A&D UP-200 User manual

INSTRUCTIONS TO USER
Dear Users, thank you very much for purchasing the UP-200 Pulse Oximeter.
In case of modications and software upgrades, the information contained in
this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter’s features and
requirements, product features, functions, specications, correct methods for:
transportation, use, repair, maintenance and storage, as well as the safety
procedures to protect both the user and equipment. Refer to the respective
chapters for details.
Please read the Manual very carefully before using this equipment. These
instructions describe the operating procedures to be followed strictly, failure to
follow these instructions 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 operation
instructions. The manufacturer’s warranty service does not cover such faults.
Due to product updates, the specic products you received may not be
totally in accordance with the description of this User Manual. We regret any
confusion.
This product can be used repeatedly. Its useful life is 3 years.
If you have any questions regarding to the use of this product, please call us at
one of the numbers listed at the end of this manual.
WARNING:
• An uncomfortable or painful feeling may appear if using the oximeter
continuously, especially for the microcirculation barrier users. It is
recommended that the sensor should not be applied to the same
nger for over 2 hours.
• For individual users, ensure proper placement of the oximeter. The
oximeter cannot be clipped on the edema and tender tissue.
• The light (the infrared is invisible) emitted from the oximeter is harmful
to the eyes, do not stare at the light.
• User cannot use enamel or other ngernail polish.
• User’s ngernail cannot be too long.
• Please review the relative content about the clinical restrictions and
caution.
• This oximeter is not intended for treatment.
The User Manual is published by our company. All rights reserved.
1 SAFETY
1.1 Instructions for Safe Operations
• 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 oximeter should be inspected at
least once a week. When there is obvious damage, stop using the oximeter.
• Necessary maintenance must be performed by qualied service engineers
ONLY. Users are not permitted to maintain it by themselves.
• The oximeter cannot be used together with devices not specied in User’s
Manual. Only use the type of accessories included in the package.
• This product is calibrated before leaving factory.
1.2 Warnings
• Explosive hazard—DO NOT use the oximeter in environment with
inammable gas such as some ignitable anesthetic agents.
• Do not use this oximeter if you are allergic to rubber.
• The disposal of the oximeter and its accessories and packaging (including
batteries, plastic bags, foam inserts and paper boxes) should follow the
local laws and regulations.
• Please check the packing before use to make sure the oximeter and
accessories are in accordance with the packing list, or else the oximeter
may not work properly.
• Please don’t measure this oximeter with a functional tester for the
oximeter’s related information.
• Warning against servicing and maintenance while the equipment is in use.
• No modication of this equipment is allowed.
• The user is an intended operator.
• The probe of the oximeter is the applied part.
1.3 Attentions
• Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
• If the oximeter gets wet, discontinue use.
• Do not use immediately after moving it from a cold environment to warm or
humid environment.
• Do not operate buttons on front panel with sharp materials.
• Do not use high temperature or high pressure steam disinfection of the
oximeter. Refer to chapter (8) for instructions of cleaning and disinfection.
• Do not immerge the oximeter in liquid. When it needs cleaning, please wipe
its surface with medical alcohol by soft material. Do not spray any liquid on
the oximeter directly.
• When cleaning the oximeter with water, the temperature should be lower
than 60 °C.
• As to the ngers which are too thin or too cold, it would probably affect the
normal measure of the users’ SpO2 and pulse rate, use a larger nger such
as thumb or middle nger and place nger deeply into the probe.
• Do not use the oximeter on infant or neonatal users.
• The product is suitable for adults (weight should be between 40 kg to 110
kg).
• The oximeter may not work for all users. If you are unable to achieve stable
readings, discontinue use.
• The update period of data is less than 5 seconds, which is changeable
according to different individual pulse rate.
• The waveform is normalized. Please read the measured value when the
waveform on the screen is steady. This measured value is optimal value,
and the waveform at the moment is the standard one.
• If some abnormal conditions appear on the screen during test process, pull
out the nger and reinsert to restore normal use.
• The lanyard is made from non-allergy material, if you are sensitive to the
lanyard, stop using it. In addition, do not wear it around the neck to avoid
harm to the users.
• The oximeter does not have low-voltage alarm function, it only shows the
low-voltage. Please change the battery when the battery energy is used up.
• The instrument does not have alarm function. Do not use the device in
situations where alarms are required.
• Batteries must be removed if the oximeter is going to be stored for more
than one month, or else batteries may leak.
• A exible circuit connects the two parts of the oximeter. Do not twist or pull
on the connection.
1.4 Indication for Use
The Pulse Oximeter is a non-invasive device intended for the spot-check of
saturation of arterial hemoglobin(SpO2) and the pulse rate of adult in home use
environments. This oximeter is not intended for continuous monitoring. The
device can be used multiple times.Pulse oximeter intended for wellness use.
2 OVERVIEW
The pulse oxygen saturation is the percentage of HbO2in the total Hb in the
blood - the O2concentration in the blood. It is an important bio-parameter for
respiration. This Pulse Oximeter was developed for the purpose of measuring
the SpO2more easily and accurately. At the same time, the oximeter can
measure the pulse rate.
The Pulse Oximeter features a compact design, low power consumption,
and convenient operation. It is only necessary for user to put one nger into
a ngertip photoelectric sensor for measurement, and a display screen will
directly show measured value of Hemoglobin Saturation.
2.1 Features
• Easy to use
• Easy to view with a display that changes direction automatically.
• Small, lightweight design
• Convenient carrying case.
• Low power consumption – allowing for 20 hours of continuous operation on
a new set of batteries.
• Standby mode when no signal is received within 5 seconds.
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used in measuring pulse oxygen saturation and
pulse rate through nger. The product is suitable for family use (It can be used
before or after doing sports, and it is not recommended to use the oximeter
during sports activity).
The problem of overrating would emerge when the user is
suffering from toxicosis which caused by carbon monoxide, the
oximeter is not recommended to be used under this
circumstance.
2.3 Environment Requirements
Storage Environment
a. Temperature: -40°C ~ +60°C
b. Relative humidity: ≤95%
c. Atmospheric pressure: 500hPa ~ 1060hPa
Operating Environment
a. Temperature: 10°C ~ 40°C
b. Relative humidity: ≤75%
c. Atmospheric pressure: 700hPa ~ 1060hPa
3 ACCESSORIES
• 1 Lanyard
• 2 Batteries
• 1 User Manual
• 1 Carrying Case
4 SET UP
4.1 View of the Front Panel
pulse bar graph pulse waveform
Low-battery indication SpO2
pulse rate
button
Figure 1: Front View
4.2 Battery
Step 1.Insert the two AAA size batteries in the proper direction (Refer to Figure
2).
Step 2. Put the cover back on.
Please take care when you insert the batteries for the improper
insertion may damage the device.
Figure 2: Batteries Installation
4.3 Attaching the lanyard
Step 1. Put the thin loop through the hole on the oximeter.
Step 2. Put the lanyard strap through the thin loop and tighten.
Figure 3: Attaching the Lanyard
Figure 4: Put Finger in Position
5 USING THE OXIMETER
5.1 Insert the two batteries properly to the direction, and then replace the
cover.
5.2 Open the clip as shown in Figure 4.
5.3 Place your nger into the rubber cushions with the nail towards the top of
the oximeter, and then clip your nger.
5.4 Press the switch button once on front panel.
5.5 Do not shake your nger and remain still.
5.6 See your results from screen display.
5.7 The button has two functions. When the oximeter is in standby mode,
pressing the button can exit it; When the oximeter is in operation status,
pressing the button for longer can change brightness of the screen.
5.8 The oximeter changes display direction according to the direction you
hold it.
Fingernails and the luminescent tube (emission tube) should be
on the same side.
6 PRINCIPLE AND CAUTION
6.1 Principle of Measurement
Principle of the Oximeter is as follows: An experience formula of data process
is established 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 instrument is:
Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance
with Capacity Pulse Scanning & Recording Technology, so that two beams
of different wavelength of lights can be focused onto human nail tip through
perspective clamp nger-type sensor. Then measured signal can be obtained
by a photosensitive element, information acquired through which will be shown
on screen through treatment in electronic circuits and microprocessor.
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
Figure 5: Operating Principle
6.2 Caution
1. The nger should be placed properly (see the attached illustration of this
manual, Figure 4), or else it may cause inaccurate measurement.
2. The SpO2sensor and photoelectric receiving tube should be arranged in a
way with the subject’s arteriole in a position there between.
3. The SpO2 sensor should not be used at a location or limb tied with arterial
canal or blood pressure cuff or receiving intravenous injection.
4. Make sure the optical path is free from any optical obstacles like rubberized
fabric.
5. Excessive ambient light may affect the measuring result. It includes
uorescent lamp, dual ruby light, infrared heater, direct sunlight etc.
6. Strenuous action of the subject or extreme electrosurgical interference may
also affect the accuracy.
7. User cannot use ngernail polish.
6.3 Clinical Restrictions
1. As the measurement 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 temperature, 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.
2. For those with a substantial amount of staining dilution drug (such as
methylene blue, indigo green and acid indigo blue), carbon monoxide
hemoglobin (COHb), methionine (Me+Hb) or thiosalicylic hemoglobin, and
some with icterus problem, the SpO2determination by this monitor may be
inaccurate.
3. Drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also
cause inaccurate SpO2measurements.
4. As the SpO2value serves as a reference value for anemic anoxia and
toxic anoxia, some users with serious anemia may report good SpO2
measurement.
7 TECHNICAL SPECIFICATIONS
1. Display Format: LCD Display
SpO2 Measurement Range: 0 ~ 100%
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm
Pulse Wave Display: bar-graph display and the waveform display.
2. Power Requirements: 2 × 1.5 V AAA alkaline battery (or rechargeable
battery), adaptable range: 2.6 V ~ 3.6 V.
3. Power Consumption: Less than 30 mA.
4. Resolution: 1% for SpO2 and 1 bpm for Pulse Rate.
5. Measurement Accuracy:
SpO2: ±2% for 70% ~ 100%; not applicable if < 70%
Pulse Rate: ±2 bpm or ±2% (whichever is larger)
Clinical Trial: SpO2 regression plot & Bland–Altman plot,Refer to Figures
6 and 7.
6. Measurement Performance in Weak Filling Condition: SpO2and pulse
rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2error is
±4%, pulse rate error is ±2 bpm or ±2% (select larger).
7. Resistance to surrounding light: The deviation between the value
measured in the condition of man-made light, indoor natural light and
darkroom is less than ±1%.
8. It is equipped with a switch function: The product will enter standby
mode when no signal is in the product within 5 seconds.
9. Optical Sensor
Red light (wavelength is 660 nm, 6.65 mW)
Infrared (wavelength is 905 nm, 6.75 mW)
Figure 6: SpO2regression plot
Figure 7: Bland–Altman plot
8 REPAIRING AND MAINTENANCE
• Please change the batteries when low-voltage is displayed on the screen.
• Clean the surface of the oximeter before using. Wipe the oximeter with
medical alcohol first, and then let it dry in air.
• Using the medical alcohol to disinfect after use prevents cross infection for
next use.
• Please take out the batteries if the oximeter is not used for a long time.
• The oximeter can be transported by ordinary conveyance or according to
transport contract. The oximeter can not be transported mixed with toxic,
harmful, corrosive material.
• The best storage environment of the oximeter is - 40ºC to 60ºC ambient
temperature and not higher than 95% relative humidity.
• There is no need to calibrate the oximeter.
High-pressure sterilization cannot be used on the oximeter.
Do not immerse the oximeter in liquid.
It is recommended that the oximeter should be kept in a dry
environment. Humidity may reduce the useful life of the oximeter,
or even damage it.
Pulse Oximeter User Manual
UP-200

9 TROUBLESHOOTING
Trouble Possible Reason Solution
The SpO2
and Pulse
Rate cannot
be displayed
normally
1. The nger is not properly
positioned.
2. The user’s SpO2is too
low to be detected.
1. Place the nger properly
and try again.
2. Go to a hospital for a
diagnosis if you are sure
the oximeter is working
correctly.
The Sp02and
Pulse Rate are
not displayed
stably
1. The nger is not placed
inside deep enough.
2. The nger is shaking or
the user is moving
1. Place the nger properly
and try again.
2. Remain still while taking
the measurement
The oximeter
cannot be
turned on
1. The batteries are drained
or almost drained.
2. The batteries are not
inserted properly.
3. Malfunction of the
oximeter.
1. Change batteries.
2. Reinstall batteries.
3. Please contact customer
support.
The display is
off suddenly
1. The product will enter
standby mode when no
signal is in the product
within 5 seconds.
2. The batteries are almost
drained.
1. Normal.
2. Change batteries.
10 KEY OF SYMBOLS
Symbol Description Symbol Description

Type BF WEEE (2002/96/EC)
Refer to instruction
manual IP22 Ingress of liquids rank
%SpO2
The pulse oxygen
saturation (%) Manufacturer
PRbpm Pulse rate (bpm) Manufacture Date
Full-voltage
Storage and
Transport
Temperature
limitation
The battery voltage
indication is decient
(change the battery
in time avoiding the
inexact measure)
Storage and
Transport Humidity
limitation

1. No nger inserted
2. An indicator of
signal inadequacy
Storage and
Transport
Atmospheric pressure
limitation

Battery positive
electrode This side UP
Battery cathode Fragile, handle with
care
1. Exit standby mode.
2. Change brightness
of the screen.
Keep dry
SN Serial number Recyclable

Alarm inhibit
11 FUNCTION SPECIFICATION
Display Information Display Mode
The Pulse Oxygen
Saturation (SpO2)
LCD
Pulse Rate (PR) LCD
Pulse Intensity (bar-graph) LCD bar-graph display
Pulse Wave LCD
SpO2Parameter Specification
Measuring Range 0% ~ 100%, (the resolution is 1%).
Accuracy 70% ~ 100%: ±2% ,Below 70% unspecied.
Optical Sensor Red light (wavelength is 660 nm)
Infrared (wavelength is 880 nm)
Pulse Parameter Specification
Measuring Range 30 bpm ~ 250 bpm (the resolution is 1 bpm)
Accuracy ±2 bpm or ±2% select larger
Pulse Intensity
Range Continuous bar-graph display, the higher
display indicate the stronger pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 24 hours
Dimensions and Weight
Dimensions 2.3 (L) x 1.3 (W) x 1.3 (H) inch / 59(L) × 33(W)
× 32(H) mm
Weight ~ 2 oz / 57 g (with the batteries)
12 APPENDIX
Guidance and manufacture’s declaration – electromagnetic emissions
for all EQUIPMENT and SYSTEMS
Guidance and Manufacture’s Declaration – Electromagnetic Emission
The UP-200 Pulse Oximeter is intended for use in the electromagnetic
environment specied below. The customer of the user of the UP-200 Pulse
Oximeter should assure that it is used in such and environment.
Emission test Compliance Electromagnetic Environment –
Guidance
RF emission
CISPR 11
Group 1 The UP-200 Pulse Oximeter uses RF
energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emission
CISPR 11
Class B The UP-200 Pulse Oximeter is suitable
for use in all establishments, including
domestic establishments and those
directly connected to the public low-
voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic
emissions
IEC 61000-3-2
N/A
Voltage
uctuations/
icker emissions
IEC 61000-3-3
N/A
Guidance and manufacture’s declaration – electromagnetic immunity
for all EQUIPMENT and SYSTEMS
Guidance and Manufacture’s Declaration – Electromagnetic Immunity
The UP-200 Pulse Oximeter is intended for use in the electromagnetic
environment specied below. The customer or the user of UP-200 Pulse
Oximeter should assure that it is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment –
Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 KV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If oor is covered with
synthetic material, the
relative humidity should
be at least 30%.
Power
frequency
(50/60Hz)
Magnetic eld
IEC-61000-
4-8
3 A/m 3 A/m Power frequency
magnetic elds
should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Guidance and manufacture’s declaration – electromagnetic immunity
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The UP-200 Pulse Oximeter is intended for use in the electromagnetic
environment specied below. The customer or the user of UP-200 Pulse
Oximeter should assure that it is used in such an environment.
Immunity
Test
IEC
60601
Test
Level
Compliance
Level
Electromagnetic Environment -
Guidance
Radiated
RF
IEC 61000-
4-3
3 V/m
80 MHz
to 2.5
GHz
3 V/m Portable and mobile RF
communications equipment should be
used no closer to any part of the UP-
200 Pulse Oximeter, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m). Field strengths from xed
RF transmitters, as determined by an
electromagnetic site survey,ashould
be less than the compliance level in
each frequency range.bInterference
may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects
and people.
a Field strengths from xed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to xed RF
transmitters, an electromagnetic site survey should be considered. If the
measured eld strength in the location in which the UP-200 Pulse Oximeter
is used exceeds the applicable RF compliance level above, the UP-200
Pulse Oximeter should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating the UP-200 Pulse Oximeter.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less
than 3 V/m.
©2020 A&D Medical. All rights reserved.
Specications subject to change without notice.
Recommended separation distances between portable and mobile RF
communications equipment and the EQUIPMENT or SYSTEM
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF
communications equipment and the UP-100CN
The UP-200 Pulse Oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the UP-200 Pulse Oximeter can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
UP-200 Pulse Oximeter as recommended below, according to the maximum
output power of the communications equipment.
Rated
maximum
output power of
transmitter (W)
Separation distance according to frequency of
transmitter (m)
150 kHz to 80
MHz
80 MHz to 800
MHz
800 MHz to 2.5
GHz
0.01 0.12 0.12 0.23
0.1 0.39 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects
and people.
13 WARRANTY
Limited Warranty:
A&D Medical (“A&D”) warrants to the rst purchaser (“You”) that the A&D
product You purchased (the “Product”) will be free from defects in material,
workmanship and design for the applicable Warranty Term stated above from
the date You purchased the Product under normal use. This Limited Warranty
is personal to You and is not transferable. If the Product is defective, then (i)
if You are a Consumer, You return the Product to the retailer You purchased
it from (if within such retailer’s return time frame) or You return it to A&D
in accordance with the procedure set forth below, or (ii) if You are NOT a
Consumer, You return the Product to A&D in accordance with the procedure
set forth below. A&D’s warranty obligation is limited to the repair or
replacement, at A&D’s option, of the defective Product that has been returned
by You within the warranty period. Such repair or replacement will be at no
charge to You. The repaired or replacement Product is warranted hereunder
for the longer of the remainder of the original warranty period or 90 days from
the date of shipment of the repaired or replacement Product. If you return the
Product for warranty service to A&D, You must return the Product, freight and
insurance prepaid, within the warranty period to the address set forth below,
together with satisfactory proof of the date of Your purchase (such as a sales
receipt or statement of online warranty registration) and a description of the
defect. Also please enclose a check for return shipping and insurance of the
Product, as provided to you by the customer service representative.
In the United States of America:
2 year warranty
A&D Engineering, Inc.
1756 Automation Parkway
San Jose, CA 95131 U.S.A.
www.andmedical.com
1-888-726-9966
In Canada:
2 year warranty
Auto Control Medical, Inc.
6695 Millcreek Drive, Unit 6 Mississauga,
Ontario, L5N 5R8 Canada
www.lifesourcecanada.com
1-800-461-0991
In Latin America
Please return to your local dealer.
CONTACT INFORMATION
Manufactured by:
Contec Medical Systems Co., Ltd.
No.112 Qinhuang West Street, Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA
Manufactured for:
A&D Engineering, Inc.
1756 Automation Parkway
San Jose, CA 95131 USA
andmedical.com
1-888-726-9966
Distributed in Canada by:
Auto Control Médical an A&D Company / une compagnie A&D
6695 Millcreek Drive, Unit 6
Mississauga, Ontario
L5N 5R8 Canada
lifesourcecanada.com
1-800-461-0991