A&D UP-200 User manual

PULSE OXIMETER
UP-200
Instruction Manual

2
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter referred
to as device).
This Manual is written and compiled in accordance with the council directive MDD93/42/
EEC for medical devices and harmonized standards. In case of modi󽗉cations and software
upgrades, the information contained in this document is subject to change without no-
tice.
It is a medical device, which can be used repeatedly.
The Manual describes, in accordance with the device’s features and requirements, main
structure, functions, specifications, correct methods for transportation, installation,
usage, operation, repair, maintenance and storage, etc. as well as the safety procedures to
protect both the user and device. Refer to the respective chapters for details.
Please read the User Manual carefully before using this device. The User Manual which
describes the operating procedures should be followed strictly. Failure to follow the
User Manual may cause measuring abnormality, device damage and human injury. The
manufacturer is NOT responsible for the safety, reliability and performance issues and
any monitoring abnormality, human injury and device damage due to users' negligence
of the operation instructions. The manufacturer’s warranty service does not cover such
faults.
Owing to the forthcoming renovation, the specific products you received may not be
totally in accordance with the description of this User Manual. We would sincerely regret
for that.
Our company has the 󽗉nal interpretation to this manual. The content of this manual is
subject to change without prior notice.

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Warnings
Remind that it may cause serious consequences to tester, user or environment.
M
Explosive hazard—DO NOT use the device in environment with in󽗊ammable gas such
as anesthetic.
M
DO NOT use the device while examining by MRI or CT, as the induced current may
cause burn.
M
Do not take the information displayed on the device as the sole basis for clinical
diagnosis. The device is only used as an auxiliary means in diagnosis. And it must be
used in conjunction with doctor’s advice, clinical manifestations and symptoms.
M
The maintenance to the device. Users are not permitted to maintain or re󽗉t the device
by themselves.
M
Uncomfortable or painful feeling may appear if using the device ceaselessly, especially
for the microcirculation disturbance users. It is not recommended that the sensor is
used on the same 󽗉nger for more than 2 hours.
M
For some special users who need a more careful inspection on the test site, please
don’t place the device on the edema or tender tissue.
M
Please do not stare at the red and infrared light emitter (the infrared light is invisible)
after turning on the device, including the maintenance sta󽗈, as it may be harmful to
the eyes.
M
The device contains silicone, PVC, TPU, TPE and ABS materials, whose biocompati-
bility has been tested in accordance with the requirements in ISO 10993-1, and it has
passed the recommended biocompatibility test. The person who is allergic to silicone,
PVC, TPU, TPE or ABS can not use this device.
M
Do NOT strand the lanyard to avoid device drop and damage. The lanyard is made of

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insensitive material. Please do not use it if any person is allergic to lanyard. Do not
wrap the lanyard around neck to avoid an accident.
M
The disposal of scrap device, its accessories and packaging should follow the local
laws and regulations, to avoid polluting to the local environment. And the packaging
materials must be placed in the region where the children are out of reaching.
M
The device can not be used with the equipment not speci󽗉ed in the Manual. Only the
accessories appointed or recommended by the manufacturer can be used, otherwise
it may cause injury to the tester and operator or damage to the device.
M
Check the device before use to make sure that there is no visible damage that may
a󽗈ect user’s safety and device performance. When there is obvious damage, please
replace the damaged parts before use.
M
Functional testers can not be used to assess the accuracy of the Pulse Oximeter.
M
Some functional testers or patient simulators can be used to verify whether the device
works normally, for example, INDEX-2LFE Simulator (software version: 3.00), please
refer to the Manual for the detailed operation steps.
M
Some functional testers or patient simulators can measure the accuracy of the device
copied calibration curve, but they can not be used to evaluate the device accuracy.
M
When using the device, please keep it away from the equipment which can generate
strong electric field or strong magnetic field. Using the device in an inappropriate
environment may cause interference to the surrounding radio equipment or a󽗈ect its
working.
M
When storing the device, keep it away from children, pets and insects to avoid a󽗈ecting
its performance.

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M
Do not place the device in places exposed to direct sunlight, high temperature,
humidity, dust, cotton wool or easy to splash water, to avoid a󽗈ecting its performance.
M
The measured accuracy will be affected by the interference of electrosurgical
equipment.
M
When several products are used on the same patient simultaneously, danger may
occur which is arisen from the overlap of leakage current.
M
CO poisoning will appear excessive estimation, so it is not recommended to use the
device.
M
This device is not intended for treatment.
M
The intended operator of the device may be a user.
M
Avoid maintaining the device during using.
M
Users should read the product manual carefully before use and operate according to
the requirements.

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1. Overview
The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the
O2 concentration in the blood, it is an important physiological parameter for the respirato-
ry and circulatory system. A number of diseases related to respiratory system may cause
the decrease of SpO2 in the blood, furthermore, some other causes such as the malfunc-
tion of human body’s self-adjustment, damages during surgery, and the injuries caused
by some medical checkup would also lead to the di󽗋culty of oxygen supply in human
body, and the corresponding symptoms would appear as a consequence, such as vertigo,
impotence, vomit etc. Serious symptoms might bring danger to human’s life. Therefore,
prompt information of patients’ SpO2 is of great help for the doctor to discover the po-
tential danger, and is of great importance in the clinical medical 󽗉eld.
Insert the finger when measuring, the device will directly display the SpO2 value mea-
sured, it has a higher accuracy and repeatability.
1.1 Features
A. Easy to use.
B. Small in volume, light in weight, convenient to carry.
C. Low power consumption.
1.2 Intended purpose
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate
through 󽗉nger. The product is suitable for being used in family, hospital, oxygen bar, com-
munity healthcare, physical care in sports (It can be used before or after doing sports, and
it is not recommended to use the device during the process of having sport) and etc.

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1.3 Environment requirements
Storage Environment
a) Temperature: -40 ℃ ~ + 60 ℃
b) Relative humidity: ≤ 95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: +10 ℃ ~ + 40 ℃
b) Relative Humidity: ≤ 75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
1.4 Precautions
1.4.1 Attention
Point out conditions or practices that may cause damage to the device or other proper-
ties.
%Before using the device, make sure that it locates in normal working state and operat-
ing environment.
%In order to get a more accurate measurement, it should be used in a quiet and com-
fortable environment.
%When it is carried from cold or hot environment to warm or humid environment,
please do not use it immediately,wait four hours at least is recommended.
%If the device is splashed or coagulated by water, please stop operating.
%DO NOT operate the device with sharp things.
%High temperature, high pressure, gas sterilizing or immersion disinfection for the
device is not permitted. Refer to User Manual in the relative chapter (6.1) for cleaning

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and disinfection..Please take out the internal battery before cleaning and disinfection.
%The product is suitable for adults.
%The device may not be suitable for all users, if you can’t get a satisfactory result,
please stop using it.
%Data averaging and signal processing have a delay in the upgrade of SpO2 data values.
When the data update period is less than 30 seconds, the time for obtaining dynamic
average values will increase, which is arisen from signal degradation, low perfusion or
other interference, it depends on the PR value.
%The device has 3-year service life, date of manufacture: see the label.
%The device hasn’t low-voltage prompt function, it only shows the low-voltage,
please change the battery when the battery voltage is used up.
%The maximum temperature at the SpO2 probe -tissue interface should be less than
41℃ which is measured by the temperature tester.
%During measuring, when abnormal conditions appear on the screen, please pull out
your 󽗉nger and reinsert it to measure again.
%If some unknown error appears during measuring, remove the battery to terminate
operating.
%Do not contort or drag the wire of the device.
%The plethysmographic waveform is not normalized, as a signal inadequacy indicator,
when it is not smooth and stable, the accuracy of the measured value may degrade.
When it tends to be smooth and stable, the measured value read is the optimal and
the waveform at this time is also the most standard.
%If the device or component is intended for single-use, then the repeated use of these

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parts will pose risks on the parameters and technical parameters of the equipment
known to the manufacturer.
%If necessary, our company can provide some information (such as circuit diagrams,
component lists, illustrations, etc.), so that the quali󽗉ed technical personnel of the
user can repair the device components designated by our company.
%The measured results will be in󽗊uenced by the external colouring agent (such as nail
polish, colouring agent or color skin care products, etc.), so don’t use them on the
test site.
%As to the 󽗉ngers which are too cold or too thin or whose 󽗉ngernail is too long, it may
a󽗈ect the measured results, so please insert the thicker 󽗉nger such as thumb or mid-
dle 󽗉nger deeply enough into the probe when measuring.
%The 󽗉nger should be placed correctly (see Attached 󽗉gure 5), as improper installation
or improper contact position for sensor will in󽗊uence the measurement.
%The light between the photoelectric receiving tube and the light-emitting tube of the
device must pass through the subject’s arteriole. Make sure the optical path is free
from any optical obstacles like rubberized fabric, to avoid inaccurate results.
%Excessive ambient light may a󽗈ect the measured results, such as surgical light (espe-
cially xenon light sources), bilirubin lamp, 󽗊uorescent lamp, infrared heater and direct
sunlight, etc. In order to prevent interference from ambient light, make sure to place
the sensor properly and cover the sensor with opaque material.
%Frequent movement (active or passive) of the subject or severe activity can a󽗈ect the
measured accuracy.
%The Pulse Oximeter should not be placed on a limb with the blood pressure cu󽗈, arte-

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rial ductus or intraluminal tube.
%The measured value may be inaccurate during de󽗉brillation and in a short period af-
ter de󽗉brillation, as it has not de󽗉brillation function.
%The device has been calibrated before leaving factory.
%The device is calibrated to display functional oxygen saturation.
%The equipment connected with the Oximeter interface should comply with the re-
quirements of IEC 60601-1.
1.4.2 Clinical restriction
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood 󽗊ow
of subject is required. For a subject with weak pulse due to shock, low ambient/body tem-
perature, major bleeding, or use of vascular contracting drug, the SpO2 waveform (PLETH)
will decrease. In this case, the measurement will be more sensitive to interference.
B.The measurement will be in󽗊uenced by intravascular staining agents (such as indocy-
anine green or methylene blue), skin pigmentation.
C.The measured value may be normal seemingly for the tester who has anemia or dys-
functional hemoglobin(such as carboxyhaemoglobin (COHb), methaemoglobin (MetHb)
and sulfhaemoglobin (SuHb)), but the tester may appear hypoxia, it is recommended to
perform further assessment according the clinical situations and symptoms.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some se-
vere anemia patients still show better pulse oxygen measured valued.
E. Contraindication:
a. The person who is allergic to silicone, PVC, TPU TPE or ABS can not use this device.
b. The damaged skin tissue can’t be measured.

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c. During cardiopulmonary resuscitation.
d. When the patient is hypovolemic.
e. For assessing the adequacy of ventilatory support.
f. For detecting worsening lung function in patients on a high concentration of oxygen.
1.5 Clinical indications
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate
through 󽗉nger.
2. Principle
Figure 1 Operating principle
Principle of the Oximeter is as follows: An experience formula of data process is estab-
lished taking use of Lambert Beer Law according to Spectrum Absorption Characteristics
of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones.
Operation principle of the device is: Photoelectric Oxyhemoglobin Inspection Technology

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is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that
two beams of di󽗈erent wavelength of lights can be focused onto human nail tip through
perspective clamp 󽗉nger-type sensor. Then measured signal can be obtained by a photo-
sensitive element, information acquired through which will be shown on screen through
treatment in electronic circuits and microprocessor.
3. Functions
A. SpO2 value display
B. PR value and bar graph display
C. Pulse waveform display
D. Low-battery indication: low-battery indication appears when the battery voltage is too
low to work
E. Automatic standby function
F. Display mode can be changed
G. Adjustable screen brightness
H. Display direction can be changed automatically

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4. Installation
4.1 View of the Front Panel
Figure 2 Front view
4.2 Battery
Step 1. Refer to Figure 3 and insert the two AAA size batteries properly in the right direc-
tion.
Step 2. Replace the cover.
Figure 3 Batteries installation

14
Figure 4 Mounting the hanging rope
Please take care when you insert the batteries for the improper insertion may
damage the device.
4.3 Mounting the Hanging Rope
Step 1. Put the end of the rope through the hole refer to Figure 4 .
Step 2. Put another end of the rope through the 󽗉rst one and then tighten it.
4.4 Structure, accessories
A. Structure: main unit.
B. Accessories: one User Manual, One hanging rope, Two batteries(optional).
Please check the device and accessories according to the list to avoid that the
device can not work normally.

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5. Operating Guide
1) Insert the two batteries properly to the direction, and then replace the cover.
2) Open the clip as shown in Figure 5.
Figure 5 Put 󽗉nger in position
3) Let the patient’s 󽗉nger put into the rubber cushions of the clip (make sure the 󽗉n-
ger is in the right position), and then clip the 󽗉nger.
4) Press the button once on front panel.
5) Do not shake the 󽗉nger and keep the patient at ease during the process. Meanwhile,
human body is not recommended in movement status.
6) Get the information directly from screen display.
When the device is in operation status, the display mode can be changed.
7) When the device is in standby mode, pressing the button can exit it; When the device
is in operation status, pressing the button long can change brightness of the screen.
8) Under non-measurement state, it will enter standby mode automatically when there
is no operation within 5s.
Fingernails and the luminescent tube should be on the same side.

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6. Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must be turned o󽗈 before cleaning, and it should not be immersed into liquid.
Please take out the internal battery before cleaning, do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, nature dry or clean it with clean and soft
cloth. Do not spray any liquid on the device directly, and avoid liquid penetrating into the
device.
6.2 Maintenance
A. Check the main unit and all accessories periodically to make sure that there is no visible
damage that may a󽗈ect patient’s safety and monitoring performance. It is recommend-
ed that the device should be inspected weekly at least. When there is obvious damage,
stop using it.
B. Please clean and disinfect the device before/after using it according to the User Manual
(6.1).
C. Please replace the batteries in time when low-battery appears.
D. Please take out the batteries if the device is not used for a long time.
E. The device need not to be calibrated during maintenance.
6.3 Transport and Storage
A. The packed device can be transported by ordinary conveyance or according to trans-
port contract. During transportation, avoid strong shock, vibration and splashing with
rain or snow, and it can not be transported mixed with toxic, harmful, corrosive material.

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B. The packed device should be stored in room with no corrosive gases and good ventila-
tion. Temperature: -40° C~+60° C; Relative humidity: ≤ 95%.
7. Troubleshooting
Trouble Possible Reason Solution
The values can
not be displayed
normally or
stably.
1) The 󽗉nger is not properly
inserted.
2) The 󽗉nger is shaking or the
patient is moving.
3) The device is not used in
environment required by the
manual.
4) The device works abnormally.
1) Please insert the 󽗉nger
properly and measure again.
2) Let the patient keep calm.
3) Please use the device in
normal environment.
4) Please contact the af-
ter-sales.
The device can
not be turned
on
1) The battery is drained away or
almost drained away.
2) The battery is installed incor-
rectly.
3) The device’s malfunction.
1) Please change batteries.
2) Please Install the battery
again.
3) Please contact the local
service center.
The display
disappears
suddenly.
1) The device enters into the
energy saving mode.
2) Low battery.
3) The device works abnormally.
1) Normal.
2) Please change batteries.
3) Please contact the af-
ter-sales.

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8. Key of Symbols
Note：Your device may not contain all the following symbols.
Symbol Description
Type BF
Refer to instruction manual/booklet
%SpO2The pulse oxygen saturation(%)
PRbpm Pulse rate (bpm)
Recyclable
1.No 󽗉nger inserted
2.An indicator of signal inadequacy
Battery positive electrode
Battery cathode
1.Exit standby mode.
2.Change brightness of the screen.
Serial number
Prompt inhibit
IP22 International Protection
WEEE (2012/19/EU)
Symbol Description
European Representative
Manufacture Date
Manufacturer
Storage and Transport Temperature
limitation
Storage and Transport Humidity lim-
itation
Storage and Transport Atmospheric
pressure limitation
This side up
Fragile, handle with care
Keep dry
This item is compliant with Directive
93/42/EEC of 14 june 1993 concerning
medical devices; Including, at 21 march
2010, the amendments by Council
Directive 2007/47/EC.
The battery voltage indication is defi-
cient
(change the battery in time avoiding
the inexact measure)

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9. Function Speci󽗉cation
SpO2 [see note 1]
Display range 0% ~ 99%
Measured range 0% ~ 100%
Accuracy [see note 2] 70%~100%: ±2%;
0%~69%: unspeci󽗉ed.
Resolution 1%
PR
Display range 30 bpm ~ 250 bpm
Measured range 30 bpm ~ 250 bpm
Accuracy
[see note 3]
±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during
the pulse rate range of 100 bpm ~ 250 bpm.
Resolution 1 bpm
Accuracy under low perfu-
sion [see note 4]
Low perfusion 0.4%:
SpO2: ±4%;
PR: ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2%
during the pulse rate range of 100 bpm ~ 250 bpm.
Light interference Under normal and ambient light conditions, the SpO2 deviation ≤ 1%
Pulse intensity Continuous bar graph display, the higher display indicates the stronger pulse.
Optical sensor [see note 5]
Red light Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light Wavelength: about 905 nm, optical output power: < 6.75 mW
Safety class Internally powered equipment, type BF applied part
International Protection IP22

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Working voltage DC 2.6 V ~ 3.6 V
Working current ≤ 30 mA
Power supply 1.5 V (AAA size) alkaline batteries × 2
Operation time The device can continuously work for 20 hours when it was powered by two
new batteries within the warranty period.
Dimension and Weight
Dimension 57(L) × 31(W) × 32(H) mm
Weight About 50 g (with the batteries)
Note 1: The claims of SpO2 accuracy shall be supported by clinical study measure-
ments taken over the full range. By arti󽗉cial inducing, get the stable oxygen level to
the range of 70 % to 100 % SpO2, compare the SpO2 values collected by the second-
ary standard pulse oximeter equipment and the tested equipment at the same time,
to form paired data, which are used for the accuracy analysis.
There are 12 healthy volunteers (male: 6. female: 6; age: 18~50; skin color: black: 2,
light: 8, white: 2) data in the clinical report.
Note 2: Because pulse oximeter equipment measurements are statistically distrib-
uted, only about two-thirds of pulse oximeter equipment measurements can be
expected to fall within ±Arms of the value measured by a CO-OXIMETER.
Note 3: Patient simulator has been used to verify the pulse rate accuracy, it is stated
as the root-mean-square di󽗈erence between the PR measurement value and the
value set by simulator.
Note 4: Percentage modulation of infrared signal as the indication of pulsating sig-
nal strength, patient simulator has been used to verify its accuracy under conditions
of low perfusion. SpO2 and PR values are di󽗈erent due to low signal conditions,