A&D UP-200 User manual

PULSE OXIMETER
UP-200
Instruction Manual

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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.