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User Instruction |
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| Test Procedure |
| The patient should fast four hours prior
to the test. Patient should not have taken antibiotics one month
prior to the test, or active acid inhibitors five days prior
to the test. The patient can normally perform the test without
strict supervision. The entire procedure takes about 20 minutes. |
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CHECK |
1.
Check that the Heliprobe™ instrument is ready to
use, by pressing the startkey. The display shall lit up
showing the text: "Ready to measure". |
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CAPSULE
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2. The patient
swallow a capsule, tablet or solution containing 14C-urea
with approximately 50 ml of water. |
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WAIT 10 MIN.
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3. At the same
time, set the timer to target time according to 14C-urea
supplier recommendation ("peak" time is typically
10 to 30 minutes). |
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OPEN PACK
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4. When the
timer rings, open the BreathCard™ (envelope and
take out the BreathCard™) |
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BLOW
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5. Instruct the patient to
exhale gently into the BreathCard™ mouthpiece. The
patient may remove the BreathCard™ from his/her
mouth in order to speak or breathe normally. Exhaling
must continue until the indicator membrane chages from
orange to yellow. This takes about 1-4 minutes. |
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INSERT
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6. When the indicator has
changed colour, the BreathCard™ is ready for analysis
and shall be inserted into the Heliprobe™ instrument. |
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START
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7. Press the green key on
the analyzer and the BreathCard™ analysis will start.
The result is automatically analyzed and presented on
the display as "Heliprobe™ grade" 0,1
or 2 see below: |
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Heliprobe™ 0 : patient
not infected
Heliprobe™ 1 : borderline (treatment according to
local practice)
Heliprobe™ 2 : patient infected |
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| User Instruction for Heliprobe™ |
| 1. General Description |
| The Heliprobe™ System 2000 is
a diagnostic system for the detection of Helicobacter pylori. |
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| 1.1 The Front Panel |
| The front panel consists of one display,
two diodes (one red and one green/yellow) and four keys (Print,
Start/Stop, Menu, OK). The fuction keys are explained in section
1.2. |
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| The diodes show the status of the Heliprobe™. |
- Constant green light – indicates stand-by-mode.
To activate the Heliprobe™ press any key or insert
a BreathCard™ and the display will light up.
- Intermittent green light – the Heliprobe™
is ready for measurement. Insert a Breath Card™ and
press the
key.
- Intermittent yellow light – the measurement is in
progress. The measurement can be interrupted by pressing
the
key or withdrawing the BreathCard™.
- Constant yellow light – the measurement is complete.
- Confirm the measured values by withdrawing the BreathCard™
or pressing the OK key.
- Constant red light – an internal system error has
occurred. See chapter 4 “Warning and error indication”.
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| 1.2 The Keys |
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PRINTER/COMPUTER ACTIVATE
KEY
Transfer Heliprobe™ data to a printer or a computer.
Can also be used to step parameters “down”
in the loop-to-loop programming set up mode. |
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START/STOP
Indicates or stops the analyzing if the BreathCard™
is inserted. |
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MENU |
| OK |
CONFIRM KEY
By pressing the menu key, a selection of programming possibilities
can be selected. When the menus of choice appears on the
display, presss the confirm key to enter the program to
be changed. Within this program, programming possibilities
again can be selected by using the menu and confirm keys.
Can also be used to step parameters “up” in
the loop-to-loop programming set-up mode. |
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| 1.3 Power Supply |
| Connect the power supply (9V DC, 4W)
to the lower back side of the Heliprobe™. |
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| 1.4 Calibration Card |
| The Calibration Card has the same shapes
as the BreathCard™. The Calibration Card must always be
inserted in the Heliprobe™ when the instrument is not
in use. The Calibration Card is important to ensure correct
background radiation level measurement. |
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| 1.5 Connection of printer or
computer |
| A printer or a computer can be connected
at the back of the unit via a RS232 cable (optional). |
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| 2. Operation |
| 2.1 General |
The first time the Heliprobe™
is installed, or when the Heliprobe™ is moved to an other
location, set-up installation should be performed, in order
to adapt the instrument to the actual background radiation environment.
This setup installation also enables a verification and/or modification
of the programmed parameters for “cut off”, calculations
etc.
Note: Do not forget the Calibration Card during the 1000 seconds
calibration period after setup, if E-prom has been cleared. |
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| 2.2 Setup Installation |
To activate the set up menu:
- Hold the
key while connecting the power supply to the instrument.
The display will show the text:
- Setup menu. Press OK.
- Press “OK.”
(If the “OK” key is not pressed within 40 seconds,
the Heliprobe™ will restart automatically).
Note: The loop-to-loop diagram can be run through by pressing
the
key see (the double edged squares in the diagram). If some
function has to be changed or adjusted, select the function
by pressing OK as shown in the diagram.
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| 2.3 Loop-to-loop
Diagram |
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(To view the
diagram click) |
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| The following keys can also be used
as programming keys in the setup programming mode. |
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= |
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(Increase) |
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= |
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(Decrease) |
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| 2.4 Regular Operation |
| Incase of short power losses and if
the Heliprobe™ has not been moved, the Heliprobe™
can be re-powered without activating the set-up mode. The Heliprobe™
will automatically start a self test showing on the display.
After this automatic internal control, the display will show
“ready to measure” and the Heliprobe™ is then
ready for use.
The Heliprobe™ should always
be switched on, with the Calibration Card inserted when not
in use. |
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| 3. BreathCard™
Reading |
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1. Insert the
BreathCard™ into the Heliprobe™. The display
will show “ready to measure”.
2. Press the key. The standard measurement will last for
250 seconds. |
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3. When the measurement is
completed the Heliprobe™ will emit two beeps and
the result will be presented on the display as a Heliprobe™
grading 0,1 or 2. By pressing the OK key, the numerical
result will be displayed. |
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4. The result will be shown on the display until the measurement
is confirmed by pressing the OK key. The result may be
printed out by pressing the print key, providing a printer
has been connected to the Heliprobe™.
5. By pressing the OK key the display will show the last
measurement result at any time.
6. The Heliprobe™ grading 0,1 or 2 is based on clinical
trials using 1u Curie 14-C-urea. Using the Heliprobe™
standard setup program the corresponding cut-off values,
are shown below.
Heliprobe™ 0 – NOT infected patient.  <25
Heliprobe™ 1 – Borderline case. 25<
<50
Heliprobe™ 2 – Infected patient,
>50
7. Incase that the measurement of the BreathCard™
falls into the Heliprobe™ 1 grade limits, the instrument
automatically re-measures the BreathCard™. If the
second measurement also falls into Heliprobe™ grade
1, a third measurement is proceeded.
After three measurements the instrument calculates a mean
value of all three measurements and a final result is
presented. This situation therefore may require up to
750 seconds to be completed. The mean value is also calculated
after the first re-measurement. |
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| 4. Warning and error
indication |
| The Heliprobe™ has a number of
“indications” implemented in the software to prevent
erroneous readings from contamination, etc. The red diode indicated
that an error has occurred. The type of warning or error will
be displayed, e.g. |
- High background radiation level compared to setup value.
- Unexpected variation in background radiation during the
measurement.
- Damaged sensor.
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| Note: For further information contact
Noster System AB. See the rear page for address. |
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| 5. Maintenance of the
Heliprobe™ |
| The Heliprobe™ may be cleaned
using mild cleaning agents. Running water should be avoided
since there is high voltage in the Heliprobe™. Avoid insertion
of any sharp object into should be carried out by authorized
personnel. |
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| 6. Technical Specification |
| Detector : |
GM-tubes end window
50 mm in diameter mounted face to face. Internal High
voltage, 520V Life time 10E8 pulses |
| Display : |
LCD, 16 position x 2 rows, background
illumination |
| Acoustic indication : |
Beeper |
| Operating Voltage : |
9 V DC (stabilized), External
battery eliminator |
| Power consumption : |
4 W |
| Measuring sensitivity : |
Activity of 25 Bq 14-C enclosed
as during the same condition as in the BreathCard™,
give 1 pulse per second |
| Temperature Range : |
0-50 degree C |
| Humidity : |
RH max 95% |
| Weight : |
4,2 kg |
| Serial output
: |
RS 232, |
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| Protocol |
| Baud rate 9 600 |
| No parity |
| 8 data bits |
| 1 stop bit |
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Cable available from Noster |
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| The Heliprobe™ system 2000 consist
of the following components |
| Article |
Article
No |
| Analyzer |
2000 A |
| Power Supply |
2000 A-PS |
| Connector cable |
2000 A-CC |
| BreathCard™ |
2000 B |
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| All specifications can be subjected
to changes without notice. |
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| 7. Safety Consideration |
| Pharmaceutical
Formula |
Recommended 14 C-urea
doze to be used, is 1µCi, corresponding to a body
exposure of 0.0006 mSi. (This exposure is equivalent to
one half of an hour in an aeroplane. The total exposure
is 250 times less than a mammography). |
| 14C : |
The carbon isotype “14C”
emits low energy b- radiation. |
| BreathCard : |
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| Note : |
- The BreathCard™ contains concentrated Alkaline
that can irritate the respiratory tract.
- Only exhale into the BreathCard™. Do not inhale
while the BreathCard™ is in mouth.
- Do not disassemble the BreathCard™.
- Do not manipulate or ortherwise come into contact
with the absorption area or the colour indicator of
the BreathCard™.
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The BreathCard™ has a limited
shelf-life, see BreathCard™ envelope labeling.
Always put the BreathCard™ back into the envelope
before storing or discarding.
The disposal of the BreathCard™ waste must be handled
according to local regulations. |
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