Instructions for Use
Insufflator for laparascopy Insufflator für die Laparoskopie Insufflateur pour la laparoscopie Insuflador para la laparoscopia Insufflatore per laparoscopia Инсуффлятор для лапароскопии
Instrucciones de uso
Istruzioni per l’uso
Руководство по эксплуатации
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Debido al desarrollo constante de nuestros productos, nos reservamos el derecho a llevar a cabo modificaciones técnicas sin aviso previo. El funcionamiento y el diseño podrán diferir parcialmente de la descripción en el manual. Rogamos establezcan contacto con nosotros, si desean adquirir más información sobre este o cualquier otro producto. Las denominaciones que son, a su vez, marcas registradas, no han sido identificadas especialmente. La falta de la identificación con marca no implica que el producto en cuestión no posea marca comercial alguna. Asimismo, no pueden sacarse conclusiones del presente manual, sobre la existencia o inexistencia de patentes ni modelos de utilidad. WORLD OF MEDICINE agradecerá a los usuarios de los productos de WORLD OF MEDICINE cualquier aviso, indicación u observación con respecto a posibles fallos, incongruencias o explicaciones poco claras que puedan encontrarse en el presente manual. Copyright © W.O.M. WORLD OF MEDICINE GmbH Il presente manuale contiene informazioni protette dal diritto di proprietà e soggette ai diritti di autore. Sono riservati tutti i diritti. Senza il consenso espresso scritto da parte della WORLD OF MEDICINE non è consentito riprodurre né pubblicare per intero o parzialmente il presente manuale mediante fotocopia, microfilm o altri procedimenti.
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W.O.M. WORLD OF MEDICINE GmbH Salzufer 8 10587 Berlin, Germany Phone: +49 30 39981-550 Fax: +49 30 39981-545 E-mail: [email protected]
CE marking according to Directive 93/42/EEC CE-Kennzeichnung gemäß Richtlinie 93/42/CEE Marquage CE conforme à la directive 93/42/CEE Identificación CE conforme a la directriz 93/42/CEE Marchio CE conforme alla direttiva 93/42/CEE
W.O.M. WORLD OF MEDICINE GmbH Alte Poststraße 11 96337 Ludwigsstadt, Germany Phone: +49 9263 877-0 Fax: +49 9263 877-152 E-mail: [email protected]
Маркировка CE согласно директиве 93/42/EEC
Model: F102/1200108/10000002589 04/2014-07/nho
Follow instructions for use
Lire les instructions d‘utilisation
Observe las instrucciones de uso
Leggere la documentazione allegata
Соблюдать инструкцию по эксплуатации
General Warning Sign
Warnzeichen für allgemeine Gefahr
Signalisation générale de danger
Señal de advertencia general
Segnale generale di pericolo
Символ предупреждения об опасностях общего характера
Symbol for type BF equipment
Symbol für ein Gerät des Typs BF
Symbole pour un appareil de type BF
Símbolo para un aparato del tipo BF
Simbolo per un apparecchio mod. BF
Символ прибора типа BF
Degrees of protection provided by enclosures (IP-Code)
Degrés de protection procurés parles enveloppes (Code IP)
Grado de protección proporcionado por los envolventes (Código IP)
Grado di protezioni degli involucri (codice IP)
Класс защиты корпуса (IP-код)
Symbol for potential equalization
Symbol für Potentialausgleich
Símbolo para la conexión equipotencial
Simbolo per la compensazione del potenziale
Символ выравнивания потенциалов
Numero di ordinazione
Номер для заказа
Single use only
Nicht zur Wiederverwendung
Не для повторного использования
Sterile with ETO
Sterilisiert mit ETO
Stérilisés à l’ETO
Esterilizado con ETO
Sterilizatto con ETO
Стерилизовано с помощью ЭТО
Numéro de lot
Denominación de partida o lote
Numéro de série
Número de serie
Numero di serie
Date of manufacture
Date de fabrication
Fecha de fabricación
Data di produzione
Date limite d’utilisation
Utilizzabile fino al
Non contiene latex
Number of autoclaving cycles
Anzahl der Autoklavierungen
Paramètres pour la stérilisation à l‘autoclave
Número de esterilizaciones por autoclave
Numero trattamenti inautoclave
Do not get wet
Vor Nässe schützen
Protéger de l‘humidité
Proteger contra la humedad
Беречь от влаги
Haut - bas
Alto - basso
Élimination des déchets
Gestión de residuos
Reset (Zurücksetzen auf Null)
Remise à zero
Reset (puesta a cero)
Regolamentazione a zero
Ingresso/uscita per signali
Сигнал входов/ выходов
Table of contents 1
Important User Notes ... 3
Safety Information... 4 2.1 Hazards... 4
Purpose... 7 3.1 Device-Inherent Dangers ... 7
Initial Device Startup ... 11 4.1 Gas Connection... 12 4.2 Connecting a Gas Cylinder... 12
Operating the Device ... 13 5.1 Front of the Device... 13 5.2 Rear of the Device ... 13 5.3 Switching Device On... 14 5.4 Preselecting the Nominal Pressure ... 14 5.5 Preselecting Nominal Flow... 15 5.6 Starting Insufflation ... 15 5.7 Stopping Insufflation ... 16 5.8 Switching Device Off ... 16
Safety Functions... 17
User Menu ... 19
Functional Test ... 21 8.1 Testing the Device ... 21 8.2 Testing the Veress Cannula... 22 8.3 Filling Tube System with CO2 ... 22
Using the Device during Surgery ... 24 9.1 Insufflating with Veress Cannula... 24 9.2 Insufflating with the Trocar... 24
Care and Maintenance... 26 10.1 Cleaning the Device... 26 10.2 Annual Inspection ... 26 10.3 Maintenance by Authorized Service Technician... 26 10.4 Replacing the Fuse ... 27 10.5 Cleaning the Reusable Tube Set ... 28 10.6 Disinfecting the Reusable Tube Set... 29 10.7 Sterilization of Reusable Tube Set ... 29
Annual Inspection ... 31 11.1 Safety Test... 31 11.2 Basic Function Test... 31 11.3 Pressure Sensor Test ... 32 11.4 Pressure Monitoring Test ... 33 11.5 Venting Valve Test ... 33 11.6 Max. Device Pressure Test... 33 11.7 Gas Flow Rate Test ... 34
Electromagnetic Compatibility... 35 12.1 Impact of Mobile and Portable HF Communication Devices... 35 12.2 Electrical Connections... 35 12.3 Accessories ... 35 12.4 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions ... 36 12.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 37 12.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - for the Insufflator. 38 12.7 Recommended Safety Distances between Portable and Mobile HF Telecommunications Devices and the Insufflator... 39
Technical Data ... 40
Error and Warning Messages... 41
Accessory List ... 42
Test Log... 44 16.1 Test Log... 44 16.2 Return Form ... 45
Important User Notes 1
Important User Notes
Read the manual 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 supplied product through continued product development.
Subject to technical changes
The words WARNING, CAUTION, and NOTE carry special meanings. Sections marked with these words must be read especially attentively.
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 parties.
CAUTION! These paragraphs include information provided to the operator concerning the intended and proper use of the device or accessories.
NOTE! Here you will read information about the maintenance of the device or the accessories.
Federal Law (only for U.S. market)
U.S. federal law restricts use of this device to use by or on the order of a physician.
Exclusion of liability
The manufacturer is not liable for direct or consequential damage and the warranty is null and void if: • the device and/or the accessories are improperly used, prepared, or maintained, • the instructions and rules in the manual are not adhered to, • non-authorized persons perform repairs, adjustments, or alterations on or to the device or accessories, • non-authorized persons open the device, • the prescribed inspection and maintenance schedules are not adhered to. Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations on or to the device or accessories.
Authorized service technician
Only an authorized service 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 service technicians are only trained and certified by the manufacturer.
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 complete and functional before each use.
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.
WARNING! Condensation / Water penetration Protect device from moisture. Do not use if moisture has penetrated the device.
WARNING! Original accessories For your own safety and that of your patient, use only original accessories.
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.
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.
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.
WARNING! Not explosion-proof The device is not explosion-proof. Do not use in an area where flammable anesthetic gases are present.
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! Disconnect device from power supply Pressing the ON/OFF key does not disconnect the device from the power supply. This requires pulling the plug located in the rear of the device.
WARNING! Replacing fuse Replace the fuse only with a fuse of the same type and rating.
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.
WARNING! Sterile mediums and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated.
Safety Information WARNING! Cleaning the device Do not sterilize the device.
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! Device-inherent dangers Read the warnings specific to this device in chapter 3.1 "Device-Inherent Dangers".
WARNING! Device defect If a device defect is suspected or confirmed, do not use it. Make sure the device can no longer be used until a qualified service technician conducts the appropriate tests and repairs.
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.
The device serves to insufflate CO2 into the abdomen during a diagnostic or therapeutic laparoscopy. Please consult the instructional manual of your laparoscope for additional information and special application indications. The insufflator limits the pressure to max. 30 mm Hg (mm mercury column) and the gas flow to max. 20 l/min. The device measures the pressure within the abdomen in short intervals and continuously compares the nominal with the actual abdominal pressure. The function of this device is to maintain the nominal pressure. Any overpressure within the abdomen is lowered to the preset nominal pressure by the automatic venting system. If the nominal flow is set too low, the nominal pressure cannot be reached.
Check for possible leaks. The device may not be used to fill an abdomen with CO2 if a laparoscopy 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.
The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos.
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. The abdomen is sufficiently distended using a pressure between 10 to 15 mmHg. Pressure values above 15 mmHg are required for only a few cases but do increase the risk of intravasation. Never exceed the max. intra-abdominal pressure of 30 mmHg.
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! 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! 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
Purpose problems. The risk for hypothermia can be significantly reduced with the use of gas that is pre-warmed to body temperature. Always monitor the patient's body temperature during the entire insufflation. Make especially sure that the following, hypothermia promoting, surgical conditions are avoided as best as possible: • High gas flow due to large leaks • Long surgeries • Use of cold (not preheated) irrigation and infusion solutions
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 air or CO2 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. CO2 embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pressure settings and close damaged blood vessels at once.
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 applications should be carried out with a gas flow of 4-10 l/min. An even lower gas flow is recommended for diagnostic purposes. It is recommended to perform endoscopies with the lowest gas flow possible.
WARNING! Keep filled CO2 bottle on hand Always keep a filled CO2 bottle on hand ready for replacement. This avoids having to interrupt surgery due to a lack of insufflation gas (see chapter 4.2 "Connecting a Gas Cylinder").
WARNING! The venting rate of the automatic venting system is limited. Always monitor the actual pressure when using additional insufflation sources.
WARNING! Additional insufflation sources 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.
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.
WARNING! Filter Use a new/sterile filter for each patient. You must work with a 0.2 μm two-way (retention rate 99.99 %) hydrophobic filter between patient and device. This should prevent bodily fluids from entering the device and also prevents impurities from possibly entering into the patient’s body. Reduced flow capacity should be considered when using a hydrophobic filter.
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! 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 channel. Always insufflate through the elevated side of the patient.
WARNING! 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.
WARNING! Removing the insufflation tube Always disconnect the insufflation tube after ending surgery and before switching off the device to prevent backflow of bodily fluids. Fluid may penetrate the insufflation tube whenever you change the gas bottle and/or when you stop the gas flow during the operation. If this happens, you must immediately disconnect the insufflation tube from the trocar or from the device.
Purpose 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! 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! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (i.e., helium, N2O, argon), mixtures of gases, high pressure compressed gases, gases with entrapped liquids, or polluted gases must not be used with this device.
WARNING! Service connection Connected devices have to comply with the EN 60950 standard. Do not connect a device to the service connection during surgery.
CAUTION! Electrical Interference (See chapter 12 "Electromagnetic Compatibility"). Electrical interference with other devices or instruments was practically eliminated when developing this devices and none was detected during testing. However, if you still 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! Peripheral devices Additional peripheral equipment connected to interfaces of the medical monitor has to 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.
Initial Device Startup 4
Initial Device Startup
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 service company.
If it becomes necessary to return the device, always use the original packaging. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging.
Returning the device
Please fill out the return form enclosed at the end of the instructions. Enclose the manual with the device. Please make sure that all required information has been supplied: • Name of owner • Address of owner • Device type and model • Serial number (see identification plate) • Description of defect Place the device on a level surface and install in a dry environment. The ambient temperature and humidity must meet the requirements mentioned in chapter 13 Technical Data, page 40.
Setting up the device
WARNING! Not explosion-proof The device is not explosion-proof. Do not use in an area where flammable anesthetic gases are present. 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 connection cable may be plugged only into a properly installed, grounded safety wall socket (shockproof socket) (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.
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 IEC 60320. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.
Only for U.S. operators
Integrate the device into the potential equalization system as specified by local safety rules and regulations.
Initial Device Startup 4.1
WARNING! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (i.e., helium, N2O, argon), mixtures of gases, high pressure compressed 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.
Connecting a Gas Cylinder
CAUTION! The total length with a directly connected gas bottle may not exceed 35.5 cm (incl. valve) with a max. diameter of 8.5 cm.
The gas bottle pressure may not exceed 80 bar. The bottom of the gas bottle has to be at the same height as the baseline of the device (see Fig. 4-1 "Min. angle of tilt for gas bottle").
Min. angle of tilt for gas bottle
CAUTION! Gas cylinders with riser pipe can release dirt and oily fluids into the device. Do not use a gas cylinders with riser pipe.
Operating the Device 5
Operating the Device
Front of the Device
(18)(17) (16) (15)
(1) (2) (3)
(4) (5) (6) (7)
Familiarize yourself with the control and function elements at the front of the device.
LED for On/Standby key (green/ yellow)
Nominal pressure setting
Nominal pressure display
Nominal Flow Setting
LED VERESS mode
LED INSUFFLATION mode
Connection for insufflation tube
Nominal gas flow display
Actual gas flow display
Actual pressure display
LED > 25 bar (green)*
LED < 25 bar (orange)*
Rear of the Device Abb. 5-2 (25)
(19) (20) (21)
Cover (optional data interface)
Potential Equalization Plug
Device data plate
Familiarize yourself with the connection elements at the rear of the device.
Operating the Device 5.3
Switching Device On
(See Abb. 5-1 "Device Front") 1. Connect gas supply to gas connection port. 2. Open the gas supply line. 3. Connect the power cable. The LED (2) is illuminated in green; the device is automatically switched on and conducts a self-test. Press the On/Standby key if the device is already connected to the power supply and in Standby mode (1). The device conducts a self-test. Self-test displays
1. All LEDs and segment displays are briefly illuminated. 2. Three warning signals can be heard.
Displays after self-test has concluded
The displays and indicators depend on the preset/set values in the user menu. The following information is based on factory settings. Actual pressure (PRESSURE) (14)
Actual gas flow (FLOW) (12)
Nominal pressure (SET mm Hg) (4)
Nominal flow (SET l/min) (11)
Start/stop LED (15)
LED VERESS (8)
LED INSUFFLATION (9)
LED On/Standby (2)
The device test concluded successfully. The device is operational.
Preselecting the Nominal Pressure
First nominal pressure
The nominal pressure indicator (4) already displays a nominal pressure (4) value after the device self-test has concluded. This "first nominal pressure" can range from 1 to 15 mm Hg (factory setting = 10 mm Hg) depending on the user menu settings.
The nominal pressure can be set while in standby mode as well as during the started insufflation. The desired nominal pressure can be preset to range of 1-30 mm Hg. Reduce the nominal pressure with the minus key (3) (in one-step increments down to 1 mm Hg). This set value is a "volatile value". The initially set "first nominal" value entered into the user menu is restored after stopping the insufflation, turning the device off and back on or starting the device. Increase the nominal pressure with the plus key (3) (in one-step increments from 1 to 15 mm Hg and from 15 to 30 mm Hg). This set value is a "volatile value". The initially set "first nominal" value entered into the user menu is restored after stopping the insufflation, turning the device off and back on or starting the device.
The nominal pressure value "15 mm Hg" is a threshold value. This is where the recommended range for the intra-abdominal pressure ends (starting to flash at 15 mm Hg). Exceeding this safety limit is to be decided by and the responsibility of the user/operator. Release the plus key for at least 1 second to adjust to a higher setting. The display switches from flashing to being continuously illuminated. Now you can set a value up to 30 mm Hg. This set value is a "volatile value". The initially set "first nominal" value entered into the user menu is restored after
Operating the Device stopping the insufflation, turning the device off and back on or starting the device.
Preselecting Nominal Flow
The nominal gas flow indicator (11) already displays a nominal flow value after the device self-test has concluded. This value can range from 1 to 5 l/min depending on the "Gas flow rate 1" user menu settings. (Factory setting 3 l/min)
Nominal gas flow start value
The nominal gas flow can be set while in standby mode as well as during operation of the device. The desired nominal gas flow can be preset to range of 1-20 l/ min.
Reduce the nominal gas flow with the minus key (7) (in one-step increments down to 1 l/min). This set value is a "volatile value". The initially set "Gas flow rate 1" value entered into the user menu is restored after stopping the insufflation, turning the device off and back on or starting the device. Increase the nominal gas flow with the plus key (7) (in one-step increments up to max. 20 l/min). Keep the plus key or the minus key depressed to scroll to gas flow rate 1, 2, 3 after a delay of 1.5 seconds (values depend on preset selections in user menu). The device monitors the gas flow in two different operating modes:
"Veress Operating Mode"
• Veress (1-5 l/min) operating mode • "Insufflation Operating Mode“ (6-20 l/min) The operating mode "Veress" is intended for gentle insufflation since the actual pressure does not exceed the preset nominal pressure even in case of small volumes (e.g., abdomen of a child). To minimize the risks of a faulty incision, the manufacturer recommends using the "Veress" operating mode to start off a procedure (filling abdomen with CO2). Please note that the automatic venting system is not active during the Veress operating mode. Reduce the nominal gas flow with the minus key (7) until the following is displayed: • Nominal gas flow value less or equal to 3 l/min • LED VERESS -> On • LED INSUFFLATION -> Off Pressure drops due to leaks are quickly equalized during the "Insufflation Operating Mode". APC technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. In case of large volumes, the actual pressure does not exceed the nominal pressure (cf. 6 "Safety Functions"). Tube, filter, and instrument can reduce the gas flow.
"Insufflation Operating Mode"
Increase the nominal gas flow with the plus key (7) until the following is displayed: • Nominal gas flow value > 5 l/min • LED VERESS -> Off • LED INSUFFLATION -> On
Press the Start/Stop key (16). Actual gas flow display (12) -> depicts actual flow value
Display after pressing Start/Stop key
LED Start/Stop (15) -> On
Operating the Device
Resetting the gas consumption display
The gas consumption display can be reset (volume indicator) when insufflation has been stopped or during insufflation. The display depicts 3 ranges: • 0.0-9.9 l • 10.0-99.9 l • 100-999 l Press the reset key (5). The gas consumption display (13) is reset to "0.0".
Press the Start/Stop key (16). Display after pressing Start/Stop key
The values for pressure and flow are reset to the starting values preselected in the user menu. • Displayed volume value -> is not automatically reset to 0. • LED INSUFFLATION -> off • LED VERESS -> On • Nominal flow -> 3 l/min, or preselected value • Nominal pressure -> 10 mm Hg, or preselected value
Switching Device Off
Press the On/Standby key (1) for longer than 1 second. The device is now in Standby mode. Display after pressing On/Standby key
Standby LED (2) -> continuous yellow LED. CAUTION! Pressing the On/Standby key does not disconnect the device from the power supply. This requires pulling the plug located in the rear of the device.
Pull the power plug if you wish to turn off the device completely.
Safety Functions 6
The device is equipped with an automatic venting system.
Automatic Venting System
• The venting system is always deactivated while using Veress mode. • The venting system can be activated/deactivated in the user menu when using the Insufflation mode. • The threshold values for the venting pressure and the venting response time are adjustable in the user menu. The relief or venting system is triggered if the actual pressure exceeds the venting pressure set in the user menu. The activation is triggered after the time delay set in the user menu. The venting system releases gas until the set nominal value has been reached again. CAUTION! The venting system is only active in the operating mode “Insufflation” and not the “Veress” mode.
WARNING! The venting rate of the automatic venting system is limited. Always monitor the intra-abdominal pressure when using additional insufflation sources.
CAUTION! The manufacturer advises against using additional, non-pressure controlled insufflation sources during minimally invasive surgical procedures. The self-inflating property of lasers cooled with CO2 and argon beamers can lead to values exceeding the nominal pressure. (See Abb. 5-1 "Device Front")
Overpressure within Insufflation System
• If pressure exceeds the nominal pressure by 3 to 5 mm Hg for a duration of 3 to 5 seconds, • as well as with pressure > 29 mm Hg the actual pressure display (14) flashes and 3 warning beeps are emitted after 3 seconds. If the tube, Veress cannula, or the trocar has a blockage:
In Case of Occlusion
• “0” in display and flashing actual flow display (12) • and 3 warning beeps. If the device is malfunctioning, can no longer be operated safely, and requires service:
In Case of Malfunction
• Exx (xx=error code) display and flashing of the actual flow display (12) according to error list and warning signal. The device has deactivated itself. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. • Green LED (17) is on. • Orange LED (18) is off.
Gas bottle pressure > 25 bar
• Green LED (17) is off. • Orange LED (18) is flashing.
Gas bottle pressure < 25 bar
If gas bottle pressure continues to drop during insufflation:
Safety Functions • Orange LED flashes and 3 warning beeps are heard. • Gas flow is deactivated after a volume of 10 l has been supplied; warning beeps are emitted (repeated after 1 minute). • Actual flow display “0.”
EN House Gas Supply OK
If the central or house gas supply is functioning properly: • orange LED is illuminated and • green LED is off.
House Gas Supply Malfunction
If the central or house gas supply is malfunctioning or insufficient: • gas flow is deactivated, • orange LED is flashing, • green LED is off. • 3 warning beeps are emitted (repeated after 1 minute).
Error Message "Contamination"
Three beeps and the display E21 for 5 s warn the user that fluid has penetrated into the device via the insufflation tube. It is possible to conclude any currently ongoing surgery with this device. Insufflation is not possible after turning the device off and back on using the On/Off key. This is to prevent cross-contamination. The display E21 is depicted if the device is already contaminated and you turn the device back on. 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 technician conducts the appropriate tests and repairs.
If the power fails for less than 1 second, all settings are retained. If the power fails for an extended time period, the device will function as it does when it is being restarted.
User Menu 7
The device features an option-dependent user menu as well as a service menu. Device parameters can be changed before surgery in the user menu. The following pages list a user menu overview. The service menu is protected from unauthorized access by a numeric code only known to the service technician.
Abb. 7-1 (12)
(1) (5) (6)
Menu control elements
Nominal gas flow minus key
Display field for the actual gas flow
Display field for the actual pressure
1. Initial Status: The device is turned off. Keep the menu key (5) depressed while briefly pressing the On/Standby key (1) as well. 2. Continue pressing the menu key until the LED test is finished. 3. Increasingly louder beeps are emitted after the end of the LED test and P is displayed in the display field for the actual pressure (14). The device is now in the first menu level of the user menu. 4. Switch between user and service menu with the +/- keys (7). 5. Confirm the user menu selection with the menu key (5). 6. The values to be set are depicted in the actual gas flow (12) display field. The factory default values are initially displayed - then the last saved value. 7. Use the nominal gas flow Plus or nominal gas flow Minus keys (7) to select the desired menu level. 8. Press the Menu key to access the selected menu level. Scroll with the nominal gas flow Plus or Minus key (7) to change settings. 9. Save settings with menu key (5). You are then automatically switched to the next higher menu level. 10. Press the reset key (6) to exit menu level without saving. 11. Turn the device off and wait 10 seconds before turning back on to enter normal mode. 12. The following page lists an overview over the setting options.
How do I use the user menu?
Functional Test 8
WARNING! Functional test The functional test must be performed prior to each surgery.
WARNING! Sterilize reusable instruments and tubing before surgery to prevent infections. Check all the single-use/disposable items before removing them from the package 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.
Testing the Device (1)
1. The device is turned off. 2. Connect and open the gas supply. 3. Use the On/Standby key to turn the device on. The device now conducts a self-test. 4. Connect the device with a hydrophobic filter, an insufflation tube, and a Veress cannula. 5. Attach the stopcock (valve) to the Veress cannula. 6. Select a nominal pressure of 10 mm Hg (2) and a nominal gas flow of 3 l/min (5). 7. Press the reset key (4) (display (3) has to show 0.0 l). 8. Start insufflation: Press the Start/Stop key (1). Insufflate for approx. 30 s. After max. 4 s the actual gas flow display (6) flashes. 9. Stop insufflation: Press the Start/Stop key (1). WARNING! If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If
Functional Test this happens, use steps 10 to 12 outlined below to locate the leak.
10. Repeat items 7 to 9 without Veress cannula and with closed tube end. The previously connected Veress cannula has a leak if gas consumption is now below 0.4 l. 11. Repeat items 7 to 9 without Veress cannula and without tube if another leak becomes apparent. Close the end of the insufflation tube connection for this test. If the gas consumption is then below 0.4 l, the previously used tube set has a leak. 12. If another leak is detected, this leak is then directly within the device. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. WARNING! Never work with a leaky insufflation tube, accessory, and/or device. This can lead to an incorrect measurement of the actual pressure values, which can cause an uncontrolled pressure increase in the abdomen.
Testing the Veress Cannula (1)
It is also necessary to check that the Veress cannula is functioning properly before surgery. 1. 2. 3. 4. 5. 6.
Open the stopcock (valve) at the Veress cannula. Set a nominal gas flow rate of 10 l/min (3). Press the reset key (2). Press the Start/Stop key (1). Insufflate for approx. 30 s. Stop insufflation: Press the Start/Stop key (1).
A soiled or blocked Veress cannula is indicated if the actual gas consumption display shows a value of less than 0.5 l.
Filling Tube System with CO2
At least 1 l of CO2 has to be let out from the system before every surgery while the tube is connected and the end of the tube is open. This will expel any air within the tube system and the device. 1. Press the RESET key (2). 2. Start insufflation: Press the Start/Stop key (1). Wait until the gas consump-
Functional Test tion display shows "1.0." 3. Stop insufflation: Press the Start/Stop key. Press the RESET key to reset the gas consumption display to 0.0 l. This ensures the gas consumption is correctly displayed during surgery.
The function test is complete. The device is tested and ready to be used for surgery. WARNING! Do not use this device if a defect is suspected or detected during the function check. This also applies to obvious defects, especially defects on the power plug and power cable.
Using the Device during Surgery 9
Using the Device during Surgery
WARNING! Functional test The functional test must be performed prior to each surgery. Before surgery
1. The device is turned on. 2. The insufflation tube is connected. WARNING! Always use a filter hydrophobic on both sides between device and patient.
Insufflating with Veress Cannula
On delivery from the factory, a gas flow value of 3 l/min and the Veress operating mode are set for insufflation through the Veress cannula. WARNING! Select "Veress Operating Mode" when using the Veress cannula. This manual does not include instructions for the safe use of the Veress cannula. Only when you have ensured endoscopically that an aeroperitoneum can be generated, should a gas flow of more than 3 l/min and a pressure of more than 10 mmHg be selected. 1. Insert the Veress cannula into the abdomen. Check to see if the Veress cannula is correctly positioned in the abdomen. 2. Connect the insufflation tube to the Veress cannula. 3. Select the desired nominal pressure and nominal gas flow. 4. Start insufflation: Press the Start/Stop key. Check the actual pressure display and the gas consumption display.
Insufflating with the Trocar
1. Insert the trocar into the abdomen. Connect the tube to the trocar. CAUTION! Stopping insufflation during surgery can diffuse CO2 through the wall of the tube, which results in a high negative tube pressure. This can damage the device. Therefore, the tube connection between patient and device has to be severed. This can be done at the trocar as well as directly at the device. 2. Make sure the trocar is correctly positioned in the abdomen. Then select the desired pressure and desired gas flow as intraoperative conditions. 3. The actual pressure display shows the current measured value for insufflation. As soon as this value approximates the selected nominal value, the gas flow is automatically minimized. The gas consumption display shows the volume of gas consumed. 4. Check how the patient's body reacts to the selected pressure and gas flow rate. Compare the abdominal filling rate to the selected nominal pressure. You can change the nominal gas flow and the nominal pressure during surgery without interrupting the insufflation process. The venting system is automatically triggered (not during Veress mode and not if the venting system has been deactivated in the user menu) if the measured actual pressure (cf. Chapter Safety functions) exceeds the set nominal pressure. CAUTION! Make sure that the venting valve is switched on in the user menu "Venting sys-
Using the Device during Surgery tem".
The device interrupts insufflation and releases gas until the set nominal pressure has been reached again. 5. Stop insufflation: Press the Start/Stop key. The following values are displayed: • Actual pressure: current measured value • Gas consumption: last display value The nominal gas flow is reset to the basic setting. 6. Remove the tube set from the device. Observe applicable hygiene regulations when disposing of the tube set. CAUTION! If the tube set remains connected to the device, there is the danger that leftover fluid in the tube or the instruments will be sucked into the device. 7. Close the gas supply. 8. Use the ON/OFF key to turn the device off. CAUTION! Observe applicable hygiene regulations when disposing of the tube set.
Care and Maintenance 10
Care and Maintenance
Special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories.
Cleaning the Device
1. Use the On/Standby key to turn the device off. 2. Remove the power cable. 3. Wipe the surface of the device with a soft cloth moistened with the disinfectant. The concentration of the used disinfectant depends on the information provided by the manufacturer of the disinfectant. Make sure moisture does not enter the device. NOTE! Do not sterilize the device.
10.2 Manufacturer's specifications
The manufacturer stipulates that qualified personnel or hospital technicians must regularly test the device to assess its functionality and technical safety. This inspection has to be carried out once a year. The tests are described in chapter 10 Care and Maintenance, page 26. Regular inspections will assist in early detection of possible malfunctions. This helps preserve the device and increases its safety and service life.
10.3 Two-year maintenance interval
Maintenance by Authorized Service Technician
An authorized service technician has to inspect and service the device at appropriate 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 liability 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 manufacturer.
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.
The manufacturer is not liable for the operational safety of the device if unauthorized persons conduct this maintenance or any other service tasks.
Unauthorized opening of the device and repairs performed by unauthorized personnel or third parties and/or changes or modifications release the manufacturer of any liability concerning the operational safety of the device.
Receiving technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations on the device or accessories/peripherals.
Ask the service technician for a certificate after he or she has inspected the unit or performed any service tasks. This certificate lists the type and scope of the service as well as the date and name of the servicing company together wit the signature of the service technician.
Care and Maintenance 10.4
Replacing the Fuse
CAUTION! Before replacing the fuse, check the values of the fuse to be inserted acc. to chapter 13 Technical Data, page 40.
The fuse may be defective and is in need of replacement 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 replace the fuse. 1. 2. 3. 4. 5. 6. 7. 8. 9.
Switch device off. Disconnect device from power supply. Remove power connection cable from mains socket. The fuse holder is located next to the mains socket. Remove fuse holder as depicted in Abb. 10-1 "Opening the fuse holder". A Undo the latch of the fuse holder with a small screwdriver. B Remove the fuse holder. C Check fuse. Insert a new fuse. Use only the specified type of fuse (see chapter 13 Technical Data, page 40). 10. Insert the fuse holder until it can be heard snapping into place. 11. Use the power cable to reconnect the shockproof safety socket with the rear mains socket. Abb. 10-1 Opening the fuse holder
Care and Maintenance 10.5
Cleaning the Reusable Tube Set
WARNING! The reusable tube set is made of silicone, polysulfone (PSU), and stainless steel. For cleaning and disinfection, use only pH-neutral or slightly alkaline cleaning agents (e.g. neodisher MediClean 2.0 %), disinfectants (e.g. Lysetol V 8 %), and drying and rinsing agents approved for the tube set materials. Using unsuitable agents (e.g. neodisher MediKlar rinsing agent) may damage the tube system and especially the PSU connectors. Reprocessing restrictions
The manufacturer has tested and approved the reusable tube set for a specific number of reprocessing cycles. Always comply with the instructions on the label. Never exceed the number of uses indicated by the manufacturer. WARNING! Use the tear-off tabs attached to the tube to keep track of the number of sterilization cycles. The tube may not be sterilized after the last tab has been removed. Please check the reusable tube for signs of damage after sterilization and before use. Never use a tube showing signs of damage, especially brittleness and perforation.
The reusable tube set should be reprocessed as soon as possible following use (recommended: max 30 minutes). In case of heavy contamination (blood, tissue) it is recommended to remove these residues with a soft cloth while still at the site of the surgery. This cloth may be moistened with a slightly alkaline cleaner. The tube set is then transported, preferably in a dry basket, to the actual reprocessing location where the complete process is carried out. 1. Preparatory cleaning at the reprocessing location: Disassemble the individual parts of the tube set. 2. Preparatory cleaning: Use a soft cloth to carefully wipe off each component. Remove any remaining blood and tissue residues. The cloth to be used may be moistened with a slightly alkaline cleaner.
1. Automatic cleaning and disinfecting: The cleaning and subsequent disinfection of the individual components of the tube set can be carried out with the appropriate programmable cleaning and disinfecting systems for medical devices. The manufacturer has validated the applicability of this method in terms of hygiene success and material compatibility using the "Vario" program of the disinfector manufactured by the company Miele. Suitability of the cleaning device used in the context of automated cleaning and disinfection, the selected program, and the used cleaning or disinfecting agent, as well as a guarantee with respect to the attainable hygiene status and material compatibility are the sole responsibility of the operator! Individual automatic processing methods must be independently validated by the operator. 2. Manual cleaning: • Place the prepared individual components of the tube set in demineralized water (room temperature, 20 °C to 30 °C ) for a period of at least 3 minutes to 5 minutes and then rinse them off under running water. Any remaining residues such as adherent clotted blood should be removed with a soft brush. • Use a soft cloth to thoroughly dry the components. • The completely dried tube set components must now soak for a period of 25 minutes to 30 minutes in a suitable cleaning agent (e.g., neodisher MediClean 2.0% or equivalent). Comply with the instructions and notes of the
Care and Maintenance manufacturer of the used cleaning agent. Make sure the components are fully immersed in the cleaning agent. • Place the components once more in demineralized water (room temperature, 20 °C to 30 °C ) for a period of at least 3 minutes to 5 minutes and then rinse them off under running water. • Flush the silicone tube for 15 seconds with demineralized water. Then use a high-pressure cleaning gun to emit 10 pressure surges, each one with a length of one second (1 second ) into the silicone tube. • After cleaning, allow the components to dry. For this purpose, they are to be placed in an appropriate tray and allowed to drip dry or use an air gun to dry the components. It is also possible to use, where appropriate, a sterile, soft cloth. Or, the components can be dried in an air dryer (10 minutes at 100°C).
Disinfecting the Reusable Tube Set
After cleaning, the individual tube set components must be disinfected. Only disinfect a thoroughly cleaned tube set.
1. Automatic disinfection: The cleaning and subsequent disinfection of the individual components of the tube set can be carried out with the appropriate programmable cleaning and disinfecting systems for medical devices. The manufacturer has validated the applicability of this method in terms of hygiene success and material compatibility using the "Vario" program of the disinfector manufactured by the company Miele. Suitability of the cleaning device used in the context of automated cleaning and disinfection, the selected program, and the used cleaning or disinfecting agent, as well as a guarantee with respect to the attainable hygiene status and material compatibility are the sole responsibility of the operator! Individual automatic processing methods must be independently validated by the operator. 2. Manual disinfection: • The cleaned and completely dried tube set components must now soak for a period of 25 minutes to 30 minutes or as specified by the manufacturer in a suitable disinfectant (e.g, Lysetol 8% or equivalent). Make sure the components are fully immersed in the cleaning agent and are not stacked on top of one another. Comply with the instructions and notes of the manufacturer of the used disinfecting agent. The tube set can be damaged if the concentration is too high or the components are soaked too long. • After the soaking time, the individual tube set components should be removed from the disinfectant liquid with pliers with smooth jaws. • Place the components once more in demineralized water (room temperature, 20 °C to 30 °C ) for a period of at least 3 minutes to 5 minutes and then rinse them off under running water. • Flush the silicone tube for 15 seconds with demineralized water. Then use a high-pressure cleaning gun to emit 10 pressure surges, each one with a length of one second (1 second ) into the silicone tube. • After cleaning, allow the components to dry. For this purpose, they are to be placed in an appropriate tray and allowed to drip dry or use an air gun to dry the components. It is also possible to use, where appropriate, a sterile, soft cloth. Or, the components can be dried in an air dryer (10 minutes at 100°C).
Sterilization of Reusable Tube Set
Reassemble the tube set from the cleaned and disinfected parts as described in the manual.
Preparing for sterilization
Check the individual components and the assembled tube set for signs of damage. Never sterilize a tube set that shows signs of damage, especially brittleness and perforation. Tube sets with evidence of or suspected of damage must be blocked from further use.
Inspection and function test
Care and Maintenance
Maintenance of the tube set is not required. In case of loss or damage to the pressure chamber membrane, this component must be replaced (see instructions in the manual).
Only clean, dry, disinfected, and assembled tube sets should be sterilized. • Packaging Pack the dry and reassembled tube set in a suitable sterile packaging for sterilization (cloth, bag, or tray). • Sterilization The manufacturer has validated saturated steam sterilization as a suitable method of sterilization for the tube set based on the parameters listed below using the pre-vac process. Sterilize the tube set according to these specifications. Pre-vacuum Sterilization method
5 min (273 °F/134 °C, 3 bar)
CAUTION! The indicated drying time depends on several variables, including the following: Altitude, humidity, type of packaging, preconditioning, size of chamber, mass of load, and placement in chamber. Users must verify that the drying time set in their autoclave yields dry surgical equipment when using the method of saturated steam sterilization described here.
Please comply with the instructions of the operating manual included with your autoclave. • Storage Always store the tube set after sterilization in a suitable sterile packaging or in a suitable environment to avoid contamination. • Additional information When sterilizing several tube sets, instruments etc. at once using one sterilization cycle, make sure not to exceed the max. load of the sterilizer. Sterilization with ETO
Sterilization with ethylene oxide (ETO) is possible but has not been approved by the manufacturer.
Sterilization with gamma rays
Do not sterilize with gamma rays.