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