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Insufflator for laparoscopy
Insuflador para laparoscopia
Insufflateur pour la laparoscopie
Insufflator für die Laparoskopie

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Some of the parts and equipment referred to in this manual bear microfilm ou autres procédés de reproduction sans l’autorisation
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Users of this product should not hesitate to point out to us any errors or réservons le droit de procéder à des modifications techniques sans avis
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Pictographs/Pictogramas/Symboles/Bildzeichen

Pictographs Pictogramas Symboles Bildzeichen
¡Atención!
Attention, lire la Achtung
See operating Observe la
documentation Begleitpapiere
manual documentación
jointe! beachten
adjunta

Símbolo para un Symbole pour un Symbol für ein
Symbol for type
aparato del tipo appareil de type Gerät des Typs
BF equipment
BF BF BF

Symbol for Símbolo para la
Fiche Symbol für den
potential conexión
équipotentielle Potentialausgleich
equalization equipotencial

Degrees of Grado de protección Degrés de

IP 41 protection provided
by enclosures
(IP-Code)
proporcionado por
los envolventes
(Código IP)
protection procurés
par les enveloppes
(Code IP)
Gehäuseschutz-
klasse (IP-Code)

Alternating current Corriente alterna Courant alternatif Wechselstrom

Service Servicio Service Service

Référence
REF Order number Número de pedido
produit Bestellnummer

Nicht zur
Single use only No reutilizable Usage unique Wiederverwendung

Esterilizado con Sterilisiert mit
STERILE EO Sterile with ETO
ETO
Stérilisés à l´ ETO
ETO

Denominación de Chargen-
LOT Lot no. partida o lote Numéro de lot bezeichnung

Serial number Número de serie Numéro de série Seriennummer

Date of Fecha de Herstellungs-
fabricación Date de fabrication datum
manufacture

Expiration day Date limite
Utilizable hasta Verwendbar bis
d'utilisation

Stück Pieces, quantity Pieza, cantidad Pièces, quantité Anzahl, Menge
pieces

QTY Quantity Cantidad Quantité Menge

Pictographs/Pictogramas/Symboles/Bildzeichen

Pictographs Pictogramas Symboles Bildzeichen

LATEX
FREE Latex free Sin latex Sans latex

134 °C Number of Número de Paramètres pour la Anzahl der
3 bar autoclaving cycles esterilizaciones stérilisation à Autoklavierungen
5 min
xx por autoclave l´autoclave

Do not get wet Proteger contra Protéger de Vor Nässe
la humedad l'humidité schützen

Top-Bottom Arriba-abajo Haut-bas Oben - Unten

Frágil Fragile Zerbrechlich

Encendido /
apagado Marche/ Arrêt

Start/ Stop Tecla Start/Stop Touche Start/Stop Start/ Stopp

Heater Calefacción Chauffage Heizung

Creciente/ Croissant/ zunehmend/
Increase/ decrease
decreciente décroissant abnehmend

Connector- Entrada para Eingang für
Entrée de signaux
signal input señales Signale

Connector- Salida para Ausgang für
Sortie de signaux
signal output señales Signale

Enregistrement
Data logger Registro de datos Datenaufzeichnung
des données

Direct current Corriente continua Courant continu Gleichstrom

Gas output Salida de gas Sortie de gaz Gasausgang

............................................... 47 9...................... 33 8 Options ................................................................................................................ 16 5.........................................................................................................................................8 Start/Stop Key.............................................. 48 9....................................................................4.................................................................................................... 43 8...... 18 5.................................1 Insufflating with Veress Cannula.......................................1 Presetting Nominal Pressure with High Flow Application .............................................................................................................................................................................................. 7 3......................3 Fill Tube System with CO2..............................2 Display.........................................................................................................................................................1 Video Messaging (Superposition) .............................2 Preselecting Nominal Flow with High Flow Application ....................................................... 60 12........................................................................................................5 Venting Valve Test..................................................................... 3 EN 2....... 22 5........................................................................................... 58 12........................................................................................................................................................................................................................................................................................................................ 17 5........................................................................................1 Cleaning the Device......................................................... 14 5 Operating the Device.............................................................................................................................................................................1 High Flow Application ........................................................................................1 Safety Test.................................1 Front of the device............................................................................................ 53 11...................................... 51 10.................................................................. 19 5.... 15 5................7 Preselecting Nominal Flow/Nominal Pressure with Low Flow Application ......................... Device Pressure Test.......................................................................................... 15 5. 54 11.....................................................1 Gas Connection ....................................................................................................................... 43 9 Function Test ..............................................................................................12 Gas Heating ......................................... 57 12...................................................................................................................................................................................................................................................................................13 Switching Device Off...................................................................................................................................................................... 29 7 User Menu................................................... 54 11......................6 Max..... 49 10 Use of the Device During Surgery ...................................2 Basic Function Test (in High Flow Mode).....................................9 Actual Pressure Display................................................................ 59 12..................................................................................7............................................................... 47 9.7..1 Device-inherent Dangers.................... 53 11................................................................2 Testing the Veress Cannula ................................................................................................................................. 53 11.........2 Insufflating with the Trocar.................................1 Dangers and Risks......................................................................................... 13 4....................... 16 5........................................................................................................................................ 55 12 Annual Inspection................................................ 51 10.............................5 Gas Supply Display ...... 59 12.................................................................................................................................................. 23 5....4 Sterilization of Reusable Tube Set ......................................................10 Gas Consumption Display ........2 Preselecting Nominal Flow with Low Flow Application ............................................................................................................ 57 12.............. 12 4 Initial Use of the Device ............4................................................................... 15 5......................................................................................................................................................3 Rear of the device ......6 Presetting Nominal Flow/Nominal Pressure with High Flow Application.......... 21 5......... 1 2 Safety Instructions.............................5 Annual Inspection...........................................4 Pressure Monitoring Test .................. 61 .............6 Maintenance Carried out by Authorized Service Technician ...........................................................................................................................................11 Insufflation Tube Connection..................................... 55 11.........................................................................................................................................................................................................................................................4 Device Setup........................................... 28 6 Safety Functions ...................7 Replacing the Fuse........................... 4 3 Purpose of the Device..................................................................... 18 5............... 18 5........ 26 5..................................................................................6.........................................................1 Testing the Device ....................................1 Preselecting Nominal Pressure with Low Flow Application ...............6.............................................................................................................................................................................................................................2 Cleaning of the Reusable Tubing Set ..................................................................................................... 17 5................. 26 5................................................................ 53 11...............................................................2 Manufacturer’s Notice: Device Versions..................................... Contents 1 Important User Notes............................3 Test of the Pressure Sensors....................................................................................................................................7 Gas Flow Rate Test............................................................ 51 11 Care and Maintenance ................................ 25 5............. 26 5................................................................................................................................................................... 60 13 Technical Data ............. 8 3...........................................................................2 Low Flow Application (optional)................................................................................................................................................... 25 5..................................................................................................3 Disinfecting the Reusable Tube Set................................ 57 12...

...................... 65 17.... 69 ......................................................................................................................................................................... 65 14.... 67 15................................................................4 Guidelines and Manufacturer's Statement .............................................................................................................................................................................................................................................................................................................................................. 63 EN 14................ 67 15............3 Accessories .................................................... 68 16 Error and Warning Messages.....................................................................................1 Accessories for 40L Core Insufflator with integrated low flow.................................... 65 17..................................................................................................3 Remote Control (only for EU Version) .......... 67 18 Index ....................................................................................................................2 Electrical Connections.............. 63 14..........................Electromagnetic Interference Immunity ................. 64 14...............Electromagnetic Emissions.................................................Electromagnetic Interference Immunity - 40 L Core Insufflator ..............7 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and the 40 L Core Insufflator ................1 Test Record......................................................1 Impact of Mobile and Portable RF Communication Devices ......................... mode US...................... 63 14.. 63 14.........2 Accessories for 40L Core Insufflator with integrated low flow....................................... 64 14..................................2 Return Form .6 Guidelines and Manufacturer's Statement ..................................................................................................................................................5 Guidelines and Manufacturer's Statement .......... Contents 14 Electromagnetic Compatibility................................................................................................................................................................................................... 67 15....... mode EU... 66 15 Accessories ...................... 69 17 Appendix..........................................................................................

Paragraphs with the words DANGER. nursing staff or service personnel. Comply with this warning to avoid injury to the patient. user. Subject to Technical Changes and technical data of the product through continued development of the product. user. WARNING Here you will read information about the maintenance of the device or accessories. or third party. The manufacturer reserves the right to modify the appearance. WARNING. or • to damage or malfunction of device and/or accessories. DANGER These paragraphs contain information concerning the intended and proper use of the device or accessory. NOTE 1 . graphics. Noncompliance with the manual may lead • to life-threatening injuries of the patient. and NOTE carry special meanings and should be read attentively. Important User Notes 1 Important User Notes EN Read the manual carefully and become familiar with the operation and Reading this Manual function of the device and the accessories before using either for surgical procedures. The safety and/or health of the patient. or a third party is at risk. • to severe injuries of the surgical team.

Important User Notes EN Left Blank on Purpose 2 .

S. prepared. or maintained. To guarantee safe operation. all devices and accessory parts that are sent in to be repaired must be prepared for shipment as described in the manual. Observe national waste management regulations when disposing of Disposal device and accessories. If this is not possible. adjustments. • the product must be clearly marked with a contamination warning and • double-sealed in safety foil. For the protection of the patient and the operating team. New products as well as repaired products must be prepared and tested according to the manual instructions prior to use. or alterations on the device or accessories/peripherals. Federal Law physician. check that the device is complete and functional before each use. or alterations on the device or accessories.S. The manufacturer has the right to refuse carrying out repairs if the product is contaminated. adjustments. Market) The manufacturer does not assume any liability for direct or No Liability consequential damage if: • the device or the accessories are improperly used. (Only for U. • non-authorized persons perform repairs. Only an authorized service technician may perform repairs. Safety Instructions 2 Safety Instructions EN U. Authorized Service Technician or alterations on the device or accessories and use the service menu. For the protection of the service personnel and to maintain safety during Contamination transportation. federal law restricts use of this device by or on the order of a U. Receiving technical documentation from the manufacturer does not authorize individuals to perform repairs. • non-authorized persons open the device. it is absolutely necessary to carry out Care and Maintenance proper care and maintenance of the device and accessories. • the prescribed inspection and maintenance schedule is not adhered to. adjustments. • the instructions and rules in the manual are not adhered to.S. 3 . Authorized service technicians are only trained and certified by the manufacturer.

chapter 7 User Menu. Risk of Electrical Shock To prevent electrical shock. Available Mains Voltage Check to make sure that the available mains voltage matches the data DANGER listed on the label attached to the back of the device. DANGER 4 . Refer servicing to qualified service personnel. The doctor is responsible for all settings that pertain to the operation performed by him/her. Technique and Procedures Only the physician can evaluate the clinical factors involved with each DANGER 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. do not open this device. Do not use if moisture or liquid has penetrated DANGER the device. Incorrect voltage can cause errors and malfunctions and destroy the equipment. Safety Instructions 2. Do not use in an area DANGER where flammable gases are present. use only original accessories.1 Dangers and Risks EN Condensation / Water Penetration Protect device from moisture. Never open this DANGER device yourself. DANGER page 33). Such internal standard settings are not necessarily prescribed for the doctor. Not Explosion-Proof Electrical components are not explosion-proof. DANGER Factory Settings Check all user menu settings and values (cf. Original Accessories For your own safety and that of your patient. Replacing Fuse Replace the fuse only with a fuse of the same type and rating.

DANGER Replacement Device and Accessories In case the device or any of the accessories fail during an operation. Only specially trained and qualified personnel may use this device on children. and sterile accessories. 5 . sterile gas. stop using the device until it has been checked by authorized service personnel. Function Test The function test must be performed prior to each operation. It is also not intended to introduce to or train DANGER physicians in the use of surgical techniques. DANGER Endoscope The device may only be connected to endoscopes designed for use with the device for the intended medical procedure. DANGER Device Defect If a device defect is suspected or confirmed. DANGER Sterile Substances and Accessories Always work exclusively with sterile substances and mediums. page 7. DANGER Cleaning the Device Do not sterilize the device. The endoscopes must DANGER comply with the most recent versions of IEC 60601-2-18 and ISO 8600. Device-inherent Dangers Read the warnings specific to this device in chapter 3 Purpose of the Device. Safety Instructions Professional Qualification EN This manual does not include descriptions or instructions for surgical procedures/techniques. a replacement device and replacement accessories should be kept within DANGER easy reach to be able to finish the operation using the replacement device or replacement accessory. Medical accessories and devices may be used only by physicians and medical assistants under the direction of a physician with the appropriate technical/medical qualification.

Safety Instructions EN Left Blank on Purpose 6 .

The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kg.5 l/min Children between 1 to 3 years approx. it may not be used to distend the uterus.0 -2. 1-9 kg 0. infants..1 -0. The function of the device is to maintain the nominal or set point pressure. The insufflator has two operating options. The device measures the pressure within the abdomen in short intervals and continuously compares the nominal with the actual abdominal pressure. Any overpressure within the abdomen is lowered to the preset nominal pressure by the automatic venting system. The device is not suitable for hysteroscopic insufflations. it is recommended to control and adjust the device and the nominal flow based on the following factors: Age Group Weight Flow Range Children younger than 1 year approx.e. 40 l/min. The Low Flow application is specially designed for use on newborns.0 l/min The nominal pressure cannot be reached if the nominal flow is set too low.0 l/min Children between 3 to 4 years approx.5 -1. 7 . 10-15 kg 0. i. Purpose of the Device 3 Purpose of the Device EN The device serves to insufflate CO2 into the abdomen during a diagnostic Intended Use or therapeutic laparoscopy. 20 l/min.0 l/min Children between 4 to 14 years $ 20 kg > 2. and children. 30 mm Hg (mm High Flow Application mercury column) and the gas flow to max. Please consult the instructional manual of your laparoscope for absolute and relative contraindications. Check for possible leaks. the speed of equalizing the leak is slower than when using the High Flow application (lower effective flow in Low Flow application). 16-19 kg 1. 20 mm Hg (mm Low Flow Application mercury column) and the gas flow to max. The Low Flow application limits the pressure to max. Due to the special operating method used during the Low Flow application (optional). The High Flow application limits the pressure to max. When used on children. The device may not be used to fill an abdomen with CO2 if a laparoscopy Contraindications is contraindicated. Please consult the instructional manual of your laparoscope for additional information and special application indications.

When the patient is placed on an angle. Always insufflate through the elevated side of the patient. DANGER Increased Airway Pressure/Compression of the Vena Cava When using the Low Flow application on children. If this occurs. immediately disconnect the insufflation tube at the trocar. an increased risk of high airway pressure and/or compression of the vena cava (low input DANGER syndrome) exists.1 Device-inherent Dangers EN Gas Flow Limit The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos. always carefully and closely monitor the patient’s vital signs during the entire insufflation process and make sure patient is breathing well. DANGER Pneumolabium/Pneumoscrotum Children are at risk of a pneumolabium or pneumoscrotum. Intravasation causes the body to absorb part of the CO2 gas used for insufflation. Intra-abdominal pressure can be increased DANGER and fluid can penetrate the insufflation tube if the patient is repositioned during surgery. CO2 Absorption CO2 is absorbed during insufflation (intravasation). Idiosyncratic Reactions Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk of metabolic imbalance related to excessive CO2 absorption DANGER (idiosyncratic reaction). Metabolic and Cardiac Reactions A pressure of more than 20 mm Hg can result in metabolic acidosis. shifting of internal tissue may block the insufflation channel. Positioning the Patient Always position the patient lower than the device to prevent body fluids from leaking into the device. Purpose of the Device 3. Sufficient respiration can help avoid or limit problems with CO2. High pressure or high gas flow promote CO2 absorption. CO2 DANGER concentrations in the blood or respiratory system that are too high can lead to death of the patient in extreme cases. This can lead to cardiac irregularities and the following symptoms : DANGER •Reduced respiration with restricted diaphram function •Reduction of venous reflux •Reduced cardiac output •Metabolic acidosis 8 . To lower this risk.

Backflow Body secretion or contaminated gas can result in a backflow into the device. Continuously monitor intra-abdominal pressure over the DANGER course of the entire insufflation if additional sources are used. CO2 embolisms can also be caused by a high intra-abdominal pressure. resulting in air or CO2 embolisms. Additional Insufflation Sources The use of additional insufflation sources increases the intra-abdominal pressure. •the actual pressure is higher than the nominal pressure or •the automatic venting valve is activated. To DANGER reduce the risk of air or CO2 embolism. Long DANGER surgeries and large leaks increase the risk of dehydration (especially at the insertion points of the trocars or when changing instruments). Fluid may DANGER penetrate the insufflation tube whenever you change the gas cylinder and/or when you stop the gas flow during the operation. This can result in organ tissue damage and cardiovascular reactions of the patient. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value. Dehydration Insufflation can lead to dehydration of the tissue. This in turn can cause heart and cardiovascular DANGER problems. perform initial insufflation at a low flow rate and ensure that the insufflation instrument is correctly positioned. hypothermia promoting. Disconnecting the Insufflation Tube Always disconnect the insufflation tube after ending surgery and before switching off the device to prevent backflow of bodily fluids. Purpose of the Device Hypothermia/Monitoring Body Temperature EN The gas flow can lead to a lowering of the patient’s body temperature during insufflation. if DANGER •a filter is not used. operation 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. The risk for hypothermia can be significantly reduced with the use of gas pre-warmed to body temperature. 9 . Make especially sure that the following. Avoid high pressure settings and close damaged blood vessels at once. Embolism Improper placement of the insufflation instrument could cause insufflation of gas into a vessel. you must immediately disconnect the insufflation tube from the trocar or from the device. If this happens. Always monitor the patient’s body temperature during the entire insufflation.

Purpose of the Device EN Gas Flow A high gas flow can be due to large leaks within the surgical system or instrument. This should prevent bodily fluids from entering the device and also prevents impurities from possibly entering into the patient’s body. You must work with a 0. DANGER Connecting the Tube The tube outlet may only be connected to instruments which are intended for intra-abdominal CO2-insufflation. DANGER chapter 16 Error and Warning Messages. Whenever you use additional insufflation sources. you should constantly monitor the DANGER intra-abdominal pressure. Automatic Venting System The automatic venting system has a limited venting rate. tube.99 %) DANGER hydrophobic filter between patient and device. Contaminated Filter Exchange a contaminated filter immediately during surgery to ensure an unhindered gas flow.2 µm two-way (retention rate 99. an inability to concentrate. or even death. unconsciousness. page 69). Filter Use a new/sterile filter for each patient. DANGER 10 . since an increasing CO2 DANGER level in the air can cause the medical personnel to suffer fatigue symptoms. you should make sure to supply the operating area with enough fresh air. and instruments immediately. In case of a disrupted gas flow you should therefore inspect device. Fatigue Symptoms When there is a high level of CO2 consumption. Reduced flow capacity should be considered when using a hydrophobic filter. 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 (cf. It is recommended to perform laparoscopies with the lowest gas flow possible. which in DANGER turn may endanger the patient. This can result in an false actual pressure reading. Contamination Do not use device and/or accessories if signs of a contamination are detected. Make sure the device/accessories can no longer be operated DANGER until a qualified service technician conducts the appropriate tests and repairs.

Peripheral Devices Additional equipment connected to the interfaces of the device have to meet the following specifications: DANGER EN 60601-2-18 for endoscopic devices and EN 60601-1 for electrical medical devices. However. The electronic control unit of the device adjusts the DANGER intra-abdominal pressure as desired. please follow these suggestions: •move this device to a different location or move the other device. A person connecting additional devices to the signal IN or OUT sockets is considered to be a system configurator and as such responsible for adherence with the EN 60601-1-1 standard. if you still detect or suspect such interference. Electromagnetic Interference (cf. All configurations have to comply with EN 60601-1-1 specifications. Service Connection Connected devices have to comply with the standard EN 60950. 11 . •increase distances between all used devices. Other gases (i. page 63) Electromagnetic interference with other devices or instruments was practically eliminated when developing this devices and none was detected DANGER during testing.. e. chapter 14 Electromagnetic Compatibility. Devices may not be connected to the service connection during the surgical DANGER procedure. argon). helium. or polluted gases may not be used with this device. gases DANGER with entrapped liquids. Medically Pure CO2 Make sure to use only medically pure CO2. mixtures of gases. N2O. •consult an electromedicine expert. high pressure compressed gases. Purpose of the Device Electronic Device Control EN The valve located at the trocar sleeve may not be closed intraoperatively.

IT. DA. IT. PT. EL 0620-040-511 SIDNE EN.2 Manufacturer’s Notice: Device Versions EN 40L Core Insufflator with integrated low flow US (available in USA. DE 0620-040-515 Standard EN. FI 0620-040-507 PAL EN. FR. PT. ES. DA. ES. SV. NO. DE 0620-040-506 PAL EN. PT. Canada and South America) STRYKER article number Version Language 0620-040-503 NSTC EN. NL. NL. EL 0620-040-505 PAL EN. SV. DE 0620-040-512 SIDNE EN. PT. IT. EL 0620-040-508 NSTC EN. ES. FI 0620-040-513 SIDNE EN. FR. NO. FI 0620-040-510 NSTC EN. EL 12 . NO. NL. FR. DA. IT. DE 40L Core Insufflator with integrated low flow EU (not for sale in USA) STRYKER article number Version Language 0620-040-514 Standard EN. FI 0620-040-516 Standard EN. DA. FR. DE 0620-040-504 SIDNE EN. ES. SV. NO. ES. NL. ES. DE 0620-040-509 NSTC EN. Purpose of the Device 3. FR. SV. FR.

13 . 3 conductors. Enclose the manual with the device. The ambient Setup temperature has to range from 10 °C to 40 °C. Do not use in an area where flammable gases are present. DANGER Power Supply Check to make sure that the available mains voltage matches the data listed on the label attached to the back of the device. type SJT. The power cord may be plugged only into a properly installed safety wall plug (see DIN VDE 0107). Inspect for external damage as well. Electrical components are not explosion-proof. WARNING Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. the relative humidity has to be between 30% and 75%. Use only an approved detachable power supply cable. other end for IEC 320/CEE22. one end configured for NEMA 5-15. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket. use of the original packaging Returning the Device is required. minimum Only for US Operators 18 AWG. Use the original power cable to Protective Contact plug into the wall socket on one side and the rear device jack on the other. Please fill out the return form enclosed at the end of the manual. Initial Use of the Device 4 Initial Use of the Device EN Always check all parts and accessories of the device immediately after Input Control receiving the shipment. Incorrect voltage can cause errors and malfunctions and destroy the equipment. Integrate the device into the potential equalization system according to Equipotential Bonding local safety rules and regulations. If it becomes necessary to return the device. The power supply has to be grounded. The manufacturer considers only replacement claims that have been immediately submitted or reported to a sales representative or an authorized service company. Please make sure that all required information has been supplied: • Name of owner • Address of owner • Device type • Serial number (see identification plate) • Description of defect Place the device on a level surface in a dry environment. Read the device label (device data plate) located in rear of device to determine the operating voltage of the device.

Do not use a gas bottle with riser pipe. DANGER Use a high-pressure tube to connect a CO2 gas bottle to the rear gas inlet connection or connect to centralized CO2 gas supply. 2. Fix the high pressure tube with the nut. Gas Bottle Always use a high-pressure tube to connect gas bottle and device.1 Gas Connection EN Always use medical grade CO2. Gas bottles with riser pipe can release dirt and oily fluids into the device. Initial Use of the Device 4. Never use any other type of gas. WARNING Gas Connection 1. Connect the high pressure tube to the gas connection. WARNING The gas bottle has to be in a vertical position. 3. 14 . Tighten the nut. The gas bottle pressure may not exceed 80 bar.

2 Display Fig. 5-2-1 Display (1) Status display/Error & warning messages (1) (2) (3) (2) Actual pressure (3) Actual flow (4) Nominal gas flow (5) Gas consumption Insufflation stopped (6) Gas supply (7) Nominal pressure Bottle Gas (7) (6) (5) (4) 15 . 5-1-1 Front of the Device (1) Start/stop key (1) (2) (3) (2) Display (3) Gas heater connection (4) Insufflation tube connection (5) Increasing nominal gas flow (6) Reducing nominal gas flow (7) Gas consumption reset key (8) Menu key (9) Increasing nominal pressure (10) Reducing nominal pressure (11) IR sensor (12) ON/OFF key (12) (11) (10) (9) (8) (7) (6) (5) (4) 5.1 Front of the device Fig. Operating the Device 5 Operating the Device EN 5.

Use the user menu option "Application" (cf. 16 .4 Device Setup 1. Device ok followed by Select values appears in the display. Connect the gas supply to the gas connection port. Press the ON/OFF key. The device switches on. Open the gas supply line. Device check The device now conducts a self-test. 5-3-1 Rear of the Device (1) Type plate (1) (2) (3) (4) (5) (6) (7) (2) Device data plate (3) SIDNE Interface (optional) (4) Data input/output (5) Connection for equipotential bonding (6) Sockets for VIDEO RGB/CSCC OUT Signal (optional) (7) Socket for VIDEO S-VHS OUT Signal (optional) CO 2 (8) Sockets for the VIDEO RGB/CSCC IN Signal (optional) (9) Socket for the VIDEO S-VHS IN Signal (optional) (10) Device plug (12) (11) (10) (9) (8) (11) Fuse holder (12) Gas connection 5. 2. 3. page 33) to switch between Low Flow or High Flow application.3 Rear of the device EN Fig. The corresponding display is depicted after switching the device on again depending whether the device was last operated in the High Flow WARNING or Low Flow mode. 7 User Menu. Operating the Device 5.

5. With activated Low Flow mode.2 Low Flow Application (optional) If the device was switched off while in Low Flow mode. 17 . the displayed logo NEONATAL indicates that the device is still in Low Flow mode. The device is operational. the following is displayed during the self-test Low Flow Application Application: Low Flow Device check The display Device Check in the status line is replaced with the display Device OK->Select values followed by the display Insufflation stopped. Insufflation stopped 8 Bottle 0. Operating the Device 5. the following is EN displayed after the self-test has concluded after switching the device back on: Insufflation stopped Bottle Gas The display Device Check in the status line is replaced with the display Device OK->Select values followed by the display Insufflation stopped.4.1 High Flow Application If the device was switched off while in High Flow mode. The device test concluded successfully.1 Gas The device test concluded successfully.4. The device is operational.

the gas supply indicator returns to the upper display (House Gas Supply Pressure OK).5 Gas Supply Display EN Gas Supply with Gas Bottle The following gas bottle pressures are displayed: Bottle Gas > 40 bar Bottle Gas 15-40 bar Bottle Gas < 15 bar House Gas Supply The following house gas supply pressures are displayed: House House gas supply pressure Gas OK House House gas supply pressure Gas too low The status of the house gas supply cannot be evaluated until after insufflation has started due to technical reasons. The gas supply display depicts the lower display (House Gas Supply Too Low).6 Presetting Nominal Flow/Nominal Pressure with High Flow Application 5.6.5 seconds activates scrolling in increments of 1. Press the % key once to activate setting the values in increments of 1.1 Presetting Nominal Pressure with High Flow Application This setting is possible in standby mode and during operation of the device. The display will show Check Gas Supply after approx. Once insufflation has stopped. 5. Keeping the % key depressed longer than 1. Operating the Device 5. 18 . 5 seconds if the gas supply is insufficient.

Now you can set a value up to 30 mm Hg.30 mm Hg. The values for the nominal gas flow refer to a device without connected tube. A safety limit message is displayed starting with 15 mm Hg. Keeping the %/& key depressed allows you to adjust 3 levels for the nominal gas flow. WARNING 5.6. or instrument. The preset value is indicated in the nominal pressure display. Release the key at that point. filter.2 Preselecting Nominal Flow with High Flow Application This setting is possible in standby mode and during operation of the device. filter. The display switches back to the nominal value setting after 2 seconds. Safety limit The nominal pressure of "15 mm Hg" is a threshold value. 19 . Exceeding this safety limit is to be decided by and the responsibility of the user/operator. The preset value is indicated in the nominal gas flow display. Pressing the nominal pressure % key again does not increase the pressure any further. This is where the recommended range for the intra-abdominal pressure ends. Decreasing Nominal Pressure EN Press the %key to increase the nominal pressure. Increasing Nominal Pressure Select a nominal pressure between 1 . Level 20 l/min 3. and instrument can reduce gas flow. Tube. Factory setting: 1. Level 40 l/min The preset values of the user menu can be customized as well. Operating the Device Press the &key to reduce the nominal pressure. Level 3 l/min 2. Select a nominal gas flow between 1-40 l/min.

3 l/min (depending on the setting in the user menu). Keeping the key depressed allows you to adjust the nominal gas flow in increments of 3. the actual pressure does not exceed the nominal pressure (cf.Level 1) • "Insufflation on" (6-40 l/min) The setting "Veress on" is intended for gentle insufflation since the actual pressure does not exceed the preset nominal pressure even in case of small volumes. 1. page 29). The device monitors the gas flow in two different operating modes: • "Veress on" (1-5 l/min . Please note that the automatic venting system is not activated during the "Veress" operating mode and High Flow application. Press the %key to increase the nominal gas flow $ 6 l/min.40 l/min in increments of 1 l/min.40 l/min in increments of 1 l/min. The APC technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. Start the device again with the Start/Stop key. 20. The nominal gas flow is EN lowered in the range of 1 l/min . Veress on Insufflation Operating Mode Pressure drops due to leaks are quickly equalized during the "Insufflation Operating Mode". Keeping the & key depressed allows you to adjust the nominal gas flow in increments of 40. Operating the Device Decreasing Nominal Gas Flow Press the & key to reduce the nominal gas flow. 40 l/min (depending on the setting in the user menu). To minimize the risks of a faulty incision point . filter. the manufacturer recommends using the "Veress" operating mode to start off a procedure (filling abdomen with CO2). 1. Tube. chapter 6 Safety Functions. The nominal gas flow is increased in the range of 1 l/min . In case of large volumes. 20 . 2. Increasing Nominal Gas Flow Press the % key to increase the nominal gas flow. and instrument can reduce the gas flow. Start the device again with the Start/Stop key. Insufflation on 6 20 .

1 .0. However. it is recommended to control and adjust the device and the nominal flow based on the following factors: Age Group Weight Flow Range Children younger than 1 year approx. The patient's circulatory system should be monitored at all times. and children. It is recommended to always ensure good ventilation and to work with low flow values and pressure values not exceeding 12 mm Hg.0 l/min Children between 3 to 4 years approx. Pneumolabium/Pneumoscrotum Children are at risk of a pneumolabium or pneumoscrotum.7 Preselecting Nominal Flow/Nominal Pressure with Low Flow Application EN The Low Flow application is specially designed for use on newborns. Compression of the Vena Cava When insufflating the abdomen of a child with medical CO2. the increased intra-abdominal pressure also increases the risk for higher airway DANGER pressures.0 l/min Children between 4 to 14 years $ 20 kg > 2. DANGER Increased Airway Pressure When laparoscopic procedures are performed on children.0 l/min Recommended Work Settings The Low Flow flow values listed here for laparoscopic procedures on newborns. Always strictly monitor respiration and airway function when performing laporoscopic procedures on children younger than 12 years of age. 1-9 kg 0. adhering to the values listed above ensures an optimal performance of the Low Flow mode of the insufflator. 16-19 kg 1.5 l/min Children between 1 to 3 years approx.5 -1. an increased risk of compressing the vena cava exists. infants. 10-15 kg 0. When used on children.0 -2. infants. Operating the Device 5. Haemodynamic Stability A laparoscopy performed on children younger than 12 years of age can result in the phenomenon of the increased CO2 content in the blood and DANGER with that to problems of the haemodynamic system. and children are only suggested values. The selection DANGER of the suitable flow and pressure values is solely the responsibility of the attending physician. This risk can be DANGER reduced by monitoring the systolic and diastolic blood pressure during the entire surgery. 21 .

22 . A safety limit message is displayed in the status line starting at 12 mm Hg. Exceeding this safety limit is to be decided by and the responsibility of the user/operator. Press the % key once to activate setting the values in increments of 1. a gas flow of more than 1 l/min poses an increased risk of hypothermia for the patient. Operating the Device EN Hypothermia The insufflation gas flow usually drops significantly after the target pressure has been reached and is then only required to maintain the DANGER abdominal pressure. The preset value is indicated in the nominal pressure display. The display switches back to the nominal value setting after 2 seconds. DANGER 5.20 mm Hg. Now you can set a value up to 15 mm Hg. The nominal pressure value "12 mm Hg" is a threshold value and should not be exceeded for newborns.1 Preselecting Nominal Pressure with Low Flow Application This setting is possible in standby mode and during operation of the device. Keeping the % key depressed longer than 1. Increasing Nominal Pressure Press the %key to increase the nominal pressure. 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 12.5 seconds activates scrolling in increments of 1. The patient's body temperature has to be monitored at all times during surgery. However. The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kg. WARNING Release the key at that point. Select a nominal pressure between 1 . Decreasing Nominal Pressure Press the &key to reduce the nominal pressure. Pressing the nominal pressure % key again does not increase the pressure any further. Corresponding measures to prevent hypothermia include the use of blankets or prewarmed gas.7.

7.2 l/min in increments of 1. Press the &key to reduce the nominal gas flow.. In the range of 0. This is where the recommended range for the intra-abdominal pressure ends.2 Preselecting Nominal Flow with Low Flow Application This setting is possible in standby mode and during operation of the device. In the range of 0. Increasing Nominal Gas Flow The nominal gas flow is increased in the range of • 0.< 2 l/min is rounded down to 1 or 2 l/min. In the range of 20. 23 . Then in increments of 1 up to 20 l/min. The display switches back to the nominal value setting after 2 seconds.1 l/min -2 l/min in increments of 0. Press the %key to increase the nominal gas flow. 5..< 2 l/min is rounded up to 1 or 2 l/min.1 l/min • 2 l/min -20 l/min in increments of 1 l/min Keeping the % key depressed longer than 1. Now you can set a value up to 20 mm Hg.1 l/min .1 l/min • 2 l/min -20 l/min in increments of 1 l/min Keeping the & key depressed longer than 1.1 l/min -2 l/min in increments of 0..5 seconds activates scrolling. Release the key at that point. Operating the Device EN Safety limit The nominal pressure of "15 mm Hg" is a threshold value.5 seconds activates scrolling.. Pressing the nominal pressure % key again does not increase the pressure any further. Decreasing Nominal Gas Flow The nominal gas flow is decreased in the range of • 0.1 l/min .

Tube. filter. Venting System "In Veress mode on " With this setting. With a nominal flow setting of >1 l/min. Insufflation on is displayed. Veress on The "Veress" setting is intended for the gentle development of an aeroperitoneum.key to reset the volume counter. Flow Mode) Above 1 l/min. Insufflation on is displayed. Venting system "In Veress mode off" or With a nominal flow setting of # 1 l/min. and instrument can reduce the gas flow. Insufflation on is displayed after pressing the (only in Low Flow Mode) Start/Stop key even if the nominal flow is set to # 1 l/min.) Release the key to increase the nominal gas flow further. Now you can set a value of up to 20 l/min.1 l/min -1 l/min). The APC technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. Start the device with the Start/Stop key. cf. Please note that the automatic venting system is only active during the "Veress" operating mode if "In Veress Operating Mode" has been set in WARNING the user menu (only in Low Flow mode. To minimize the risks of a faulty incision. The venting system is turned on. The nominal gas flow emitted by the device in this case is very low (in the range of 0. Insufflation on While in Insufflation on operating mode. Veress on is displayed in the "Venting disabled" (High Flow and Low status line after pressing the Start/Stop key. Use the RESET. the manufacturer recommends using the "Veress" operating mode to start off a procedure (filling abdomen with CO2). The display switches back to the nominal value setting after 2 seconds. The display of the calculated insufflated volume is done in increments of 100 ml. page 37). EN A safety limit message is displayed in the status line starting at 5 l/min. and after restarting insufflation by pressing the Start/Stop key. Menu Level Venting System. Operating the Device Increase the nominal gas flow. (This safety threshold can be deactivated in the user menu. any pressure loss due to leaks can be quickly equalized. Bottle Gas 24 .

The nominal gas flow is reset to the preset setting. Start insufflation: Press the Start/Stop key.9 Actual Pressure Display The actual pressure display depicts the current pressure within the abdomen in mm Hg. The nominal gas pressure is reset to the set values. The following values are displayed: •Actual pressure: current measured value •Gas consumption: last measured value. 25 . The following values are displayed: •Actual pressure: current measured value •Gas consumption: current measured value 2. Operating the Device 5. Stop insufflation: Press the Start/Stop key once again. 5.8 Start/Stop Key EN Insufflation stopped Bottle Gas 1.

Fig. and subsequently described.12 Gas Heating Use the gas heater and the heating tube to insufflate lukewarm gas (37° C). 5. The gas is automatically heated. 2. Resetting the Gas Consumption Display Press the Reset key to reset the gas consumption display to "0. Operating the Device 5. Connect insufflation tube and heater plug with the device as depicted in Fig.11 Insufflation Tube Connection 1." 5. Always connect a hydrophobic filter to the silicone tube or use the PVC tube set with filter. 5-12-1 Connecting the Gas Heating. Connect the insufflation tube to the insufflation tube connection and to the Veress cannula/trocar. 5-12-1 Connecting the Gas Heating (1) (2) 26 . page 26.10 Gas Consumption Display EN 5. Start insufflation.0.0 l The gas consumption display shows the CO2 volume in liters consumed since the last reset.

The gas heating returns to its preheating state. Stop gas heating: Press the Start/Stop key again. Operating the Device The heating tube consists of an insufflation tube (2) with plug (1) for the gas heater. loose plug). If the gas heating is functioning properly.g. the following message is displayed: The gas heating tube is automatically preheated to 33° C.0 l/min). This time might be extended if the ambient temperature is lower or in case of a draft in the vicinity of the tube. Connecting the Gas Heating 2. Start gas heating: Gas Heating ON/OFF Press the Start/Stop key. call an authorized service technician to check the device. broken cable. The gas heater warms the gas to 37° C in approx.. Check gas heating after surgery using a different tube. EN Do not subject the heater tube to direct heat (e. Check gas heating using a different tube. 2. 27 . operating room lamp) or high room temperature. 1. you can continue using the device without gas heating by observing the risks for hypothermia. Turn off gas heating: Pull the gas heating plug from the gas heating connection. 3.. WARNING 1. Connect the plug of the heater tube with the gas heating connection. Gas Heating Error Heater defect/Call service This message is displayed in case of a gas heating malfunction (e.g. Connect the filter and the heating tube. If the message Heater defect /Call service persists. 10 minutes (room temperature 22° C/gas flow rate higher than 1. 3. Should the error message be displayed again.

Press the ON/OFF key. you can continue using the device without gas heating by observing the risks for hypothermia. Should the error message be displayed again. Hot gas in the abdomen can lead to serious injuries. unplug the heating plug from the device. The device insufflates without heating the gas. Continue operation without connecting gas heating. Press the Start/Stop key. 6. 3. Switch the device off and back on after approx. Disconnect the insufflation tube from the trocar or Veress needle. 5. 2. 8. 1. 10 seconds have expired. The gas heater is reactivated. 28 . Operating the Device Gas Temperature Exceeds 42° C EN If the temperature sensor measures a gas temperature of > 42 °C. DANGER A warning signal is audible. 5. The device switches itself off. Unplug the plug for the gas heating from the device. Gas heating and insufflation are deactivated. Let hot gas escape until the tube is only warm to the touch. Check gas heater using a different tube after the operation. Call an authorized service technician to check the gas heating. 4. 7.13 Switching Device Off 1.

Automatic Venting System When the insufflator detects an overpressure it automatically activates the venting system. Whenever you use additional insufflation sources. cf. The function "Automatic venting system" can be deactivated in the user menu. Please note that the automatic venting system is only active during the "Veress" operating mode if "In Veress Operating Mode" has been set in the user menu (only in Low Flow mode. Exceeding nominal pressure for more than 5 seconds This display is depicted if the overpressure cannot be reduced by the automatic venting system within 5 seconds. DANGER The manufacturer advises against using additional. The venting system releases gas until the set nominal value has been reached again. Menu Level Venting System ). you should constantly monitor the intra-abdominal pressure. Exceeding Nominal Pressure This display is depicted after 3 to 5 seconds when the nominal pressure is exceeded by more than 3-5 mm Hg (depending on the setting in the user menu). non-pressure controlled insufflation sources during minimally invasive surgical procedures. 29 . WARNING The automatic venting system has a limited venting rate. The self-inflating property of lasers cooled with CO2 and argon beamers can lead to values exceeding the nominal pressure. Safety Functions 6 Safety Functions EN The device is equipped with an automatic venting system.

insufflation is not interrupted. Safety Functions Nominal Pressure Threshold 30 mm Hg / EN 20 mm Hg *LF This display is depicted after 3 to 5 seconds when the nominal pressure is exceeded by more than 3-5 mm Hg (depending on the setting in the user menu). 1x again after 1 minute). Is displayed whenever the actual pressure has reached 30 mm Hg / 20 mm Hg*LF. Insufflation is cancelled. 30 . Acoustic signals are emitted (3x. page 18) Low gas level Bottle Gas Displayed when the gas bottle pressure drops below 20 bar. Gas supply empty Bottle Gas This message appears again for 10 seconds if the pressure drops below 15 bar or if the house supply pressure is insufficient. An audible warning signal is emitted. Check gas supply. However. An acoustic signal is emitted. *LF=Low Flow Setting Gas Supply Display (cf.5 Gas Supply Display. 5.

The following messages might be displayed: Contamination Electronic defect Sensor defect Valve defect Calibration error Temperature error Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. The acoustic massage (warning signal) can be deactivated in the user menu. the warning signal is deactivated (in Low Flow mode). can no longer be operated safely. Error Message "Service" The display depicted above is shown if the device is malfunctioning. and requires service. Veress cannula. An audible warning signal is emitted. 31 . Safety Functions Warning Message "Occlusion" EN Displayed when tube. In Veress mode # 1 l/min. or trocar experience a temporary blockage.

the device will function as it does when it is being reactivated. Displayed when the device is being turned on while contaminated. Safety Functions Error Message "Contamination" EN Displayed when fluid has penetrated the device via the insufflation tube connection. The device can no longer be used. This is to prevent cross-contamination. all settings are retained. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. Message is repeated with each Start/Stop. If the power fails for an extended time period. Insufflation is not possible after turning the device off and back on using the ON/OFF key. It is possible to conclude the current surgery with this device. 32 . Power Failure If the power fails for less than 1 second. The contaminated device has to be clearly marked as contaminated and sealed in two separate protective layers of safety foil.

Gas supply TV Standard 14. Video Offset Vertical* Display Actual Flow 20. The device has fourteen menu levels in High Flow mode and thirteen in Low Flow mode. Application Application 2. Language Language 3. Venting System Venting Pressure Limit 11. Venting Pressure Limit Video position* 13. Brightness Invert Display 24. Program Version Customer Version 26. Display Actual Flow Contrast 22. Video Position* Video Input* 15. Customer Version *Optionally available with video superpositioning. WARNING 33 . Video Text* Video Offset Vertical* 18. Venting Response Time Gas Supply 12. High Flow Mode Low Flow Mode 1. Loudness Loudness 4. Warning Signal Occlusion Warning Signal Occlusion 5. Contrast Brightness 23. Gas Flow Rate 2 First Nominal Pressure 8. The optional equipping of the device with video superpositioning offers additional menu levels marked with * if this function is activated. Maximum Nominal Pressure Maximum Nominal Pressure 6. TV Standard* Video Text* 16. Gas Flow Rate 3 Venting System 9. Gas Flow Rate 1 Default Preset Flow 7. First Nominal Pressure Venting Response Time 10. Video Color* Video Offset Horizontal* 19. Video Offset Horizontal* Safety Limit Flow 21. Video Input* Video Color* 17. All settings are mode-dependent and are retained only for the selected mode. Invert Display Program Version 25. User Menu 7 User Menu EN Device parameters are changed before surgery with the user menu.

34 . Select the user menu and press the MENU key to display the first menu level. Use the nominal gas flow % or & key to select the desired menu level. “RESET” key Nominal flow keys: Scroll function How do I use the user menu? 1. 5. Press the MENU key to access the selected menu level. Sections marked with *LF apply only to devices with the Low Flow application option. Press the MENU key to access the selected menu. press the RESET key twice. Scroll with the nominal gas flow % or & to change the settings. User Menu Function of the Keys Menu key: Menu selection and confirming. Scroll with the nominal gas flow % or nominal gas flow & key to select the user or service menu. EN "MENU" key Reset key: Back to main level. Menu Level Application User menu Application 10 mm Hg Gas okok esc Factory setting: High Flow Select the following setting in this menu level: High Flow Application or Low Flow Application. 3. 4. User menu 10 mm Hg Gas okok esc 2. Confirm a selection to automatically exit the user menu and immediately access OP mode. To exit the user menu. Press the MENU key to save the desired setting.

35 . Menu Level Occlusion Warning Factory Setting: ON Set the acoustic occlusion warning to ON or OFF in this menu level. The following languages are available: • English • Dutch • French • German Menu Level Loudness Factory Setting: 3 Select the volume of the acoustic warning signals in this menu level (Levels 1. In Veress mode <1 l/min. User Menu Menu Level Language EN User menu Language 10 mm Hg Gas okok esc Factory Setting: English Select the desired language in this menu level. "ON" means a sound is audible. 2 . the warning signal is deactivated *LF.3).

High Flow Application: 5-30 mm Hg.1 l/min *LF (0. Gas flow level 1: High Flow Application: 1. Rates 2 and 3 do not exist in Low Flow mode. Low Flow Application *LF: 5-20 mm Hg. 3 User menu Gas flow rate 1 10 mm Hg Gas okok esc Change the factory settings for the respective rates in these menu levels.20 l/min (3 l/min) Low Flow Application: 0. With the Low Flow application. High Flow Application: 1-15 mm Hg Low Flow Application: 1-12 mm Hg *LF 36 .1 l/min) Gas flow level 2: High Flow Application: Rate 1-40 l/min (20 l/min) Low Flow Application: Not available *LF Gas flow level 3: High Flow Application: Rate 2-40 l/min (40 l/min) Low Flow Application: Not available *LF Menu Level First Nominal Pressure Factory setting: 15 mm Hg/8 mm Hg *LF Select the first nominal pressure in this menu level. Menu Level Gas Flow Rate 1. User Menu Menu Level Maximum Nominal Pressure EN Factory setting: 30 mm Hg / 20 mm Hg *LF Select the desired nominal pressure limit in this menu level. the menu displays Default Preset Flow instead of Gas Flow Rate 1.1 . 2. Factory Settings = (Values in parentheses).

User Menu Menu Level Venting System EN Setting: Corresponds with last operating mode/state. Venting disabled*HF *LF The venting system is deactivated in the "Veress" operating mode and "Insufflation" mode. In Veress mode on*LF The venting system is activated in the operating modes "Insufflation" and "Veress" (setting only possible for Low Flow application). 2. 37 . In Veress mode off*HF *LF The venting system is deactivated in the "Veress" operating mode and activated in the "Insufflation" mode (factory setting). select between • In Veress mode off • In Veress mode on *LF • Venting disabled Any overpressure within the abdomen is lowered to the set nominal pressure by the automatic venting system. Possible overpressures are not reduced if the venting system is deactivated. WARNING Menu Level Venting Response Time Factory Setting: 3 s Select a time setting between 2 and 5 seconds after which the venting valve is activated when the preset pressure limit has been exceeded. The automatic venting system has three setting options (setting corresponds with last operating mode/state): 1. 3. In this menu level.

page 18.5 Gas Supply Display. The gas supply display is described in Chapter 5. 2.5 Gas Supply Display. page 18. The gas supply indicators and displays are described in chapter 5. Menu Level Gas Supply User menu Gas supply 10 mm Hg Gas okok esc Factory Setting: Bottle Select the type of gas supply. It is not possible to operate the device if "Bottle" is set and a house gas supply is actually connected. The venting system is triggered after the response time if the actual pressure exceeds the nominal pressure and set tolerance value. If house gas supply has been selected but a gas bottle (pressure >15 bar) is connected to the device. 1. User Menu Menu Level Venting Pressure Limit EN Factory Setting: 3 mm Hg Select a tolerance value of between 2 and 5 mm Hg. Select Bottle if you want to work with a gas bottle. Select House Gas Supply if you are working with house gas supply.5 Gas Supply Display. the gas supply display automatically switches as described in chapter 5. 38 . page 18.

39 . NOTE Factory Setting: 5 Video Offset Vertical Select a setting between 0 and 15. User Menu Menu Level Video Superposition (optional) EN Use this menu level to deactivate/activate the video superposition or change the position of the superimposed video on the monitor. Factory Setting: Right down Use this menu level to select the position on the monitor where the insufflation information and error messages are to be displayed. synchr. The following positions are available: OFF ->Left Up -> Right Up -> Left Down -> Right Down -> Variation 1-> Variation 2. Factory Setting: US Version NTSC TV Standard EU Version NTSC or PAL Select between PAL and NTSC.). Factory Setting: Pressure /Flow/Volume/Alarm Video Text Select: Alarm ->Pressure/Alarm ->Flow/Alarm ->Pressure/Flow/Alarm->Pressure /Flow/Volume/Alarm. Factory Setting: Y/C (S-VHS) Video Input Select: FABS -> Y/C (S-VHS) -> RGB (synchr. Factory Setting: 5 Video Offset Horizontal Select a setting between 0 and 15. on green) -> RGB (extern. Factory setting: White Video Color Select: white-> yellow -> green -> blue The color setting applies only while in RGB mode.

select a setting between 140 and 180. Menu Level Safety Limit Flow Only Low Flow Mode Factory Setting: US Version OFF EU Version ON Select the following for the safety limit flow: ON or OFF. Set values by scrolling in increments of 1. Menu Level Contrast Factory Setting: 155 In this menu level. User Menu Menu Level Display Actual Flow EN Factory Setting: yes Select the display of the actual flow in this menu level (yes or no). 40 .

User Menu

Menu Level Brightness
EN

Factory Setting: 200
In this menu level, select a setting between 50 and 250. Set the values by
briefly pressing the keys (scrolling in increments of 1) or by scrolling in
increments of 10.
Menu Level Invert Display

Factory Setting: White text on black background

Press "OK" to invert the display. The display lists inverted. Press "OK"
again to save this setting. Press "ESC" to exit the menu without saving
the setting and restore the display to its original state.

Menu Level Program Version

Use this menu level to query the program version of the individual
boards in the device.

41

User Menu

Customer Version
EN

Use this menu level to query the customer version of the individual
boards in the device.

42

Options

8 Options
EN
8.1 Video Messaging (Superposition)
When you connect the video messaging or video superposition option, the
monitor displays all important parameters of the insufflation and the
warning messages.

Never use the RGB/CSCC and S-VHS system simultaneously (cf. 5.3 Rear
of the device, page 16, (6)- (9)).
WARNING
Use the user menu to select different video messaging settings.
1. Connect the video camera cable with the corresponding device jack. Connecting Video Messaging
2. Connect the video monitor cable with the corresponding device jack. (Superposition)
3. Use the ON/OFF key to turn the device on. If the video camera and
monitor are activated, you will see the following parameters
displayed on the monitor:

(1) (2) (3)

(6) (5) (4)

• Nominal Pressure (1) and Actual Pressure (2)
• Nominal Gas Flow (6) and Actual Gas Flow (4)
• Gas Consumption (5)
• Error Messages (3)
4. In case of a malfunction, the corresponding warning message will be
displayed.
• OVERPRESSURE: Overpressure
• OCCLUSION: Occlusion
• SERVICE: Service
• GAS LOW : Too little gas
• HEATER > 42° C : Check heating
• HEATER ERROR: Heating malfunction
Using the remote control, you can switch the video messaging (video
superpositioning) on and off.

43

Options

EN

Left Blank on Purpose

44

0 l). 2. 8. 9-1-1 Setup to Check Device (1) Start/Stop key (1) (2) (3) (4) (2) Nominal pressure display (3) Gas consumption display (4) Nominal flow display (5) Gas consumption reset key (5) 4.4 l. Connect the device with a hydrophobic filter. 9. For your own safety and that of your patient. use only original accessories. there is a leak in the system. Make sure the gas supply is connected and open. The device is switched off. use steps 10 to 12 outlined below to locate the leak. DANGER 47 . 5. Function Test 9 Function Test EN The function test must be performed prior to each surgical procedure. 4 seconds. 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. and a Veress cannula. Insufflate for approx. If this happens. Fig. the message Occlusion and Actual Flow=0 is displayed. After max. 9. Stop insufflation: Press the Start/Stop key (1). 7. an insufflation tube. Start insufflation: Press the Start/Stop key (1). Use the ON/OFF key to turn the device on. Attach the stopcock (valve) to the Veress cannula. 30 s. Press the reset key (5) (display (3) has to show 0. If the actual gas consumption is higher than 0. 6.The device now conducts a self-test. Select the nominal pressure to 15 mm Hg (2) and nominal flow (4) to 3 l/min. 3.1 Testing the Device 1. Sterilize reusable instruments and tubing before surgery to prevent DANGER infections.

Select a gas flow rate of 10 l/min (2). 30 s. 4. 6. Press the reset key (3). (1) (2) (3) 1. 3.4 l. 2.2 Testing the Veress Cannula It is also necessary to check that the Veress cannula is functioning properly before surgery. Function Test 10. 11. and/or device that is leaking. 9. Stop insufflation: Press the Start/Stop key (1). Close the end of the insufflation tube connection for this test. Repeat items 7 to 9 without Veress cannula and with closed tube end. EN The previously connected Veress cannula has a leak if gas consumption is now below 0. A soiled or blocked Veress cannula is indicated if the actual gas consumption display shows a value of less than 0. 48 . 5. Insufflate for approx. accessory.5 l. Never work with an insufflation tube. 12.Any still detected leak is located directly inside of the device. which can cause an uncontrolled pressure increase in DANGER the abdomen. This can lead to an incorrect measurement of the actual pressure values. Press the Start/Stop key (1). Make sure the device or system can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. Open the stopcock (valve) at the Veress cannula.Repeat items 7 to 9 without Veress cannula and without tube if another leak becomes apparent.

0. especially on power plug and power cable. 1. This concludes the function check. Start insufflation: Press the Start/Stop key. DANGER 49 . Do not use this device if a defect is suspected or detected during the function check.0 l. Function Test 9.3 Fill Tube System with CO2 EN At least 1 l of CO2 has to be bled from the system before every surgery while the tube is connected and the end of the tube is open." 2.This ensures the gas consumption is correctly displayed during surgery. This will expel any air within the tube system and the device. Press the reset key to reset the gas consumption display to 0. The device has been checked and is ready for surgery. This also applies to obvious defects. Stop insufflation: Press the Start/Stop key. Wait until the gas consumption display shows "1.

Function Test EN Left Blank on Purpose 50 .

Stopping insufflation during surgery can diffuse CO2 through the wall of the tube. Compare the abdominal filling rate to the selected nominal pressure. The gas consumption display shows the actual volume of gas consumed. for corresponding settings for children). You can change the nominal gas flow and the nominal pressure during the operation without interrupting the insufflation process. This can damage the device. Check to see if the Veress cannula is correctly positioned in the abdomen. Before Surgery 2.2 Insufflating with the Trocar 1. DANGER 1. Check the actual pressure display and the gas consumption display.1 Insufflating with Veress Cannula On delivery from the factory. Make sure the trocar is correctly positioned in the abdomen. 2. As soon as this value approximates the desired value. 51 . Check how the patient’s body reacts to the selected pressure and gas flow rate. Connect the insufflation tube to the Veress cannula. The insufflation tube or the gas heating system is connected. Connect the tube to the trocar. The actual pressure display depicts the measured abdominal pressure. 1. Insert the trocar into the abdomen. Use of the Device During Surgery 10 Use of the Device During Surgery EN The function test must be performed prior to each surgery. Select the desired nominal pressure and nominal gas flow. 10. Then select the desired pressure and desired gas flow as intraoperative conditions. Start insufflation: Press the Start/Stop key. Always use a filter hydrophobic on both sides between device and patient. page 7. the gas flow is automatically minimized. This can be done at the trocar as well as directly at the device. Insert the Veress cannula into the abdomen. This manual does not include instructions for the safe use of the Veress cannula. 3. 2. Select "Veress Operating Mode" when using the Veress cannula. 3. chapter 3 Purpose of the Device. Therefore. a gas flow value of 3 l/min. Only when you have ensured endoscopically that an aeroperitoneum can be generated. The device is turned on. should a gas flow of more than 3 l/min and a pressure of more than 10 mm Hg be selected (cf. DANGER 10.1 l/min). the tube connection between patient and device has to be WARNING severed. High Flow mode and the Veress operating mode are set for insufflation through the Veress cannula (in Low Flow mode 0. 1. which results in a high negative tube pressure.

WARNING 1. the venting system can be set to "always on. Observe applicable hygiene regulations when disposing of the tubing set. 2. If the tube set remains connected to the device." The device interrupts insufflation and releases gas until the set nominal value has been reached. page 3) exceeds the set nominal pressure. Remove the tube set from the device. NOTE 52 . Close the gas supply. there is the danger that leftover fluid in the tube or the instruments will be sucked into the device. The following values are displayed: • Actual pressure: current measured value • Gas Consumption: last measured value The nominal gas flow is reset to the basic setting. Observe applicable hygiene regulations when disposing of the tubing set. Stop insufflation: Press the Start/Stop key. Use of the Device During Surgery EN 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 WARNING measured actual pressure (cf. Use the ON/OFF key to turn the device off. In Low Flow mode. 1. 2. chapter 2 Safety Instructions.

DANGER Do not place the plug of the reusable gas heating tube into the disinfectant solution. Clean the inner chamber of the Veress cannula with a cleaning pistol. Further sterilization is absolutely required after the disinfecting process. Clean and rinse the parts with demineralized water.2 Cleaning of the Reusable Tubing Set 1. 3. 3. Wipe the surface of the device with a soft cloth moistened with the disinfectant. For disinfection. NOTE 11. open the stopcock at the Veress cannula. The sterilization and disinfection rules apply as described in chapter 11 Care and Maintenance. 4. NOTE 1. Let all parts drip off and dry them with a sterilized soft cloth. maintaining and storing the device and additional equipment to maintain the functionality of the device and the equipment. 2. 2. Do not sterilize the device. 2. 4. Before cleaning: Notes about the Veress Cannula Dismantle the Veress cannula (unscrew the insertion cannula from the insufflation cannula with the stopcock open). Dismantle the tubing set. 1. Care and Maintenance 11 Care and Maintenance EN Special care is necessary when servicing. 53 . Wash the parts carefully with running water. Place all tube set components into a disinfectant for a short period. Only a thoroughly cleaned tube set may be disinfected. The tube set can be damaged if the concentration is too high.3 Disinfecting the Reusable Tube Set Disinfection of the tube and instruments is insufficient to achieve a sterility of SAL 10-6. 2. Use the ON/OFF key to turn the device off. 3. Remove the power cable. Wash the parts carefully under running cold and warm water. Should this happen once. 11. 11. The concentration and the application duration of the disinfectant depend on the information provided by the manufacturer of the disinfectant. page 53. 5.1 Cleaning the Device 1. ensure that the plug is thoroughly dried prior to sterilization. The concentration and the application duration of the disinfectant depends on the information provided by the manufacturer of the disinfectant. Make sure moisture does not enter the device.

Place the tube set in a sterile container if stored for a longer period of time. dry. and assembled tube sets should be sterilized. 4. Care and Maintenance EN Do not leave tube set or other silicone parts in the solution for more than 30 minutes. including cracking. The tube set may not be sterilized after the last tab has been removed.5 Annual Inspection Manufacturer's Specifications The manufacturer stipulates that the user or a hospital technician must regularly test the device to assess its functionality and technical safety. disinfected. Remove the parts from the solution using forceps with a soft edge. 7. Dry all parts with a sterile cloth and wrap each part in a separate sterile cloth. 11. These tests must be performed on an annual basis. Please follow the instruction manual of the autoclave you are using. 11. Place the individual parts into the disinfection solution. The manufacturer recommends autoclaving as follows: 134° C / 3 bar / 5 min Gas Sterilization Only clean. 8. This helps preserve the device and increases its safety and service life. Gamma Ray Sterilization Do not perform gamma ray sterilization. The tests are described in chapter 12 Annual Inspection . and assembled tube sets should be sterilized in an autoclave. 6. or signs of perforation. Never use a tube set which shows signs of WARNING deterioration. Silicon absorbs various disinfectants and thus can be WARNING damaged when sterilized with steam. 54 . Autoclave Sterilization Only clean. 5. WARNING Always check the reusable tube set for signs of deterioration before use and after sterilization. Regular inspections will assist in early detection of possible malfunctions. Assemble all components before sterilization. Do not stack them on top of each other.4 Sterilization of Reusable Tube Set The maximum number of sterilization cycles for the tube set is determined by the manufacturer (see tube packaging). 3. Please follow your gas sterilizer's intruction manual for proper use. dry. brittleness. Never exceed the number of uses recommended by the manufacturer. Any remaining disinfection solution should be rinsed off with sterile water under sterile conditions. Using the tear-off tabs attached to the tube set to keep track of the number of sterilization cycles. disinfected.

If the service interval is not adhered to. Check to make sure • the main power supply cable is properly connected to the power supply input and to a safety socket. 55 . • the house power supply fuse is functioning. depending on frequency and duration of use.6 Maintenance Carried out by Authorized Service Technician EN An authorized service technician has to inspect and service the device in Two-Year Maintenance Interval appropriate intervals to ensure the safety and functionality of the unit. Insert a new fuse. A sticker located on the rear panel of the device will remind you of the latest date for the next service or maintenance check. chapter 13 Technical Data. Use only the specified types of fuses (cf. Remove the fuse holder. the manufacturer does not assume any liability for the functional safety of the device. This certificate should list the type and scope of the performed services. • the device does not function. 3. Check fuse. Use the power cable to establish a connection between the protective contact socket and the connector plug located in the rear of the device. Ask the service technician for a certificate after he or she has inspected Certification the unit or performed any service tasks. 5. Undo the latch of the fuse holder with a small screwdriver. DANGER 2. 11. 4.7 Replacing the Fuse The fuse may be defective and is in need of replacement if: • displays and LEDs do not light up. Authorized service technicians are only trained and certified by the manufacturer. Care and Maintenance 11. 6. page 61). Insert the fuse holder until it can be heard snapping into place. date of service. and service company with signature. The minimum service interval is two years. Unplug the power supply cable from the device before checking the fuse. 1.

Care and Maintenance EN Left Blank on Purpose 56 .

2 Ω. 12.6 • Syringe 60 ml • Silicone tube 8 x 2 mm • T adapter 8-8-8 mm • Veress cannula length 100 mm. The measurement of voltage stability should not be performed using high voltage. 12.2 Basic Function Test (in High Flow Mode) 1. inner cannula diameter 1. Of particular importance is that • the fuse corresponds with the specifications indicated by the manufacturer. The device now conducts a self-test. 57 . The following values are displayed: Actual Pressure 15* [mm Hg] Nominal Gas Flow 3* l/min] Actual Pressure 0 [mm Hg] Gas Consumption 0. error class 1. Annual Inspection 12 Annual Inspection EN Each test conducted has to be documented with date and signature on the test log. Perform the measurement of the leakage current in accordance with DIN EN 60601-1. The following measuring tools and resources were used by the Measured Values and Tolerances manufacturer to determine the specified measurements and tolerance levels: • Manometer range 0-50 mm Hg.6 mm An authorized service technician has to check the device if the specified parameters and tolerances are exceeded. The minimum value is 50 MΩ. The factory default settings are 15 mm Hg for the nominal pressure and 3 l/min for the nominal flow. The maximum value is 0.0 [l] *These values correspond with the factory setting. Use the ON/OFF key to turn the device on. Set to High Flow mode. 3. Remove filter and insufflation tube from the device. • text and labels on the device are legible. As an alternative. opening diameter 1. 2. • no safety-impairing soiling is present. 3. The protective conductor resistance is measured with the power cable connected.4 mm. perform safety test according to DIN VDE 0751 Section 1. A short signal can be heard. Perform the measurement of the protective conductor resistance in accordance with DIN EN 60601-1. 4. 4. • the mechanical condition of the device allows for its safe use. these changed values are displayed. Perform the measurement of the insulation resistance with 500-700 V DC. If values in the user menu were changed. 2.1 Safety Test 1. Perform a visual inspection of the device.

6.0 [l] The basic function test of the device is complete. The following values are displayed: Actual Pressure 0 [mm Hg] "Veress on" is displayed. Never use the syringe to extract gas from the device. Streaming gas can be heard at the insufflation tube. Press the reset key. Select a nominal gas flow rate of 1 l/min.3 Test of the Pressure Sensors (1) (3) (2) 1. Streaming gas can be heard at the insufflation tube. WARNING 2. nominal gas flow.0 [l] 8. The following values are displayed: Nominal Gas Flow Max. The following values are displayed: Actual Pressure 0 [mm Hg] Gas Consumption >0. Connect a manometer (1) and an air-filled syringe (2) to the insufflation tube connection (3). 12. 58 . Do not press the Start/Stop key. Select the max. Stop insufflation: Press the Start/Stop key. Gas Consumption 0. Value [l/min] Actual Pressure 0 [mm Hg] "Insufflation on" is displayed. Start insufflation: EN Press the Start/Stop key. 7. Annual Inspection 5.

which registers on the manometer.4 Pressure Monitoring Test See also 12. 1. which registers on the manometer. Start insufflation. Actual Pressure Display 30 ± 2 [mm Hg] 12. 4. EN Actual Pressure Display 10 ± 2 [mm Hg] 4. The warning ends when the pressure falls below 19 mm Hg (nominal pressure plus 4 mm Hg). Start insufflation: An acoustic warning sound is emitted without delay and the display depicts "Overpressure" with a pressure of more than 30 mm Hg. 59 . 3. Start insufflation: An acoustic warning sound is emitted and the display depicts "Overpressure" (venting system active) with a pressure of more than 21 mm Hg (for 5 seconds). Annual Inspection 3.3 Test of the Pressure Sensors. Use the syringe to generate a pressure of 10 mm Hg. activate the venting system (set to In Veress mode off). which registers on the manometer. 5. The venting valve is activated and the display depicts "Venting System Active" with a pressure of more than 18 mm Hg (for 5 seconds). Stop insufflation. 5. 3. Use the syringe to generate a pressure of 30 mm Hg. Reduce the pressure. Select a nominal pressure of 15 mm Hg and a nominal gas flow of 1 l/min. Select a nominal pressure of 15 mm Hg and a nominal gas flow of 10 l/min. Use the syringe to generate a pressure of at least 21 mm Hg. In the user menu Venting Pressure Limit set a venting pressure of 3 mm Hg. 2. which registers on the manometer. In the user menu Venting System. page 58. Select a nominal pressure of 29 mm Hg. Reduce the pressure. 1. 6. 12. set a venting time of 3 seconds. Use the syringe to generate a pressure of 20 mm Hg.5 Venting Valve Test See also 12. which registers on the manometer. Stop insufflation. 4. Actual Pressure Display 20 ± 2 [mm Hg] 5. The warning ends when the pressure falls below 30 mm Hg. Use the syringe to generate a pressure of 30 mm Hg. Use the syringe to generate a pressure of 19 mm Hg. 2. page 58.3 Test of the Pressure Sensors. which registers on the manometer. In the Venting Response Time menu.

Connect a manometer (1) and an open Veress cannula (2) to the insufflation tube connection (3). the manometer registers a maximum pressure of 40-60 mm Hg. When the pressure stabilizes. 60 . 1. Select the max. Stop the insufflation after one minute. Press the reset key (0. Stop insufflation: Press the Start/Stop key. Annual Inspection 12. The gas consumption should be at least 11-12 l. Select a nominal gas flow rate of 14 l/min.0 l has to be displayed). 4. nominal gas flow. The manometer registers a pulsing pressure increase.7 Gas Flow Rate Test Test setup with open connection. 3.6 Max. Each successfully conducted test has to be documented with the test log. 3. 2. 12. 2. Start insufflation: Press the Start/Stop key. 4. Now start measuring for one minute. Device Pressure Test EN (1) (3) (2) 1. Start insufflation: Press the Start/Stop key.

+158° F 10-85 % rel. Bank 30. Video CSCC IN/OUT.70 [in] Weight Approx. to EN 60601-1 EMC EN 60601-1-2 Insufflation medium Medical CO2 Maximum output pressure 55 mm Hg (1 mm Hg V1. Technical Data 13 Technical Data EN Power supply 100-240 V~ Mains fuse T 3.+70° C /-40 . SIDNE Interface Infrared remote control (only for EU Version) Transfer protocol R5 Code.83 x 18. air humidity (14 days) Manufactured and tested acc. power consumption 150 VA Maximal current consumption 100 V: 1500 mA 240 V: 630 mA Classification according to Directive 93/42/EEC IIa Protection class I Protection level Type BF Moisture protection IP41 Dimensions Width x height x depth 318 x 148 x 475 [mm]/12. 9 kg Operating conditions 10-40° C / 50-104° F 30-75 % rel.33 mbar V 133 Pa) Maximum gas supply pressure 80 bar/1160 PSI Minimum gas supply pressure 5 bar/73 PSI Measurement range of gas supply 0-50 bar/0-725 PSI Maximum gas flow 20 l/min Low Flow 40 l/min High Flow Pressure range 1-20 mm Hg Low Flow 1-30 mm Hg High Flow Accuracy of pressure measurement 5% Accuracy of gas flow measurement 5% Accuracy of volume measurement 10% Accuracy of gas supply pressure measurement 10% Connections (optional) Video S-VHS IN/OUT . Video RGB IN/OUT Data input/output. Power supply with 2 batteries type AA (1.15 A Connection for equipotential bonding Frequency 50-60 Hz Max.52 x 5. Width x height x depth 64 x 22 x 119 [mm] 61 . Device Interface RS232. humidity Storage and transportation conditions -40 . humidity 85-100 % rel.5V).

Technical Data EN Left Blank on Purpose 62 .

which can be connected to an additional video source or display unit with a video cable (SVHS cable 2m or RGB. It should not be longer as 3 m.3 Accessories A serial cable RS 232 can be connected to the 40 L Core Insufflator to Data Transfer transfer data from/to an external computer. set up. For EU Version only Tube Heating A tube set with tube heating can be connected to the 40 L Core Insufflator (heatable tube set.g. CSCC cable). The 40 L Core Insufflator is equipped with the video interfaces IN/OUT Video Interface and S-VHS IN/OUT. 14. 14. cell phones. cable length < 3. 63 .0 m).2 Electrical Connections Electrical connections equipped with this warning symbol may not be touched and connections between these plugs and sockets may not be established without first implementing ESD precautionary measures.1 Impact of Mobile and Portable RF Communication Devices The emission of high frequency energy by mobile communication devices may impact the function of the electrical medical device. This device is to be used only for the purposes described in the manual and has to be installed. and operated in compliance with the EMC notes and instructions. Z1415-01. Electromagnetic Compatibility 14 Electromagnetic Compatibility EN Medical devices are subject to special precautionary measures Precautionary Measures concerning electromagnetic compatibility (EMC). Z1411-01 or Item No. 14. GPS phones) in the proximity of the electrical medical device is prohibited. The following are ESD precautionary measures: ESD Precautionary Measures • Apply potential equalization (PE) to all devices to be connected.. Personnel have to be informed about and trained in ESD precautionary measures. • Use only the listed equipment and accessories. reusable / Item No. Operating such devices (e.

and 5% UT* (> 95% dip of the UT) In compliance The quality of the supply voltage fluctuations of the power for ½ period should be the same as the voltage of supply according to IEC 40% UT (60% dip of the UT) for a typical business or hospital 61000-4-11 5 periods environment. The user/operator of the insufflator should make sure the device is operated within such an environment. If the user/operator of 70% UT (30% dip of the UT) for the insufflator requires the 25 periods continuation of functionality after < 5% UT (> 95% dip of the UT) power interruptions/disruptions. Power frequency magnetic 3 A/m In compliance Magnetic fields of the mains supply field (50/60 Hz) according to should comply with the typical IEC 61000-4-8 values of business and hospital environments *Note: UT is the mains alternating voltage before applying the test levels. Therefore. IEC 60601 Test Level Compliance Electromagnetic Environment ference Immunity Tests Guidelines Discharge of static electricity ± 6 kV contact discharge In compliance Floors should be made of wood or (ESD) according to ± 8 kV air discharge concrete or feature ceramic tiles. Emitted Interference Compliance Electromagnetic Environment Guidelines Measurements RF emission according to Group 1 The 40 L Core Insufflator uses electromagnetic energy only CISPR 11 for its internal functions. it is for 5 s recommended to provide the insufflator with power from an uninterruptible power supply.Electromagnetic Emissions EN The 40 L Core Insufflator is intended for use in an environment as described below. RF emission according to Class B The 40 L Core Insufflator is suitable for use in all facilities CISPR 11 including those in residential areas and those directly connected to a public utility network also supplying Emission of harmonic oscillations Class A buildings used for residential purposes.4 Guidelines and Manufacturer's Statement . Electromagnetic Compatibility 14. Electromagnetic Inter. Blackouts. The user/operator of the insufflator should make sure the device is operated within such an environment.5 Guidelines and Manufacturer's Statement . its RF emission is very low and it is unlikely that devices in close proximity will experience interference. according to IEC 61000-3-2 Emission of voltage fluctuations / In compliance flickers according to IEC 61000-3-3 14. the rel.Electromagnetic Interference Immunity The 40 L Core Insufflator is intended for use in an electromagnetic environment such as the one described below. 64 . brownouts. humidity should be at least 30%. Electrical fast transients / ± 2 kV for AC power lines In compliance The quality of the supply voltage bursts according to IEC ± 1 kV for input and output should be the same as the voltage of 61000-4-4 lines a typical business or hospital environment. If IEC 61000-4-2 the floor covering consists of synthetic material. Surges according to ± 1 kV differential mode In compliance The quality of the supply voltage IEC 61000-4-5 ± 2 kV common mode voltage should be the same as the voltage of a typical business or hospital environment.

Additional measures might become necessary. the insufflator should be monitored to documents proper functionality and operation as intended. A site study is recommended to determine the electromagnetic environment as it pertains to the stationary transmitters.5 GHz In compliance frequency and the applicable formula.5 GHz with P as the rated output of the transmitter in watts [W] according to the information provided by the manufacturer of the transmitter and d as recommended safety distance in meters [m].g. The spread of electromagnetic quantities differs depending on the absorption and reflection of buildings. Note 1: The higher frequency range applies for 80 MHz and 800 MHz. Note 2: These guidelines may not be applicable in all cases. Field strengths from fixed RF transmitter as determined by an electromagnetic site survey (a). e. Recommended safety distance: d = 1. 65 . amateur radio stations. b The field strength should be less than 3 V/m for the frequency range of 150 kHz to 80 MHz. should be less than the compliance level in each frequency range (b). Electromagnetic Compatibility 14.6 Guidelines and Manufacturer's Statement . modifying orientation or a different location for the insufflator. AM and FM radio and TV broadcasters are theoretically not 100% predictable. Interference is possible in the proximity of devices featuring the following pictograph.2 √ P d = 1. a The field strength of stationary transmitters such as base stations of mobile phones and land mobile devices. If the measured field strength at the proposed 40 L Core Insufflator installation and operation site exceeds the compliance levels listed above.Electromagnetic Interference Immunity - 40 L Core Insufflator (Non-Life Support) EN Electromagnetic IEC 60601 Test Level Compliance Electromagnetic Environment Interference Immunity Guidelines Tests Conducted RF interference 3 Vrms 150 kHz to 80 MHz In compliance Portable and mobile wireless devices quantities according to IEC should not be used in closer 61000-4-6 proximity to the insufflator (including cables/lines) than the Radiated RF interference recommended safety distance quantities according to IEC calculated based on the transmitting 61000-4-3 3 V/m 80 MHz to 2.. and people. objects.2√ P for 80 MHz to 800 MHz d = 2.3 √ P for 800 MHz to 2. if unusual performance characteristics are observed.

Rated output of the Safety distance based on the transmitting frequency [m] transmitter [W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.12 0.5 GHz d = 1.2 √ P d = 2. 66 .depending on the output power of the communication device listed below.3 100 12 12 23 The safety distance d in meters [m] for transmitters with a max. Note 1: The higher frequency range applies for 80 and 800 MHz. objects.01 0.38 0.73 1 1.2 √ P d = 1.38 0. Note 2: These guidelines may not be applicable in all cases. and people.2 1.23 0.3 10 3. The distribution and spread of electromagnetic quantities differs depending on the absorption and reflection of buildings.12 0.2 2. Electromagnetic Compatibility 14.8 7. rated output not listed in the table above can be calculated by applying the corresponding formula in the respective column. The user/operator of the insufflator can contribute to lowering electromagnetic emissions by complying with the minimum distance between portable and mobile RF telecommunications devices (transmitters) and the insufflator .3 √ P 0.8 3. P is the max. rated output of the transmitter in watts [W] as specified by the transmitter manufacturer.1 0.7 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and EN the 40 L Core Insufflator (Non-Life Support) Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and the 40 L Core Insufflator The 40 L Core Insufflator is intended for use in an electromagnetic environment where RF interference quantities are controlled.

2 m Z0166-01 Remote control Z0525-01 Sterile packing for remote control For your own safety and that of your patient. mode US Order No. Items 1000-400-737 40L CORE Insufflator manual US. EN/NL/FR/DE 1000-400-833 40L CORE Insufflator manual EU. DISS Z5043-34 DISS hose for house gas connection Z0175-01 Gas connection CO2 US Z0171-01 Gas connection CO2 central gas supply (Non EU only) Power supply cord Z0102-01 Power supply cord US. device connection: US Length: 6" Wrench for high pressure tubes Z0600-01 Wrench for high pressure tube US Gas connection Z5020-34 Gas connection CO2 for central gas supply.EN/ES/FR/DE 0620-040-002 DISS house gas connection. use only original accesso.2 Accessories for 40L Core Insufflator with integrated low flow.5m 0105-170-797 Needle Veress. mode EU Order No. 2. 2. bottle connection: US. 67 . Accessories 15 Accessories EN 15. for central gas supply 0620-040-003 DISS hose for house gas supply 0105-195-003 Back gas connector 0105-189-317 Power supply cord US.5 m Miscellaneous Z0500-01 Adapter PIN-Index for high pressure tube CO2 Z5040-01 Fuse T 3. Original Accessories ries. EN/NO/SV/DA/FI 1000-400-832 40L CORE Insufflator manual EU. 100 mm 0620-030-503 CO2 Switching valve 15. Items Z0498-01 High pressure tube CO2. 100 mm. EN/ES/IT/PT/EL Z5000-01 Video cable Z0131 S-VHS cable.15 A Z0701-01 Veress cannula. chrome plated 1000-400-834 40L CORE Insufflator manual EU.1 Accessories for 40L Core Insufflator with integrated low flow.

check if the remote control influences other devices or if other existing remote controls influence the device. then you can continue increasing the pressure further (safety function). The nominal pressure value "12 mm Hg" *LF or "15 mm Hg" *HF is a threshold value. Before surgery. Accessories 15. you cannot increase the nominal pressure once 12 mm Hg or 15 mm Hg has been reached. This requires bypassing and exceeding the safety limit. Follow these steps: Release the key for 1 second. The following device functions can be controlled with the remote control: (1) (2) (5) (3) (4) Increasing/Reducing Nominal Pressure • Press the (1) key to increase/reduce the nominal pressure. In Low Flow mode.3 Remote Control (only for EU Version) EN Use the remote control to operate the device from the operating table. It is not possible to sterilize the remote control. 68 . You can disinfect the remote control by wiping it with a disinfectant. the safety limit is at 15 mm Hg. Exceeding this safety limit is to be decided by and the responsibility of the user/operator. In High Flow mode. Increasing the pressure further is initially not possible. WARNING Please put the remote control into a sterile bag before using it. WARNING Do not use the remote control without sterile cover within the sterile area. the safety limit is at 12 mm Hg. Depending on the selected application mode (Low Flow or High Flow). This is where the recommended range for the intra-abdominal pressure ends.

Exceeding this safety limit is to be decided by and the responsibility of the user/operator. • Use the (3) key to reset the gas consumption display to zero. In High Increasing/Reducing Nominal Gas Flow Flow mode. then you can continue increasing the flow further (safety function). Gas Consumption Display • Use the (4) key to start/stop the insufflation. EN The nominal flow value 5 l/min is a threshold value. Follow these steps: Release the key for 1 second. 69 . Then press the desired key to operate the device. Start/Stop • Use the (5) key to switch video messaging (superpositioning) ON/OFF Video Messaging (Superposition) (optional) ON/OFF Point the remote control in the direction of the receiver window at the left front of the device. Increasing the flow further is initially not possible. This requires bypassing and exceeding the safety limit. the safety limit is at 5 l/min. Accessories • Press the (2) key to increase / reduce the nominal gas flow.

Accessories EN Left Blank on Purpose 70 .

Tube. The gas supply pressure has • Prepare for changing the gas bottle. overpressure was not chapter 12 Annual Inspection. chapter 12 Annual Inspection. • Check the house supply. trocar occlusion. Error and Warning Messages 16 Error and Warning Messages EN Error and Warning Cause Troubleshooting Messages After pressing the ON/OFF • Open gas bottle or key: • replace with new bottle. dropped below 20 bar. • Terminate insufflation with the Start/Stop key. page 57). sealed. if possible or necessary. the nominal pressure. page 57). Gas supply empty Existing gas supply pressure is too low. The overpressure exists for a longer period of time (cf. 69 . It is possible device. Check the electronic controls of the device if mm Hg and 2-5 second above overpressure exists for a longer period of time (cf. During surgery: • Close gas supply valve. • Detach the insufflation tube. • Open gas supply valve. • Continue insufflation with the Start/Stop key. The actual pressure is at least Determine the cause for exceeding the nominal 2-5 mm Hg and 2-5 s above pressure. the nominal pressure. pressure is 2-5 mm Hg above Check the electronic controls of the device if the nominal pressure. dropped below 15 bar. reduced within 5 seconds by Reduce the nominal pressure and determine the cause the venting system. Fluid has penetrated the Message is repeated with each Start/Stop. of exceeding the nominal pressure. The device is contaminated with fluid. Low gas level The pressure monitor shows Determine the cause for exceeding the nominal that the actual pressure is 2-5 pressure. Check the electronic controls of the device if overpressure exists for a longer period of time (see chapter 12 Annual Inspection. The gas supply pressure has • Replace gas supply. Veress cannula. The following messages are The device has to be checked by an authorized service depicted on the display technician or clearly marked with a label referring to the consecutively: contamination and then twice enclosed in a safety foil. Check that the Veress cannula is positioned correctly in Faulty Veress needle the abdomen and make sure the instrument's stopcock insertion. or Determine the cause and open/eliminate the occlusion. to continue using the device with this error message until the device is turned off with the ON/OFF key. The pressure monitor Determine the cause for exceeding the nominal indicates that the actual pressure. if possible or Hg *LF. • Connect insufflation tube. necessary. The actual pressure has Reduce the nominal pressure and determine the cause reached 30 mm Hg / 20 mm of exceeding the nominal pressure. and returned to the manufacturer for repairs. is open. page 55).

The temperature of the gas • Unplug the insufflation tube at the trocar and the plug exceeds 42° C. for the gas heater located at the device. back on after approx. internal safety system. The device does not work Switch the device off and back on after approx. The device temperature is Turn the device off for about 10 minutes using the ON/OFF below 10° C. If this error message is displayed again. Error and Warning Messages EN Error and Warning Cause Troubleshooting Messages Gas heating malfunction. The device is defective if the error message is displayed again. The surrounding room temperature must be above 10° The insufflation is stopped or C. heating and insufflation. have the device checked by a qualified service technician. 3 seconds properly and activates the have expired using the ON/OFF key. The error message is repeated with each Start/Stop. have the device checked by an authorized service technician. • Check gas heating after surgery using a different tube. It is possible to continue using the device without gas heating. Turn device off and on again. cool off for about 10 minutes. Heater defect/Call service Check tube and cable for defects. • Let hot gas escape until the tube is only warm to the The device terminates gas touch. • Press the Start/Stop key. The device temperature is Switch the device off with the ON/OFF key and allow it to above 70° C. It is possible to continue using the device without gas heating. The device can be still operated but without venting system. • Continue the operation without gas heating or use a different gas heating tube. If this error message is Valve defect/Call service displayed again after the device self-test has concluded. Venting system Use the ON/OFF key to turn the device off and turn device malfunctioning. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. Check that the plug is inserted correctly into the gas heating connection. have the device checked by a qualified service technician. If this error message is displayed again. The device insufflates without heating the gas. cannot be started. This reactivates the gas heating. 3 seconds. 70 . Make sure the device is not set up in the vicinity of heat sources. key. Check gas heating using a different tube.

Appendix 17 Appendix EN 17.1 Test Record Date Result Comment Signature 65 .

Appendix EN Left Blank on Purpose 66 .

Appendix 17.2 Return Form EN Return form Please fill out the card below and mail it back with the device Name of owner: Sales representative: Address of return Street: ZIP code: City: State: Country: Type of device: Important! Serial number (SN. see identification plate): Description of defect: Name of responsible person Signature Date 67 .

Appendix EN Left Blank on Purpose 68 .

Nominal Pressure 36 Endoscope 5 Menu Level Occlusion Warning 35 Error Message "Contamination" 32 Menu Level Safety Limit Flow 40 Error Message "Service" 31 Menu Level Venting Pressure Limit 38 ESD Precautionary Measures 63 Menu Level Venting Response Time 37 Exceeding Nominal Pressure 29 Menu Level Venting System 37 Exceeding nominal pressure for more than 5 seconds Menu Level Video Superposition (optional) 39 29 Menu Level Volume 35 F Metabolic and Cardiac Reactions 8 Factory Settings 4 N Fatigue Symptoms 10 Nominal Pressure Threshold 30 Filter 10 Not explosion-proof 4 Function of the Keys 34 Notes about the Veress cannula 53 Function Test 5 O G Original Accessories 4. 29 High Flow Application 7 Available Mains Voltage 4 How do I use the user menu? 34 B Hypothermia 22 Backflow 9 Hypothermia/Monitoring Body Temperature 9 Before Surgery 51 I C Idiosyncratic Reactions 8 Care and Maintenance 3 Increased Airway Pressure 21 Central Gas Supply 18 Increased Airway Pressure/Compression of the Vena Certification 55 Cava 8 Changes 1 Increasing Nominal Gas Flow 20. 23 Cleaning the Device 5 Increasing Nominal Pressure 19. 8 Menu Level Application 34 Disconnecting the Insufflation Tube 9 Menu Level Display Actual Flow 40 Disposal 3 Menu Level First Nominal Pressure 36 E Menu Level Gas Flow Rate 1. 2. 10 L Contraindications 7 Liability 3 D Low Flow Application 7 Decreasing Nominal Gas Flow 20. 21 Gas Flow Limit 8 Positioning the Patient 8 Gas heating error 27 Power Failure 32 Gas Heating ON/OFF 27 69 . Index 18 Index Gas Sterilization 54 A Gas Supply Display 30 EN Gas Supply with Gas Bottle 18 Additional Insufflation Sources 9 Gas temperature exceeds 42° C 28 Authorized Service Technician 3 H Autoclave Sterilization 54 Haemodynamic Stability 21 Automatic Venting System 10. 22 CO2 Absorption 8 Increasing/Reducing Nominal Gas Flow 69 Compression of the Vena Cava 21 Increasing/Reducing Nominal Pressure 68 Condensation / Water Penetration 4 Insufflation on 24 Connecting the gas heating 27 Insufflation Operating Mode 20 Connecting the Tube 10 Intended Use 7 Connecting Video Messaging (Superposition) 43 K Contaminated Filter 10 Keep Filled CO2 Bottle on Hand 10 Contamination 3. 67 Gamma Ray Sterilization 54 P Gas consumption display 69 Peripheral Devices 11 Gas Flow 10 Pneumolabium/Pneumoscrotum 8. 3 36 Electromagnetic Interference 11 Menu Level Gas Supply 38 Electronic Device Control 11 Menu Level Language 35 Embolism 9 Menu Level Max. 23 M Decreasing Nominal Pressure 19. 22 Maintenance Interval 55 Dehydration 9 Manual 1 Delivered Device Check 13 Measured Values and Tolerances 57 Device Defect 5 Medically Pure CO2 11 Device-inherent Dangers 5.

S. Federal Law 3 US Operators 13 V Venting System "In Veress Operating Mode" 24 Veress on 24 Video Color 39 Video input 39 Video Offset Horizontal 39 Video Offset Vertical 39 Video Text 39 W Warning Message "Occlusion" 31 70 . Index Power supply 13 EN Precautionary Measures 63 Professional Qualification 5 Protective Contact 13 R Recommended Work Settings 21 Replacement Device and Accessories 5 Replacing Fuse 4 Resetting 26 Returning the Device 13 Risk of Electrical Shock 4 S Service Connection 11 Sterile Substances and Accessories 5 T Techniques and Procedures 4 TV Standard 39 U U.

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