Gima PC-900B User manual

PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
CAPNOGRAPH AND OXIMETER
PC-900B
User manual
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
M33698-GB-Rev.1.05.18
Shenzhen Creative Industry Co., Ltd. 2/F Block 3
Nanyou Tian’an Industry Town - 518054 Shenzhen, GD - P.R.C.
Made in China ( P.R.C.)
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537 Hamburg, Germany
33698 / PC-900B
0123

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Welcome to using the Capnograph and Oximeter manual.
This manual is copyright reserved. It is prohibited to copy, duplicate
or translate into other languages without our written permission.
Please to read this manual carefully and then follow its instructions when
operating this monitor.
It is not permitted to open the monitor’s main cover, modify or
disassemble it without our permission or ofcial service training.
The buyer will not be advised of Technology updates which do not
inuence the monitor’s key functionality. Furthermore, please pay attention
to the difference between the parts or components provided as information
in this manual.

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CONTENTS
Chapter I Preface ................................................................................ 4
Chapter II Technical specications and characteristics ....................... 5
Chapter III Introduction of Monitor ........................................................ 7
Chapter IV Patient connection .............................................................. 9
Chapter V Screen display and Operation ........................................... 13
Chapter VI Charging, Maintenance, Cleaning ..................................... 23
Chapter VII Trouble Shooting Analysis ................................................. 25
Appendix 1. Explanations of Terms in this Manual ................................ 26
Appendix 2. ENGINEER MENU:
Changing compensation of balance gas ........................... 27
Appendix 3. Calibration of EtCO2Accuracy .......................................... 28

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Chapter I
Preface
I. Brief
The purpose of this manual is to provide the User with a brief understanding
of the characteristics, functions and operation of the monitor thereby
preventing incorrect operation and user error.
This device can monitor four physiological parameters for the patient at
the same time: End tidal CO2concentration (EtCO2), Respiration Rate (RR),
functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor you
bought may have functions with two or more parameters mentioned above,
but this manual can be used in common for the applicable functions.
II. Warranty and Maintenance
Warranty on Hardware and Battery
This Monitor has a warranty of 12 Months from the date of purchase.
The following will invalidate the warranty:
• if the monitor is damaged due to misuse or incorrect operation
(i.e. without following the User manual instruction),
• the monitor is damaged due to incorrect connection with another
instrument.
• the monitor is accidentally damaged or dropped
• if the user modies or changes the monitor without written authority
of the company.
• the serial number is deliberately damaged, torn off or unreadable.
Maintenance
If the monitor is non-functional outside of the warranty period, the
manufacturer or distributor will offer an estimate for repair. The maintenance/
repair/calibration place depends on actual conditions.
Re-packing for Repair or Calibration
It is recommended to use the original packing boxes and packing materials
when returning for repair or maintenance.
III. Safety Requirements
For the purposes of safety, please read the following and abide by these
instructions of medical instrumental products.
Warning: Indicating the possible injury on patient or operator.

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• This monitor is not suitable for use during the operation of MRI or CT.
This Monitor is not MRI Compatible.
• To ensure that the monitor is safely grounded when charging use
a three-pole socket.
• Only use manufacturer designated accessories to ensure compliance
with appropriate standards
• It is not allowed to remove the cover of the monitor.
• This monitor provides End tidal CO2(EtCO2) concentration, Respiration
Rate, Oxygen saturation and Pulse Rate. This data only provides assistance
for diagnosis and actual diagnosis shall be made by suitably qualied
clinical staff using all the clinical information and symptoms.
• In order to prevent pressure sores and correct circulation the SpO2sensor
must be repositioned regularly, depending on the type of sensor used.
Chapter II
Technical specifications and Characteristics
EtCO2
Method: Creative proprietary non-dispersive InfraRed
Spectroscopy
Range: 0 – 150mmHg or 0 – 20kPa or 0 – 20% (v/v)
Accuracy: ±2mmHg for EtCO2range 0 - 40mmHg
±5% for EtCO2range from 41 - 70mmHg
±8% for EtCO2range from 71 - 100mmHg
Over 100mmHg ±10%
Note: The accuracy of CO2concentration measurement is inuenced by
any interfering gas and/or vapour, for example N2O gas can raise the CO2
reading (2-10%), and Helium and O2can reduce the CO2reading (1-10%),
so compensation should be set in the balance gas MENU to meet the
accuracy requirements if such gases or vapours are present.
Update/Averaging Time: Option of every breath or 10, 20 or 30 seconds
Warm Up Time: <20 seconds
Sample Flow Rate: 50–250ml/min User Adjustable. Default =100ml/min
Patient Modes: Adult and Neonatal
Memory: 24 hours on Screen Trend and Numeric
Sensor: <25g Single Use Gas Sample Line and Adapter for
Intubated and /or Non Intubated Patients
Color Change: Connector housing has additional built-in LED
Colour change feature. Purple (or Red) during
occlusion or pump err.
Respiration Rate
Range: 3 - 150 breaths/minute

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Accuracy: ±1% of reading or ±1 breaths/min whichever
is greater
Memory: 24 hours on Screen Trend and Numeric
SpO2(optional)
Method: Creative Patented Proprietary Pulse Oximetry
Range: 0 - 100%
Accuracy: ±2% for SpO2range from 70 - 100%
±3% for SpO2range from 50 - 69%
Memory: 24 hours on Screen Trend and Numeric
Pulse Rate (optional)
Range: 30 – 250bpm
Accuracy: ±2%forPRrangefrom30 – 250bpm
Memory: 24 hours on Screen Trend and Numeric
Power
AC Input: 100V - 250V, 50Hz/60 Hz to 5VDC Adapter with
5V mini USB adapter Cable
Optional Vehicle 12V to 5V Mini USB Charger Lead.
Battery
Type: Built-in rechargeable lithium battery pack
(3.6V, 3000mAH)
Charging Time: 4 hours from at
Operating Time: 10 hours on full charge
Operating Conditions
Temperature: -5 to +50°C
Humidity: < 93% % (non-condensing) = < 29.45 hPa
Atmospheric pressure: 70 - 120 kPa
Storage Conditions
Temperature: -30 to +70°C
Relative Humidity: <93% (non-condensing)
Atmospheric pressure: 50 - 120 kPa
Dimensions of Monitor
Size: 70x160x40mm (W x H x D)
Weight: Weight on Airway ETT/LMA <25g. Monitor 600g
Warranty & Maintenance/ Calibration
24 Months warranty on Main Unit and Lithium Ion Rechargeable Battery.
Auto self-zeroing calibration, annual calibration check recommended.

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IP rating
IP32 when used in specied Carry Case.
CE & Product classification
As per IEC 60601- 1 / CSA601.1 / UL2601-1
Type of Protection
Class II
Degree of Protection: Type BF-Applied Part
Mode of Operation: Continuous
93/42/EEC Medical Device Directive Compliant
CE 0123 Shenzhen Creative Industry Co. Ltd
Chapter III
Introduction of Monitor
I. Introduction
Figure 1

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1. Screen: Displays waves, menu, alarm and all measuring parameters.
2. / : Function button:
a) When menu (except the TREND menu) is activated, press this
button to move the cursor.
b) When the TREND menu is activated, this button changes between
the trend graph and data table
On the main display, to press this button to silence alarms
for 2 minutes.
3. : Press this button to move the cursor when menu is activated.
4. + : Multifunction button.
a) Press this button to increase gures on the menu.
b) In the main display screen, to press this button to freeze the display
wavefor m (if frozen, the data to print is the data of the frozen moment)
5. - : Press this button to decrease gures.
6. ENTER: Conrmation button;
a) Press this button to “Conrm” on the menu.
b) In the main menu, to press this button to turn on the pump directly
if it has automatically time switched OFF
c) If the device is connecting with Bluetooth printer, press this button
for 2 seconds to print capnography and other result parameters
(EtCO2, RR, SpO2, PR).
7. Press this button to enter or quit menu or change display
8. Power button: hold for >2 seconds to activate
9. Indicator POWER: Blue LED is lit when the Monitor is either switched
ON or subject to external power when not switched ON.
If the yellow LED is lit, the internal battery is being charged.
10. CO2: The faucet of lter, blue color indicator ashes if the lter T3 is
off. when the lter T3 is plugged in ,the indicator color will change to be
blue all the time, and it will change to be red during occlusion or pump
err.
11. SpO2: The socket of SpO2(optional).
12. DC5V Mini USB Charging interface.
Note: this interface must only be connected to a device which meets
safety standards.
13. Exhaust outlet: Do not occlude.
14. Speaker location
15. Battery Compartment with clip on Battery Door
16. Hanging Point for Lanyard if required.

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Chapter IV
Patient connection
I. CO2measurement
Push in and twist 45° clockwise to connect the lter/water trap T3
to the Connector on the top of the Monitor. Attach the selected Gas Sampling
Line to the CO2lter/water trap Female Luer Connector (Use a Male to Male
Luer adapter if necessary) and then select a sampling point as close as possi-
ble to either the Patient or the Ventilator Breathing Circuit.
Figure 2
Filter/water trap T3:
WARNING
Do not use the Monitor if the lter/water trap T3 is not installed to avoid
contamination and damage to the IR measurement cell.
In order to avoid vapor and respiratory mucus entering into the IR Cell,
the machine must be used with the lter/water trap T3.

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Figure 3
Instruction for use of the filter/water trap T3:
1. Insert the convex cleat of lter/water trap T3 into the notch of the inlet port
of device and turn T3 45°clockwise.
2. Attach male luer lock sample line connector to lter/water trap T3
(Use a Male to Male Luer adapter if the sample line has Female Luer
connector)
3. Connect the other end of the Sample line to the chosen sampling point
of Patient or Ventilator Circuit.
4. Change the lter/water trap T3 as needed – This item may dried if very wet
and re-used, subject to local Infection Control requirements. If the
lter/water trap T3 becomes dirty or the Occlusion Alarm is activated
when it is dry then the lter/water trap must be replaced.
WARNING
Ensure that connections are air tight as if there is leakage, measured values
are likely to be inaccurate.
WARNING
Use only recommended Original bespoke lter/water trap T3 to ensure
accuracy.
II. Respiration rate measurement
The calculation of respiration rate derives from monitoring the CO2waveform.

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III. Theory introduction
1 The measuring principle:
The device working theory is NON-DISPERSIVE INFRA RED GAS ANALYZER.
The device has an AUTO ZERO ADJUSTMENT SYSTEM and GAIN
CONTROL
2 Automatic Offset Calibrations
The device was designed to automatically perform calibrations in order to
correct for changes in temperature, altitude and electronic component drift.
The air surrounding the device may have elevated concentrations of CO2
present (such as in an enclosed compartment or room with poor ventilation).
Therefore, we recommend use in well ventilated locations to ensure that the
CO2baseline does not cause inaccuracy.
3 The Moisture Separation System:
This instrument uses a patented lter/water trap T3 which can lter a large
amount of moisture whilst maintaining a minimum dead space thereby
improving the accuracy of the waveform. PLEASE NOTE that if the
lter/water trap becomes full of water or dirt the display will show
"OCCLUSION ', the operator needs to change the lter/water trap T3. The old
lter can be reused after natural drying in a ventilated and dry environment.
Discard the old lter/water trap if dirty.
IV. Oxygen saturation measurement (optional)
1. It is also recommended to use Pulse Oximetry for ventilated or sedated
patients. Measurement will begin when your nger is put into the sensor clip,
meanwhile, the photoplethysmogram wave will appear on the screen, after
several seconds the oxygen saturation and pulse rate appear. The monitor
will give a pulse tone sound when each heart beat happens. The tone will
change to an alarm tone if the values of SpO2and Pulse Rate breach the
alarm level settings. The volume of pulse beep can be adjusted by the item
BEEP VOLUME in the SOUND SET menu. The pulse beep tone will
disappear under the silent condition.
Figure 4

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2. The use of different SpO2sensors
There are a number of different SpO2Sensors for use with this monitor.
Please see brochure or listing at rear of Manual for details.
PLEASE NOTE: when SpO2is not being monitored the probe should be
disconnected from the monitor to save battery life, or the two windows
of sensor should be kept face to face, otherwise the light window will remain
operational and the photoplethysmogram wave will be disordered and the
screen will display “FAIL SEARCH”.
V. Notice
1. Caution:
Under conditions of electromagnetic inuence, for example: electrosurgical
devices, MRI, CT etc. they may cause incorrect operation.
This device is not MRI/CT Compatible.
The lter/water trap T3 should be taken off and replaced when it is nearly
full of water, otherwise water ingress may cause irreversible damage for IR
measurement detector cell. Be sure that the collecting pipe is not occluded
to avoid stressing the inner sampling pump reduction of pump life.
2. Attention:
other important information.
1) CO2:
The approved sampling lines provided by or specied by the manufacturer
or distributor, shall be used, otherwise readings may be inaccurate.
Fast changes in ambient Temperature may cause inaccuracy and in this
instance the Display will show “TEMP IMBALANCE”.
The measured data may be inuenced by different kinds of anaesthetic gases.
If it is required to calibrate interference gases please refer to Appendix 2.
Any circumstances of blocking of the gas sampling line, such as bending,
folding, contamination blocking the sampling tube and lter or water trap etc.
may lead to inaccurate measurement.
Serious respiratory conditions leading to exhaled CO2concentration being
extremely high or low, e.g. EtCO2lower than 0.5% or higher than 11%, may
generate inaccurate measurement.
Any air leaks in the sampling line circuit will seriously inuence accuracy
of data measured and waveform shape.
2) Oximeter:
The monitor’s measurement of SpO2may be inuenced by strong ambient
light. Therefore the user should unplug the SpO2Sensor when it is not being
used.
Accuracy of oximeter readings will be inuenced if there is imaging dye
in the blood or if CO has been inhaled by the Patient.

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Only use Creative SpO2probes approved for use with this Monitor.
Always make sure that the sensor is not contaminated or broken before use.
Always take care to check that the sensor is applied correctly.
Warning:
Do not use the SpO2sensor if it is damaged or dirty.
If shock, low blood pressure, serious blood vessel constriction, serious
anemia, very body low temperature, artery block near sensor or incomplete
heart asystole occur the pulse signal may disappear.
Chapter V
Screen display and Operation
I. Screen main display menu
Figure 5
The rst line of data shows time (hour, minute)/patient ID, patient type:
Adult (ADU) or Neonate (NEO), the memory area full indicator ( ) alarm
sound closing (!), silence () or non silence (), bluetooth symbol ( )
and battery indicator .
Attention:
a) When the memory full indicator is displayed, further patient data cannot
be stored. If you want to save the new data effectively, you need to enter
the NEW PATIENT menu toe delete the data in the storage area, or to
change patient ID., beside you can set up trend RENEW into AOTO mode,

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please see the details in VIII. NEW PATIENT
b) If the symbol appears, the menu is locked, the setting menu will be
disabled unless user press the three buttons , , - at the same time,
or enters engineer menu to unlock the menu (Refer to Appendix 2
ENGINEER MENU: Changing compensation of balance gas)
c) The symbol ( ) appears if the bluetooth module is equipped. If this symbol
is green, it indicates that no bluetooth equipment is connected (e.g,
bluetooth printer), if this symbol becomes white, it indicates that some
bluetooth equipment is connected (e.g, bluetooth printer).
d) The middle part of the screen shows results data: EtCO2concentration,
respiratory rate, inhaling CO2concentration (optional), oxygen PLETH,
exhaling or inhaling state (during exhaling, becomes blue color).
The bottom area shows CO2respiratory wave. If it is equipped with SpO2,
it will show SpO2, pulse, oxygen PLETH waveform and histogram.
When the pump is not operating “PUMP OFF” will appear on the screen.
If the lter/water trap is NOT inserted into the inlet port, the screen will show
‘LINE OFF, the pump will also be automatically switched off to prevent ingress
to the unprotected IR detector Cell.
Alarm indication:
1. If the EtCO2’s value exceeds the limit of high or low alarm level, the word
‘EtCO2’ will ash and alert with the audible high priority alarm. This high
priority alarm will also sound for respiration rate, SpO2and pulse rate
alarms.
2. If the battery level is almost fully depleted the battery indicates
completely empty, the monitor will alarm continuously and will shut down
automatically.
3. When the apnea alarm is turned on and apnea occurs the monitor will give
a high priority audio/visual alarm. The screen will ash the message
‘APNEA’ (meaning no EtCO2has been detected for a certain time period)
and if the sound alarm is turned on, it will alert a high priority audible
alarm.
4. When the SpO2sensor is disconnected or not applied, the screen will ash
the message ‘SENSOR OFF’. If a heart beat pulse is not detected for a
period of time, the screen will ash the message ‘FAIL SEARCH’.
5. The volume of continuous or interval alarm tone sounds mentioned above
can be adjusted up and down by the menu item ALARM_VOLUME.
The sound will inaudible under the silent condition. If the alarm volume
is 0, the silence indicator in the main menu will show '!'
6. All the parameter alarms for over limits and apnea alarm, will lead to the
ashing of the red alarm indicator on the panel.

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II. The Main Menu
Figure 6
Press the MENU button to enter the Main Menu to set monitor parameters
(as FIGURE 6).
WARNING
All Menu Settings are LATCHING and remain when the Monitor is
powered off. Ensure that all necessary settings are reviewed and are
suitable for the patient BEFORE use.
This menu includes the following options:
The setting menu for CO2: CO2_SETUP
The setting menu for SpO2: SpO2_SETUP
The trend menu: TREND
The time menu: TIME_SETUP
The sound menu: SOUND_SETUP
The new patient menu: NEW PATIENT
In this menu, to press or button to move the cursor up or down to
highlight an option and Press the ENTER button to select and enter the next
level of the menu. To return to the Main menu select EXIT option and press
ENTER (not available on Trend screen).

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III. CO2SET Menu
Figure 7
In this menu, press or button to move the cursor up or down, press +
button or - button to change the data highlighted by the cursor.
To return to the main menu highlight EXIT and press the ENTER
button. If you want to return the monitor to its default settings highlight
LOAD DEFAULTS and Press the ENTER button.
This menu includes the following setups:
1. The high alarm limits of EtCO2: EtCO2ALARM_H: 22-99mmHg, off
2. The low alarm limits of EtCO2: EtCO2ALARM_L: off, 10-60mmHg
3. The high alarm limits of respiration rate: RESP ALARM_H:
5-60 breaths/min, off
4. The low alarm limits of respiration rate: RESP ALARM_L: off,
4-40 breaths/min
5. Pump ow rate setup: FLOW-SET: 50cc/min-250cc/min
6. The setup of apnea time: APNEA TIME: 15s-44s, off
7. The unit of CO2: CO2UNIT: %, mmHg or kPa
8. Pump switch: ON or OFF
9. Pump auto-closing time: AUTO-OFF-TIME: 10-30min
10. Screen speed of capnograph: SWEEP SPEED: SLOW, NORMAL or FAST
11. CO2Wave scale: WAVE SCALE: 54mmHG or 76mmHG
12. EtCO2average computation time: EtCO2Averaging: every breath,
10sec, 20sec, 30sec
13. Default reload: LOAD-DEFAULTS
14. Exit: EXIT
Attention:
Pump auto-closing time means that the pump will automatically be closed
down when no respiration occurs in the set period (default 10 min).

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The wave scale means the maximum value of waveform amplitude
display but it does not mean data on full-scale. Data on full-scale still
means 99mmHg.
Default values are as follows:
EtCO2alarm high limit: 50 mmHg
EtCO2alarm low limit: 19 mmHg
RESP alarm high limit: 30 breaths/min
RESP alarm low limit: 08 breaths/min
FiCO2alarm high limit: OFF
FLOW_SET: 100 CC/Min
Apnea time: 30S
CO2unit: %
CO2_PUMP: ON
AUTO_OFF_TIME: 10 Min
SWEEP SPEED: NORMAL
EtCO2Averaging: 1 Breath
WAVE SCALE: 54mmHg
IV. SpO2SET Menu
Figure 8
In this menu, press or button to move the cursor up or down, press +
button or -button to change the data highlighted by the cursor.
To return to the main menu highlight EXIT and press the ENTER button.
If you want to return the monitor to its default settings highlight LOAD
DEFAULTS and Press the ENTER button.

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This menu includes the following setups:
1. The high alarm limits of SpO2: SpO2ALARM_H: 50%-100%, off
2. The low alarm limits of SpO2: SpO2ALARM_L: off, 50%-99%
3. The high alarm limits of pulse rate: P_RATE ALARM_H:
70-250 beats/m, OFF
4. The low alarm limits of pulse rate: P_RATE ALARM_L: OFF,
40-100 beats/m
5. Wave curve selection: CURVE WAVE: FILL or LINE
6. Renewing of defaults. LOAD DEFAULTS
The wave curve selection means that: FILL indicates the beneath part
of photoplethsmogram is lled. LINE indicates the photoplethysmogram is
drawn in curve line.
Default values as follow:
SpO2alarm high limit: 100%
SpO2alarm low limit: 92%
Pulse Rate alarm high limit: 130 beats/min.
Pulse Rate alarm low limit: 50 beats/min.
Curve: Line
V. TIME SET Menu
Figure 9
In this menu, press or button to move the cursor up or down, press
+button or -button to change the data highlighted by the cursor.
Attention: Any time adjustment will delete any stored trend data, so please
take care before making this adjustment.
The procedure is as follows:
1. Change time.
2. Move the cursor to SAVE then press the ENTER button to enter the

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following menu FIGURE 9.;
3. YES is already selected (highlighted in white) and if you wish to conrm
this change press Enter if you do not wish to conrm the change move
the cursor and highlight NO and press Enter.
4. Only by conrming can the time adjustments be made.
Figure 10
VI. Sound SET Menu
Figure 11
In this menu, press or button to move the cursor up or down, press
+button or -button to change the data highlighted by the cursor.
This menu includes following setups:
Pulse sound volume: BEEP_VOLUME: 0(OFF)-8
Alarm sound volume: ALARM_VOLUME: 0(OFF)-8

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If the alarm volume is 0, the top line in the main menu will show '!'
VII. Trend
1. The graph trend
Figure 12
The monitor stores EtCO2, PR, SpO2and PR as a group of data every
12 seconds (Adjustable in Store Interval under New Patient menu) with
accumulated trend up to 24hours respectively. The stored data is retained
even the device is shut off.
The symbol will appear on screen when the storage is full. There are three
options to further store the data.
1. Change patient ID under NEW PATIENT menu.
2. Change store mode to AUTO under NEW PATIENT menu, in auto mode
data will be stored and renewed when reaches its limits.
3. Select CLEAR MEMORY under NEW PATIENT menu to empty the stored
data.
Figure 12 shows that the time base for the trend page is 1 hours and
every point indicates the result of every 12 second. The top line of this
page indicates patient’s ID number, the start time of this page
(date/month/year hour : minute), current page no. and sum pages
(24 pages in total).