Beijing Choice Electronic Technology MD300M122 Handheld Pulse Oximeter User Manual

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PULSE OXIMETER
INSTRUCTION
MANUAL
V1.0M122
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PULSE OXIMETER INSTRUCTION MANUAL
Copyright
Our company owns all rights of this unpublished work and intends to maintain it as a
confidential work. We may also seek to maintain this work as an unpublished copyright.
This publication is to be used solely for the purpose of reference or operation of our
device. No part of this work can be disseminated for other purposes.
In the event of inadvertent or deliberate publication, we intend to enforce its rights to this
work under copyright laws as a published work. Those having access to this work may
not copy, use, or disclose the information in this work unless expressly authorized by our
company.
All information contained in this publication is believed to be correct. We shall not be
liable for errors contained herein nor for incidental or consequential damages in
connection with the furnishing, performance, or use of this material. The information this
publication refers to is protected by copyrights or patents and does not convey any
license under the patent rights of our company, nor the rights of others. We do not
assume any liability arising out of any infringements of patents or other rights of third
parties.
Content of the manual is subject to change without prior notice.
ALL RIGHTS RESERVED
Bluetooth® and the Bluetooth® Logo are registered trademarks of Bluetooth® SIG, Inc.
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Issue date: 5th January, 2010
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Content
1 Introduction...........................................................................................3
1.1 Brief Introduction...........................................................................3
1.2 Safety Information .........................................................................3
1.3 Electromagnetism Interference ....................................................5
2 General Descriptions ............................................................................6
2.1 Appearance ....................................................................................6
2.2 Explanation of Symbols .................................................................8
2.3 Power Supply..................................................................................9
2.4 Product Features .........................................................................11
3 Install the Probe..................................................................................11
4 Setting ID, Date and Time...................................................................12
4.1 Date & Time Settings...................................................................12
4.2 ID number Setting ........................................................................13
5 Take a Measurement...........................................................................14
6 Other Settings .....................................................................................15
6.1 Alarm Setting ...............................................................................15
6.2 Data Management ........................................................................17
6.3 System setting .............................................................................20
7 Maintain and Repair ............................................................................22
7.1 Maintenance.................................................................................22
7.2 Safety Checks ..............................................................................23
7.3 Calibration and Verification.........................................................24
7.4 Trouble Shooting ..........................................................................25
7.5 Warranty and Repair ....................................................................25
7.6 Storage and Transportation ........................................................27
APPENDIX A Specifications ...................................................................27
1 Introduction
1.1 Brief Introduction
Thank you for purchasing the handheld pulse oximeter. The main functions of the device
include SpO2 and PR measurements, visual and audible alarm, batteries charging, data
storage and review and USB cable&Bluetooth transferring, etc. Please read this manual
carefully before using the device.
Intended use：
The pulse oximeter is intended for spot checking, displaying, storing and transmitting
Haemoglobin Saturation and pulse rate of single adult, pediatric and neonatal patient in
hospital (including clinical use in surgeries, anesthesia, intensive care and etc.), in home
care environment, and social medical organizations.
Notes：
) The illustration applied in the manual may differ slightly from actual device.
) The device is designed of handheld structure and please be sure not to turn
upside down when using it.
1.2 Safety Information
Conception of Warning, Precaution and Note
The Warning, precaution and Notice at this document are special information in favor of
user’s operation.
¾
Warning - Indicates a potential hazard or unsafe practice that, if not avoided, will
result in death or serious injury.
¾
Caution - Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
¾
Note: - Provides application tips or other useful information to ensure that you get
the most from your product.
Warnings
z The handheld pulse oximeter should be confined to sophisticated operator exclusively.
Prior to application, users should follow instructions listed in this manual, otherwise any
wrong operation may cause serious damage. Our company will assume no warranty for
using this equipment improperly.
z Do not use the oximeter in the presence of flammable anesthetics, vapors or liquids.
z Do not use the oximeter in an MRI or CT environment.
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z This equipment is for use in the medical field, and measurement results only serve as a
reference for any relevant treatment.
z Connect the probe correctly; please see the directions for use of any accessories.
z Please follow the doctor’s suggestions when starting to monitor the vital sign
parameters.
z When connecting this device to other peripherals, make sure that you are qualified to
operate this device. Any peripheral must be certified according to the protocol of IEC
950 and IEC 601-1-1. Any input/output device should follow the protocol of IEC
601-1-1.
z Considering the probe is a sensitive device so please strictly follow the probe
application instructions.
z The malfunction of probe may cause inaccurate data which serves as a foundation to
treat patients, so make sure to pay more attention to the probe and inspect it usually.
z The worn-out data cables may cause inaccurate data which is used as a reference to
treat patients, so please pay attention to the data cable and check it frequently.
z Do not touch the AC adapter with wet hands. Otherwise，You may suffer electric shock.
z The disposable accessories should not be cycled.
z 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 received, including interference that may
cause undesired operation.
Cautions
z Clean the probe with an H2O solution and a neutral detergent. Don’t submerge the
probe. Do not use in autoclave (sterilizer).
z This device is intended for use by persons trained in professional health care. The
operator must be thoroughly familiar with the information in this manual before using
the device.
z Before cleaning or disinfecting the probe, unplug it from the oximeter to prevent probe
or oximeter from being damaged, and to protect user under safety situation.
z To avoid an electrical hazard, never immerse the unit in any liquid or attempt to clean it
with liquid cleaning agents. Always disconnect the device from AC adapter before
performing cleaning of maintenance.
z Alarm must be set up according to different situations of individual patient. Make sure
that chime sound can be activated when alarm function begins to work.
Notes
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z Application of this device may influence the measuring accuracy in the background of
electromagnetic areas such as electro-surgery environment.
z SpO2 measurements may be adversely affected in the presence of high ambient light.
Shield the probe area (with a surgical towel, for example) if necessary.
z Dyes introduced into the bloodstream, such as methylene blue, indocyanine green,
indigo carmine, and fluorescein, may adversely affect the accuracy of the SpO2
reading.
z Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes
in systemic vascular resistance, may cause a failure to determine accurate pulse rate
and SpO2 readings.
z Remove fingernail polish or artificial fingernails before applying SpO2 probes.
Fingernail polish or artificial fingernails may lead to inaccurate SpO2 readings.
z Hazards arising from software errors have been minimized. Hazard analysis conforms
to meet ISO14971: 2000 and EN60601-1-4: 1996. Significant levels of dysfunctional
hemoglogins, such as carboxyhemoglogin or methhemoglobin, will spawn an affection
of the accuracy of the SpO2 measurement.
z Optical cross-talk can occur when two or more probes are located in adjoining area. It
can be eliminated by covering each site with opaque material. Optical cross-talk may
adversely affect the accuracy of the SpO2 readings.
z Obstructions or dirt on the probe’s red light or detector may cause a probe failure. Make
sure there are no obstructions and the probe is clean.
z The AC adapter and accessories used with the device should be complied with the
requirement of IEC60601-1.
z For routine equipment maintenance, please refer to the service procedures at the
associated section as indicated in the manual.
z As to the other concerns for attention, please carefully look through the specific chapter
in this instruction.
1.3 Electromagnetism Interference
This oximeter is designed and tested in compliance with the EMC standard, complying
with the international standard for the EMC of the electronic medical device - IEC
60601-1-2. However, because of the proliferation of radio frequency transmitting
equipment and other sources of electrical noise in the health-care and home environments
(e.g. cellular phones, mobile two-way radios, electrical appliances), it is possible that high
levels of such interference due to close proximity or strength of a source, may result in
disruption of performance of this device.
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This apparatus complies with the IEC 60601-1-2 international standard. The requirements
of this international standard are: CISPR11, GROP1, and CLASS B.
2 General Descriptions
The handheld pulse oximeter adopts 2.8 inch TFT screen, which can display the SpO2%
and pulse rate value, other indication parameters, such as time, ID number, pulse
amplitude bar and battery power status, alarm limits and the connections of Bluetooth and
probe, etc.
2.1 Appearance
Fig.2-1
Description of Fig.2-1：
SpO2 socket: for connecting the SpO2 probe with the oximeter.
Alarm lamp: When SpO2 or/and PR alarm occurs, It flashes（the color of the lamp is
yellow）.
Up button: press this button to increase the value by one increment. Or press it and hold
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it down to continuously increase the value.
Down button: press this button to decrease the value by one decrement. Or press it and
hold it down to continually decrease the value.
Menu/Select button: for entering main menu, or confirming the selection/setting.
Alarm inhibit/off button: Press this button to inhibit alarm sound for 120 seconds. And
long press the button, power off the alarm.
Return/Lock button：On the measuring screen, it serves as Lock button；On the menu
and sub-menu screen, it serves as Return button.
Power switch: Press and hold it down for about 3 seconds to power it on, and for about 4
seconds to turn it off.
Charge indicator: During the oximeter is being charged, the lamp is flashing; when it is
charged to full, the lamp is lighted without flashing; And the lamp is not lighted when it is
not charged.
Adapter socket:
for connecting the power adapter.
USB socket：designed to update the software of the device and only serves engineer.
Measurement screen:
Fig.2-2 Digital display
Fig.2-3 Wave display
1. Status bar 1&3: The status of the oximeter is shown on the bar.
2. Status bar 2&4: If the measured SpO2% or PR value exceeds the alarm limits, there will
be the corresponding information.
3 SpO2%：SpO2 area of display
◆It shows the oxygen saturation level of functional hemoglobin during normal
measurement.
◆The background color of the SpO2 value is red when the SpO2 is outside the alarm
limits.
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◆It shows two dashes throughout probe off and finger out conditions.
4：99: SpO2% upper alarm limit indicator
5：90: SpO2% lower alarm limit indicator
6：
Pulse amplitude bar.
It indicates the dynamic pulse amplitude and rate. As the detected pulse becomes stronger,
more bars is illumined with each pulse. The reverse is true for weak pulses.
7：75: PR upper alarm limit indicator
8：60: PR lower alarm limit indicator
9：PR: PR area of display
◆It shows the pulse rate in beats per minute during normal measurement.
◆The background color of the PR value is yellow when the PR is outside the alarm
limits.
◆It shows three dashes throughout probe off and finger out conditions.
10.15:00: The current time.
2.2 Explanation of Symbols
Symbol
Explanation
Type BF applied part
Symbol
Explanation
IPX1
Protected form dripping water
Attention,
ID indication
consult
ACCOMPANYING
DOCUMENTS
Audible alarm off/inhibition
Audible alarm on
It indicates alarm inhibition
when the countdown of 120s
displayed
Pulse Beep on
Pulse Beep off
The adapter is connected
Battery power indication
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Keyboard is unlocked
Keyboard is locked
USB cable is connected
USB cable disconnected
SpO2 probe is inserted
SpO2 probe off
Bluetooth activated
Bluetooth deactivated
2.3 Power Supply
2.3.1 Powered by batteries
Fig.2-4
Batteries Installation :
1) Open the battery cover: Rotate the fixing screw slightly in the rear panel to the position
which is marked with “ ” and then push the cover as indicated by arrowhead, as shown
in Fig.2-4.
2) Install 3 batteries lightly as indicated by the polarity signs in battery housing.
Note: Make sure the polarities of the batteries are correct.
3) Close battery housing cover
Close the battery housing cover and rotate the screw to the position which is marked with
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. And the batteries are locked.
Battery life and replacement
There are five shapes of the indicator: the centre with 4 bars(full), 3 bars, 2 bars, 1 bar,
empty and the frame in red. That the frame of indicator become red means few of battery
capacity remains. You should replace the batteries with new ones timely. Or else, the
indicator displays with a red frame constantly until battery capacity reaches critical
condition (the battery voltage is 3.5V±1V) at which time the unit shuts down.
Cautions!
—
Be sure to install batteries with correct polarities.
—
Only the approved batteries are recommended to be used..
—
Do not use batteries not specified for this unit.
—
Do not dispose of batteries in fire.
—
If battery fluid gets on your skin or clothing, rinse with plenty of clean water
immediately.
—
Remove the batteries from this unit when you are not going to use it for a long
period of time (approximately one month).
—
Do not use batteries of different types together.
—
Do not use new and used batteries together.
—
Dispose of batteries in accordance with the local ordinances and regulations.
2.3.2
Charging Batteries through adapter
To charge, please ensure the installed batteries are NI-MH ones. Firstly connect the
device with the oximeter and secondly with the wall outlet by adapter, and then press and
hold the power switch down for 3 seconds to power the device on.
A prompt window appears enquiring you “Are the batteries NI-MH ones?”, select “Yes” to
charge them or “No” to abandon charge and the device can be powered by wall outlet.
2.3.3 Charging Batteries by charger stand
The device can also be charged by charger stand provided with the oximeter. For more
information, refer to “Charger Stand Instruction Manual”.
Note:
1. To avoid the device from being damaged due to shot circuit, please keep the adapter is
firstly connected with the oximeter and secondly with the wall outlet. While disconnected
the connection, please keep the adapter is firstly disconnected from the wall outlet and
then disconnected from the oximeter.
2. During battery charge, the “Power Auto” and “Brightness” item can not be accessed.
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3. It is not recommended to measure SpO2 during the oximeter is powered by wall outlet or
being charged, for the damages and injuries may be caused to the device or users.
4. DO NOT charge when the non-rechargeable batteries are installed, otherwise, the
damages or injuries may be caused to the devices or users.
2.4 Product Features
— Simple to use and easy to operate.
— Compact, light in weight and convenient to carry.
— TFT display with adjustable backlight displays SpO2, pulse rate, pulse amplitude bar,
etc.
—
—
—
—
—
—
—
Up to 127 patients’ ID and 72-hour records storage.
Visual and three-level audible alarms, Battery power low alarm.
Adjustable pulse beep and backlight.
Data transfer to PC for review by Bluetooth or USB cable
Powered by three AA alkaline/ NI-MH batteries.
Battery charge function with adapter or charge stander(optional).
Suitable for adult, pediatric and neonatal users.
3 Install SpO2 Probe
The SpO2 Probe is shown in the following figure:
Fig.3-1
Insert the SpO2 probe to the socket, as shown in Fig.3-1. Then indicator
is shown on
the display (refer to Fig.2). If the SpO2 probe is disconnected from the unit，the indicator
appears and the prompt “Probe Off！！！” appears in the status column.
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The socket is also used for USB cable connected with the PC for data transmission. For
more information on data transmission and data management，refer to corresponding
software instruction manual.
4 Setting ID, Date and Time
Always set the date and time before using the unit for the first time. Set different ID
numbers for different users.
Check the date and time are correct before using the unit,and reset them if necessary. The
date and time are important indicators when a measurement is taken.
4.1 Date & Time Settings
Set the correct time according to the following steps:
1) Press the power switch for 3 seconds to power on the oximeter and then press the
menu button to enter the main menu, refer to the fig.4-1.
Fig.4-1
2) Press the Down button to select “Date and Time” item, and then press the Menu button
to enter the time setup screen， refer to Fig.4-2.
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Fig.4-2
Fig.4-3
Pick different sub-items to set and press the Select button to highlight it and then using the
Up or Down button to adjust the value. At last, press the Select button to confirm.
Set other sub-items of data and time according to the “Year setting” illustrated in the above
figures 4-2&4-3.
4.2 ID number Setting
Enter the “User ID Setting” from the main menu screen, refer to Fig.4-4. Press the Select
button to make the User ID number highlighted, and then press the Up or Down button to
increase or decrease the ID number, and then press the Select button to confirm your
settings. The range of ID number is: 001-127.
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Fig. 4-4
5 Take a Measurement
Before taking a measurement:
z Select the suitable probe in terms of type and dimension.
z Plug probe into SpO2 socket on top panel of pulse oximeter.
z Clip the patient finger to the rational position of the probe as the illustration as Fig.5-1.
Fig.5-1 Placement of the probe
Note：If the finger is not in the probe, “Finger Out！！” will be shown.
Warnings!
z The measurement would not be performed if the following instances come across
in operation:
z Shock
z Low temperature of hand
z Have taken vascular activity medicine
z Anemia
z carboxyhemoglobin
z methemoglobin
z methylene blue
z Indigo carmine
z Only use the SpO2 probes provided by manufacturer for SpO2 measurements.
Other SpO2 probes may cause improper performance.
z Do not use the SpO2 probe with exposed optical components.
z Excessive patient movement may cause inaccurate measurements.
z Tissue damage can be caused by incorrect application or use of probe, for
example by wrapping the probe too tightly. Inspect the probe site to ensure skin
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integrity and correct positioning and adhesion of the probe. More frequently
inspection should be taken depend on different patients if necessary.
z Inaccurate measurements may be caused by:
z Incorrect application or use of probe
z Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or
methemoglobin)
z Intravascular dyes such as indocyanine green or methylene blue
z Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight
z High-frequency electro surgical interference and defibrillators
z Venous pulsations
z Placement of a probe on an extremity with a blood pressure cuff,
arterial
catheter, or intravascular line.
z The patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia
z There is arterial occlusion proximal to the probe
z The patient is in cardiac arrest or is in shock
z Loss of pulse signal can occur in any of the following situations:
z The probe is too tight
z There is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight
z A blood pressure cuff is inflated on the same extremity as the one to which an
SpO2 probe is attached
Note：SpO2 probe should obviate the light source, e.g. radial lamp or infrared lamp.
The measured results are recorded into the memory of the oximeter, and Store up to
72-hours SpO2% and Pulse rate value, the time interval is 4 seconds. When the
memory is full, a prompt window of “Space Expire!” appears. To recorded the
newest measurements, you can delete the old ones for free space.
6 Other Settings
6.1 Alarm Setting
From the main menu, select and enter the “Alarm setting” screen, refer to Fig.6-1.
1) SpO2 alarm setup
To set SpO2 alarm high limit, In the “Alarm setting” screen, press the Up or Down button to
select the “High limit（SpO2）”. And then press the Select button to highlight the value.
Press the Up or the Down button to adjust the value, and at last press the Select button to
finish the setting of SpO2 high limit. The range of SpO2 high limit is 71%-100%.
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Fig.6-1
Set the low limit for SpO2 as the above steps of SpO2 high limit settings. The range of
SpO2 lower limit is 70%-99%.
2) PR alarm setting
Also, the limits settings of PR are performed as similarly as the SpO2 limits. The range of
High limit is 31bpm-235bpm. And the range of low limit is 30bpm-234bpm.
3) Alarm on/off
In the Alarm Setting screen, press the Up or Down button to move the cursor to the
Alarm(SpO2 ) or Alarm(PR) sub-item, and press the Select button to it highlighted. Press
the Up or Down button to select ON or OFF(refer to Fig.6-2). And then press the Select
button to confirm your settings. If you set the SpO2 and/or PR alarm off, the corresponding
limits on the measurement display is crossed with “×”.
Fig.6-2
ALARM PRIORITY:
There are three-level priorities for selection.
High priority: indicates the patient is in the very dangerous situation.
Medium priority: indicates the warnings should be paid attention to.
Low priority: indicates the technical alarm caused by the device itself.
Alarms of the oximeter include technical and physiological alarms. All the three priorities
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are divided by built-in module and can not be changed by user.
Assignment of priority:
High
Medium
Paramter
SpO2
PR
Low
Value
Red
Yellow
Alarm lamp
Flashing with yellow
Flashing with yellow
Lamp
Frequency
1.5Hz
0.5Hz
Audiblesound
Di- Di – Di ----- Di - Di
Di - Di - Di
Alarm cycle
3s
5s
20 s
Alarm info
SpO2 too high/low
PR too high/low
Probe off/Finger out
Di
Notes:
1. The alarm sound will go on until alarm disappears or is turned off.
2. After silencing the alarm, the corresponding indicator will indicate this.
3. The power low alarm: the corresponding indication lamp will be flashing with a red
frame.
AUDIBLE ALARM INHIBITION/OFF:
Short press the
button to silence the audible alarm for 2 minutes, the audible alarm
indicator will be displayed as
，together with the countdown from 120s to 0s，short
press it again，you can cancel alarm inhibition; Long press the
alarm indicator will be displayed as
long press the
button, the audible
which indicates the audible alarm off. And then
button, you can activate the audible alarm again.
Warnings!
When an alarm occurs, check patients’ conditions immediately.
Check which parameter is alarming or which alarm is going on.
Check patient’s condition.
Search for the source of alarm.
Make the alarm mute if necessary.
Check the alarm when no warning.
6.2 Data Management
From the main menu screen, select and enter the “Data Manage” screen, refer to fig.6-3.
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Fig.6-3
Press the Up button or Down button select the sub-item to set, and then press the Select
button to confirm or Return button to return to the previous screen.
6.2.1 Data Review
Pick ”Data Review” sub-item and enter by pressing the Select button. The screen as in
fig.6-4 will appear.
Press the Select button again, a dialog box will pop up, refer to fig.6-5. After selecting a ID
number, press the Up or Down button to select “Delete” or “Review” and then press the
Select button to confirm, you can delete or review all the records saved under the ID.
Fig.6-4
Fig.6-5
6.2.2 SpO2 Trend
Pick ” SpO2 Trend” sub-item and enter by pressing the Select button. The screen as in
fig.6-6 will appear.
Press the Select button again, a dialog box will pop up, refer to fig.6-7. After selecting a ID
number, press the Up or Down button to select “Delete” or “Review” and then press the
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Select button to confirm, you can delete or review all the SpO2 trends saved under the ID.
Fig. 6-6
6.2.3 PR Trend
Fig. 6-7
The operation is referred to 6.2.2 SpO2 Trend.
Fig.6-8
6.2.4 Clear Data
Fig.6-9
Pick ”Clear Data” sub-item and enter by pressing the Select button. A dialog box will pop
up, refer to fig. 6-10. Press the Up or Down button to pick the Yes or No and then press the
Select button to determine whether to delete all the records.
Note: Pay attention to data deletion, as you make the deletion, the data will not be
restored again.
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Fig.6-10
6.2.5 In the data management screen, the upper half screen will display the maximum,
minimum and average values of SpO2 and PR for the current ID. Refer to fig.6-11.
Fig.6-11
6.3 System setting
From the main menu, select and enter the System Setting screen, refer to Fig.6-12&6-13.
Press the Up or Down button to pick the different sub-items to set and press the Select
button to enter.
Fig.6-12
Fig.6-13
6.3.1 Brightness
Pick the Brightness sub-item and enter it from the System Setting screen，and set the
brightness level and brightness time.
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Brightness level: 1-7
Bright time: ON, 15, 30, 45, 60, 75, 90,105,120 seconds.
6.3.2 Bluetooth
Enter BlueTooth screen from the System Setting screen, and set the Bluetooth on or off
before transferring data to software for reviewing or analyzing data.
Notes:
—
—
For details, refer to attached Software Instruction Manual.
When the Bluetooth is free from transferring data for 2 minutes, the Bluetooth will be
closed.
6.3.3 Beep setting
Enter Beep setting screen from the System Setting screen, and set the beep level and
on/off.
Beep level: 1-7
Beep(switch):
on or off.
6.3.4 Display mode
Enter Display Mode screen from the System Setting screen, and select the display mode
for measurement screen from Wave and digital.
Select ‘Wave”, SpO2 plethysmogram will be displayed on the lower screen of the
measurement screen.
6.3.5 Keyboard lock
Enter Keyboard lock screen from the System Setting screen, and set the lock function
on/off. If set to on, long press the Lock button， the Menu/select, Up and Down, Alarm
inhibition buttons on front panel will be deactivated，except the Alarm off，power switch and
lock buttons.
To unlock the keyboard，long press the Lock button again.
6.3.6 Power Auto
Enter Power Auto screen from the System Setting screen, and set the auto power-off time
and set the auto power-off on/off.
Auto power-off time: Set how long not any operation is taken before the device
automatically power off.
Time: 1,2,3,4,5…15 minutes.
Auto: Set the auto power-off function on or off.
6.3.7 About
Enter About screen from the System Setting screen, the version of software is displayed.
6.3.8 Default Setup
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Enter Default Setup screen from the System Setting screen, and you can restore the
default configurations.
Default configuration includes:
ID:
001
SpO2 low limit: 90%
SpO2 high limit: 100%
PR low limit: 60 bpm
Brightness Level：3
PR high limit: 100bpm
SpO2 alarm: on
PR alarm: on
Bright time: On
Bluetooth: Off
Beep level: 4
Beep(switch): on
Display(mode): Wave
Keyboard lock: On
Auto power-off time: 3 minutes
Auto(power-off): on
Note: After changing the batteries, the settings may get back to the default settings.
7 Maintain and Repair
7.1 Maintenance
Use only the substances approved by us and methods listed in this chapter to clean or
disinfect your equipment. Warranty does not cover damage caused by unapproved
substances or methods.
We make no claims regarding the efficacy of the listed chemicals or methods as a means
for controlling infection. For the method to control infection, consult your hospital’s
Infection Control Officer or Epidemiologist. Keep your equipment and accessories free of
dust and dirt. To avoid damage to the equipment, follow these rules:
Always dilute according the manufacturer’s instructions or use lowest possible
concentration.
Do not immerse part of the equipment into liquid.
Do not pour liquid onto the equipment or accessories.
Do not allow liquid to enter the case.
Never use abrasive materials (such as steel wool or silver polish), or erosive
cleaners (such as acetone or acetone-based cleaners).
CAUTION:
If you spill liquid on the equipment or accessories, contact us or your service personnel.
NOTE:
To clean or disinfect reusable accessories, refer to the instructions
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delivered with the accessories.
7.2 Safety Checks
Before every use, or after your pulse oximeter has been used for 6 to 12 months, or
whenever your pulse oximeter is repaired or upgraded, a thorough inspection should be
performed by qualified service personnel to ensure the reliability. Follow these guidelines
when inspecting the equipment:
Make sure that the environment and power supply meet the requirements.
Inspect the equipment and its accessories for mechanical damage.
Make sure that only specified accessories are applied.
Inspect if the alarm system functions correctly.
Make sure that the batteries meet the performance requirements.
Make sure that the pulse oximeter is in good working condition.
In case of any damage or abnormity, do not use the pulse oximeter. Contact your
hospital’s biomedical engineers or your service personnel immediately.
Cleaning
Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of
dust and sand in your place, the equipment should be cleaned more frequently. Before
cleaning the equipment, consult your hospital’s regulations for cleaning the equipment.
Recommended cleaning agents are:
Mild soap (diluted)
Ammonia (diluted)
Sodium hypochlorite bleach (diluted)
Hydrogen peroxide (3%)
Ethanol (70%)
Isopropanol (70%)
To clean your equipment, follow these rules:
1. Shut down the pulse oximeter and take the batteries out of the battery housing.
2. Clean the display screen using a soft, clean cloth dampened with a glass cleaner.
3. Clean the exterior surface of the equipment using a soft cloth dampened with the
cleaner.
4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary.
5. Dry your equipment in a ventilated, cool place.
Disinfecting
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The applied parts touching the patients’ body are required to be disinfected once after
each use. The recommended disinfectants include: ethanol 70%, isopropanol 70%,
glutaraldehyde-type 2% liquid disinfectants.
Disinfection may cause damage to the equipment and is therefore not recommended for
this pulse oximeter unless otherwise indicated in your hospital’s servicing schedule. Clean
the pulse oximeter before disinfecting it.
CAUTION
Never use EtO or formaldehyde for disinfection.
Please note during operation:
Should take out probe and take good care of it after operating monitor If not used for long
time please take out battery.
Battery maintenance
○Please take out battery if you will not use the monitor for a long time.
○Please charge the battery fully if you will not use it for a long time.
○Please charge over 14 hours at the first time, or may reduce the battery life.
If any abnormal phenomena occurs, should stop using immediately and reuse after
inspection by technical person.
f) Inspect the equipment and accessories for mechanical and functional damages.
g) Inspect the safety relevant labels for legibility.
h) Verify that the device functions properly as described in the instructions for use.
7.3 Calibration and Verification
The performance should be checked every one year and after maintenance and repair.
Required Test Equipment: SpO2 signal Simulator
Note: The simulator cannot be used to assess the accuracy of a pulse oximeter probe or a
pulse oximeter.
7.3.1 Control Key Verification.
Press Menu key, display the history data.
7.3.2 Sound Verification
a．Set the oximeter sound ON.
b．The simulated heart beep sound will be issued.
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7.3.3 SpO2 & Pulse Rate Measurement Value Verification
a)．Connect SpO2 Probe to the SpO2 connector on the oximeter.
b)．Insert the operator’s finger into the finger probe, the SpO2 measured value of healthy
person should be from 95% to 99%, and the pulse rate is same as heart rate,
c)．If SpO2 Simulator is available, verify the accuracy of Oxygen Saturation Value with
probes as follows:
Oxygen Saturation
Tolerance
96%
±2%
86%
±2%
70%
±3%
7.3.4 SpO2 & Pulse Rate Alarm Verification
a). Connect SpO2 Probe to the SpO2 connector on the oximeter.
b). Insert the operator’s finger into the finger probe, the SpO2 measured value of healthy
person should be more than 96%.
c). Set the SpO2 high limit as 90, low limit as 80.
d). Verify the SpO2 visual and auditory alarms, the backgroud color of the SpO2 data
should be red and "dudu" voice should be heard.
7.4 Trouble Shooting
a) Can’t power on the oximeter
Please check the batteries voltage.
b) "Probe OFF " alarm
Please check if the probe was connected with the oximeter correctly. If the probe is
with extension cable please check if the extension cable is connected with the probe
correctly.
7.5 Warranty and Repair
7.5.1 Maintenance Method
a）Maintenance responding time: 9:00am ～ 17:30pm, Monday to Friday
b）Service support: Our company will offer user telephone and e-mail technology support
and parts change.
Parts change: our company will change parts if it is necessary free of charge in the
warranty period.
Because parts are the sources of maintenance, user should send them back to our
company if not specified.
c）Update the system software free of charge.
7.5.2 Exempt and Limitation:
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a) Our company isn’t responsible for such damage caused by force majeure. For example:
fire, thunder flash, flood, cyclone, hail, earthquake, house collapse, commotion, plane
failing and traffic accident, deliberate damage, lack of fuel or water, labor and capital
bother, strike and stop-working etc.
b) No-service offer
The corresponding fee and insurance fee of disassembly, refurbishment, repackaging
and conveying of the oximeter or the part of it doesn’t comply with the instruction
manual.
The damage is caused by the third company which is not commended by our company
adjusting, installing or replacing the parts of the oximeter.
The damage and failure caused by user or its representative doesn’t comply with the
instruction manual.
c) The oximeter is installed or connected with such external device without our company
permission as printer, computer, internet line and lead to oximeter failure. Our company
will charge for the maintenance.
d）Responsibility limitation
During the period of maintenance contract validity, if user changes the parts
manufactured by other manufacturers without our company permission, our company
is entitled to stop contract.
7.5.3 User Guarantee
a) Please read the instruction manual completely before operation
b) Please operate and make daily maintenance as request of manual and guarantee
c) Power supply and environment.
7.5.4 No-guarantee Principle
There is no-dispelled smut and not-original mark in the crust.
●There is physical damage on oximeter and its accessory.
●There are liquid leftover and eyewinker on oximeter and lead to short circuit and
plugboard failure.
●All the probe and accessories belong to consumption and beyond free change range.
●Such damage of probe caused by mechanical force doesn’t belong to free change range.
●During measurement of SpO2, principle leads to measure value difficult or inaccurate
measurement.
●Maintenance seal of oximeter are not opened.
●Not-original package lead to oximeter during transportation
●Not-professional person operation leads to oximeter failure. Not our company
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professionals or authorized personnel disassemble oximeter and lead to oximeter
failure.
●Not carefully read manual and so wrong operation lead to oximeter damage and failure.
7.5.5 User’s Special Request for Guarantee Time
Our guarantee constitution for oximeter complies with electronic product after-sale service
standard regulated by national laws. The guarantee time of mainboard regulated by our
company is one year and all the accessories are three months. If users request the
guarantee time beyond our regulated guarantee time, we should take it into consideration.
Because electronic product has such a character of changing quickly, for such user asking
more than three years guarantee time, our company will not buy oximeter parts during
maintenance. Our company will upgrade oximeter or change new maintenance methods,
for this, we charge the lowest price for new oximeter with user permission.
7.5.6 Repackage
●Take all the accessories and put them into plastic cover
●Try to use original package and packing material. user will be responsible for such
damage caused by bad package during transportation.
●Please offer guarantee list and copy of invoice to standby with the period of guarantee.
●Please describe failure phenomenon in detail and altogether offer oximeter.
7.6 Storage and Transportation
Storage：Storage Temperature -20～55℃，Relative Humidity ≤93%，no condensation
Transportation：Transport by airline, train or vessel after packing according to request.
Package：We pack the product with the hard bag. We put the foam between the inner box
and the cartoon to alleviate the shake.
APPENDIX A Specifications
Notices:
Specifications may be changed without prior notice.
The circuit diagrams, the list of components, the illustration of diagrams, and
the detailed rules of calibration, are provided exclusively to professional
personnel authorized by our company.
Specifications:
Display:
Data: SpO2%, PR, pulse column
Others: connection status of probe and other alarm information.
Data update time: less than 5 seconds
Alarm:
Alarm:
SpO2% and pulse rate value, probe off, battery exhausted
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Alarm mode:
audible alarm, visual alarm and information
Alarm limits range: SpO2 70%-100%, PR 30-235 bpm
Default limits: SpO2 High 100%, low 90%; PR High 100 bpm; low 60 bpm
SpO2
Display range:
0%~100%
Measurement range: 70%~100%
Resolution:
Accuracy:
1%
70%-100%
＜70%
: ±3 Digit；
unspecified
Probe LED Specifications:
RED
IR
Wavelength
660±2nm
940±10nm
Radiant Power
1.8mW
2.0mW
Pulse Rate
Display range:
0~254 bpm
Measurement range: 30~235 bpm
Resolution: 1 bpm
Accuracy: ±2 bpm or 2%（The larger）
Environment Requirements
Operation temperature: 5～40 centigrade
Operation humidity:
≤80%,no condensation
Storage temperature:
-20～55 centigrade
Storage humidity:
≤93%, no condensation
Power supply:
Three AA alkaline/NI-MH batteries or adapter
Working time:
work for 16 hours continuously at most
AC adapter：
Input Voltage： AC 100~240V
Input Frequency: 47~63Hz
Output Voltage：DC 5V±5%
Output Current：2A MAX
Store and replay
Store and replay 72 hours SpO2% and Pulse rate value, the time interval is 4
seconds.
Classification
According to the type of protection against electric shock:
Internal powered equipment and class II equipment
According to the degree of protection against ingress of water：
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Outline of product
Dimension: 125mmX60mmX30mm
Weight: 195g (excluding the batteries)
Accessories:
z Standard accessories:
1. Three AA alkaline batteries.
2. One instruction manual
3. One adult finger probe:
Model：M-50E.
4. The key for screwing the screw.
5. Bluetooth adapter
6. Software CD
7. USB Cable
z Optional accessories:
1. Binding sensor for pediatric, infant and neonatal:
(Pediatric 15-45 Kg, Infant 3-15 Kg).
Model： M-50C
2. Fingertip sensor for pediatric
Model： M-50B
3. Soft sensor for pediatric
(Pediatric 15-45 Kg, Infant 3-15 Kg).
Model：M-50H
4. Soft sensor for adult
Model：M-50G
5. Charger Stand (with adapter and USB Cable)
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FCC ID: WWIMD300M122
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 received, including interference that may cause
undesired operation.
changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
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
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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