Gima CAPNO-T User manual

PROFESSIONAL MEDICAL PRODUCTS
CAPNO CUBE CAPNOGRAPH
User manual
M33831-GB-Rev.0-06.22
Imported by: Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
0482
IP33
Beijing Kingst Commercial & Trade Co., Ltd.
6th Floor, 2-7, Road Beibinhe in Xibianmen,
100045 Beijing, China
MADE IN CHINA
CAPNO-T (GIMA 33831)
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

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This Manual is written and compiled in accordance with the IEC 60601-1 (Medical
electrical equipment Part1: General requirements for safety) and the General
Principles of GB/T9969-2008 User Manual for Industrial Products issued by the
State Technological Supervision Bureau of China. It complies with both international
and enterprise standards and is also approved by State Technological Supervision
Bureau. The Manual is written for the current Capno-T Capnograph.
The Manual describes, in accordance with the Capnograph’s features and
requirements, main structure, functions, specications, correct methods for
transportation, installation, usage, operation, repair, maintenance and storage, etc.
as well as the safety procedures to protect both the user and equipment. Refer to
the respective chapters for details.
The Manual is published in English and we have the ultimate right to explain the
Manual.
All rights reserved. Marks in the Manual:
Warning: must be followed to avoid endangering the operator and/or the
patient.
Attention: must be followed to avoid causing damage to the monitor.
Note: some important information and tips about operations and application.
Caution:
Federal law restricts this device to sale
by or on the order of a physician

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Notice
Welcome to use the Capnograph
This manual includes the materials and copyright reserved. It is not allowed to
copy, reduplicate or translate into other languages without our written permission.
Please to read this manual carefully and then to operate by the instruction of this
manual.
It is not allowed to open the monitor’s cover without our permission. If any software
revisions are made, it must be updated by the factory. And the software cannot be
altered by the keyboard.
Some changes on the product due to the technologies’ promotion or due to the
special demands of user which do not inuence the monitor’s work will not be
informed further. Furthermore please pay attention to the di󰀨erence between the
parts or components and this manual. You may apply to our company for technical
documents about the electric circuit diagram relevant batch and lists of parts or
components and so on because the continuous promotion of the product. You may
contact us by means of the following address.
Beijing Kingst Commercial & Trade Co., Ltd.
Add: The 6th Floor, No.2-7, Road Beibinhe in Xibianmen, Dist. Xicheng,
Beijing, P.R.C.
Tel: [phone]
E-mail: mail@ ekingst.com Web: www.ekingst.com

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CONTENTS
Chapter 1 Preface.......................................................................................6
1.1 Brief........................................................................................................6
1.2 Warranty and Maintenance ....................................................................6
1.3 Safety Requirements..............................................................................6
Chapter 2 - Technical specications and characteristics ........................10
Chapter 3 - Introduction of Monitor............................................................13
Chapter 4 - Patient connection ...................................................................14
4.1 CO2 measurement..............................................................................14
4.2 Respiration rate measurement............................................................15
4.3 The sensor's zero................................................................................16
4.4 Notice ..................................................................................................16
Chapter 5 Screen display and Operation ................................................17
5.1 Screen main display menu..................................................................17
5.2 The Main Menu ...................................................................................20
5.3 CO2 SET Menu...................................................................................20
5.4 TIME SET Menu..................................................................................22
5.5 NEW PATIENT Menu ..........................................................................23
Chapter 6 Charging, Maintenance, Cleaning............................................23
6.1 Charge ...............................................................................................23
6.2 Maintenance.......................................................................................24
6.3 Cleaning .............................................................................................24

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Chapter 7 Trouble Shooting Analysis......................................................26
Appendix 1. Explanations of Terms in this Manual ................................27
Appendix 2. ENGINEER MENU: Changing compensation
of balance gas............................................................................................28
Appendix 3. Guidance and manufacturer’s declaration- Electromagnetic
compatibility...............................................................................................30

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Chapter 1 - Preface
1.1 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 two physiological parameters for the patient at the same
time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR).
1.2 Warranty and Maintenance
Warranty 1 Year Warranty on Hardware and Battery
This Monitor has a warranty of 12 Months from the date of purchase.
All the Accessories have a warranty of 3 months or “out of box” for Disposable
Items.
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 o󰀨 or unreadable.
Maintenance
If the monitor is non-functional outside of the warranty period, the manufacturer or
distributor will o󰀨er 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.
1.3 Safety Requirements
For the purposes of safety, please read the following and abide by these instructions
of medical instrumental products.

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Warning: Indicating the possible injury on patient or operator.
General
• Warning: To ensure accurate performance and prevent device failure, do
preventive maintenance inspection (including performance and safety check)
each 6 or 12 months to verify that the monitor operate functionally in good
condition as ensuring patient and medical personnel safety.
• Warning: Check the safety and performance of this monitor every time before
using it to ensure it works normally and safely.
• Warning: This monitor should be used for only one patient at the same time.
• Warning: This capnograph is intended only as an adjunct in patient assessment,
not a treatment device, nor an equipment used in home.
• Warning: If uncertain about the accuracy of any measurement, rst check the
patient’s vital signs by any alternate means, and then make sure the monitor is
functioning properly.
• Warning: To ensure patient safety, do not place the monitor in any position that
may cause it to fall on the patient.
• Warning: DO NOT lift the monitor by the cables and hoses of the applied parts,
as they could disconnect from the monitor, causing the monitor to fall on the patient.
• Warning: If the monitor falls o󰀨 accidentally, please do not operate it until its
safety and performance have been carefully tested and positive testing results
obtained.
• Warning: DO NOT position the sensor cables or tubing in any manner that may
cause entanglement or strangulation.
• Warning: To ensure accurate performance and prevent device failure, do not
expose the monitor to extreme moisture, such as rain.
• Warning: The use of accessories, sensors power adapter and cable other
than those specied with the equipment may result in increased emission and/or
decreased immunity of the equipment or other systems.
• Warning: CO2, respiratory rate readings and signals can be a󰀨ected by sensor
application errors, certain ambient environmental conditions, and certain patient
conditions.
• Warning: The monitor is a prescriptive device and is to be operated by qualied
healthcare personnel only.
• Warning: Dispose of the device, accessories and its packing, the local law should
be followed.
• Warning: This monitor provides End tidal CO2 (EtCO2) concentration, Respiration
Rate. This data only provides assistance for diagnosis and actual diagnosis shall
be made by suitably qualied clinical sta󰀨 using all the clinical information and

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symptoms.
• Warning: Biocompatibility tests have been performed on all the applied parts,
some exceptional allergic patients may still have anaphylaxis. Do not apply to
those who have anaphylaxis.
• Warning: do not modify this equipment without authorization from the
manufacturer.
• Warning: The setting of alarm could be restored automatically within 30 seconds
of loss of power.
• Warning: The machinery life of capnograph is 5 years. The capnograph shall be
collected and recycled in accordance with local law after 5 years. Please contact
with local agency or manufacture for any questions.
MRI scanning
• There are some electromagnetic or inductance circuit designed in the device,
use during MRIenvironment could burns or adversely a󰀨ect the MRI image or the
device’s accuracy. So the device is MR unsafe.
• Warning: Turn o󰀨 the monitor and take away the sensors from the patient during
MRI scanning. Use during MRI scanning may cause a burn to the patient and a󰀨ect
the quality of MRI image or the measurement accuracy of the monitor.
• Warning: MR-unsafe!
• Do not expose the device to a magnetic resonance (MR) environment.
• The device may present a risk of projectile injury due to the presence of
ferromagneticmaterials t hat can be attracted by the MR magnet core.
• Thermal injury and burns may occur due to the metal components of the device
that canheat du ring MR scanning.
• The device may generate artifacts in the MR im age.
• The device may not function properly due to the strong magnetic and
radiofrequency
elds generated by the MR scanner.
Alarms
• Warning: Do not silence the audible alarm if patient safety may be compromised.
• Warning: Always respond immediately to a system alarm since the patient may
not be monitored during certain alarm conditions.
• Warning: Before each use, verify that the alarm limits are appropriate for the
patient being monitored.
• Warning: Check the audible alarm silence duration before temporarily silencing
audible alarms.

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Fire Hazard
• Warning: The monitor is not suitable for use in the presence of ammable
anesthetic mixture with air, oxygen or nitrous oxide.
Electrical
• Warning: To protect against electric shock hazard, the monitor’s cover is to be
removed only by qualied service personnel. There are no user- serviceable parts
inside.
• Warning: To ensure patient electrical isolation, connect only to other equipment
with circuits that are electrically isolated.
• Warning: Refer service to qualied service personnel.
• Warning: Do not open the sensor cabinet at will, as electric shock hazard may
occur.
• Warning: Measure the device's leakage current whenever an external device is
connected to the serial port. Leakage current must not exceed 100 microamperes.
• Warning: Electrical installation of the room or the building in which the monitor
is to be used must comply with regulations specied by the country in which the
equipment is to be used.
Electro-Magnetic Interference
• Warning: Operating high frequency electrosurgical equipment in the vicinity
of the monitor can produce interference in the monitor and cause incorrect
measurements.
Indication for Use
The Capnograph is designed for monitoring the vital physiological signs of the
patient. It is use for non-invasive continuous monitoring of EtCO2 and Respiration
Rate.
The Capnograph is indicated for in patients from newborn (neonate) to adult in a
hospital
environment. It is intended to be used only under regular supervision of clinical
personnel
Contraindication
• The device should not be used as an apnea monitor.
• Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the
function of the monitor may be disturbed.

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Chapter 2 - Technical specications and characteristics
EtCO2
Method: Creative proprietary non-dispersive InfraRed Spectroscopy
Range: 0 – 150mmHg or 0 – 20kPa or 0 – 20% (v/v)
Accuracy: ±2mmHg for EtCO2 range 0 - 40mmHg ±5% for EtCO2 range
from 41 - 70mmHg ±8% for EtCO2 range from 71 - 100mmHg
Over 100mmHg ±10%
Note 1: The accuracy of CO2 concentration 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 O2 can reduce the CO2 reading (1-10%), so compensation
should be set in the balance gas MENU to meet the accuracy requirements if such
gases or vapours are present.
Note 2: The accuracy of CO2 concentration measurement is also inuenced by
Respiration rate. The corresponding relationship is as follows:
Table1 EtCO2/ Respiration Rate Accuracy
EtCO2
(mmHg)
Respiration Rate
(bpm)
Accuracy
0 - 40 0-79 ± 2 mmHg
>80 ±12%
41 - 70 0-79 ±5%
>80 ±12%
71 - 100 0-79 ±8%
>80 ±12%
>100 0-79 ±10%
>80 ±12%
Test method:
As shown in table 1, test the accuracy of dierent concentrations of gas at dierent
respiratory rates. Set up the gas ow rate of 1 L/min, the sampling rate is 100ml/
min. And then record the data.
The device in real time measures CO2 in the breathing loop, when inhaling, CO2

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in the gas loop is evacuated and its concentration measured is decreased and
reaches zero, when exhaling, CO2 enters the breathing loop and its concentration
rises rapidly and is kept at a certain platform, at the end tidal breathing it reaches
maximum. In this repeated way, a real-time and high or low waveform is
formed and by the virtue of this waveform, the device calculates the respiration
status and also by me asuring respiration cycle, the device meantime calculates
the respiration rate.
Update/Averaging Time: Option of every breath
Warm Up Time: <15 seconds
Total system response time: < 1s
Memory: 24 hours on Screen Trend and Numeric
Respiration Rate
Range: 3 - 150 rpm
Accuracy: ±1% of reading or ±1 rpm whichever is greater
Memory: 24 hours on Screen Trend and Numeric
Sensor: Adapter for intubated Patients
Alarm limit
The high alarm limits of EtCO2: 22-99mmHg
The low alarm limits of EtCO2: 10-60mmHg
The high alarm limits of respiration rate: 5-60 breaths/min
The low alarm limits of respiration rate: 4-40 breaths/min
Power
AC Input: 100V - 240V, 50Hz/60 Hz to 5VDC Adapter with 5V mini USB adapter
Cable.
Battery
Type: Built-in rechargeable lithium battery pack (3.7V, 1200mAH)
Charging Time: 4 hours from at
Operating Time: 6 hours on full charge
Operating Conditions
Temperature: 5 to 40 °C
Humidity: 30%~75%

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Atmospheric pressure: 86-106 kPa
Storage Conditions
Temperature: -20 to +55oC
Relative Humidity:<93% (non-condensing) = < 29.45 hPa
Atmospheric pressure: 50 - 120 kPa
Dimensions of Monitor
Size: 38 x 42 x 44mm (W x H x D)
Weight: 80g (including lithium battery and adult airway adapter)
Warranty & Maintenance/ Calibration
One year warranty on Main Unit and Lithium Ion Rechargeable Battery
IP rating
IP33
93/42/EEC Medical Device Directive Compliant EC-Representative:
SUNGO Europe B.V. Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Type of Protection
Class II
Degree of Protection: Type BF-Applied Part
Mode of Operation: Continuous

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Chapter 3 - Introduction of Monitor
Figure 1
(1) Screen: Displays waves, menu, alarm and all measuring parameters.
(2) S button: Press this button to move the cursor when menu is activated.
(3) +/ Multifunction button
a) When menu is activated, to press this button as conrmation button or increase
(+) button.
b) In the main screen, if the bluetooth printer is equipped, to press this button for
two seconds to drive the printer to print CO2 reaction curve and result data of all
parameters.
(4) Multifunction button
a) When menu is activated, to press this button to decrease data selected.
b) In the main display screen, to press this button to silence alarm for two minutes.
c) In the main display screen, to press this button over 2 seconds, the display
screen will change to big font display mode as the gure showing:

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Figure 2
(5): Multifunction button
a) Power switch, to press this button for two seconds to turn on or turn o󰀨 power.
b) To press this button and quickly be o󰀨 the button to enter or quit the menu.
(6) Light indicator: Flickering green light indicates power adapter is connected and
green light indicates the device begins to work.
(7) Battery compartment location
(8) DC5V Mini USB Charging interface. Note: this interface must only be connected
to a device which meets safety standards.
(9) Hanging Point for Lanyard if required.
(10) Airway adapter
Note: The direction sensor is installed in the device so the screen display direction
will be automatically adjusted according to the vertical direction of the device.
Chapter 4 - Patient connection
4.1 CO2 measurement
Usage of the monitor
The device is a solid mainstream CO2 sensor and user can use it immediately
without calibration.

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Theory introduction
The principle is based on the fact that CO2 molecules absorb infrared light energy
of specic wavelengths, with the amount of energy absorbed being directly related
to the CO2 concentration. When an IR light beam is passed through a gas sample
containing CO2, the electronic signal from a infrared sensor (which measures
the remaining light energy), can be obtained. This signal is then compared to the
energy of the IR source, and calibrated to accurately reect CO2 concentration in
the sample. To calibrated, the infrared sensor’s response to a known concentration
of CO2 is stored in the monitor’s memory.
In addition, the circuit module has the atmospheres absolute pressure sensors.
Modules can measure atmospheric pressure, and atmospheric pressure can
compensate the calculation for the concentrations of carbon dioxide which improve
the design accuracy.
Then the monitor (CO2 module) determines CO2 concentration in the breathing
gases by measuring the amount of light absorbed by these gases. EtCO2 is display
as a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals
(kPa). In addition, a CO2 waveform (capnogram) may be displayed which is a
valuable clinical tool that can be used to assess patient airway integrity and proper
endotracheal tube placement. Respiration rate is calculated by measuring the time
interval between detected breaths.
Connection and Installation
1) Install the airway adapter on the monitor
2) Install the monitor in the patient’s gas loop
Figure 3
4.2 Respiration rate measurement
The calculation of respiration rate derives from monitoring the wave of CO2.

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4.3 The sensor's zero
1). Zero
The vapour-prevent window of the airway adapter has a certain attenuation to
infrared signal but due to individual diversity, its attenuation is di󰀨erent. So the
sensor needs to be zeroed when changing new adapter. In addition, the sensor and
in fared source have a certain of drifting, the sensor need to be zeroed after long
usage, if the data is not correct, sensor also needs zero.
Attention: Zero needs to be careful, otherwise the false zero calibration will cause
deviation of measurement data. 2). Zero method:
Connect the probe with host and warm up 5-10 minutes. Input the device into
space without CO2 and attention, do not breathe near it. Then, enter CO2 setting
submenu, move cursor to’ZERO’, if this item is high-luminance colour, that means
the sensor's data is stable and can make zero. Then press +/ button, send zero
order and ‘ZEROING’ will be shown and wait for 15-20 seconds till ‘ZEROING’
disappears.
4.4 Notice
Caution: Under the conditions of electromagnetic inuence, for example:
electrosurgical devices, MRI, CT etc. will cause negative impact.
Attention: indicating other important information.
The readings of CO2 may be wrong if the monitor does not warm up.
Use the airway adapter only provided by the manufacturer otherwise, measurement
data might be not correct.
Measurement data might not be correct if under strenuous temperature changing
surrounding. Therefore, if short temperature change comes beyond a certain
range, ‘TEMP IMBALANCE’ will be shown on the screen, so should better use
under stable temperature surrounding. When patient is used with anaesthesia
gas, the measurement data will be a little bit inuenced. If needs to calibrate on
anaesthesia gas, please refer to Appendix 2. Warning:
The power adapter with naked electric point must not be applied- Dangerous for
electric shock!

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Chapter 5 - Screen display and Operation
5.1 Screen main display menu
Figure 4
1. The rst line of data shows time (hour, minute)/patient ID, the memory area full
indicator ) , 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 e󰀨ectively, you need to enter the NEW
PATIENT menu to delete the data in the storage area, or to change patient ID.,
beside you can set up trend RENEW into AOTO mode, please see the details in
5.5 NEW PATIENT
b) 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).
2. The other part of the screen shows results data and waves: EtCO2 concentration,
respiratory rate, exhaling or inhaling state (during exhaling, becomes blue
colour),CO2 respiratory wave.
3. It also shows the status, e.g. when take out airway adapter, ’NO ADAPTER’ will
be shown on the screen, when the probe needs zero calibration, ’ZERO REQ’ will
be shown on the screen to indicate that probe might need zero calibration.

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Alarm setting:
The alarm settings of the system will not change after shutting down the power of
capnograph.
Alarming level:
There are two types of alarming: physiological alarm and technical alarm.
Physiological alarm refers to the alarm causing by physiological change of patient,
patient’s life may in danger. Technical alarm refers to system fault which cause
capnograph working unproperly or providing unreliable readings. This capnograph
adopt only medium priority alarm as there are three level of alarming. Level of
alarm is preset by system, which cannot be changed by medical personnel.
Medium priority alarm means serious warning.
Warning: Medical personnel should set alarm limit based on clinical experience.
DO NOT set value over maximum limit of alarm.
Warning: Same or similar device with di󰀨erent setting of alarm may cause potential
danger in isolated area like ICU or operating room.
Please refer to the content of menu setting of CO2.
It is critical to set alarm of physiological parameter which gives alarm clinical
signicance.
Alarm delay:
The sum of maximum delay of alarming state and signal generation is less than
10 seconds.
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.
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 no CO2 detected alarm is turned on and no CO2 detected occurs the
monitor will give a audio/visual alarm. The screen will ash the message ‘APNEA’
(meaning no EtCO2 has been detected for a certain time period) and ‘Beep’ sound
will also be heard.
4) Symbol of parameter will turn yellow and blink if any over ranging parameter
triggers alarm.

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Alarm sound:
Alarm sounds as following description. Time interval cannot be changed.
Level of alarm Sound Sound
pressure
Medium priority alarm Beep-Beep Beep”, triggered
each 8 seconds 45-70dB
Alarm light:
Alarm light looks like following description
Level of alarm Light
Intermediat alarm Parameter indicator turn yellow, blinking with
frequency of 0.5Hz
Alarm silence:
In the main display screen (menu is not open), to press the button to silence
alarm for two minutes and meantime, trumpet icon becomes , two minutes later,
trumpet icon becomes , meanwhile, alarm begins to
work if there is sound alarm. If to press the button in this period, the silence
alarm can be released. Silence alarm time will not vary with operator. When silence
alarm is on, physical alarm and technical alarm both will be silent.
Alarm counterplan:
WARNING: Always check status of patient as alarm is triggered.
Check the alarm information displayed on the screen, correctly identify the alarm,
and reasonably handle the alarm according to the cause of the alarm.
Check patient’s status.
Identify type or parameter of alarming.
Find the reason.
Turn o󰀨 alarming if necessary.
Check alarm after removing alarming condition.

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5.2 The Main Menu
Figure 5
In the main display screen, to press the button to enter the setup menu, see
the picture above.
In this menu, to press button S to move the cursor to choose item.
In this menu, to press button +/ to enter the next submenu, to press again
to go back to the main display screen.
This menu includes the following options:
The setting menu for CO2: CO2_SETUP.
The time menu: TIME_SETUP
The new patient menu: NEW PATIENT.
WARNING: All Menu Settings are LATCHING and remain when the Monitor is
powered o󰀨. Ensure that all necessary settings are reviewed and are suitable
for the patient BEFORE use.
5.3 CO2 SET Menu
Figura 6