natgillin/translations-raw huggingface dataset:
For performance of the test, 200 ml 100% orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13 C-urea powder) are necessary.
Da bo test učinkovit, morajo bolniki stari nad 12 let zaužiti 200 ml 100 -% pomarančnega soka ali 1 g citronske kisline v 200 ml vode (obrok, zaužit pred testom) ter navadno vodo, v kateri raztopimo prašek s 13 C- sečnino.
In case it is necessary to repeat the test procedure, this should not be done until the following day.
V primeru, da je test potrebno ponoviti, morate počakati do naslednjega dne.
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable.
Pomembno je, da natančno upoštevate navodila za uporabo (glejte poglavje 6. 6), sicer bo veljavnost rezultata vprašljiva.
2 4.3 Contraindications
Testa ne smete uporabiti pri bolnikih, ki imajo ali sumite, da imajo okužbo želodčne sluznice ali atrofični gastritis, ki lahko vplivata na sečninski dihalni test (glejte poglavje 4. 2).
Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e. g. ulcer, autoimmune gastritis and malignancies.
Morda bo potrebna diferencialna diagnoza z invazivnimi endoskopskimi metodami, da ugotovite prisotnost drugih bolezenskih stanj, npr. razjede, avtoimunskega gastritisa in malignosti.
There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI to recommend its use in patients with gastrectomy.
O diagnostični zanesljivosti Testa Helicobacter INFAI ni dovolj podatkov, da bi lahko priporočili njegovo uporabo pri bolnikih z gastrektomijo.
For children from the age of 3, Helicobacter Test INFAI for children aged 3 to 11 is available.
Za otroke stare 3 leta ali več, je na voljo test Helicobacter INFAI za otroke, stare od 3 do 11 let.
In individual cases of A-gastritis (atrophic gastritis) the breath test may have false positive results; other tests may be required to confirm the Helicobacter pylori status.
Pri posameznih bolnikih z A- gastritisom (atrofičnim gastritisom) ima lahko dihalni test lažno pozitiven rezultat; za potrditev statusa Helicobacter pylori bodo morda potrebne še druge preiskave.
If the patient vomits during the test procedure, necessitating the repetition of the test, this should be done in fasted condition and not before the following day (see section 4.2).
Če bolnik med postopkom bruha in je potrebna ponovitev testa, mora biti ta opravljena na tešče in ne pred naslednjim dnem (glejte poglavje 4. 2).
Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status or urease activity.
Na Test Helicobacter INFAI bo vplivala vsaka terapija, ki vpliva na status Helicobacter pylori ali aktivnost ureaze.
Helicobacter Test INFAI has no influence on the ability to drive and use machines.
Test Helicobacter INFAI ne vpliva na sposobnost vožnje in upravljanja s stroji.
Due to the fact that only 75 mg of 13C-urea is delivered, an overdose is not expected.
V enem odmerku je le 75 mg 13C- sečnine, zato ne pričakujemo možnosti prevelikega odmerjanja.
Other diagnostic agents, ATC-code:
Farmakoterapevtska skupina: drugi diagnostiki, oznaka ATC:
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
3 Za količino 75 mg 13C- sečnine, ki se uporabi za dihalni test, farmakodinamični učinki niso opisani.
In the presence of Helicobacter pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori.
V prisotnosti bakterije Helicobacter pylori se 13 C- sečnina presnovi z ureazo bakterije Helicobacter pylori.
Enzyme urease
encim ureaza
4NH3 + 213CO2
4NH3 + 213CO2
In the presence of bacterial urease the ratio of the 13C/ 12C-carbon isotopes is significantly changed.
V prisotnosti bakterijske ureaze se razmerje med 13C in 12C- ogljikovimi izotopi znatno spremeni.
The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS) and stated as an absolute difference (Δδ -value) between the 00-minute- and the 30-minute-values.
Delež 13 CO2 v izdihanem zraku je določen s spektrometrično metodo določanja razmerja mase izotopov (IRMS, isotope ratio mass spectrometry) in predstavljen kot absolutna razlika (vrednost Δδ) med 00- minutnimi in 30- minutnimi vrednostmi.
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to be Δδ -value of 4 ‰, which means that an increase of the Δδ -value by more than 4 ‰ indicates an infection In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved in clinical trials on 457 patients, a sensitivity in the range of 96.5% to 97.9% [95 %-CI:
Mejna točka za razločevanje na Helicobacter pylori negativne in pozitivne bolnike je določena kot Δδ - vrednost 4 ‰.
94.05 %-99.72%], and a specificity range from 96.7% to 100%.
To pomeni, da povečanje Δδ- vrednosti za več kot 4 ‰ pomeni okužbo.
[95 %-CI:
94, 05% - 99, 72%] in obseg specifičnosti od 96, 7% do 100% [95% - IZ:
94.17 %-103.63%], whereas in clinical trials on 93 adolescents from the age 12– 17, a sensitivity of 97.7% [90 %-CI:
V kliničnih preskušanjih na 93 mladostnikih od 12 do 17 let je dosegel občutljivost 97, 7% [90% - IZ:
91.3%], and a specificity of 96.0% [90 %-CI:
91, 3%] in specifičnost 96, 0% [90% - IZ:
Ammonia which is produced as described above by the bacterial hydrolysis is included into the metabolism as NH4+.
Amoniak, ki nastane z bakterijsko hidrolizo (kot je opisano zgoraj), se vključi v presnovo v obliki NH4+.
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the body’ s own urea cycle.
Zaužita 13C- sečnina se presnovi v ogljikov dioksid in amoniak ali se vključi v cikel sečnine v telesu.
Therefore, the rate limiting step in the whole process is the cleavage of 13C-urea by Helicobacter's urease.
Torej je razkroj 13C- sečnine z bakterijsko ureazo tista stopnja, ki omejuje hitrost celotnega postopka.
Only in Helicobacter pylori- positive patients does the administration of 75 mg labelled urea lead to a significant increase of 13CO2 in the breath sample within the first 30 minutes.
Samo pri bolnikih, ki so pozitivni na Helicobacter pylori, 75 mg označene sečnine povzroči znatno povečanje 13CO2 v izdihanem zraku v prvih 30 minutah po zaužitju..
None.
Ne vsebuje pomožnih snovi.
4 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
No.
št.
Component
sestavine
Jar (10 ml volume, polystyrene with polyethylene snap cap)
kocarek (prostornina 10 ml, iz polistirena s polietilenskim pokrovčkom), ki vsebuje 75 mg 13C- sečnine praška za peroralno raztopino
containing 75 mg 13C-urea powder for oral solution Labelled sample glass or plastic containers for sampling, storing and transporting the breath samples for analysis:
označeni stekleni (ali plastični epruvete za zbiranje, shranjevanje in prenašanje vzorcev za analizo:
Sampling time:
Čas vzorčenja:
00-minute-value Sampling time:
00- minutna vrednost Čas vzorčenja:
30-minute-value Bendable straw for collection of the breath samples into the
30- minutna vrednost
Data sheet for patient documentation Package leaflet Page of barcode labels and sticker
upogljiva slamica za zbiranje vzorcev izdihanega zraka v ustrezne vsebnike podatkovni list za dokumentacijo bolnika navodilo za uporabo list z etiketami s črtno kodo in nalepka
Each patient should be documented according to the provided data sheet.
Podatke o vsakem bolniku morate zabeležiti v priloženi formular.
The test starts with the collection of samples for the determination of baseline-value (00-minute-value):
Postopek pričnemo z zbiranjem vzorcev za določitev začetne vrednosti (00- minutne vrednosti):
Take the straw and the two sample tubes with the label “Sampling time:
"Čas vzorčenja:
00-minute-value” out of the test set.
00- minutna vrednost ".
Hold the sample tube upright and stick the bar-code label marked “00-minute-value” round the sample tube, so that the lines of the bar-code are horizontal.
Epruveto držite pokonci in nanjo prilepite črtno kodo z napisom "00- minutna vrednost" tako, da so črte v vodoravnem položaju.
Fill up the second sample tube (Label “Sampling time:
"Čas vzorčenja:
00-minute-value”) with breath by following the same procedure.
00 - minutna vrednost ").
Now 200 ml of 100% orange juice or 1 g citric acid in 200 ml water must be drunk by the patient without delay.
Takoj po tem mora bolnik popiti 200 ml 100 -% pomarančnega soka ali 200 ml vode z 1 g citronske kisline.
The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to three quarters of its volume with tap water.
Iz kompleta vzemite plastenko z napisom "13C- sečnina prašek", jo odprite in do 3/ 4 napolnite • z navadno vodo.
Close the jar and shake it carefully until all the powder is dissolved.
Plastenko zaprite in jo previdno stresajte, dokler se prašek ne raztopi.
Fill the 13C-urea jar to the brim with water for a second and third time and add these contents to the drinking glass (total volume of tap water should be approximately 30 ml).
Plastenko do roba napolnite z vodo še drugič in tretjič in dodajte to vsebino v kozarec (celotna količina vode mora biti približno 30 ml).
This test solution must now be drunk immediately by the patient, and the time of application must be noted.
Zapišite si točen čas zaužitja.
30-
"Čas vzorčenja:
5 minute-value”), as described under steps 3 to 4.
30- minutna vrednost ”), kot je opisano v korakih 3 in 4.
Use the bar-code labels marked “30-minute- value” for these samples.
Za ta vzorca uporabite nalepki z napisom » 30- minutna vrednost «.
Put the relevant bar-code label on the data sheet for patient documentation.
Ustrezno nalepko s črtno kodo nalepite tudi na bolnikov podatkovni list.
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
Analiza razmerja med 13C in 12C v izdihanem ogljikovem dioksidu je sestavni del diagnostičnega postopka Testa Helicobacter INFAI.
• Sample preparation for (IRMS)
• Priprava vzorcev za IRMS
The automatic preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based on a gas-chromatographic continuous flow separation technique.
Avtomatski sistem priprave vzorcev za masne spektrometre, namenjen analizi izdihanega zraka, je osnovan na plinsko- kromatografski tehniki ločevanja z neprekinjenim pretokom.
Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic preparation system that separates the individual gases in a gas chromatographic column with Helium as eluent.
Vodo odstranimo iz vzorca z vodno zaporo z nafionom ali s plinsko- kromatografskim sistemom, ki loči posamezne pline v plinsko- kromatografski koloni s helijem kot eluentom.
• Mass spectrometric analysis
• Masno spektrometrična analiza
To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a beam, accelerated by an electric field, deflected in a magnetic field, and finally detected.
Molekule se nato pospešijo v električnem polju, odklonijo v magnetnem polju in na koncu detektirajo.
• Sample inlet
6 • Dovod vzorca
• Specifications for determining 13 C/ 12C-ratios
Specifikacije za določitev razmerja med 13C in 12C •
6 • The mass spectrometer must be capable of:
Masni spektrometer mora imeti naslednje funkcije:
Multiple replicate analyses:
Večkratna ponovitev analize:
Minimum of 3 replicate analyses on the same sample during operation
Nastavitev:
Security access:
Vsaj tri zaporedne analize istega vzorca.
Storing of operating parameters and of results under security access to avoid later manipulation 13
Shranjevanje delovnih parametrov in rezultatov z varovanim dostopom, da se prepreči poznejše spreminjanje podatkov.
C/12C-ratio with respect to Pee Dee Beliminate (PDB)
Razmerje med 13C in 12C glede na standard PDB (Pee Dee Belemnite)
Sample loop:
Zanka za vzorec:
• All mass spectrometers for breath analysis must comply with the following specifications:
Vsi masni spektrometri za analizo izdihanega zraka morajo ustrezati naslednjim specifikacijam:
≤ 0.5 ‰ for breath samples varying between 1% and 7% CO2- concentration
≤ 0, 5 ‰ za vzorce izdihanega zraka v različnih koncentracijah med Linearnost:
≤ 0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube with 3% CO2 breath concentration
1% in 7% CO2 ≤ 0, 2 ‰ pri 10 zaporednih pulzih Stabilnost: ≤ 0, 3 ‰ pri običajni naravni prisotnosti 13C, z uporabo 10 ml Natančnost meritev: epruvete s 3% CO2 v izdihanem zraku
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute- value exceeds 4.0 ‰.
Okužba s Helicobacter pylori je prisotna, če razlika 13C/ 12C med osnovno vrednostjo in 30- minutno vrednostjo presega 4, 0 ‰.
INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Germany
INFAI, Institut für biomedizinische Analytik & NMR- Imaging GmbH, Universitätsstraße 142 D- 44799 Bochum Nemčija
14/08/1997 14/08/2007
14. 08. 1997/ 14/ 08. 2007
Helicobacter Test INFAI 75 mg powder for oral solution
IME ZDRAVILA Test Helicobacter INFAI, 75 mg prašek za peroralno raztopino
1 jar contains 75 mg of 13C-urea powder.
Učinkovina:
For a full list of excipients, see section 6.1.
13C- sečnina, prašek, 75 mg Za celoten seznam pomožnih snovi glejte poglavje 6. 1
Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:
Test Helicobacter INFAI lahko uporabljamo za in vivo diagnosticiranje gastroduodenalne okužbe s Helicobacter pylori pri:
Helicobacter Test INFAI is a breath test for single administration.
Test Helicobacter INFAI je dihalni test.
Patients from the age of 12 must take the contents of 1 jar with 75 mg.
Mladostnikom od 12 let naprej in odraslim damo vsebino ene plastenke (75 mg).
For performance of the test, 200 ml 100% orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13 C-urea powder) are necessary.
Da bo test učinkovit, morajo bolniki nad 12 let zaužiti 200 ml 100 -% pomarančnega soka ali 1 g citronske kisline v 200 ml vode (obrok, zaužit pred testom) ter navadno vodo, v kateri raztopimo prašek s 13C - sečnino.
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable.
Natančno morate upoštevati navodilo za uporabo v poglavju 6. 6, sicer bo veljavnost rezultata vprašljiva.
8 4.3 Contraindications
4. 3 Kontraindikacije
The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).
Testa ne smete uporabiti pri bolnikih, ki imajo (ali sumite, da imajo) okužbo želodčne sluznice ali atrofični gastritis, ki lahko vplivata na sečninski dihalni test (glejte poglavje 4. 2 – Odmerjanje in način uporabe).
4.4 Special warnings and precautions for use
9 4. 4 Posebna opozorila in previdnostni ukrepi
For children from the age of 3, Helicobacter Test INFAI for children aged 3 to 11 is available.
O diagnostični zanesljivosti Testa Helicobacter INFAI ni dovolj podatkov, da bi lahko priporočili njegovo uporabo pri bolnikih z gastrektomijo in bolnikih, Za otroke stare 3 leta ali več, je na voljo test Helicobacter INFAI za otroke, stare od 3 do 11 let.
If the patient vomits during the test procedure, necessitating the repetition of the test, this should be done in fasted condition and not before the following day (see section 4.2).
Če bolnik med postopkom bruha in je potrebna ponovitev testa, mora biti ta opravljena na tešče in ne pred naslednjim dnem, kot je navedeno v poglavju 4. 2.
Due to the fact that only 75 mg of 13C-urea is delivered, an overdose is not expected.
V enem odmerku je le 75 mg praška 13C- sečnine, zato ne pričakujemo možnosti prevelikega odmerjanja.
VO4CX
Farmakoterapevtska skupina: drugi diagnostiki, oznaka ATC:
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
VO4CX Za količino 75 mg 13C- sečninepraška, ki se uporabi za dihalni test, farmakodinamični učinki niso opisani.
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed.
V prisotnosti bakterijske ureaze se razmerje med 13C in 12C- ogljikovimi izotopi znatno spremeni.
The portion of 13CO2 in the breath samples is determined by non-dispersive infrared spectrometry and stated as an absolute difference (Δδ-value) between the 00-minute- and the 30-minute-values.
Delež 13 CO2 v izdihanem zraku je določen z nedisperzivno infrardečo spektrometrijo (NDIR, non- dispersive
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to be Δδ-value of 4 ‰, which means that an increase of the Δδ-value by more than 4 ‰ indicates an infection.
To pomeni, da povečanje Δδ- vrednosti za več kot 4 ‰ pomeni okužbo.
In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved, in clinical trials on 457 patients, sensitivity in the range of 96.5% to 97.9% [95 %-CI:
V primerjavi z bioptično diagnostiko okužbe s Helicobacter pylori je dihalni test v kliničnih preskušanjih na 457 bolnikih dosegel obseg občutljivosti 96, 5% do 97, 9% [95% - interval zaupanja, IZ:
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the body’s own urea cycle.
Zaužita 13C- sečnina se presnovi v ogljikov dioksid in amoniak ali se vključi v cikel sečnine v telesu.
Therefore, the rate-limiting step in the whole process is the cleavage of 13C-urea by Helicobacter's urease.
Torej je razkroj 13C- sečnine z bakterijsko ureazo tista stopnja, ki omejuje hitrost celotnega postopka.
Only in Helicobacter pylori- positive patients does the administration of 75 mg labelled urea lead to a significant increase of 13CO2 in the breath sample within the first 30 minutes.
Samo pri bolnikih, ki so pozitivni na Helicobacter pylori, 75 mg označene sečnine povzroči znatno povečanje 13CO2 v izdihanem zraku v prvih 30 minutah po zaužitju.
None.
Navedba smiselno ni potrebna.
3 years.
Rok uporabnosti je 3 leta.
10 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
A test set contains 1 jar with the additional components:
Testni komplet vsebuje 1 kozarec z dodatnimi sestavinami:
Component
sestavina kocarek (prostornina 10 ml, iz polistirena s polietilenskim lomljivim
Quantity
količina 1
Jar (10 ml volume, polystyrene with polyethylene snap cap)
11 pokrovčkom), ki vsebuje 75 mg 13C- sečnine v obliki praška za peroralno raztopino
containing 75 mg 13C-urea powder for oral solution Breath bags:
vrečke za vzorce izdihanega zraka:
corresponding sample bags
30- minutna vrednost
Data sheet for patient documentation Package leaflet Page of Barcode labels and sticker
upogljiva slamica za zbiranje vzorcev izdihanega zraka v ustrezne vrečke podatkovni list za dokumentacijo bolnika navodilo za uporabo etikete s črtno kodo in nalepka
A test set contains 50 jars with the additional components:
Test vsebuje 50 kozarcev z dodatnimi sestavinami:
containing 75 mg 13C-urea powder for oral solution Breath bags:
sestavina kocarek (prostornina 10 ml, iz polistirena s polietilenskim lomljivim pokrovčkom), ki vsebuje 75 mg 13C- sečnine v obliki praška za peroralno raztopino
50
količina 50
corresponding sample containers
30- minutna vrednost
Data sheet for patient documentation Package leaflet Page of barcode labels and sticker
upogljiva slamica za zbiranje vzorcev izdihanega zraka v ustrezne vrečke podatkovni list za dokumentacijo bolnika navodilo za uporabo etikete s črtno kodo in nalepka
50 50 50
50 50 50 50
6.6 Special precautions for disposal and other handling
6. 6 Navodila za za pripravo in ravnanje z zdravilom in odlaganje
Take the straw and one breath bag with the label “Sampling time:
Iz kompleta vzemite slamico in vrečko z napisom:
Remove the stopper from one of the breath bags, unwrap the straw and place the straw into the breath bag.
Z ene izmed vrečk odstranite zamašek; odvijte slamico in jo vstavite v vrečko.
By continuously breathing the patient must pull out the straw and immediately close the breath bag with its stopper.
Medtem ko bolnik neprekinjeno izdihuje, izvlecite slamico in takoj zaprite vrečko s
(If the breath bag remains open for more than 30 seconds, the test result might be falsified.)
priloženim zamaškom (Če ostane odprta več kot 30 sekund, bo izid testa morda napačen.)
Hold the breath bag upright and stick the bar-code label marked “00-minute-value” on the breath bag.
Vrečko držite pokonci in nanjo prilepite črtno kodo z napisom "00- minutna vrednost".
Pour the contents into a drinking glass.
Prelijte vsebino v
11
kozarec.
Thirty minutes after administration of the test solution (point 6), collect the 30-minute-value samples in the breath bag, which is left in the test package (Label “Sampling time:
"Čas vzorčenja:
30-minute- value”), as described under step 3.
30- minutna vrednost "), kot je opisano v
Use the bar-code labels marked “30-minute-value” for this sample.
Za ta vzorec uporabite nalepko z napisom » 30- minutna vrednost «.
Put the relevant bar-code label on the data sheet for patient documentation.
Ustrezno etiketo nalepite tudi na formular s podatki o bolniku.
• Sample preparation for Infrared Spectroscopy (NDIR)
• Priprava vzorcev za infrardečo spektroskopijo (NDIR)
• Infrared spectroscopic analysis
• Infrardeča spektroskopska analiza
To analyse the carbon dioxide in breath a broad band infrared radiation bunch emitted by an infrared radiation source is alternately sent through the measuring chamber and a reference chamber by means of a beam chopper.
Pri analizi ogljikovega dioksida v izdihanem zraku izmenično usmerjamo širokopasovno infrardečo svetlobo skozi merilno komoro ter kontrolno komoro, s pomočjo prekinjevalca svetlobnega žarka.
The modulated infrared beams then enter the infrared detectors, which are double layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure gases (13CO2 or 12CO2, respectively) to be measured.
To so 2- plastni detektorji s prednjo in zadnjo komoro, ki sta napolnjeni z enim od izotopno čistih plinov (13CO2 ali 12CO2), na katerem opravljamo meritve.
12 • Sample Inlet
• Dovod vzorca
This enables measurement of the 13C/12C ratio at any CO2 concentration above 1%.
To omogoča meritev razmerja med 13C in 12C v vseh koncentracijah CO2 nad 1%.
• Specifications for determining 13C/12C-ratios
Specifikacije za določitevrazmerja med 13C in 12C •
• Infrared spectrometers for breath analysis must comply with the following specifications:
Infrardeči spektrometri za analizo izdihanega zraka morajo ustrezati naslednjim specifikacijam:
Minimum of 3 replicate analyses of the same sample during operation
13 Večkratna ponovitev analize: vsaj tri zaporedne analize istega vzorca.
Security access:
Zavarovan dostop:
Storing of operating parameters and of results under security access to avoid later manipulation
shranjevanje merilnih parametrov in rezultatov z varovanim dostopom, da se prepreči poznejše spreminjanje podatkov.
≤ 0.5 ‰ for breath samples varying between 1% and 7% CO2- concentration
0, 5 ‰ za vzorce izdihanega zraka v različnih koncentracijah med 1% in 7% CO2 Stabilnost:
≤ 0.3 ‰ at 10 consecutive pulses ≤ 0.5 ‰ for 13C at natural abundance using a 100 ml breath bag with 3% CO2 breath concentration
0, 3 ‰ pri 10 zaporednih pulzih Natančnost meritev:
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute- value exceeds 4.0 ‰.
0, 5 ‰ pri običajni naravni prisotnosti 13C, z uporabo 100 ml vrečke s 3% CO2 v izdihanem zraku 13 C/ 12C med osnovno vrednostjo in 30- minutno Okužba s Helicobacter pylori je prisotna, če razlika vrednostjo presega 4, 0 ‰.