device completes the Power-On Self-Test (POST), it will directly
switch to measurement interface.
%SpO2 BPM
3) Long press the buon to switch device interface of PULSE OXIMETER, and
adjust parameters. See table-1.
3. Low perfusion test
SpO2 simulator is used to simulate SpO2 and pulse rate values to verify oximeter’s
performance under low perfusion condion. First, the oximeter is clamped onto the
opcal signal generator of the SpO2 simulator, then the simulator is turned on to set
specific SpO2 and pulse rate values. In addion, different perfusion levels like 0.1%
can also be set on the simulator. The values of SpO2 and pulse rate displayed on the
oximeter are then compared to those preset on the SpO2 simulator to verify whether
accuracy requirements can be met.
General Operaon
The PULSE OXIMETER can be measure funconal oxygen saturaon in the blood
by itself or plug an accessory of MED-LINKET SpO2 probe into the instrument. To
measure the body temperature by apply a temperature probe of MED-LINK. See
table-1.
● Preparave for operang
1) Insert baeries according to the installaon procedure above.
2) Press the “power ” key for 1 second to acvate the device.

English 13
● SpO2 measurement
1) Open the clip of PULSE OXIMETER, See figure 5.①.
2) Place a finger ( The preferred applicaon is middle finger and index finger) on
the silicone and ensure the finger posion is correct , see figure 5.②, and then
clamp the finger, see figure 5.③.
3) Turn on the PULSE OXIMETER by pressing the Power buon “ ”
4) Get the informaon of SpO2 directly from screen display.
① ② ③
Figure 5: measurement
Note:
1. The detail of seng see table - 1.
2. When put finger into the silicone cushions of the clip, make sure nail is
upturned.
● Temperature measurement
1) Plug the temperature probe connector side into the instrument’s USB
female connector , and then place another side of the temperature probe to
paent’s surface or Esophageal/Rectal for collecng the temperature signal.
2) Get the informaon of Temperature directly from screen display.
● Switch screen display mode
1) Press the Display mode switch, See figure 6.
Figure 6
%SpO 2
97 75
BPM

English 14
Safety
1) Safety
Instrucons for safe operaons
● Check the main unit and all accessories periodically to make sure that there is no
visible damage that may affect paent’s safety and monitoring performance. It is
recommended that the device should be inspected once a week at least. Please stop
using the device when there is obvious damage.
● Necessary maintenance must be performed by qualified service engineers
ONLY. Users are not permied to maintain it by themselves.
● The oximeter cannot be used together with devices not specified in User’s
Manual. Please use the device recommended by Manufacturer.
● Please remove the finger from the instrument to stop measure and pull the acces-
sories from the instrument, then the PULSE OXIMETER will power off automacally
within 8 seconds if the instrument must be closed for the urgent status.
2) Warnings
● Explosive hazard—DO NOT use the oximeter in environment with inflammable gas
such as some ignitable anesthec agents.
● DO NOT use the oximeter while the testee is under measurement of MRI and CT.
● Be cauous of the cable. Please do not break the cable during usage to avoid
device damage. Please don’t use cable if allergic to cable.
● Please don’t use this product if you are allergic to silicone pad and ABS plasc.
● Please dispose the device, accessory and packing (including plasc bag, foam and
carton) according to local law.
Figure 7
2) There are nine display modes for your choice, See Figure 7. Figure 7.①-
Figure 7.⑧ display SpO2 and pulse rate, Figure 7. ⑨ display SpO2, pulse rate
and temperature.
①②③
75
%SpO 2
97
BPM
%SpO 2
97 75
BPM
%SpO 2
97
75
BPM
⑦⑧⑨
TEMP
36.7
℃
97%SpO2
75 BPm
%SpO 2
97
75
BPM
%SpO 2
97
75
BPM
④⑤⑥
%SpO 2
BPM
97
75
%SpO 2
97
75
BPM
%SpO 2
97
75
BPM

English 15
● Power on
Turn on the PULSE OXIMETER by press-
ing the Menu/Power buon “ ”.
● Power off seng
Short press the buon, move the cursor
to select the item of “power off”, and
then long press the buon to turn the
power off.
Note:
The device will power off automacally
within 8 seconds when there is no any
signal input.
Menu Seng
Table 1：Instrucon for Menu seng
Funcon Instrucon for operaon Figures
Power “on”
and “off”
%SpO2 BPM
3) The aenon of Operaon
● The equipment should be fully tested to see if it can be used normally before
using.
● The finger should be placed properly (see figure 5 of this manual), or else it may
cause inaccurate measurement.
● The SpO2 sensor and photoelectric receiving tube should be arranged in a way
with the testee’s arteriole in a posion in between.
● The SpO2 sensor should not be used at a locaon or limb ed with arterial cathe-
ter or blood pressure cuff of receiving intravenous injecon.
● Make sure the opcal path is free from any opcal obstacles like rubberized fabric;
otherwise it may result in venous pulsaon and inaccurate measure of SpO2.
● Excessive ambient light may affect the measuring result. It includes fluorescent
lamp, dual ruby light, infrared heater, direct sunlight and etc.
● Strenuous acon of the testee or extreme electrosurgical interference may also
affect the accuracy.
● Testee cannot use enamel or other makeup.
● Please clean and disinfect the device aer operang according to the user manual.
● The device is not intended for use under moon condions.
Funcon Seng Introducon
Press the Pulse Oximeter Menu buon to power on and access to the tesng
interface, or press the Menu buon repeatedly during normal operaon to
switch to parameter-seng interfaces to set up the parameters and then
return to the POST display. Seable parameters include high and low SpO2
limit, high and low bpm limits, high and pulse beep volume.
The device will power off automacally within 8 seconds when there is no any
signals input, which can also be turned off by using the menu buon under
parameter-seng interfaces.

English 16
Exit PULSE OXIMETER seng interface
● Short press the buon, move the
cursor to select the item of “Exit”, long
press the buon to return to the POST
display.
“Beep” on or off seng
Short press the buon, move the cursor
to select the item of “Beep”, and then
long press the buon to turn the func-
ons on or off.
Default seng
Short press the buon, move the cursor
to select the item of “Restore”, then long
press the buon to return the PULSE
OXIMETER to factory default seng.
Aer compleng the seng, the inter-
face will indicate “OK”.
Move the cursor to select the item of
“Exit” by short press the buon, and
then long press the buon to return to
the POST display.
“prompt” on or off seng
● Short press the menu buon to enter
the interface of sengs of “Setup 1”.
Move the cursor to select the item of
“prompt”, and then long press the buon
to turn the funcons on or off.
● Short press the buon, move the
cursor to select the item of “Exit”, and
then long press the buon to return to
the POST display.
Seng enter
Long press the buon to enter the
interface of sengs.
The seng interface of PULSE OXIME-
TER includes “ Setup 1”, “ Setup 2” and
“Sounds Setup”.
Seng enter
and exit
“prompt” on
or off seng
“Beep” on or
off seng
Default
seng
SpO2 High Limit seng
Long press the buon to enter the
interface of sengs of “Setup 2”. Short
press the buon, move the cursor to
select the item of “SpO2 Hi”, long press
the buon to adjust the parameter of
SpO2 in the scope of 52% to 100%.
The default upper limit is 100%.
SpO2High
Limit seng
sengs
Setup 1 on
off
ok
Prompt
Beep
Power off
Restore
Exit
＊
sengs
Setup 1 on
off
ok
Prompt
Beep
Power off
Restore
Exit
＊
sengs
Setup 1 on
off
ok
Prompt
Beep
Power off
Restore
Exit
＊
sengs
Setup 2
100
130
50
94
+/- +
SpO2 Hi
SpO2 Lo
PR Hi
PR Lo
Exit
＊
sengs
Setup 1 on
off
ok
Prompt
Beep
Power off
Restore
Exit
＊
sengs
Setup 1 on
on
Prompt
Beep
Power off
Restore
Exit
＊

English 17
%SpO 2
97 75
BPM
Short press the buon in the interface
of “Setup 2”, move the cursor to select
the item of “PR Lo”, long press the
buon to adjust the parameter of BPM
in the scope of 30-243bpm. The default
lower limit is 50bpm.
Short press the buon in the interface of
“Sounds Setup”, move the cursor to
select the item of “Temp Hi”, long press
the buon to adjust the parameter of
temperature in the scope of 10-45℃.
Short press the buon in the interface of
“Sounds Setup”, move the cursor to
select the item of “Temp Lo”, long press
the buon to adjust the parameter of
temperature in the scope of 10-45℃.
Aer completed above seng, press the
buon switch to any interface of seng,
move the cursor to select the item of
“Exit” to return to the POST display.
Short press the buon in the interface
of “Setup 2”, move the cursor to select
the item of “PR Hi”, long press the
buon to adjust the parameter of BPM
in the scope of 32-245bpm. The default
upper limit is 130bpm.
SpO2 Low Limit seng
Short press the buon in the interface
of “Setup 2”, move the cursor to select
the item of “SpO2 Lo”, long press the
buon to adjust the parameter of SpO2
in the scope of 50% to 98%.
The default lower limit is 94%.
SpO2Low
Limit seng
Pulse Rate (PR)
High Limit
seng
Pulse Rate (PR)
Low Limit
seng
Temp High
Limit seng
Temp low
Limit seng
Return to the
POST display
sengs
Setup 2
100
130
50
94
+/- +
SpO2 Hi
SpO2 Lo
PR Hi
PR Lo
Exit
＊
sengs
Setup 2
100
130
50
94
+/- +
SpO2 Hi
SpO2 Lo
PR Hi
PR Lo
Exit
＊
sengs
Setup 2
100
130
50
94
+/- +
SpO2 Hi
SpO2 Lo
PR Hi
PR Lo
Exit
＊
sengs
Setup 3
38
36
+/- +
Temp Hi
Temp Lo
Exit
＊
sengs
Setup 3
38
36
+/- +
Temp Hi
Temp Lo
Exit
＊

English 18
Warning
● Uncomfortable or painful feeling may appear if use the device ceaselessly,
especially for the microcirculaon barrier paents. It is recommended that the
sensor should not be applied to the same finger for over 4 hours.
● For the special paents, there should be a more prudent inspecng in the placing
process. The device cannot be clamped on the edema and tender ssue.
● The light (the infrared is invisible) emied from the device is harmful to the eyes,
so the user and the maintenance man should not stare at the light.
● Testee cannot use enamel or other makeup.
● Testee’s fingernail cannot be too long.
● This device is not intended for treatment.
● The user is not allowed to repair the equipment. Changes or modificaon not
expressly approved by Shenzhen Med-link may void the warranty.
● Removing the baeries to avoid baery leakage and device damage if long me
no use.
●The symbol of "?" will be displayed on the screen when there's signal inadequacy,
indicang the displayed SpO2 or pulse rate value is potenally incorrect.
Note: The device has No Alarm System, just only warning signal is provided.
Section 3- Troubleshooting
This secon explains how to troubleshoot the PULSE OXIMETER. Tables list possible
PULSE OXIMETER difficules, along with probable causes, and recommended
acons to correct the difficules. Detailed see table 2 as below.
Table 2：Instrucon for Menu seng
Phenomena Possible Causes Soluons
Abnormal starng-up
of Pulse-Oximeter
(display screen and
transming tube of
LCD presenng lights
off）
The power buon was not
pressed in place
Re-press the power buon
in place, and keep 1-2
seconds
Not Install baery Install baery
Replace baery
Check and re-install baery
Contact authorized
distributors
Contact authorized
distributors
Baery use-out
Install baery improperly Paral
damage of Metal dome (which is
directly connected to the baery).
Damage in Connecon between
mainboard and baery holder
(i.e. Damage in flexible printed
circuit board (FPCB) or break in
welding spot).

English 19
Electromagnec Interference Cauon
This device has been tested and found to comply with the limits for medical devices
to the IEC 60601-1-2 and MDD 93/42/EEC. These limits are designed to provide
reasonable protecon against harmful interference in a typical medical installaon.
However, because of the proliferaon of radio-frequency transming equipment
and other sources of electrical noise in healthcare environments (for example,
electrosurgical units, cellular phones, mobile two-way radios, electrical appliances,
and high-definion television), it is possible that high levels of such interference
due to close proximity or strength of a source may result in disrupon of
performance of this device. This Fingerp pulse oximeter is not designed for use in
environments in which the pulse can be obscured by electromagnec interference.
During such interference, measurements may seem inappropriate or the monitor
may not seem to operate correctly.
Electromagnec Environment
The PULSE OXIMETER is intended for use in an electromagnec environment in
which radiated RF disturbances are controlled. The customer or user of the PULSE
OXIMETER can help prevent electromagnec interference by maintaining a
minimum distance between portable and mobile RF communicaons equipment
(transmiers) and the PULSE OXIMETER as recommended below, according to the
maximum output of the communicaons equipment.
Section 4- Electromagnetic Environment
Contact authorized
distributors
Contact authorized
distributors
With damage in display screen or
break in the connecon spot of
display screen
No display on
screen, but the
transming tube of
LED lights on.
No reading display
on Pulse-Oximeter
Poor perfusion problem (general-
ly, there's no display on pulse
amplitude indicator but the light
of LED transming tube is on
and the finger is inserted in
place)
The transming tube of LED
lights off
If there's no pulse amplitude
displayed on the screen,
Please,Adjust the finger
posion;Use your middle or
index finger in preference;
Warm your fingers;
Fail auto-off
Inaccurate Temp
Measurement
External Temp-probe is
sll working Pull out the external temp-probe
Damage in collecon tube or
other device parts. Contact authorized
distributors
Sck the Temp-Probe on the
proper measuring posion
by medical proof fabric
Place the Temp-Probe in
proper posion according
to the specificaon
Keep the correct measuring
method by 10 mins, and then
get the result.
The surface Temp-Probe did not
firmly sck on the skin surface.
Wrong posion of Temp-Probe
No enough measuring me

English 20
Warning:
PULSE OXIMETER should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, PULSE OXIMETER should be
observed to verify normal operaon in the configuraon in which it will be used.
Table 3—Declaraon electromagnec emissions
PULSE OXIMETER is intended for use in the electromagnec environment specified
below. The customer or the user of the Oximeter probe should assure that it is used in
such an environment.
Emissions test Compliance Electromagnec environment-guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Group 1
Class B
The PULSE OXIMETER uses RF energy for its
internal funcon. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The PULSE OXIMETER is suitable for use in
domesc establishment and in establishment
directly connected to a low voltage power
supply network which supplies buildings used
for domesc purposes.
● Guidance & Declaraon - Electromagnec Immunity
Table 4—Guidance & Declaraon — electromagnec immunity
The PULSE OXIMETER is intended for use in the electromagnec environment specified
below. The customer or the user of the PULSE OXIMETER should assure that It is used in
such an environment.
±8 kVcontact
±2 kV,±4kV,
±8 kV,
±15 kV air
±8kVcontact
±2 kV,±4kV±8 kV
±15 kV air
10 V/m
80MHz to2.7GHz
80% AM at 1kHz 10 V/m
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Immunity test IEC 60601
test level Compliance level Electromagnec environment-guidance
Electrostac
discharge (ESD)
lEC 61000-4-2
Radiated RF
Electromagnec
Fields IEC61000-4-3
Power frequency
magnec field
IEC 61000-4-8
Floors should be wood,
concrete or ceramic le. If
floors are covered with
synthec material, the
relave humidity should
be at least 30 %.
Power frequency mag-
nec fields should be at
levels characterisc of a
typical locaon in a
typical commercial or
hospital environment.