Boston Life Labs PC-68A Wrist Oximeter User Manual Use manual

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User Manual for OW1.0 Wrist Oximeter
User Manual
Wrist Oximeter
Model: PC-68A
Brand: Boston Life Labs
User Manual for OW1.0 Wrist Oximeter
Instructions to User
OW1.0 Wrist Oximeter is a precision measuring device,
please read the manual very carefully before using this
device. Failure to follow these instructions may cause
measuring abnormality or device damage.
The Manual is published in English and Boston Life Labs
LLC. has the ultimate right to explain the Manual. No part
of this manual may be photocopied, reproduced or
translated into another language without the prior written
consent. Boston Life Labs LLC. reserves the right to
improve and amend it at any time without prior notice.
Version of This Manual: Ver 1.0
All rights reserved.
II
User Manual for OW1.0 Wrist Oximeter
Notes
z The contents contained in this manual are subject to
change without prior notice.
z Information furnished by Boston Life Labs is believed
to be accurate and reliable. However, no responsibility
is assumed by us for its use, or any infringements of
patents or other rights of third parties that may result
from its use.
Instructions for Safe Operations
Check the device to make sure that there is no
visible damage that may affect user’s safety or
measurement performance with regard to sensors
and clips. It is recommended that the device should
be inspected minimally once a week. When there is
obvious damage, stop using the device.
Necessary maintenance must be performed only by
qualified service technicians. Users are not
permitted to maintain it by themselves.
The oximeter cannot be used together with devices
not specified in User Manual.
Cautions
Explosive hazard—DO NOT use the oximeter in
environment with inflammable gas such as some
III
User Manual for OW1.0 Wrist Oximeter
ignitable anesthetic agents.
DO NOT use the oximeter while the testee is under
MRI or CT scanning.
Warnings
An uncomfortable or painful feeling may appear if
using the oximeter continuously on the same place
for a long time, especially for poor microcirculation
patients. It is recommended that the oximeter
should not be applied to the same location for
longer than 2 hours. If any abnormal condition is
found, please change the position of oximeter.
DO NOT clip this device on edema or tender tissue.
The light (the infrared light is invisible) emitted
from the device is harmful to the eyes, so service
technician or testee should not stare at the light.
The local law must be followed when disposing of
the device.
Attentions
Keep the oximeter away from dust, vibration,
corrosive substances, explosive materials, high
temperature and moisture.
The device should be kept out of the reach of
children.
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User Manual for OW1.0 Wrist Oximeter
If the oximeter gets wet, please stop using it and do
not resume operation until it is dry. When it is
carried from a cold environment to a warm and
humid environment, please do not use it
immediately.
DO NOT operate the button on the front panel with
sharp materials.
High temperature or high pressure steam
disinfection to the oximeter is not permitted. Refer
to related chapter for instructions of cleaning and
disinfection.
User Manual for OW1.0 Wrist Oximeter
Table of Contents
1 OVERVIEW ....................................................................1
1.1 Appearance ................................................................1
1.2 Name and Model .......................................................2
1.3 Conformation ............................................................3
1.4 Features......................................................................3
1.5 Intended Use ..............................................................4
1.6 Key of Symbols..........................................................4
2 BATTERY INSTALLATION.........................................5
3 OPERATION...................................................................6
3.1 Measuring Operation................................................6
3.2 Alarm Limit Settings .............................................. 11
3.3 Upload Data .............................................................14
3.4 Low Battery Indication ..........................................15
4 ADDITIONAL ADVICE FOR OPERATION............16
5 TECHNICAL SPECIFICATIONS..............................17
6 ACCESSORIES.............................................................19
7 REPAIR AND MAINTENANCE ................................19
7.1 Maintenance ............................................................19
7.2 Cleaning and Disinfecting Instruction..................20
8 TROUBLESHOOTING ...............................................21
9 APPENDIX ....................................................................22
Common Knowledge for SpO2 Measurement ............22
B Wristband Installation and Disassembly ................25
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User Manual for OW1.0 Wrist Oximeter
1 Overview
1.1 Appearance
Figure 1 Front View
1. LCD screen
2. Set key: shift display modes, confirm the
operation etc.
3. Scroll key: move display cursor, modify parameter
values etc.
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User Manual for OW1.0 Wrist Oximeter
Figure 2 Frontal Side View
4. Buzzer
5. Data interface
6. Wristband Underlay
Figure 3 Right Side View
7. SpO2 probe receptacle
1.2 Name and Model
Name: Wrist Oximeter
Model: OW1.0
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User Manual for OW1.0 Wrist Oximeter
1.3 Conformation
It comprises the main unit and SpO2 probe.
1.4 Features
Wrist Oximeter can be used to monitor pulse oxygen
saturation (SpO2) and pulse rate accurately. Simply put
your finger into sensor, SpO2 value and pulse rate value
will be displayed on screen and stored in the device.
y It is lightweight, small in size and easy to carry;
y Segment LCD display;
y Automatic starts to measure SpO2 and Pulse
Rate(PR) and display pulse intensity bar graph
as well;
y Numerical value flash alarm function;
y Data storage and transmission to PC for viewing and
analysis;
y Smart battery power management with low battery
indication;
y Two AAA batteries can be used for over 50 hours’
monitoring continuously.
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User Manual for OW1.0 Wrist Oximeter
1.5 Intended Use
The Wrist Oximeter is intended to use in hospital, other
medical community and at home. It is available and
convenient for you to monitor SpO2 in long-term while
sleeping or at other daily activity simultaneously.
1.6 Key of Symbols
Symbols
Descriptions
With Type BF applied part
Warning ─ See User Manual
%SpO2
BPM
Pulse Oxygen Saturation
Pulse rate icon(Unit: beats per minute)
Low battery voltage
Memory full.
SN
Serial number
Separate collection for this device.
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User Manual for OW1.0 Wrist Oximeter
2 Battery Installation
Figure 4 Battery Installation
1. Lift up the cloth covered on the battery cover. Then, use
your index finger and middle finger to press against the
battery cover. Meanwhile, slide it towards the side with
SpO2 probe (as shown in Figure 4).
2. Refer to Figure 4, insert two AAA size batteries into the
battery compartment properly in the right direction.
3. Replace the cover.
Remark:
After finishing battery installation, the oximeter will
automatically power on and display software version
number firstly.
In order to record data in real time in future, please set the
date/time in the oximeter via PC software-“Oximeter Data
Manager”.
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User Manual for OW1.0 Wrist Oximeter
Please take care when you insert the batteries, as the
improper insertion may make the device not work.
3 Operation
3.1 Measuring Operation
1. Insert the external SpO2 probe connector into SpO2
probe receptacle properly.
Figure 5 Sp02 Probe Connection
2. Fix the oximeter on your left wrist as shown in Figure 6
(Refer to Appendix for details);
3. Then, hold the probe with its opening towards your
index finger. The probe should be oriented in such a way
that the sensor side with a finger tip sign is positioned on
the top (Figure 6).
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User Manual for OW1.0 Wrist Oximeter
Finger tip sign
Figure 6 Placement Demonstration
3. Next, insert your index finger into the probe until the
fingernail tip rests against the stop at the end of the probe
(Figure 7). Adjust the finger to be placed evenly on the
middle base of the sensor (make sure the finger is in the
right position). If the index finger cannot be positioned
correctly, or is not available, other finger can be used.
Figure 7
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User Manual for OW1.0 Wrist Oximeter
Wrong Placement of the Probe:
Finger out
Not deep enough
Figure 8
4. The oximeter will automatically start measurement in 2
seconds. Then the default screen will be displayed (Figure
9). User can read the values from the display screen.
Figure 9 Default Screen
— “%SpO2”: SpO2 icon; “98”: SpO2 value;
— “
BPM”: Pulse rate icon; “BPM”: pulse rate
unit, beats per minute; “78”: Pulse rate value;
— “ ”: Pulse intensity bar graph.
Key Operations:
y Longtime press “■” key: alarm limit setting screen
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User Manual for OW1.0 Wrist Oximeter
will be displayed, refer to section 3.2 for details;
y Longtime press “▲” key: turn on/off LCD display;
5. Prompt Information
During monitoring, if there is no signal to be detected, the
short lines will be prompted on the screen instead of the
numerical values, as shown in Figure 10.
Figure 10 No Signal
During measuring, the measured values are recorded every
2 seconds. The length of data record is limited to 30
seconds at least, and the maximal length for one record is
also limited to 2 hours.
During measuring, if the memory is full or the total
number of the records is 256 pieces, the earliest records
will be overwritten and the icon “
” will appear on the
screen for prompt, as shown in Figure 11.
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User Manual for OW1.0 Wrist Oximeter
Memory full
Figure 11 Memory Full
Note: It is suggested that the data shall be uploaded
to computer for saving, or the earliest records will be
overwritten.
6. Working Mode
y The measurement will start automatically when the
finger is inserted into the soft rubber of the sensor, so
the data recording (SpO2 and PR values) starts
simultaneously as well. The display is as shown in
Figure 9.
y During measuring, long time press“▲” key to blank
the screen (the measurement and data recording are
still undergoing.), but long time pressing any key
will activate the display for viewing the current
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User Manual for OW1.0 Wrist Oximeter
measuring information again.
y If there is no signal to be detected (e.g. finger off) for
20 seconds, the device will be at idle state (i.e. blank
screen and standby for measurement).
y When the device is at idle state, long time pressing
any key will activate the LCD display, or once the
finger is inserted in the soft rubber of the sensor, the
measurement will start and LCD display will be
activated as well.
3.2 Alarm Limit Settings
3.2.1 SpO2 Lower Alarm Limit Setting
On default display screen(Figure 9), longtime press “■”
key to enter SpO2 Lower Limit Setting Screen, as shown in
Figure 12A.
Figure 12A
Figure 12B
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User Manual for OW1.0 Wrist Oximeter
— “%SpO2 Lo”: SpO2 lower alarm limit; “90”: SpO2
preset value;
— “ ”: selecting cursor;
Key Operations:
y On SpO2 Lower Limit Setting screen (Figure 12A),
press “■” key to move cursor to SpO2 value (Figure
12B).
y Then press “▲” key to change its value;
Short time press “▲” key: increase the numerical
value single time;
Long time press “▲” key: increase the numerical
value continuously;
y Next, long time press “■” key to confirm the preset
value and exit the setting.
3.2.2 PR Lower and Higher Alarm Limit Settings
On SpO2 Lower Limit Setting Screen (Figure 10A), when
the cursor stays in the upper area, short time press “▲”
key to shift the screen among PR Lower Limit Setting
screen (Figure 11A), PR Higher Limit Setting screen
(Figure 12A) and SpO2 Lower Limit Setting screen (Figure
10A).
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User Manual for OW1.0 Wrist Oximeter
Figure 11A
Figure 11B
Figure 12A
Figure 12B
— “Lo
BPM”: PR lower alarm limit; “60”: preset
value;
BPM”: PR higher alarm limit; “120”:
— “Hi
preset value;
— “ ”: selecting cursor;
—
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User Manual for OW1.0 Wrist Oximeter
Key Operations:
y Short time press “■” key: move the cursor upwards
or downwards;
y Short time press “▲” key: increase the numerical
value single time;
y Long time press “▲” key: increase the numerical
value continuously;
y Long time press “■” key: confirm the preset value
and exit the setting.
Note: During measuring if SpO2 or/and PR values
exceed the preset alarm limit, the numerical value
exceeded limit will flash.
3.3 Upload Data
Before uploading the data to PC, please quit from the menu
screen if you are doing the setup. When start uploading,
connect the data cable between the device and PC, then do
the following operation by the instruction in “Oximeter
Data Manager User Manual”, the data uploading will be
activated. If the device and the PC realize communication
successfully, the oximeter will display the screen as shown
in Figure 13.
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User Manual for OW1.0 Wrist Oximeter
Figure 13 Data Upload
3.4 Low Battery Indication
When “
” occurs on the screen, it indicates battery
power is not enough. If you keep on using, the measuring
error may be caused, please change batteries in time.
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User Manual for OW1.0 Wrist Oximeter
4 Additional Advice for Operation
y The finger should be put in properly and correctly.
y Avoid shaking finger as possible as you can during
measuring;
y Do not put wet finger directly into sensor.
y Avoid placing the device on the same limb which is
wrapped with a cuff for blood pressure measurement
or during venous infusion.
y Do not let anything block the emitting light from
device.
y Electrosurgical device interference may affect the
measuring accuracy.
y Using enamel or other makeup on the nail may affect
the measuring accuracy.
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User Manual for OW1.0 Wrist Oximeter
5 Technical Specifications
A.
Display mode：Segment LCD Screen
B. Power supply requirement:
1.5V (AAA size) alkaline battery × 2
Supply voltage: 2.2 V~3.3V
C. Operating current: ≤40mA
D. SpO2 Parameter Specifications
Measuring range: 35%~99%
Accuracy: 70%~75% ±3digits,
75%~99% ±2digits
E.
Pulse Rate Parameter Specifications
Measuring range: 30bpm~240bpm
Accuracy: ±2bpm or ±2% (whichever is greater)
F. Preset alarm limits:
SpO2 alarm:
Lower limit: 90%
Pulse Rate alarm:
Upper limit: 120bpm
Lower limit: 50bpm
G. Record Interval
2 seconds per group (SpO2 and PR values)
H. Performance under low perfusion condition
The measurement accuracy still keeps the above
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User Manual for OW1.0 Wrist Oximeter
specification while the perfusion index is as low as
0.6%.
I.
Resistance to interference of surrounding light:
The difference between the SpO2 value measured in
the condition of indoor natural light and that of
darkroom is less than ±1%.
J.
Resistance to 50Hz /60Hz interference
SpO2 and PR are precise which have been tested by
BIO-TEK pulse oximeter simulator.
K. Physical feature
Dimensions: W 59mm×D 49mm×H 22mm
Net Weight: about 60g (not including batteries)
L.
Classification
The type of protection against electric shock:
Internally powered equipment.
The degree of protection against electric shock:
Type BF applied part.
The degree of protection against harmful ingress
of liquids: Ordinary equipment without protection
against ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
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User Manual for OW1.0 Wrist Oximeter
6 Accessories
y A data cable (optional)
y Oximeter Data Manager software (optional)
y A wristband
y A SpO2 probe
y Two batteries (AAA)
y A User Manual
y Quality Certificate
Note: The accessories are subject to change. See the
Packing List for detailed items and quantity.
7 Repair and Maintenance
7.1 Maintenance
The life of this device is 5 years. In order to ensure its long
service life, please pay attention to the use of maintenance.
y Please change the batteries when the low-voltage
indicator lightens.
y Please clean the surface of the device before using.
Use cloth with alcohol to wipe the device first, and
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User Manual for OW1.0 Wrist Oximeter
then let it dry in air or wipe it dry.
y Please take out the batteries if the oximeter will not
be used for a long time.
y The best storage environment of the device is -20ºC
to 70ºC ambient temperature and 10%~95% relative
humidity.
High-pressure sterilization cannot be used on the
device.
Do not immerse the device in liquid.
7.2 Cleaning and Disinfecting Instruction
y Surface-clean sensor with a soft gauze by saturating
with a solution such as 75% isopropyl alcohol, if
low-level disinfection is required, use a 1:10 bleach
solution. Then surface-clean with a damp cloth and
dry with a piece of cloth.
y Clean the wristband with soapy water. Please detach
the wristband from the oximeter firstly.
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User Manual for OW1.0 Wrist Oximeter
8 Troubleshooting
Trouble
The SpO2
and Pulse
Rate
display
instable
Possible Reason
Solution
1. The finger is not 1. Place the finger
placed inside
properly and try
enough.
again.
Can not
turn on the
device
1. The batteries are
drained or almost
drained.
2. The batteries are
not inserted
properly.
3. The device’s
malfunction.
1. Change batteries.
2. Reinstall
batteries.
3. Please contact the
local service center.
Always
display
“No
Signal”
1. The probe is not
connected to the
oximeter properly.
2. The finger is not
placed well.
3. The probe
connector or the
probe sensor is
broken.
1. Connect the
probe to the
oximeter properly
and try again.;
2. Place the finger
properly and try
again.
3. Please contact
the local service
center.
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User Manual for OW1.0 Wrist Oximeter
9 Appendix
Common Knowledge for SpO2 Measurement
1 Meaning of SpO2
SpO2 is the saturation percentage of oxygen in the blood,
so called O2 concentration in the blood; it is defined by the
percentage of oxyhemoglobin (HbO2) in the total
hemoglobin of the arterial blood. SpO2 is an important
physiological parameter to reflect the respiration function;
it is calculated by the following method:
SpO2 = HbO2/ (HbO2 +Hb)×100%
HbO2 are the oxyhemoglobins (oxygenized hemoglobin),
Hb are those hemoglobins which release oxygen.
2 Principle of Measurement
Based on Lamber-Beer law, the light absorbance of a given
substance is directly proportional with its density or
concentration. When the light with certain wavelength
emits on human tissue, the measured intensity of light after
absorption, reflecting and attenuation in tissue can reflect
the structure character of the tissue by which the light
passes. Due to that HbO2 and Hb have different absorption
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User Manual for OW1.0 Wrist Oximeter
character in the spectrum range from red to infrared light
(600nm~1000nm
wavelength),
by
using
these
characteristics, SpO2 can be determined.
Clinical application of pulse oximeters: SpO2 is an
important physiological parameter to reflect the respiration
and ventilation function, so SpO2 monitoring used in
treatment has become more popular. (For example, such as
monitoring patients with serious respiratory disease,
patients under anesthesia during operation and premature
and neonatal infants) The status of SpO2 can be determined
in timely manner by measurement and will allow finding
the hypoxemia patient earlier, thereby preventing or
reducing accidental death caused by hypoxia effectively.
3 Factors affecting
(interference reason)
SpO2
measuring
accuracy
— Intravascular dyes such as indocyanine green or
methylene blue
— Exposure to excessive illumination, such as surgical
lamps, bilirubin lamps, fluorescent lights, infrared
heating lamps, or direct sunlight.
— Vascular dyes or external used color-up product such
as nail enamel or color skin care
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User Manual for OW1.0 Wrist Oximeter
— Excessive patient movement
— Placement of a sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line
— Exposure to the chamber with High pressure oxygen
— There is an arterial occlusion proximal to the sensor
— Blood vessel contraction caused by peripheral vessel
hyperkinesias or body temperature decreasing
4 Factors causing
(pathology reason)
low
SpO2
Measuring
value
— Hypoxemia disease, functional lack of HbO2
— Pigmentation or abnormal oxyhemoglobin level
— Abnormal oxyhemoglobin variation
— Methemoglobin disease
— Sulfhemoglobinemia or arterial occlusion exists near
sensor
— Obvious venous pulsations
— Peripheral arterial pulsation becomes weak
— Peripheral blood supply is not enough
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User Manual for OW1.0 Wrist Oximeter
B Wristband Installation and Disassembly
Step 1: Fix the wristband on your left wrist(Fig.A).
Fig. B
Wristband
underlay
Wristband
Fig. A
Fig.C
Step 2: Put the oximeter on the propriate site of the
wristband. Then press the oximeter to make the wristband
underlay(Fig.B) stick to the wristband firmly. Next, follow
the Fig.C to fix the oximeter well.
Step 3: The process of wristband disassembly is similar to
the installation method, but with reverse procedure.
Note: Please detach the wristband from the
oximeter before cleaning the wristband.
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User Manual for OW1.0 Wrist Oximeter
FCC ID: YTKPC-68A
IMPORTANT REGULATORY INFORMATION
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 and
2. This device must accept any interference that is
received, including any interference that may cause
undesired operation.
WARNING: Changes or modifications to this unit not
expressly approved by the party responsible for
compliance could void the user’s authority to operate
the equipments.
FCC Part 15.105b statement
NOTE: 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
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User Manual for OW1.0 Wrist Oximeter
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 which the receiver is connected.
-Consult the dealer or an experienced radio/TV
technician for help.
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