AirSeal i.F.S Instructions for Use Rev D

EN

Table of Contents 1 Important User Notes...3 2 Safety Information...4 2.1 Hazards...5 3 Device Purpose...7 3.1 Device-inherent Dangers...7 3.2 Pediatric Operating Mode Warnings...11 4 Initial Device Setup...13 4.1 Device Setup and Connection...13 4.2 Gas Connection...14 4.2.1 Connecting a Gas Cylinder...15 4.2.2 Connecting to Central Gas Supply...16 4.2.3 Gas Consumption Display...16 5 Operating the Device...18 5.1 Device Front...18 5.2 Device Rear...18 5.3 Bottom of the Device...18 5.4 Display...19 5.5 Switch Device On...19 5.5.1 Selecting Operating Mode...20 5.5.2 Insufflation Tube Sets...20 5.5.3 Starting/Stopping Insufflation...21 5.5.4 Power Device Off...22 6 Using and Controlling the AirSeal iFS...23 6.1 AirSeal Mode...23 6.1.1 AirSeal Access Port...23 6.1.2 Initial Insufflation...24 6.2 Smoke Evacuation Mode...27 6.3 Standard Insufflation Mode...29 6.4 Pediatric AirSeal Mode...31 7 Thoracoscopic Uses...32 7.1 Settings...32 7.2 Clinical Literature Supporting the Use of AirSeal in Thoracoscopic Procedures...33 8 Safety Functions...35 8.1 General Safety Functions...35 8.2 Contamination Alarm ...35 8.3 Safety Functions in AirSeal Mode ...36 8.4 Fill Level Display...36 9 User Menu...37 9.1 Setting First Nominal Pressure...37 9.2 Gas Flow Rates...38 9.3 Setting Smoke Evacuation Level ...38 9.4 Setting General Volume...38 9.5 Setting Brightness...38 9.6 Setting Audible Occlusion Signal...39 9.7 Setting Gas Supply...39 9.8 Setting the Language...39 9.9 Checking Software Version...39 9.10 Resetting or Restoring to Factory Setting...39

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10 Care and Maintenance... 40 10.1 Cleaning the Device... 40 10.2 Maintenance Intervals... 40 10.3 Maintenance by Authorized Service Technician... 40 10.4 Resetting the Fuse (Only for 2 Pole Breaker)... 41 10.5 Replacing the Fuse (Only for Inlets with Fuse Drawer)... 41 11 Annual Inspection... 43 11.1 Electrical Safety Test... 43 11.2 Basic Function Test... 43 11.3 Pressure Sensor Test... 44 11.4 Pressure Monitoring Test... 45 11.5 Max. Device Pressure Test... 45 11.6 Gas Flow Rate Test... 45 12 Electromagnetic Compatibility... 46 12.1 Impact of Mobile and Portable HF Communication Devices... 46 12.2 Electrical Connections... 46 12.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity... 47 12.4 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity... 50 13 Informational, Warning and Error Messages... 51 14 Technical Data... 53 14.1 Characteristics of Circuit Breaker... 54 15 Accessories... 55 16 AirSeal iFS Warranty... 56 17 Test Log... 57 17.1 Test Log... 57 17.2 Return Form... 58 18 Index... 59

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EN

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. Nonobservance of the instructions listed in this manual can lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing staff or service personnel, or • to damage or malfunction of device and/or accessories. Subject to technical changes

The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product through continued development of its products.

Please note

The words WARNING, CAUTION, and NOTE carry special meanings. Sections marked with these words must be given special attention. WARNING! The safety and/or health of the patient, user, or a third party are at risk. Comply with this warning to avoid injury to the patient, user, or third party. CAUTION! These paragraphs include information provided to the operator concerning the intended and proper use of the device or accessories. NOTE! These paragraphs contain information to clarify the instructions or provide additional useful information.

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Safety Information 2 Safety Information

EN

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

Federal Law (only for U.S. market)

The manufacturer is not liable for direct or consequential damages, and the warranty becomes null and void if:

Exclusion of liability

• 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. Only a CONMED 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.

Authorized trained personnel

The CONMED AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments and to evacuate surgical smoke.

Indications for Use

It is indicated for use in abdominal, thoracic, and pediatric (≥ 20 kg) procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be 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. 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.

Care and maintenance

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

Contamination

• 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. 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.

Waste management

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Safety Information EN

2.1 Hazards WARNING! Condensation/Water penetration Protect device from moisture. Do not use if moisture has penetrated the device. 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. 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.

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Safety Information EN

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. WARNING! Sterile mediums and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated. WARNING! Replacement device and accessories In case the device or any of the accessories fail during surgery, a replacement 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 angers”. 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

EN Indications for Use

Essential performance

Contraindications

The CONMED 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 gassealed obstruction-free path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures (≥ 20 kg) where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be 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. 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. The device should not be used to fill a cavity with CO2 if an endoscopy is contra-indicated. 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. 3.1 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. Laparoscopic and colorectal 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. Thoracoscopic procedures should be performed with a gas flow of 1-3 l/min.

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Device Purpose EN

WARNING! Gas supply Maintain adequate gas supply at all times. 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. 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! Medical grade CO2 Make sure to use only medical grade 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.

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Device Purpose EN

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 60601-2-18 for endoscopic devices and IEC 60601-1/EN 60601-1 for electrical medical devices. All configurations have to comply with IEC 60601-1/EN 60601-1 specifications. Whoever connects additional equipment to signal output or 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. 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 in laparo-endoscopic procedures are required for only a few cases but do increase the risk of intravasation. Never exceed the max. cavity pressure of 30 mmHg in laparoscopic procedures. It is recommend to not exceed insufflation pressures >15 mmHg in colorectal procedures, > 10 mmHg in thoracoscopic procedures and >15 mmHg in pediatric 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/hypercarbia • Reduction of venous reflux • Reduced cardiac output • Metabolic acidosis Additional reactions associated with insufflation of the thoracic cavity include: • Bradycardia • Increased central venous pressure • Increased pulmonary artery pressure • Increased end tidal CO2 • Decreased SpO2

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Device Purpose EN

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. WARNING! Lowest flow and pressure Depending on age and health condition of the patient, the lowest possible flow and pressure for establishing the pneumoperitoneum/pneumorectum or for use in the thoracic cavity should be selected. It is not recommended to exceed insufflation pressures of 15 mmHg in colorectal procedures, 10 mmHg in thoracic procedures or 15 mmHg in pediatric procedures. 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 9 “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.

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Device Purpose EN

CAUTION! Electrical interference This device was tested for electrical safety and electromechanical compatibility. However, if you detect or suspect such interference, please follow these suggestions: • Move this, the other or both devices to a different location • Increase distance between used devices • Consult an electro-medical expert WARNING! Intrathoracic pressure Intrathoracic pressures greater than 15 mmHg may increase the risk of cardiovascular collapse. Ensure full deflation of the passive lung at initial insufflation. Maintain intrathoracic pressure at 5 – 10 mmHg using the lowest pressure possible to allow for adequate visibility. Insufflate at 1 – 3 LPM. WARNING! Contact with cardiac tissue The AirSeal iFS is a Type BF classification and is not intended for direct contact with cardiac tissue. WARNING! Use of insufflation on high risk patients Frequent arterial blood gas sampling and/or monitoring is recommended in high risk patients undergoing procedures with CO2 insufflation to avoid hypercarbia and acidosis. 3.2 Pediatric Operating Mode Warnings WARNING! Pneumolabium/pneumoscrotum Children are at risk of a pneumolabium or pneumoscrotum. WARNING! Only those who are specially trained and qualified for procedures with children or endoscopic vessel harvesting procedures may use this device for these purposes. WARNING! Increased airway pressure When laparoscopic procedures are performed on children, the increased intraabdominal pressure also increases the risk for higher airway pressures. Always strictly monitor respiration and airway function when performing laparoscopic procedures on children younger than 12 years of age. WARNING! Compression of the vena cava When insufflating the abdomen of a child with medical CO2, an increased risk of compressing the vena cava exists. This risk can be reduced by monitoring the systolic and diastolic blood pressure during the entire surgery.

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Device Purpose EN

WARNING! Haemodynamic stability A laparoscopy performed on children younger than 12 years of age may result in problems of the haemodynamic system due to the CO2 content in the blood. It is recommended to increase the breathing rate of the patient and to work with low flow values and pressure values not exceeding 12 mmHg. The patient’s circulatory system should be monitored at all times. WARNING! Hypothermia The insufflation gas flow usually drops significantly after the target pressure has been reached and it is then only required to maintain the abdominal pressure. However, leaks within the abdomen or the instrument can lead to a constant gas flow of above 1 l/min. When operating on children younger than 12, a gas flow of more than 1 l/min poses an increased risk of hypothermia for the patient. Corresponding measures to prevent hypothermia include the use of blankets or pre-warmed gas. The patient’s body temperature has to be monitored at all times during surgery. WARNING! Laparoscopy with CO2 should not be performed on children with cardiovascular problems. WARNING! Emphysema Because pediatric patients are especially susceptible to hypercapnia, it is recommended to establish an end-tidal CO2 monitoring routine.

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Initial Device Setup 4 Initial Device Setup

EN

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 14 “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 environment. 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 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 14 “Technical Data”. WARNING! Use only parts and/or devices from ME systems (see chapter 12 “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 12 “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 12 “Electromagnetic Compatibility”). Operation of the ME device in vicinity of nonME 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.

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Initial Device Setup EN

CAUTION! Ventilation of the device Avoid device overheating. Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm). CAUTION! Position the device in such a way that it is easy to operate and switch off. CAUTION! Place the device outside the sterile field. CAUTION! Position of the user To avoid a malfunction, the user must be positioned correctly • within a display viewing angle of ±50° to operate the device • up to 2 m/6.5 ft from the device front for monitoring the actual values Mains connection CAUTION! Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device. Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The mains power supply cable must be plugged into a properly installed safety wall plug (see DIN VDE 0100-710). Read the device label located in rear of device (type plate) to determine the operating voltage of the device. 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 or 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! Medical grade CO2 Make sure to use only medical grade 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 tube to connect a CO2 gas cylinder to the rear gas inlet connection or connect to centralized CO2 gas supply.

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Initial Device Startup EN

4.2.1 Connecting a Gas Cylinder CAUTION! Always use a high-pressure tube 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 pipe can release dirt and oily fluids into the device. Do not use a gas cylinders with riser pipe. 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.

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Initial Device Startup 4.2.2 Connecting to Central Gas Supply

EN

Use the following device connectors and high-pressure tubes 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 1. Attach the high-pressure tube to the gas connection 2. Fasten the high-pressure tube with the nut 3. Tighten the nut 4. Power on device 5. Select MENU 6. Select Gas supply and choose HOUSE GAS Mode in menu NOTE! The default gas settings are selected at the factory and should be changed as necessary by the user. If a gas supply of greater than 15 bars/218 psi is supplied to the device, regardless if the default setting is set to bottle gas or house gas, the device will automatically default to bottle gas mode. 4.2.3 Gas Consumption Display The gas consumption display indicates the insufflated volume of 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!” is displayed and acoustic signals (beeps) are emitted. The gas bottle should be changed immediately. If insufflation is stopped, the warning message “Change gas bottle!” is displayed 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!” is displayed and acoustic signals (beeps) are emitted. The gas bottle should be changed immediately. If insufflation is stopped, the warning message “Change gas bottle!” is displayed and insufflation cannot be restarted. 16

Initial Device Startup EN

House gas supply

The following house gas supply pressures are displayed: House gas supply pressure OK House gas supply pressure too low

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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 device. Fig. 5-1 Front of the Device 1. ON/OFF switch 2. Touch screen display 3. Receptacle for AirSeal and Smoke Evacuation mode 4. Lever for locking tube set in place 5. Insufflation tube connection for Standard Insufflation Mode (barbed connection) 1

2 5.2 Device Rear

3

4

5

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 equalization 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)

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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.

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Operating the Device 5.4 Display

EN Fig. 5-4 Display 1. Nominal gas flow rate level 1 2. Actual flow rate display 3. Nominal gas flow rate level 2 4. Nominal gas flow rate level 3 5. Decreasing nominal pressure 6. Actual pressure display 7. Nominal pressure display 8. Increasing nominal pressure 9. Gas supply display 10. Gas Consumption Display 11. Reset key for consumption display 12. Smoke gas evacuation level LOW 13. Smoke gas evacuation status 14. Smoke gas evacuation level HIGH 15. Status display/error & warning messages 16. Mode 17. START/STOP key 18. MENU key 19. HOME key

1

3

2

4

5

6

7

8

9

10 11 12 13 14 15

19

18

17

16

The above depicted display shows all displays and keys. Additional explanations for individual elements are presented in the subsequent respective control element descriptions. Not all displays and functions are available for all modes. 5.5 Switch Device On

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1

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 now initializes and then runs the initial self test. The start screen and a progress 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 warning signal is emitted (see 13 “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 select a language. Press the desired language.

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