MedLinket AM-806 User manual

REF: AM-806
20211230 A.1
Temp-pulse oximeter
P2-24
P1-23
Instruction Manual
Original
(Suitable for A4 paper printing)
Manual de Instrucciones
Traducción
(Adecuado para impresión en papel A4)

English 1
Contents
Quick Start Guide…………………………………………………………………………………………
Foreword ……………………………………………………………………………………………………
Warning ………………………………………………………………………………………………………
Latex Content Statement ……………………………………………………………………………
Secon1-Overview ………………………………………………………………………………………
Intended Use …………………………………………………………………………………………………
Essenal Performance ……………………………………………………………………………………
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……………………………………………………………………………
Warnings…………………………………………………………………………………………………………
Disposal……………………………………………………………………………………………………………
Warranty…………………………………………………………………………………………………………
Qualified cerficate…………………………………………………………………………………………
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English 2
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,Spanish Scan the QR code to watch
the instrucon video on YouTube!
hps://www.med-linket.com/
uploads/US_manual_AM-806.pdf

English 3
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.
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 users. If skin integrity changes, move the sensor to another site.
At elevated ambient temperatures, users 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 users applicaon sites frequently. The temperature of the
sensor contacng with skin won't exceed 105.8℉ if the inial skin temperature
doesn't exceed 95℉.
Be aware that following removal of the sensor from the users, it is possible that
environmental light may cause the oximeter device 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
ELECTRICAL 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.
●
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Warning

English 4
The PULSE OXIMETER is not made with natural rubber latex in any locaon that may
result in users contact.
Latex Content Statement
Intended Use
This pulse oximeter is not a medical device and is not intended to diagnose and/or
treat any medical condion or disease. It is intended for non-medical use by healthy
people to monitor their pulse rate and blood oxygen levels. It is for sports and/or
aviaon use.
Target populaon: Adult, adolescent and child.
Essenal Performance
The essenal performance of this device is defined as SpO2 accuracy and pulse rate
accuracy, or an indicaon of abnormal operaon. Accuracies may be affected as a
result of exposure to electromagnec disturbances that are outside of the
environments listed in this Instrucon For Use. If such a kind of situaon appears,
move the device away from the source of electromagnec disturbances. When
there's signal inadequacy, the symbol of "?" will be displayed on the screen, indicang
the displayed SpO2 or pulse rate value is potenally incorrect.
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.
Section 1- Overview

English 5
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.
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(Storage,
Transportaon and Operang)
No SpO2 Alarm
Batch Code
Compliance with WEEE Standard
MR unsafe
Protected against vercally
falling water drops when
enclosure lted up to 15°
NON
STERILE
80%
0%
-10℃
40℃
5℃
40℃
LOT
Atmospheric Pressure
limitaon(Storage,
Transportaon and
Operang)
Type BF (Body Floang)
Applied Part
Storage & transportaon
temperature limit
Operaon temperature
limit
10 Environment-friendly
use period
Date of manufacture

English 6
Technical Specifications
Reminder Baery-low indicator
Method Dual wavelength LED
Pulse Rate Range 30 to 245 bpm
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
Pulse Rate Resoluon
Pulse Accuracy
(under good
& low perfusion)
±3 bpm
LED Wavelengths Red: approximately 660nm; Infrared: approximately 905nm
Less than 15mW
Range, Accuracy
Display Resoluon
1 bpm
Opcal output power
Temperature
Note: The funcon of temperature measure 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 SpO 2 funcon works
Less than 55mA
Only Temp funcon works Less than 40mA
SpO2 and Temp funcon
work together Less than 60mA
Apply the accessory of
SpO2 probe Less than 55mA
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
77°to 113°F (25℃ to 45℃): ±0.2°F（±0.1℃）
±0.2°F （±0.1℃）

English 7
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
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
Equipment classificaon Safety Standards: IEC 60601-1:2012,
EMC: IEC 60601-1-2:2014
Type of protecon Internally powered equipment (on baery power)
Product parts and accessories
The Pulse Oximeter is composed of instrument and accessories, detail of the
instrument and accessories see figure 2 - figure 4.
1. Instrument
Control buon Display
Screen
Applied
part
Baery cover
Accessories
Port Connector lanyard
Figure 2: instrument

English 8
Principle of Measurement
The measurement of PULSE OXIMETER uses a mul-funconal
oxyhemoglobinometer 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.
Fractional O2Hb saturation=
Oppositely, pulse oxygen oximeter measure functional O2Hb saturation:
RHb+O2Hb+MetHb+COHb
O2Hb x100
Functional O2Hb saturation= RHb+O2Hb
O2Hb x100
Connector
Cable
3. Accessories (Separate Purchase)
3.1 Wrist strap adapter
Accessories
Port Connector
Figure 4-1: Wrist strap adapter
2. Temperature probe
Applied part
Figure 3: Temperature probe
3.2 Adapter Cable
Cable
Connector
Yoke for connect with SpO2 probe
Figure 4-2: Adapter Cable

English 9
● 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 140℉.
Aenons
Unpacking and Inspecon
Remove the equipment 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]
Included in the package
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on is between 70% to 100%.
The device can not be used for users 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
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

English 10
Section 2- Operation
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. Install new baeries.
1. Unplug all accessories from the Pulse Oximeter, and press the menu buon 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 5.
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.
Note: The Pulse Oximeter automacally starts the Power-On Self-Test (POST) to
ensure that its internal circuits are funconing properly.
Baery rear cover
Figure 5: Installing Baeries

English 11
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
① ② ③
Figure 6: measurement
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 3% and
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 measure funconal oxygen saturaon in the blood by itself
, which can also be obtained through plugging an accessory of MED-LINKET SpO2
probe into the instrument. Body temperature can be measured by applying 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.
● SpO2 measurement
1) Open the clip of PULSE OXIMETER, See figure 6.①.
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 6.②, and then clamp the
finger, see figure 6.③.
3) Turn on the PULSE OXIMETER by pressing the Power button “ ”
4) Get the information of SpO2 directly from screen display.

English 12
Note:
1. The detail of seng see table - 1.
2. When placing finger onto the silicone pad, make sure nail is upturned.
● Temperature measurement
1) Plug the temperature probe connector side into the instrument’s USB female
connector .
● Switch Screen turn switch
1) Press the Screen turn switch, See figure 7.
Figure 7
%SpO 2
97 75
BPM
TEMP
96.8
℉97%SpO2
75 BPm
3) Get the informaon of temperature directly from screen display.
2) Place another side of the temperature probe to user’s surface or esophageal/rec-
tal for collecng the temperature signal.
Recommended measure
5-8 minutes
Recommended measure
8-10 minutes
Recommended measure
3-5 minutes

English 13
2) There are nine display modes for your choice, See Figure 8. Figure 8.①-Figure
8.⑧ display SpO2 and pulse rate, Figure 8. ⑨ display SpO2, pulse rate and tem-
perature.
Figure 8
①②③
75
%SpO 2
97
BPM
%SpO 2
97 75
BPM
%SpO 2
97
75
BPM
⑦⑧⑨
TEMP
96.8 ℉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
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 user’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 equipment to stop measure and pull the
accessories from the equipment, then the PULSE OXIMETER will power off auto-
macally within 8 seconds if the equipment 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
C T.
● 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.

English 14
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 4 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 device should not be used at a locaon or limb ed with arterial catheter 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.
Funcon Seng Introducon
Press the Pulse Oximeter Menu buon to power on and access to the tesng inter-
face, 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 parame-
ter-seng interfaces.
● 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

English 15
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.
“Alm” on or off seng
● Short press the menu buon to enter
the interface of sengs of “Alm Setup
1”. Move the cursor to select the item
of “Alm”, 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 “Alm Setup 1”, “Alm Setup
2” and “Sounds Setup”.
Seng enter
and exit
“Alm” 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 “Alm Setup 2”.
Short press the buon, move the cursor
to select the item of “SpO2 Alm 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%.
SpO2 High
Limit seng

English 16
%SpO 2
97 75
BPM
Short press the buon in the interface
of “Alm Setup 2”, move the cursor to
select the item of “PR Alm 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 Alm Hi”, long press the
buon to adjust the parameter of tem-
perature in the scope of 78-113℉.
Short press the buon in the interface of
“Sounds Setup”, move the cursor to select
the item of “Temp Alm Lo”, long press the
buon to adjust the parameter of tem-
perature in the scope of 77-112℉.
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 “Alm Setup 2”, move the cursor to
select the item of “PR Alm Hi”, long
press the buon to adjust the parame-
ter of BPM in the scope of 32-245bpm.
The default upper limit is 130 bpm.
SpO2 Low Limit seng
Short press the buon in the interface
of “Alm Setup 2”, move the cursor to
select the item of “SpO2 Alm 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

English 17
Warning
● Uncomfortable or painful feeling may appear if use the device ceaselessly, espe-
cially for the microcirculaon barrier users. It is recommended that the sensor
should not be applied to the same finger for over 4 hours.
● For the special users, 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 18
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.
Contact authorized
distributors
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
Electromagnec Interference Cauon
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 device 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 mini-
mum distance between portable and mobile RF communicaons equipment (trans-
miers) and the PULSE OXIMETER as recommended below, according to the maxi-
mum output of the communicaons equipment.
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.
Section 4- Electromagnetic Environment

5
English 19
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.