FORA TD-8255B PO200 Fingertip Pulse Oximeter Instruction Manual

FORA TD-8255B PO200 Fingertip Pulse Oximeter

Operation Instruction

WARNINGS

•  Do not use the oximeter in an MRI or CT environment.
•  The oximeter is not intended for use in the diagnosis or screening of any symptoms or diseases. The data measured is for reference only. Do not base a conclusive diagnosis on the results of a single test. A physician or healthcare provider should make a diagnosis after all other clinical and laboratory findings are evaluated.
• If trauma, disabilities or other medical conditions are likely to affect results, a physician should be consulted before use.
• To obtain an accurate SpO2 measurement, the oximeter must be able to measure the pulse properly. Any objects such as blood pressure cuffs must be removed as they will affect results. Federal law (USA) restricts the sale of this device to physicians only.
• Keep the batteries out of reach of small unsupervised children. The batteries detached from the device may cause choking.
• The device may only be used indoors.
•  The use of the device is not recommended for long periods.

CAUTIONS

• The oximeter is not an apnea monitor.
• The oximeter determines the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin such as carbonxyhemo globin or methemoglobin may affect the accuracy of the measurement.
• Cardio green and intravascular dyes, depending on the concentration, may affect the accuracy of SpO2 measurements.
• The performance of the oximeter might be affected by the presence of a defibrillator.
• The oximeter may not work on all users. Refrain from use if unstable readings are obtained.
•  The oximeter has motion-tolerant software which distinguishes between movement and pulse. In some circumstances, however, the oximeter may still interpret the movement as good pulse quality. Therefore, it is recommended to minimize movement as much as possible.
•  Do not use caustic or abrasive cleaning agents on the oximeter or probes.
•  Do not use new and old batteries together as it may cause leaks. Dispose of batteries properly.
•  Batteries might leak chemicals if unused for a long period of time. Remove the batteries if the oximeter is expected to be stored for more than one month.
•  The oximeter is an electronic instrument and must be repaired by trained personnel only.
•  Follow local government waste regulations to dispose of or recycle the device and device components accordingly.
•  Always store the oximeter in a cool and dry place: temperatures between -25°C to 70°C (-13°F to 158°F) relative humidity less than 95%. Avoid direct sunlight.

INTRODUCTION

Intended Use
The Fingertip Pulse Oximeter measures the oxygen saturation of arterial blood by sensing and recording capillary pulsations. It is intended for adult patients weighing more than 40 kg.
This device is intended for non-invasive spot-checking.

Principle of Measurement
The Fingertip Pulse Oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light which passes through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate.

Meter Appearance and Key Function

1. Bluetooth Indicator
   Blue light appears when Bluetooth is turned on.

2. SpO2 %
   The measurement result of oxygen saturation in percentage.

3. Battery Indicator

4. Pulse Amplitude
   The strength of the signal is detected by the oximeter.

5. Backlight (White or Red)
   The backlight is white during the measuring mode. Backlight blinks red when the oxygen saturation value is below 85% (high priority visual alarm).

6. Pulse Rate
   The measurement result of pulse rate in beats per minute.

7. On/Off Button
   Is used to turn on or turn off the oximeter by pressing the On/Off button.

8. Battery Compartment

Contents of the System
The Fingertip Pulse Oximeter includes the following items:

•  Fingertip Pulse Oximeter
•  Operation Instruction x 1
•  AAA-Size Alkaline Batteries x 2
•  Warranty Card

Confirm that the items listed are packed with the Fingertip Pulse Oximeter. If any item on this list is missing or damaged, contact your distributor. All of the system with accessories is provided non-sterile.

BEFORE USE

Battery Replacement
Make sure the oximeter is off when replacing the batteries.
The oximeter is powered by two 1.5V AAA-size alkaline batteries. You can replace new batteries by the following steps.

1.  Press the edge of the battery cover and lift it up to remove.
2.  Remove the old batteries and replace them with two 1.5V AAA-size alkaline batteries.
3.  Close the battery cover carefully and make sure the cover is snug and fits correctly. It is important that the cover is closed correctly to ensure the oximeter remains waterproof.

NOTE
Use only 1.5V AAA new batteries with this device. Replace the batteries as soon as possible after a low battery symbol appears.

Operation

1.  Turn on the oximeter by pressing . Do not move your finger whenB starting the test. Do not move you body while testing.

2. Open the clamp and put one of your fingers into the rubber hole of the oximeter. It is better to let your finger touch the bottom before releasing the clamp.
   NOTE
   Consult healthcare professionals before starting to use the oximeter.
   The oximeter sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the sensor.
   Check the sensor application site frequently to determine circulation, positioning and skin sensitivity. The recommended maximum application time on a single site is 4 hours.

3. After detecting the pulse signal, the oximeter shows the readings of SpO2 and pulse rate on the display. The readings will be updated based on the signal received with each pulse.

4.  While testing, if you press , the screen will rotate 180 degrees.
   NOTE
   The backlight will turn to blink red if the oxygen saturation value is below 85%.

5.  Keep pressing and the oximeter will turn off.

NOTE
Below is the description of the effect on displayed and transmitted SpO2 and pulse rate data values by:

• data averaging and other signal processing for 8 secs,
•  the data update period for 1 sec,
•  the alarm condition delay for 1 sec,
•  alarm signal generation delay for 1 sec including the effects of any selectable operating mode that affects these properties.

DATA TRANSMISSION VIA BLUETOOTH
You can transmit your SpO2 and pulse rate data from the meter to your device (e.g. smart phone, tablet, PC…) via Bluetooth. Please contact your local customer service or place of purchase for assistance. Please note that you must complete the pairing between meter and Bluetooth receiver before transmitting data.

1.  With the meter off, press and hold for 4 seconds. The meter enters pairing mode.
2. Turn on the Bluetooth function of your device so that it can begin searching for the meter. When the name of the meter appears on the pairing list, select and add it to the list.
3.  The meter will show that it is paired with your device, suggesting successful pairing.

NOTE
Under which circumstances will a pairing be required?: (A) When you are using the meter for the first time; (B) When changing a new device and re- pairing is required.

Bluetooth indicator on the oximeter:

BLUETOOTH

INDICATOR

| STATUS
---|---
Flash Fast| The meter is pairing and connecting
Lit Solid| The connection is established. The meter is transmitting data now.

MOBILE PHONE COMPATIBILITY ISSUES
The Bluetooth functionality is implemented in different ways by the various mobile phone manufacturers. Unfortunately, in some mobile phone models, even with Bluetooth functionality, they may be compatible only with certain types of devices. If a problem occurs in the connection between your mobile phone and the oximeter or if you are uncertain regarding your mobile phone’s Bluetooth capabilities, please consult your mobile phone manual or contact your local customer service for assistance.

WARNINGS
Make sure your device has the Bluetooth function turned on and the meter is within the receiving range before transmitting the data.

CLEANING THE OXIMETER
Cleaning the oximeter is just as important as proper use. For cleaning the surface and disinfecting the oximeter as well as reusing the SpO2 probes, we recommend the following procedure:

1.  Turn off the oximeter before cleaning.
2.  Wipe the surface with a soft cloth dampened with a mild detergent or isopropyl alcohol solution. If low-level disinfection is required, a cloth dampened with 10% bleach / 90% water solution may also be used. Do not use undiluted bleach or any cleaning solution other than that recommended solution other than those.

NOTE
Do not spray, pour, or spill any liquid on the oximeter, accessories, switches or openings.

MAINTENANCE AND STORAGE

•  Replace batteries as soon as a low voltage is indicated.
•  Clean the surface of the Fingertip Oximeter before use.
• Remove batteries inside the battery compartment if the oximeter has not been operated for a long time.
•  It is best to preserve the product in a place where ambient temperatures range from -25°C to 70°C (-13°F to 158°F) and humidity range below 95% R.H.
•  It is recommended that the product be kept in a dry place. A damp environment may affect its lifetime and even damage the product.

TROUBLESHOOTING

batteries.
The batteries are installed incorrectly.| Verify correct battery orientations.
SpO2 or pulse rate displays are missing.| Defective LCD displays.| Displayed values may not be reliable; discontinue use of the oximeter.
SpO2 or pulse rate displays unstably.| Finger might be trembling or place incorrectly on the probe.| Try not to move or retry by placing the finger at the correct position on the probe.
Disruption in the oximeter performance.| Electromagnetic interference (EMI).| Remove the oximeter from the EMI environment.
Battery is low and ”           bAt Lo ” is shown on LCD.| The batteries are low.| Replace the batteries immediately.

SPECIFICATIONS

• Product Name: FORA® PO200
• Dimension & Weight: 32 (L) x 37 (W) x 63 (H) mm, 40g without batteries
• External Output: Bluetooth 4.0

Display: LCD

• Battery Life: Batteries can be used continuously for 20 hours (for reference only, it depends on different brands of AAA alkaline batteries)
• Power Source: Two 1.5V AAA alkaline batteries Operating Conditions: 10°C to 40°C (50°F to 104°F); below 95% R.H. (non-condensing)
• Meter Storage / Transportation Conditions: -25°C to 70°C (-13°F to 158°F); below 95% R.H. (non-condensing)

Oxygen Saturation (SpO2)

• Measurement and Displayed Range: 0% to 100%Resolution: 1%
• Accuracy: 100% ~ 80% ±2% ; 79% ~ 70% ±3%Method : Dual wavelength LED

Heart rate (Pulse)

• Measurement Range and Displayed Range: 30 to 250bpm
• Resolution: 1bpm
• Accuracy: ±1bpm or ±1%, whichever is greater

SYMBOL INFORMATION

Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to the EMC information provided. Careful consideration of this information is essential when stacking or collocating equipment and when routing cables and accessories.
Warning : RF mobile communications equipment can affect medical electrical equipment.

Manufacturer’s declaration-electromagnetic emissions

The FORA PO200 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of the FORA PO200 should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment-guidance

(for home healthcare and professional healthcare)

RF emissions CISPR 11| Group 1| The FORA PO200 uses RF energy only for internal use. Therefore, its RF emissions are very low and are not likely to cause any interference from nearby electronic equipment.
RF emissions CISPR 11| Class B| The FORA PO200 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations /flicker emissions IEC 61000-3-3| Not applicable

Manufacturer’s declaration-electromagnetic immunity

The FORA PO200 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of the FORA PO200 should assure that it is used in the environment specified below.
Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment-guidance (for home healthcare and professional healthcare environment)
Electrostatic ischarge(ESD) IEC 61000-4-2| Contact:±8 kV

Air±2 kV,±4 kV,±8 kV,±15 kV

| Contact:±8 kV

Air±2 kV,±4 kV,±8 kV,±15 kV

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| ± 2kV for power supply lines

± 1kV for input/output lines

| Not applicable Not applicable| Mains power quality should be that of a typical home healthcare and professional healthcare environment.
Surge IEC 61000-4-5| ± 0.5kV, ±1kV line(s) to line(s)

± 0.5kV, ±1kV, ±2kV line(s) to earth

| Not applicable Not applicable| Mains power quality should be that of a typical home healthcare and professional healthcare environment.
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| Voltage dips:

0 % UT; 0,5 cycle

0 % UT; 1 cycle

70 % UT; 25/30 cycles

| Voltage dips: Not applicable Not applicable Not applicable| Mains power quality should be that of a typical home healthcare and professional healthcare environment. If the user of the FORA PO200 requires continued operation during power mains interruptions, it is recommended that the FORA PO200 be powered from an uninterruptible power supply or a battery.
 | Voltage interruptions: 0 % UT; 250/300 cycle| Voltage interruptions: Not applicable|
Power frequency(50, 60 Hz) magnetic field IEC 61000-4-8| 30 A/m

50 Hz or 60 Hz

| 30 A/m

50 Hz and 60 Hz

| The FORA PO200 power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare and professional healthcare environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration-electromagnetic immunity

The FORA PO200 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of the FORA PO200 should assure that it is used in the environment specified below.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance (for home healthcare and professional healthcare environment)
Conducted RF IEC 61000-4-6| 3 Vrms:

0,15 MHz – 80 MHz

6 Vrms:

in ISM and amateur radio bands between 0,15 MHz and 80 MHz

| Not applicable Not applicable| Portable and mobile RF communications equipment must not be used close to any parts of the FORA PO200 including cables, other than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
 | 80 % AM at 1 kHz|  |
Radiated RF IEC 61000-4-3| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| Recommended separation distance:

d = 1,2 √P

d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 800MHz to 2,7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a   Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FORA PO200 is used exceeds the applicable RF compliance level above, the FORA PO200 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the FORA PO200.

b   Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distance between portable and mobile RF communications equipment and the FORA PO200

The FORA PO200 is intended for use in an electromagnetic environment (for home healthcare and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the FORA PO200 can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and the FORA PO200 as recommended below, depending on the maximum output power of the communications equipment.
Rated maximum output power of transmitter

W

| Separation distance according to frequency of transmitter m
150 kHz to 80 MHz

d =1,2√P

| 80 MHz to 800 MHz

d =1,2√P

| 800 MHz to 2,7 GHz

d =2,3√P

0,01| N/A| 0,12| 0,23
0,1| N/A| 0,38| 0,73
1| N/A| 1,2| 2,3
10| N/A| 3,8| 7,3
100| N/A| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) depending on the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Manufacturer’s declaration-electromagnetic immunity

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

The FORA PO200 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
Test frequency (MHz)| Band a)

(MHz)

| Service a)| Modulation b)| Maximum power (W)| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

| Compliance LEVEL (V/m) (for home and professional healthcare)
385| 380 – 390| TETRA 400| Pulse modulation| 1,8| 0,3| 27| 27

450

|

430 – 470

|

GMRS 460,

FRS 460

| FM c)

±5 kHz deviation

1 kHz sine

|

2

|

0,3

|

28

|

28

710|

704 – 787

|

LTE Band 13,

17

| Pulse modulation b) 217 Hz|

0,2

|

0,3

|

9

|

9

745
780
810|

800 – 960

| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

|

Pulse modulation b) 18 Hz

|

2

|

0,3

|

28

|

28

870
930

1 720

|

1 700 – 1 990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1, 3,

4, 25; UMTS

|

Pulse modulation b) 217 Hz

|

2

|

0,3

|

28

|

28

1 845

1 970

2 450

|

2 400 – 2 570

| Bluetooth, WLAN,

802.11 b/g/n, RFID

|

Pulse modulation b) 217 Hz

|

2

|

0,3

|

28

|

28

5 240|

5 100 – 5 800

|

WLAN 802.11

a/n

|

Pulse modulation b) 217 Hz

|

0,2

|

0,3

|

9

|

9

5 500
5 785
NOTE To achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.

c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

TaiDoc Technology Corporation
B1-7F, No. 127, Wugong 2nd Rd.,
Wugu Dist., 24888 New Taipei City, Taiwan
MedNet EC-REP GmbH
Borkstraβe 10,
48163 Mϋnster, Germany

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