AirSeal INGLES

Instructions for use EN
This manual contains information that is subject to copyright.
EN 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.
Manufactured for: EMERGO EUROPE

Molenstraat 15
2513 BH, The Hague
SurgiQuest, Inc. The Netherlands
488 Wheelers Farms Road Phone: +31.70.345.8570
Milford, CT 06461, USA Fax: +31.70.346.7299
Ph: +1.203.799.2400 0086 CE marking according to Directive 93/42/EEC
Type: F121/10000013799 Revision 13/2017-08/Manzano

Symbols
EN
Follow instruc-
tions for use
(white image on a Serial number Stop Start
blue background)
Date of manufac-
Consult instruc-
tions for use ture (YYYY- Home Reset key
MMDD)
Not made with

Caution Use by date Menu natural rubber
(YYYY-MMDD)
latex
Electrostatic sen- Protective

Quantity Information key
sitive devices earth(Ground)
Non-ionizing elec-
Type BF applied
part Increase Back to menu tromagnetic radi-
ation
House gas supply

Equipotentiality Decrease full
Degrees of protec-
tion provided by House gas supply
Keep dry
enclosures low
(IPCode)
Alternating cur- Gas bottle full

rent Top-Bottom (> 40 bar)
Low supply gas

Service Fragile bottle
(30 - 40 bar)
Low supply gas

Catalogue num- Waste manage-
bottle (15 - 30
ber ment
bar)
Too low supply

Do not reuse Manufacturer gas bottle (5 - 15
bar)
Do not use if
Sterilized using Gas bottle empty
package is dama-
ethylene oxide (0-5 bar)
ged
Sterilized using
Keep away from
ethylene irradia- Do not resterilize
sunlight
tion
Authorized for On/Off (push but-

Batch code Sale or use by Phy-
ton)
sician only
Table of contents
EN
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
1
15 AirSeal® iFS Warranty ......................................................................................................................................................... 52
EN 16 Test Log................................................................................................................................................................................ 53
16.1 Test Log........................................................................................................................................................................................ 53
16.2 Return Form ............................................................................................................................................................................... 54
Index ................................................................................................................................................................................... 55
2
Important User Notes
1 Important User Notes

Read the instructions for use carefully and become familiar with the operation
EN
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.
The manufacturer reserves the right to modify the appearance, graphics, and Subject to technical changes
technical data of the product through continued development of its products.
The words WARNING, CAUTION, and NOTE carry special meanings. Sections Please note
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.
3
Safety Information
2 Safety Information
EN 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.
4
Safety Information
WARNING!
Technique and procedures EN
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.
5
Safety Information
WARNING!
EN 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.
6
Device Purpose
3 Device Purpose
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or ther- Intended use EN
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.
The device measures the actual pressure in the cavity and compares it with the Essential performance
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.
The device should not be used to fill a cavity with CO2 if an endoscopy is contra- Contraindications
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.
7
Device Purpose
WARNING!
EN 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 CO2 consumption, you should make sure to supply
the operating area with enough fresh air, since an increasing CO2 level 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 CO2 insufflation.
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
8
Device Purpose
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- EN
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 CO2 absorption (idiosyncratic
reaction).
WARNING!
CO2 absorption
CO2 is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO2 gas used for insufflation. CO2 concentrations 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 CO2 absorption. 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 CO2 should 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 CO2 may 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.
9
Device Purpose
WARNING!
EN 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 CO2 should 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.
10
Device Purpose
CAUTION!
Electrical interference EN
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
11
Initial Device Startup
4 Initial Device Startup

EN 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.
12
CAUTION!
Ventilation of the device EN
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.
The power connection must be equipped with a grounding contact. Use the orig- Grounding contact
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 use a certified (UL-listed), removable mains connection cable, type SJT, min- Only for U.S. operators
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.
The potential equalization denotes a highly electrically conductive connection, Potential equalization
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 CO2 gas cylinder to the rear gas inlet con-
13
nection or connect to centralized CO2 gas supply.

EN
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:
Designation
High Pressure Hose Device US / Bottle DIN
High Pressure Hose Device US / Bottle ISO
High Pressure Hose Device US / Bottle PIN Index
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 gas bottle using the open-end wrench SW 30.
High Pressure Hoses with ISO Connector

• 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
14
1. Attach the high-pressure hose to the gas connection

2. Fasten the high-pressure hose with the nut EN
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 CO2 in 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.
The status of the gas supply is monitored by the device and indicated with sym- Gas supply displays
bols and acoustic signals.
The following gas bottle pressures are displayed: Gas supply with gas bottle
> 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.
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.
appears and insufflation cannot be restarted.
The following house gas supply pressures are displayed: House gas supply
15
EN House gas supply pressure OK
House gas supply pressure too low
16
Operating the Device
5 Operating the Device

EN
5.1 Device Front
Familiarize yourself with the control and function elements at the front of the de-
vice.
Fig. 5-1 Front of the Device

(1) ON/OFF switch
(2) Touch screen display
(3) Receptacle for AirSeal and Smoke
Evacuation Modes
(4) Lever for locking tube set in place
(5) Insufflation tube connection for
Standard Insufflation Mode
(barbed connection)
(1) (2) (3) (4) (5)
5.2 Device Rear

Familiarize yourself with the connection elements at the rear of the device.
(6)(7) (8) (9) Fig. 5-2 Rear of the Device

(6) USB port (service only)
(7) Connection for potential equaliza-
tion
(8) Gas connection
(9) Ventilation slots (air outlet)
(10) Type plate
(11) Device data plate
(12) Device connector plug with fuse
holder
(12) (11) (10)
5.3 Bottom of the Device
Fig. 5-3 Bottom of the device

(13) Ventilation slots (air intake)
(13)
WARNING!
The device is equipped with a powerful ventilation system with air intake locat-
ed at the bottom of the device. The suction can be so strong that is can trap
sheets of paper or soiling if they come in proximity. Keep ventilation slots free of
obstructions or soiling to ensure optimal cooling of the device.
17
5.4 Display
EN
Fig. 5-4 Display
(1) Nominal gas flow rate level 1 (1) (2) (3) (4) (5) (6) (7) (8) (9)
(2) Actual flow rate display
(3) Nominal gas flow rate level 2
(4) Nominal gas flow rate level 3 (10)
(5) Decreasing nominal pressure
(6) Actual pressure display (11)
(7) Nominal pressure display (12)
(8) Increasing nominal pressure (13)
(9) Gas supply display (14)
(10) Gas Consumption Display (15)
(11) Reset key for consumption display
(12) Smoke gas evacuation level LOW
(13) Smoke gas evacuation status
(14) Smoke gas evacuation level HIGH
(19) (18) (17) (16)
(15) Status display/error & warning
messages
(16) Mode The above depicted display shows all displays and keys. Additional explanations
(17) START/STOP key for individual elements are presented in the subsequent respective control ele-
ment descriptions.
(18) MENU key
(19) HOME key Not all displays and functions are available for all modes.
5.5 Switch Device On

(2) 1. Plug the device into the power outlet.
2. Connect the gas supply to the gas connection port and open the gas supply.
3. Make sure no tube set is connected before switching the device on.
4. Press the ON/OFF switch (see Fig. 5-1 "Front of the Device" (1)). The device
(1) now initializes and then runs the initial self test. The start screen and a prog-
ress bar are depicted on the display during the initial self test.
If the initial self test was unsuccessful, an error message and information
about how to possibly remedy the problem are displayed. An acoustic warn-
ing signal is emitted (see 12 "Informational, Warning and Error Messages").
5. The message Device ready is shown after the successful initial self test. An
acoustic signal is emitted and the display depicts Mode Selection.
NOTE!
After the successful initial self test, factory-new devices will request the user se-
lect a language. Press the desired language.
6. Press the respective key to choose the desired operating mode (e.g. Smoke
Evacuation Mode).
Press the Information symbol for a short instruction about the desired oper-
ating mode. Tutorials for the three insufflation operating modes are avail-
able.
18
Press HOME key to return to Mode Selection.

EN
5.5.1 Selecting Operating Mode

Press the corresponding key in Mode Selection to select the desired operating
mode.
The device can be used with three different insufflation operating modes:
1. AirSeal Mode: Insufflation with Tri-Lumen Filtered Tube Set and AirSeal® Ac-
cess Port.
2. Smoke Evacuation Mode: Traditional insufflation and smoke evacuation with
a Bifurcated Smoke Evac Filtered Tube Set for two conventional cannulas.
3. Standard Insufflation Mode: Traditional insufflation with a Single Lumen Fil-
tered Tube Set and conventional cannula.
5.5.2 Insufflation Tube Sets

Please use the indicated accessories when working in the respective modes.
A conventional tube for Standard Insufflation Mode can be connected to the

front of the device (see Fig. 5-1 "Front of the Device" (5)). The tube sets for the
operating modes Smoke Evacuation and AirSeal are connected to the filter recep-
tacle (see Fig. 5-1 "Front of the Device" (3)).
Single Lumen Filtered Tube • Disposable conventional single lumen tube

Set (hereafter referred to as with standard insufflation filter
single lumen tube) Filter
Single lumen tube
Bifurcated Smoke Evac Fil- Disposable insufflation tube set with filter
tered Tube Set (hereafter
referred to as bifurcated • Dual-lumen bifurcated tube, transparent
tube) tube for insufflation, blue tube for smoke Bifurcated tube Filter
evacuation
Tri-Lumen Filtered Tube Set Disposable insufflation tube set with filter for
(hereafter referred to as tri- use with:
lumen tube)
• Tri-lumen tube only for use with AirSeal® Tri-lumen tube
Access Port Filter
SurgiQuest Single Lumen AirSeal® Single Lumen Adapter Single Lumen Adapter
Adapter
• Short section of tube for use with a Veress
needle or conventional cannula with the Tri-
Lumen Filtered Tube Set
connects to connects to
Veress needle tri-lumen tube
SurgiQuest AirSeal® Blade-
less Optical Tip Obturator
(hereafter referred to as
Optical Obturator)
19
SurgiQuest AirSeal® Blunt

EN Tip Obturator (hereafter
referred to as Blunt Tip Obtu-
rator)
SurgiQuest AirSeal® Cannula

(hereafter referred to as
AirSeal® Cannula)
AirSeal® Cannula and Low

Profile Obturator with Blade-
less Optical Tip (hereafter
referred to as AirSeal® Access
Port)
After pressing the operating mode key, an informational window opens for the
required tube (only for AirSeal and Smoke Evacuation Mode). Insert the tube set
by positioning the filter canister into the AirSeal® iFS and pulling down the lever
(AirSeal and Smoke Evacuation Mode) or by pushing the open side of the tube set
over the barbed connector (Standard Insufflation Mode).
5.5.3 Starting/Stopping Insufflation

Start insufflation:
Press START to start insufflation.
Activated insufflation:
The status line depicts Initial Insufflation. The Initial Insufflation phase remains
in operation until the set nominal pressure has been reached through the insuf-
flation for the first time.
CAUTION!
For the safety of the patient please fill the tube set with CO2 gas prior to begin-
ning the insufflation by activating the insufflation for a few seconds and then
turning it off again before introducing the insufflation instrument to the cavity
and beginning the surgery.
Stop insufflation:
Press STOP to stop insufflation.
20
5.5.4 Power Device Off

EN
Use the ON/OFF button to turn the device off.
CAUTION!
Disconnection from the power supply is only guaranteed if the mains plug is
pulled from the mains wall socket.
21
Using and Controlling the AirSeal® iFS in its Different Modes
6 Using and Controlling the AirSeal® iFS in its Different

EN Modes
The device can be used with three different insufflation operating modes (see
5.5.2 "Insufflation Tube Sets"):
1. AirSeal Mode: Insufflation with Tri-Lumen Filtered Tube Set and AirSeal® Ac-
cess Port.
2. Smoke Evacuation Mode: Traditional insufflation and smoke evacuation with
a Bifurcated Smoke Evac Filtered Tube Set for two conventional cannulas.
3. Standard Insufflation Mode: Traditional insufflation with a Single Lumen Fil-
tered Tube Set and conventional cannula.
6.1 AirSeal Mode

The AirSeal Mode is intended to establish and maintain a pathway of entry for
laparoendoscopic instruments to the field of surgery within endoscopic proce-
dures. The cavity pressure is maintained by a gas barrier within the AirSeal® can-
nula that allows valve-free access to the body cavity and that does not collapse
when introducing instruments.
WARNING!
Please read the respective instruction manual before using the AirSeal® Access
Port.
6.1.1 AirSeal® Access Port

The AirSeal® Access Port is packaged in three configurations:
• Optical obturator
Fig. 6-1 AirSeal® Optical Obturator (2) (1) (4)

(1) Bladeless optical tip obturator
(2) Cannula
(3) Manifold plug
(4) Cannula latch
(3)
22
• Blunt obturator with suture anchor

EN
Fig. 6-2 AirSeal® Blunt Obturator with
Suture Tie Down
(1) Blunt obturator
(2)
(2) Cannula
(3) Manifold plug
(4) (1)
(4) Spring anchor
(3)
• cannula and Low Profile Obturator with Bladeless Optical Tip
(4) Fig. 6-3 AirSeal® Cannula and Low Pro-

file Obturator with Bladeless
(2) Optical Tip
(1) Bladeless optical tip obturator
(2) Cannula
(3) Manifold plug
(1)
(4) Cannula latch
(3)
The AirSeal® Optical Obturator and Cannula System is composed of a sterile sin-
gle patient use instrument consisting of an obturator (1) and a cannula (2) (see
Fig. 6-1, Fig. 6-2, and Fig. 6-3). The obturator may be used with or without visual-
ization for primary and secondary insertions.
If the Optical cannula is being used for primary entry, use of a laparoscope to pro-
vide visualization to enhance safe abdominal entry is advised.
1. Use sterile techniques to remove the instrument from the package.

2. The obturator (1) and the cannula (2) (see Fig. 6-1, Fig. 6-2, and Fig. 6-3) are
packaged together.
3. When using optical obturator
• Connect an appropiate 0° endoscope to the light supply and monitor (see
manufacturer's instructions).
• Insert the endoscope into the opening at the proximal end of the obturator
until it reaches the distal tip of the obturator.
6.1.2 Initial Insufflation

When working in the AirSeal Mode, it is possible to initiate insufflation either
through the open cannula, through the cannula with inserted obturator or
through a Veress needle.
CAUTION!
The manufacturer strongly advises to begin the insufflation by using the Veress
needle for intra-abdominal procedures. For trans-anal procedures, insufflation
should be performed through a standard Luer port or AirSeal® Access Port.
Initial insufflation with Veress needle entry or AirSeal® Cannula
1. Switch device on (consult section 5.5 "Switch Device On" for additional infor-
mation).
23
2. At the conclusion of the initial self test, insert the Tri-Lumen Filtered Tube Set
EN and AirSeal Mode will automatically launch. Alternatively, press the AirSeal
Mode key to select this operating mode.
Inserting the Tri-Lumen Filtered Tube Set
• To be carried out by non-sterile technician:

• Open packaging of the Tri-Lumen Filtered Tube Set.
• Have a sterile technician remove the tube set from the inside of the package.
To be carried out by sterile technician:
distal end proximal end • Keep the distal end of the Tri-Lumen Filtered Tube Set (AirSeal® Cannula con-
nector) in the sterile area and hand the tube end with filter to the non-sterile
technician.
Option a) Initial insufflation with Veress needle or conventional cannula
(advised)
Use the Single Lumen Adapter to connect the tri-lumen tube with the Luer
lock connector of a conventional Veress needle or a conventional cannula
(see 5.5.2 "Insufflation Tube Sets"). The Single Lumen Adapter comes con-
nected to the tri-lumen tube upon delivery. Ensure the connection is tight
before use.
Option b) Initial insufflation with AirSeal® Access Port
Connect the Tri-Lumen Filtered Tube Set with the AirSeal® Access Port (see
6.1.1 "AirSeal® Access Port").
To be carried out by non-sterile technician:
• Insert the Tri-Lumen Filtered Tube Set into the receptacle at the front of the
device. Use the lever to lock the filter housing in place or to unlock and re-
lease it.
3. Insert the Veress needle, conventional trocar, or AirSeal® Access Port in accor-
dance with proper laparoscopic technique.
(1) (3) (4) 4. Choose desired settings.
Setting the nominal flow and nominal pressure (increase/decrease) is possi-
ble during insufflation or while insufflation is stopped.
Setting nominal flow:
The device features three different flow level rates that can be adjusted in the
user menu (see chapter 8 "User Menu" for additional information). The facto-
ry defaults are:
Level 1 -> 5 l/min
Level 2 -> 20 l/min
Level 3 -> 40 l/min
• To set the flow rate, press the key (1), (3) or (4).
Setting the nominal pressure:
Press the key » or º ((5) or (8)), to set the nominal pressure. Values may
(5) (8) range from 5 to max. 20 mmHg and can be adjusted in increments of 1. The
starting value for the pressure can be set in the user menu within a range of
5 - 15 mmHg.
• Scrolling is enabled by keeping the » or º key depressed longer than 1.5
24
seconds.
Increasing the nominal pressure to > 15 mmHg: EN
Status line depicts the message: Safety threshold: Pressure >15 mmHg!
This is where the recommended range for intra-abdominal and colorectal
pressure ends. Release the key for 2 seconds, then pressure can be increased
above 15 mmHg.
CAUTION!
Exceeding this safety limit is to be decided by and the responsibility of the user/
operator.
5. Start insufflation with the START key.
NOTE!
For the safety of the patient, it is advised to start intra-abdominal insufflation
with a Veress needle and at the lowest flow rate (level 1, key (1)).
6.
Initial Insufflation with a Veress Needle or Conventional Cannula
Note that the use of a Veress needle is automatically detected by the device. The
AirSeal® recirculation gas flow is NOT ACTIVATED when performing initial insuf-
flation with a Veress needle in the AirSeal Mode.The status line depicts Initial In-
sufflation. Initial Insufflation ends when the AirSeal® Cannula is attached to the
Tri-Lumen tube set.
Once the set pressure is achieved, (message appears on screen- Connect Tri-Lu-
men Filtered Tube Set to AirSeal® Cannula…)
• Insert the AirSeal® Access Port with inserted obturator.

• Detach the tri-lumen tube from the single lumen adapter.
• Remove the manifold plug.
• Attach the tri-lumen tube to the AirSeal® Access Port bullseye manifold and
tighten.
• The iFS will automatically launch into AirSeal Mode once the tri-lumen tube set
is connected.
• When stabilized, the display will indicate to remove the obturator.
• Upon removal of the obturator, the iFS will perform a calibration. This will take
approximately 8-15 seconds.
• Once complete, an audible tone will sound alerting the user that AirSeal Mode
is active and ready for use and a green bar will appear on the iFS screen show-
ing AirSeal Active.
CAUTION!
If the obturator is removed from the AirSeal® cannula before the desired pres-
sure is achieved, pressure in the cavity may not be maintained.
25
Initial Insufflation with AirSeal® Access Port

EN
• Remove the manifold plug from the bullseye manifold on the AirSeal® Access
Port. Connect the Tri-Lumen Tubing connector to AirSeal’s bullseye manifold
by turning the Tube Set and tighten.
• Press START on the screen.
• It is ideal to leave the obturator in place during initial insufflation, but not re-
quired. Wait until proper abdominal pressure is achieved and follow the
prompts on the screen.
• Remove the obturator when prompted and wait for the calibration cycle to
complete prior to inserting any instruments through the AirSeal® cannula or
inserting any additional trocars into the abdomen.
• Once complete, an audible tone will sound alerting the user that AirSeal Mode
is active and ready for use and a green bar will appear on the screen showing
AirSeal Active.
Conclusion of Procedure
7. When procedure is completed, stop insufflation by pressing the STOP key.

AirSeal Mode will undergo a final calibration prior to shut down. Wait for fi-
nal calibration to complete prior to powering off the iFS unit.
Possible Fluid in AirSeal Tube Set
8. When working in AirSeal Mode, it is possible that fluids can be extracted from
the surgical field through the evacuation line and into the filter housing. In
order to prevent contamination of the device, fluid is retained by the fluid
trap of the housing component. The capacity of the fluid trap is limited. A
warning message and an audible signal will be emitted if the fill level LOW is
reached. AirSeal® Cannula and tubing placement should be checked to make
sure no more fluid enters the fluid trap. At this point, insert AirSeal obturator
and change the filtered tube set. Insufflation can be continued with full func-
tionality. If fluid level HIGH is reached, AirSeal function will shut down. Insert
obturator in AirSeal® cannula to maintain pressure with normal insufflation.
Change the tube set to finish the procedure.
If the AirSeal Mode has been stopped because the fluid level HIGH was reached,
the iFS should be inspected to assess any possible damage. Call for service.
6.2 Smoke Evacuation Mode

The Smoke Evacuation Mode is intended for standard insufflation with continu-
ous evacuation of smoke from the cavity as it may occur during the use of stan-
dard ultrasonic, laser and electric energy devices. Use the Bifurcated Smoke Evac
Filtered Tube Set with conventional cannulas when working in this mode. The
Smoke Evacuation Mode is automatically activated when the second line of the
bifurcated tube set (blue-colored tube) is attached to a second cannula with an
open inflow stopcock.
1. Switch device on.

2. At the conclusion of the initial self test, insert the Bifurcated Smoke Evac Fil-
tered Tube Set and Smoke Evacuation Mode will automatically launch. Alter-
natively, press the Smoke Evacuation Mode key to select this operating mode.
Inserting the Bifurcated Smoke Evac Filtered Tube Set

proximal end • Open packaging of the Bifurcated Smoke Evac Filtered Tube Set.
• A sterile technician then removes the tube set from the inside of the pack-
age.
distal end
To be carried out by sterile technician:
• Keep the Luer lock connectors of the distal bifurcated tube in the sterile
area and hand the proximal tube end connected to the filter to the non-
26
sterile technician.
• Connect the Luer lock connector of the clear tube to the conventional can- EN
nula. Open the inflow valve/stopcock.
• Follow prompts on iFS. When instructed, connect the Luer lock connector of
the blue tube to a different conventional cannula to activate smoke evacu-
ation.
• Insert the Smoke Evacuation filter housing into the receptacle at the front
of the device. Use the lever to lock the filter housing in place or to unlock
and release it.
3. Choose desired settings.

Setting nominal flow:
ry defaults are:
Level 1 -> 5 l/min
Level 2 -> 20 l/min
Level 3 -> 40 l/min
Press the key » or º ((5) or (8)) to set the nominal pressure. Values may
range from 5 to max. 20 mmHg and can be adjusted in increments of 1. The
5 - 15 mmHg.
seconds.
Increasing the nominal pressure to > 15 mmHg:
above 15 mmHg.
CAUTION!
operator.
4. Start insufflation by pressing the START key.

The status line depicts Initial Insufflation. The initial insufflation ends when
the nominal pressure value has been reached for the first time. The device
prompts the user to connect the blue tube to enable Smoke Evacuation func-
tion.
To enable smoke evacuation, connect the blue tube of the bifurcated tube set
27
to a second cannula and open the stopcock.

EN
NOTE!
with a Veress needle and at the lowest flow rate (level 1, key (1)). Exchange the
Veress needle with a conventional cannula once the nominal pressure is reached
and the initial insufflation phase ends.
5. Stop insufflation by pressing the STOP key.
When working in the Smoke Evacuation Mode, it is possible that body fluids are
extracted from the surgical field over the evacuation line. In order to prevent con-
tamination of the device, these are retained by the fluid trap of the Smoke Evac-
uation tube set filter component. The capacity of the fluid trap is limited. A
warning message and an audible signal will be emitted if the fill level LOW is
reached. Cannula and tubing placement should be checked to make sure no more
fluid enters the filter. At this point, change the filtered tube set. Insufflation can
be continued with full functionality. If fluid level HIGH is reached, the Smoke
Evacuation function will shut down but insufflation is still active.
If the Smoke Evacuation Mode has been stopped because the fluid level HIGH
was reached, the iFS should be inspected to assess any possible damage. Call for
service.
6.3 Standard Insufflation Mode

The Standard Insufflation Mode is intended for use with a Single Lumen Filtered
Tube Set and conventional cannulas.
1. Switch device on (consult section 5.5 "Switch Device On" for additional infor-
mation).
2. Press the Standard Insufflation Mode key to select this operating mode.
3. Connect the Single Lumen Filtered Tube Set.
Inserting the Single Lumen Filtered Tube Set

• Open packaging of the Single Lumen Filtered Tube Set.
• Have a sterile technician remove the tube set from the inside of the pack-
age.
distal end proximal end To be carried out by sterile technician:
• Keep the distal tube Luer lock connector in the sterile area and hand the
proximal tube end with filter to the non-sterile technician.
• Connect the Luer lock connector with the conventional cannula. Open in-
flow valve.
• Attach the insufflation tube set to the insufflation tube set connection at
the front of the device (barbed connector).
(1) (3) (4)(5) (8)
4. Choose desired settings.

28

Setting nominal flow: EN
ry defaults are:
Level 1 -> 5 l/min
Level 2 -> 20 l/min
Level 3 -> 40 l/min
Press the key » or º ((5) or (8)) to set the nominal pressure. Values may
range from 5 to max. 20 mmHg and can be adjusted in increments of 1. The
5 - 15 mmHg.
seconds.
Increasing the nominal pressure to > 15 mmHg:
above 15 mmHg.
CAUTION!
operator.
5. Start insufflation with the START key.
The status line depicts Initial Insufflation. The initial insufflation ends when
the nominal pressure value has been reached for the first time. The status
line depicts Standard Insufflation Active.
NOTE!
with a Veress needle and at the lowest flow rate (level 1, key (1)). Exchange the
Veress needle with a conventional cannula once the nominal pressure is reached
and the initial insufflation phase ends.
CAUTION!
Always use Single Lumen Filtered Tube Set with filter (see 5.5.2 "Insufflation
Tube Sets").
WARNING!
Positioning the patient
Always position the patient lower than the device to prevent body fluids from
leaking into the insufflation tube. Actual pressure may increase and fluid may
penetrate the insufflation tube if the patient is repositioned during surgery. If
this occurs, immediately disconnect the insufflation tube. When the patient is
repositioned onto his or her side, internal tissue may block the insufflation chan-
nel. Always insufflate through the elevated side of the patient.
29
WARNING!
EN Backflow
Body secretions or contaminated gas may backflow into the device through the
insufflation tube if
• a filter is not used,
• the actual pressure is higher than the nominal pressure or
• the automatic venting valve is activated.
6. Stop insufflation with the STOP key.
30
Safety Functions
7 Safety Functions
EN
7.1 General Safety Functions
The device is equipped with an automatic venting system. Venting system
When the insufflator detects that the nominal pressure was exceeded by more
than 3 mmHg for longer than 3 seconds, it automatically activates the venting
system. The status line then depicts Venting active!.
WARNING!
The venting rate of the automatic venting system is limited. Always monitor the
actual pressure when using additional insufflation sources.
If the overpressure of more than 3 mmHg exists longer than 5 seconds, the status Overpressure
line depicts a corresponding message and a warning signal is emitted.
CAUTION!
In case of overpressure above 30 mmHg for longer than 5 seconds insufflation is
deactivated.
When tube, Veress needle, or AirSeal® cannula are blocked, the message Occlu- Occlusion
sion is depicted and a warning signal is emitted. The actual pressure display de-
picts 0.
The warning tone can be deactivated in the user menu (see chapter 8 "User
Menu"). Remove the occlusion if this is not done intentionally, e.g. with a closed
stopcock. Check tubes or cannula for proper fit (not in tissue) and check for pos-
sible blockages.
7.2 Contamination Alarm

Contamination occurs when fluid has penetrated the device via the conventional Contamination
barbed fitting tube connection. A contamination message and an audible signal
occurs. It is possible to conclude the currently ongoing surgery with this device.
Insufflation is no longer possible after turning the device off and back on using
the ON/OFF switch. This is to prevent cross-contamination.
The display depicts Contamination if you are switching on an already contami-

nated device. The device can no longer be used.
The contaminated device has to be clearly marked as contaminated and sealed

in two separate protective layers of safety foil.
Make sure the device can no longer be operated until a qualified service techni-
cian conducts the appropriate tests and repairs.
31
Safety Functions
7.3 Safety Functions in AirSeal Mode

EN Stop insufflation / System calibration The pressure is reduced slowly before the system comes to a complete stop when
stopping AirSeal® insufflation.
When procedure is completed, AirSeal Mode will undergo a final calibration prior
to shut down. During this process no pressure or insufflation is built up.
Severed tube connection If the connection of the AirSeal® filter tube set with the AirSeal® cannula is inter-
rupted or severed, the system stops and the warning Check connection of Tri-Lu-
men Filtered Tube Set! is depicted and a 15 second countdown begins. During
these 15 seconds, AirSeal functionality will automatically restart if the tri-lumen
tube set is reconnected to the AirSeal® cannula. Alternatively, insufflation func-
tionality will automatically restart if the Single Lumen Adapter is reconnected to
the tri-lumen tube set and to a conventional cannula.
Leakage warning If a large leak makes it impossible to maintain the AirSeal® function, the warning
message Check for excessive leakage and suction is depicted.
7.4 Fill Level Display

Tri-lumen and bifurcated filtered tube sets are equipped with fluid sensors to
monitor the fluid level in the filters and to warn users of a possible device con-
tamination.
When working in the AirSeal Mode and Smoke Evacuation Mode, body fluids may
be flushed from the surgical field through the evacuation line and into the filter
housing. In order to prevent contamination of the device, bodily fluid is retained
by the fluid trap of the housing component. The capacity of the fluid trap is lim-
ited.
Fluid level LOW (AirSeal Mode and Smoke A warning message and an audible signal will be emitted if the fill level LOW is
Evacuation Mode) reached. Cannula and tubing placement should be checked to make sure no more
fluid enters the filter. Change the filtered tube set, and insufflation can be con-
tinued with full functionality.
Fluid level HIGH (Smoke Evacuation Mode) If fluid level HIGH is reached in Smoke Evacuation Mode: Smoke Evacuation func-
tion will stop but insufflation can still be continued.
The iFS should be inspected to assess any possible damage. Call for service.
Fluid level HIGH (AirSeal Mode) If fluid level HIGH is reached in AirSeal Mode, AirSeal function will stop. You will
be prompted to change to the tri-lumen tube set to resume AirSeal function. The
iFS should be inspected to assess any possible damage. Call for service.
Note: If no new tri-lumen tube set is available, the iFS will continue with insuffla-
tion (one-way) with the existing tri-lumen tube set. This requires that the obtu-
rator is reinserted into the AirSeal® cannula or that the tri-lumen tube is
connected with the single lumen adapter to a conventional cannula after con-
ventional cannula is inserted. If AirSeal® cannula is removed, the surgeon may
wish to insert a conventional cannula in same entry point.
32
User Menu
8 User Menu
While insufflation is stopped, press the MENU key (Fig. A) to open the user menu
EN
(Fig B).
Fig. A Fig. B
Device parameters can be changed in the user menu. The following pages pro-
vide an overview as well as a detail description.
Access to the service menu is restricted to trained and authorized service person- Access to the service menu
nel.
33
User Menu
8.1 Setting First Nominal Pressure

EN In the user menu, tap the Starting Pressure key to access the setting.
Select the desired Starting Pressure for the currently selected insufflation mode.
Press the º or » keys to increase or decrease the nominal pressure.
Insufflation operating mode Factory setting Range

AirSeal Mode 15 mmHg 5-15 mmHg
Smoke Evacuation Mode 15 mmHg 5-15 mmHg
Standard Insufflation Mode 15 mmHg 5-15 mmHg
8.2 Gas Flow Rates

In the user menu, tap the Gas Flow Rates key to access the selection. You can se-
lect one of three gas flow rates for each insufflation mode.
Press the º or » keys to increase or decrease the gas flow.
Insufflation operating mode Range

AirSeal Mode (Initial Insufflation) Gas flow between 1 and 40 l/min
Smoke Evacuation Mode Gas flow between 1 and 40 l/min
Standard Insufflation Mode Gas flow between 1 and 40 l/min
8.3 Setting Smoke Evacuation Level

In the user menu, tap the Smoke Evacuation Level key to access the selection. For
AirSeal Mode a pre-setting can be chosen.
AirSeal Mode LOW

HIGH
8.4 Setting General Volume

In the user menu, tap the Audio/Display key to access the signal volume selec-
tion.
You can select one of four volume levels for the warning signals as well as the
info and alert signals, all in the form of acoustic signals. The selection/setting ap-
plies to all insufflation operating modes.
Press the º or » key to set the desired volume.
Warning signals Alert signals Info signals

I (Low) I (Low) I (Low)
II (Medium) II (Medium) II (Medium)
III (High) III (High) III (High)
IIII (Very High) IIII (Very High) IIII (Very High)
8.5 Setting Brightness

In the user menu, tap the Audio/Display key to access the brightness selection.
Use the Brightness option to adjust the screen display to the ambient light con-
ditions within the operating room.
34
User Menu
8.6 Setting Audible Occlusion Signal

In the user menu, tap the Audio/Display key to access the audible occlusion sig-
EN
nal selection.
The audible signal which comes with the occlusion alert can be switched off. The
alert message remains nevertheless.
8.7 Setting Gas Supply

In the user menu, tap the Gas Supply key to access the gas supply selection.
You can select house or bottle gas supply.
House gas button will be greyed out if pressure is > 15 bar/218 psi. To select
house gas supply, close and disconnect gas bottle from device.
Press the corresponding key to select the desired gas supply.
In this menu item, press the º or » key to select the desired volume for No Gas
Alarm.
8.8 Setting the Language

In the user menu, tap the Language key to access the language selection.
Select one of 14 available languages.
Language
English (factory setting) Chinese
French Japanese
German Korean
Spanish Russian
Italian Greek
Portuguese Romanian
Brazilian Portuguese Polish
Press the corresponding language key to select the desired language or press the
arrow key to access to further languages.
8.9 Checking Software Version

In the user menu, tap the Software Version key.
The software version is depicted.
8.10 Resetting or Restoring to Factory Setting

In the user menu, tap the Reset key. This allows you to reset all setting done in
the user menu to factory default.
35
Care and Maintenance
9 Care and Maintenance

EN Special care is necessary when servicing, maintaining, and storing the device and
its accessories to maintain the functionality of the device and its 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.
9.1 Cleaning the Device

Manufacturer’s specifications The manufacturer recommends that the device is cleaned after every procedure
as follows:
1. Use the ON/OFF key to turn the device off.

2. Remove the power cable.
3. Wipe all outer surfaces of the device with a disposable soft cloth moistened
with an appropiate disinfectant (for example Meliseptol® rapid). The concen-
tration of the disinfectant and the application should be adjusted according
to the information provided by the manufacturer of the disinfectant. Make
sure moisture does not enter the device.
NOTE!
Do not sterilize the device.
9.2 Maintenance Intervals

Manufacturer's specifications The manufacturer stipulates that qualified personnel or hospital technicians
must regularly test the device to assess its functionality and technical safety. The
device needs to be serviced at least every two years. The tests are described in
chapter 10 "Annual Inspection".
Regular inspections will assist in early detection of possible malfunctions. This

helps preserve the device and increases its safety and service life.
NOTE!
Service or maintenance work may not be carried out during surgery.
9.3 Maintenance by Authorized Service Technician

Two-year maintenance interval An authorized service technician has to inspect and service the device at appro-
priate intervals to ensure the safety and functionality of the unit. The minimum
service interval is two years, depending on frequency and duration of use. If the
service interval is not maintained, the manufacturer does not assume any liabil-
ity for the functional safety of the device.
A sticker located on the rear panel of the device will remind you of the latest date
for the next service or maintenance check.
Authorized service technicians are only trained and certified by the manufactur-
er.
Authorized trained personnel All of the service tasks, such as changes, modifications, repairs, calibrations, etc.
may be carried out only by the manufacturer or manufacturer-approved trained
and skilled technicians.
Unauthorized personnel The manufacturer is not liable for the operational safety of the device if unau-
thorized persons conduct this maintenance or any other service tasks.
Liability Unauthorized opening of the device and repairs performed by unauthorized per-
sonnel or third parties and/or changes or modifications release the manufactur-
er of any liability concerning the operational safety of the device.
Technical documents Receiving technical documentation from the manufacturer does not authorize
36
individuals to perform repairs, adjustments, or alterations on the device or acces-

sories/peripherals. EN
Ask the service technician for a certificate after he or she has inspected the unit Certification
or performed any service tasks. This certificate lists the type and scope of the ser-
vice as well as the date and name of the servicing company together with the sig-
nature of the service technician.
9.4 Resetting the Fuse (only for 2 pole breaker)

The fuse may have to be reset if:
• displays and LEDs (if available on your equipment) do not light up,
• the device does not function.
Check to make sure
• the main power supply cable is properly connected to the power supply input
and to a safety socket,
• the house power supply fuse is functioning.
WARNING!
Unplug the power cable from the device before checking the fuse.
The device does not have to be opened to reset the fuse.
1. Switch device off.

2. Disconnect device from power supply.
3. Remove power connection cable from mains socket.
4. The fuse switch is located next to the mains socket.
5. Check the switch setting of the fuse as depicted in Fig. 9-1.
6. Press the fuse switch to reset the fuse.
7. Use the power cable to reconnect the shockproof safety socket with the rear
socket.
Fig. 9-1 Fuse for 2 pole breaker

9.5 Replacing the Fuse (only for inlets with fuse drawer)
WARNING!
Replace the fuse
Replace the fuse only with a fuse provided by the manufacturer (see chapter 14
"Accessories").
The fuse may be defective and in need of replacement if:
• Indicators and display (if present on the device) do not light up,
• the device does not function.
Check whether
• the main power supply cable is properly connected to the power supply input
and to a grounded safety wall socket,
• the house power supply fuse is functioning.
WARNING!
Unplug the power cable from the device before checking the fuse.
The device does not have to be opened to replace the fuse.
37
1. Switch device off.

EN 2. Disconnect device from power supply. For this, pull the mains plug from the
mains socket.
3. Remove the power connection cable from mains socket.
4. The fuse holder is located next to the mains socket.
5. Remove the fuse holder as shown in Fig. 9-2 "Opening the fuse holder".
6. Undo the latch of the fuse holder with two fingers.
7. Remove the fuse holder.
8. Check fuse.
9. Insert a new fuse. Use only the specified type of fuse (see chapter 13 "Techni-
cal Data").
10. Insert the fuse holder until it can be heard snapping into place.
11. Reconnect the device to the power supply. For this, insert the mains plug into
the mains socket.
Fig. 9-2 Opening the fuse holder
38
Annual Inspection
10 Annual Inspection
Each test conducted should be documented with date and signature on the test Measured values and tolerances EN
log.
The following measuring tools and resources were used by the manufacturer to
determine the listed measurements and tolerances:
Manometer Range 0-100 mmHg, error class ± 1.6%

Syringe 60 ml
Silicone tube 8 mm x 2 m
T adapter 8-8-8 mm
Veress needle length 100 mm
opening diameter 1.4 mm,
inner cannula diameter 1.6 mm
An authorized service technician must check the device if the specified parame-
ters and tolerances are exceeded.
10.1 Electrical Safety Test

1. Perform a visual inspection. Make sure that
• the fuse corresponds with the specifications indicated by the manufactur-
er,
• labels and stickers on device are legible,
• the mechanical condition of the device allows for its safe use,
• the device is clean to ensure proper and safe functionality.
2. Carry out the measurements for the ground leakage current, short-circuit
current/housing leakage current, and the protective conductor resistance as
per IEC 62353 in the current version or according to the applicable national
standard.
10.2 Basic Function Test

1. Conduct this test without the Single Lumen Filtered Tube Set connected to
the AirSeal® iFS
2. Use the ON/OFF switch to turn the device on. The device now conducts a self-
test. A short acoustic signal can be heard. Press the Standard Insufflation
Mode key to select this operating mode.
3. The factory default settings are 15 mmHg for the nominal pressure and 5 l/
min for the nominal flow.
4. The following values are displayed:
Nominal pressure 15 mmHg
Nominal gas flow rate 5 l/min [button 1]
Actual pressure 0 mmHg
Gas consumption 0 l
5. Start insufflation:
Press the START key.
The following values are displayed: Actual pressure 0 mmHg
Initial insufflation is depicted.
Streaming gas can be heard at the insufflation tube connection.
6. Select the max. nominal gas flow.
The following values are displayed:
Actual gas flow equals nominal gas flow rate
Initial Insufflation is displayed.
Streaming gas can be heard at the insufflation tube connection (barbed con-
39
Annual Inspection
nector).
EN 7. Stop insufflation:
Press the STOP key.
The following values are displayed:
Gas consumption > 0.0 l
8. Press the RESET key.
Gas consumption 0.0 l
The basic function check of the device is complete.
10.3 Pressure Sensor Test

(1)
(3) (2)
1. Select the Standard Insufflation Mode as the operating mode.

2. Do not press the START/STOP key.
CAUTION!
Never use the syringe to extract gas from the device.
3. Connect a manometer (1) and an air-filled syringe (3) to the insufflation

tube connection (2).
4. Use the syringe to generate a pressure of at least 10 mmHg, which is indicat-
ed on the manometer.
Actual pressure display: 10 ±2 [mmHg]
5. Use the syringe to generate a pressure of at least 20 mmHg, which is indicat-
ed on the manometer.
6. Use the syringe to generate a pressure of at least 30 mmHg, which registers
on the manometer.
10.4 Pressure Monitoring Test

2. Select a nominal pressure of 15 mmHg and adjust in the user menu the gas
flow rate 1.
3. Use the syringe to generate a pressure of at least 19 mmHg, which registers
on the manometer.
An acoustic warning sound is emitted with a pressure of more than 19 mmHg
40
Annual Inspection
(for 5 seconds) and the display depicts Overpressure.

4. Reduce the pressure. EN
The warning ends when the pressure falls below 19 mmHg (nominal pressure
plus 4 mmHg).
10.5 Max. Device Pressure Test

(1)
(3) (2)
2. Select the max. nominal gas flow.
3. Connect a manometer (1) and an open Veress cannula (3) to the insufflation
tube connection (2).
4. Select the max. gas flow.
5. Start insufflation:
Press the START key.
The manometer registers a pulsing pressure increase. When the pressure sta-
bilizes, the manometer indicates a maximum pressure between 50 and 75
mmHg.
6. Stop insufflation:
Press the STOP key.
10.6 Gas Flow Rate Test

Test setup with open connection, without connected insufflation tube.
1. Adjust in the user menu the gas flow rate 2 (20 liters).
2. Press the RESET key (0.0 L must be depicted).
3. Start insufflation: Press the START key. Now begin timing for one minute.
4. Stop the insufflation after one minute. Press the STOP key.
The gas consumption should be between 15.5 - 20.5 liters.
41
Electromagnetic Compatibility
11 Electromagnetic Compatibility
EN Precautionary measures Medical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
This device is to be used only for the purposes described in the manual and has
to be installed, set up, and operated in compliance with the EMC notes and in-
structions.
CAUTION!
Accessories
To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-
sion, the device AirSeal® iFS must be used only with the accessories listed in
chapter 14 "Accessories".
In order to ensure the basic safety and the essential performance in relation to
electromagnetic interference over the lifetime of the device, the AirSeal® iFS
must be restarted after 24 hours to allow the self test to be repeated. Further-
more, the service interval described in chapter 9.2 "Maintenance Intervals" must
also be adhered to.
CAUTION!
Continuous operation
After 24 hours of continuous operation, a device self-test must be carried out.
• Switch device off and on again.
11.1 Impact of Mobile and Portable HF Communication Devices

The emission of high frequency energy by mobile communication devices may
impact the function of the electrical medical device. Operating such devices (e.g.,
cell phones, GSM phones) in the proximity of the electrical medical device is pro-
hibited.
11.2 Electrical Connections

ESD (Electrostatic Discharge) precautionary The following are ESD precautionary measures:
measures
• Apply potential equalization (PE), if available on your equipment, to all devices
to be connected.
• Use only the listed equipment and accessories.
Hospital employees should be informed about and trained in ESD precautionary

measures.
42
11.3 Guidelines and Manufacturer's Statement - Electromagnetic In-

terference Immunity EN
The insufflator AirSeal® iFS is intended for use in an electromagnetic environ-
ment as described below. The user/operator of the insufflator should make sure
the device is operated within such an environment.
Electromagnetic interfer- IEC 60601 test level Compliance Levels Electromagnetic environment guidelines
ence immunity tests
Electrostatic discharges ± 8 kV contact ± 8 kV contact Floors should be made from wood or con-
(ESD) IEC 61000-4-2 ± 15 kV air ± 15 kV air crete or covered with ceramic tiles. If the
floor covering consists of synthetic material,
the relative humidity should be at least 30%.
Electrical fast transients/ ± 2 kV for power lines ± 2 kV for power lines The quality of the supply voltage should be
bursts according to ± 1 kV for input and out- ± 1 kV for input and the same as the voltage of a typical business
IEC 61000-4-4 put lines output lines or hospital environment.
Modulation 100 KHz Modulation 100 KHz
Surges according to IEC ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) The quality of the supply voltage should be
61000-4-5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth the same as the voltage of a typical business
or hospital environment.
Blackouts, brownouts, 0 % UT; 0.5 cycle 0 % UT; 0.5 cycle The quality of the supply voltage should be
and fluctuations of the the same as the voltage of a typical business
power supply according At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, or hospital environment. If the user/opera-
to IEC 61000-4-11 180°, 225°,270° and 315° 180°, 225°,270° and tor of the device requires continuation of
315° functionality after power interruptions/dis-
ruptions, it is recommended to supply the
0 % UT; 1 cycle and 70 % 0 % UT; 1 cycle and device with power from an uninterruptible
UT; 25/30 cycles Single 70 % UT; 25/30 cycles power supply or battery.
phase : at 0° Single phase : at 0°
0 % UT; 250/300 cycles 0 % UT; 250/300 cycles
Supply frequency (50/60 30 A/m 30 A/m Magnetic fields of the mains power fre-
Hz) magnetic field IEC quency should comply with the typical val-
61000-4-8 ues of business and hospital environments.
Portable and mobile wireless devices should
not be used in closer proximity to the 40L
High Flow Insufflator (including cables/lines)
than the recommended safety distance cal-
culated based on the transmitting frequency
and the applicable formula. Recommended
safety distances:
Conducted RF IEC 61000- 3 Vrms 150 kHz to 3V Recommended safety distances
4-6 80 MHz
d = 1.2P for 150 KHz to 80 MHz
d = 1.2P for 80 MHz to 800 MHz
d = 2.3 P for 800 MHz to 2.7 GHz
Transients RF IEC 61000- 3 V/m 80 MHz to 2.7 GHz 3 V/m where P is the max. rated output of the
4-3 transmitter in watt (W) according to the
80% AM by 1 KHz information provided by the manufacturer
of the transmitter. d is the recommended
separation distance in meters (m).
The field strength of stationary transmitters
for all frequencies tested on site a should be
lower than the concordance level. b
Interference is possible in the proximity of
devices featuring the following pictograph.
*Note: UT is the mains alternating voltage before applying the test levels.
43
Note 1: The higher frequency range applies at 80 MHz and 800 MHz.
EN
Note 2: These guidelines are probably not realizable in all cases. Electromagnetic
propagation is affected by absorption and reflection of buildings, objects and
persons.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. A
study of the installation site should be considered to determine the electromag-
netic environment concerning the stationary transmitter. If the field strength
measured at the usage site of the insufflator exceeds the compliance levels listed
above, the insufflator should be monitored for proper function. If abnormal per-
formance is observed, additional measures may be necessary, such as re-orient-
ing or relocating the insufflator.
b The field strength should be less than 3 V/m for the frequency range of 150 kHz
to 80 MHz.
IMMUNITY TEST
Transients HF IEC 61000-4-3
Test frequency Band (MHz) Service Modulation Maximum Distance (m) IMMUNITY
(MHz) power (W) TEST LEVEL
(V/m)
385 380-390 TETRA 400 Pulse modula- 1.8 0.3 27
tion
18 Hz
450 430-470 GMRS 460, FRS FM 2 0.3 28
460
±5 kHz devia-
tion
710 Pulse modula-
tion
745 704-787 LTE Band 13, 17 0.2 0.3 9
780 217 Hz
810 GSM 800/900, Pulse modula-

TETRA 800, tion
870 800-960 IDEN 820, 2 0.3 28
930 CDMA 850, LTE 18 Hz
Band 5
1720 GSM 1800; Pulse modula-
CDMA 1900; tion
1845 1700-1990 GSM 1900; 2 0.3 28
1970 DECT; LTE Band 217 Hz
1,3, 4, 25; UMTS
2450 2400-2570 Bluetooth, Pulse modula- 2 0.3 28
WLAN, tion
802.11 b/g/n
RFID 2450, LTE 217 Hz
Band 7
5240 WLAN 802.11 Pulse modula-
a/n tion
5500 5100-5800 0.2 0.3 9
5785 217 Hz
WARNING!
Portable HF communication devices can have an effect on the performance char-
acteristics of the device. Therefore such devices must be kept a minimum dis-
tance of 30 cm (independent of any calculation) from the insufflator, its
44
accessories and cables.

EN
11.4 Guidance and manufacturer's declaration - electromagnetic
emissions
The AirSeal® iFS is intended for use in an environment as described below. The
user/operator of the insufflator should make sure the device is operated within
such an environment.
Emissions test Compliance Electromagnetic environment - guid-

ance
RF emissions CISPR 11 Group 1 The AirSeal® iFS uses RF energy
solely for its internal function. There-
fore, its RF emissions are very low
and are not likely to cause any inter-
ference in nearby electronic equip-
ment.
RF emissions CISPR 11 Class B The AirSeal® iFS is suitable for use in
all establishments, other than
Harmonic emissions Class A domestic establishments and those
IEC 61000-3-2 directly connected to the public low-
Voltage fluctuations/ Complies voltage power supply network that
flicker emissions supplies buildings used for domestic
IEC 61000-3-3 purposes.
45
Informational, Warning and Error Messages
12 Informational, Warning and Error Messages

EN Status line display Information for users displayed in the status display are depicted only temporar-
ily and disappear again after a few seconds.
Informational, warning and error messages Depending on the type of message, windows with green, yellow, and red frames
are depicted.
Informational message Green frame

Warning message Yellow frame
Error message Red frame
Critical message Red frame
Informational message Cause

AirSeal is shutting down. System Auto Pressure is slowly reduced. Pump keeps running for a few seconds. No pressure build
Calibration in progress. up.
Do not turn device off. Wait for calibration.
Connect blue tube. Smoke evacuation To enable the smoke gas evacuation function, connect the blue tube to a trocar and
initiating... open the valve.
Warning message Cause Remedy

Check for excessive leakage or suction Long suction or leaks. Check for possible leakage! Use suction
carefully.
Fluid Detected in Filter. Change Tube Set Low fluid level of the fluid trap in the Please insert a new tube set.
to Protect iFS Unit and Continue with filter housing during Smoke Evacua-
Smoke Evacuation Function. tion mode.
Fluid Detected in Filter. Insert Obturator Low fluid level of the fluid trap in the Please insert a new tube set.
into AirSeal® Cannula to Maintain Pres- filter housing during AirSeal mode.
sure. Change Tube Set to Protect iFS Unit
and Continue with AirSeal Function.
Smoke Evacuation stopped. Insufflation Leaks or low cavity pressure. Check for possible leakage! Use suction
active. carefully.
Smoke Evacuation stopped. Suction line Evacuation blocked. Check the evacuation/suction system for
blocked! proper function.
Safety threshold: Pressure >15 mmHg! The set value of 15 is reached and the Release the key for 2 seconds. Now you
user tries to increase the pressure fur- can set a value up to 20 mmHg.
ther.
Starting... Do not install tube set until Initial self test is "running". Wait until the initial self test has com-
self test is completed! pleted.
Occlusion! Cannula tubing or Veress needle has a Verify cannula / needle placement and
blockage. tubing continuity.
Check House Gas Supply! Delivered Pressure is too low. Check connection from device to house
gas. Make sure house gas is working prop-
erly.
Connect blue tube. Smoke Evacuation Cannula tubing or Veress needle has a Verify cannula / needle placement and
initiating... Occlusion! blockage. tubing continuity
Connect Tri-Lumen Filtered Tube Set to Cannula tubing or Veress needle has a Verify Cannula / needle placement and
AirSeal® Cannula with Obturator in blockage. tubing continuity. Continue with connec-
Place. AirSeal will Start Automatically. tion of tubing and cannula. AirSeal will
Occlusion! start automatically.
46
Error message Cause Remedy

EN
Venting valve error! Restart the device. Valve malfunction. Restart the device. If the error occurs
If the error occurs again call service! again, call service!
Electronic error! Restart the device. If Malfunctions in the electronic system. Restart the device. If the error occurs
the error occurs again, call service! again, call service!
Sensor error! Restart the device. If the Sensor malfunction. Restart the device. If the error occurs
error occurs again call service! again, call service!
Device temperature error! Do not use Temperature in device too high. Serious defect. Do not use device. Call ser-
device. Call service! vice!
Valve error! Do not use device. Call ser- Do not use device. Call service!
vice!
Calibration error! The device must be re- The device is not calibrated properly. The device must be re-calibrated. Call ser-
calibrated. Call service! vice!
Contamination! Fluid has penetrated The device is contaminated with fluid. The device must be checked by an autho-
the Control Unit internally! Ongoing sur- rized service technician or clearly marked
gery can be finished! Do not use device with a label referring to the contamina-
for next procedure! Contact technical tion and then twice enclosed in a safety
service! foil, sealed, and returned to the manufac-
turer for repairs.
Critical message Cause Remedy

Check connection of Tri-Lumen Filtered Tube set improperly connected. Connect the tube set correctly.
Tube Set! Insufflation will shut down in
15s!
Cannula partly occluded! Ensure black Tube or cannula has a blockage. Determine the cause for the occlusion.
lines on distal cannula are visible inside Check the positioning of the cannula.
cavity!
Filter contaminated! Insert new tube High fluid level of the fluid trap in the Please insert a new tube set.
set! filter housing
Fluid Threshold in Filter Exceeded. High fluid level of the fluid trap in the Finish procedure and call service.
AirSeal Insufflation Stopped. Change filter housing during AirSeal mode.
Tube Set to Complete Current Proce-
dure. Inspection Required to Assess Pos-
sible Damage to iFS Unit. Call for
Service.
Fluid Threshold in Filter Exceeded. High fluid level of the fluid trap in the Finish procedure and call service.
Smoke Evacuation Function Stopped. filter housing during Smoke Evacua-
Change Tube Set to Complete Current tion mode.
Procedure. Inspection Required to
Assess Possible Damage to iFS Unit. Call
for Service.
Change gas bottle! Insufflation stopped! Low insufflation gas supply (bottle or Check gas supply.
house supply) during insufflation.
Change gas bottle! Low insufflation gas supply (bottle or Check gas supply.
house supply).
Change gas bottle! AirSeal Insufflation Low insufflation gas supply (bottle or Check gas supply.
shut down in 100 s! Pressure limited to house supply) during AirSeal® insuffla-
12 mmHg! tion.
Insufficient gas! Check gas supply and Device has no gas supply. Check gas supply.
restart device!
Check gas supply! Device has no gas supply. Check gas supply.
Check gas supply! Insufflation stopped! Low insufflation gas supply (bottle or Check gas supply.
house supply) during insufflation.
Check gas supply! AirSeal Insufflation Low insufflation gas supply (bottle or Check gas supply.
will stop in 100 s! Pressure limited to house supply) during AirSeal® insuffla-
12 mmHg! tion.
Gas level low. Prepare to change gas Low insufflation gas supply (bottle or Check gas supply.
bottle. house supply) during insufflation.
47
Overpressure! The actual pressure is 3 mmHg above Determine the cause for exceeding the
EN the nominal pressure for longer than 5 nominal pressure. Check the electronic
seconds. displays of the device if overpressure
exists for a longer period of time.
Overpressure! Venting active! The actual pressure is above the nomi- Determine the cause for exceeding the
nal pressure. nominal pressure. Check the electronic
displays of the device if overpressure
exists for a longer period of time.
48
Technical Data
13 Technical Data
EN
Model AirSeal® iFS
Supply frequency range [Hz] 50 Hz/60 Hz
Mains voltage range1 [V] EU: 230 V
US: 100 V - 120 V
Fuse designation for 2 pole breaker (see chapter 9.4) 2 pole breaker, 10 A, 240 VAC (see chapter 13.1 for characteristic)
Fuse designation for inlet with fuse drawer (see chapter 2xT 10 A, 250 VAC, UL-recognized
9.5)
Power consumption Current [A] Voltage [V]
230 V 50/60 Hz
Normal operation 2.7 230
120 V 50/60 Hz
100 V 50/60 Hz
Protection class (I, II, III) I
Application part of the type (B, BF, CF) BF
2) 21
Protection type (IP code
3 (I, IIa, IIb, III)
Classification IIa
Conformity with the following standards in the respective DIN EN 60601-1 / IEC 60601-1
currently valid version
EN 60601-1-2 / IEC 60601-1-2
Operating conditions 10 to 30 °C / 50 to 86 °F
30 to 75 % rel. humidity
700 to 1060 hPa air pressure
3000 m max. altitude above sea level for device use
Storage and transportation conditions -25 to +70 °C / -13 to +158°F
10 to 95 % rel. humidity
700 to 1060 hPa air pressure
Max. sound level 71 db
Inlet pressure range 3.4 - 80 bar/49 - 1160 psi
Flow volume (range) 40 sl/min.
Adjustable values Pressure [mmHg] 5-20
Flow [l/min] 1-40
4
Accuracy Pressure [mmHg] ±1 mmHg
Flow [l/min] ±2.5 sl/min.
Accuracy5 Pressure [mmHg] ±1 mmHg
Flow [l/min] ±2.5 sl/min.
Dimensions Width x Height x 420 x 220 x 470
Depth [mm3]
Weight [kg] 26
Interfaces Service interface (USB port)

Mains power connection (IEC-60320-1 C14)
Software version See User Menu
1. Identification according to IEC 61293; example: 100-240V or 110V/220V
49
Technical Data
2. See DIN EN 60
EN
3. Acc. to 93/42/EEC
4. Formerly "repetition accuracy" - describes the reproducibility of a measurement ("internal precision")
5. Degree of match between displayed (actual) and correct (nominal) value; typical info "x% Full Scale"
13.1 Characteristics of circuit breaker
Effect of ambient temperature
The units are calibrated for an ambient temperature of 23 °C. To determinate the
rated current for a lower or higher ambient temperature, use a correction factor
(typical value) from the table below:
Ambient temperature (°C) Correction factor

0 0.90
+23 1.00
+40 1.03
Example: Rated current = 5 A; Enviroment temperature = 50 °C; --> Correction

factor = 1.04; Resulting current = 5.2 A --> Fount to next higher rated current: 6 A
50
Accessories
14 Accessories
EN
Cart/Valve Accessories
IFS-VALVE1 Switching valve w/hoses & mounting bracket
IFS-TOWER1 Pin Index Yoke mounted valve w/hoses
iFS-HGSV iFS house gas switching valve
AS-iCART iFS Cart w/bottle racks (E size)
AS-iCART-V iFS Cart w/bottle racks (E size) & Valve1
AS-iCART-V2 iFS Cart w/bottle racks (E size) & supports
AS-iCART-V2R iFS Cart w/bottle racks (E size), supports, & Valve1
AS-iCART-6 iFS Cart w/bottle racks (6" / 160 mm)
AS-iCART-6V iFS Cart w/bottle racks (6" / 160 mm) & Valve1
Connectors
iFS-BC1 Bottle Gas Connector
iFS-WC1 DISS Wall Connector
iFS-WC2 NIST Wall Connector
Tube Sets
Tri-Lumen Filtered Tube Set (AirSeal Mode)
Bifurcated Smoke Evac Filtered Tube Set (Smoke Evacuation Mode)
Single Lumen Filtered Tube Set (Standard Insufflation Mode)
Pressure Hoses
High pressure hoses for connection to "E" size CO2 tanks
High pressure hoses for connection to DIN, ISO, or Pin Index Bottle Gas tanks
Low pressure hoses for connection to DISS, Chemetron, DIN, AGA, NF, or UNI
Wall Connections
Access
AirSeal® Access Ports
Conventional cannulas with Luer port
Veress Needles
Miscellaneous
iFS-FUSE
iFS-ORING
iFS-SEAL
51
AirSeal® iFS Warranty
15 AirSeal® iFS Warranty

EN Standard Warranty
SurgiQuest, Inc. (the "Company") warrants this product against defects in mate-
rials and workmanship to the registered owner at the time of purchase. All com-
ponents are covered by the warranty for a period of one year from the date of
purchase. The Company will repair such defects in materials and workmanship
during the warranty period at no charge to the customer.
This warranty does not apply to any unit that has been subject to misuse, neglect,
improper installation or that has been altered, adjusted, or tampered with by any
person other than the Company's authorized personnel.
If upon examination by authorized service personnel, it is determined that a mal-

function is due to misuse, abuse or any other circumstance set forth in the pre-
ceding paragraph, the warranty provisions will not apply. In such a case, an
estimate of the cost of repair work will be provided to the customer prior to ser-
vicing and repairing the unit.
During the warranty period for covered repairs, SurgiQuest, Inc. shall bear the
cost of shipping for both the defective unit and any replacement equipment pro-
vided. After the warranty period or with respect to repairs not covered by this
warranty, however, the customer is responsible for returning the defective
equipment to the company authorized repair location at its own expense. The
Company or its representative will service the unit, repair or replace any defec-
tive parts thereof, and return the unit.
If, upon examination, it is determined that the fault is not covered by this war-
ranty, the repairs will be billed to the customer as out-of-warranty repairs. Devic-
es repaired under the Company's standard repair program will be remain covered
by this warranty for the longer of thirty days or the balance of the original prod-
uct warranty.
The warranty and the remedies as set forth herein are exclusive and in lieu of all
other warranties, remedies, obligations and liabilities of SurgiQuest, Inc., ex-
pressed or implied, including the implied warranties of merchantability and fit-
ness for a particular purpose. In no event shall SurgiQuest, Inc. be liable for any
breach of warranty in any amount exceeding the purchase price of the product.
No agent, employee or representative of SurgiQuest, Inc. has the authority to

bind the Company to any other warranty, affirmation, or representation con-
cerning this device.
This warranty is valid only to the original purchaser of SurgiQuest, Inc. products
directly from SurgiQuest, Inc. or from a SurgiQuest, Inc. authorized agent. The
warranty cannot be transferred or assigned by the original purchaser.
Sales
Contact your local SurgiQuest reprentative for additional information.
Service and Claims:
If service is needed either during or after the warranty period:
• In the United States, call 877-509-3947 extension 3 or contact your local sales
representative.
• Outside the United States, call +1-203-799-2400 extension 3 or contact your
sales representative.
• Package all the components carefully in the original shipping container. If the
original shipping container is not available, an equivalent shipping container
must be obtained.
• Print the Return Authorization and prepare for shipment pickup at scheduled
time and location.
52
Test Log
16 Test Log
EN
16.1 Test Log
Date Results Comment Signature
53
Test Log
16.2 Return Form

EN Please fill out and include this form when returning the device:
Name of owner:
Sales partner:
Address of person returning unit:
Street:
ZIP/Postal code: City:
Country:
IMPORTANT!
Serial number (see identification plate):
Device REF:
Description of defect or requested service:
Contact Signature Date
54
Index
Index
A
EN
Access to the service menu 33
Authorized trained personnel 36, 36
C
Care and maintenance 4
Certification 37
Contamination 4, 31
Contraindications 7
D
Delivery inspection 12
E
ESD (Electrostatic Discharge) precautionary measures 42
Exclusion of liability 4
F
Federal Law 4
Fluid level HIGH 32
Fluid level LOW 32
G
Gas supply displays 15
Gas supply with gas bottle 15
Grounding contact 13
H
House gas supply 15
I
Informational, warning and error messages 46
Intended use 7, 7
L
Leakage warning 32
Liability 36
M
Mains connection 13
Manufacturer’s specifications 36
Measured values and tolerances 39
O
Occlusion 31
Only for U.S. operators 13
Overpressure 31
P
Potential equalization 13
Precautionary measures 42
S
Setting up 12
Setting up the device 12
Status line display 46
Stop insufflation 32
Subject to technical changes 3
Severed tube connection 32
System calibration 32
T
Technical documents 36
Two-year maintenance interval 36
U
Unauthorized personnel 36
V
Venting system 31
W
Waste management 4
55
W55-186- EN AA

AirSeal INGLES

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Instructions for use EN

This manual contains information that is subject to copyright.

EN All rights reserved. This manual should not be photocopied, du-

Copyright © SURGIQUEST, Inc.

Manufactured for: EMERGO EUROPE

Ph: +1.203.799.2400 0086 CE marking according to Directive 93/42/EEC

Type: F121/10000013799 Revision 13/2017-08/Manzano

Not made with

Electrostatic sen- Protective

House gas supply

Alternating cur- Gas bottle full

Low supply gas

Low supply gas

Too low supply

Authorized for On/Off (push but-

1 Important User Notes

• to life-threatening injuries of the patient,

The handing over of technical documents does not constitute authorization to

Maintenance of the device may not be performed during the operation.

• the product must be clearly marked with a contamination warning and

3.1 Device-inherent Dangers

4 Initial Device Startup

4.1 Device Setup and Connection

4.2 Gas Connection

nection or connect to centralized CO2 gas supply.

4.2.1 Connecting a Gas Cylinder

Installation High Pressure Hoses with PIN Connector

• Connect or loosen to the device using the open-end wrench SW 14.

High Pressure Hoses with DIN Connector

• Connect or loosen to the device using the open-end wrench SW 14.

High Pressure Hoses with ISO Connector

• Connect or loosen to the device using the open-end wrench SW 14.

4.2.2 Connecting to Central Gas Supply

• Connector and hose for house gas supply NIST or

1. Attach the high-pressure hose to the gas connection

4.2.3 Gas Consumption Display

> 40 bar/580 psi

30 - 40 bar/435 - 580 psi

5 - 15 bar/73-218 psi; warning screen "Gas level low. Prepare to

EN House gas supply pressure OK

House gas supply pressure too low

5 Operating the Device

Fig. 5-1 Front of the Device

(1) (2) (3) (4) (5)

5.2 Device Rear

(6)(7) (8) (9) Fig. 5-2 Rear of the Device

(12) (11) (10)

5.3 Bottom of the Device

Fig. 5-3 Bottom of the device

5.5 Switch Device On

Press HOME key to return to Mode Selection.

5.5.1 Selecting Operating Mode

5.5.2 Insufflation Tube Sets

A conventional tube for Standard Insufflation Mode can be connected to the

Single Lumen Filtered Tube • Disposable conventional single lumen tube

SurgiQuest AirSeal® Blunt

SurgiQuest AirSeal® Cannula

AirSeal® Cannula and Low

5.5.3 Starting/Stopping Insufflation

Press START to start insufflation.