Exalenz Bioscience Ltd.

Exalenz Bioscience Ltd. Drugs

• Idkit Hp One
  

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  Idkit Hp One

  

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  Remind the patient that the Citrica contains 84 mg of phenylalanine per packet of Citrica. Phenylketonurics restrict dietary phenylalanine.The patient should have fasted at least one hour before administering the solution.The patient should not have taken antimicrobials, proton pump inhibitors or bismuth preparations within two weeks prior to administering the test.

  PATIENT MODE

  MaterialsA single BreathID®  IDkit: Hp™ ONE is provided to perform the Breath Test in the PATIENT MODE.Each IDkit: Hp™ ONE for the Exalenz BreathID® Breath Test System contains:

  One Tablet of  13C-enriched urea, 75 mg. One Packet of 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder. One IDcircuit™ nasal cannula. One straw for stirring and drinking.

  SystemCheck One SystemCheck accessory is supplied for every 25 units of BreathID® kits, IDkit: Hp™ ONE. The SystemCheck accessory supplied with the BreathID® kits provides quality control for the BreathID® system as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.

  Materials Needed But Not Provided:

  A drinking cup with a capacity of eight ounces (236 ml) or greater. Tap water.

  Step-by-Step Procedure for the PATIENT MODEFor more detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.For performing the BreathID® H. pylori test in PATIENT MODE, use the IDkit: Hp™ ONE single-use kit.

  1. Before opening the kit, verify that the entire package is intact. 2. Ensure that the BreathID® device is activated on PATIENT MODE. The device mode appears on the top corner of the screen. 3. Follow the screen instructions. 4. Connecting the IDcircuit™: a. Take the IDcircuit™ out of its bag and slide the tubing sleeve down as far as it will go. Gently place the cannula tips into the patient’s nostrils, and place the cannula tubing over the ears, as shown in Figure 1. b. Slide the tubing sleeve up towards the neck to fit comfortably under the chin. c. Connect the IDcircuit™ to the BreathID® device by twisting the yellow connector at the free end of the cannula clockwise until it is secured into the dedicated socket of the BreathID® device, as shown in Figure 2. d. Verify that the IDcircuit™ is not twisted or kinked and that the cannula tips are in the nostrils. Ensure that the IDcircuit™ cannula tips moldings are positioned inwards. e. Click on the OK button to proceed. The baseline values will be measured by the BreathID® device and the results will be shown on the screen. 5. Preparing the test drink: Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability. a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity. b. Stir thoroughly with the provided straw for one to two minutes, until the Citrica Powder and the urea tablet are completely dissolved. Note: Tiny particles may remain visible after thorough mixing.  However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit. 6. Administering the test drink and starting measurement: Note: Do not administer the drink until prompted by the screen instructions on the device (this makes certain that the baseline sample has been collected properly). a. Ensure that the patient drinks the solution through the straw. b. The patient must drink the solution within two minutes and consume the entire amount. c. After the patient finishes drinking the solution, press the OK button to proceed. 7. Measurement: The BreathID® device continually analyzes the trend of measured results. When the BreathID® device determines that the final value will be positive or negative, i.e. greater or less than 5 Delta Over Baseline, it will automatically end the test and print out the results. 8. Removing and discarding the IDcircuit™: When the measurement is complete, disconnect the IDcircuit™ from both the patient and the device. Dispose of the IDcircuit™ and all other used components of the kit, according to standard operating procedures or local regulations for the disposal of used medical waste.Note: If you do not disconnect the IDcircuit™, instructions will appear on the device screen reminding you to do so. The device will not proceed to the next screen until the IDcircuit™ is disconnected. 9. Printing Results: a. After the measurement is complete, the device will automatically print the test results. The printout contains the graph as seen on the screen, including the date, time, test number and Delta Over Baseline value of the last point measured. b. Tear off the printed results and fill in the patient data. Figure 1: Position of the IDcircuit™ Figure 2: Connecting the IDcircuit™

  BAG MODE

  MaterialsA single BreathID® IDkit: Hp™ TWO is provided to perform the Breath Test in the BAG MODE. Each Exalenz IDkit: Hp™ TWO for the Exalenz BreathID®  Breath Test System contains:

  One Tablet of 13C-enriched urea, 75 mg One Packet with 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder Two differently colored Breath Collection Bags. One bag is silver and marked as BASELINE (T-0) while the other is blue and marked as POST-INGESTION (T-20). One mouthpiece. Two caps, one for sealing each of the collection bags after the breath collections. One straw for stirring and drinking. One abridged User Guide (Instruction for Use - IFU). One patient requisition form. Two labels (stickers) to be completed with patient and clinical institution information. One plastic bag for the filled breath collection bags and the patient requisition form.

  SystemCheck One SystemCheck accessory is supplied for every 25 units of BreathID® IDkit: Hp™ TWO. The SystemCheck accessory supplied with IDkit: Hp™ TWO provides quality control for the BreathID® System, as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.Materials Needed But Not Provided:

  A drinking cup with a capacity of 8 oz (236 ml) or greater. Tap water.

  Step-by-Step Procedure of the BAG MODE For detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.For performing the BreathID® H. pylori test in the BAG MODE, use the IDkit: Hp™ TWO single-use kit.

  1. Before opening the kit, verify that the entire package is intact. 2. Open a single-use test kit and fill in the patient requisition form. 3. Prepare the silver-colored Breath Collection Bag(T-0) for the breath test: a. Fill in the first label (sticker), marked (T-0). b. Take out the silver-colored “Breath Collection Bag - BASELINE (T-0)” for the breath test. c. Affix the label (sticker) on the silver Breath Collection Bag (T-0). 4. Preparing the test drink: Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability. a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity. b. Stir thoroughly with the provided straw for one to two minutes until the Citrica Powder and the urea tablet are completely dissolved. Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes, discard the solution and repeat the procedure with a new kit. 5. Baseline bag filing: a. Take the silver bag marked as "Breath Collection Bag - BASELINE (T-0)". b. Insert the provided mouthpiece approximately halfway into the BASELINE bag. c. While holding the bag, instruct the patient to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag. d. Lock the bag tightly with one of the provided caps immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed. 6. Administering the test drink: a. Ensure that the patient drinks the solution through the straw. b. The patient must drink the solution within two minutes and must consume the entire amount. 7. Prepare the blue “Breath Collection Bag- POST INGESTION (T-20)” for  the breath test: a. Fill in the label (sticker) marked (T-20), including the time that the second breath sample will be collected (which is time of ingestion + 20 minutes). b. Take out the blue Breath Collection Bag for the breath test. c. Affix the label (sticker) onto the blue bag. 8. Post-Ingestion bag filling: a. Exactly twenty minutes after ingestion (as indicated on the sticker), insert the mouthpiece into the blue bag marked "Breath Collection Bag POST-INGESTION (T-20)" b. While holding the bag, the patient is instructed to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag. c. Lock the bag tightly with the remaining cap immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed. Place the two sealed bags and the patient requisition form in the provided plastic bag. 9. Measurement: a. Ascertain that the BreathID® device is operating in H. pylori BAG MODE. b. The device's mode of operation appears on the upper corner of the screen. To switch modes of operation, refer to the Operator’s Manual. c. Open the plastic bag containing the breath collection bags and patient requisition form. d. Connect the silver bag marked as "Breath Collection Bag BASELINE (T-0)" via the bag adaptor (supplied as part of the accessories kit for IDkit: Hp™ TWO) and the bag connector (supplied as part of the Device’s Accessories Box). e. Prompt the BreathID® to measure the baseline. f. Disconnect the first bag when instructed to do so by the device and then connect the blue "Breath Collection Bag POST-INGESTION (T-20)". g. The BreathID® automatically computes the Delta Over Baseline (DOB), and after the measurement is complete, the device will automatically print the test results. The printout contains the date, time, test number and the Delta Over Baseline value. h. Tear off the printed results, and attach it to the patient requisition form. i. Disconnect the Breath Collection Bag. f. Disconnect the Bag Adaptor.

  PATIENT MODE

  MaterialsA single BreathID®  IDkit: Hp™ ONE is provided to perform the Breath Test in the PATIENT MODE.Each IDkit: Hp™ ONE for the Exalenz BreathID® Breath Test System contains:

  One Tablet of  13C-enriched urea, 75 mg. One Packet of 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder. One IDcircuit™ nasal cannula. One straw for stirring and drinking.

  SystemCheck One SystemCheck accessory is supplied for every 25 units of BreathID® kits, IDkit: Hp™ ONE. The SystemCheck accessory supplied with the BreathID® kits provides quality control for the BreathID® system as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.

  Materials Needed But Not Provided:

  A drinking cup with a capacity of eight ounces (236 ml) or greater. Tap water.

  Step-by-Step Procedure for the PATIENT MODEFor more detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.For performing the BreathID® H. pylori test in PATIENT MODE, use the IDkit: Hp™ ONE single-use kit.

  1. Before opening the kit, verify that the entire package is intact. 2. Ensure that the BreathID® device is activated on PATIENT MODE. The device mode appears on the top corner of the screen. 3. Follow the screen instructions. 4. Connecting the IDcircuit™: a. Take the IDcircuit™ out of its bag and slide the tubing sleeve down as far as it will go. Gently place the cannula tips into the patient’s nostrils, and place the cannula tubing over the ears, as shown in Figure 1. b. Slide the tubing sleeve up towards the neck to fit comfortably under the chin. c. Connect the IDcircuit™ to the BreathID® device by twisting the yellow connector at the free end of the cannula clockwise until it is secured into the dedicated socket of the BreathID® device, as shown in Figure 2. d. Verify that the IDcircuit™ is not twisted or kinked and that the cannula tips are in the nostrils. Ensure that the IDcircuit™ cannula tips moldings are positioned inwards. e. Click on the OK button to proceed. The baseline values will be measured by the BreathID® device and the results will be shown on the screen. 5. Preparing the test drink: Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability. a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity. b. Stir thoroughly with the provided straw for one to two minutes, until the Citrica Powder and the urea tablet are completely dissolved. Note: Tiny particles may remain visible after thorough mixing.  However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit. 6. Administering the test drink and starting measurement: Note: Do not administer the drink until prompted by the screen instructions on the device (this makes certain that the baseline sample has been collected properly). a. Ensure that the patient drinks the solution through the straw. b. The patient must drink the solution within two minutes and consume the entire amount. c. After the patient finishes drinking the solution, press the OK button to proceed. 7. Measurement: The BreathID® device continually analyzes the trend of measured results. When the BreathID® device determines that the final value will be positive or negative, i.e. greater or less than 5 Delta Over Baseline, it will automatically end the test and print out the results. 8. Removing and discarding the IDcircuit™: When the measurement is complete, disconnect the IDcircuit™ from both the patient and the device. Dispose of the IDcircuit™ and all other used components of the kit, according to standard operating procedures or local regulations for the disposal of used medical waste.Note: If you do not disconnect the IDcircuit™, instructions will appear on the device screen reminding you to do so. The device will not proceed to the next screen until the IDcircuit™ is disconnected. 9. Printing Results: a. After the measurement is complete, the device will automatically print the test results. The printout contains the graph as seen on the screen, including the date, time, test number and Delta Over Baseline value of the last point measured. b. Tear off the printed results and fill in the patient data. Figure 1: Position of the IDcircuit™ Figure 2: Connecting the IDcircuit™

  BAG MODE

  MaterialsA single BreathID® IDkit: Hp™ TWO is provided to perform the Breath Test in the BAG MODE. Each Exalenz IDkit: Hp™ TWO for the Exalenz BreathID®  Breath Test System contains:

  One Tablet of 13C-enriched urea, 75 mg One Packet with 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder Two differently colored Breath Collection Bags. One bag is silver and marked as BASELINE (T-0) while the other is blue and marked as POST-INGESTION (T-20). One mouthpiece. Two caps, one for sealing each of the collection bags after the breath collections. One straw for stirring and drinking. One abridged User Guide (Instruction for Use - IFU). One patient requisition form. Two labels (stickers) to be completed with patient and clinical institution information. One plastic bag for the filled breath collection bags and the patient requisition form.

  SystemCheck One SystemCheck accessory is supplied for every 25 units of BreathID® IDkit: Hp™ TWO. The SystemCheck accessory supplied with IDkit: Hp™ TWO provides quality control for the BreathID® System, as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.Materials Needed But Not Provided:

  A drinking cup with a capacity of 8 oz (236 ml) or greater. Tap water.

  Step-by-Step Procedure of the BAG MODE For detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.For performing the BreathID® H. pylori test in the BAG MODE, use the IDkit: Hp™ TWO single-use kit.

  1. Before opening the kit, verify that the entire package is intact. 2. Open a single-use test kit and fill in the patient requisition form. 3. Prepare the silver-colored Breath Collection Bag(T-0) for the breath test: a. Fill in the first label (sticker), marked (T-0). b. Take out the silver-colored “Breath Collection Bag - BASELINE (T-0)” for the breath test. c. Affix the label (sticker) on the silver Breath Collection Bag (T-0). 4. Preparing the test drink: Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability. a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity. b. Stir thoroughly with the provided straw for one to two minutes until the Citrica Powder and the urea tablet are completely dissolved. Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes, discard the solution and repeat the procedure with a new kit. 5. Baseline bag filing: a. Take the silver bag marked as "Breath Collection Bag - BASELINE (T-0)". b. Insert the provided mouthpiece approximately halfway into the BASELINE bag. c. While holding the bag, instruct the patient to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag. d. Lock the bag tightly with one of the provided caps immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed. 6. Administering the test drink: a. Ensure that the patient drinks the solution through the straw. b. The patient must drink the solution within two minutes and must consume the entire amount. 7. Prepare the blue “Breath Collection Bag- POST INGESTION (T-20)” for  the breath test: a. Fill in the label (sticker) marked (T-20), including the time that the second breath sample will be collected (which is time of ingestion + 20 minutes). b. Take out the blue Breath Collection Bag for the breath test. c. Affix the label (sticker) onto the blue bag. 8. Post-Ingestion bag filling: a. Exactly twenty minutes after ingestion (as indicated on the sticker), insert the mouthpiece into the blue bag marked "Breath Collection Bag POST-INGESTION (T-20)" b. While holding the bag, the patient is instructed to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag. c. Lock the bag tightly with the remaining cap immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed. Place the two sealed bags and the patient requisition form in the provided plastic bag. 9. Measurement: a. Ascertain that the BreathID® device is operating in H. pylori BAG MODE. b. The device's mode of operation appears on the upper corner of the screen. To switch modes of operation, refer to the Operator’s Manual. c. Open the plastic bag containing the breath collection bags and patient requisition form. d. Connect the silver bag marked as "Breath Collection Bag BASELINE (T-0)" via the bag adaptor (supplied as part of the accessories kit for IDkit: Hp™ TWO) and the bag connector (supplied as part of the Device’s Accessories Box). e. Prompt the BreathID® to measure the baseline. f. Disconnect the first bag when instructed to do so by the device and then connect the blue "Breath Collection Bag POST-INGESTION (T-20)". g. The BreathID® automatically computes the Delta Over Baseline (DOB), and after the measurement is complete, the device will automatically print the test results. The printout contains the date, time, test number and the Delta Over Baseline value. h. Tear off the printed results, and attach it to the patient requisition form. i. Disconnect the Breath Collection Bag. f. Disconnect the Bag Adaptor.

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