Surgiquest AirSeal iFS User manual

EN
Instructions for use

SurgiQuest, Inc.
488 Wheelers Farms Road
Milford, CT 06461, USA
Ph: +1.203.799.2400
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299
Type: F121/10000013799 Revision 13/2017-08/Manzano
Manufactured for:
CE marking according to Directive 93/42/EEC
0086
This manual contains information that is subject to copyright.
All rights reserved. This manual should not be photocopied, du-
plicated on microfilm or otherwise copied or distributed, com-
pletely or in part, without the approval of SURGIQUEST.
Some of the parts and equipment referred to in this manual bear registered
trademarks but are not identified as such. It should therefore not be assumed
that the absence of the trademark indicates that any given designation is not
subject to trademark protection.
Users of SURGIQUEST products should not hesitate to point out to us any er-
rors or unclarities in this manual.
Copyright © SURGIQUEST, Inc.
EN

Symbols
EN
Follow instruc-
tions for use
(white image on a
blue background)
Serial number Stop Start
Consult instruc-
tions for use
Date of manufac-
ture (YYYY-
MMDD) Home Reset key
Caution Use by date
(YYYY-MMDD) Menu Not made with
natural rubber
latex
Electrostatic sen-
sitive devices Quantity Information key Protective
earth(Ground)
Type BF applied
part Increase Back to menu Non-ionizing elec-
tromagnetic radi-
ation
Equipotentiality Decrease House gas supply
full
Degrees of protec-
tion provided by
enclosures
(IPCode)
Keep dry House gas supply
low
Alternating cur-
rent Top-Bottom Gas bottle full
(> 40 bar)
Service Fragile Low supply gas
bottle
(30 - 40 bar)
Catalogue num-
ber Waste manage-
ment
Low supply gas
bottle (15 - 30
bar)
Do not reuse Manufacturer Too low supply
gas bottle (5 - 15
bar)
Sterilized using
ethylene oxide
Do not use if
package is dama-
ged
Gas bottle empty
(0-5 bar)
Sterilized using
ethylene irradia-
tion
Keep away from
sunlight Do not resterilize
Batch code Authorized for
Sale or use by Phy-
sician only
On/Off (push but-
ton)


1
EN
Table of contents
1 Important User Notes ......................................................................................................................................................... 3
2 Safety Information.............................................................................................................................................................. 4
2.1 Hazards........................................................................................................................................................................................ 4
3 Device Purpose.................................................................................................................................................................... 7
3.1 Device-inherent Dangers ....................................................................................................................................................... 7
4 Initial Device Startup .......................................................................................................................................................... 12
4.1 Device Setup and Connection............................................................................................................................................... 12
4.2 Gas Connection......................................................................................................................................................................... 13
4.2.1 Connecting a Gas Cylinder..................................................................................................................................................... 14
4.2.2 Connecting to Central Gas Supply....................................................................................................................................... 14
4.2.3 Gas Consumption Display...................................................................................................................................................... 15
5 Operating the Device.......................................................................................................................................................... 17
5.1 Device Front ............................................................................................................................................................................... 17
5.2 Device Rear................................................................................................................................................................................. 17
5.3 Bottom of the Device .............................................................................................................................................................. 17
5.4 Display ......................................................................................................................................................................................... 18
5.5 Switch Device On...................................................................................................................................................................... 18
5.5.1 Selecting Operating Mode..................................................................................................................................................... 19
5.5.2 Insufflation Tube Sets ............................................................................................................................................................. 19
5.5.3 Starting/Stopping Insufflation............................................................................................................................................. 20
5.5.4 Power Device Off ...................................................................................................................................................................... 21
6 Using and Controlling the AirSeal® iFS in its Different Modes........................................................................................... 22
6.1 AirSeal Mode.............................................................................................................................................................................. 22
6.1.1 AirSeal® Access Port ................................................................................................................................................................ 22
6.1.2 Initial Insufflation..................................................................................................................................................................... 23
6.2 Smoke Evacuation Mode........................................................................................................................................................ 26
6.3 Standard Insufflation Mode.................................................................................................................................................. 28
7 Safety Functions.................................................................................................................................................................. 31
7.1 General Safety Functions ....................................................................................................................................................... 31
7.2 Contamination Alarm ............................................................................................................................................................. 31
7.3 Safety Functions in AirSeal Mode........................................................................................................................................ 32
7.4 Fill Level Display........................................................................................................................................................................ 32
8 User Menu........................................................................................................................................................................... 33
8.1 Setting First Nominal Pressure............................................................................................................................................. 34
8.2 Gas Flow Rates .......................................................................................................................................................................... 34
8.3 Setting Smoke Evacuation Level .......................................................................................................................................... 34
8.4 Setting General Volume ......................................................................................................................................................... 34
8.5 Setting Brightness.................................................................................................................................................................... 34
8.6 Setting Audible Occlusion Signal......................................................................................................................................... 35
8.7 Setting Gas Supply................................................................................................................................................................... 35
8.8 Setting the Language.............................................................................................................................................................. 35
8.9 Checking Software Version.................................................................................................................................................... 35
8.10 Resetting or Restoring to Factory Setting ......................................................................................................................... 35
9 Care and Maintenance........................................................................................................................................................ 36
9.1 Cleaning the Device................................................................................................................................................................. 36
9.2 Maintenance Intervals............................................................................................................................................................ 36
9.3 Maintenance by Authorized Service Technician.............................................................................................................. 36
9.4 Resetting the Fuse (only for 2 pole breaker)..................................................................................................................... 37
9.5 Replacing the Fuse (only for inlets with fuse drawer) ................................................................................................... 37
10 Annual Inspection ............................................................................................................................................................... 39
10.1 Electrical Safety Test................................................................................................................................................................ 39
10.2 Basic Function Test................................................................................................................................................................... 39
10.3 Pressure Sensor Test ................................................................................................................................................................ 40
10.4 Pressure Monitoring Test ....................................................................................................................................................... 40
10.5 Max. Device Pressure Test...................................................................................................................................................... 41
10.6 Gas Flow Rate Test ................................................................................................................................................................... 41
11 Electromagnetic Compatibility........................................................................................................................................... 42
11.1 Impact of Mobile and Portable HF Communication Devices....................................................................................... 42
11.2 Electrical Connections............................................................................................................................................................. 42
11.3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ............................................................... 43
11.4 Guidance and manufacturer's declaration - electromagnetic emissions................................................................ 45
12 Informational, Warning and Error Messages ..................................................................................................................... 46
13 Technical Data..................................................................................................................................................................... 49
13.1 Characteristics of circuit breaker......................................................................................................................................... 50
14 Accessories .......................................................................................................................................................................... 51

2
EN 15 AirSeal® iFS Warranty ......................................................................................................................................................... 52
16 Test Log................................................................................................................................................................................ 53
16.1 Test Log........................................................................................................................................................................................ 53
16.2 Return Form ............................................................................................................................................................................... 54
Index ................................................................................................................................................................................... 55

Important User Notes
3
EN
1ImportantUserNotes
Read the instructions for use carefully and become familiar with the operation
and function of the device and the accessories before use during surgical proce-
dures. Non-observance of the instructions listed in this manual can lead
• to life-threatening injuries of the patient,
• to severe injuries of the surgical team, nursing staff or service personnel, or
• to damage or malfunction of device and/or accessories.
Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and
technical data of the product through continued development of its products.
Please noteThe words WARNING, CAUTION, and NOTE carry special meanings. Sections
marked with these words must be given special attention.
WARNING!
The safety and/or health of the patient, user, or a third party are at risk. Comply
with this warning to avoid injury to the patient, user, or third party.
CAUTION!
These paragraphs include information provided to the operator concerning the
intended and proper use of the device or accessories.
NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.

4
Safety Information
EN 2 Safety Information
Federal Law (only for U.S. market) CAUTION: Federal Law restricts this device to sale by or on the order of a physi-
cian.
Exclusion of liability The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
• the device and/or the accessories are improperly used, prepared, or main-
tained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the de-
vice or accessories;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedule is not adhered to.
The handing over of technical documents does not constitute authorization to
make repairs or alterations to the device or accessories.
Authorized trained personnel Only a SurgiQuest technician may perform repairs, adjustments, or alterations
on the device or accessories and use the service menu. Any violation will void the
manufacturer's warranty.
Intended use The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or ther-
apeutic endoscopic procedures to distend a cavity by filling it with gas, to estab-
lish and maintain a path of entry for endoscopic instruments and to evacuate
surgical smoke. It is indicated to facilitate the use of various laparoscopic instru-
ments by filling the abdominal cavity with gas to distend it, by creating and
maintaining a gas sealed obstruction-free instrument path and by evacuating
surgical smoke. This instrument is used to insufflate the rectum and colon to fa-
cilitate endoscopic observation, diagnosis and treatment. The trocar of the
AirSeal® iFS System is indicated for use with or without visualization.
Care and maintenance The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protec-
tion of the patient and the operating team, check that the device is properly con-
nected and functional.
Maintenance of the device may not be performed during the operation.
Contamination Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in this manual. If this is not pos-
sible,
• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Waste management
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed of as unsorted municipal waste and must be collected separately
instead. Please contact the manufacturer or an accordingly authorized disposal
or waste management company for further information.
2.1 Hazards
WARNING!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.

Safety Information
5
EN
WARNING!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this device is indicated. The physician must deter-
mine the specific technique and procedure that will accomplish the desired clin-
ical effect.
WARNING!
Check all factory settings
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.
WARNING!
Check all the sterile disposable items before removing them from the packaging
to ensure that the packaging is intact and that the expiration date is still valid.
WARNING!
Original accessories
For your own safety and that of your patient, use only original accessories.
WARNING!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environ-
ments.
WARNING!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Refer servicing to qualified service personnel.
WARNING!
Professional qualification
This manual does not include descriptions or instructions for surgical proce-
dures/techniques. It is not suitable for training physicians in the use of surgical
techniques. Medical peripherals and devices may be used only by physicians or
medical assistants with the appropriate technical/medical qualifications work-
ing under the direction and supervision of a physician.
WARNING!
Functional test
The functional test must be performed prior to each surgery. Because the func-
tional test is performed during initial start up, the unit must be power cycled
(off/on) prior to each surgery.

6
Safety Information
EN WARNING!
Sterile mediums and accessories
Always work exclusively with sterile substances and mediums, sterile fluids, and
sterile accessories if so indicated.
WARNING!
Replacement device and accessories
In case the device or any of the accessories fail during surgery, a replacement de-
vice and replacement accessories should be kept within close proximity to be
able to finish the operation with the replacement components.
WARNING!
Cleaning the device
Do not sterilize the device.
WARNING!
Replacing fuse
Replace the fuse only with a fuse of the same type and rating.
WARNING!
Device-inherent dangers
Read the warnings specific to this device in chapter 3.1 "Device-inherent Dan-
gers".
WARNING!
Risk of electrical shock
To avoid the risk of electrical shock, only use this device when connected to a
properly grounded power supply network.
WARNING!
Reprocessing of sterile disposable products
Infection hazard for patients and/or users and impairment of product function-
ality due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product! Do not reprocess the product.
CAUTION!
Endoscope
The device may only be connected with endoscopes designed for and featuring
the technical specification permitting such a combined use. Any utilized endo-
scopes must comply with the most recent versions of IEC 60601-2-18 and ISO
8600. Combining/connecting with other devices generates a medical electrical
system (MES). The system configurator is responsible for compliance with the
standard IEC 60601-1 / EN 60601-1 in its latest version.

Device Purpose
7
EN
3 Device Purpose
Intended useThe SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or ther-
apeutic endoscopic procedures to distend a cavity by filling it with gas, to estab-
lish and maintain a path of entry for endoscopic instruments and to evacuate
surgical smoke. It is indicated to facilitate the use of various laparoscopic instru-
ments by filling the abdominal cavity with gas to distend it, by creating and
maintaining a gas sealed obstruction-free instrument path and by evacuating
surgical smoke. This instrument is used to insufflate the rectum and colon to fa-
cilitate endoscopic observation, diagnosis and treatment. The trocar of the
AirSeal® iFS System is indicated for use with or without visualization.
Essential performanceThe device measures the actual pressure in the cavity and compares it with the
set nominal pressure. The function of this device is to maintain the nominal pres-
sure. Any overpressure within the cavity is lowered to the preset nominal pres-
sure by the automatic venting system.
ContraindicationsThe device should not be used to fill a cavity with CO2if an endoscopy is contra-
indicated. Please consult the manual of your laparoscope for absolute and rela-
tive contraindications. The device is not suitable for hysteroscopic insufflations,
i.e., it may not be used to distend the uterus.
3.1 Device-inherent Dangers
WARNING!
Positioning the patient
Positioning the patient lower than the device can prevent body fluids from leak-
ing into the tube set. Actual pressure may increase and fluid may penetrate the
insufflation tube if the patient is repositioned during surgery.
WARNING!
Removing the insufflation tube
When insufflation is no longer required, press "stop" and disconnect the insuffla-
tion tubing when appropriate.
WARNING!
Backflow
Body secretions or contaminated gas may backflow into the device through the
insufflation tube set if
• a filter is not used,
• the actual pressure is higher than the nominal pressure or
• the automatic venting valve is activated.
WARNING!
Gas flow
A high gas flow can occur due to large leaks within the surgical system or instru-
ment. This can result in a false actual pressure reading, which in turn may endan-
ger the patient. In case of a disrupted gas flow, you should therefore inspect
device, tube, and instruments immediately. Surgical procedures should be per-
formed with a gas flow of 4 to 10 l/min. An even lower gas flow is recommended
for diagnostic purposes.
WARNING!
Gas supply
Maintain adequate gas supply at all times.

8
Device Purpose
EN WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected.
Make sure the device or/and accessories can no longer be operated until a qual-
ified service technician conducts the appropriate tests and repairs.
WARNING!
Fatigue symptoms
When there is a high level of CO2consumption, you should make sure to supply
the operating area with enough fresh air, since an increasing CO2level in the air
can cause the medical personnel to suffer fatigue symptoms, an inability to con-
centrate, unconsciousness, or even death.
WARNING!
The venting rate of the automatic venting system is limited. Always monitor the
actual pressure when using additional insufflation sources.
WARNING!
Contaminated filter
Replace a contaminated filter immediately during surgery to ensure unhindered
gas flow.
WARNING!
Connecting the tube
Always use the proper tube set for the device. The tube outlet may only be con-
nected to instruments which are intended for intra-abdominal CO2insufflation.
WARNING!
Electronic device control
Do not close the valve at the trocar sleeve during surgery. The electronic control
unit of the device adjusts the actual pressure as desired.
WARNING!
Medically pure CO2
Make sure to use only medically pure CO2. Other gases (e.g., helium, N2O, ar-
gon), mixtures of gases, gases with entrapped liquids, or polluted gases must not
be used with this device.
WARNING!
Service connection
Access to the service menu is restricted to authorized service personnel.The con-
nected equipment must comply with the standard EN 60950 in the currently val-
id version. Do not connect a device to the service connection during surgery.
WARNING!
Peripheral devices
Additional peripheral equipment connected to interfaces of the AirSeal® iFS
must meet the requirements of the following specifications: IEC 60601-2-18 / EN

Device Purpose
9
EN
60601-2-18 for endoscopic devices and IEC 60601-1 / EN 60601-1 for electrical
medical devices. All configurations have to comply with IEC 60601-1 / EN 60601-
1 specifications. Whoever connects additional equipment to signal output or sig-
nal input is considered the system configurator and as such is responsible for
complying with requirements of the standard IEC 60601-1 / EN 60601-1.
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive CO2absorption (idiosyncratic
reaction).
WARNING!
CO2absorption
CO2is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO2gas used for insufflation. CO2concentrations in the blood or re-
spiratory system that are too high can lead to death of the patient in extreme
cases. To lower this risk, always carefully and closely monitor the patient's vital
signs during the entire insufflation process and make sure patient is breathing
well. Sufficient respiration can help avoid or limit problems with CO2. High pres-
sure or a high gas flow promotes CO2absorption. Pressure values above
15 mmHg are required for only a few cases but do increase the risk of intravasa-
tion. Never exceed the max. cavity pressure of 30 mmHg. It is recommend to not
exceed insufflation pressures >15 mmHg in colo-rectal procedures.
WARNING!
The insufflation of CO2should be done carefully and while monitoring the pa-
tient's response. The user, particularly the anesthetist, should be informed about
possible cardiovascular and respiratory problems of the patient and monitor
these intra-operatively.
WARNING!
Metabolic and cardiac reactions
Insufflating CO2may result in metabolic acidosis. This can lead to cardiac irregu-
larities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
• Reduced cardiac output
• Metabolic acidosis
WARNING!
Hypothermia/monitoring body temperature
The gas flow can lead to a lowering of the patient's body temperature during in-
sufflation. Hypothermia during insufflation can cause heart and cardiovascular
problems. To reduce this risk, minimize high gas flows due to large leaks, the use
of cold irrigation and infusion solutions. Always monitor the patient's body tem-
perature during the entire surgical procedure.

10
Device Purpose
EN WARNING!
Lowest flow and pressure
Depending on age and health condition of the patient, the smallest possible flow
and pressure for establishing the pneumoperitoneum or pneumorectum should
be selected. It is not recommended to exceed insufflation pressures of 15mmHg
in colo-rectal procedures.
WARNING!
Laparoscopy with CO2should not be performed on children with cardiovascular
problems.
WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue. This can result in organ tissue
damage and cardiovascular reactions of the patient. Long surgeries and large
leaks increase the risk of dehydration (especially at the insertion points of the
trocars or when changing instruments).
WARNING!
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating
a vessel or an internal organ, resulting in gas embolisms. To reduce the risk, use
a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument
immediately if the actual pressure rapidly reaches the nominal pressure value.
gas embolisms can also be caused by a high intra-abdominal pressure. Avoid
high-pressure settings and close damaged blood vessels at once.
WARNING!
Emphysema
Incorrect placement of a cannula or a trocar into subcutaneous tissue may lead
to emphysema. To reduce the risk, use a low gas flow rate for the first insuffla-
tion and ensure that the insufflation instrument is correctly positioned. Long sur-
geries (> 200 min.), the use of many access points, duration and size of leaks at
these points may also contribute to emphysema. Be sure to close leakages in tro-
car access points immediately.
WARNING!
Additional insufflation sources/automatic venting system
Make sure the automatic venting system is activated (see chapter 8 "User
Menu"). The use of additional insufflation sources increases the intra-abdominal
pressure. Continuously monitor intra-abdominal pressure over the course of the
entire insufflation if additional sources are used.

Device Purpose
11
EN
CAUTION!
Electrical interference
This device was tested for electrical safety and electromechanical compatibility.
However, if you detect or suspect such interference, please follow these sugges-
tions:
• Move this, the other or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert

12
Initial Device Startup
EN 4 Initial Device Startup
The operation of the device AirSeal® iFS is reserved for medical staff with the rel-
evant professional qualifications trained to use the device.
Delivery inspection Always check all parts and accessories of the device immediately after receiving
the shipment. The manufacturer considers only replacement claims that have
been immediately submitted or reported to a sales representative or an autho-
rized agent.
Setting up the device Place the device on a flat surface and install in dry environment. The ambient
temperature and humidity must meet the requirements mentioned in chapter
13 "Technical Data".
Ensure good ventilation of the device. The vents are located on the underside and
on the back (see 5.2 "Device Rear" and 5.3 "Bottom of the Device").
NOTE!
Locations
The device is only to be used in a professional facility healthcare enviroment.
WARNING!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environ-
ments.
4.1 Device Setup and Connection
Setting up Place the device on a flat surface free of vibration located in a dry environment.
The ambient temperature and humidity must meet the requirements mentioned
in chapter 13 "Technical Data".
WARNING!
Use only parts and/or devices from ME systems (see chapter 11 "Electromagnetic
Compatibility") in patient environments in compliance with the standard
IEC60601-1 in the respective currently valid version.
CAUTION!
ME Device in Rack
If it should be necessary to operate the device close to stacked with other devic-
es, the ME device or ME system (see chapter 11 "Electromagnetic Compatibility")
should be monitored to ensure it works properly as configured.
CAUTION!
The medical electrical (ME) device is suitable for integration in ME equipment
systems (see chapter 11 "Electromagnetic Compatibility"). Operation of the ME
device in vicinity of non-ME devices may result in voiding the intended use of the
ME device.
CAUTION!
Equipment should be positioned such that power cord can be easily disconnect-
ed.

Initial Device Startup
13
EN
CAUTION!
Ventilation of the device
Avoid device overheating. Ensure free air circulation especially to the bottom
and rear of the device (rear panel distance of at least 10 cm).
CAUTION!
Position the device in such a way that it is easy to operate and switch off.
CAUTION!
Place the device outside the sterile field.
CAUTION!
Position of the user
To avoid a malfunction, the user must be positioned correctly
• within a display viewing angle of ±50° to operate the device
• up to 2 m/6.5 ft from the device front for monitoring the actual values
Mains connection
CAUTION!
Check to make sure the available mains voltage matches the data listed on the
type label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and may destroy the device.
Make sure the connection data and technical specifications of the power supply
comply with DIN VDE or national requirements. The mains power supply cable
must be plugged into a properly installed safety wall plug (see DIN VDE 0100-
710). Read the device label located in rear of device (type plate) to determine the
operating voltage of the device.
Grounding contactThe power connection must be equipped with a grounding contact. Use the orig-
inal power cable (if included in scope of delivery) to establish a connection be-
tween the mains wall socket and the non-heating device plug located in the rear
of the device.
Only for U.S. operatorsOnly use a certified (UL-listed), removable mains connection cable, type SJT, min-
imal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 and IEC
16320-C13. Grounding will only be reliable if the equipment is connected to a
corresponding hospital grade socket.
Potential equalizationThe potential equalization denotes a highly electrically conductive connection,
minimizing the different electrical potentials according to requirements of IEC
60601-1 in the respectively valid version. The installation must be according to
the relevant local safety regulations.
4.2 Gas Connection
WARNING!
Medically pure CO2
Make sure to use only medically pure CO2. Other gases (e.g., helium, N2O, ar-
gon), mixtures of gases, gases with entrapped liquids, or polluted gases must not
be used with this device.
Use a high-pressure hose to connect a CO2gas cylinder to the rear gas inlet con-

14
Initial Device Startup
EN nection or connect to centralized CO2gas supply.
4.2.1 Connecting a Gas Cylinder
CAUTION!
Always use a high-pressure hose to connect gas cylinder and device.
The gas cylinder must be in a vertical position. The gas bottle pressure may not
exceed 80 bar/1160 psi. For the device start, the gas cylinder pressure must be at
least 25 bar/363 psi.
CAUTION!
Gas cylinders with riser pipes can release dirt and oily fluids into the device. Do
not use gas cylinders with riser pipes.
High pressure hoses The following high pressure hoses are available:
Installation High Pressure Hoses with PIN Connector
• Connect or loosen to the device using the open-end wrench SW 14.
• Connect or loosen to the gas bottle with your hand.
High Pressure Hoses with DIN Connector
• Connect or loosen to the device using the open-end wrench SW 14.
• Connect or loosen to the gas bottle using the open-end wrench SW 30.
High Pressure Hoses with ISO Connector
• Connect or loosen to the device using the open-end wrench SW 14.
• Connect or loosen to the gas bottle using the open-end wrench SW 32.
4.2.2 Connecting to Central Gas Supply
Use the following device connectors and high-pressure hoses available as addi-
tional equipment to connect to a central gas supply (house supply):
• Connector and hose for house gas supply NIST or
• Connector and hose for house gas supply DISS
Designation
High Pressure Hose Device US / Bottle DIN
High Pressure Hose Device US / Bottle ISO
High Pressure Hose Device US / Bottle PIN Index

Initial Device Startup
15
EN
1. Attach the high-pressure hose to the gas connection
2. Fasten the high-pressure hose with the nut
3. Tighten the nut
4. Power on device
5. Select MENU
6. Select Gas supply and choose HOUSE GAS Mode in menu
NOTE!
The default gas settings are selected at the factory and should be changed as
necessary by the user. If a gas supply of greater than 15 bars/218 psi is supplied
to the device, regardless if the default setting is set to bottle gas or house gas,
the device will automatically default to bottle gas mode.
4.2.3 Gas Consumption Display
The gas consumption display indicates the insufflated volume of CO2in liters
since the last resetting of the display. The display depicts values between 0 and
999 liters.
The gas consumption display can be reset by pressing the RESET key and then re-
turns to 0.
Gas supply displaysThe status of the gas supply is monitored by the device and indicated with sym-
bols and acoustic signals.
Gas supply with gas bottleThe following gas bottle pressures are displayed:
House gas supplyThe following house gas supply pressures are displayed:
> 40 bar/580 psi
30 - 40 bar/435 - 580 psi
15 - 30 bar/218-435 psi;
5 - 15 bar/73-218 psi; warning screen "Gas level low. Prepare to
change gas bottle." appears and audible signals can be heard.
If insufflation is stopped, the warning message "Change gas bottle!"
appears and insufflation cannot be restarted until the pressure is >
15 bar/218 psi.
< 5 bar/73 psi; If insufflation is started, the warning message
"Change gas bottle!" appears and acoustic signals (beeps) are emit-
ted. The gas bottle should be changed immediately.
If insufflation is stopped, the warning message "Change gas bottle!"
appears and insufflation cannot be restarted.
Smoke evacuation level will switch to LOW until tank is replaced.
While in AirSeal mode, a countdown of 100 s is displayed during
which the empty gas bottle can be changed while maintaining
abdominal pressure.
0 bar/0 psi; If insufflation is started, the warning message "Change
gas bottle!" Insufflation stopped!" appears and acoustic signals
(beeps) are emitted. The gas bottle should be changed immediately.
If insufflation is stopped, the warning message "Change gas bottle!"
appears and insufflation cannot be restarted.

16
Initial Device Startup
EN House gas supply pressure OK
House gas supply pressure too low
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