BreathTek UBT Customer Support

Answers to the most common questions about BreathTek UBT are below.

For more information, contact OAPI customer service at 1.888.637.3835 or productinfo@otsuka.com so we can have a representative contact you.

Note: While UBiT®-IR300 Infrared Spectrophotometers are no longer for sale, servicing is still available on a limited basis to OAPI customers. Please call OAPI customer service at 1.888.637.3835 or productinfo@otsuka.com for more information.

  • Accessories and Consumable Items
  • Maintenance and Operation
  • Caution, Error and Warning Messages
  • Measurement Principle Utilized in the POCone Instrument
  • Warranty Information for the POCone Instrument
  • Clinical
  • Patient Preparation
  • Breath Sample Collection
  • Product Transport and Storage
  • Ordering Kits, Instruments, and Supplies
  • Warnings, Precautions, and Limitations of the BreathTek UBT

Accessories and Consumable Items

How often should the consumable items be replaced?

O-rings should be replaced after analyzing 1000 patient samples. To check the current number of patient samples analyzed on your machine, please refer to POCone Instruction Manual.* Please see instructions on changing the O-rings below:

  1. Remove the sample joints by pushing on the white "ejection" ring. The sample joints should fall out.
  2. Use a sharp razor blade to cut the O-rings off the joints.
  3. Replace both O-rings (black and orange) with new O-rings. The black O-rings on the back slit, the orange O-rings on the front slit. See the POCone instruction manual (page 7-3) for correct positioning of O-rings.
  4. Reinsert the sample joints.
  5. For more details, please see pages 9-4 and 9-5 of the Instruction Manual.*

Very Important! The lifetime of the cartridge will vary depending on the carbon dioxide concentration and humidity level in the vicinity of the instrument. The system will display a caution 3-1 message when it's time to replace the cartridge.

Do not remove the trapping cartridge adapter from the instrument when exchanging the trapping cartridge.

Instructions on replacing the trapping cartridge are located on pages 9-8 and 9-9 of the POCone Instruction Manual.*

When mounting the trapping cartridge and adapter onto the instrument, does the orientation matter?

Yes. The word "PUSH" on the back of the adapter and print on the back of the cartridge should be facing inward.

Are there special disposal requirements for any of the consumable items?

Yes. The CO2 trapping cartridge contains approximately 60 to 70 grams of Lithium Hydroxide; the substance is considered a corrosive and must be disposed of in a heavy metal disposal facility. Please contact OAPI Medical Affairs at 1-888-637-3835 for a copy of the Materials Safety Data Sheet (MSDS). Your local hospital's environmental services department may dispose of the CO2 trapping cartridge at no charge.

Is it possible to store the data for a long period of time when the data is printed on heat sensitive paper?

The data on the printer paper does fade over time. It's recommended that copies of all the data are made or sent to a personal computer.

How often do we need to replace the paper?

Thermal paper replacement is dependent upon the number of samples analyzed.

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Maintenance and Operation

How often should we calibrate the instrument?

The operator is not required to perform an instrument calibration. The system performs its own internal calibration upon warm-up, once each hour the instrument is on, and before sample analysis.

To ensure proper calibration, always change the trapping cartridge when prompted by the system.

What are the proper environmental conditions for installation and operation?

  • Indoors (protected from direct sunlight)
  • 15°-30°C (free from rapid temperature change)
  • Do not store near a vent or window. If stored near a window be sure to locate the instrument not less than 15 cm away.
  • Dust free environment
  • Good ventilation around the exhaust joints (at least 6" clearance around all sides)
  • Do not permit vibration of instrument or supporting surface

What type of preventative maintenance is recommended?

  • Keep the instrument in a dust free environment, and off the floor.
  • Change the O-rings every 1000 patient samples or when prompted by the system.
  • Change the trapping cartridge when prompted by the system.
  • Turn the system off when not in use.

When we don't use the POCone for a certain period of time, is there anything that we need to be aware of, in terms of the maintenance contract and regular maintenance?

Yes, if the device has been off during the non-use period, when turned on, the unit will go through two self-diagnosis routines. During the routines, the instrument's components are evaluated; if during this time, the components do not meet required specifications then a warning, caution, or error message will occur. After a warning, caution, or error message is displayed, you will not be able to continue with testing until the problem is resolved. If a repair is needed you should notify OAPI Technical Support Services for servicing. While in use, regular maintenance should be performed at least once a year.

What is the recommended Quality Control Procedure for the instrument?

Otsuka Electronics, Ltd. and Otsuka Diagnostics Group of Otsuka America Pharmaceutical, Inc. recommend running a reproducibility test on the instrument at least once a month. This is a 20 minute test that measures the overall stability of the instrument. Please see pages 7-23 and 11-4 of the POCone Instruction Manual* for test specifications. You may also call Technical Support Services at 1-888-637-3835 for more information. See below for evaluation criteria.

Evaluation Criteria for the Reproducibility tests:

  1. The light intensity ratios are between 1.00 and 1.15
  2. The average delta over baseline (DOB) +/- 0.3‰
  3. The S.D. is less than 0.3

The instrument has internal electronic monitoring systems. During the 10 minute warm-up phase the instrument conducts 2 self-diagnostic routines (tests) to determine the overall stability of the instrument. If one of these tests is judged to be out of specifications, the system will display a warning, caution, or error message, and will not allow the system to measure any samples. In addition, if any abnormalities are found during sample analysis the system will not continue to measure the sample and will display a warning, caution, or error message.

When using the present device close to a cellular phone, cordless phone, or X-ray device, does this affect the measurement data?

There is a strong possibility that an X-ray device may affect the instrument therefore affecting the data. Store the instrument in a place free from strong magnetic or electric fields.

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Caution, Error, and Warning Messages

How to prevent them and avoid wasting patient samples.

I received several caution 4-1 messages while running a patient's sample. How can I prevent this from occurring in the future?

Be sure to completely insert the breath sample bags onto the sample joints. The breath sample bags must cover both the black and orange O-rings of the sample joints. If the O-rings are not covered, leakage from the bags could occur and the systems' syringe may not be fully able to extract air from the bag.

The sample joints may not be fully attached to the instrument. To check this, gently pull the sample joints out from the instrument then reattach them.

The CO2 concentration in the bag is less than 0.5%. Please recollect the sample from the patient. If it's been more than 20 minutes since post collection, you must retest the patient after 24 hours using a new UBT kit. The bags were stored without the caps, causing the breath sample to leak out of the bag.

I received a caution 4-2 (CO2 concentration is less than 1%) message while running the patient's sample. How can I prevent this in the future?

A breath sample that contains less than 1% CO2 is not considered a valid sample. If the system determines that the breath sample (S1 or S2) contains insufficient CO2 (<1%), it will report a caution 4-1 message along with the final result. To prevent this from happening in the future the operator should be aware of the following items:

The patient should take a deep breath and pause momentarily before blowing into the pre-collection and post collection bag. This will allow the patient to increase the CO2 in lungs and emit a CO2 concentration that is 1% or greater.

Recap the bags immediately after collection and store them at room temperature, if not analyzed right after collection. The breath bags must be firmly attached to the sample joints, over both the black and orange O-rings.

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Measurement Principle Utilized in the POCone Instrument

Describe the calculation method for 13CO2 utilized by the instrument:

The instrument determines the amount of light absorbance by each breath/gas sample. The instrument then determines the difference between the 13CO2 / 12CO2 concentration ratios in each breath sample. If the result is found to be equal to or greater than 2.4 ‰ (delta per mils) then the result is considered positive. For a more detailed calculation, please refer to page 4-2 of the Instruction Manual.*

What is the cutoff value for a positive result?

Delta over baseline (DOB) > 2.4 ‰ (delta per mils).

Can the instrument measure H2 concentrations?

No.

Can the instrument be modified?

No.

Is the POCone compatible with LIS?

Currently the POCone is not compatible with a LIS. You'll need to write your own interface for this system.

I need to know the bar code size and the bar code standards which can be used for the breath bag labels and the POC-AS10 Autosampler.

Bar Code Reader
Type: MS5145-AV
Light Source: VLD 650nm +/- 10nm
Laser Power: Under 1.0mW (Peak)
Bar Code Type: NW-7, ITF, CODE-39
Resolution 0.102 mm

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Warranty Information for the POCone Instrument

What types of warranties are available for the POCone?

A new POCone instrument comes with a one-year seller warranty.* Additional warranties and service agreements are available for purchase. For details please contact the Customer Service office at 1-888-637-3835.

* Warranty subject to change without notice

* If you no longer have the Instruction Manual for your instrument, please contact OAPI Customer Service for a replacement manual, or download a copy to view here.

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Clinical

If clinical questions arise that are not covered by this website or in the product literature, who should these be referred to?

Contact OAPI Customer Service at 1-888-637-3835, or by email at productinfo@otsuka.com. Contact OAPI Technical Support at 1-888-637-3835.

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Patient Preparation

For patient preparation tearsheet, download now.

Does the patient need to be off ALL medications prior to the administration of the BreathTek UBT test?

Do not take any of the following medications for 2 weeks prior to the test:

  1. All antibiotics
  2. Proton Pump Inhibitors or their generic versions such as Zegerid® (omeprazole/sodium bicarbonate), Prilosec® (omeprazole) and Prilosec OTC® (omeprazole), Prevacid® (lansoprazole), Aciphex® (rabeprazole), Protonix® (pantoprazole) and Nexium® (esomeprazole)
  3. Bismuth preparations such as Pepto Bismol®

BreathTek UBT should be used 4 weeks or more after the end of treatment for the eradication of H. pylori, as earlier post-treatment assessment or confirmation may give false negative results.

What alternatives are there to the medications listed above?

Histamine blockers (H2 antagonists) may be substituted for Proton Pump Inhibitors. These medications do not appear to affect the accuracy of the UBT and include Zantac®, Tagamet®, Pepcid®, and Axid®.

Many labs suggest that you do not use H2RAs 24 to 48 hours prior to testing.

If the patient has been on antibiotics for something other than the treatment of ulcers, how long does the patient have to be antibiotic-free before the initial BreathTek UBT breath test?

Two weeks.

After completing eradication therapy, how long must the patient be free from medications before re-testing?

Four weeks.

If the patient has not fasted, can the breath test still be administered?

No, the patient should have fasted at least one (1) hour before administration of the BreathTek UBT.

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Breath Sample Collection

After administering Pranactin®-Citric drug solution, is the 15 minute timing period important for the second breath sample?

Yes. The most accurate test results are obtained by following the procedure as written in the Package Insert.

What are the most common collection errors?

  • Collecting the sample in the wrong bag (very common). Collect the BASELINE sample in the Pink Bag and POST-DOSE sample in the Blue Bag. There is no substance inside the bags that will interfere with the breath sample; however, collecting the breath sample in the wrong bag may result in an inaccurate reading on the POCone. If the samples were collected in the wrong bags, immediately document this information on the bags for the lab technician analyzing the samples.
  • Not properly and firmly re-capping the breath collection bag after use.
  • Administration of Pranactin-Citric drug solution before collecting the baseline breath sample.
  • Consumption by the patient of food, beverage or smoking during the 15 minute test interval. This is important if samples will not be immediately analyzed on the POCone.

Can physician office staff be easily trained in this procedure?

Yes. Any healthcare professional can be trained to perform the collection of this test sample. The BreathTek UBT is CLIA non-regulated, so no special licensing or personnel are needed. However, all staff administering the BreathTek UBT should thoroughly review the Package Insert before administration.

Can this test be administered to pregnant women?

No information is available on the use of the drug solution during pregnancy.

If the patient does not drink all of the Pranactin-Citric drug solution, will the test still be valid?

No. The test has been validated based on complete consumption of the Pranactin-Citric drug solution as indicated in the Package Insert.

What is phenylalanine?

Phenylalanine is one of the amino acids which the body cannot manufacture itself. Aspartame which contains phenylalanine is used as a sweetener in the Pranactin-Citric drug solution (roughly equivalent to the amount in one diet cola soft drink).

What will happen if I accidentally give the test to a PKU patient?

PKU patients can take the test but must be made aware that the drug solution contains approximately the same amount of phenylalanine as a 12-ounce can of typical diet cola soft drink.

If I have a question regarding breath collection, who should I call?

Call OAPI Technical Support Services at 1-888-637-3835.

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Product Transport and Storage

How long will the specimen integrity be maintained after collection?

The specimens should be processed within 7 days of collection and be stored at 59°-86°F (15°-30°C) per the Package Insert.

What are the storage requirements needed for the BreathTek UBT kit?

Kits should be stored at room temperature, 59°-86°F (15°-30°C).

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Ordering Kits, Instruments, and Supplies

How do I get kits, instruments, or supplies?

Contact OAPI Customer Service at 1-888-637-3835.

Is there a minimum order?

Yes. Kits are shipped in 5-piece package configurations.

Who should monitor the kit expiration date?

Once a physician's office or lab has received a kit, it is the responsibility of that lab or physician's office to monitor the expiration date.

What if a kit has expired?

  • Do not use it.
  • Contact OAPI Customer Service at 1-888-637-3835.

What if I have a complaint about the kit, such as a missing component? What do I need to do?

Please contact OAPI at 1-888-637-3835.

What is the cost for kits, instruments, and other supplies?

Please contact OAPI Customer Service at 1-888-637-3835.

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Warnings, Precautions, and Limitations

What Warnings, Precautions, and Limitations of the BreathTek UBT should I be aware of?

For a complete listing of Warnings, Precautions and Limitations, please see the Package Insert.

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