Model: PO8201
Ver 1.0 May, 2010
311-8201100-003
Owner’s Manual
Model: PO8201
4
About the Manual
The precautions, warnings and notes throughout this manual are very important.
Please read this entire manual carefully before using the nu-beca Handheld
Pulse Oximeter.
The information in the manual has been carefully checked and is believed to
be accurate.
5
Handheld Pulse Oximeter
Table of Content
SAFETY INFORMATION 06
Warnings 06
Cautions 07
INTRODUCTION 08
Intended Use 08
General Description 08
Principle of Measurement 08
Meter Appearance and Key Function 09
Content of the System 11
BEFORE USE 12
Battery Replacement 12
Connecting the Probe 13
Power On/Off 13
Set up the Oximeter 14
Power On Self-Test 19
OPERATION 20
CLEANING THE OXIMETER 23
TROUBLESHOOTING 24
SYMBOL INFORMATION 26
SPECIFICATION 27
6
SAFETY INFORMATION
Warning
● Federal law (USA) restricts this device to sale by or on the order of a
physician.
● Do not use the oximeter in an MRI environment.
● The use of accessories, probes, and cables other than those listed
in this manual may result in increased emission and/ or decreased
immunity of the device.
● The oximeter is intended only as an adjunct in subject assessment. It
must be used in conjugation with other methods of assessing clinical
signs and symptoms.
●
Explosion Hazard: Do not use the oximeter in an explosive atmosphere.
● If subjects’ monitoring sites have trauma, disability or other medical
status that make inaccurate results, operators should consult doctors
before use.
● Use probe manufactured by manufacturer. Using other manufacturers’
probes may cause improper oximeter performance. Also, do not use a
damaged probe.
● Because operating environments vary, use caution to ensure that all
audible alarms and indicators can be heard. Users must determine
the acceptable audible distance of all alarms.
● When a system fault occurs, the subject will no longer be monitored.
● The oximeter has to measure the pulse properly to obtain accurate
SpO
2
measurement. Blood flow restrictors (e.g., blood pressure
cuffs) may hinder pulse measurements. Remove any objects that
may hinder the performance of the oximeter.
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Handheld Pulse Oximeter
Cautions
● The oximeter is not an apnea monitor.
● The oximeter determines the percentage of arterial oxygen saturation
of functional hemoglobin. Significant levels of dysfunctional
hemoglobin such as carboxyhemoglobin or methemoglobin may
affect the accuracy of the measurement.
● Cardiogreen and intravascular dyes, depending on the concentration,
may affect the accuracy of SpO
2
measurements.
● The performance of the oximeter might be affected by the presence
of a defibrillator.
● The oximeter may not work on all subjects. If you are unable to
achieve stable readings, discontinue use.
● The oximeter has monition tolerant software that minimizes the
likelihood of motion artifact being misinterpreted as good pulse
quality. In some circumstances, however, the oximeter may still
interpret motion as good pulse quality. Minimize subject motion as
much as possible.
● Verify that all visible indicators illuminate and that an audible
indicator sounds during the startup (initialization) sequence, if any
indicator is
not lit or the audible indicator does not sound, do not use
the oximeter. Please contact your agent for help.
● Do not immerse the oximeter or probes in liquid to clean, and also
do not expose them to excessive moisture or liquids.
●
Do not use caustic or abrasive cleaning agents on the oximeter or probes.
● Do not mix new and old batteries at the same time. It may cause the
batteries to leak. Disposed of batteries properly.
● Batteries might leak chemicals if unused for a long period of time.
Remove the batteries if the oximeter is going to be stored for more
than one month.
● Batteries may leak or explode if used or disposed of improperly.
● The oximeter is a precision electronic instrument and must be
repaired by trained personnel only
● Follow local governing ordinances and recycling instructions regards
disposal or recycling of the device and device components. Follow
local governing ordinances and recycling instructions regards
disposal or recycling of the device and device components.
8
INTRODUCTION
►Intended for Use
The nu-beca Handheld Pulse Oximeter is indicated for use in measuring and
displaying functional oxygen saturation of arterial hemoglobin (SpO
2
) and pulse
rate. It is intended for patients during no-motion condition. The oximeter is suitable
for use at home, in hospital, clinical sites and home care environment.
This device is indicated for non-invasive spot checking or continuous monitoring.
►General Description
The oximeter is a digital handheld that displays numerical values for blood oxygen
saturation. It provides audible alarm for both medium and high priority conditions.
The range of the peak wavelengths and maximum optical output power of the light
emitted by the oximeter probe and the reading result can be especially useful to
clinicians.
The oximeter with reusable SpO
2
probe accessories operates on battery power for
up to 40 hours. The oximeter requires no routine calibration or maintenance other
than replacement of alkaline batteries. When the batteries are low, the indicator will
blink to warn users to replace the batteries.
►Principle of Measurement
The nu-beca Handheld Pulse Oximeter determines functional oxygen saturation
of arterial hemoglobin (SpO
2
) by measuring the absorption of red and infrared light
passing through perfused tissue. Changes in absorption caused by the pulsation of
blood in the vascular bed are used to determine oxygen saturation and pulse rate.
9
Handheld Pulse Oximeter
►Meter Appearance and Key Function
Reading Value Display Area
1
2
3
4
9
10
6
7
5
8 Pulse Amplitude
8
Low Battery Indicator
SpO
2
indicator
LED Screen
Set Button
Advance Button
On/Off Button
SpO
2
%
Pulse Rate
Oximeter Sensor Port
10
1. Low Battery Indicator
Red light appears when power is insufficient to the oximeter.
2. SpO2 Indicator
Red light appears when probe disconnects from oximeter. Orange light appears
when probe does not connect properly with the subject or the signal is not detected
stably.
3. Set Button
Is used to set up settings and keep the oximeter silence when it is alarming.
4. Advance Button
Is used to review status or adjust alarm volume.
5. On/Off Button
Is used to turn on or turn off the oximeter by pressing On/Off button.
6. SpO2 %
The measurement result of oxygen saturation in percentage.
7. Pulse Rate
The measurement result of pulse rate.
8. Pulse Amplitude
The strength of the signal is detected by the oximeter.
9. LED Screen
Display measurement results.
10. Oximeter Sensor Port
Connect the probe and the oximeter.
11
Handheld Pulse Oximeter
►Content of the System
The nu-beca Handheld Pulse Oximeter includes the following items:
A. Handheld Pulse Oximeter with Probe
B. Owner's Manual x 1
C. AA
Alkaline Batteries x 4
D. Warranty Card
Confirm that the items listed are packed with the nu-beca Handheld Pulse
Oximeter. If any item on this list is missing or damaged, contact your distributor.
All of the system with accessories is provided non-sterile.
Owner's Manual
A B C D
12
BEFORE USE
Low battery capacity is indicated with a flashing red light. We recommend that you
replace the new batteries if the low battery indicator turns red.
►Battery Replacement
Make sure the oximeter is switched off when replacing the batteries.
The oximeter is powered by 4 AA alkaline batteries. Replace new batteries by the
following steps.
STEP1.
Loosen the screw at the back of the oximeter and remove the battery cover.
STEP2.
Remove the old batteries from battery compartment.
STEP3.
Insert four new AA alkaline batteries. Correctly align the polarities (+ and -)
with battery indication marks on the oximeter.
STEP4.
Replace the battery cover and tighten the screw.
CAUTION!
1.Use only 1.5 AA new batteries with this device. Replace the batteries as soon
as possible after a low battery indicator appears.
2.If the oximeter does not work after installed the batteries. Reinstall the batteries.
STEP1
STEP4
STEP2 STEP3
13
Handheld Pulse Oximeter
►Connecting the Probe
Connect the probe to the top of the oximeter as shown below. Make sure that the
probe is firmly plugged into the oximeter.
►Power On/Off
• Turn on the oximeter by pressing and releasing the button.
• Turn off the oximeter by pressing and holding the
button for about 3 seconds.
Spo
2
%
BPM
14
►Set up the Oximeter
Your oximeter comes with the alarm function including the upper/lower limit of SpO2
and heart rate, and the brightness of LED backlight preset. If you need to set these
parameters, please follow below steps.
Start with the oximeter is off.
STEP 1. Press
Button and button at the same time to enter setting mode.
The first screen shows SpO
2
upper limit settings. The factory default is off.
STEP 2. Press
button to change settings. You can press button to increase
the number from 91% to 100%.
When the setting value goes to the upper limit, press
button again and
the screen will turn back “OFF” setting.
15
Handheld Pulse Oximeter
When the setting value goes to the upper limit, press button again and
the screen will turn back “OFF” setting.
STEP 4. Press button to change settings. You can press button to increase
the number from 85% to 94%.
STEP 3. When the desired setting is displayed on the screen, press button to
enter SpO
2
lower limit setting. The factory default is off.
16
STEP 6. Press button to change settings. You can press button to increase
the number from 105 BPM to 250 BPM.
When the setting value goes to the upper limit, press button again and
the screen will turn back “OFF” setting.
STEP 5. When the desired setting is displayed on the screen, press button to
enter heart rate upper limit setting. The factory default is off.
17
Handheld Pulse Oximeter
STEP 8. Press button to change settings. You can press button to increase
the number from 30 BPM to 100 BPM.
When the setting value goes to the upper limit, press button again and
the screen will turn back “OFF” setting.
STEP 7. When the desired setting is displayed on the screen, press button to
enter heart rate lower limit setting. The factory default is off.
18
STEP 10. Press button to change settings. L1 setting is brighter than L2
setting. press
button to turn off the oximeter.
(For PO-8201B )
STEP 11. Press
to change settings. Press button to turn on Bluetooth.
STEP 9. When the desired setting is displayed on the screen, press button to
enter LED backlight setting mode.
19
Handheld Pulse Oximeter
Setting Table
Alarm Limit Default Adjustment Options Increments
SpO2 High Off Off, 91-100 1%
SpO
2
Low Off Off, 85-94 1%
Pulse Rate High Off Off, 105-250 5 BPM
Pulse Rate Low Off Off, 30-100 5 BPM
Brightness L1 L1 and L2 N/A
►Power On Self-Test
When the oximeter is turned on for normal operation, the unit will check if the
oximeter is ready for use. If probe does not connect to oximeter, the SpO
2
indicator
will appear red light. If probe does not touch the subject’s measurement site or the
signal is unstable, the SpO
2
indicator will turn orange light.
20
OPERATION
All functions of the oximeter are controlled by and buttons found on the
front of the unit.
STEP 1. Turn on the oximeter by press
Button.
STEP 2. Clip subject’s finger as below:
The LED Screen shows as above to indicate the oximeter is ready to use.
CAUTION!
1. Consult health professional before you start to use the oximeter.
2. The oximeter probe might not work on cold extremities due to reduced circulation.
Warm or rub the finger to increase circulation, or reposition the probe.
3.
Check the probe application site frequently to determine circulation, positioning
and skin sensitivity. The recommended maximum application time at a single
site is 4 hours.
21
Handheld Pulse Oximeter
STEP 3. After detecting the pulse signal, the oximeter shows the readings of SpO2
and pulse rate on LED.
STEP 4. The readings will be updated based on the signal received with each pulse.
► SpO2 Symbol (%SpO2)
The SpO
2
symbol shows the current oxygen saturation in percentage .
► Pulse Rate Symbol (
)
The pulse rate symbol shows pulse rate in beats per minute.
► Pulse Amplitude
The strength of signal is detected by the oximeter.
22
► Alarm Silence
When the alarm is beeping, you can press
button to turn off the alarm for one
minute. After one minute, the alarm will beep again. The alarm turns off unless the
ot refer esaelp ,mrala ffo nrut oT .lamron si sutats eht ro dellecnac si noitcnuf mrala
"Set up the Oximeter" section for details.
Adjusting alarm settings is only possible when the oximeter is in setting mode. For
every power on in which alarm settings have not been recalled or adjusted in Setup
mode, the default alarm settings remain in effect.
Refer to the table below for detailed information about alarm conditions, activation criteria.
Condition Alarm Activation Criteria
SpO
2
High
Activates when displayed SpO
2
is equal to or greater than
the SpO
2
upper limit setting.
SpO
2
Low
Activates when displayed SpO
2
is equal to or less than
the SpO
2
lower limit setting.
Pulse Rate High
Activates when the displayed pulse rate is equal to or
greater than the pulse rate upper limit setting.
Pulse Rate Low
Activates when the displayed pulse rate is equal to or less
than the pulse rate lower limit setting.
23
Handheld Pulse Oximeter
CLEANING THE OXIMETER
Cleaning oximeter is just as important as proper use. For surface-cleaning and
disinfecting the oximeter and reusable SpO
2
probes we recommend the following
procedures:
► Turn off the oximeter before cleaning.
► Wipe exposed surfaces with a soft or a pad moistened with a mild detergent
solution or medical alcohol (70% isopropyl alcohol solution).
► Clean your oximeter whenever you see any type of soil, dirt or obstruction in it.
► Ensure that no dirt or blood is on the optical components.
► SpO
2
probes can be cleaned and disinfected with same solutions. Let the probe
dry before using it again. The rubber inside of the SpO
2
probe belongs to medical
rubber, which has no toxin and no harmful to the skin of human being.
► Replace the batteries timely when battery indication is low. Please follow the law
of the local government to deal with used batteries.
► Remove the batteries inside the battery cassette if the oximeter will not be
operating for a long time.
► It is recommended that the oximeter should be kept in a dry environment
anytime. A wet ambient might affect its lifetime and even might damage the
oximeter.
► Caution: Do not spray, pour, or spill any liquid on the oximeters, their
accessories, switches or openings.
24
TROUBLESHOOTING
Problem Possible Cause Possible Solution
The oximeter won’t turn on.
The batteries are out. Replace all batteries.
The batteries are
installed incorrectly.
Verify correct battery
orientations.
A dash appears in the LED.
A probe fault exists.
The probe may have
become dislodged
from the oximeter or
from the subjects.
Verify that the probe
is correctly connected
to the oximeter and
the subject. Try a new
probe if the condition
persists.
The displayed pulse rate
does not correlate to the
pulse rate displayed on
the ECG monitor connects
to patient.
Excessive motion
at the probe site
may be prohibiting
the oximeter from
acquiring a consistent
pulse signal.
Eliminate or reduce the
cause of the motion
artifact or reposition
the probe to a new
probe site where
motion is not present.
The subject may
have an arrhythmia
resulting in some
heart beats that do
not yield a pulse
amplitude signal at
the probe site.
Examine the subject:
the condition may
persist even though
both monitors are
functioning properly
if the subject's
arrhythmia persists.
A non-oximeter probe
is being used.
Replace the probe with
a oximeter probe.
The ECG monitor may
not be functioning
properly.
Examine the subject:
replace the ECG
monitor or refer to the
operator's manual for
the ECG monitor.
25
Handheld Pulse Oximeter
Problem Possible Cause Possible Solution
Segments of the SpO
2
or
pulse rate displays are
missing.
Defective LED
displays.
Displayed values may not
be reliable; discontinue
use of the oximeter.
Disruption in the oximeter
performance.
Electromagnetic
interference (EMI).
Remove the oximeter from
the EMI environment.
Displays and indicators
are off, but a continuous
audible alarm is sounding.
Problem in operation.
Turn the oximeter off and
replace the batteries. If
the problem still persists,
contact your agent for
help.
Red light battery indicators
appears accompanying
the message displayed on
LED as shown below:
The batteries are low.
Replace the batteries.
If you have followed the actions recommended above but the problem keeps
unsolved, please contact your local dealer for assistance.
26
SYMBOL INFORMATION
Type BF applied part Part- not defibrillator proof
Resistant to liquid ingress
Caution, consult accompanying documents
Manufacturer
Authorised representative in the European Community
cinortcele dna lacirtcele rof noitcelloc etarapes setacidnI
equipment (WEEE).
CE Marking indicating conformance to EC directive No. 93/42/
EEC concerning medical device
Consult instructions for use
Do not use if package is damaged
Serial number (located under the battery cover)
27
Handheld Pulse Oximeter
SPECIFICATION
Pulse Oximetry
Range: 0% to 100%
Resolution: 1%
Accuracy: 70% to 100% range: ±2%; <69%: unspecified
Method: Dual wavelength LED (660nm/905nm)
Neonate mode Not Available
Heart (pulse) Rate
Range: 30 to 250bpm
Resolution: 1bpm
Accuracy: ±1bpm or ±1%, whichever is greater
Displays
Type: Segment LED
Parameters: SpO
2
; pulse rate; pulse bar (can also indicate low perfusion)
Status:
Indicate a stable reading is taken;
Probe fall-off detection indication
Battery status indication
Keys
On/Off key One button
Functional key Two buttons
Alarm:
Urgent alarm
SpO
2
value is higher/lower than predefined setting, or probe fall
off, pulse too high/low
Reminding alarm Low battery
Setting
SpO2 high/low value Alarm level setting
Pulse high/low
value
Alarm level setting
Mechanical
Weight: With batteries: 240g
Size: Reference dimension 14cm (H) x 7cm (W) x 3.2cm (D);
Water-resistance Against water splash
Impact-resistance Against repeat impact from 1 meter height
Transmission Bluetooth(PO-8201B)
28
Battery
Type: 4 AA alkaline battery
Usage life: 40 hrs typical operation
Environmental
Operating
Temperature:
-10ºC to 50ºC (14ºF to 122ºF) for the device ;
5ºC to 40ºC (41ºF to 104ºF) for the probe
Storage
Temperature:
-20ºC to 55ºC; -4ºF to 131ºF
Operating
Humidity:
Below 95%, non-condensing
Classification
Degree of
Protection:
Type BF applied part
Mode of
operation:
Continuous
Safety: IEC60601-1
EMC: IEC60601-1-2
Performance
standard:
ISO9919
Bluetooth: EN300 328, EN301 489
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