FORA TD-8255B Fingertip Pulse Oximeter Instruction Manual

FORA TD-8255B Fingertip Pulse Oximeter Instruction Manual

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 a motion-tolerant software which distinguishes between movement and pulse. In some circumstances, however, the oximeter may still interpret movement as good pulse quality. Therefore, it is recommended to minimize movement as much as possible. INTRODUCTION
• 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)
   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 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 when starting the test. Do not move your 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 blinking 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 sec,
• 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:

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 those recommended here as it may cause permanent damage.

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.
Sp02 or pulse rate displays are missing.| Defective LCD displays.| Displayed values may not be reliable; discontinue use of the oximeter.
Sp02 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

“ battery Low” is shown on LCD.

| The batteries are low.| Replace the batteries immediately.

SPECIFICATIONS

• Model No.: TD-8255B
• Dimension & Weight: 63(H) x 37(W) x 32(D) mm, 40g without batteries
• Display: LCD
• Power Source: Two 1.5V AAA alkaline batteries
• Battery Life : Batteries can be used continuously for 20 hours (for reference only , it depends on different brands of AAA alkaline batteries)
• External Output: Bluetooth
• Measurement and Displayed Range: 0% to 100%
• Resolution: 1%
• Accuracy: 100% ~ 80% ±2%; 79% ~ 70% ±3%; others are undefined.
• Method: Dual wavelength LED

Pulse Rate

• Measurement and Displayed Range: 30 to 250bpm
• Resolution: 1bpm
• Accuracy: ±1bpm or ±1%, whichever is greater
• 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)
• Product Life Time: 12 months

Classification

• Applied part: Type BF Applied part
• Safety: IEC60601-1
• EMC: IEC60601-1-2
• Harmonized Standard: ISO 80601-2-61:2011
• Water-resistance: IP22
• Mode of Operation: Spot Check / Monitoring

SYMBOL INFORMATION

| Type BF Equipment
---|---
| Caution, consult accompanying documents
| Manufacturer
| Authorised representative in the European Union
| Dispose of or recycle the electrical wastes according to local regulations
| Temperature limitation
| Consult instructions for use
| Serial number
| Ingress protection rating
| Humidity limitation
| Alarm
| Model number

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

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