V402+
HANDHELD
PULSE OXIMETER
& TEMP MONITOR
OPERATING MANUAL
QAM/V402+ -1–02/07
®
3
®
1 SAFETY INFORMATION 4
2 FUNCTIONS 6
3 INSTALLATION 8
4 DISPLAY AND OPERATION 9
5 SPO2 MONITORING 18
6 TEMP MONITORING 22
7 MAINTENANCE 23
8 V402+ PATIENT MONITOR DATA VIEWER 26
9 P ACKING LIST AND ACCESSORIES 26
RETURNS POLICY 29
WARRANTY 30
WARRANTY REGISTRATION 31
4
1. SAFETY
This manual provides the instructions necessary to operate the V402+ SpO2/TEMP patient
monitor in accordance with its function and intended use.
NOTE
Adherence to this manual is a requirement for proper performance and correct
operation of the V402, and ensures patient and operator safety.
This manual is an integral part of and should always be kept close to the monitor, so that it
can be to hand when necessary.
Content of this manual is subject to change without prior notice.
Statement
The manufacturer is responsible for safety, reliability and performance of this product only
in the condition that:
• All installation operations, expansions, changes, modifications and repairs of this
product are conducted by manufacturer authorized personnel
• The electrical installation of the relevant room complies with the applicable national
and local requirements
• This product is operated under strict observance of this manual.
The safety statements presented in this chapter refer to the basic safety information that
the operator of the monitor shall pay attention to and abide by. There are additional safety
statements in other chapters or sections, which may be the same as or similar to the
followings, or specific to the operations.
The following safety terms warning and caution are used throughout this manual to point
out hazards and to designate a degree or level or seriousness.
WARNING
Indicates a potential hazard situation or unsafe practice that, if not avoided,
could result in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result
in minor personal injury or product/property damage.
NOTE: Provides application tips or other useful information to ensure that you get the
most from your product.
5
1.1 Warnings
• The monitor is intended only as an addition to patient assessment. It must be used in
conjunction with clinical signs and symptoms. It is not intended as a device used for
treatment purposes.
• The monitor is intended for us e only by qualified clin ical physician s or well-train ed nurses.
• To ensure patient safety, verify this device and accessories can function safely and
normally before use.
• When using the monitor together with electrical surgery equipment, the user should
pay attention to and guarantee safety of the patient being measured.
• EXPLOSION HAZARD: Do not use the monitor in the presence of flammable
anaesthetics, explosive substances, vapours or liquids.
• Do not pull or lift the monitor by its cables. It could lead to falling and consequent
patient injury.
• It is not recommended to hang the monitor when transporting patients. Safety hazards
may arise from the swinging monitor during the transportation.
• Do not use the monitor and it’s transducer during MRI (Magnetic Resonance Imaging)
scanning because induced currents could potentially cause burns. The monitor can
interfere with the proper performance of MRI, and MRI is can interfere with the
measurement accuracy of the monitor.
• The monitor and its accessories may be contaminated by micro-organism during
transporting, use and storage. Use the recommended methods to sterilise and disinfect
the monitor or its accessories when the packing material is damaged, or if it has not
been used for a long time.
6
1.2 Cautions
• The monitor is not a fully sealed device. Keep its surface dry and clean, and prevent
any liquid from infiltrating it.
• The device should be positioned appropriately. Keep it from falling, strong vibration or
other mechanical damage.
• Do not use mobile phones near where the monitor is operating. Mobile phones may
emit electromagnetic radiation which is capable of interfering with the proper
performance of the monitor.
• The monitor should only be maintained by personnel approved by our company.
• Before using the monitor on patients, the user should be familiar with its operation.
IMPORTANT
Before use, carefully read this manual, all safety information and specifications.
The monitor is a non-invasive, handheld patient monitor. It operates on AC or rechargeable
battery power supply. It is suitable for monitoring adult and child patients. It is widely used
in the hospital’s operation room, ICU, clinic section office, out-patient department,
sickroom, emergency treatment, and the recovery and health care organisations, or in
family nursing and in patient transportation.
Parameters measured by the monitor include: arterial oxygen saturation (SPO2), pulse rate
(PR), plethysmogram waveform (PLETH), pulse strength and temperature (TEMP). The
monitor measures these parameters through a SPO2 sensor and a TEMP sensor and displays
them on the LCD screen.
The monitor is operated and controlled by the buttons on the front panel. It adopts a
monochrome LCD screen in displaying measurements and waveforms, and a dual-colour LED
in supplementary status indication. It is also capable of managing measured data and
transmitting the patient’s trend through the communication socket to a PC for display,
observation, saving and printing.
Function structure.
The monitor is composed of main unit, SPO2 sensor, TEMP probe and AC power adaptor.
2. FUNCTIONS
• The monitor has the following functions:
• Measuring: Intelligent display of SPO2, PR, PLETH, pulse strength and TEMP.
• Prompting: battery capacity, speaker volume.
• Alarm: judgement of exceeding the limits, Audio and visual alarm.
• Power saving: automatic shutdown when no monitoring.
• Data Managing: data storage, data adding, data deletion, drawing trend waveforms with
saved data.
• Communication: transmitting the patient’s trend data to a PC for display, observation,
saving and printing.
For the data display, observation, saving and printing function, you must install the data
viewer software in a PC equipped with a printer, and connect the monitor with the PC by a
special communication cable.
7
2.1 Appearance
Fig 1
1 SpO2
sensor socket
2 TEMP prove socket
3 LCD display
4 Dual-colour LED: Green = power on. Red flashes with heartbeat
5 Power button
6 Menu button: changes display modes
7
Left arrow/contrast: Adjusts display contrast whilst monitoring or
moves cursor left in setup or viewing trend graphs
8 AC power adapter socket
9 PC serial link connector socket
10
Up arrow/backlight: Turns backlight on/off whilst monitoring or
moves cursor up in setup or viewing trend graphs
11
Right arrow/graph-view: Change display to graph-view whilst
monitoring or moves cursor left in setup or viewing trend graphs
12
Down arrow/mute: Speaker on/off whilst monitoring or moves
cursor down in setup or viewing trend graphs
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3. INSTALLATION
3.1 Unpacking and Inspection
Please open the package and carefully remove the device and its accessories. Check all
materials against the packing list.
• Check the monitor for any mechanical damage.
• Check for damaged wires, sockets and accessories.
Contact supplier immediately if there is any problem.
NOTE: Please save the packing case and packaging material for future transport
and storage.
3.2 Connect SpO2 sensor and TEMP Probe
You can connect the SPO2 sensor and TEMP probe to the monitor by simply inserting their
connectors to the SPO2 socket on the monitor’s top side panel as shown in Fig. 1(1,2).
3.3 Connect AC Power Adaptor
Plug the AC adaptor into the mains and. The adaptor’s power indicator LED lights up. Insert the
adaptor’ s connector to the adaptor socket on the monitor’s right side as shown in Fig. 1(8).
WARNING: The AC power adaptor supplied is built to special requirements and should
only be used with the monitor. Never use other adaptors else the device could be
damaged and may result in patient injury.
3.4 Power-on
Press the power button and hold for more than 3 seconds to turn on the monitor. The green
LED on the front panel lights up. The LCD screen displays the monitoring mode.
3.5 Computer Data Transfer
The monitor can be connected to a Personal Computer through the serial cable supplied, to
transmit patient trend data to the computer for review and saving. The trend waveforms
can then also be printed.
Connect the serial cable to the socket on the monitor’s right side panel (see Fig 1.9) and the
RS232 connector to the PC’s serial port.
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4. DISPLAY AND OPERATION
The monitor displays three main screens: the monitoring, system setup and trend graphs.
The front panel controls operate the monitor on these screens. For more details, please see
below and refer to Fig. 1.
4.1 Power On/Off
Press the power button and hold for more than 3 seconds to turn on the monitor. The green
LED on the front panel lights up. When the monitor is on, press the power button to turn the
monitor off.
NOTE
The monitor is powered either by the built-in rechargeable battery or external AC power
supply. If not connected by the external AC power supply and the battery hasn’t enough
charge, the monitor may not turn on. If this happens, connect the external power supply to
charge the battery. The monitor will operate on the battery again after the battery is fully
charged. The battery charges automatically whilst connected to the external power supply.
If the SPO2 sensor and the TEMP cable are disconnected, or if the TEMP cable becomes
disconnected and the SpO
2
sensor stays connected but the finger is removed from the
sensor, the monitor automatically enters standby mode. In this mode, when the SPO2 sensor
is reconnected and a finger is inserted into the sensor, or the TEMP cable is reconnected,
the monitor automatically resumes operation; otherwise the monitor automatically shuts
down in 3 minutes.
4.2 Change Display Modes
The LCD initially displays the monitoring screen when the monitor is turned on. When the
monitoring screen is displayed, press the menu button once to change to the setup screen.
When the setup screen is displayed, press menu button once to change to the trend graphs
screen. When the trend graphs screen is displayed, press menu button once to return to the
monitoring screen. The menu button repeatedly cycles between the three screen modes in
the above sequence.
4.3 Monitoring Screen Display and Operation
The monitoring screen has two forms, parameter monitoring screen and
waveform/parameter monitoring screen.
4.3.1 Parameter Screen Display
The LCD displays the parameter monitoring screen. Parameter screen displays
measurements of the parameters. The monitor can identify which sensor is connected and
then display the appropriate parameter screen automatically. There are four various
parameter screens altogether.
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SPO2/PR/TEMP Screen
If the SpO2 sensor and the TEMP cable are connected, the LCD screen displ ays the
measurements of SPO2, PR, pulse strength and TEMP, status information and system
information (see Fig. 2).
Fig. 2
SPO2
/PR Screen
If only the SPO2 sensor is connected to monitor a patient’s SPO2, the LCD screen displays
the measurements of SPO2, PR and pulse strength, status information and system
information (see Fig. 3).
Fig. 3
TEMP Screen
If only the TEMP probe is connected to monitor a patient’s TEMP, the LCD screen displays the
TEMP measurement; status information and system information (see Fig. 4).
Fig. 4
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Non-parameter Screen
As described in section 4.1, when the monitor enters standby mode and no parameter needs
to be measured, the LCD screen only displays status information and system information and
an animated ‘smiley’ is displayed (see Fig. 5).
Fig.5
4.3.2 Waveform/parameter screen display
The waveform/parameter screen displays PLETH waveform and measurements of the
parameters. (See Fig. 6).
Fig. 6
No Title Description
1 SPO2 SPO2 value (refresh: 1/second)
2 Alarm audio
= ON = OFF
3 Pulse strength Max. 10 segments
4 Pulse audio
= ON = OFF
5 Clock Displays the current time
6 PR PR value (refresh: 1/second)
7 BPM PR unit
8 % SPO2 unit
9 TEMP TEMP value (refresh: 1/second)
10 °C TEMP unit
11 Battery status Four states indicating battery charge level
12 PLETH PLETH waveform display (real-time)
Use this table as the key for Figs. 2-6
2
4
5
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12
6
7
9
8
1
8
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4.3.4 Button Operation
The four multifunction buttons, Left arrow/Contrast, Waveform/Rig ht arrow, Up arrow/Backlight
and Down arrow/Mute, adjust th e monitor ’s functions on the monitoring scre en.
Contrast Button
If it is pressed continually, the LCD contrast will increase cyclically.
Waveform Button
If it is pressed, the monitoring screen will switch betwe en parameter screen and
waveform screen.
Backlight Button
If it is pressed, the LCD backlight will be turned on or turned off.
Mute Button
It is a main switch of the speaker. No matter what level the pulse sound is and whether
every parameter alarm is switched on or off, when it is pressed, pulse sound and alarm
sound become silence or audible totally.
4.3.5 Alarm Monitoring F unction
When a parameter’s measurement exceeds its alarm limit, the monitor can give audio and
visual alarms simultaneously. The speaker sounds the alarm and the parameter’s
measurement flashes on the screen. If the speaker sound is turned off by pressing the Mute
button or the parameter’ alarm switch is set off, the parameter’ alarm sound will be
silenced, but the parameter’s measurement still flashes to prompt the alarm. Please refer
to section 4.4 for parameter alarm switch setup.
The alarm sound has top priority when the speaker is not mute. When there is a alarm
whose switch is set on, the speaker sound the alarm sound but not the pulse sound. Only
when there is no measurement exceeding its alarm limit or its alarm switch is set off, the
speaker sound the pulse sound. The pulse is also indicated by the red colour LED on the
front panel no matter whether the pulse sound can be heard. The alarm sound and the pulse
sound can be heard no matter which screen is displayed.
The icon of the alarm sound on the monitoring screen reflects the status of all alarm
switches. When they are all set off or the speaker is silenced by pressing the Mute button,
the icon shows OFF status and no sound can be heard. Otherwise the icon shows ON status
and the alarm sound will be heard if any parameter’s measurement exceeds its alarm limit.
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4.4 System Setup Screen Display and Oper ation
The functions of the alarm limits setup, the system status setup and the data management
are performed on the setup screen.
4.4.1 Screen Display
The setup items and values are listed in a table on the system setup screen, as shown in Fig. 7
Fig. 7
4.4.2 Description of Information Displayed
The meanings of the words and th e range s of the valu es in Fig . 7 are li sted in table 4-2 as follo ws.
Upper limit Lower limit Alarm
SPO2 85 – 100 85 - 100 ON or OFF
PR 40 - 250 40 - 250 ON or OFF
TEMP 30.0 - 45.0 30.0 - 45.0 ON or OFF
Alarm sound
0 - 2. Pulse sound has three levels.
If set to 0, the alarm sound is silenced and the icon on the monitoring
screen also shows OFF (
).
Data output READY or WAIT
Data storage CLEAR or WAIT
Year
06 - 30
Month
01 - 12
Day
01 - 31
Hour
00 - 23
Minute
00 - 59
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4.4.3 Button Operation
The four multifunction buttons, Left arrow/Contrast, Right arrow/Waveform, Up
arrow/Backlight and Down arrow/Mute, act as cursor keys on the system setup screen.
Left and Right Arrow Buttons
The cursor moves left when the left arrow is pressed and right when the right arrow is
pressed. The cursor is indicated by a small black square. It moves to the item which is going
to be set up and this item is highlighted.
Up arrow Button
Use the up arrow to increase the values of the alarm sound level or date and time to
increase their values using the up arrow. When the values reach their maximum, they return
to the minimum and start increasing again.
With the cursor on the alarm on/off positions, press the up button to toggle between ON
and OFF.
The Up arrow button is inactive when the cursor is on the DATA OUT and STORAGE items.
Down arrow Button
Use the down arrow to decrease the values of the alarm limit values, alarm sound level or date
and time. When the values reach their minimum, they return to the maximum and start
decreasing again.
With the cursor on the alarm on/off positions, press the up button to toggle between ON and
OFF.
When the Down arrow button is pressed with the cursor on the DATA OUT or STORAGE items,
the relevant function is executed. WAIT is displayed instead of READY or CLEAR because the
data process takes a short. All buttons are invalid during these processes. WAIT will be
replaced by READY or CLEAR when the process is finished.
NOTE
• Incorrectly set time and date interrupts the continuity of the trend time. The date or
time should only be adjusted when it is incorrect and should be done immediately after
the monitor is powered on.
• Alarm limits setup is very important when monitoring. Avoid setting the upper limits
too high or the lower limits too low. For example, the PR upper alarm limit should not
be more than 20 bpm higher than the patient’s actual PR.
4.5 Trend Waveform Screen Display and Operation
The monitor saves parameter measurements every 2 seconds. The storage area can store 36
hours trend data and the new data will overwrite the oldest data automatically after 36
hours. The saved data will never be lost even if the monitor is powered off. It can be viewed
on the trend screen.
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4.5.1 Screen Display
When the LCD appears th e trend s creen due to the m enu button is pr essed on t he othe r screen,
the monitor draws the parameter trend waveforms o n the time-mea surement coordinate s eries.
One screen can only display 3 hou rs data wh ich is define d as a page. The w hole sto rage area i s
composed of 12 pages.
Fig. 8
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4.5.2 Description of Information Displayed
No Description Remarks
1 SPO2 Arterial oxygen saturation.
2 SPO2 measurement
The current SPO2 measurement indicated by the time
indicator.
3 PR Pulse rate
4 PR measurement The current PR measurement indicated by the time indicator.
5 TEMP Temperature
6 TEMP measurement
The current TEMP measurement indicated by the time
indicator.
7 SPO2 waveform SPO2 trend waveform plot - data is stored in memory
8 PR waveform PR trend waveform drawn plot - data is stored in memory
9 TEMP waveform TEMP trend waveform drawn plot - data is stored in memory
10 Time indicator
It is the scale indicator of the horizontal axis and the unit
indicator of the storage area.
11 Date and time It shows the moment indicated by the time indicator.
12 Storage area ruler It shows the total size of the trend data storage area.
13 Page indicator
The data forming one screen trend waveforms (time period of 3
hours) is defined as a page, which corresponding to 90 units of
the storage area. The page indicator points out the position of
this data segment of this page.
14 Vertical axis
It is the parameter measurement axis. It is divided into 3
segments which isSPO2 axis, PR axis and TEMP axis from top to
bottom. The terms on its left side mark the names of these
three axes.
15 Horizontal axis
It is the time axis. Its minimum scale is 2 seconds and whole
length is 3 hours. The current moment is at the right end of it
and time moves forward in the left direction.
NOTE
• Obtaining stable measurements always needs a period of time. When the monitor is
powered on or the sensors are connected, the trend data may appear sudden change or
transit because of the transition period. The measurements in this period can not be
used as diagnostic basis.
• When time indicator points to the time period without monitoring, the displays of
measurements and the corresponding times are blank because nothing is saved.
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4.5.3 Button Operation
The four multifunction buttons, Left arrow/Contrast, Wa veform/Right arrow, Up
arrow/Backlight and Down arrow/Mute, act as arrow keys on the system setup screen.
Left and Right Arrow Buttons
The left and right arrow buttons move the time indicator left and right in single steps but
remains within the current page of data.
Up and Down Arrow Buttons
The up and down arrow buttons move the time indicator 8 steps at a time. When the time
indicator is at the far right or left, continual pressing changes the page of data stored in the
memory to change forwards or backwards in time.
NOTE: When the time indicator is moved rapidly by the up arrow button or the down
arrow button, the movement may be less than 8 steps.
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5. SPO2 MONITORING
5.1 Measurement Principle
SPO2 plethysmogram measurement is employed to determine the oxygen saturation of
haemoglobin in arterial blood. The SPO2/PLETH parameter can also provide a pulse rate
signal, pulse strength and a plethysmogram wave.
How the SPO2/ PLETH Parameter Works
Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous,
non-invasive method based on the different spectra absorption of haemoglobin and
oxyhaemoglobin (the spectro-photometer principle). It measures how much light, sent from
one side of the sensor, is transmitted through the patient’s tissue (such as a finger or a toe),
to a receiver on the other side.
The sensor measurement wavelengths are nominally 660nm for the Red LED and 940nm for
Infrared LED. Maximum optical power output for LED is 4mW.
The amount of light transmitted depends on many factors, most of which are constant.
However, one of these factors, the blood flow in the arteries, varies with time, because it is
pulsating. By measuring the light absorption during a pulsation, it is possible to derive the
oxygen saturation of the arterial blood. Detecting the pulsation gives a PLETH waveform,
pulse rate signal and pulse strength.
The SPO2 value, PR v alue, pulse stre ngth and th e PLE TH wave form ca n be dis playe d on
the main screen.
SPO2 is a non-invasive measurement of the functional oxygen saturation.
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5.2 Measurement Steps
Sensor selection for SPO2 measurement depends on the patient’s age. For an adult patient,
you should select an adult finger sensor; for a child patient, you can choose either a child
hand or toe sensor. The finger SPO2 sensor is a finger clip consisting of two parts. The LEDs
are placed in one part and the photo-detector is placed in another part.
Please follow the steps and Fig. 9 below to use the adult finger SPO2 sensor:
1. Insert the sensor’s connector to the monitor’s SPO2 socket.
2. Turn on the monitor. The LCD screen will display the parameter monitoring screen.
3. Attach the sensor to an appropriate site on the patient’s finger.
4. The readings will be displayed on the LCD screen a moment later.
Fig. 9
NOTE
• Make sure to place the SPO2 sensor on the finger correctly. The LED part of the sensor
should be at the backside of the patient hand and the photo-detector part at the
inside. Make sure to insert the finger to a suitable depth into the sensor so that the
fingernail is just opposite to the light emitted from the sensor.
• To acquire accurate results, please read data until the sensor is steadily placed.
• Readings may not be accurate when either the sensor or the patient is moving.
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5.3 Measurement Limitations
If the accuracy of any measurement does not seem reasonable, first check the patient’s
vital signs by an alternate method. Then check the instrument for proper function.
Inaccurate measurements may be caused by:
• Incorrect sensor application or use;
• High-frequency electrical noise, such as noise from electrosurgical apparatus
connected to the system;
• Significant levels of dysfunctional haemog lobins (e.g. carboxyh aemoglobin
or methemoglobin) ;
• Significant concentrations of dysfunctional haemoglobin, such as
carboxyhaemoglobin and methemoglobin;
• Intravascular dyes such as indocyanine green or methylene blue;
• Intense illumination, such as surgical lamps (especially ones with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct
sunlight (exposure to intense illumination can be corrected by covering the
sensor with a dark material);
• Excessive patient motion;
• Venous pulsations;
• SPO2 Is too low;
• Improper sensor installation or incorrect contact position of the patient;
• Placement of a sensor on the same extremity with a blood pressure cuff, arterial
catheter, or intravascular line.
• Loss of pulse signal can occur in the following situation:
• The sensor is too tight;
• There is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight;
• A blood pressure cuff is inflated on the same extremity as the one with a
SPO2 sensor attached;
• The patient has hypotension, severe vasoconstriction, severe anaemia, or
hypothermia;
• There is arterial occlusion proximal to the sensor;
• The patient is in cardiac arrest or in shock.
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5.4 Precautions
NOTE: Do not perform SPO2 monitoring and NIBP measurements on the same arm
simultaneously. Obstruction of blood flow during NIBP measurements may adversely
affect the reading of the SPO2 value.
WARNING
• Check if the sensor cable is in normal condition before monitoring. Do not use
the SPO2 sensor once the package or the sensor is found damaged.
• Remove the SPO2 sensor from the patient after measurement.
• As with any medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation. Cables of electrical surgical
equipment should not be winded around that of the SPO2 sensor.
• Do not put the sensor on extremities with arterial catheter or venous syringe.
If no pulse is found or the reading is unreasonable, first check the patient’s
condition, and then check the sensor installation and connection with the
monitor, finally ask the qualified engineer to check the device and the SPO2
sensor for proper functions.
• Don’t use the monitor to measure patients whose pulse rate is lower than
30bpm, which may cause incorrect results.
• Prolonged and continuo us monitoring may increase jeopardy of unexpected
change of dermal condition such as abnormal sensitivity, rubescence, vesicle,
repressive putrescence, and so on. It is especially important to check more
frequently the sensor placement of child and patient of poor perfusion or
immature dermographia by light collimation and proper attaching strictly
according to changes of the skin. Check per 2~3 hours the sensor placement and
move it when the skin deteriorates.
• Make sure no contamination or scar exists in the site where the sensor is placed.
Otherwise, the measured result may be incorrect because the signal received by
the sensor is affected.
• Please use the SPO2 sensor supplied by t he monito r or confi ned to b e used by th e
monitor.
• When used on different patients, the monitor is prone to crossed contamination,
which should be prevented and controlled by the user. Disinfection is
recommended before using the SPO2 sensor on other patients.
CAUTION: SPO2 sensors are precision and fragile. Avoid pressure and knock. Hold the
probe and cable carefully and lightly. If not use it, you should coil up the probe and
cable into a loose circle. If the wire inside the cable is tensely pulled, it may cause
mechanical damage to the probe and the cable.
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6. TEMP MONIT ORING
6.1 Measurement Principle
The device measures temperature of body surface by taking advantage of the characteristics
of the thermal-sensitive resistor located in the temperature probe, whose impedance varies
with the body temperature. The monitor measures the impedance of the resistor and then
consults a resistance-temperature table stored in the device beforehand. The current
temperature is found in the table and displayed on the LCD screen.
The monitor has only one TEMP measurement channel for measuring the body surface
temperature of the patient.
6.2 Measurement Steps
The monitor uses a body surface TEMP probe to measure the patient’s body temperature.
Disposable or reusable probe can be selected according to your requirement. Please follow
the steps below to use the body surface TEMP probe:
1. Insert the probe’s connector to the monitor’s TEMP socket ;
2. Attach the probe to an appropriate site on the patient’s body;
3. Turn on the monitor. The LCD screen will display the parameter monitoring screen;
4. Wait until the measurement does not change frequentl y, the stable readings will
be displayed on the LCD screen.
NOTE: Because the temperature sensor’s impedance varies slowly with the temperature
of the body, an accurate result of temperature measurement is usually obtained after
monitoring for more than 5 minutes.
6.3 Precautions
WARNING
• Check if the probe cable is in normal condition before monitoring. Do not use the
TEMP probe once the package or the probe is found damaged.
• Remove the TEMP probe from the patient after measurement.
• As with any medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation. Cables of electrical surgical
equipment should not be winded around that of the TEMP probe.
• If the reading is unreasonable, first check the patient’s condition, and then check the
probe installation and connection with the monitor, finally ask the qualified engineer to
check the device and the SPO2 sensor for proper functions.
• Do no reuse disposable TEMP probes.
• When used on different patients, the monitor is prone to crossed contamination, which
should be prevented and controlled by the user. Disinfection is recommended before
using the TEMP probe on other patients.
CAUTION: Hold the probe and cable carefully and lightly. If not use it, you should coil up
the probe and cable into a loose circle. If the wire inside the cable is tensely pulled, it
may cause mechanical damage to the probe and the cable.
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7. MAINTENANCE
7.1 System Check
7.1.1 Check before Using
Before using the monitor, perform the following steps:
• Check if there is any mechanical damage;
• Check if all the outer cables and accessories are in good condition;
• Check if all the monitoring functions of the monitor can work normally so as to make
sure that the monitor is in proper working condition.
In case of any damage, abnormal f unction , hidden safet y danger o r exceptio n, do not use the
device on patient. Contact th e techni cian in yo ur ho spital or the manufac ture imm ediately.
7.1.2 Routine Check
Make sure the qualified service personnel have implemented a complete inspection,
including the functional safety check, after the monitor has been used for 6-12 consecutive
months, or after monitor servicing or system upgrading. This is to ensure the normal
operation of the system.
Store the device with a fully charged battery and charge the battery of the device every 3
months if leave the device unused for a long time. Otherwise the battery may be damaged
because of being thoroughly exhausted.
WARNING
• Failure on the part of the responsible hospital or institution employing the use of the
monitoring equipment to implement a satisfactory maintenance schedule may cause
undue equipment failure and possible health hazard.
• The safety inspection or maintenance, which requires opening the monitor housing,
must be performed by trained and authorized personnel only. Otherwise, equipment
failure and possible health hazard may be caused.
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7.2 General Cleaning.
Your equipment should be cleaned on a regula r basis. When it is polluted by dust, oil, sweat or
blood etc. it should be clea ned at once. If there is heavy pollution o r lots of dust and s and in your
place, the equipment shoul d be clean ed more freq uently. Before cleaning the equipment, consult
your hospital’s regulations for cleaning, disinfecting and steril izing eq uipment.
The exterior surfaces of the equipment may be cleaned gently with a clean and soft cloth,
sponge or cotton swap, dampened with a non-erosive cleaning solution. Drying off excess
cleaning solution before cleaning the equipment is recommended.
WARNING: Power off the monitor and stop charging the battery before cleaning.
Following are examples of cleaning solutions:
• Diluted soap water
• Diluted formaldehyde (35%~37%)
• Diluted ammonia water
• Hydrogen peroxide (3%)
• Alcohol
• Ethanol (70%)
• Isopropanol (70%)
• Diluted sodium hypochlorite solution (bleaching agent)
NOTE: Sodium hypochlorite solution with a concentration of 500ppm (1:100 diluted
bleacher solution used in family) ～5000ppm (1:10 diluted bleacher solution used in
family) is very effective. How much ppm depends on how much organic matter (blood,
propagation grume etc.) existing on the surface.
CAUTION
• Never use strong solvent, such as acetone.
• ALWAYS dilute the solutions according to the manufacturer’s suggestions.
• NEVER use abrasive, erosive cleaners, or cleaners containing acetone.
• NEVER permit fluids run into the casing, switches, connectors, or any ventilation
openings in the equipment.
• NEVER submerge the equipment into water or any cleaning solution, or pour or spray
water or any cleaning solution on the equipment.
• ALWAYS wipe off all the cleaning solution with a dry cloth after cleaning and dry the
monitor in the air. Never dry the monitor in the violent sunshine or toast it under high
temperature.
• If the monitor is polluted by chemical substance, the users should handle it effectively
according to the properties of the chemical substance.
The probes and cables may be cleaned with a clean and soft cloth, sponge or cotton swap,
dampened with ethanol.
CAUTION: NEVER permit fluids run into the probes and cables. NEVER submerge the
probes and cables into any liquid.
WARNING: The cleaning solutions above can only be used for general cleaning. If you use
them to control infections, the manufacturer shall assume no responsible for the
effectiveness. Please consult your hospital’s infection controllers or professionals.
25
7.3 Disinfection
Disinfection may cause damage to the equipment. We recommend the disinfection are
contained in the hospital’s servicing schedule only when necessary. The equipment should be
cleaned prior to disinfection.
Recommended disinfection material: Alcohol based (Ethanol 70%, Isopropanol 70%), and
aldehyde based.
The probe cables may be disinfected with hydrogen peroxide (3%) or i sopropanol (70%). Active
reagents are also effectiv e. The conn ecters c an not be s ubmerged i nto the abo ve solu tions.
NOTE: ALWAYS dilute the solutions according to the manufacturer’s suggestions and
adopt lower concentration if possible.
• NEVER submerge the equipment into water or any solution, or pour water or any
solution on the equipment.
• ALWAYS wipe off all the excess liquids on the equipment surface and accessory surface
with a dry cloth.
• Never use EtO and formaldehyde to disinfect.
• Never permit high-pressure and high-temperature disinfection of the equipment
and accessories.
WARNING: Disinfection may cause damage to the equipment; therefore, when preparing
to disinfect the equipment, consult your hospital’s infection controllers or professionals.
7.4 Disposal
To avoid contaminating or infecting personnel, the environm ent or other equi pment, make sure
you disinfect or decontamin ate the device appropriatel y before disposing of it in accordance with
your country’s law for equipment containing elec trical a nd electro nic part s. For SP O2 senso r and
TEMP probe, follow local regulations regarding disposal of hospital waste.
26
8. SPO2/TEMP PATIENT MONITOR DATA VEIWER
SPO2/TEMP Patient Monitor Data Veiwer (SPDV software) is collocated with he monitor. In
conjunction with the internal software of the monitor , the following functions can be realized.
• Download data ;
• Displaying and Previewing data of SPO2,PR and TEMP
• Saving patient data
• Printing patient data
Before using SPDV software, you must first download it from Internet and installed it in your
PC. Please refer to the download instruction and the HELP in SPDV for details.
NOTE: The download and installation procedure maybe different depending on your
operating system.
9. PACKING LIST AND ACCESSORIES
Standard Packing List
Handheld SPO2 /TEMP patient monitor main unit 1 pc
Adult finger SPO2 sensor 1 pc
Surface TEMP probe 1 pc
AC power adaptor 1 pc
Communication cable 1 pc
The operator’s manual 1 pc
Selectable Accessory
Child finger/toe SPO2 sensor 1 pc
CAUTION: Using other accessories may cause damage to the device.
27
APPENDIX A
General Specifications
Monitoring
Parameters:
SPO2, PR, PLETH, Pulse strength, TEMP
Signal
sockets:
SPO2 socket, PR socket, TEMP socket, adaptor
socket, PC communication socket
Display screen
Type: 128×64 dot matrix monochrome LCD
Display area: 45 × 30mm
Backlight colour: White
LED: Dual-colour LED (red/green)
Size: 120 × 63 × 32mm
Weight: 300g (not include probes and adaptor)
Features
• PLETH: The monitor can display PLETH waveform
• Intelligent parameter monitoring screen: The monitor automatically selects the
parameter measurements to display according to the probes connected to the monitor.
• Audio and visual alarm: The speaker sounds the alarm and the parameter’s
measurement flashes on the screen.
• Prompting: Icons of battery capacity, pulse sound switch and alarm sound switch.
• Power saving: The monitor will automatic shut down when no monitoring for 3 minutes.
• Trend: The monitor saves parameter measurements every 2 seconds and can store
trend data up to 36 hours.
• Data storage: The saved data will never be lost even if the monitor is powered off.
• Communication: Transmitting the patient’s trend to a PC for display, observation,
saving and printing.
Electrical specifications
Working Voltage 6.0 – 9.0 V DC
AC power adaptor
Input 100-240VAC, 50/60Hz, 0.7A
Output -8V DC, 800mA
Internal battery
Type 2Ahr/6V Ni/MH rechargeable battery
Run Time
15-hour continuous operation with a new, fully
charged battery (environment temperature is 25°C)
Recharge
time
10 hours
28
Environment Temperature
Operation
0 - 45 °C
Transportation and storage
-20 - 60 °C
Humidity
Operation 15 - 95 % (non-condensing)
Transportation and storage 10 - 95 % (non-condensing)
Altitude
Operation 86 - 106 KPa
Transportation and storage 50 - 106 KPa
Parameter specifications SPO2
Patient Adult, child
Range 35 - 100%
Resolution 1%
Accuracy
70 - 99%: ±2 %
0 - 69%: Unspecified
PR
Range 30 - 250bpm
Resolution 1bpm
Accuracy
±2bpm
TEMP
Channel 1
Input
Body surface thermal-sensitive resistor
temperature sensor
Range
0 - 50°C
Resolution
0.1°C
Accuracy
±0.2°C
29
Returns Policy
We want you to be completely satisfied with your purchase. If you need to return goods
purchased from DARAY Ltd, please read the following information carefully.
The DARAY Ltd returns policy provides guidance on when you can return goods we have
supplied, and what you can expect from us once you do. To see our detailed returns policy
and procedure visit www.daray.co.uk/returns
TYPE OF RETURN REMEDY
DAMAGED GOODS OR DOA*
Goods which are physically damaged on
delivery, or which do not function.
We must be notified within 24 hours of receipt.
GOODS DEVELOPING A FAULT
Goods which have developed a fault
within the warranty period.
Within 14 days of delivery we will replace the item
as DOA*.
If the fault develops after 14 days, but within the
warranty period, we will initiate the returns
procedure.
NON WARRANTY
Goods which have developed a fault
outside the warranty period.
If a fault develops outside the warranty period, we
will initiate the returns procedure.
OTHER
Any situation which is not covered by
the above.
We will try to help, but we cannot normally offer a
refund.
*DOA – dead on arrival
For additional clarification, please refer to our terms and conditions at
www.daray.co.uk/terms.
In a small number of cases, we may determine that a replacement would not work any
better than the original product we supplied. In such cases we will only offer a refund
rather than a replacement for qualifying returns.
Replacement bulbs are not eligible for returns, unless they are faulty or damaged.
Spare parts ordered on our website or from supplied part codes are not be eligible for
credit. We will accept returns and exchange for the correct item.
If you have incorrectly ordered a product and it is unopened and in perfect condition, within
seven days of the original order you may order the correct product and receive a full credit
for the returned item. In all other cases, items returned for credit are subject to a 25%
restocking fee.
If you send us goods that do not qualify for return, you will invalidate your claim to any
refund, and you will be obliged to compensate DARAY Ltd for the cost of return postage and
any other reasonable costs incurred processing the goods.
Your statutory rights are not affected.
IMPORTANT!
Before returning your item, you must call us on 0870 199 4299
30
WARRANTY
TERMS AND CONDITIONS OF WARRANTY
1. To qualify for this warranty you must register on www.daray.co.uk or return to Daray Ltd (Daray) the
duly completed warranty-registration form accompanying the product.
2. Daray warrants this product (excluding lamp) against faulty material and workmanship during the
period of the warranty. The period of warranty is the period stated on your warranty card and
commences on the date of purchase of the product. In the event that the product is not in good
working order Daray will provide, during the warranty period, a free repair service within the United
Kingdom. The warranty is subject to proof of purchase being provided; therefore, you should retain
your original receipt.
2.1 The repair service consists of the provision of spare parts and/or replacement products (at Daray’s
discretion) which will be provided on an exchange basis and will either be new, equivalent to new
or reconditioned. All replaced spare parts and products shall become the property of Daray.
2.2 Daray’s only obligation under this warranty is the provision of the service as set out above.
2.3 All products are returned to Daray at the customer’s cost and risk. Products to be returned should
be adequately packed. For the address to send returns to please visit www.daray.co.uk
3. Daray’s arrangements for providing service provided under this warranty may include the use of subcontractors.
4. This warranty does not cover damage or defects in the Product caused by or resulting from:
• Wilful neglect or negligence by anyone other than Daray;
• Improper use, storage or handling of the product;
• Use of non-Daray approved parts (such as replacement lamps) not compatible with the Product;
• Fire, accident or disaster;
• Use of non-Daray modifications other than in accordance with Daray’s instructions;
Attachment of fittings and accessories not approved by Daray;
Repairs, modifications carried out by service personnel not approved by Daray;
• Damage caused by chemical corrosion from cleaning agents not approved by Daray.
• Failure to use or install the product in accordance with the manufacturer’s instructions.
5. Nothing in this warranty shall have the effect of restricting or excluding the liability of Daray in res pect of:
a) Death and personal injury caused by the negligence of Daray, or for fraud;
b) Under the Consumer Protection Act 1987 to a person who has suffered damage caused by a
defective product or to a dependant or relative of such a person;
c) Direct damage to your property caused by the proven negligence of Daray.
6. This agreement does not give any rights other than those expressly set out above and i n particular, Daray will
not be responsible for any loss of income, profits or contrac ts or any dir ect or indire ct conseq uential loss ,
damage caused to or suffer ed by th e purchas er as a direct result of t his agreeme nt.
7. This warranty is offered (subject to these terms and conditions) in addition to, and does not affect
your statutory rights.
8. Daray may disclose your details and other personal information to companies within the Daray group
including any subsidiary company or sub contractor of Daray for the purposes of performing our
obligations hereunder.
9. You must not resell outside the UK any products supplied by Daray and covered by the Export of Goods
(Control) Order 1992 (or any law that replaces it) with out obtaining all necessary licences. You also
agree not to sell the product in the UK if you know or think that the person buying the product intends
to export it without getting the necessary licences. You agree to impose similar conditions to these on
anyone you sell the product to.
10. These conditions shall in all respect be governed and construed in accordance with English law and
the exclusive jurisdiction of the English courts.
31
COMPANY:
WARRANTY REGISTRATION
TO VALIDATE YOUR WARRANTY
PLEASE COMPLETE IN BLOCK CAPITALS
AND RETURN IN A WINDOWED DL ENVELOPE
TO OUR FREEPOST ADDRESS
NAME:
ADDRESS:
FAX:
PHONE:
EMAIL:
DATE OF PURCHASE:
PURCHASED FROM:
PRODUCT:
SERIAL No:
ALTERNATIVELY REGISTER ONLINE AT WWW.DARAY.COM
Freepost Plus RRAS-YGXE-SLBC
Daray Ltd
Marquis Drive
SWADLINCOTE
DE12 6EJ
1 YEAR WARRANTY
Occasionally DARAY would like to send you information about our special offers
and promotions. If you do not wish to receive such information, please tick here:
Privacy statement: DARAY will not pass on your details to any third party.
TM
Vet
Z
Antimicrobial protection
BioProtect
®
Marquis Drive · Moira · Derbyshire · DE12 6EJ
Tel: 0870 777 2664 · Fax: 0870 777 2665
email: info@daray.co.uk
·
u
rl: www.daray.co.uk
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