AirSeal i.F.S Instructions for Use Rev 13 Aug 2017

EN

This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely 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 errors or unclarities in this manual. Copyright © SURGIQUEST, Inc.

Manufactured for:

EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570 Fax: +31.70.346.7299

SurgiQuest, Inc. 488 Wheelers Farms Road Milford, CT 06461, USA 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 instructions for use (white image on a blue background)

Serial number

Stop

Start

Consult instructions for use

Date of manufacture (YYYYMMDD)

Home

Reset key

Caution

Use by date (YYYY-MMDD)

Menu

Not made with natural rubber latex

Electrostatic sensitive devices

Quantity

Information key

Protective earth(Ground)

Type BF applied part

Increase

Back to menu

Non-ionizing electromagnetic radiation

Equipotentiality

Decrease

House gas supply full

Degrees of protection provided by enclosures (IPCode)

Keep dry

House gas supply low

Alternating current

Top-Bottom

Gas bottle full (> 40 bar)

Service

Fragile

Low supply gas bottle (30 - 40 bar)

Catalogue number

Waste management

Low supply gas bottle (15 - 30 bar)

Do not reuse

Manufacturer

Too low supply gas bottle (5 - 15 bar)

Sterilized using ethylene oxide

Do not use if package is damaged

Gas bottle empty (0-5 bar)

Sterilized using ethylene irradiation

Keep away from sunlight

Do not resterilize

Batch code

Authorized for Sale or use by Physician only

On/Off (push button)

Table of contents 1

Important User Notes ... 3

2

Safety Information... 4 2.1 Hazards... 4

3

Device Purpose... 7 3.1 Device-inherent Dangers ... 7

4

Initial Device Startup ... 12 4.1 Device Setup and Connection... 12 4.2 Gas Connection... 13 4.2.1 Connecting a Gas Cylinder... 14 4.2.2 Connecting to Central Gas Supply... 14 4.2.3 Gas Consumption Display... 15

5

Operating the Device ... 17 5.1 Device Front ... 17 5.2 Device Rear... 17 5.3 Bottom of the Device ... 17 5.4 Display ... 18 5.5 Switch Device On... 18 5.5.1 Selecting Operating Mode... 19 5.5.2 Insufflation Tube Sets ... 19 5.5.3 Starting/Stopping Insufflation... 20 5.5.4 Power Device Off ... 21

6

Using and Controlling the AirSeal® iFS in its Different Modes... 22 6.1 AirSeal Mode... 22 6.1.1 AirSeal® Access Port ... 22 6.1.2 Initial Insufflation... 23 6.2 Smoke Evacuation Mode... 26 6.3 Standard Insufflation Mode ... 28

7

Safety Functions... 31 7.1 General Safety Functions ... 31 7.2 Contamination Alarm ... 31 7.3 Safety Functions in AirSeal Mode ... 32 7.4 Fill Level Display... 32

8

User Menu ... 33 8.1 Setting First Nominal Pressure... 34 8.2 Gas Flow Rates ... 34 8.3 Setting Smoke Evacuation Level ... 34 8.4 Setting General Volume ... 34 8.5 Setting Brightness... 34 8.6 Setting Audible Occlusion Signal... 35 8.7 Setting Gas Supply ... 35 8.8 Setting the Language ... 35 8.9 Checking Software Version... 35 8.10 Resetting or Restoring to Factory Setting ... 35

9

Care and Maintenance... 36 9.1 Cleaning the Device... 36 9.2 Maintenance Intervals... 36 9.3 Maintenance by Authorized Service Technician... 36 9.4 Resetting the Fuse (only for 2 pole breaker)... 37 9.5 Replacing the Fuse (only for inlets with fuse drawer) ... 37

10

Annual Inspection ... 39 10.1 Electrical Safety Test ... 39 10.2 Basic Function Test... 39 10.3 Pressure Sensor Test ... 40 10.4 Pressure Monitoring Test ... 40 10.5 Max. Device Pressure Test... 41 10.6 Gas Flow Rate Test ... 41

11

Electromagnetic Compatibility... 42 11.1 Impact of Mobile and Portable HF Communication Devices... 42 11.2 Electrical Connections... 42 11.3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 43 11.4 Guidance and manufacturer's declaration - electromagnetic emissions... 45

12

Informational, Warning and Error Messages ... 46

13

Technical Data ... 49 13.1 Characteristics of circuit breaker... 50

14

Accessories ... 51

EN

1

EN

15

AirSeal® iFS Warranty ... 52

16

Test Log... 53 16.1 Test Log... 53 16.2 Return Form ... 54 Index ... 55

2

Important User Notes 1

Important User Notes

EN

Read the instructions for use carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. 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 technical data of the product through continued development of its products.

Subject to technical changes

The words WARNING, CAUTION, and NOTE carry special meanings. Sections marked with these words must be given special attention.

Please note

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 additional useful information.

3

Safety Information

EN

2

Safety Information

Federal Law (only for U.S. market)

CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

Exclusion of liability

The manufacturer is not liable for direct or consequential damages, and the warranty becomes null and void if: • the device and/or the accessories are improperly used, prepared, or maintained; • the instructions and rules in the instructions for use are not adhered to; • unauthorized persons perform repairs, adjustments, or alterations on the device 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 therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments 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 facilitate 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 protection of the patient and the operating team, check that the device is properly connected 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 possible, • 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 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 determine the specific technique and procedure that will accomplish the desired clinical effect.

EN

WARNING! Check all factory settings Factory settings are not mandatory settings for the physician. The physician is responsible 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 explosive anesthetic gases and not in the vicinity of oxygen-enriched environments.

WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Refer servicing to qualified service personnel.

WARNING! Professional qualification This manual does not include descriptions or instructions for surgical procedures/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 working under the direction and supervision of a physician.

WARNING! Functional test The functional test must be performed prior to each surgery. Because the functional test is performed during initial start up, the unit must be power cycled (off/on) prior to each surgery.

5

Safety Information WARNING! Sterile mediums and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated.

EN

WARNING! Replacement device and accessories In case the device or any of the accessories fail during surgery, a replacement device 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 Dangers".

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 functionality 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 endoscopes 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 therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments 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 facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

Intended use

The device measures the actual pressure in the cavity and compares it with the set nominal pressure. The function of this device is to maintain the nominal pressure. Any overpressure within the cavity is lowered to the preset nominal pressure by the automatic venting system.

Essential performance

The device should not be used to fill a cavity with CO2 if an endoscopy is contraindicated. Please consult the manual of your laparoscope for absolute and relative contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it may not be used to distend the uterus.

Contraindications

3.1

EN

Device-inherent Dangers

WARNING! Positioning the patient Positioning the patient lower than the device can prevent body fluids from leaking 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 insufflation 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 instrument. This can result in a false actual pressure reading, which in turn may endanger the patient. In case of a disrupted gas flow, you should therefore inspect device, tube, and instruments immediately. Surgical procedures should be performed 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! 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 qualified service technician conducts the appropriate tests and repairs.

EN

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 concentrate, 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 connected 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, argon), 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 connected equipment must comply with the standard EN 60950 in the currently valid 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 606011 specifications. Whoever connects additional equipment to signal output or signal input is considered the system configurator and as such is responsible for complying with requirements of the standard IEC 60601-1 / EN 60601-1.

EN

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 respiratory 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 pressure 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 intravasation. 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 patient'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 irregularities 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 insufflation. 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 temperature during the entire surgical procedure.

9

Device Purpose WARNING! Lowest flow and pressure Depending on age and health condition of the patient, the smallest possible flow and pressure for establishing the pneumoperitoneum or pneumorectum should be selected. It is not recommended to exceed insufflation pressures of 15mmHg in colo-rectal procedures.

EN

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 instrument 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 insufflation and ensure that the insufflation instrument is correctly positioned. Long surgeries (> 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 trocar 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 This device was tested for electrical safety and electromechanical compatibility. However, if you detect or suspect such interference, please follow these suggestions: • Move this, the other or both devices to a different location • Increase distance between used devices • Consult an electro-medical expert

EN

11

Initial Device Startup 4

EN

Initial Device Startup

The operation of the device AirSeal® iFS is reserved for medical staff with the relevant 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 authorized 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 explosive anesthetic gases and not in the vicinity of oxygen-enriched environments.

4.1 Setting up

Device Setup and Connection

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 devices, 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 disconnected.

12

Initial Device Startup CAUTION! Ventilation of the device Avoid device overheating. Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm).

EN

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 0100710). 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 original power cable (if included in scope of delivery) to establish a connection between the mains wall socket and the non-heating device plug located in the rear of the device.

Grounding contact

Only use a certified (UL-listed), removable mains connection cable, type SJT, minimal 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.

Only for U.S. operators

The potential equalization denotes a highly electrically conductive connection, minimizing the different electrical potentials according to requirements of IEC 60601-1 in the respectively valid version. The installation must be according to the relevant local safety regulations.

Potential equalization

4.2

Gas Connection

WARNING! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (e.g., helium, N2O, argon), 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

Initial Device Startup 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 device using the open-end wrench SW 14. • Connect or loosen to the gas bottle using the open-end wrench SW 30. High Pressure Hoses with ISO Connector • Connect or loosen to the device using the open-end wrench SW 14. • Connect or loosen to the gas bottle using the open-end wrench SW 32.

4.2.2

Connecting to Central Gas Supply

Use the following device connectors and high-pressure hoses available as additional 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

Initial Device Startup 1. 2. 3. 4. 5. 6.

Attach the high-pressure hose to the gas connection Fasten the high-pressure hose with the nut Tighten the nut Power on device Select MENU Select Gas supply and choose HOUSE GAS Mode in menu

EN

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 returns to 0. The status of the gas supply is monitored by the device and indicated with symbols and acoustic signals.

Gas supply displays

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 emitted. The gas bottle should be changed immediately. If insufflation is stopped, the warning message "Change gas bottle!" appears and insufflation cannot be restarted. Smoke evacuation level will switch to LOW until tank is replaced. While in AirSeal mode, a countdown of 100 s is displayed during which the empty gas bottle can be changed while maintaining abdominal pressure. 0 bar/0 psi; If insufflation is started, the warning message "Change gas bottle!" Insufflation stopped!" appears and acoustic signals (beeps) are emitted. The gas bottle should be changed immediately. If insufflation is stopped, the warning message "Change gas bottle!" appears and insufflation cannot be restarted. The following house gas supply pressures are displayed:

House gas supply

15

Initial Device Startup

EN

House gas supply pressure OK

House gas supply pressure too low

16

Operating the Device 5

Operating the Device

5.1

Device Front

EN

Familiarize yourself with the control and function elements at the front of the device.

Fig. 5-1

(1)

5.2

(2)

(3)

(4)

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)

(5)

Device Rear

Familiarize yourself with the connection elements at the rear of the device. (6)(7)

(12)

5.3

(8)

(9)

Fig. 5-2

Rear of the Device

(6)

USB port (service only)

(7)

Connection for potential equalization

(8)

Gas connection

(9)

Ventilation slots (air outlet)

(10)

Type plate

(11)

Device data plate

(12)

Device connector plug with fuse holder

(11) (10)

Bottom of the Device Fig. 5-3 (13)

Bottom of the device

Ventilation slots (air intake)

(13)

WARNING! The device is equipped with a powerful ventilation system with air intake located 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