CO2 Insufflator

User Manual
 Catalogue
Foreword........................................................................2
1. P r o d u c t I n t r o d u c t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1、Application Scope........................................................3
1.2、Summarize..............................................................3
1.3、Applicable Department..................................................3
1.4、Contraindication .......................................................3
1.5、Serious Warning........................................................3
1.6、Internal and External Markers............................................4
2. Pr oduc t Us e................................................................5
2.1 Environmental Requirements and Working Conditions.........................5
2.2 Electrical Safety ........................................................5
2.3 Power Supply .............................................................5
2.4 Structural Composition...................................................5
2.5 Preparation before Installation..........................................6
2.6 Install.................................................................6
2.7 Use.................................................................6
3. Maintenance..............................................................7
3.1 Daily Inspection.........................................................7
3.2 Cleaning、Disinfect、Sterilization........................................7
3.3 Fault Analysis and Troubleshooting........................................8
3.4 Fuse Converter Replacement..............................................9
3.5 Filter Replacement.......................................................9
4. Tr an s p o r t at i o n an d S t o r ag e C o n d i t i o n s ............................................ 9
4.1 Transportation、Storage...................................................9
5. A f t er -s al e Ser v i c e........................................................9
5.1Manufacturer Commitment.....................................9
5.2 Customer Service ......................................................10
6 . E l e c t r o m a g n e t i c C o m p a t i b i l i t y （ E M C） . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

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 Foreword

Thank you for choosing the CO2 Insufflator made by our company

To ensure the safety of the patients and the users,product users should have
relevant professional knowledge and skills. Before using the product,please read this
manual carefully,use in strict accordance with the scope of application of the product,
pay attention to the contraindications of the product, and fully understand the use of
CO2 Insufflator. If the Insufflator is to be used with other equipment, the user shall be
trained in the use of the other equipment. If there is a problem in the use of the
Insufflator, please contact the local distributor or our company, we will provide you
with good service and assistance. This will help you to carry out the follow-up work
and make the operation proceed smoothly.

Thank you for your cooperation!

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 І. Product Introduction
1.1 Application Scope
For the establishment and maintenance of pneumoperitoneum during endoscopic diagnosis,
treatment, and surgery.
1.2 Summarize
1.2.1 Security Type:
1.2.1.1 Classified by electrical safety: Class I type BF equipment；
1.2.1.2 Classified by the protection of harmful liquid: conventional equipment IPX0.
1.2.1.3 Classified by use environment: Not of type AP or APG equipment;
1.2.2 Function: Using the function of controlled gas pressure to stabilize the output gas.
Transfer and control the medical CO2 gas safely into the abdominal cavity and
expand the abdominal cavity.
1.2.3 rate of flow: Four gear;
1.2.4 Indicate: the actual pressure, gas consumption, pressure, flow rate setting liquid crystal
display.
1.2.5 Operation mode: continuous operation。
1.2.6 Input power: 160VA.
1.2.7 Pressure adjustment range on the control panel: 5mmHg~30mmHg(Booting default
14mmHg).
1.2.8 Alarm pressure value: the alarm pressure difference of the over-pressure alarm of
pneumoperitoneum machine is 4mmHg, and the tolerance is 266.6Pa(2mmHg).
1.3 Applicable Department
Alarm pressure value: the alarm pressure difference of the over-pressure alarm of
pneumoperitoneum machine is 4mmHg, and the tolerance is 266.6Pa(2mmHg).
1.4 Contraindication
▲Patients with acute infectious diseases；
▲Patient with severe cardiopulmonary insufficiency；
▲Patients with uncontrolled hypertension；
▲Patient with mental disorders cannot cooperate；
▲Patient with allergic constitution and doctors think not appropriate disease.

1.5 Serious Warning

● For use during treatment, please prepare another similar device for backup.
● If the corresponding condition with laparoscopy is contraindicated, the use of the device is
also contraindicated.
● Too fast flow rate and too high pressure may lead to excessive absorption of CO2. The
abdominal cavity can be fully expanded in the range of 15-20mmHg. Therefore, the

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 intra-abdominal pressure generally does not need to exceed 20mmHg. Little absorption
exists at this pressure level. In fact, the pressure does not need to exceed 20mmHg at all,
while more than 20mmHg increases the absorption amount and absorption speed.
● Full breathing helps to avoid CO2-related problems.
● The CO2 Insufflator used during the operation should have a flow rate of at least 4-10L/min,
and a flow rate below this value should only be used in the diagnosis.
● Hypothermia. High flow rates can potentially cause the risk of hypothermia.

1.6 Internal and External Markers

Table 1.一
Logo in File Meaning device implication
flag
General safety precautions listed in
the sections Type BF equipment

Equipment/compon
Electronic hazards, warnings, and
ents can be
other notes on electronic operations
recycled
Notes that can cause property or
Identify the switch or
system failures in potentially
the switch position
hazardous situations

Refer to instructions Fragile

Waste electrical and electronic

equipment with separate handling
Upward
signs（Please comply with the local
laws and regulations）

Date of manufacture Afraid of rain

Manufacturer

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 Ⅱ. Product Use
2.1 Environmental Requirements and Working Conditions
The operating environment and working conditions are as follows
Environmental temperature:+5℃～+40℃；
Relative humidity:≤80％；
Atmospheric pressure: 860hPa～1060hPa
Clean room without corrosive gas and good ventilation.
2.2 Electrical Safety
The safety performance of the equipment fully meets the mandatory standards and
requirements of: GB9706.1- -2007 Medical Electrical Equipment- -Part 1: General Safety
Requirements.
2.3 Power Supply
Single-phase AC, voltage of 220V, frequency of 50Hz.
2.4 Structural composition
The product consists of a pneumoperitoneum mainframe (switching power supply, pressure
control, processing \ display module, shell composition), carbon dioxide pressure reducing valve,
high pressure tube, quick connector, cup connector, disposable filter and silicone tube.
Schematic diagram of the main machine:

(Front side)
1.Power switch 2.Display 3.Application port 4. Host

(Back side)
1.Air inlet connection 2.Protective earth 3.Socket 4.Name plate
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2.5 Pre-installation preparation
●. If cylinders with a volume of more than 2 litres are used, a separate fixing bracket should be
used to secure the cylinder to prevent it from tipping over.
●. Attach the pressure reducer to the gas cylinder or medical CO2 central supply connection and
secure it securely to ensure that no gas escapes in the event of an open circuit.
●. Make sure that the gas supply is sufficient, if not, have a bottle of medical CO2 with a purity
higher than 95% available for use if the gas consumption is higher than expected.
●. If the unit is using a disposable inflation tube, check that the packaging is not damaged and that
the expiry date has not been exceeded.
2.6 Installation
●. Connect one end of the gas supply tube with quick coupling to the output port of the CO2
pressure reducing valve and lock it in place.
●. Connect one end of the silicone tubing with the filter to the outlet connection on the main unit
panel and the other end to the pneumoperitoneum needle of the unit to be used. After the
pneumoperitoneum has been established transfer to the air inlet channel of the puncturer.
●. Connect the main unit to the 220 VAC network power supply using the three-pronged power
cable.
2.7 Use
2.7.1 Normal use
●. After confirming the performance of the product, plug one end of the special power cable
(female plug) supplied with the machine firmly into the power socket on the rear panel of the
machine, and the other end of the cable (male plug) into a three-eye single-phase 220V power
socket with a reliable earth wire. After installation and commissioning, the pneumoperitoneum
needle, which has obtained the medical device registration certificate and passed the test, is
connected. Insert the pneumoperitoneum needle into the cavity, select the appropriate pressure
and flow rate and then turn on the start/stop button. The user can set the pressure, flow rate and
whether to take the gas heating effect according to the need to choose between the adjustment to
achieve clinical needs. After turning on the working switch and connecting to the front panel outlet
port, the pneumoperitoneum is established according to the prescribed medical-technical
diagnosis and treatment standard specifications.
●. After use, first turn off the cylinder and allow the pneumoperitoneum to continue to work
unloaded for approximately 2 minutes, wait to remove any remaining gas that may be present in
the tubing, disconnect the power switch and disassemble the components. Proceed to the next
step according to the cleaning and disinfection and medical waste disposal procedures.
2.7.2 Safety instructions
The equipment must be used and operated in accordance with the requirements set out in these
instructions. To prevent malfunctions in equipment and safety caused by misuse, please read this
chapter carefully.
2.7.3 Precautions
●. The equipment must be operated by qualified medical personnel who have read these
instructions carefully and in strict compliance with these instructions.
●. The equipment must be connected to a single-phase 220V AC three-eye outlet with a reliable
earth connection using the supplied power cable.
●. Wherever possible, pulling of the power cable should be avoided, and the power cable should
be kept clean for the excess portion.
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●. Keep the system as far away as possible from generators, X-ray equipment, broadcasting
stations and transmission lines to avoid electromagnetic interference.
●. Ensure that the electrical installation of the relevant operating theatre complies with local
regulations and requirements.
●. The product will not produce waste and residues during normal use, but if the product is
scrapped at the end of its useful life, its metal, electronics, plastic and other materials should be
disposed of in a uniform and strict manner as medical device waste to prevent its spread or reuse
and to minimise the risk of environmental pollution.

2.7.4 Attention
●. Make sure that the gas used is medical carbon dioxide gas.
The safety and effectiveness of the product should not be judged by the value displayed on
the pressure reducing gauge, but by whether or not the protective device has operated.
●. When starting to inject gas, the set pressure should be 6 mmHg and the flow rate 10
L/min to give the body a chance to adapt to the pressure changes in the abdominal cavity.
●. If a circuit diagram and a list of components are required, please consult the
manufacturer.

III. Maintenance
3.1 Daily checks
●. Whether the power switch is working properly and whether there is any mechanical damage.
●. Whether the carbon dioxide pressure reducing valve is damaged.
●. Is there any air leakage at the pipe interface and is the silicone tube deformed?
●. Are the panel buttons working properly?
●. Whether the overpressure protection is working properly.
Calibration of the CO2 pressure reducing valve: Connect the gas source and connect a calibrated
pressure gauge (with suitable accuracy and range) to the output port of the pressure reducing
valve for calibration.
3.2 Cleaning, disinfection and sterilisation
Note: Using units are required to monitor the cleaning, disinfection and sterilization effects
according to the requirements stipulated in WS/T 367-2012 Technical Specification for
Disinfection in Medical Institutions and GB 15982-2012 Hygiene Standards for Medical
Disinfection.
● Use medical alcohol to clean the exterior of the equipment (main body).
● Silicone tubes, quick connectors and cup connectors can be sterilized by autoclaving, high
temperature 134°C, 0.210MPa,20min.
To keep the system clean, gently wipe the unit with a soft, damp cloth (gauze) soaked in warm
water or with detergent, at least once a month, but absolutely avoid penetration of liquids inside
the system unit.
● Do not use dilute ethylene oxide or other organic solutions to prevent damage to the system
casing, nor any solvents, polishes and shiners.
● Avoid the use of flammable and explosive liquids for cleaning and disinfection, if this is
unavoidable, these must be evaporated before opening the unit.

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 Attention: The internal parts of the product do not require user maintenance.
3.3 Failure Analysis and Removal
If the machine breaks down, please check it yourself according to the table below before
contacting your service provider. If the problem persists, please contact our service technical
department or the designated unit. Frequently occurring problems can be easily solved by
checking for seemingly obvious and easily overlooked problems. Doing some simple checks
beforehand can save your time and money.
Failure phenomena Methods
-Check that the power cable is connected
-Check for the presence of single-phase AC
power in the connected system
Power light does not come on when the
-Check for blown fuses at the rear of the unit
power switch is turned on
-Check that the panel is not powered up, if so the
power switch may be damaged, please contact
our service department
The display does not light up or is missing Please contact our service department
segments when the power switch is
turned on
Self-test does not sound through the Please contact our service department
speaker after turning on the power switch
-Check that the air outlet switch is pressed and
that the indicator light is on
-Check that there is air at the gas source
-Check that the CO2 reducer pressure is not too
No gas output low
-Check that the air circuit is correctly connected
-Check if there is a sound of the solenoid valve
operating, if not please contact our service
department
Pneumoperitoneum cannot be completed, If the above situation disappears, the silicone
the pressure display pulsates frequently tube or the pneumoperitoneum needle is blocked
and there is an alarm sound and can be unblocked.
-Check that the pressure setting or flow rate
Pneumoperitoneum not effective,
setting is not too low
pneumoperitoneum speed too slow
-Check for serious leaks in the connections.
Pneumoperitoneum speed too fast, -Check that the pressure setting or flow rate

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 pressure in the chamber too high setting is not too high
No change in gas temperature after the Please contact our service department
heating function has been turned on for a
period of time

3.4 Fuse replacement

The fuse on the back panel of the two network power inlet fuse specification T3AL250V even
if the equipment is not faulty, long-term use of the fuse will also fuse (caused by gas leakage and
oxidation), when the power switch is turned on the equipment does not have any response, that is,
the fuse may be damaged, should be replaced with the same type and specifications of the fuse
(generally two at the same time to replace). When replacing, the power switch should be in the “off”
state, and unplug the power cable, use a screwdriver to help pull out the fuse box, replace the new
fuse and then reset the fuse box.

3.5 Filter replacement

The air outlet connection (13) on the front panel connects to the single-use filter. Even if the filter is
used without fault, it should be replaced for the next surgical use. To replace it, the unit is placed in
standby mode and the air outlet is manually plugged in at one end and the silicone tube at the
other. The pneumoperitoneum is delivered with a brand new filter for the customer's use, please
contact our sales and service department for replacement.
The use of disposable filters is highly recommended to prevent cross-contamination of patients.

IV. Transport and storage conditions

4.1 Transport, storage
●.Transport
This machine is an electronic apparatus and should not be subjected to serious vibration,
collision or rain during transport.
Packaging markings: see Table 1
●.Storage
Ambient temperature: -5 °C to +40 °C.
Relative humidity: ≤ 80%.
Atmospheric pressure: 860hPa～1060hPa
Clean room without corrosive gases and good ventilation.

V. After Sales Service

5.1 Manufacturer's commitment
● The manufacturer or its authorised dealer is responsible for the repair and maintenance of the
main unit within 12 months of delivery, provided that the user observes the rules of use, storage,
transport and maintenance, and is only charged for the cost of replacement parts and postage.
● The manufacturer performs maintenance on products outside the warranty period, and
charges are charged on a preferential basis depending on the circumstances.
● The user is responsible for any damage to the product or accidents caused by disassembly
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and maintenance without the consent of the company.
5.2 Customer Services

●Product recycling
Disposal of air-bellies at the end of their use: non-degradable objects.
Recommendation: end-of-life pneumatophores should be recycled by special environmental
authorities.
● Warranty
The product is guaranteed for 1 year from the date of sale.

Attention: For infectious safety reasons, please ensure that any equipment is completely
washed and disinfected before returning it to us for servicing, and please advise the factory if the
equipment is to be used by HA-positive patients or other infectious patients.
Production date and use by date
Date of manufacture: see product label for details.
Use by date: 5 years.

VI. Electromagnetic compatibility (EMC)

For this CO2 Insufflator, special precautions regarding electromagnetic
compatibility (EMC) are required, and must be installed and used in accordance with
the EMC information specified in this manual.
Portable and mobile RF communications may have an effect on this endoscopic
camera system.

The use of accessories and cables (transducers) other than those sold as spare
parts for internal components may result in increased emission or reduced immunity
of the CO2 Insufflator or system.
The CO2 Insufflator or system should not be used in close proximity to or stacked
with other CO2 Insufflator machines. If it must be used in close proximity or stacked, it
should be observed to verify proper operation in the configuration in which it is used.

Electromagnetic Compatibility Information

When using this equipment the cables and accessories provided must be used,
the cable information is as follows：
Cable Name Length
Power cord (10A) 1.9 meter

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Basic Performance
Name Specific Description
In the state of interference, the LCD display shows normally,
Operating
and the gas output is continuous without any sudden speed
mode
up or slow down.

Guidelines and manufacturer's statements - electromagnetic emissions

The CO2 Insufflator is expected to be used in the electromagnetic environment specified
below, and the purchaser or user shall ensure that it is used in such electromagnetic
environment.
Emission test Conforman Electromagnetic Environment - Guidance
ce
Radio Frequency The CO2 Insufflator uses RF energy only for its
Emission internal functions, so its RF emissions are low and
Group 1
GB 4824 there is little potential for interference with nearby
endoscopic camera systems
Radio Frequency
Emission GB Class B
4824
Harmonic
The equipment is suitable for use in all facilities,
Radiation GB Class A
including domestic and direct connection to the
17625.1
residential public low-voltage supply network for
Voltage
domestic use.
Fluctuation /
Flicker Emission Conformity
GB 17625.2

Guidelines and Manufacturer's Declarations - Electromagnetic Immunity

The CO2 Insufflator is expected to be used in the electromagnetic environment specified
below, and the purchaser or user shall ensure that it is used in the electromagnetic environment
specified.
Compliant Electromagnetic
Immunity test Experimental Level
Level Environment - Guidelines
The flooring should be wood,
±6kV Contact
Electrostatic ±6kV Contact concrete or tile. If the floor is
Discharge
Discharge (ESD) Discharge covered with synthetic material,
±8kV Air
GB/T 17626.2 ±8kV Air Discharge the relative humidity should be
Discharge
at least 30%.
Electric fast ±2kV to power The network power supply
±2kV to power lines
transient pulse line should be of a quality typical of
±1kV to input/output
train GB/T ±1kV Not use in a commercial or hospital
lines
17626.4 applicable environment.
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 ±1kV line to The network power supply
Surge GB/T ±1kV line to line line should be of a quality typical of
17626.5 ±2kV line-to-ground ±2kV use in a commercial or hospital
line-to-ground environment.
< 5% UT for
0.5 cycles (on
The network power supply
UT, > 95%
should be of a quality typical of
< 5% UT for 0.5 cycles respite)
Voltage use in a commercial or hospital
(on UT, > 95% respite) 40% UT for 5
transients, short environment. If the user of the
40% UT for 5 cycles (on cycles (on UT,
interruptions and CO2 Insufflator requires
UT, 60% respite) 60% respite)
voltage variations continuous operation during
70% UT for 25 cycles 70% UT for 25
on the power power interruptions, it is
(on UT, 30% respite) cycles (on UT,
input line recommended that the CO2
< 5% UT for 5s 30% respite)
GB/T 17626.11 Insufflator be powered by an
(on UT, > 95% respite) < 5% UT for
uninterruptible power supply or
5s
battery.
(on UT, > 95%
respite)
Industrial The FT magnetic field should
frequency have the FT magnetic field
magnetic field 3 A/m 3 A/m level characteristics typical of a
(50Hz) site in a typical commercial or
GB/T 17262.8 hospital environment
Note: UT refers to the AC network voltage before the test voltage is applied.

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 Guidance and Manufacturer's Statement - Electromagnetic Immunity
The CO2 Insufflator is expected to be used in the following specified electromagnetic
environment and the purchaser or user shall ensure that it is used in such electromagnetic
environment:
Experimental Electromagnetic
Immunity test Compliant Level
Level Environment - Guidance
Portable and mobile RF
communication endoscopic
camera systems should not be
used closer to any part of the
CO2 Insufflator than the
recommended isolation
distance, including cables. This
distance is calculated by the
formula corresponding to the
transmitter frequency
Recommended isolation
distance
d = 1 .2 P
d = 1 .2 P 80 MHz ～ 800
MHz
d = 2 .3 P 800 MHz ～ 2.5
GHz
Radio frequency
In the formula：
conduction 3 V（Effective value）
3 V（Effective value） P - the maximum rated
GB/T 17262.6 150kHz - 80MHz
output power of the transmitter
Radio frequency 3 V/m
3 V/m in watts (W), according to the
radiation 80MHZ - 2.5GHZ
transmitter manufacturer.
GB/T 17262.3
d - is the recommended
isolation distance in meters
(m).
The field strength of the fixed
RF transmitter is determined by
surveying the electromagnetic
field house a, which should be
lower than the compliance level
b in each frequency range.
Interference may occur in the
vicinity of electric
hysterectomies and
accompanying surgical
instruments marked with the
following symbols

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Note 1: At 80 MHz and 800 MHz frequencies, the formula for the higher frequency band is used.
Note 2: These guidelines may not be appropriate in all cases. Electromagnetic propagation is influenced by
absorption and reflection from buildings, objects and the human body.
a fixed transmitters, such as: base stations for wireless (cellular / cordless) phones and terrestrial mobile
radios, amateur radio, AM and FM radio broadcasts and television broadcasts, etc., the field strength of which
cannot be accurately predicted in theory. To assess the electromagnetic environment of fixed RF transmitters, a
survey of the electromagnetic field site should be considered. If the field strength of the site where the air-bellied
machine is located is measured to be higher than the applicable RF compliance level described above, the CO2
Insufflator should be observed to verify that it can operate properly. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or repositioning the CO2 Insufflator.
bThe field strength should be less than 3 V/ M over the entire frequency range of 150 kHz - 80 MHz.

Recommended isolation distance between portable and mobile RF communication CO2

Insufflator and CO2 Insufflator.
The CO2 Insufflator is intended for use in electromagnetic environments with controlled RF
radiated disturbances. Based on the maximum rated output power of the communications CO2
Insufflator, the purchaser or user can prevent electromagnetic interference by maintaining the
minimum distance between the portable and mobile RF communications CO2 Insufflator
(transmitter) and the CO2 Insufflator as recommended below.
Transmitter Isolation Distance/m for different frequencies of corresponding transmitters
maximum rated 150kHz - 80MHz 80MHz - 800MHz
800MHz - 2.5GHz
output power
d = 1 .2 P d = 1 .2 P d = 2 .3 P
(W)
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitter maximum output power ratings not listed in the table above, the
recommended isolation distance, d, in meters (m), can be determined using the formula in the
corresponding transmitter frequency column, where P is the maximum transmitter output power
rating provided by the transmitter manufacturer. Measured in watts (W).
Note 1: At the 80 MHz and 800 MHz frequency points, the formula for the higher frequency
band is used.
Note 2: These guidelines may not be appropriate in all cases, electromagnetic propagation is
affected by absorption and reflection from buildings, objects and the human body.

Date of compilation (revision): May 16, 2022

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 Shenzhen New Concept Med Tec. Co., Ltd

Product Warranty
File number: NCM-XS003-001-2021A
Product warranty terms:
Shenzhen New Concept Medical Technology Co., Ltd. in order to make the
majority of users satisfied, convenient and easy to use our products, with strict reference to
the content of the relevant laws and regulations in force in the country and other specific
provisions, we have developed our after-sales service system.
1、The user should fill out the warranty form completely with the personal information of our
sales manager when purchasing our products.
2、Service period.
The company promises that if the product fails during normal use within 7 days from the
date of sale, the user can choose to exchange or repair the product for free. Users
purchase the product within three years of normal use failure, the company is responsible
for free maintenance, (excluding the replacement of major components, if you need to
replace the material costs will be charged) lifetime technical support, and use of
counseling.
3、Purchase date: Subject to the invoice date of our company or authorized dealer.
One of the following conditions cannot enjoy our free service.
① equipment non-natural damage: including non-normal use environment work, not in
accordance with the provisions of the manual operation and human factors caused by the
failure and damage, etc..
② without the consent of the Company, the user's private disassembly and modification.
③ cannot present the invoice of valid purchase, and no warranty sheet.
④ Accessories, auxiliary devices and transportation costs of the product.

...................................................
Product name: CO2 Insufflator Stamp:

Product batch number: Date of purchase:

User information: (Note that the following users should fill in properly and carefully after
purchase and keep it properly)
Unit: Contact phone number:
Address:
Zip Code:
Repair record:
Repairer employee
Date Damaged part Reason Inspection
number

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