Biolight M70 User manual

Operator’s Manual
Fingertip Pulse Oximeter
Version number of this manual: V4.3 Document No. : J/M70CE-A-008
General Description
The measurement of oxygen saturation of arterial blood (also known as pulse
oxygen saturation, usually shortened as SpO2) adopts the principles of light spectra
and volume tracing. The LED emits lights with two specific wavelengths, which are
selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin. The optical
receptor measures the changes in the light intensity after the light passes the
capillary network and estimates the ratio of oxygenated hemoglobin and the total
hemoglobin.
The mechanical activity of the heart cause arterial pulse, by measuring the pulse
we can get PR value.
The oximeter is standalone, reusable, and not reprocessed. The sensor of the
oximeter is built-in.
Caution
Federal Law Restricts this device to sale by or on the order of a physician.
Please read the user manual carefully prior to operating.
IntendedUse
The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen
saturation (SpO2) and pulse rate of adult, pediatric and adolescent patients in
hospital, hospital type facilities, as well as in the home care environment.
The oximeter isn’t suitable to monitor patient continuously for long term.
Operation Instructions
1. Install two AAA batteries into battery cassette before closing its cover.
2. Nip the oximeter, then insert one of fingers
into the rubber hole of the oximeter before
releasing the oximeter, and your nail surface
must be upward.
3. Press the function button once on front panel.
4. Your finger and body do not tremble during measuring.
5. Read corresponding data on the display screen.
6. After turning on the oximeter, each time you press the power switch,
the display screen will change to another direction.
①SpO2Plethysmogram（normalized）
②SpO2 reading
③Pulse rate reading
④Indication of battery capacity
⑤Indication of pulse intensity
Precautionsforuse
The patient is the operator when the device is used at home .
Patients can maintain and use all functions of the device safely according to this
user′s manual.
Keep this product out of reach of children to avoid injury to children.
Explosion hazard. Do not use the oximeter in the presence of flammable
anesthetics mixture with air, oxygen, or hydrogen.
When the oximeter is in use, there should not be any great power appliances as
high voltage cables, X-ray machine, ultrasound equipment and electrizer in use
nearby.
Keep the oximeter away from lint, dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
This oximeter does not have alarm function; please do not use this product in the
environment where alarm is required.
The oximeter should be handled with care so as to avoid shocks and falls.
When the oximeter is in use, it must be ensured the batteries have sufficient
capacity; otherwise there might be such phenomena as starting-up abnormalities
or inaccurate measurement data, etc.
Please do not use such pointed objects as pen point or nails for pressing
operation, otherwise it might cause permanent damage to the surface of the
keyboard.
Do not make any clinical judgments based solely on the oximeter. The oximeter
is intended only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms, as well as doctor’s diagnoses.
To ensure accurate performance and prevent device failure, do not expose the
oximeter to extreme moisture, such as direct exposure to rain. Such exposure
may cause inaccurate performance or device failure.
Do not conduct SpO2measurement on the finger smeared with nail polish,
otherwise this will lead to unreliable measurement results.
Please do not open the enclosure. The enclosure shall only be opened by the
authorized person.
In order to have more accurate measurements of SpO2and PR, the oximeter
should be used in quiet and comfortable environment.
Follow local ordinances and recycling instructions regarding disposal or recycling
of the device and device components, including batteries.
Prolonged continuous monitoring may increase the risk of unexpected changes
in skin characteristics, such as irritation, reddening, blistering or burns. Inspect
the sensor site every two hours and move the sensor if the skin quality changes.
Pulse oximeter simulator can not be used to access the accuracy of the pulse
oximeter.
The expected service life of the device is five years.
For assistance with installation, use or maintenance, contact the manufacturer or
manufacturer's representative.
To validate the PR accuracy, we reference to the electronic pulse simulator the
computation the PR accuracy.
When used at room temperature from the lowest or highest storage temperature
environment, the product can be used directly without needing to be placed for a
period of time to achieve its expected function.
Battery Installations
1. Press the button down on the back panel of oximeter (only for M70A) and push
the battery cover horizontally along the arrow as below.
2. Install the two AAA batteries into battery cabin
in correct polarities.
3. Close the battery cover.
Notes:
Please put or remove batteries in right order,
or it is likely to damage the device bracket.
Battery polarities must be correctly installed. Otherwise, damage might be
caused to device.
Please remove the battery if the oximeter will not be used for long time.
Maintenance
1. Disinfection: use a soft cloth dampened with 70% Isopropanol, lightly wipe the
surfaces of the oximeter.
2. The casing of the oximeter should be kept from the contamination of filth and dirt,
and it can be wiped with non-velvet soft cloth. When cleaning, do not spill the
liquid onto the instrument. Ensure no liquid is allowed to enter the inside of the
oximeter.
3. It is forbidden to use such grinding materials as wire brush or metal polishing
agent, because these materials may cause damage to the panels of the
oximeter.
4. Please do not soak the oximeter in liquid.
5. Under normal circumstances, it is unnecessary for the oximeter to have special
maintenance, and cautions must be exercised on the following points during the
use of the oximeter:
Please use the oximeter in the environment according to the requirements of the
performance criteria.
Avoid exposure or direct sunlight.
Avoid excessive radioactive infrared rays or ultraviolet rays.
Avoid contacts with organic solutions, dusts or corrosive gases.
ProductSpecifications
Measurement specifications
SpO2
Measuring Range 0~100%
Resolution 1%
Accuracy At 70%~100%, ±2%;
At 0~69%, unspecified
Accuracy in the discrete
SpO2 ranges
At 70%~80%, ±2%;At 80%~90%, ±2%;
At 90%~100%, ±2%
Data update period <13 s
PR
Measuring Range 25 bpm ~250 bpm
Resolution 1 bpm
Accuracy ±1% or ± 1 bpm, whichever is greater
Data update period < 13 s
Battery specifications
Type Voltage
two AAA alkaline battery 1.5 Volts DC (per battery)
The oximeter uses two 1.5 V A AA type batteries and a set of new batteries
can be used for more than 18 hours, depending on concrete battery types.
Environmental specifications
Operation
Temperature +5℃～+40℃
Atmospheric Pressure 700hPa～1060hPa
Relative Humidity 15%～85% （non condensing）
Transport and Storage
Temperature -20℃～+55℃
Atmospheric Pressure 500hPa～1060hPa
Relative Humidity 10%～93%（non condensing）
Physical specifications
Weight about 21g (exclude battery)
about 54g (include battery)
Dimensions M70:57mm(length) ×36mm(width)×31mm(height)
M70A: 57mm(length) × 39mm(width) ×32mm (height)
Sensors specifications
Wavelength
Pulse oximetry sensors contain LEDs that emit red light at
a wavelength of approximately 660 nm and infrared light at
a wavelength of approximately 905 nm.
The total optical output power of the sensor LEDs is less
than 15 mW.
This information may be useful to clinicians, such as those
performing photodynamic therapy.
Note: Sensor LED light emissions fall within Class 1 level,
according to IEC 60825-1. No special safety precautions
are required.
%100
lobindeoxyhemogbinoxyhemoglo hemoglobinoxygenated
%SpO2


Press the button down
⑤
③
②
①
④

PossibleProblemsandresolutions
Problems Possible causes Solution
There is no
response to
the function
button
The button can not be pressed to
its position
Ensure that the button is
fully depressed.
Battery capacities are low
The batteries may be
missing, discharged, or
oriented incorrectly.
Replaced them with new
ones.
The Pulse
search time is
too long
Perfusion may be too low
Check the patient. Change
the measuring site. Try
another oximeter.
Patient movement
Interference due to patient
activity may be preventing
the oximeter from tracking
the pulse. Keep the patient
still, if possible.
Electromagnetic interference
may be preventing the oximeter
from tracking the pulse.
Remove the source of
interference.
There may be interference due
to ambient light, or the oximeter
may be on an extremity with a
blood pressure cuff, arterial
catheter, or intravascular line.
Reposition oximeter, as
necessary.
Display is
dark-or-bright Battery capacities are low. Replace the batteries.
SymbolsDefinitions
Symbol Definition
Type BF equipment (Refer to IEC 60601-1)
%SpO2Oxygen saturation of arterial blood
/Min Pulse rate
Non-Alarm indication (The device does not have alarm function)
IPX1 Enclosure degree of ingress protection.
Serial number
Refer to this user’s manual.
Symbol for the marking of electrical and electronics devices
according to Directive 2002/96/EC.
The device, accessories and the packaging have to be disposed of
waste correctly at the end of the usage. Please follow Local
Ordinances or Regulations for disposal.
Note: The Oximeter is applied to this regulation.
Guidance and manufacture’s declaration – electromagnetic
ermissions-for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The Fingertip Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer of the user of the Fingertip Pulse
Oximeter should assure that it is used in such and environment.
Emission
test Compliance Electromagnetic environment – guidance
RF
emissions
CISPR 11
Group 1 The Fingertip 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 Fingertip 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.
Declaration: After the electromagnetic compatibility test, the essential performance
of SpO2 and PR meet the requirements as follow:
a) SpO2: Accuracy at 70%~100% is ±2%, at 0~69% is unspecified. Measuring
range is 0~100%.
b) PR: Accuracy is ±1% or ± 1 bpm, whichever is greater. Measuring range is
25bpm~250bpm.
InstructionsonEnvironmentalAspects
Instructions for minimizing environmental impact during normal use.
1. Instructions on how to install the fingertip pulse oximeterin order to minimize the
ENVIRONMENTALIMPACT during its EXPECTED SERVICE LIFE;
Try to keep the integrity of the non-disposable packing material and put away the
packing materials for future use or put into the specified location where complying
with the rules and regulations of the local and the hospital. Avoid overusing the
cleaning reagents and other substances.
2. Instructions on how to use and maintain the fingertip pulse oximeter in order to
minimize the ENVIRONMENTAL IMPACT during its EXPECTED SERVICE LIFE;
Do not mix disinfecting solutions (such as bleach and ammonia) as this may
result in hazardous or poisonous gases or liquids. When there is a need to maintain,
please follow the instruction for use of follow the rules and regulations of the
hospital.
3. Consumption during NORMAL USE (e.g. energy, consumable materials/parts,
disposables, water, gasses, chemicals/reagents etc.);
During normal use of this device, it will consume electricity (battery). The
batteries shall be disposed following the rules. For cleaning or disinfection for the
machine, the water and ethanol will be used and the waste liquid shall be thrown
following the rules.
4. Emissions during NORMAL USE (e.g. WASTE water, WASTE consumable
materials, acoustic, energy, heat, gasses, vapours, particulates, HAZARDOUS
SUBSTANCES and other WASTE);
Consumption of the battery during use.
5. Information on the location within the device of HAZARDOUS SUBSTANCES,
radioactive sources and induced radioactive materials.
This product has no hazardous substances, such as radioactive sources or
induced radioactive materials.
Information for end of life management.
1. The location of components and parts within the device that contain stored
energy or pose other hazards that can result in an unacceptable risk to
disassembles or others and methods for controlling such risks.
The device uses an alkaline battery.May heat,explode or leak if
shotted,recharged,disposed of in fire or dissected.
2. The identity and location of hazardous substances requiring special handling and
treatments.
The battery is installed in the battery case.
3. Disassembly instructions sufficient for the safe removal of these hazardous
substances including radioactive sources and induced radioactive materials within
the monitor.
For other hazards that may result in unacceptable risk, the main concern is the
handing with battery.Do not store the battery in a high temperature environment
and store the battery in a cool, ventilated environment.
As for disposing or recycling of the device and device components at end of life，
follow local ordinances and recycling instructions regarding.
ClinicalTrialResults
70-100 70-79 80-89 90-100
Count 325 83 87 155
Mean Bias -0.1692 -0.0843 -0.2874 -0.1484
Standard Deviation 1.4779 1.9140 1.6347 1.0678
Standard Error 0.0819 0.2100 0.1753 -0.086
95%CI
Lower
Bound
-0.3305 -0.5023 -0.6358 -0.3178
Upper
Bound
-0.0080 0.3336 0.0610 0.0210
Minimum 70.00 70 80 90
Maximum 99.00 79 89 99
Arms 1.4853 1.9043 1.6900 1.0746
70.00 80.00 90.00 100.00
SaO2
-4.00
-2.00
0.00
2.00
4.00
Deviation
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Applicable Models
M70, M70A, M70B
PackingList
NO. Item Quantity
1 Oximeter 1
2 AAA battery 2
3Cord1
4 User’s manual 1
GuangdongBiolightMeditech Co.,Ltd.
No.2 Innovation First Road, Technical
Innovation Coast, Hi-tech Zone Zhuhai
PEOPLE’S REPUBLIC OF CHINA
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537
Hamburg Germany
ALL RIGHTS RESERVED
PN: 22-025-0002