Drive HANDY-OX 18720 User Manual
Handy-Ox
DIGITAL COLOR
PULSE OXIMETER
OXÍMETRO DE PULSO DIGITAL
OXYMÈTRE DE POULS DIGITAL
AVEC AFFICHAGE EN COULEURS
User Manual
Instrucciones para su uso
Guide d’utilisation
18720
www.drivemedical.com
REF.
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INSTRUCTIONS FOR USE
This manual is written in compliance with the council directive MDD93/42/EEC for medical
devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
The manual describes, in accordance with the Digital Handy-Ox Pulse Oximeter’s features and
requirements, main structure, functions, specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, as well as the safety procedures
to protect both the user and equipment. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual describes
the operating procedures which should be followed strictly. Failure to follow the User Manual may cause measurement inaccuracies, equipment damage and/or human injury. The
manufacturer is NOT responsible for the safety, reliability and performance issues and any
monitoring abnormality, human injury and equipment damage due to users’ negligence of the
operation instructions. The manufacturer’s warranty service does not cover such faults.
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WARNING:
• An uncomfortable or painful feeling may occur if using the device continuously, especially
for the microcirculation barrier patients. It is recommended that the sensor should not be
applied to the same finger for over 2 hours.
• For special patients, there should be prudent inspection of the skin when placing the nger
probe onto the patient. This device should not be clipped onto an edema or onto tender
tissue.
• The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user
and the technician should not stare at the light.
• Patient should not use enamel or other makeup.
• Patient’s ngernail should not be too long.
• Please refer to the user instruction manual for clinical use restrictions and cautions.
• This device is not intended for treatment.
Caution: Federal (US) Law restricts this device to sale by or on the order of a physician.
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CONTENT
1 Safety ................................................................................................................................. 6
1.1 Instructions for Safe Operations ............................................................................ 6
1.2 Warning .................................................................................................................. 6
1.3 Attention ................................................................................................................. 7
2 Overview ............................................................................................................................ 9
2.1 Features ................................................................................................................. 9
2.2 Environment Requirements ................................................................................. 10
3 Principle ........................................................................................................................... 10
4 Technical Specifications ................................................................................................. 11
4.1 Main Performance ................................................................................................ 11
4.2 Main Parameters .................................................................................................. 12
5 Installation ....................................................................................................................... 14
5.1 View of the Front Panel ........................................................................................ 14
5.2 Underside View and Left View ............................................................................. 14
5.3 Rear View ............................................................................................................. 15
5.4 Accessories .......................................................................................................... 15
6 Operating Guide .............................................................................................................. 16
6.1 Application Method .............................................................................................. 16
6.2 Attention for Operation ........................................................................................ 26
6.3 Clinical Restrictions.............................................................................................. 27
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7 Maintain, Transportation and Storage ........................................................................... 28
7.1 Cleaning and Disinfecting ................................................................................... 28
7.2 Maintain ................................................................................................................ 28
7.3 Transportation and Storage ................................................................................. 28
8 Troubleshooting .............................................................................................................. 29
9 Key of Symbols ............................................................................................................... 30
10 Function Specification .................................................................................................... 31
Appendix 1 ............................................................................................................................ 33
Appendix 2 ............................................................................................................................ 37
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1 SAFETY
1.1 Instructions for Safe Operations
• Check the main unit and all accessories periodically to make sure that there is no visible
damage that may affect patient’s safety and monitoring performance. It is recommended
that the device is inspected at least once a week. When there is obvious damage, stop
using the device.
• Necessary maintenance must be performed by qualied service technicians ONLY. Users
are not permitted to maintain the pulse oximeter themselves.
• The oximeter cannot be used together with accessories not specied in User Manual. Only
the accessory that is recommended by Drive Medical can be used with this device.
• This product is calibrated before leaving factory.
1.2 Warning
• Explosive hazard—DO NOT use the oximeter in the environment with ammable material
such as anesthetic.
• DO NOT use the oximeter while the patient is being scanned by MRI or CT.
• The person who is allergic to rubber cannot use this device.
• The disposal the pulse oximeter and its accessories and packing (including battery, plastic
bags, foams and paper boxes) should follow the local laws and regulations.
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• Please check the packing before use to make sure the device and accessories are in accordance with the packing list.
• Please only use accessories and probes approved by Drive Medical, or else it may damage
the device.
• The device can only be matched with the compatible probe.
• Please don’t measure this device with functional tester for the device’s related information.
1.3 Attention
• Keep the oximeter away from dust, vibration, corrosive substances, explosive materials,
high temperature and moisture.
• If the oximeter gets wet, please stop operating it.
• When it is carried from cold environment to warm or humid environment, please do not use
it immediately.
• DO NOT operate keys on front panel with sharp materials.
• High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer
to User Manual in the relative chapter (7.1) for instructions of cleaning and disinfection.
• Do submerge the oximeter in liquid. When it needs cleaning, please wipe its surface with
medical alcohol by soft material. Do not spray any liquid on the device directly.
• When cleaning the device with water, the temperature should be lower than 140° F (60° C).
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• Fingers which are too thin or too cold may affect the measurement accuracy. Please clip
the thicker nger, such as thumb and middle nger deeply into the probe.
• The pulse oximeter can be used for adult and pediatric patients, based on the manufacturer
supplied finger probe.
• The update period of data is less than 5 seconds, and is subject to change based on variations in individual pulse rates.
• Please read the measurements on the waveform screen once the readings have stabilized.
This measure value is most accurate.
• If some abnormal conditions appear on the screen during test process, pull out the patient
finger and reinsert to restore normal use. If continued abnormal conditions appear, contact
your equipment provided.
• The device has a normal life expectancy of three years since the rst electried use.
• This device has alarm functions. Please reference chapter 6.1 for details.
• The device may not work for all patients. If you are unable to achieve stable readings, dis-
continue use.
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2 OVERVIEW
The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called
the O2 concentration in the blood. It is an important bio-parameter for the respiration. A number
of diseases relating to respiratory system may cause the decrease of SpO2 in the blood, furthermore, some other causes such as the malfunction of human body’s self-adjustment, dam-
ages during surgery, and the injuries caused by some medical checkup would also lead to the
difficulty of oxygen supply in human body, and the corresponding symptoms would appear as
a consequence, such as vertigo, impotence, vomit etc. Serious symptoms might bring danger
to human’s life. Therefore, prompt information of patients’ SpO2 is of great help for the doctor to
discover the potential danger, and is of great importance in the clinical medical field.
The Handy-Ox Pulse Oximeter is a compact, efficient and convenient portable pulse oximeter. It is
only necessary for a patient to put one finger into probe for diagnosis, and the display screen will
directly show the measured value of SpO2 and pulse rate with a high level of accuracy.
2.1 Features
A. Operation of the product is simple and convenient.
B. The product is compact, light weight and portable.
C. Low power consumption.
The problem of overrating would emerge when the patient is suffering from toxicosis
which caused by carbon monoxide, the device is not recommended to be used
under this circumstance.
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2.2 Environment Requirements
Storage Environment
a) Temperature -40° ~ 140° F (-40 ° ~60 ° C)
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature: 50 ° ~ 104 ° F (10 ° ~40 ° C)
b) Relative Humidity: ≤75%
c) Atmospheric pressure:700hPa~1060hPa
3. PRINCIPLE
Principle of the Oximeter is as follows: An experience formula of data process is established
taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones. Operation
principle of the device is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in
accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of
different wavelength of lights can be focused onto human nail tip through perspective clamp
finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits
and microprocessor.
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Figure 1
4. TECHNICAL SPECIFICATIONS
4.1 Main Performance
A. SpO2 value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator will appear before operation and
accuracy are affected.
E. The display mode can be changed
F. Screen brightness can be changed
G. Pulse sound indication
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H. Alarm function
I. With SpO2 value and pulse rate value record function, the stored data can be uploaded to
computer
J. It can be connected with an external oximeter probe
K. Real-time data can be transmitted to computer
4.2 Main Parameters
A. Measure of Sp
O
2
Measure range: 0%~100%
Accuracy:
When the SpO2 measure range is 70%~100%,the permission of absolute error is ±2%;
below 70% unspecified
B. Measure of pulse rate
Measure range:30bpm~250bpm
Accuracy: ±2 bpm or ±2% (select larger)
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C. Resolution
SpO2: 1%, Pulse rate: 1bpm.
D. Measure Performance in Weak Filling Condition
SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is ±4%,
pulse rate error is ±2 bpm or ±2% (select larger).
E. Resistance to surrounding light
The deviation between the value measured in the condition of man-made light or indoor natural
light and that of darkroom is less than ±1%.
F. Power supply requirement: 3.6 V DC ~ 4.2V DC.
G. Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
H. Adjustable alarm range
SpO2: 0%~100%
Pulse Rate:0bpm~254bpm
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5 INSTALLATION
5.1 View of the Front Panel
Figure 2
Front View
5.2 Underside View and Left View
Figure 3
Underside
and Left View
1. Probe jack: It is used to connect a ngertip probe to measure the oxygen saturation and
pulse rate.
2. USB port: It is used to connect a personal computer to export the trend data(or real-time
data) or charge the lithium battery.
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5.4 Rear View
Figure 4
Rear View
(Refer to Figure 4 and insert the lithium battery properly in the right direction.)
5.4 Accessories
A. A lithium battery
B. A User Manual
C. A power adapter
D. USB Cord
E. A disk (PC software)
F. An adult-oximeter probe 18720-ADPROBE
An infant-oximeter probe (optional) 18720-PDPROBE
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6 OPERATING GUIDE
6.1 Application Method
A. Measuring the data
a) Open the lid of battery box and put the battery inside, then close.
b) Put the ngertip probe into the jack on the underside of the oximeter. Only use Drive Medical
supplied accessories.
c) Put the nger into the probe.
d) Press and hold the “power on/off button” for a few seconds. The device will power on within a
few seconds and will start to self-check. The device displays the user interface after self-check.
e) Do not shake the nger and keep the patient in a calm state during measurement.
f) The data can be read directly from the screen in the user interface.
Fingernails and the luminescent tube should be at the same side.
If the alarm function is on, the device will provide a medium priority alarm signal when the
probe plug or finger is out. An intermittent alarm will occur and the user interface presents
“FINGER OUT”.
Medium priority indicates that prompt operator response is required.
The corner position of the plug should
be inserted into the right place of the
recessed portion of the socket, just as
shown in the picture.
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Figure 5
Figure 6
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B. Change display direction
On the user interface, press the”screen change button” to change the display direction.
C. Pause alarm
a) The Digital Handy-Ox will alarm if the PR or SpO2 exceed preset low and high parameters, if
the battery has a low charge, and if the patient’s finger is removed.
b) When alarm is on, press the ”alarm pause button” to pause the alarm. In order to reset the
alarm, press the “alarm pause button” again within 60s.
c) If you want to turn off the alarm for good, enter the menu.
D. Menu operation
In the user interface, press the ”menu button” to enter the menu options screen ((Figure 7).
Users can adjust the setting through the main menu, such as alarm, pulse sound indication, PR
and SpO2 low and high alarm settings, backlight, data storage, and ID function.
Figure 7
Main Menu Interface
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a) Alarm setting
In the main menu interface, press the ”up button” or ”down button”, and move the menu choice
bar to “Alarm”, then press the “menu button” to enter the alarm setting menu of (Figure 8).
Figure 8
Alarm Setting Menu
a. The high/low alarm limit setting
Press the ”up button” or “down button” to choose the parameter to be adjusted, then press
the “menu button” again to enter the similar dialog box shown as gure 9, then press the “up
button” or “down button” to change data. Each press of the “up button” or “down button”, the
data will raise or descend in single increments. Continue until the desired setting is reached,
then press the “menu button” to save the setting.
If the alarm function is on, the device will provide medium priority alarm signal when
the data of SpO2 or pulse rate is beyond the limit. Intermittent alarm will occur and
the measure value becomes yellow.
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Medium priority indicating that prompt operator response is required.
When setting up operation, the operator inserts the patient’s finger, and sets the SpO2
ALM HI lower than the current measure value, then the machine will start alarm. The
pulse rate alarm test is the same with the above.
Figure 9
b. The alarm state setting
Press the “up button” or “ down button”, and move the menu choice bar to “Alarm”, then
choose the alarm state “on/off” by pressing the “menu button”. Choose “on” to start the alarm
function, and choose “off” to disable it.
b) Pulse sound indication setting
In the main menu interface, press the “up button” or “down button”, and move the menu
choice bar to “Pulse Sound”, then choose the pulse sound indication state “on/off” by pressing
the “menu button”. Choose “on” to start the function, and choose “off” to disable it.
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c) Backlight adjustment
In the main menu interface, press the “up button” or “down button”, and move the menu
choice bar to “Brightness”, then press the “menu button” to change the number in order to
adjust the brightness of screen.
d) Data storage setting
This device has the function of 24 hours data storage, it has the capability of accurately storing
pulse rate and SpO2 data, then transmitting the data to a computer with the data line for review
and analysis.
a. In the main menu interface, press the “up button” or “down button”, and move the menu
choice bar to “Record”, then press the “menu button” again to enter the dialog box of Fig-
ure 10. If it is in recording state, the “Stop” is displayed in the Menu; if it is not in recording
state, the “Start” is displayed in the Menu.
Figure 10
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b. When the “Start” is displayed in the menu, if the memory still has old data in storage, the “Do
you really want to recover the memory” dialog box will be displayed when pressing the “menu”
button. Press the “up button” or “down button” to choose setting, and press the “menu button”
to confirm setting, then the dialog box will be displayed as in Figure 11. To set the starting time
for data storage by users, the user can change the setting value by pressing the “up button”
or “down button”, and can conrm the setting value by pressing the “menu button”. The black
cursor will move to next place after setting. When the black cursor moves to “Yes”(store) or
“No”(don’t store), press the “up button” or “down button” to choose setting, then press the”menu
button” to conrm setting.
Figure 11
c. When the “Stop” is displayed in menu,the “Do you really want to stop recording” dialog box
will be displayed when pressing the “menu button”. Press the “up button” or “down button” to
choose setting, then press the “menu button” to conrm setting.
d. If the data storage function is turned on, when return to the measure interface, a red “REC” sign
and a ashing red dot would appear on screen, which means the device is in the state of storing.
e. In the state of storing, whatever interface the device is in (measure interface, menu interface), the
sign “Recording” would appear on the screen in 30 seconds, then the screen will be automatically
shut down. If pressing any button(power on/off excluded) at this moment, the sign “Recording”
would appear on the screen, then the screen will be automatically shut down again; if pressing
the “power on/off button”, the device would return to the former interface.
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f. If turning on the data storage function, the old data will be automatically removed.
g. In the state of data storing, after the screen is automatically shut down, the pulse sound
indication would be off for saving power.
h. When the storage space is full, it displays “Memory is full” on the screen, and then shut
down in a few seconds. But it will still display “Memory is full” the next time you power on
the device. If pressing any button (power on/off excluded) again, it will enter the measure
interface.
e) Stored data transmission setting
a. Connect the device to computer with data line, then open the PC software. Please refer
to <SpO2 Assistant user manual> for detailed operation method of uploading data. The
software symbol is as Figure 12.
The computer the device is connected to should accord to the standard of IEC60950,
and the system which is composed with the device accord with the requirements of
IEC60601-1-1.
Figure 12
Software Symbol
b. In the state of storing, it is not applicable for the users to upload the stored data to computer.
c. When the stored data is being uploaded, the screen displays as figure 13.
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Figure 13
d. When the uploading of stored data is finished, the device will automatically return to the
measuring Interface.
f) Device ID
The user can set device ID by PC software. Please refer to <SpO2 Assistant user manual> for
details.
g) Exit the main menu
In the main menu interface,press the “up button” or “down button” in order to move the menu
choice bar to”Exit”, then press the “menu button” to exit the main menu.
E. PC software operation
Please connect the device with computer by the USB data line,then double click “SpO2 Assistant“ icon to run the PC software. The functions such as uploading data and changing device
ID could be carried out by the software. Please refer to <SpO2 Assistant user manual> for
detail.
If the user choose to turn on the synchronizing display function in computer, it would probably
take several seconds for the data to appear on the computer screen.(If there is no data on the
computer screen, unplug USB data line, then repeat step “E” again.)
Power supply by battery only, and battery status is full
Battery status is not full
Battery status is draining away
Low power alarm indication (Please charge the battery)
the four status above shows
dynamically in turn
Battery is charging
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F. Charge
There are two kinds of charge methods:
a) Connect the device with computer by data line, then the device should be under charge
state.
b) Connect the device with power supply by power adaptor, then the device should be under
charge state.
c) The ve status of battery power are shown as follows.
If the alarm function is on, the device will provide high priority alarm signal when the
battery is in low power status .Intermittent alarm will occur and the battery icon turns
red in the state of flashing. High priority indicating that immediate operator response
is required.
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6.2 Attention for Operation
A. Please check the device before use, and conrm that it can work normally.
B. The nger should be in a proper position (see the attached illustration of gure 6 for reference), or
else it may result in inaccurate measure.
C. The ray between luminescent tube and photoelectric receiving tube must get across subject’s
arteriole.
D. The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure
cuff or receiving intravenous injection.
E. Do not fix the SpO2 sensor with adhesive, or else it may result in venous pulsation and inaccurate
measure of SpO2 and pulse rate.
F. Excessive ambient light may affect the measure result. It includes uorescent lamp, dual ruby
light, infrared heater, direct sunlight and etc.
G. Intense activity of the subject or extreme electrosurgical interference may also affect the accuracy.
H. Patient should not use enamel or other makeup.
I. Please clean and disinfect the device after operating according to the User Manual (7.1).
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6.3 Clinical Restrictions
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood ow of
subject is required. For a subject with weak pulse due to shock, low ambient/body tempera-
ture, major bleeding, or use of vascular contracting drug, the SpO2 waveform (PLETH) will
decrease. In this case, the measure will be more sensitive to interference.
B. For those with a substantial amount of staining dilution drug (such as methylene blue,
indigo green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine
(Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem, the SpO2 determina-
tion by this device may be inaccurate.
C. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major
factor resulted in serious error of SpO2 measure.
D. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic
anoxia, and some patients with serious anemia may also report good SpO2 measure value.
7 MAINTAIN, TRANSPORTATION AND STORAGE
7.1 Cleaning and Disinfecting
Use medical alcohol to disinfect the device. Dry or clean it with clean soft cloth.
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7.2 Maintain
A. Please clean and disinfect the device before use according to the User Manual (7.1).
B. Please recharge the battery when the screen shows.
C. Recharge the battery soon after the over-discharge. The device should be recharged
every six months when it is not regularly used. It can extend the battery life following this
guidance.
D. Please take out the battery if the oximeter is not in use for a long time.
E. Users are advised to calibrate the device annually, or in according to the calibration
program of the hospital or the healthcare provider facility. It also can be performed at the
state-appointed agent.
7.3 Transportation and Storage
A. The packed device can be transported by ordinary conveyance. The device cannot be
transported mixed with toxic, harmful, corrosive material.
B. The packed device should be stored in room with no corrosive gases and good ventilation.
Temperature: -40°F ~ 140°F(-40°C~60°C); Humidity: ≤95%.
Trouble Possible Reason Solution
The SpO2 and Pulse Rate cannot be displayed normally
1. The finger is not properly positioned.
2. The patient’s SpO
2
is too low to be detected.
1. Place the finger properly and try again.
2. Try again; Go to a hospital for a diagnosis
if you are sure the device is operating
properly.
The SpO
2
and Pulse Rate are
not displayed stably
1. The finger is not placed inside deep enough.
2. The nger is shaking or the patient is moving.
1. Place the finger properly and try again.
2. Let the patient keep calm.
The device cannot be
turned on
1. The battery is drained away or almost drained
away.
2. The battery is installed incorrectly.
3. The malfunction of the device.
1. Please recharge the battery.
2. Please Install the battery again.
3. Please contact your equipment provider.
The display is off suddenly The battery is drained away or almost drained away. Please recharge the battery.
The device cannot be used for
full time after charge
1.The battery is not full charged.
2. The battery is dead.
1. Please recharge the battery.
2. Please contact the local service center.
The battery cannot be full
charged even after 10 hours
charging time
The battery is dead. Please contact the local service center.
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8 TROUBLESHOOTING
Signal Description
Refer to instruction manual/booklet
The pulse oxygen saturation(%)
PRbpm
Pulse rate (bpm)
Close the alarm sound indication
forever
Pause the alarm sound indication
Open the alarm sound indication
Close the pulse sound indication
Open the pulse sound indication
Power on/off button
Alarm pause button/up button
Signal Description
Menu button
Screen change button/down button
BF Type application part
SN
Serial number
1. The finger clip falls off
( no nger inserted)
2. Probe error
3. Signal inadequacy indicator
IP22
International Protection
WEEE (2002/96/EC)
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9 KEY OF SYMBOLS
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