16
This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility
for medical electrical equipment and/or systems. However, because of the proliferation of
radio-frequency transmitting equipment and other sources of electrical noise in healthcare
and other environments, it is possible that high levels of such interference due to close
proximity or strength of a source might disrupt the performance of this device.
17
Portable and mobile RF communications equipment can affect medical electrical
equipment. The portable and mobile RF communications equipment should be used no
closer than 30cm (12 inches) to any part of the device, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
18
This equipment is not intended for use during patient transport outside the healthcare
facility. Do not take measurements in a moving vehicle.
19
The patient is an intended operator. The patient can safely use all functions of the device.
20
It may be unsafe to:
-use accessories, detachable parts and materials not described in the instructions for use
-interconnect this equipment with other equipment not described in the instructions for use
-disassemble, repair or modify the equipment
21
The material that contact with the patient’s skin has passed the ISO10993-5 Tests for
invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
22
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
23
The use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
24
When the signal is not stable, the reading may be inaccurate. Please do not refer to it.
25
The equipment is calibrated to display functional oxygen saturation.
26
Do not take measurements when there are drops of water on your skin, such as from
sweat or after bathing.
device description
Front
Back
Charging the device
Connect the device with the power adapter by the attached
magnetic charging cable:
1.
Connect the standard USB plug to a power adapter and
then contact the magnetic connector with the magnetic suction
charging interface of the device.
2.
Plug the power adapter into a power outlet.
Using the Lanyard
1.
Thread the thinner end of the lanyard through the hanging hole.
2.
Thread thicker end of the lanyard through the threaded end and tighten.
Warnings!
* Keep the device away from young children. Small items such as the lanyard are choking hazards.
* Please notice that the lanyard may cause strangulation due to excessive length.
introdUction
Thank you for purchasing
Multi-parameters Health Examination System
. Please read
this manual carefully before use the device. Failure to follow the instructions may cause
measurment abnormalities or equipment damage.
ChoiceMMed (the “Company”) assumes no responsibility for personal injury or device
damage sustained by or through the use of this product. No part of this instructions may
be copied, reproduced or translated into another language without prior written consent
of the Company. The Company reserves the right to revise this guide at any time without
prior notice.
SpO
2
measurement principle
SpO
2
measurement works by applying a sensor to a fingertip. The sensor contains a dual
light source and photo detector. The one wavelength of light source is 660nm, which is
red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous
vessels normally absorb a constant amount of light over time. The photo detector in finger
sensor collects and converts the light into electronic signal which is proportional to the
light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light
during systole and diastole, as blood volume increases and decreases. The ratio of light
absorbed at systole and diastole is translated into an oxygen saturation measurement.
This measurement is referred to as SpO
2
.
Diagram of Operation Principle
1. Red and Infrared-ray Detector 2. Red and Infrared-ray Light Source
Intended use
The
Multi-parameters Health Examination System
is a handheld non-invasive device
intended for checking of electrocardiogram (ECG) and heart rate and for use by
healthcare professionals, patients with known or suspected heart conditions and health
conscious individuals in hospitals, hospital-type facilities and homecare. It is not intended
for pediatric use.
The device can also be used as a pulse oximeter to spot check blood oxygen saturation (in
%SpO
2
) and pulse rate for wellness only and the values are not intended to diagnosis any
medical condition or to be used in medical applications.
Contraindication
Contraindicated in persons with pacemakers.
Product features
● Pocket size, easy to carry
● Both ECG and blood oxygen could be measured
● Support real-time and offline mode measurement
precaUtions for Use
1
Before use, carefully read the manual.
2
Operation of the the device may be affected by the use of an electrosurgical unit (ESU).
3
The the device must be able to measure the pulse properly to obtain an accurate SpO
2
measurement. Verify that nothing is hindering the pulse measurement before relying on
the SpO
2
measurement.
4
Do not use the device in an MRI or CT environment.
5
Do not use the device in situations where alarms are required. The device has no alarms.
It is not for continuous monitoring.
6
Do not use the device in an explosive atmosphere.
7
Do not use the device with a cardiac pacemaker or defibrillator.
8
Do not use the device near flammable anesthetics, or near pressurized oxygen such
as in a hyperbaric chamber, ultraviolet sterilizer or oxygen tent.
9
Do not use the device near strong electromagnetic forces.
10
Do not use the device in areas with extreme temperatures or humidity. Avoid using the
device immediately after a significant change in temperature or humidity.
11
Do not expose the device to static electricity. Disperse static electricity from your body
before handling the device.
12
Do not operate the device after it has been immersed in liquid.
13
The the device is intended only as an adjunct in patient assessment. It must be used
in conjunction with other methods of assessing clinical signs and symptoms.
14
In order to ensure correct sensor alignment and skin integrity, the maximum application
time at a single site for our device should be less than half an hour.
15
Follow local ordinances and recycling instructions regarding disposal or recycling of
the device and device components.
take a measUrement
Follow these instructions carefully for use. Failure to comply with any of these instructions
will result in an inaccurate measurement.
■
Power on
Press the
Power Button
to turn the unit on.
The display will show current date and time first and then
the ECG symbol .
→
→
■
ECG measurement
1. Place two fingers from each hand on the two
electrodes (
you may hold the device as the figure
).
2. The device will start a 30s’ recording after a
countdown of 3s. Hold still until it completes.
3. Read the data
(The measurement will be saved
automatically).
→
■
SpO
2
measurement
1. Press the
Power Button
to switch to SpO
2
measurement (
the display will show the
SpO
2
symbol
).
2. Place a finger (
the index/middle finger is
recommended
) on the SpO
2
sensor. Read the data.
(The measurement will be saved automatically)
.
→
■
Real-time ECG/SpO
2
measurement by APP & Data transmission
Connect the unit with iChoice APP via Bluetooth.
Real-time measurements will be transferred to the APP automatically. You can view the
result analysis from the APP as well as historical record and trend.
You can upload offline measurements to the APP and view the result analysis.
■
Check records
Press the
Power Button
for 2s to check measurements records.
Latest 20 ECG and 20 SpO
2
measurements can be saved.
■
Power off
Press the
Power Button
until the battery indocator appears,
then the device will power off.
Inaccurate SpO
2
measurements may be caused by
1.
Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or
methemoglobin).
2. Intravascular dyes such as indocyanine green or methylene blue.
3. High ambient light. Shield the sensor area if necessary.
4. Excessive patient movement.
5.
High-frequency electrosurgical interference and defibrillators.
6. Venous pulsations.
7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9. The patient is in cardiac arrest or is in shock.
10.
Fingernail polish or false fingernails.
11. Weak pulse quality (low perfusion).
12. Low hemoglobin.
Notes
* The screen will display “Charging” in the charging process.
* Low batteries may affect the HR measurement accuracy. Charge the device when
the screen displays " ".
* The device will turn off when batteries are too low for normal operation.
Notes
* Do not take measurements with overly wet skin.
*
Do not take a recording if the electrodes are dirty. Clean them first.
*
Too dry skin will cause weak ECG signal, please measure after moisturizing skin.
* When measuring ECG, keep your fingers and arms in a relaxed position for full
duration of the measurement. If the device senses poor contact-the device will indicate
"Lead off" or the measurement is interrupted by a hand adjustment, you will need to
repeat the recording.
*
Make sure your left and right fingers placed on right electrodes for ECG measuring.
* Make sure the electrodes or SpO
2
sensor is in direct contact with your skin. DO NOT
press firmly.
* The device will automatically shut off in 8 seconds with no any operation.
* After each use, carefully disinfect the contact electrodes only with a disinfectant
swab or equivalent.
Multi-parameters
Health Examination System
User Manual