User Manual Innovo IP900AP Oximeter

Documents for Innovo IP900AP

The following documents are available:
User Manual Photos
IP900AP photo
Fingertip
Pulse Oximeter
USER MANUAL Ver1.1
General Description
SpO
2
stands for peripheral capillary oxygen saturation. Oxygen saturation is defined as the ratio of oxyhemoglobin (HbO
2
) to the
total concentration of hemoglobin (i.e. Oxyhemoglobin + reduced hemoglobin) present in the blood. It is an important physiological
parameter involved in respiration and circulation. The Pulse Oximeter feature herein is small, portable, non-invasive and easy to
use. The user only needs to insert a finger into the chamber to measure his/her SpO
2
level and pulse rate. It has also been proven
to be highly precise and reliable in clinical tests.
Measurement Principle
Oxygenated blood absorbs light preferentially at 905nm (near infrared light), whereas deoxygenated blood absorbs light
preferentially at 660nm (red light). A pulse oximeter works by passing a beam of red and infrared light through a pulsating capillary
bed and then measure the amount of red and infrared light emerging from the tissues via a sensor. To improve accuracy, the
iP900AP uses a proprietary algorithm to collect data from pulsatile arterial blood and excludes noise from the tissues. The relative
absorption of light by oxyhemoglobin (HbO) and deoxyhemoglobin is then calculated according to the Beer-Lambert's law and a
quantitative measurement of the users’ oxyhemoglobin status i.e. Oxygen saturation level (SpO
2
) is derived.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Sensor
Precautions For Use
1 Please read the manual carefully before use.
2 Do not use the fingertip pulse oximeter in an MRI or CT environment.
3 This device is not for continuous monitoring.
4 Do not use the fingertip pulse oximeter in an explosive environment.
5 In order to ensure proper sensor alignment and skin integrity, the maximum application time at a single site for the device
should be less than half an hour.
6 Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not
intended for sterilization.
7 Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,
including batteries.
8 This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility for medical electrical equipment and/or
systems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical
noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or
strength of a source might disrupt the performance of this device.
9 Portable and mobile RF communications equipment can affect medical electrical equipment.
10 Do not disassemble, repair or modify the equipment.
11 It may be unsafe to
use accessories, detachable parts and materials not described in the instructions for use
interconnect this equipment with other equipment not described in the instructions for use
disassemble, repair or modify the equipment
12 The medical silicone and ABS plastic enclosure which contact the users skin when the device is used have been assessed
by and passed the ISO10993-5 Tests for in vitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type
hypersensitivity.
13 The fingertip pulse oximeter is dependent on blood flow to obtain an accurate SpO
2
measurement. Verify that nothing is
hindering your blood flow before taking your SpO
2
readings.
14 This device is not intended to diagnose or treat any medical condition or disease. It is intended for non-medical
use by healthy people to monitor their pulse rate and blood oxygen levels. It is for sports and/or aviation use.
People who need SpO
2
and pulse rate measurements because of a medical condition should not use this pulse
oximeter and should consult with their physician.
Inaccurate measurements may be caused by
1 Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin).
2 Intravascular dyes such as indocyanine green or methylene blue.
3 High ambient light. Shield the sensor area if necessary.
4 Excessive user movement.
5 High-frequency electrosurgical interference and defibrillators.
6 Venous pulsations.
7 Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
8 The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9 The user is in cardiac arrest or is in shock.
10 Fingernail polish or artificial fingernails.
11 Weak pulse quality (low blood perfusion).
12 Low hemoglobin.
Product Features
1 Easy to operate. Measure your SpO
2
non-invasively.
2 Small, light and portable.
3 OLED screen displays SpO
2
, Pulse Rate, Pulse bar, Plethysmograph and Perfusion Index (PI). Six different display options.
4 Level 1-5 adjustable brightness.
5 Preset alarm function.
6 2pcs AAA-size alkaline batteries; low-battery indicator and low power consumption.
7 When no or low signal is detected, the screen will display ‘Finger Out’ and the device will power off automatically in about 8
seconds.
Intended Use
The iP900AP Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial
hemoglobin (SpO
2
) and pulse rate of children (>12 years old) and adult. The device is for sports and/or aviation use.
It is intended for non-medical use by healthy people to monitor their pulse rate and blood oxygen levels for sports and/or aviation
use only. This pulse oximeter is not a medical device and is not intended to diagnose and/or treat any medical condition or disease.
People who need SpO
2
and pulse rate measurements because of a medical condition should consult with their physician.
Operation Instructions
1 Install two AAA batteries according to the Battery Installation instructions.
2 Place one of your fingers into the finger chamber of the pulse oximeter.
3 Press the power button on the front panel to turn the pulse oximeter on.
4 Keep your hand and finger still for the reading. It is recommended that you do not move your body
while taking a reading.
5 Read the data from the display screen.
6 Press (<1 sec) the button again to toggle between six display modes (see below).
After turning the oximeter on, each time you press the power button, the oximeter will switch to another display mode.
There are 6 display modes shown as follows:
Tips to getting a good reading
1) Make sure that your finger is inserted deep into the chamber so that the fingertip is placed directly in between the LED sensor
and the LED light source.
2) Avoid making any body movement, especially your finger while taking measurement.
3) Long fingernails may obstruct the light sensor and prevent accurate measurement. Please keep the fingernails short while using
the device.
4) Excessive ambient infra-red light, especially in an overly bright lit room, can interfere with the sensor, preventing an accurate
measurement.
5) Poor blood circulation can affect oximeter readings. Warm your hands and fingers before taking your measurements. Note that
the pulse oximeter is measuring your SpO
2
and PR based on your blood flow. If the blood flow in your finger drops below a perfusion
index of 0.3, the pulse oximeter will not be able to get a reading.
6) Some people with medical conditions such as anemia, hypotension and hypothermia may experience an inaccurate reading
during use. In such case, we suggest that you consult a physician.
Front Panel
The pulse bar graph, plethysmograph and perfusion index (PI) are useful features that can be used to determine the reliability of a
reading. If the height of the pulse bar is less than 30%, this indicates signal inadequacy and the displayed SpO
2
or pulse rate value
is potentially incorrect. Adjust your finger so that it is directly between the LED lights and sensor.
The plethysmograph indicates the amount of blood flow detected by the pulse oximeter and the perfusion index indicates the
strength of your pulse. Each wave in the plethysmograph corresponds to a heartbeat and the wave amplitude corresponds to the
amount of blood detected by the pulse oximeter. The pulse oximeter is optimized when the height of the wave amplitude is
consistent throughout as shown in the figure above. That is when you should take the reading. The pulse oximeter can function with
a PI reading as low as 0.3%. If your PI is below 0.3%, this means that your blood perfusion is too low for a reliable read. Warm your
hands to increase blood flow and retake your measurement. In general, a higher PI will give you a more reliable reading.
Settings
In the measuring interface, press and hold the power button to enter the settings interface.
To scroll down the menu, short press (<1 sec) the power button. The icon indicates the line selected.
To select an option, long press (>1 sec) the power button.
Settings menu
Alm Setup To enter the Alarm Setup submenu.
Alm To turn audible alarm on/off.
Beep To turn audible beep for pulse beat on/off.
Brightness To adjust screen brightness from 1-5. Level 5 is the brightest.
Default level is 4.
Reset To restore default settings.
Exit To return to the measuring interface.
Alm Setup submenu
+/- Select + to increase value. Select to decrease value.
SpO
2
Alm Hi Upper limit for SpO
2
alarm (71% - 100%)
SpO
2
Alm Lo Lower limit for SpO
2
alarm (70% - 99%)
PR Alm Hi Upper limit for PR alarm (35bpm - 250bpm)
PR Lo Lower limit for PR alarm (30bpm - 245bpm)
Exit To return to the Settings menu
Setting the alarm parameters
When SpO
2
or PR reading exceeds a defined range, an alarm will trigger and the SpO
2
or PR reading will start to flash respectively.
In addition, an audible alarm can be turned on by setting the ‘Alm’ under the Settings menu to on.
The upper and lower limit for the SpO
2
and PR alarm can be user defined. Under the Settings menu, select ‘Alm Setup’ to enter the
Alarm Setup submenu. To increase a value, + should be selected. To decrease a value, - should be selected. SpO
2
limit can be
adjusted in increment of 1%; PR limit in increment of 5bpm.
Default limits: SpO
2
Alm High 100%, Low 90%; PR Alm High 100bpm, Low 60bpm
Note: Audible alarm can be snoozed/silenced for 30 seconds by pressing the power button. Visual alarm will remain. After 30
seconds, if reading still exceeds the set limit, the audible alarm will turn back on.
Beep - An audible beep to indicate each pulse beat can be turned on by setting the Beep’ under the Settings menu to on.
Brightness - The screen brightness can be adjusted from 1-5. Level 5 is the brightest. Default level is 4.
Reset - To restore default parameters setting, press and hold the power button until Yes’ appears.
Exit - Press and hold the power button to return to the measuring interface.
Note: In the settings interface, if no operation is detected, device will return to the measuring interface automatically in about 30
seconds.
Product Accessories
1. One pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
Battery Installation
1. Open the battery door cover.
2. Install two AAA batteries into the battery compartment by matching the plus (+) and minus (-) signs in the compartment.
Note: Incorrectly installed batteries may damage the device.
3. Align the battery door cover and press until it snaps back in place.
Note:
Please remove the batteries if the pulse oximeter will not be used for a long period of time.
Please replace the batteries when the low power indicator appears.
Using the Lanyard
1. Thread the thin end of the lanyard through the lanyard hole on the device.
2. Thread the thick end of the lanyard through the thin loop (threaded in step 1) and pull
to tighten.
Warnings!
Keep the oximeter away from young children. Small items such as the battery door,
battery, and lanyard are choking hazards.
Do not hang the lanyard from the device’s electrical wire.
Please note that the lanyard tied to the oximeter may cause strangulation due to its
length.
Maintenance and Storage
1. Replace the batteries when the low power indicator appears.
2. Clean the finger chamber and surface of the oximeter before use.
3. Remove the batteries if you are not planning to use the oximeter for a long period of time.
4. Store the oximeter in a cool and dry place. Extreme moisture may damage the oximeter or affect its lifespan.
5. Dispose battery properly. Follow any applicable local battery disposal laws.
Cleaning the fingertip pulse oximeter
It is recommended to clean the oximeter before and after use. To clean, use a soft cloth lightly dampened with water to wipe the
iP900AP
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