Transcription:

13 CO 2 Urea Breath Analyzer Infrared Spectrophotometer Instruction Manual

Caution Read the contents of this Instruction Manual carefully in order to use POCone
properly and safely. Keep the Instruction Manual readily available so that they can be
referenced immediately when necessary. This manual is applicable to software
version 0.00

<<<Structure of Instruction Manual>>> This Instruction Manual is comprised of

Chapters 1-12, which explain the following items. Chapter 1 Outline Explanations on
the intended use of and instructions for the POCone Chapter 7 Operating Procedures
Explanations on the four functions of the POCone Chapter 2 Installation Explanations
on procedures and conditions for installation of the POCone Chapter 8 Specifications
for External Communication Explanations on external (on-line) communication
Chapter 3 Structure and Specifications Explanations on the structure and
specifications of the POCone Chapter 9 Replacement of Consumables Explanations
on procedures for replacing consumables Chapter 4 Principle of Measurement
Explanations on the principle of measurement and how results are calculated Chapter
10 Error Displays and Corrective Action Explanations on the content of error displays
and corrective action Chapter 5 Key Operation Methods Explanations on procedures
for key operation Chapter 11 Checking and Maintenance Explanation on checking and
maintenance procedures for the POCone Chapter 6 Preparation for Use Explanations
on preparation procedures from turning on the power to performing measurements
Chapter 12 Consumables and Options Lists of consumables and options

Contents Chapter 1 Outline... 1-1 1.1 Safety-related precautions... 1-1 1.2 Intended
use... 1-2 1.3 Precautions... 1-2 Chapter 2 Installation... 2-1 2.1 Unpacking... 2-1 2.2
Environmental conditions... 2-1 2.4 Installation space... 2-3 2.5 Installing the trapping
cartridge... 2-4 2.6 Connecting the power cable... 2-5 2.7 Fixing sample joints... 2-6
2.8 Inspection after installation... 2-6 2.9 List of accessories... 2-7 Chapter 3 Structure
and Specifications... 3-1 3.1 Name and function of each part... 3-1 3.2 Specifications...
3-3 3.3 Explanation of terminology... 3-5 Chapter 4 Principle of Measurement... 4-1
4.1 Principle of Measurement... 4-1 4.2 Calculation method for 13 CO 2 DOB ( )... 4-
2 Chapter 5 Key Operation Methods... 5-1 5.1 Key operation... 5-1 Chapter 6
Preparation for Use... 6-1 6.1 Checks before use... 6-1 6.2 Self-Diagnosis... 6-1 6.3
Warm-up and Self-Diagnosis... 6-2 6.4 Measurement Screen... 6-4 6.5 Turning off the
power... 6-4

Chapter 7 Operating Procedures... 7-1 7.1 Measurement... 7-3 7.1.1 Attaching breath
collection bags and measurement... 7-3 7.1.2 Displays during measurement... 7-4 7.1.3
Example of printout... 7-7 7.2 Setting the internal clock..7-8 7.3 System condition... 7-
9 7.3.1 Setting printer paper feed... 7-10 7.3.2 Setting the number of printouts of
measurment results... 7-11 7.3.3 Setting RS-232C condition (set-up of communication
parameters)... 7-12 7.3.4 Setting USB condition (set-up of communication
parameters)... 7-13 7.4 Data output... 7-15 7.4.1 Selection of output destination... 7-16
7.4.2 Retrieval and output of patient data by date of measurement... 7-17 7.4.3
Retrieval and output of patient data by patient ID... 7-18 7.4.4 Retrieval and output by
order of measurement... 7-19 7.4.5 Retrieval and output of QC data of
measurement...7-22 7.5 Reproducibility... 7-23 7.6 Maintenance... 7-25 7.6.1 Self-
Diagnosis... 7-27 7.6.2 Trapping cartridge check... 7-28 7.6.3 Inetnsity check... 7-29
7.6.4 Temperature check... 7-30 7.6.5 Syringe check... 7-31 7.6.6 Chopper check... 7-
32 7.6.7 Printer check... 7-33 7.6.8 Leakage check... 7-34 7.6.9 Sheetkey check... 7-35
7.6.10 Power ON hours check... 7-36 7.6.11 Measured times check... 7-37 7.6.12
Pressure check... 7-38 Chapter 8 Specifications for External Communication... 8-1 8.1
Outline... 8-1 8.2 Hardware specifications... 8-2 8.2.1 Connector... 8-2 8.2.2
Transmission system... 8-2 8.2.3 Signal input interface... 8-2

(1) Terminal No. and signal type... 8-2 (2) Pin configuration (cross cable)... 8-3 8.3
Message specifications... 8-3 8.3.1 Message types... 8-3 8.3.2 Message format... 8-4
8.4 Transmission method - Communication protocol... 8-6 8.4.1 Transmission without
flow control... 8-6 8.4.2 Transmission with flow control... 8-7 (1) Data text format...
8-7 (2) Communication procedures... 8-8 Chapter 9 Replacement of Consumables... 9-
1 9.1 Changing the printer paper... 9-1 9.2 Changing the O-rings... 9-4 9.3 Changing
the fuses... 9-6 9.4 Changing the trapping cartridge... 9-8 Chapter 10 Error Displays
and Corrective Action... 10-1 10.1 Error messages... 10-1 Error 1 Syringe motor
error... 10-1 Error 2 Chopper motor error... 10-2 Error 3 Intensity error... 10-3 Error 4
Warm up failed... 10-5 Error 5 Valve check error... 10-7 Error 6 Pressure calibration
error... 10-8 Error 7 Valve leak error... 10-9 Error 8 Electrical failure... 10-10 10.2
Warning messages... 10-11 Warning 1-1 Intensity is not stable... 10-11 Warning 1-2
Intensity is too low... 10-11 Warning 1-3 Intensity is too high... 10-11 Warning 2-1
Detector temperature is not stable... 10-12 Warning 2-2 Detector temperature is low
[##.#]... 10-12 Warning 2-3 Detector temperature is high[##.#]... 10-13 Warning 3-1
Cell temperature is not stable... 10-14 Warning 3-2 Cell temperature is low[##.#]...
10-14 Warning 3-3 Cell temperature is high[##.#]... 10-15 10.3 Caution messages...
10-16 Caution 1-1 Paper end... 10-16

Caution 1-2 Printer cover open... 10-16 Caution 2 Battery life(set clock DATE &
TIME)... 10-16 Caution 3-1 Change trapping cartridge... 10-17 Caution 3-2 Prepare
for trapping cartridge... 10-17 Caution 4-1 CO2 conc. is too low(<0.5%)... 10-18
Caution 4-2 CO2 conc. is low(<1%)... 10-18 Caution 5 Check setting of sample bag...
10-19 Caution 6 Time for O-rings has expired... 10-19 Caution 7-1 RS-232C/USB
initialize failed... 10-20 Caution 7-2 RS-232C/USB Over flow... 10-20 Caution 7-3
RS-232C/USB data bit error... 10-21 Caution 7-4 RS-232C/USB parity error... 10-21
Caution 7-5 RS-232C/USB incorrect data... 10-22 Caution 7-6 RS-232C/USB
incorrect ENQ... 10-22 Caution 7-7 RS-232C/USB incorrect ACK... 10-23 Caution 7-
8 RS-232C/USB incorrect EOT... 10-23 Caution 7-9 RS-232C/USB send data error...
10-24 Caution 7-10 RS232C/USB recv. Data error... 10-24 Chapter 11 Checking and
Maintenance... 11-1 11.1 Checks before use... 11-1 11.2 Checks during and after use...
11-3 11.3 Simple maintenance... 11-4 11.4 Waste disposal... 11-4 Chapter 12
Consumables and Options... 12-1 12.1 Consumables... 12-1 12.2 Options... 12-1

Chapter 1 Outline... 1-1 1.1 Safety-related precautions... 1-1 1.2 Intended use... 1-2
1.3 Precautions... 1-2 1

Chapter 1 Outline 1.1 Safety-related precautions Symbols The following symbols are
used in this Instruction Manual and on parts of the POCone in order to ensure safe
use. Accidents that may arise from incorrect operation due to ignoring these symbols
are classified as follows. Memorize the meanings of these symbols before reading this
manual. Warning Refers to an item potentially causing death or serious injury.
Caution Refers to an item potentially causing injury or property loss. Note Refers to
an item related to the correct use of the POCone and its accessories. 1-1

1.2 Intended use The POCone is an infrared spectrophotometer for in vitro diagnostic
purpose which uses infrared spectroscopic method to measure changes in 13 CO 2
content in breath ( 13 CO 2 DOB). 1.3 Precautions Caution Follow with care! Because
the POCone is a precision instrument, read the following precautions carefully before
use. Failure to follow these precautions may result in equipment failure or may cause
accidents such as fire and electric shock. (1) Do not use the POCone unless you have
been trained to do so.(people without specialized knowledge of the POCone are
prohibited from using it in the absence of an expert.) (2) Be sure to meet the following
conditions when installing the POCone Install in a place away from water. Install in a
place free from negative influences related to atmospheric pressure, temperature,
humidity, ventilation, sunlight, dust, salty or sulfurous air, etc. Do not install in a
place with risk of radio interference or electric power supply problems. Keep machine
stable regarding slopes, vibration and shock (including during shipping). Do not
install in a place where chemicals are stored or gas is emitted. Install in a place free
from strong magnetic and electric or x-ray fields. Pay attention to the frequency and
voltage of power and the allowable current (or consumed electricity). Be sure to
ground the unit properly. Take into account the following conditions when installing
the POCone. Installation site: Indoors (away from direct sunlight) Ambient
temperature: 15-30 C (free from rapid temperature change) (3) Before using the
POCone: Ventilation fan should not be blocked nor covered. Check that all the cords
and grounded are connected correctly. Check that the Trapping cartridge are
connected correctly. 1-2
(4) After using the POCone: Turn off the power by following the proper procedures.
When detaching cords, do not pull or force in any way. When storing the POCone:
Store away from water. Install in a place free from negative influences related to
atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, salty or
sulfurous air, etc. Keep machine stable as regards slopes, vibration and shock
(including during shipping). Do not store in a place where chemicals are stored or gas
is emitted. Store in a place free from strong magnetic and electric x-ray fields. Clean
accessories and cords, and store together. Keep the system clean so as not to interfere
with subsequent use. (5) Recommendable storage and transportation conditions. The
device should be stored under the condition that won t be affected adversely by
temperature, humidity, wind, dust, salt, sulfur, vibration, water, etc. Also, inclination,
vibration and shock should be avoided when the device is being transported. Below
are the recommendable storage and transportation condition. Ambient temperature: -
20~70 C Relative humidity: 10~100%(no condensation) (6) Do not use a machine,
when it is out of order including a functional stop. Contact the nearest distributor. (7)
If the equipment is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired. (8) There is no possibility of the
biohazard by the trapping cartridge. (9) Do not modify the machine. (10) Check the
POCone and its parts yearly. (11) When using the POCone after a prolonged period of
disuse, check before use that the machine is functioning normally and safely. 1-3

Chapter 2 Installation... 2-1 2.1 Unpacking... 2-1 2.2 Environmental conditions... 2-1
2.4 Installation space... 2-3 2.5 Installing the trapping cartridge... 2-4 2.6 Connecting
the power cable... 2-5 2.7 Fixing sample joints... 2-6 2.8 Inspection after installation...
2-6 2.9 List of accessories... 2-7 2 1-4

Chapter 2 Installation 2.1 Unpacking After unpacking the unit, check the amount,
contents and outer appearance for damage, against 2.9 List of Accessories (p. 2-7). In
the event of missing or damaged accessories, contact an authorized dealer. 2.2
Environmental conditions Note When installed near windows, the POCone may not
function normally due to differences in temperature. Especially during winter or
summer, the temperature near a window may differ greatly from ambient room
temperature. Please install machine as far away from windows as possible. Install in
an environment that meets the following conditions to ensure that the POCone
performs properly. Installation site: Indoors (protected from direct sunlight) Ambient
temperature: 15-30 C (free from rapid temperature change) Relative humidity: 30-
80% (no possibility of condensation) Atmospheric pressure conditions:75-106kpa (
No pressure change ) Environment: little or no dust, no corrosive atmosphere, good
ventilation Vibration: none Do no install near the outlet port of an air conditioner.
Altitude:2000m 2-1
2.3 Power supply Warning Use the correct grounding conductor to avoid electric
shocks and electronic circuit noise in the event of a short circuit. Use a grounding
conductor with a ground resistance of not more than 100 Ω to guard against a short
circuit accident. Do not connect the grounding conductor to a gas pipe. When the
grounding conductor is grounded or detached, be sure to disconnect the power cable
from the outlet. Check that the following electric power supply conditions are met for
the POCone. (1) The POCone can be used in a power voltage range of 120V±10%. (2)
Secure a power supply capacity with sufficient margin for the following values. Main
unit of the POCone Power: Frequency: Power consumption: AC120 V 60 Hz 200 VA
2-2

2.4 Installation space Note Install the POCone with a space of not less than 10 cm
around the system (not less than 15 cm when installed near a window). Do not install
in a place exposed to direct sunlight or near the outlet port of an air conditioner. A
space of approximately 20 cm is necessary in front of the system in order to allow the
breath collection bag to be attached. The dimensions of the POCone are as follows.
POCone main unit Width: 220 mm Height: 272 mm Depth: 361 mm Special
UBiT/POCone breath collection bag Width: 110 mm Depth: 170 mm Height Width
Depth 2-3

2.5 Installing the trapping cartridge See below for how to install the trapping cartridge
accessories. Trapping cartridge Completed installation 2-4

2.6 Connecting the power cable Note To prevent risk of electric shock when
connecting the power cable, insert the cable into the outlet after checking that the
power switch is in the off position (switch turned to 0). Connect the power cable as
shown below. Power cable Turn the power switch to the off position (switch to 0). 2-5

2.7 Fixing sample joints Push the sample joints into the two holes in front of system
until the joints snap into place. 2.8 Inspection after installation After installation is
complete, refer to section 6.2 Self-Diagnosis, (p. 6-1) and 6.3 Warm-up and Self-
Diagnosis, (p. 6-2). Check that there are no problems with the Self-Diagnosis
function. 2-6

2.9 List of accessories (1) Cartridge adapter... 1 (2) Trapping cartridge (consumable)...
1 (3) Sample joints... 2 (4) Printer paper (consumable)... 2 (5) O-rings (Orange &
black color, consumable)... 4/ea. (6) Power cable... 1 (7) Spare fuse (4A,
consumable)... 2 (8) Y-shape joint (for checking system performance)... 1 (9) Breath
collection bags (5 L) (for checking system performance)... 2 (10) Instruction Manual...
1 (11) Quick Manual... 1 2-7
Chapter 3 Structure and Specifications... 3-1 3.1 Name and function of each part... 3-1
3.2 Specifications... 3-3 3.3 Explanation of terminology... 3-5 3 3-1

Chapter 3 Structure and Specifications 3.1 Name and function of each part The name
and function of each part shown in Figure 3-1 are as follows. 1) Power switch: Turns
power on or off. 2) Operating switch panel: Panel on which key operations are
performed. 3) LCD panel: Displays the current operation and the current status of the
system. 4) Printer: Prints the data and comments. 5) Sample joint: Joint to attach the
reference gas (reference breath gas) (BASELINE) bag. 6) Sample joint: Joint to attach
the sample gas (sample breath gas) bag. (SAMPLE) 7) Sample LED: Displays the
measurement status of the reference gas (BASELINE) (reference breath gas).
(Preparing for measurement: light on, during measurement: flashing, completion of
measurement: light off) 8) Sample LED: Displays the measurement status of the
sample gas (SAMPLE) (sample breath gas). (Preparing for measurement: light on,
during measurement: flashing, completion of measurement: light off) 9) Error LED:
Flashes when an abnormality of the system or the sample is detected. 10) Power
indicator: Displays the status of power (on: light on, off: light off) 11) Power cord
connector: Site where the power cable is connected. 12) Exhaust port: The exhaust
port of breath gas and air. 13) Trapping cartridge: Absorbs CO 2 gas in the air supply.
14) Cartridge adapter: Trapping cartridge connecting adapter. 15) Cartridge adapter
Piping port for the Cartridge adapter tube. piping port : 16) Bar code reader-
connecting The terminal to connect the cable of bar code reader terminal: (option). 17)
Light source cooling fan: Cools heat of the light source. 18) Detector cooling fan:
Cools heat of the cooling element. 19) External output-connection The connecting
terminal for the host PC, etc. terminal(usb,rs-232c ): 20) Cell pressure monitor:
Displays the value of cell pressure 21) Calendar panel: Displays date and time. 22)
Power unit cooling fan: Cools heat of the Power unit. 23) Cartridge holder: Holder for
the trapping cartridge. 3-1

Figure 3-1 Name of each part <Front> 9) Error LED 4) Printer 3) LCD panel 2)
Operating switch panel 5) Sample joint (BASELINE) 6) Sample joint (SAMPLE) 10)
Power indicator 21) Calendar panel 17) Light source cooling fan <Back> 8) Sample
LED (SAMPLE) 7) Sample LED (BASELINE) 20) Cell pressure monitor 19)
External output-connection terminal(usb,rs-232c) 16) Bar code reader-connection
terminal 18) Detector cooling fan 12) Exhaust port 14) Cartridge adapter 1) Power
switch 23) Cartridge holder 13) Trapping cartridge 15) Cartridge adapter piping port
11) Power cord connector 22) Control unit cooling fan 3-2

3.2 Specifications (1) Main unit Power: Power consumption: Dimensions: Weight: (2)
Measuring Measuring system: Light source: Chopper: Measuring cell Material: Cell
window material: Detector: AC 120V, 60 Hz 200 VA 220 mm wide, 361 mm deep,
272 mm high. Approximately 10 kg Interference filter method Ceramic heater
Stepping motor-driven Aluminum Sapphire Infrared detection element (3)
Input/output Display: LCD (40 characters x 2 lines) Operation keys: Number &
Alphabet keys (0-9,A-Z) Function keys (9 types) Operating system: Dialogue-type
operation Printer: Thermal printer Printer paper: Thermal paper, 60 mm(w)x 25 m(l)
External output terminal: USB & RS-232C Bar code reader terminal: Bar code reader
(option) Calendar : Month, date, time and count-down of 15 minutes Timer precision :
Within±60sec/month (4) Performance Reproducibility*: Standard deviation Not more
than 0.3 (Condition: 10 times measurement of DOB 0 standard gas with 3% CO 2
concentration) Precision*: Within ± 0.3 (Condition: Average value of 10 times
measurement using DOB 2 standard gas with 3% CO 2 concentration) CO 2
concentration range Not less than 0.5% to be measured: Necessary sample amount:
Not less than 120 ml/bag Sample injection: Automated injection Measuring time:
Approximately 2 minutes (when measuring 2 bags for 1 sample). The measuring time
varies according to the CO 2 concentration in sample. *10 times measurement of the
standard gas with CO 2 concentration of 1% or higher. 3-3

(5) Warm-up time: 10 minutes The warm-up time may be automatically prolonged up
to a maximum of 30 minutes depending on installation environment (temperature). (6)
Optical system (7) V6 (5) (3) (2) (4) V2 V4 V1 (1) V3 V5 (6) (1) Syringe: Injects
proper amount of sample into cell. (2) 12 CO 2 cell: Measures absorption of 12 CO 2.
(3) 13 CO 2 cell: Measures absorption of 13 CO 2. (4) Compensation cell:
Compensates for the length of the 12 CO 2 and 13 CO 2 cells. (5) Chopper: A
revolving plate that effects bright/dark changes to the detector at a set velocity. (6)
Trapping cartridge: Absorbs CO 2 in the air supply. (7) Pressure sensor: Displays the
value of cell pressure (8) Electromagnetic valves The valves to switch among fluid
circuits for sample, reference (V1-6): air, and cleaning air, etc. 3-4

(7) Protection against electric shock Type: Class-I Over-voltage category:Ⅱ Pollution
degree:2 (8) MISC On the device, you find the following symbol. 02/2005
Manufacture The numeric in digits is year of production. Dispose of chemical waste.
<Note> You may find label inside the device. 3.3 Explanation of terminology
(permil): per mil. DOB (Delta Over Baseline): difference in change of 13 CO 2. S.D.
(Standard Deviation): standard deviation. C.V. (Coefficient of Variation): coefficient
of variation (%). 3-5

Chapter 4 Principle of Measurement... 4-1 4.1 Principle of Measurement... 4-1 4.2

Calculation method for 13 CO 2 DOB ( )... 4-2 4 3-6

Chapter 4 Principle of Measurement 4.1 Principle of Measurement 12 CO 2 and 13

CO 2 each have their own characteristic absorption wavelength in the infrared region.
The POCone measures absorption of breath gas by utilizing the difference in the
characteristic absorption wavelength, and obtains the change in the 13 CO 2 DOB( )
by calculating the ratios of 13 CO 2 / 12 CO 2 for the reference gas and for the sample
gas, and calculating the difference in the ratio of 13 CO 2 / 12 CO 2. Interference
filter Absorption spectra 12 CO 2 and 13 CO 2 for 12 CO 2 Interference filter
Absorbance for 13 CO 2 2400 2300 2200 Wave-number(cm -1 ) 4-1

4.2 Calculation method for 13 CO 2 DOB ( ) Obtaining the abundance ratio of 13 CO

2 for the reference gas and the sample gas. Abundance ratio of 13 CO 2 in the
reference gas = 13 CO 2 concentration in the reference gas 12 CO 2 concentration in
the reference gas Abundance ratio of 13 CO 2 in the sample gas = 13 CO 2
concentration in the sample gas 12 CO 2 concentration in the sample gas Obtaining δ
13 CO 2. δ 13 CO 2 in the reference gas = Abundance ratio of 13 CO 2 in the
reference gas - Abundance ratio of 13 CO 2 in the standard substance Abundance ratio
of 13 CO 2 in the standard substance δ 13 CO 2 in the sample gas Abundance ratio of
13 CO 2 in the sample gas - Abundance ratio of 13 CO 2 in the standard substance =
Abundance ratio of 13 CO 2 in the standard substance * Abundance ratio of 13 CO 2
in the standard substance: The value measured by using PEE DEE Belemnite, which
is commonly used as the standard substance to measure the natural abundance ratio of
13 CO 2. Abundance ratio of 13 CO 2 in PEE DEE Belemnite = 0.0112372 Obtaining
13 CO 2 DOB ( ) from δ 13 CO 2 13 CO 2 DOB ( )= δ 13 CO 2 in the sample gas - δ
13 CO 2 in the reference gas * Reference gas: Breath gas in the sample bag attached
to S1 Sample gas: Breath gas in the sample bag attached to S2 4-2

Chapter 5 Key Operation Methods... 5-1 5.1 Key operation... 5-1 5

Chapter 5 Key Operation Methods 5.1 Key operation Push the keys firmly and one at
a time. Each key beeps when pushed. The location, name and function of each key are
explained below. Name LCD panel key NO key ENTER key CLEAR key Number
key TIMER key PAPER FEED key SHIFT key key key Main function Liquid crystal
display. Displays information. Selects Yes for an item. Selects No for an item. Enters
input when inputting numerical values and Sample IDs. Erases input content when
inputting numerical values and Sample IDs. Used when inputting numerical values
and Sample IDs. Count-down of 15 minutes Calendar display when pressed for 3sec.
or longer. Feeds paper through the printer. This key can be used regardless of display,
as long as the power is on. Switch to English text Move onto next. Move cursor for
text input. Go back to pervious menu. Move cursor for text input. 5-1

The basic key operations are categorized roughly into the following three types. (1)
/NO alternative (2) Input of numerical values (3) Selection from multiple items
(Selection from the parameters previously held in the system) (1) /NO Alternative In
the following screen, push or NO. Other keys will not be accepted. 1. H.Pylori? [ / NO
] Push the Push the NO key to set the item displayed on the screen. key to cancel an
item and move on to the next item. (2) Input of numerical values In the following
screen, input numerical values with the number keys and enter by pushing the ENTER
key. Push the CLEAR key to clear any mistakes in input and then input the values
again. The key and NO key will not be accepted. Input patient ID! [ ] When the
display appears as [ ] and the inside of the square brackets is blank, input in the [ ]
field. Input Year [ 2003 ] When the display appears as [####] and the inside is a
numerical value, input in the [####] field. 5-2

(3) Selection from multiple items In the following screen, push the key or NO key.
Other keys will not be accepted. Baud Rate [ ] : Select [NO] : Change [ 9600] When
not altering the number in [9600], push the key. Push the NO key when making an
alteration. Push the NO key in this screen to get to the screens below. Baud Rate [ ] :
Select [NO] : Change [ 9600] NO Baud Rate [ ] : Select [NO] : Change [ 1200] Push
the Push the NO key to scroll the number in [####] and alter from push to push. key
to select the displayed content. (4) Input of Alphabet strings In the following screen,
input alphabet strings with the number keys and enter by pushing the ENTER key.
Push the CLEAR key to clear any mistakes in input and then input the values again.
The key and NO key will not be accepted. Input patient ID! [ ] When the display
appears as [ ] and the inside of the square brackets is blank, input in the [ ] field. 5-3

Chapter 6 Preparation for Use... 6-1 6.1 Checks before use... 6-1 6.2 Self-Diagnosis...
6-1 6.3 Warm-up and Self-Diagnosis... 6-2 6.4 Measurement Screen... 6-4 6.5 Turning
off the power... 6-4 6

Chapter 6 Preparation for Use 6.1 Checks before use (1) Check power cable. Connect
the power cable after making sure the power is turned off. (2) Check printer paper. If
the paper supply is low or empty, please see 9.1 Changing the printer paper (p. 9-1).
6.2 Self-Diagnosis When the power is switched on, the POCone automatically
conducts a Self-Diagnosis. When an error is detected during the Self-Diagnosis, a
message appears in the LCD with an audio warning. In this case, please see section
Chapter 10 Error Displays and Corrective Action for an explanation of the error
content. The Self-Diagnosis evaluates the following functions. (1) Printer status (2)
Timer battery level (3) Key panel (4) LCD panel (5) LED operation (6) Valve
operation (7) Syringe operation (8) Chopper operation (9) Warning beep The
processes (1), (3), (4), (5)and (9) above require confirmation by the operator. During
the Self-Diagnosis after turning on the power switch, the operator must wait with the
POCone in order to make these confirmations. The Self-Diagnosis takes
approximately 2 minutes. If no abnormalities are detected during the Self-Diagnosis,
the following message is printed and the system automatically enters the warm-up
state. Example of printout Printer check -------------------- Version 1.000 ----------------
---- Serial 0001 -------------------- Date 2003-Oct-01 Time 10:00 -------------------- ------
-------------- *END 10:01 V1.000 6-1
6.3 Warm-up and Self-Diagnosis Note Because ambient temperature may deviate
greatly in summer and winter, the system may require 30 minutes to stabilize when
turned on after being left off overnight. If expecting extreme temperatures, stabilize
the temperature by using heating or air conditioning before turning on the power.
Warm-up screen Displays time remaining for warm-up. Warm up!! Wait 10 min.
After completing the Self-Diagnosis, the system automatically enters the warm-up
period. This period lasts for 10 minutes after turning on the power switch, and is
required for correct measurement. 7 minutes after starting the warm-up, the system
automatically starts a Self-Diagnosis. The Self-Diagnosis evaluates the system status
of the following 5 items: (1) Intensity and stability of light source. (2) Temperature
and stability of detection element and measurement cell. (3) Sample volume injected
into cell. (4) Cell pressure and leakage test. (5) CO 2 gas-absorption capacity of
trapping cartridge. 6-2

If an error is detected during the Self-Diagnosis in either (1) or (2) above, the
instrument judges that the warm-up time was insufficient. Insufficient warm-up is
displayed as a warning message in the LED for 3 seconds and the warm-up period is
automatically extended for 5 minutes. The warm-up period may be prolonged a
maximum 4 times (20 minutes). If this error is not corrected and the system is not
stabilized even after an automatic 20-minute extension of the warm-up period, the
LCD displays the following message. Refer to Chapter 10 Error Displays and
Corrective Action (p. 10-5) to check system status. Error 4 : OFF [CLEAR] Beep If
the absorption capacity of the trapping cartridge is judged to be low in Self-Diagnosis,
replace the cartridge according to the directions in 9.4 Changing the trapping cartridge
(p. 9-8). Caution 3-1 : Change [] If the Self-Diagnosis completes all checks and no
abnormalities appear in the system, the message in 6.4 Measurement Screen (p. 6-4)
appears. 6-3

6.4 Measurement Screen The Measurement Screen appears when the warm-up and
Self-Diagnosis are completed. See Chapter 7 Operating Procedures for details on
operating procedures. 1. H.Pylori? [ / NO ] 6.5 Turning off the power Note Never turn
off the power during measurement of a sample or data transmission via external
communication. Return the LCD display to the Measurement Screen before turning
off power. 1. H.Pylori? [ / NO ] 6-4

Chapter7 Operating Procedures 7-1 7.1 Measurement... 7-3 7.1.1 Attaching breath
collection bags and measurement... 7-3 7.1.2 Displays during measurement... 7-6 7.1.3
Example of printout... 7-7 7.2 Setting the internal clock... 7-8 7.3 System condition..7-
9 7.3.1 Setting printer paper feed... 7-10 7.3.2 Setting the number of printouts of
measurment results... 7-11 7.3.3 Setting RS-232C condition (set-up of communication
parameters)... 7-11 7.3.4 Setting USB condition (set-up of communication
parameters)... 7-13 7.4 Data output... 7-15 7.4.1 Selection of output destination... 7-16
7.4.2 Retrieval and output of patient data by date of measurement... 7-17 7.4.3
Retrieval and output of patient data by patient ID... 7-18 7.4.4 Retrieval and output by
order of measurement... 7-19 7.4.5 Retrieval and output of QC data by date of
measurement... 7-22 7.5 Reproducibility... 7-23 7.6 Maintenance... 7-25 7.6.1 Self-
Diagnosis... 7-27 7.6.2 Trapping cartridge check... 7-28 7.6.3 Light intensity check...
7-29 7.6.4 Temperature check... 7-30 7.6.5 Syringe check... 7-31 7.6.6 Chopper
check... 7-32 7.6.7 Printer check... 7-33 7.6.8 Leakage check... 7-34 7.6.9 Sheet key
check... 7-35 7.6.10 Power on hours check... 7-36 7.6.11 Measuered times check... 7-
37 7.6.12 Pressure check... 7-38 7

Chapter 7 Operating Procedures This software has the following structure. Turning on
the power Self-Diagnosis, Warm-up and Self-Diagnosis 1. H.Pylori? Measurement 2.
Set calendar? 3.System condition? Setting calendar Setting the system 3-1. Set paper
feeds? 3-2. Set number of copies? 3-3. Set RS-232C condition? 3-4. Set USB
condition? 4. Data output? Data output 4-1. Output port select? 4-2. Output patient
data < DATE >? 4-3. Output patient data < Patient ID>? 4-4. Output patient data
<DATA No.>? 4-5. Output QC data < DATE >? To next page, 5. Reproducibility 7-1

5. Reproducibility? Reproducibility test 6. Maintenance? Maintenance 6-1. Self-

check? 6-2. Trapping cartridge check? 6-3. Intensity check? 6-4. Temperature check?
6-5. Syringe check? 6-6. Chopper check? 6-7. Printer check? 6-8. Leakage check? 6-
9. Sheet key check? 6-10. Power ON hours check? 6-11. Measured times check? 6-12.
Pressure check? 7-2

7.1 Measurement 7.1.1 Attaching breath collection bags and measurement Attaching
breath collection bags Pre-dose patient sample collection bag (baseline sample) Post-
dose patient ample breath collection bag As shown in the above figure, insert the
breath collection bag for the pre-dose patient sample firmly to Baseline Joint and the
breath collection bag for post-dose patient sample to Sample Joint, (Insert the breath
collection bag until the black O-ring is no longer visible.) Improper insertion of the
breath collection bag will cause outside air to contaminate the sample and prevent
accurate measurement. Black O-ring Orange O-ring 7-3

When the Warming-up and Self Inspection were completed, the following
Measurement screen appears. Please press key if QC sample needs to be measured
prior to routine measurements. If not necessary, please press NO key and confirm no
use of QC sample. 1 H.pylori? [ / NO] NO To 2.Set calendar Please run QC sample? [
/ NO] NO NO Measurement without QC sample? [ / NO] NO Set QC sample? [ / NO]
Measurement Printing Continue QC sample? [ / NO] NO Input patient ID! [418-731 ]
After inputting ID, push ENTER, CLEAR or input bar code(note 1) Input ID of 15
letters or less. You can input also from the bar code reader(option) Set patient Sample
[ 418-731] [/ NO / CLEAR] Continued on next page 7-4 To 1.H.Pylori? The ID you
have input is displayed for Confirmation. This is to confirm whether the breath-
collecting bag is attached. After confirming it is attached, push key.

Measurement Printing Continue Patient sample? [ / NO] When you continue

measurement, push key, and when you terminate. Measurement, push NO key. When
you measure the next breath sample, confirm that the next sample is set correctly and
Push key. When you select NO key, the scope returns to the initial Measurement
screen. (Note1) When you do not input Sample ID, push only ENTER key. The bar
codes usable in the bar code reader(option)are NW-7, ITF and CODE-39. When you
wish to after the Sample ID, Push CLEAR key 7-5

7.1.2 Displays during measurement LCD Patient ID appears here. Measurement status
flashes on LCD Flash position 1 2 3 4 5 6 7 8 9 CO 2 concentration measurement 13
CO 2 Δ ( ) measurement Flash positions 1, 3 2, 4 5, 7, 9 6, 8 Content of measurements
Reference measurement Sample measurement Reference measurement Sample
measurement LED Baseline Sample Content Starting measurement (Reference
measurement) Measuring Baseline (CO 2 concentration measurement) Measuring
Sample (CO 2 concentration measurement) * Measuring Baseline ( 13 CO 2 Δ ( )
measurement) * Measuring Sample ( 13 CO 2 Δ ( ) measurement) Completing
measurement : Light on, : Flashing, : Light off *: Measurement of 13 CO 2 Δ ( ) starts
from the sample with a lower CO 2 concentration according to the CO 2
concentrations measured in the concentration measurement. 7-6

7.1.3 Example of printout OTSUKA ELECTRONICS POCone Serial 00001 Date

2003-Nov-05 Time 09:15 Cut off Δ ( ) 2.4 Start Intensity 13C 6000000 12C 6025610
R 0.9806 Serial No. of the system Date of measurements Cut-off value (POSITIVE if
above 2.4 ) Initial reference light intensity November 5,2008 4:00 p.m. ID.481-1
Patient name Sample ID (ID input by key operation or ID read by bar code reader) S.1
(3.6%) S.2 (3.0%) DOB 2.3 INTERP. : NEGATIVE CO 2 concentration S1: CO 2
concentration of base-line S2: CO 2 concentration of patient sample Measurement
result: 13 CO 2 DOB ( ) End intensity 13C 6021217 12C 6030102 R 0.9933 *END
16:01 V0.400 Software version 7-7

7.2 Setting the internal clock Push the key in the following screen to set date and time.
Setting procedures are as follows: The current settings are displayed in each screen.
Use the number keys to input new settings. When no changes are necessary, simply
push the ENTER key to continue. 2. Set calendar? [ / NO ] NO To 3. System
condition Input Year (2004 2099) [2003] Year settings (range 2004-2099) Input
Month (1 12) [11] ENTER Input Day (1 31) [01] ENTER ENTER Input Hours ( 24H)
(0 23) [10] Input time by 24-hour clock. Input Minutes (0 59) [00] ENTER ENTER
After completing the setting, go to 3. System condition 7-8
7.3 System condition When the NO key is pushed in the Measurement Screen, the
following System Condition setting screen appears. 3. System condition [ / NO ] NO
To 4. Data Output Push the key in this screen to set the following items. (1) Printer
paper feed (2) Number of copies of printouts of measurement results (3)
Communication parameters for RS-232C (4) Communication parameters for USB
Each item has the following structure. 3-1. Set paper feed? [ / NO ] Setting the paper
feed for printing NO 3-3. Set number of copies? [ / NO ] Setting number of copies of
printouts of measurement results NO 3-3. Set RS-232C condition? [ / NO ] Setting the
communication Parameters for RS-232C NO 3-4. Set USB condition? [ / NO ] Setting
the communication Parameters for USB NO To 1. H.pylori 7-9

7.3.1 Setting printer paper feed Push the key in the following screen to set the paper
feed for printouts of measurement results. The setting Procedure is as follows: 3-1. Set
paper feeds? [ / NO ] NO To Set number of copies Input number of line for paper
feed. (0 10) [ 1] Initial value is set at 1. ENTER Input range is 0-10. After completing
the setting, go to 3-2 Set number of copies Example) Printout with the number of lines
for paper feed set at 3: November 5,2008 4:00 p.m. ID.481-2 Patient name S.1 (3.6)
S.2 (3.0) Δ 2.3 INTERP. : NEGATIVE November 5,2008 4:08 p.m. ID.481-3 Patient
name Three lines between measurements results S.1 (3.6) S.2 (3.0) Δ 2.0 INTERP. :
NEGATIVE 7-10

7.3.2 Setting the number of printouts of measurement results Push the key in the
following screen to set the paper feed for printouts of measurement results. The
setting Procedure is as follows: 3-2. Set number of copies? [ / NO ] NO To 3-3 Set
RS-232C condition Input copy number (1 10) [ 2] Initial value is set at 1. ENTER
Input range is 1-10. After completing the setting, go to 3-3 Set RS-232C condition
Example) Printout of measurement results with number of copies set at 2: November
5,2008 4:00 p.m. ID.481-2 Patient name S.1 (3.6) S.2 (3.0) Δ 2.3 INTERP. :
NEGATIVE Same data are printed 2 times. November 5,2008 4:00 p.m. ID.481-2
Patient name S.1 (3.6) S.2 (3.0) Δ 2.3 INTERP. : NEGATIVE 7-11

7.3.3 Setting RS-232C condition (set-up of communication parameters) The

communication conditions for the RS-232C must be set when incorporating
measurement data from the POCone into the host computer. Push the key in the
following screen to set the communication conditions for the RS-232C. The setting
procedures are as follows: 3-3. Set RS-232C condition? [ / NO ] NO To 3-4 Set USB
condition Current settings are displayed in each screen. Use the key to enter values.
NO key to edit values and the Baud Rate []:Select [NO]:Change [9600] Baud Rate
setting 1200/2400/4800/9600 Data Bit []:Select [NO]:Change [Bit8] Data Bit setting
Bit7/Bit8 Parity []:Select [NO]:Change [None] Parity setting None/Odd/Even Stop Bit
[]:Select [NO]:Change [Bit1] Stop Bit setting Bit1/Bit2 Return Code []:Select
[NO]:Change [CR ] Return Code setting CR/LF/CRLF Handshake []:Select
[NO]:Change [NO ] Handshake setting : Set NO: No setting Continued on next page
7-12

Meas. End Data Send []:Select [NO]:Change [ NO ] Measure End Data Send setting :
Set NO: No setting To 3-4.Set USB condition 7.3.4 Setting USB condition (set-up of
communication parameters) The communication conditions for the USB must be set
when incorporating measurement data from the POCone into the host computer. Push
the key in the following screen to set the communication conditions for the USB. The
setting procedures are as follows: 3-4. Set USB condition? [ / NO ] NO To 1. H.Pylori
Current settings are displayed in each screen. Use the key to enter values. Baud Rate
[]:Select [NO]:Change [9600] NO key to edit values and the Data Bit []:Select
[NO]:Change [Bit8] Data Bit setting Bit7/Bit8 Continued on next page 7-13

Parity []:Select [NO]:Change [None] Parity setting None/Odd/Even Stop Bit []:Select
[NO]:Change [Bit1] Stop Bit setting Bit1/Bit2 Return Code []:Select [NO]:Change
[CR ] Return Code setting CR/LF/CRLF Meas. End Data Send []:Select [NO]:Change
[NO ] Measure End Data Send setting : Set NO: No setting To 1. H.Pylori Note: The
device is equipped with a USB port, but data handling inside the software is
performed according to RS-232C. Therefore the conditions for data transfer need to
be set up according to RS-232C condition set-up. An exclusive USB driver needs to
be installed in a PC for data transfer from the device to PC. 7-14

7.4 Data output! Note The POCone stores measurement data in memory for up to
1000 measurements concerning patient sample and 200 measurement for QC sample,
respectively. The most recent measurement always appears as No. 1. When the
number of samples exceeds 1000 or 200,the oldest measurements are deleted from the
data. Data in the memory, such as that seen on the following example screen, can be
output using the printer,rs-232c or the USB. 4. Data Output? [ / NO ] NO To 5.
Reproducibility Push the key in this screen to retrieve and output the data by the
following procedure. (1) Select the output for the measurement data. (2) Retrieval and
output of patient data by date of measurement. (3) Retrieval and output of patient data
by patient ID. (4) Retrieval and output by order of measurement. (5) Retrieval and
output of QC data by date of measurement. 4-1. Output port select? [ / NO ] Selection
of output destination NO 4-2. Output patient data < DATE >? [ / NO ] Retrieval and
output by date NO 4-3. Output patient data < Patient ID >? [ / NO ] Retrieval and
output by patient ID NO Continued on next page 7-15

4-4. Output patient data < Data No. >? [ / NO ] NO 4-5. Output QC data < DATE >? [
/ NO ] Retrieval and output by order of measurement Retrieval and output of QC data
by date of measurement To: 1. H.Pylori 7.4.1 Selection of output destination To
retrieve data sorted in a particular order, see 7.4.2 Retrieval and output by of patient
date of measurement (p. 7-17) to 7.4.4 Retrieval and output by order of measurement
(p. 7-19). Push the key in the following screen to select data output via the printer,rs-
232c or the USB. The procedure is as follows: 4-1. Output port select? [ / NO ] NO To
4-2. Output patient data Output port select []:Select [NO]:Change [Printer] Selection
of output destination Printer RS-232C USB To 4-2. Output patient data 7-16

7.4.2 Retrieval and output of patient data by date of measurement Push the key in the
following screen to retrieve measurement data sorted by a designated date from
among data in memory and to output all applicable data. The procedure is as follows:
4-2. Output patient data <DATE>? [ / NO ] NO To Output patient data Input Year
(2004 2099) [2004] Input range: 2004-2099 ENTER Input Month (1-12) [10] Input
range: 1-12 ENTER Input Day (1 31) [01] ENTER Retrieval of the applicable data
Input range: 1-31 The input range varies depending on the designated month. Total
items 20. Patient data output? Output: Printer [ / NO ] Output NO To 1.H.Pylori with
no output Displays number of applicable data. If there are no applicable data, NOT
FOUND is displayed. To 1.H.Pylori You can interrupt the output by pushing NO key.
Output destination Printer RS-232C USB 7-17

7.4.3 Retrieval and output of patient data by patient ID Push the key in the following
screen to retrieve measurement data sorted by designated patient IDs from among data
in memory, and to output all applicable data. The procedure is as follows: 4-3. Output
patient data<patient ID >? [ / NO ] NO To 4-4. Output patient data Please input
patient ID [ ] Total items 20. Patient data output? Output: Printer [ / NO ] NO Input
ID of 15 numbers or less. Input can also be done via a bar code reader. Displays
number of applicable data. If there are no applicable data, NOT FOUND is displayed.
To 1.H.Pylori with no output Output To 1.H.Pylori You can interrupt the output by
pushing NO key. Output destination Printer: Printer RS-232C & USB:PC 7-18

7.4.4 Retrieval and output by order of measurement Push the key in the following
screen to retrieve measurement data sorted for a designated range from among the
data in memory, and to output all the applicable data. The maximum range that can be
designated is designated by numbers 1 through 1000. The most recent measurement
appears as No. 1. When the total measurement count exceeds 1000, only the most
recent 1000 samples remain in memory. The procedure is as follows: Example) To
retrieve data of the previous 20 samples 4-4. Output patient data <Data No. >? [ / NO
] NO To 1. H.Pylori Please input start No. [SHIFT]: SELECTOR START [ ] END [ ]
SHIFT To Data Selection Screen (See p. 7-20, 7-21) 1 ENTER Please input END No.
[SHIFT]: SELECTOR START [ 1 ] END [ ] 2 0 Retrieval of the applicable data
ENTER Total items 20. Patient Data output? Output: Printer [ / NO ] SHIFT NO To
Data Selection Screen (see p. 7-20, 7-21) Displays number of applicable data. If there
are no applicable data, NOT FOUND is displayed. To 1.H.Pylori with no output
Output You can interrupt the output by pushing NO key. To 1.H.Pylori Output
destination Printer: Printer RS-232C & USB: PC 7-19
(1) Data selection screen When designating the data output range in 4-4 Select by
DATA, the following screen appears when the NO key is pushed. When moving to
this screen, the data and Sample IDs currently in memory are listed in the order of
measurement. Select data for the output range from the list. The procedure is as
follows: Cursor Data No. 1 123-456-789-10 [ ] [CLEAR] JUMP 2 123-456-789-09 [ ]
[ENTER] END Information from key Blank when no patient ID. Use the following
keys: Moves Data No. and patient ID display forward by one. CLEAR ENTER Moves
Data No. and patient ID display backward by one. Moves cursor to the designated
Data No. (see p. 7-21). Selects the Data No. indicated by the cursor and closes the
screen. 7-20

(2) Moving the cursor The cursor-moving screen appears when the move the cursor to
the input Data No. CLEAR key is pushed. Use this screen to! Note The cursor does
not move when the Data No. input is higher than the actual number of data. Select
from the data selection screen. 1 123-456-789-10 [ ] [CLEAR] JUMP 2 123-456-789-
09 [ ] [ENTER] END Please input jump No. [ 10] CLEAR Input Data No. The input
range is from 1 to the number of measured samples. ENTER 10 123-456-789-01 [ ]
[CLEAR] JUMP 11 123-456-789-10 [ ] [ENTER] END Move the cursor to the input
Data No. to return to the data selection screen. 7-21

7.4.5 Retrieval and output of QC data by date of measurement Push the key in the
following screen to retrieve measurement data sorted by a designated date from
among data in memory and to output all applicable data. The procedure is as follows:
4-5. Output QC data <DATE>? [ / NO ] NO To 1.H.Pylori Input Year (2004 2099)
[2004] Input range: 2004-2099 ENTER Input Month (1-12) [10] Input range: 1-12
Input Day (1 31) [01] ENTER ENTER Retrieval of the applicable data Input range: 1-
31 The input range varies depending on the designated month. Total items 20. Patient
data output? Output: Printer [ / NO ] Output NO To 1.H.Pylori with no output
Displays number of applicable data. If there are no applicable data, NOT FOUND is
displayed. To 1.H.Pylori You can interrupt the output by pushing NO key. Output
destination Printer RS-232C USB 7-22

7.5 Reproducibility When the NO key is pushed in the Data Output setting screen, the
following Maintenance setting screen appears. 5. Reproducibility? [ / NO ] NO To 6.
Maintenance Push the key in the following screen to execute a system check of the
reproducibility of test measurements. Measuring procedures 1) Prepare a Y-shape
joint and breath bag (5 L). 2) Detach the sample joint of the unit and attach the Y-
shape joint. 3) After holding breath for approximately 10 seconds, exhale into the
breath bag (5 L) to fill it more than half and attach to the Y-shape joint. 4) Repeat the
measurement 10 times. Evaluation criteria 1) The range of 13 CO 2 / 12 CO 2 is
1.000~1.150. 2) The average change in 13 CO 2 is within ±0.3. 3) The standard
deviation of changes in 13 CO 2 is not more than 0.3. When conditions 1)-3) above
are met, the system is judged as normal. 5. Reproducibility? [ / NO ] NO To 6.
Maintenance Please input meas. repeat times (2-100) [ 10] Input 10 as meas. repeat
times Input meas. repeat times and push ENTER. Test start? [ / NO ] One set of ten
measurements takes approx. 20 min. Test starts 7-23

When the measurements are completed, the following printout is obtained. -------------
------------------- Reproducibility Test -------------------------------- Serial. 0001 ----------
---------------------- Date 2003-Sep-01 Time 17:16 -------------------------------- 13C
6377132 12C 6340498 R 1.0273 -------------------------------- No.1 ------------------------
-------- S.1 1.0908 (3.0)% S.2 1.0909 (3.0)% Δ( ) 0.0 (-) No.2 -----------------------------
--- S.1 1.0912 (3.0)% S.2 1.0915 (3.0)% Δ( ) 0.2 (-) S1: First value of 13 CO 2 / 12
CO 2 light intensity ratio S2: Second value of 13 CO 2 / 12 CO 2 light intensity ratio
CO 2 concentration (%) in breath sample Δ( ) = Second value of δ 13 CO 2 - First
value of δ 12 CO 2 No.9 -------------------------------- S.1 1.0908 (3.0)% S.2 1.0915
(3.0)% Δ( ) 0.7 (-) No.10 -------------------------------- S.1 1.0910 (3.0)% S.2 1.0912
(3.0)% Δ( ) 0.1 (-) -------------------------------- End intensity ----------------------- 13C
6377088 12C 6340470 R 1.0273 Standard substance generally used for natural
abundance ratio of 13 CO 2 PDB (PEE DEE Belemnite) Abundance ratio of 13 CO 2 :
1.12372 10-2 (%) Average value Within ±0.3 S.D. Not more than 0.3 -------------------
------------- n 10 Ave. 0.22 S.D. 0.28 Max 0.7 Min 0.0 --------------------------------
*END17:35 V1.000 7-24

7.6 Maintenance When the key is pushed in the Data Output setting screen, the
following Maintenance setting screen appears. 6. Maintenance? [ / NO ] NO To 1.
H.Pylori Push the key in this screen to select and execute the following maintenance
items. (1) Self-Diagnosis (2) Trapping cartridge check (3) Light intensity check (4)
Temperature check (cell and detector) (5) Syringe check (6) Chopper check (7) Printer
check (8) Leakage check (9) Sheet key check (10) Power ON hours check (11)
Measured times check (12) Pressure check The following screens appear for each
maintenance item. 6-1. Self check? [ / NO ] Execution of Self-Diagnosis NO 6-2.
Trapping cartridge check? [ / NO ] Trapping cartridge check NO 6-3. Intensity check?
[ / NO ] Light intensity check NO 6-4. Temperature check? [ / NO ] Temperature
check NO Continued on next page 7-25

6-5. Syringe check? [ / NO ] Syringe check NO 6-6. Chopper check? [ / NO ] Chopper

check NO 6-7. Printer check? [ / NO ] Printer check NO 6-8. Leakage check? [ / NO ]
Leakage check NO 6-9. Sheet key check? [ / NO ] Sheet key check NO 6-10. Power
ON hours check? [ / NO ] Power ON hours check NO 6-11. Measured times check? [ /
NO ] Measured times check NO 6-12. Pressure check? [ / NO ] Pressure gauge check
NO To 1. H.Pylori 7-26
7.6.1 Self-Diagnosis Self-Diagnosis evaluates the following functions. Push the key in
the following screen to start Self-Diagnosis. 6-1. Self check? [ / NO ] To 6-2.
Trapping cartridge check NO Execution of Self-Diagnosis Self-Diagnosis evaluates
the following functions. (1) Printer status (2) Timer battery level (3) Key panel (4)
LCD panel (5) LED operation (6) Valve operation (7) Syringe operation (8) Chopper
operation (9) Warning beep The processes (1), (3), (4), (5) and (9) above require
confirmation by the operator. During Self-Diagnosis after turning on the power
switch, the operator must wait with the POCone in order to make these confirmations.
Example of printout Self check ------------------------------ Serial 0001 --------------------
---------- Date 2003-Oct-01 Time 10:00 ------------------------------ Self Check O.K -----
------------------------- *END 10:01 V1.000 When an error is detected, check each item
in items (2)-(9) in 7.6 Maintenance (p. 7-24) and follow the directions specified for
each item. Self-Diagnosis requires approximately 2 minutes. 7-27

7.6.2 Trapping cartridge check Push the key in the following screen to execute a
system check of the absorption capacity of the trapping cartridge. The absorption
capacity is evaluated by the light intensity ratio obtained by measuring the light
intensity of the air that does not pass through the trapping cartridge and the light
intensity of the air that does pass through the trapping cartridge. 6-2. Trapping
cartridge check? [ / NO ] NO To 6-3. Intensity check In checking Trapping cartridge
Please wait After one minute To 6-2. Trapping cartridge check Example of printout
Trap.cart.check ------------------------------- Serial 0001 ------------------------------- Date
2003-Oct-01 Time 10:00 ------------------------------- Air 4862095 Ref. 5020996 Ratio:
0.970 ------------------------------- Check O.K ------------------------------- *END 10:01
V1.000 Normal value in checking of absorption capacity of the trapping cartridge The
normal range of absorption capacity of the trapping cartridge is as follows: Light
intensity ratio: Less than 0.985 When exceeding the above range, the result is NG.
When the result is NG, the trapping cartridge must be replaced. Remove the old
trapping cartridge by pushing on the part marked PUSH on the trap cartridge adapter
and pulling on the trap cartridge. Insert a new cartridge, check the direction of the
trapping cartridge adapter, match the two holes, and push until the cartridge snaps into
place. * See 9.4 Changing the trapping cartridge (p. 9-8) for details of changing the
trapping cartridge. * To purchase a trapping cartridge, contact an authorized dealer. 7-
28

7.6.3 Light intensity check Push the key in the following screen to execute a system
check of light intensity. Light intensity is evaluated by the average light intensity and
C.V. value measured during 10 minutes of airflow. 6-3. Intensity check? [ / NO ] NO
To 6-4. Temperature check 13C = 5001530 pass time = 00:00:00 12C = 5246840
Escape : [ ] After 10 minutes Interrupted and sent to 6-3 To 6-3. Intensity check
Example of printout Intensity check ------------------------------- Serial 0001 -------------
------------------ Date 2003-Oct-01 Time 10:00 ------------------------------- (sec) 13C
12C 10 6011230 6011439 20 6010760 6011031 30 6011030 6010950 590 6010901
6010103 600 6010403 6010138 ------------------------------- Average(n=60) 13C
6010805 12C 6010393 S.D. 13C 226 12C 383 CV(%) 13C 0.0 12C 0.0 -----------------
-------------- Intensity Check O.K ------------------------------- *END 10:10 V1.000
Normal value of light intensity Each normal range of light intensity ( 13 CO 2 and 12
CO 2 ) is as follows: Average light intensity: 4,000,000-8,000,000 Coefficient of
variation (C.V.) (%): Less than 1.0% The result is NG if the above ranges are
exceeded. When the result is NG, check the following items. 1. Is the environmental
temperature within a range of 15-30 C? 2. Is the unit out of direct sunlight? 3. Is the
light source-cooling fan located on the right side of the unit operating? If any
problems are found, take necessary measures and check again after approximately one
hour. If the error is still not corrected, or if the cooling fan is not operating, contact an
authorized dealer to request repair. 7-29

7.6.4 Temperature check Push the key in the following screen to execute a system
temperature check of the cell and detector. The temperature is evaluated by the
maximum and minimum values measured over a 3 minute period. 6-4. Temperature
check? [ / NO ] NO To 6-5. Syringe check Detector = 17.9 Cell = 42.3 Escape : [ ]
After 3 minutes Interrupted and sent to 6-4 Example of printout To 6-4.Temperature
check Temp. check ------------------------------- Serial 0001 -------------------------------
Date 2003-Oct-01 Time 10:00 ------------------------------- (sec) Cell Detect 0 41.8 18.0
5 41.8 18.0 10 41.8 18.0 175 41.8 18.0 180 41.8 18.0 -------------------------------
Detector temperature Max 18.1 Min 18.0 Cell temperature Max 41.8 Min 41.8 ---------
---------------------- Temperature O.K ------------------------------- *END 10:03 V1.000
Normal temperature values of the cell and detector The normal temperature ranges of
the cell and detector are as follows: Detector: 17-20 C Variation range: Not more than
±0.2 C Cell: 40-47 C Variation range: Not more than ±0.2 C The result is NG if the
above ranges are exceeded. When the result is NG, check the following items. 1. Is
the environmental temperature within a range of 15-30 C? 2. Is the unit out of direct
sunlight? 3. Is the light source-cooling fan located on the right side of the unit
operating? 4. Is the dust-protection cover completely detached? If any problem is
found, take necessary measures and check again after approximately one hour. If the
error is still not corrected, or if the cooling fan is not operating, contact an authorized
dealer to request repair. 7-30

7.6.5 Syringe check Push the key in the following screen to execute a system check of
syringe operation. 6-5. Syringe check? [ / NO ] NO To 6-6. Chopper check In
checking syringe ( 0 < - - - 40mL ) ## times Escape : [ ] To 6-5. Syringe check In
checking syringe ( 0 - - - > 40mL ) ## times Escape : [ ] To 6-5. Syringe check
Repeats until the Example of printout key is pushed. Syringe check ----------------------
--------- Serial 0001 ------------------------------- Date 2003-Nov-01 Time 10:00 ----------
--------------------- Syringe O.K(10) ------------------------------- *END 10:11 V1.000
Normal value for syringe operation check Checks the amount of time needed for the
syringe to move from start to maximum stroke and back to the starting point. The
normal range of time required is as follows: Time required for one full stroke: Not
more than 60 seconds. The result is NG if the above ranges are exceeded. If the result
is NG, turn power off and on again, and execute the check again. If this does not
correct the error, contact an authorized dealer to request repair. 7-31

7.6.6 Chopper check Push the key in the following screen to execute a system check
of chopper operation. Chopper operation is evaluated by the component point count of
one peak measured during the operation check. 6-6. Chopper check? [ / NO ] NO To
6-7. Printer check Now in checking chopper level Please wait... Chopper level = 33
Escape [ ] Chopper level value is a one peak structure To 6-6.Chopper check Example
of printout Chopper check ------------------------------- Serial 0001 -------------------------
------ Date 2003-Oct-01 Time 10:00 ------------------------------- Chopper level: 33 ------
------------------------- Chopper check O.K ------------------------------- *END 10:01
V1.000 Normal value in chopper operation check The normal range in checking
chopper operation is as follows: Chopper level: 33 ± 3 The result is NG if the above
range is exceeded. If the result is NG, turn power off and on again, and execute check
again. If this does not correct the error, contact an authorized dealer to request repair.
7-32

7.6.7 Printer check Push the key in the following screen to execute a system check of
the printer. Printer operation is evaluated by observing the dot resolution in the
printout. 6-7. Printer check? [ / NO ] NO To 6-8. Leakage check In checking
PRINTER Example of printout To 6-7. Printer check Printer check ----------------------
-------- Version 0.234 ------------------------------ Serial 0001 ------------------------------
Date 2003-Oct-01 Time 10:00 ------------------------------! #$%& ()*+,-./01234
56789:;<=>?@ABCDEFGH IJKLMNOPQRSTUVWXYZ[ ]^_`abcdefghijklmnop
qrstuvwxyz>< Δδ 2 Judgment in checking printer operation Since the system cannot
execute a check of the printer status, the operator is requested to check the printout by
macroscopic observation. Use the following items as standards for printer checks: Are
there any abnormally generated characters for numbers, etc.? In the event that any
problems are detected, the printer must be replaced. Contact an authorized dealer to
request repair. ------------------------------- *END 10:01 V1.000 7-33

7.6.8 Leakage check Push the key in the following screen to execute a system check
of leakage. 6-8. Leakage check? [ / NO ] NO To 6-9.Sheet key check In checking
VALVE #1 In checking valve leakage(1/2) Pressure valve 0.399 In checking valve
leakage(2/2) Pressure valve 0.398 To 6-8.Leakage check Example of printout Leakage
check ------------------------------- Serial 0001 ------------------------------- Date 2003-
Oct-01 Time 10:00 ------------------------------- Leakage result : OK -----------------------
-------- *END 10:01 V1.000 Judgment in checking printer operation Pressure
fluctuation should be less than 0.005Mpa when measured in 10 sec after applying
0.4Mpa. If NG, leakage check should be repeated 3-4 times. If this does not correct
the error, contact an authorized dealer to request repair. 7-34

7.6.9 Sheet key check Push the key in the following screen to execute a system check
of the Sheet key. It checks pushing a sheet key and operating normally. 6-9. Sheet key
check? [ / NO ] NO To 6-10. Power ON hours check Hit Any KEY _ [ENTER]:
Escape Push the any key and it checks whether it is displayed correctly. ENTER Push
the ENTER key to finish. To 6-9. Sheet key check 7-35

7.6.10 Power on hours check Push the use time. key in the following screen to execute
a system check of the equipment 6-10. Power ON hours check? [ / NO ] NO To 6-11.
Measured times check Total Power ON hours : 1234.5H Escape:[] Total Power ON
hours print out? [ / NO ] NO To 6-10. Power ON hours check To 6-10. Power ON
hours check Example of printout Check PowerON hrs. ------------------------------
Serial 0001 ------------------------------ Date 2003-Oct-01 Time 10:00 ---------------------
--------- Hours 1234.5H ------------------------------ *END 10:01 V1.000 7-36

7.6.11 Measured times check Push the measurement. key in the following screen to
execute a system check of the number of 6-11. Measured times check? [ / NO ] NO
To 6-12. Pressure check Total measurement count : 123 Escape:[] Measured times
print out? [ / NO ] NO To 6-11. Measured times check To 6-11. Measured times
check Example of printout Measurement count ------------------------------ Serial 0001 -
----------------------------- Date 2003-Oct-01 Time 10:00 ------------------------------ Total
: 123 ------------------------------ *END 10:01 V1.000 7-37

7.6.12 Pressure check Push the key in the following screen to execute a system check
of the injection volume. Sample injection volume is automatically calculated so as to
maintain the pressure at 0.4Mpa,if any keys but no is pressed. Pressure calculation is
performed every one hour. 6-12. Pressure check? [ / NO ] NO To 1. H.Pylori Used
pressure VOL.29.146 ( 6.000 )ml... Check[/NO] NO To 6-12. Pressure check Pressure
calibrating (#/3)... After the end of measurement, a sheet is outputted shown as the
example of printout and 6-12, the initial screen returns. It is normal when Pressure
calib. is O.K on the printout. Go to 7.6.8 Leakage check when Pressure Calib. is N.G.
on the printout.(pages 7-34) Example of printout Pressure calibration --------------------
-- Serial 0001 ---------------------- Date 2003-Sep-01 Time 19:14 ---------------------- 1)
0.398Mpa 29.146mL 2) 0.398Mpa 29.073mL 3) 0.398Mpa 29.219mL -------------------
--- Calib.vol. 29.146mL ---------------------- Pressure calib. O.K ----------------------
@END 19:14 V0.400 7-38
Chapter 8 Specifications for External Communication... 8-1 8.1 Outline... 8-1 8.2
Hardware specifications... 8-2 8.2.1 Connector... 8-2 8.2.2 Transmission system... 8-2
8.2.3 Signal input interface... 8-2 (1) Terminal No. and signal type... 8-2 (2) Pin
configuration (cross cable)... 8-3 8.3 Message specifications... 8-3 8.3.1 Message
types... 8-3 8.3.2 Message format... 8-4 8.4 Transmission method - Communication
protocol... 8-6 8.4.1 Transmission without flow control... 8-6 8.4.2 Transmission with
flow control... 8-7 (1) Data text format... 8-7 (2) Communication procedures... 8-8 8

Chapter 8 Specifications for External Communication 8.1 Outline This chapter

summarizes the on-line communication specifications between the POCone and the
system computer (hereafter referred to as the host). The communication between the
POCone and the host includes output of measurement data. Communication timings
include real time and batch. Output of measurement data Real time Sent as each
measurement is completed. Batch Past data are sent in one package. To have online
output or error output can be selected using the POCone. The structure of on-line
connection is shown below. POCone RS-232C/USB Host PC 8-1

8.2 Hardware specifications 8.2.1 Connector POCone To be covered by POCone

Connector DB-9P Cable Host PC 8.2.2 Transmission system 1. Signal type RS-
232C/USB 2. Synchronization system Start-stop synchronous all double 3. Baud rate
9600 bps (convertible to 4800, 2400, 1200) 4. Bit structure Start bit: 1 bit Data bits: 8
bits (or 7) Parity bit: None (or odd, even) Stop: 1 bit (or 2) 8.2.3 Signal input interface
(1) Terminal No. and signal type Terminal No. Code Name Signal direction 1 CD
Carrier detection IN 2 RXD (RD) Receiving data IN 3 TXD (SD) Sending data OUT
4 DTR (ER) Terminal ready OUT 5 GND (SG) Signal ground 6 DSR (DR) Data set
ready IN 7 RTS (RS) Requiring send OUT 8 CTS (CS) Send-capable IN * Signal
direction OUT: POCone Host PC IN: POCone Host PC 8-2

(2) Pin configuration (cross cable) 8.3 Message specifications 8.3.1 Message types
Messages include measurement data output (real time and batch). Message type
Timing of occurrence Direction Measurement data Output upon completion of sample
POCone Host PC measurement 8-3

8.3.2 Message format A message (datum) comprises several fields. The measurement
datum comprises the following fields: Field name Size (byte) Example Datum class 1
(letter sequence) D(patient sample) or Q (QC sample) Datum No. 4 1 Date of
measurement 10 (letter sequence) 1998-04-25 Time of measurement 5 (letter
sequence) 12:13 Sample ID 15 (letter sequence) 1123456789 DOB 5 5.5 (to first
decimal place) Judgment 8 (letter sequence) 8 letters of POSITIVE or NEGATIVE
First concentration value (%) 4 5.2 (to first decimal place) Second concentration value
(%) 4 5.3 (to first decimal place) Cut-off value 4 2.4 (to first decimal place) Remarks
2 (letter sequence) 01 Example) D 11998-04-2512:131123456789 5.5POSITIVE5.2
5.3 2.401 Remarks: A remark is expressed as 2 bytes of 00-FF. In the event of an
error, the bit corresponding to each error is 1. Bit 8 7 6 5 4 3 2 1 8-4

List of remark contents with corresponding Bit Nos. Bit Content The CO 2
concentration exceeds the range of 1.0-6.0%. 1 The breath sample may not have been
collected properly. Re-measurement is recommended. 13 CO 2 DOB is below -5. 2
The sample bag may have been attached improperly. Re-measurement is
recommended. Bits 3-8 are spare. Example) If the sample gas concentration is out of
the range and 13 CO 2 DOB is below -5, Bit 1 and Bit 2 are 1. Bit 0 0 0 0 0 0 1 1
Therefore, the remark no. is 03. 00 is used in the absence of a remark. 8-5

8.4 Transmission method - Communication protocol The POCone is equipped with

flow control, which uses control codes such as ACK and NAK, and with non-flow
control transmission which does not use these control codes. Real time or batch
processing is available. 8.4.1 Transmission without flow control The format of the
data text transmitted from the POCone to the host during transmission without flow
control is shown below. Measurement data (maximum 62 bytes) Message Delimiter
The maximum length for a measurement datum is 62 bytes. The CR of the delimiter
can be changed to CR, LF and CRLF. For setting the Delimiter, see 3-3. Set RS-232C
condition (p. 7-12)or 3-4. Set USB condition (p. 7-13). 8-6

8.4.2 Transmission with flow control (1) Data text format The POCone adds flow
control when sending text for the answer ACK and NAK responses from the receiver.
Also, in order to detect errors during data text transmission, the POCone uses a 4 byte
(hexadecimal) check-sum character. The check-sum character is a 4-byte text type
character which is the sum of all codes between STX and ETX. The format of the data
text transmitted from the POCone to the host PC during transmission with flow
control is shown below. STX Measurement datum (maximum 62 bytes) ETX Check
sum The measurement datum is framed with STX (02H) and ETX (03H). A 4-byte
checksum character (hexadecimal number) is added after the ETX character. The
maximum length of the measurement datum is 62 bytes. 8-7

(2) Communication procedures Definition of Master and Slave The Master is defined
as the side with text transmission rights. The Slave has no transmission rights. The
Slave transmits responses (ACK, NAK) after receiving text notifying the validity of
the data. Transmission rights are obtained by getting permission from ENQ.
Procedures (A) The side which obtains permission from ENQ during the initial state
becomes the Master. (B) After receiving data text, the Slave checks the data for errors.
Data errors are checked by the 4-byte check-byte following ETX. (a) If the data are
correct: The Slave transmits any data to be transmitted. If there is no text to be
transmitted, the Slave returns the ACK character. (b) If the data are incorrect (the
check sum is incorrect): The Slave transmits NAK. (C) After transmitting the text, the
Master waits for a transmission control character. (a) If the transmission control
character is ACK: The Master transmits any text to be transmitted. If there is no text
to be transmitted, the Master transmits EOT. (b) If the transmission control character
is NAK, an invalid character, or the transmission control character is not received
within the time-out, the Master will re-transmit the text a maximum 3 times. If the
same phenomenon occurs, Recovery Procedure 1 is performed. (c) If the transmission
control character is EOT: The Master stops message transmission and performs
Recovery Procedure 2. Recovery Procedure 1 The Master transmits EOT and notifies
the operator. Recovery Procedure 2 The Master notifies the operator and returns to its
initial state. 8-8

Measurement data transmission phase Measurement data text #1 POCone Host PC

Measurement data text #n 8-9

Chapter 9 Replacement of Consumables... 9-1 9.1 Changing the printer paper... 9-1
9.2 Changing the O-rings... 9-4 9.3 Changing the fuses... 9-6 9.4 Changing the
trapping cartridge... 9-8 9

Chapter 9 Replacement of Consumables 9.1 Changing the printer paper Use only
exclusive printer paper. Note The printing paper has a front and back. Insert the roll
with the back side up. <Step 1> Lift up the printer cover as shown in the figure below.
9-1

<Step 2> Remove the printer paper roll. <Step 3> Insert the new roll of printer paper
as shown in the figure below. Insert the roll of paper with the back side up. 9-2

<Step 4> Close the printer cover until it snaps into place. <Step 5> Check that the
paper is feeding properly by pushing the paper feed button on the key panel. 9-3

9.2 Changing the O-rings Note Always change the O-rings of both Sample joint 1 and
Sample joint 2 at the same time. The following message appears when 1000
measurements (1000 samples) have been completed. Caution 6: Done [] Time for O-
ring replacement Notyet[NO] When this message is displayed, change the sample
joint O-rings. The steps for changing the O-rings are shown below. Note) The O-ring
replacement message does not appear when using the Autosampler. <Step 1> Remove
sample joints. Pushing here easily detaches the sample joint. 9-4

<Step 2> Use a knife or similar sharp instrument to cut away the old O-rings. <Step
3> Replace with new O-rings. <Step 4> Attach the sample joints to the main unit, and
push the key. 9-5
9.3 Changing the fuses Warning Be sure to turn off the power and remove the power
cable from the outlet to avoid risk of electric shock. <Step 1> Remove the power
cable from the outlet. <Step 2> Remove the fuse box. Fuse box 9-6

<Step 3> Replace the fuses.(fuse:ac125v T4A) <Step 4> Return the fuse box its
original position. 9-7