Answers to the most common questions about BreathTek UBT are below.
For more information, contact OAPI customer service at 1.888.637.38351.888.637.3835 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 1.888.637.38351.888.637.3835 or e-mail productinfo@otsuka.com for more information.
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:
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.*
Yes. The word "PUSH" on the back of the adapter and print on the back of the cartridge should be facing inward.
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.
The data on the printer paper do fade over time. It's recommended that copies of all the data are made or sent to a personal computer.
Thermal paper replacement is dependent upon the number of samples analyzed.
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.
Yes, if the device has been off during the non-use period, when turned on, the unit will go through 2 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.
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 1-888-637-38351-888-637-3835 for more information. See below for evaluation criteria.
Evaluation criteria for the reproducibility tests:
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.
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.
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.
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.
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.*
Delta over baseline (DOB) > 2.4 ‰ (delta per mils).
No.
No.
Currently the POCone is not compatible with a LIS. You'll need to write your own interface for this system.
While the testing procedure will not change, an analysis calculation is needed for pediatric test results. You or your lab technician will need to use the Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) to conduct the analysis. For your convenience, you can access this web-based application at BreathTekKids.com. The Delta-over-Baseline result from the POCone or UBiT®-IR300 cannot be used to determine infection status in pediatric patients, and it is used to calculate the urea hydrolysis rate (UHR) metric to provide a positive/negative result.
To complete the analysis, the pUHR-CA requires the following patient information: age* (years), gender, collection date, analysis date, height (inches or centimeters), weight (pounds or kilograms), and patient ID.
*Use the patient’s current age and do not round up.
When visiting the BreathTekKids.com website, first-time users must register. Once registered and access is granted, a user ID and a temporary password will be sent to the requestor. Please enter the following information upon registration:
Allow some time to ensure processing and account validation for a new user name and password.
Yes.
Assistance is available at 1-888-637-38351-888-637-3835.
New POCone instrument comes with a 1-year seller warranty.* Additional warranties and service agreements are available for purchase. For details, please contact the Customer Service office at 1-888-637-38351-888-637-3835.
* 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 please contact the Customer Service office at 1-888-637-38351-888-637-3835.
Contact OAPI at 1-888-637-38351-888-637-3835, or by e-mail at productinfo@otsuka.com.
Yes. Breath sample may be collected no later than 30 minutes POST-DOSE.
Collecting the sample in the wrong bag. Be sure to Collect the BASELINE sample in the Blue Bag and POST-DOSE sample in the Pink Bag. If you immediately recognize that you have collected the sample in the wrong order/bag, i.e. BASELINE sample in the Pink Bag and POST-DOSE sample in the Blue Bag, immediately document this information on the bags for the lab technician analyzing the samples. Note: 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.
How do I prevent this problem from occurring in the future? Be sure to Collect the BASELINE sample in the Blue Bag and POST-DOSE sample in the Pink Bag then place the bags on the instrument in the correct order prior to analysis.
Other common collection issues: Not properly and firmly re-capping the breath collection bag after use. This is important if samples will not be immediately analyzed on the POCone.
Other administration errors: The patient drinks the Pranactin-Citric drug solution before the administrator collects the baseline breath sample. If repeat testing is needed, BreathTek UBT can be repeated again on the following day.
Yes. Any healthcare professional can be trained to administer the test. 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.
The safety of using the BreathTek UBT kit during pregnancy and lactation is not established.
No. The test has been validated based on complete consumption of the Pranactin-Citric drug solution as indicated in the Package Insert.
Phenylalanine is one of the amino acids that 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).
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-oz can of typical diet cola soft drink.
Call OAPI Technical Support Services at 1-888-637-38351-888-637-3835.
The specimens should be processed within 7 days of collection and be stored at 59°-86°F (15°-30°C) per the Package Insert.
Kits should be stored at room temperature, 59°-86°F (15°-30°C).
Contact OAPI Customer Service at 1-888-637-38351-888-637-3835.
Yes. Kits are shipped in 5-piece package configurations.
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.
Do not use it.
Contact OAPI Customer Service at 1-888-637-38351-888-637-3835.
Please contact OAPI at 1-888-637-38351-888-637-3835.
Please contact OAPI Customer Service at 1-888-637-38351-888-637-3835.
Warnings and Precautions for BreathTek UBT are as follows:
For a complete listing of Warnings, Precautions and Limitations, please see the Package Insert.