Medic Therapeutics YM201 User manual

FINGERTIP BLOOD PULSE OXIMETER
Operating Instructions - Product Model: YM201
SAFETY PRECAUTIONS
• Do not attempt to repair. Should damage occur, contact the manufacturer directly.
• For best results, periodically change the oximeter position and switch the finger.
• Not for use on newborn babies.
• Seek medical assistance if the reading exceeds the normal reading range and you are certain the
device has not malfunctioned.
• To avoid harm, do not expose eyes to the light-emitting components.
The following may disrupt the accuracy of the Oximeter:
• Use in a high-frequency environment or around CT machines.
• Used on the same area as a blood pressure cuff, arterial duct, or intravenous injection.
• User suffers from hyper-tension, severe vascular atrophy, severe anemia, or low oxygen.
• User is in sudden cardiac arrest or state of shock.
• Use on a finger with nail polish or fake nails.
WARNINGS
Do not use around a flame or any flammable agents.
• Choking hazard.
• Keep away from children.
• Do not discard batteries in a fire.
• Do not attempt to charge device batteries. Charging can result in battery leakage, fire, or explosion.
• Always discard batteries according to environmental safety guidelines.
• Do not use around MRI, CT or other X-Ray machines.
• Do not operate if wet.
• Avoid moving device between hot, cold or humid temperatures.
• Install batteries properly. Remove batteries if being stored for a long period of time.
• Always close the battery cover properly.
• Operate only as directed.
• Do not modify or use for any reason other than the intended purpose.
• Only certified doctors are qualified to evaluate and use the produced results.
PRODUCT ACCESSORIES
1. One user’s manual.
SYMBOL CONVENTIONS
WORKING PRINCIPLES, EXPECTED USAGE, AND APPLICABLE SCOPE
Based on full digital technology, the Finger Pulse Oximeter non-invasively measures the actual content
(oxygen saturation) of oxyhemoglobin (HbO2) in arterial blood using the optical transmittance method.
The Finger Pulse Oximeter measures the blood oxygen saturation and pulse rate of a human body via
finger artery. It is applicable to a wide range of fields, such as families, hospitals (including operation
rooms of the departments of internal medicine and surgery, the department of anesthesiology, the
department of paediatrics, and intensive care rooms), oxygen bars, social medical care institutions, and
sports & health. Use this instrument for measurement before or after sports. You are not advised to use
this instrument during sports activities. Do not use it for continuous care for patients.
APPEARANCE OF THE STRUCTURE
SCREEN DISPLAY
POWER-ON BUTTON/FUNCTIONAL BUTTON OPERATIONS
After powering on the Oximeter, hold the power-on Button/functional button for about one second. The
Oximeter shows a parameter setting interface. Press or hold the power-on/functional button to perform
corresponding operations. Hold it to set an item, or press it to switch an option or switch the display
mode. Press means no more than 0.5 seconds, while Hold means more than 0.5 seconds.
ALERT SOUND SETTING
Hold the power-on button/functional button while the Oximeter is in powered-on state. Parameter setting
interface 1 is displayed, as shown in the following figure. Move “*” to the corresponding option, and hold
the functional button to set “Sound Reminder” to on and set Beep to off. When “Sound Reminder” is set
to on and the measured values of the blood oxygen saturation and pulse rate go beyond the upper limit or
lower limit, the Oximeter gives off an alert sound. When “Sound Reminder”is set to off and the measured
values go beyond the limit, the Oximeter will not give any alert sound. When Beep is set to on, a tick will
be heard along with pulse beats during pulse rate measurement. When Beep is set to off, no sound will be
output along with pulse beats during pulse rate measurement. While the “*” symbol stays on the Restore
option, hold the functional button to restore factory settings.
BRIGHTNESS SETTING
On parameter interface 1, press the functional button to select the Brightness option and then hold the
functional button to set the brightness to a value ranging from 1 to 5. The greater the value, the greater
the brightness of the screen.
ALERT RANGE SETTING
On parameter interface 2, press the functional button to switch between options. On this interface, you can set
the upper limit and lower limit of SpO2 Alm and PR Alm. While the “*” symbol stays on the +/- option, hold the
functional key to set the option to + or -. In + mode, select the corresponding option and hold the functional
button increment the upper or lower limit; in - mode, hold the functional button to discrete the upper or lower
limit. Move “*” to the Exit option, and hold the functional key to return to the monitoring interface.
OPERATION GUIDE
Stick one finger completely into the measuring parts of the Oximeter, keep the fingernail surface upward,
and release the clip. Then press the power button to power on the Oximeter.
If you do not yet completely insert your finger into the
cavity, the measurement result may be inaccurate.
Do not vibrate your finger during measurement.
Preferably, ensure that your body does not move. After
the readings become stable, read the measured values
of oxygen saturation and the pulse rate on the screen.
NOTE: The Oximeter will automatically shut down 10 seconds later after your finger leaves away.
REPLACE THE BATTERIES (BATTERY TYPE: AAA)
Replace the batteries when the battery capacity
is insufficient and the symbol flickers on the
screen. Open the battery cover with your
fingers, you can replace the batteries according
to the correct battery polarity.
CLEANING
Power off the instrument and remove the batteries before cleaning. Ensure that the appearance of the
instrument is neat, dust-free, and dirt-free. Clean the outer surface of the instrument (including the LED
screen) using 75% medical alcohol and a piece of dry soft cloth.
Caution: Avoid liquid flowing into the instrument during cleaning.
Caution: Do not immerse any part of the instrument into any liquid.
DISINFECTION
Before measurement with the instrument, wipe the rubber finger pad using a piece of dry soft cloth
dipped with 75% medical alcohol. Clean the finger to be measured using the medical alcohol for
disinfection purposes before and after using.
Do not disinfect the instrument by means of high-temperature /high-pressure or gas disinfection.
MAINTENANCE
• Remove the batteries from the battery slot and properly store them if you do not plan to use the
Oximeter for a long period of time.
• Avoid using the Oximeter in an environment with inflammable gases or using it in an environment
where the temperature or humidity is excessively high or low.
• Check the accuracy of the oxygen saturation and pulse rate readings by using an appropriate
calibration apparatus.
TECHNICAL SPECIFICATIONS
1. Dimensions: 58 mm (Width) × 34 mm (Depth) × 32.5 mm (Height)
Weight: 39 g (with batteries)
2. Peak wavelength range of the light emitted from the probe: red light 660 nm ± 3;
infrared light 905 nm ± 5.
3. Maximum optical output power of the probe: 1.2 mW for infrared light (905 nm).
4. Manufacturing date: see the label
5. Normal working condition
6. Default values and conditions of alert
OVERVIEW
Oxygen saturation is the percentage of oxyhemoglobin (HbO2) that is combined with oxygen against
all combinable hemoglobin (Hb). It is an important physiological parameter involved in respiration and
circulation. The oxygen saturation of arterial blood in a normal human body is 98%. Oxygen saturation
is an important indicator of the oxygen condition in the human body. In general, the normal values of
oxygen saturation shall not be lower than 94%. If the measured value of oxygen saturation is lower
than 94%, an insufficient supply of oxygen is considered. The pulse rate is the number of pulse beats
per minute. Normally, the pulse rate is consistent with the heart rate. In general, the pulse rate of every
people is 60 to 90 beats per minute.
Symbol Descripon
Type BF applied part
Cauon: Please see this manual
%SpO2 Symbol of oxygen saturaon
bpmPR Symbol of pulse rate
No SpO2alarms
Consult the instrucons for use
IP22 The degree of protecon against harmful ingress of water and parculate maer
When end users abandon this product, they must send the product to the collecon
place for recycling.
DC 2.0V~3.0 V 5ºC to 40ºC (41ºF to 104ºF)
Relave Humidity 15% to 80%, non-con
Atmospheric Pressure 70 kPa to 106 kPa
Rated Voltage DC 2.0V~3.0 V
Parameter Value
Oxygen saturaon Upper limit: 100
Lower limit: 9
Pulse rate Upper limit: 130
Lower limit: 50
Alert condion The actual measured value goes beyond the preset alert
parameter range, the Oximeter gives an alert sound.
Display screen
Power on Key/function key
Battery cover
Symbol of
oxygen saturation
Measured value of
oxygen saturation
Plethysmogram
%SpO2
98 75
PI%
10.1
bpmPR
Battery power indication
Symbol of pulse rate
Perfusion Index
Measured value of pulse rate
Bar Graph
Interface 1
Settings
Alm setup *
Alm on
Beep off
Demo off
Restore ok
Brightness 1
Exit
Interface 2
Settings
Sound setup *
SpO2 Alm Hi 100
SpO2 Alm Lo 94
PR Alm Hi 120
PR Alm Lo 50
+/- +
Exit

7. Technical parameters
SAFETY TYPE
Anti-electric-shock type: internal power supply device
Anti-electric-shock degree: Type BF applied part
Running mode: continuous working
Waterproof grade: IP22
STORAGE AND TRANSPORTATION
Temperature : –10°C - 50°C(14°-122°)
Relative humidity : 10%-93% (no condensation)
Atmospheric pressure : 50kPa–106 kPa.
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES
LIMITED LIFETIME WARRANTY
Your Medic Therapeutics Special Edition Fingertip Blood Pulse Oximeter is backed by a limited lifetime
manufacturer’s warranty. Medic Therapeutics will repair or replace your device at any time should it fail
due to a defect in material or workmanship, subject to the certain limitations.
This limited warranty does not cover any damage that results from unauthorized or improper use, service,
or repair. Further, it does not cover damage caused by accident, impact, negligence, or normal wear and
tear. Should you discover your Medic Therapeutics Special Edition Fingertip Blood Pulse Oximeter is not
functioning properly, please send your device to our repair center for evaluation. If your product cannot
be repaired or serviced we will reserve the right to change it for a similar or newer model.
Please note that a flat rate of $35.00 will be charged to cover a service evaluation fee and return
shipping of your device. All warranty claims must be accompanied by a copy of your proof of purchase
from an authorized retailer. Please send your device, proof of purchase, and a check or money order in
the amount of $35.00 made out to Medic Therapeutics to:
Medic Therapeutics Service Center
3069 Taft Street
Hollywood, FL 33009
Guidance and manufacturer’s declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601
Test level
Compliance level Electromagnec environment-guidance
Electrostac discharge
(ESD) lEC61000-4-2
±6kV
contact
±8kV air
±6kV contact
±8kV air
Floors should be wood , concrete or
ceramic le. If oors are covered with
synthec material, the relave humidity
should be at least 30%
Electrical fast transient/
burst IEC 61000-4-4
±2 kV for power
supply lines
± 1 kV
Input/ output line
not applicable not applicable
(For INTERNALLY POWERED ME
EQUIPMENT)
Surge
IEC 61000-4-5
± 1 kV
Dierena l mode
voltage
± 2 kV
Common
mode voltage
not applicable not applicable
(For INTERNALLY POWERED ME
EQUIPMENT)
Voltage dips, short
interrupons and
voltage variaons on
power supply input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
not applicable not applicable
(For INTERNALLY POWERED ME
EQUIPMENT
Power frequency
(50Hz/60Hz)
magnec eld
IEC 61000-4-8
3A/m 3A/m Power frequency magnec elds
should be at levels characterisc of a
typical locaon in a typical commercial
or hospital environment.
NOTE: UT is the a.c. mains voltage prior to applicaon of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or
the user of device should assure that it is used in such an environment.
Immunity test IEC 60601
test
level
Compliance
level
Electromagnec environment - guidance
Radiated RF
IEC
61000-4-3
3 V/m
80 MHz
to 2.5 GHz
3 V/m Portable and mobile RF communicaons equipment
should be used no closer to any part of the Blood
Pressure Monitor, including cables, than the
recommended separaon distance calculated from the
equaon applicable to the frequency of the transmier.
Recommended separaon distance
d=1.2 P80 MHz to 800 MHz
d=2.3 P800 MHz to 2.5 GHz
Where P is the maximum output power rang of the
transmier in was (W) according to the transmier
manufacturer and d is the recommended separaon
distance in metres (m).
Field strengths from xed RF transmiers, as determined
by an electromagnec site survey,a should be less than
the compliance level in each frequency range.b
Interference 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 reflection from structures, objects and people.
a Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theorecally
with accuracy. To assess the electromagnec environment due to xed RF transmiers, an electromagnec
site survey should be considered. If the measured eld strength in the locaon in which the Blood Pressure
Monitor is used exceeds the applicable RF compliance level above, the Blood Pressure Monitor should be
observed to verify normal operaon. If abnormal performance is observed, addional measures may be
necessary, such as reorienng or relocang the Blood Pressure Monitor.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [Vi] V/m.
Recommended separation distances between portable and mobile RF communications equipment and
the device.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the
communications equipment.
Maximum
output power of
transmier
(W)
Separaon distance according to frequency of transmier (m)
80 MHz to 800
MHz
d=1.2 P
800 MHz to2.5
GHz
d=1.2 P
800 MHz to 2.5
GHz
d=2.3 P
0.01 / 0.12 0.23
0.1 / 0.38 0.73
1 / 1.2 2.3
10 / 3.8 7.3
100 / 12 23
For transmitters rated at a maximum output power not listed above, There commended 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) accordable to
the transmitter manufacturer.
NOTE I: 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 refection from structures, objects and people.
Parameter Value
Display range
Oxygen
saturaon 35% to 100%
Pulse rate 25 bpm to 250 bpm
Resoluon
Oxygen
saturaon 1%
Pulse rate 1 bpm
Measurement
precision
Oxygen
saturaon
±2% (70% to 100%)
No requirement (≤ 69%)
Pulse rate ±2 bpm
Alert range
Oxygen
saturaon
Upper limit: 50% to 100%
Lower limit: 50% to 100%
Pulse rate Upper limit: 25 bpm to 250 bpm
Lower limit: 25 bpm to 250 bpm
Alert error
Oxygen
saturaon ± 1% of the preset value
Pulse rate The greater of ±10% of the preset value and ±5 bpm