Biolight Meditech M70C Fingertip Pulse Oximeter User Manual

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Document ID	2438320
Application ID	4cg+os4EXw+2wGNh7l0eug==
Document Description	Users Manual
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Permanent Confidential	No
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Document Type	User Manual
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Filesize	14.55kB (181880 bits)
Date Submitted	2014-11-07 00:00:00
Date Available	2014-11-07 00:00:00
Creation Date	2014-11-05 16:02:33
Producing Software	GPL Ghostscript 8.64
Document Lastmod	2014-11-05 08:02:34
Document Title	Users Manual
Document Creator	PScript5.dll Version 5.2.2
Document Author:	June-YJ_Chen

which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC RADIATION EXPOSURE STATEMENT:
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any
other antenna or transmitter.
Operator’s Manual
Fingertip Pulse Oximeter
Version number of this manual: V1.1
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.
oxygenated hemoglobin
SpO 2 % =
oxyhemoglo bin + deoxyhemog
lobin
× 100 %
The mechanical activity of the heart cause arterial pulse, by measuring the pulse
we can get PR value .
Precautions For Use

 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
such as high voltage cables, X-ray machine, ultrasound equipment and
electrizer in use nearby.

 Keep the oximeter away from 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 that the batteries have
sufficient capacity; otherwise there might be such phenomena as starting-up
abnormalities or inaccurate measurement data, etc.

 Please don’t use pointed objects such as pen point or nails to press operation,
otherwise it might cause permanent damage to the surface of the keyboard.

 Don’t make any clinical judgments based only 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.

 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, 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.

 This device complies with Part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference; (2) This device must accept any interference received, including
interference that may cause undesired operation.
The user is cautioned that changes or modifications not expressly approved
by the party responsible for compliance could void the user's authority to
operate the equipment
FCC STATEMENT:
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to
Intended Use
The Fingertip Pulse Oximeter is intended to measure functional arterial
oxygen saturation (SpO2) and pulse rate of adult and pediatric 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. Press the button down on the back panel of oximeter and push
the battery cover horizontally along the arrow shown as below: Press the button down
2. Install the batteries into battery cabin in correct polarities.
3. Close the battery cover.
Notes:

 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.
Software Download And Installation
1.
Software download methods：
Users who use the ISO system device can log in iphone App Store,
enter ”wearcare” and search for the of “SpO2 monitoring software” in the
searching results.
Users who use the Android system device can log in the wearcare official
website: http://www.wearcare.cn for download.
Download SpO2 monitoring software, click installation button for free
installation.
2.
Operation Instructions
1.
2.
Install two AAA batteries into battery cassette before closing its cover.
Open the receiving device (such as mobile phone, tablet PC etc.), then
turn on the Bluetooth.
Start the SpO2 monitoring software and connect automatically, the prompt
message” Complete device connection”. Till now, users can perform
SpO2 monitoring.
Nip the oximeter, then insert one finger into the rubber hole of the
oximeter before releasing the oximeter, and your nail must be upward.
Press the function button once on front panel.
Your finger and body do not tremble during measuring.
Read corresponding data on the display screen.
After turning on the oximeter, 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.
3.
4.
5.
6.
7.
8.
③
①
②
⑤
⑥
①
②
③
④
⑤
⑥
⑦
④
SpO2 Plethysmogram（normalized）
SpO2 reading
Pulse rate reading
Indication of battery capacity
Indication of pulse intensity
Indication of screen brightness
Display modes
⑦
Maintenance
1. Use a soft cloth dampened with either a commercial, nonabrasive cleaner, or a
solution of 70% alcohol in water, softly 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
many types of 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, don’t
spill the liquid onto the instrument. Ensure no liquid is allowed to enter the
inside of the oximeter.
5. It’s forbidden to use such grinding materials as wire brush or metal polishing
agent, for 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 or direct sunlight.

 Avoid excessive radioactive infrared rays or ultraviolet rays.

 Avoid contacts with organic solutions, dusts or corrosive gases.
Possible Problems And Solutions
Problems
There is no
response to the
function button
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
PR
Measuring Range
25bpm~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 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
≤85%
The Pulse
search time is
too long
Display is
dark-or-bright
Possible causes
The button can not be
pressed to its position
Solution
Ensure that the button is fully
depressed.
Battery capacities are
low
The batteries may be lost, discharged,
or oriented incorrectly. Replaced
them with new ones.
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.
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.
Battery capacities are
low.
Replace the batteries.
EQUIPMENT and SYSTEMS
Temperature
-20℃～+55℃
Atmospheric Pressure
500hPa～1060hPa
Weight
Reposition oximeter, as necessary.
Guidance and manufacture’s declaration–electromagnetic ermissions-for all
Transport and Storage
Relative Humidity
 Physical specifications
Remove the source of interference.
≤93%
about 21g/54g (exclude / include battery)
Dimensions
57mm(length) × 33mm(width) ×30mm(height)
 Sensors specifications
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.
Wavelength
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 60825-1:2001. No special
safety precautions are required.
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
Group 1
The Fingertip Pulse Oximeter uses RF
CISPR 11
energy only for its internal function. Thus,
its RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emission
Class B
The Fingertip Pulse Oximeter is suitable
CISPR 11
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.
Applicable Models
Symbols Definitions
Symbol
Definition
Type BF equipment (Refer to IEC 60601-1:2012)
%SpO2
/Min
M70C
Packing List
NO.
Item
Quantity
Oxygen saturation of arterial blood
Oximeter
Pulse rate
AAA battery
Cord
User’s manual
Non-Alarm indication (The device does not have alarm function)
IPX1
Enclosure degree of ingress protection.
SN
Serial number
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.
Refer to this user’s manual.
GuangdongBiolightMeditech Co.,Ltd.
No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone
Zhuhai
PEOPLE’S REPUBLIC OF CHINA
Eiffestrasse 80, 20537
Hamburg Germany
Shanghai International
Trading Corp. GmbH (Hamburg)
ALL RIGHTS RESERVED
PN: 22-025-0019

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