Life Smart M70C User manual

M70C
Operator’s Manual Fingertip Pulse Oximeter
Version number of this manual: V1.0 Document No. : J/M70-O-346-001
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.
Method for evaluating SpO2 accuracy: The SpO2 accuracy of pulse oximeter is
measured by comparing SpO2 readings of the pulse oximeter to values of SaO2
determined with a CO-OXIMETER.The healthy volunteers who consent to induced
hypoxia and arterial blood sampling as part of the experimental procedure (see
ISO80601-2-61 Annex EE.2)
Caution
 Please read the user manual carefully prior to operating.
Intended Use
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 is not suitable to monitor patient continuously for long term
Battery Installations
1. Push the battery cover.
2. Install two AAA batteries into battery cabin in correct
polarities, as shown on the right.
3. Close the battery cover.
Notes:
 For battery installation, see picture to the right.
Put or remove batteries in right order, or it may
damage the 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.
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 should not tremble during measuring.
5. Read corresponding data on the display screen.
6. After turning the oximeter on, each time you press the power switch, the
display screen will change to another direction. There are two display modes. If you
long press the power switch, you can adjust the brightness of screen from 1 to 5.
① SpO
2 Plethysmogram
② SpO
2 reading
③ Pulse rate reading
④ Indication of battery capacity
⑤ Indication of pulse intensity
⑥ Indication of screen brightness
⑦ Display modes
Precautions for Use
 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 an alarm function; please do not use this product in
the environment where an 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 pointed objects such 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 SpO2 measurement 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 SpO2 and 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, redness, blisters 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 refer to the electronic pulse simulator.
 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.
Download and Install APP Software
1. Software download methods：
 IOS device users, login to your App Store account and search for LifeSmart
Health.
 Android device users, login to your Google Play account and search
LifeSmart.
QR Code for download:
Android system IOS system
2. Download the Free LifeSmart App
Note: App software only applied for the oximeter with Bluetooth.
Maintenance
1. Using a soft cloth dampened with either a commercial nonabrasive cleaner, or
a solution of 70% alcohol in water, lightly wipe the surfaces of the oximeter.
2. The most commonly used hospital cleaning agent and non-corrosive
detergents can be used for cleaning the oximeter, but please be careful that
most detergents must be diluted before use; Please use them according to the
directions of the manufacturers of the detergents.
3. Avoid using alcohol-based, amido or acetone-based detergents
4. 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.
5. 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.
6. Please do not soak the oximeter in liquid.
7. 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 to direct sunlight.
 Avoid excessive radioactive infrared rays or ultraviolet rays.
 Avoid contacts with organic solutions, dusts or corrosive gases.
Product Specifications
 Measurement specifications
SpO2
Measuring Range 0~100%
Resolution 1%
Accuracy At 70~100%, ±2%；
At 0~69%, unspecified
Data update period <13 s
%100
lobindeoxyhemog bin oxyhemoglo
hemoglobin oxygenated
%SpO2


⑦
④
②⑤
③
①
⑥

PR
Measuring Range 25~250 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 AAA type batteries. A set of new batteries can be
used after 18 hours, depending on 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 60mm(length) × 35mm(width) ×35mm(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.
Possible Problems and Resolutions
Problems Possible causes Solution
There is no
response to
the function
button.
The button cannot 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.
Replace them with new
ones, or insert them
correctly
The Pulse
search time
is too long
Perfusion may be too low Check the patient. Change
the measuring site.
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.
Symbols Definitions
Symbol Definition
Type BF equipment (Refer to IEC 60601-1)
%SpO2 Oxygen saturation of arterial blood
/ Min Pulse rate
Non-Alarm indication (The device does not have alarm function)
IP22 Enclosure degree of ingress protection.
Serial number
Refer to this user’s manual.
Symbol for the marking of electrical and electronics devices
according to Waste Electrical and Electronic Equipment
Directive.
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 manufacturer's declaration–electromagnetic
emissions -for all EQUIPMENT and SYSTEMS
Guidance and manufacturer's declaration – electromagnetic emission
The Fingertip Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The user of the Fingertip Pulse Oximeter should
assure that it is used in such an 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.
Instructions on Environmental Aspects
 Instructions for minimizing environmental impact during normal use.
1. Instructions on how to install the fingertip pulse oximeter in order to minimize the
ENVIRONMENTAL IMPACT 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 council or 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 instructions for use or 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
disassemblers or others and methods for controlling such risks.
The device uses an alkaline battery. May heat, explode or leak if shorted,
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
handling the 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
Applicable Models
M70C
Packing List
NO. Item Quantity
1 Oximeter 1
2 AAA battery 2
3 Cord 1
4 User’s manual 1
Sponsor: Genesis Biotech Pty Ltd.
Level 1, 16 McDougall Street, MILTON QLD 4064 | www.mylifesmart.net.au
AUSTRALIA & NEW ZEALAND - [e-mail]
Australia: Ph 1300 110 155 (AEST - Mon-Fri, 11 am - 4 pm)
Distributed in Australia & New Zealand by: Genesis Biotech Pty Ltd., QLD, Australia.
Distributed in India by: LifeSmart Healthcare Pvt. Ltd, India
India Support: [e-mail]
For Warranty and Registration please refer to our website www.mylifesmart.net.au and
register your product.
Guangdong Biolight Meditech 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: 22-025-0066