Stryker 40L Manual [PDF]

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Manual

Manual DE Manuel

Handbuch

US Version

EU Version

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

EN

ES

FR

DE

This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the approval of STRYKER. Some of the parts and equipment referred to in this manual bear registered trademarks but are not identified as such. It should therefore not be assumed that the absence of the trademark indicates that any given designation is not subject to trademark protection. Users of this product should not hesitate to point out to us any errors or unclarities in this manual.

EN

Copyright © STRYKER

Ce manuel contient des informations protégées par la législation des droits de propriété et des droits d’auteur. Tous droits sont protégés. Il est interdit de reproduire ou de distribuer ce manuel - que ce soit intégralement ou partiellement par photocopie, microfilm ou autres procédés de reproduction sans l’autorisation écrite expresse de l’entreprise.

FR

En raison du perfectionnement permanent de nos produits, nous nous réservons le droit de procéder à des modifications techniques sans avis préalable. Il se peut que les fonctionnalités ou que le design des produits diffèrent partiellement de la description figurant dans le manuel. Pour de plus amples informations concernant ce produit ou d’autres produits, n’hésitez pas à nous contacter. Les désignations qui représentent en même temps des marques déposées n’ont pas été spécifiquement caractérisées. L’absence du logotype ne peut en aucun cas faire supposer que la désignation représente une marque non déposée. De la même manière, cela n’indique pas la présence de brevets ou de modèles déposés. STRYKER remercie d’avance les utilisateurs de ses produits qui lui fourniront des informations eu égard à des errata possibles ou à des imprécisions susceptibles d’être contenus dans ce présent manuel. Copyright© STRYKER

Este manual contiene informaciones protegidas por el derecho de propiedad (copyright), que forma parte de los derechos de autor. Todos los derechos están protegidos. Sin autorización por escrito de STRYKER, este manual no podrá ser ni total ni parcialmente reproducido ni divulgado por medio de fotocopia, microfilm u otros medios y procedimientos. Debido al desarrollo constante de nuestros productos, nos reservamos el derecho a llevar a cabo modificaciones técnicas sin aviso previo. El funcionamiento y el diseño podrán diferir parcialmente de la descripción en el manual. Rogamos establezcan contacto con nosotros, si desean adquirir más información sobre este o cualquier otro producto. Las denominaciones que son, a su vez, marcas registradas, no han sido identificadas especialmente. La falta de la identificación con marca no implica que el producto en cuestión no posea marca comercial alguna. Asimismo, no pueden sacarse conclusiones del presente manual , sobre la existencia o inexistencia de patentes ni modelos de utilidad. STRYKER agradecerá a los usuarios de los productos de STRYKER cualquier aviso, indicación u observación con respecto a posibles fallos, incongruencias o explicaciones poco claras que puedan encontrarse en el presente manual.

Dieses Handbuch enthält eigentumsrechtlich geschützte Informationen, die dem Urheberrecht unterliegen. Alle Rechte sind geschützt. Ohne ausdrückliche, schriftliche Genehmigung von STRYKER darf dieses Handbuch weder vollständig noch in Auszügen durch Photokopie, Mikrofilm oder andere Verfahren vervielfältigt oder verbreitet werden.

Copyright © STRYKER

Copyright © STRYKER

ES

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA Stryker European Rep - RA/QA Manager ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex

DE

Durch die ständige Weiterentwicklung unserer Produkte behalten wir uns technische Änderungen ohne Ankündigung vor. Funktion oder Design können teilweise von der Beschreibung im Handbuch abweichen. Bitte kontaktieren Sie uns, um weitere Informationen zu diesem oder anderen Produkten zu erhalten. Bezeichnungen, die zugleich eingetragenes Warenzeichen sind, wurden nicht besonders gekennzeichnet. Es kann nicht aus dem Fehlen des Warenzeichens geschlossen werden, dass eine Bezeichnung ein freies Warenzeichen ist. Ebensowenig ist zu entnehmen, ob Patente oder Gebrauchsmuster vorliegen. STRYKER ist Anwendern von STRYKER -Produkten dankbar für jeden Hinweis auf mögliche Fehler oder Unklarheiten dieses Handbuches.

0197

CE marking according to Directive 93/42/EEC Identificación CE conforme a la directriz 93/42/CEE Marquage CE conforme à la directive 93/42/CEE CE- Kennzeichnung gemäß Richtlinie 93/42/CEE

Model / Modelo / Série/Baureihe F112_MIO/201-5199-C/1204/ksc

Pictographs/Pictogramas/Symboles/Bildzeichen

Pictographs

Pictogramas

Symboles

Bildzeichen

See operating manual

¡Atención! Observe la documentación adjunta

Attention, lire la documentation jointe!

Achtung Begleitpapiere beachten

Symbol for type BF equipment

Símbolo para un aparato del tipo BF

Symbole pour un appareil de type BF

Symbol für ein Gerät des Typs BF

Symbol for potential equalization

Símbolo para la conexión equipotencial

Fiche équipotentielle

Symbol für den Potentialausgleich

Degrees of protection provided by enclosures (IP-Code)

Grado de protección proporcionado por los envolventes (Código IP)

Degrés de protection procurés par les enveloppes (Code IP)

Gehäuseschutzklasse (IP-Code)

Alternating current

Corriente alterna

Courant alternatif

Wechselstrom

Service

Servicio

Service

Service

Order number

Número de pedido

Référence produit

Bestellnummer

Single use only

No reutilizable

Usage unique

Nicht zur Wiederverwendung

Sterile with ETO

Esterilizado con ETO

Stérilisés à l´ ETO

Sterilisiert mit ETO

Lot no.

Denominación de partida o lote

Numéro de lot

Chargenbezeichnung

Serial number

Número de serie

Numéro de série

Seriennummer

Date of manufacture

Fecha de fabricación

HerstellungsDate de fabrication datum

Expiration day

Utilizable hasta

Date limite d'utilisation

Verwendbar bis

Stück pieces

Pieces, quantity

Pieza, cantidad

Pièces, quantité

Anzahl, Menge

QTY

Quantity

Cantidad

Quantité

Menge

IP 41

REF

STERILE EO

LOT

Pictographs/Pictogramas/Symboles/Bildzeichen

LATEX FREE

134 °C 3 bar 5 min

xx

Pictographs

Pictogramas Symboles

Latex free

Sin latex

Sans latex

Number of autoclaving cycles

Número de esterilizaciones por autoclave

Paramètres pour la Anzahl der stérilisation à Autoklavierungen l´autoclave

Do not get wet

Proteger contra la humedad

Protéger de l'humidité

Vor Nässe 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

Increase/ decrease

Creciente/ decreciente

Croissant/ décroissant

zunehmend/ abnehmend

Connectorsignal input

Entrada para señales

Entrée de signaux

Eingang für Signale

Connectorsignal output

Salida para señales

Sortie de signaux

Ausgang für Signale

Data logger

Registro de datos

Enregistrement des données

Datenaufzeichnung

Direct current

Corriente continua Courant continu

Gas output

Salida de gas

Sortie de gaz

Bildzeichen

Gleichstrom

Gasausgang

Contents 1 2 3 4 5

6 7 8 9

10 11

12

13

Important User Notes................................................................................................................................... 1 Safety Instructions........................................................................................................................................ 3 2.1 Dangers and Risks............................................................................................................................................. 4 Purpose of the Device................................................................................................................................... 7 3.1 Device-inherent Dangers................................................................................................................................ 8 3.2 Manufacturer’s Notice: Device Versions.................................................................................................... 12 Initial Use of the Device ............................................................................................................................... 13 4.1 Gas Connection ................................................................................................................................................. 14 Operating the Device.................................................................................................................................... 15 5.1 Front of the device............................................................................................................................................ 15 5.2 Display.................................................................................................................................................................. 15 5.3 Rear of the device ............................................................................................................................................. 16 5.4 Device Setup....................................................................................................................................................... 16 5.4.1 High Flow Application ..................................................................................................................................... 17 5.4.2 Low Flow Application (optional)................................................................................................................... 17 5.5 Gas Supply Display ........................................................................................................................................... 18 5.6 Presetting Nominal Flow/Nominal Pressure with High Flow Application....................................... 18 5.6.1 Presetting Nominal Pressure with High Flow Application ................................................................... 18 5.6.2 Preselecting Nominal Flow with High Flow Application ....................................................................... 19 5.7 Preselecting Nominal Flow/Nominal Pressure with Low Flow Application .................................... 21 5.7.1 Preselecting Nominal Pressure with Low Flow Application ................................................................. 22 5.7.2 Preselecting Nominal Flow with Low Flow Application ........................................................................ 23 5.8 Start/Stop Key.................................................................................................................................................... 25 5.9 Actual Pressure Display................................................................................................................................... 25 5.10 Gas Consumption Display .............................................................................................................................. 26 5.11 Insufflation Tube Connection........................................................................................................................ 26 5.12 Gas Heating ........................................................................................................................................................ 26 5.13 Switching Device Off........................................................................................................................................ 28 Safety Functions ........................................................................................................................................... 29 User Menu..................................................................................................................................................... 33 Options ......................................................................................................................................................... 43 8.1 Video Messaging (Superposition) ................................................................................................................ 43 Function Test ................................................................................................................................................ 47 9.1 Testing the Device ............................................................................................................................................ 47 9.2 Testing the Veress Cannula ........................................................................................................................... 48 9.3 Fill Tube System with CO2.............................................................................................................................. 49 Use of the Device During Surgery ................................................................................................................ 51 10.1 Insufflating with Veress Cannula................................................................................................................. 51 10.2 Insufflating with the Trocar........................................................................................................................... 51 Care and Maintenance ................................................................................................................................. 53 11.1 Cleaning the Device.......................................................................................................................................... 53 11.2 Cleaning of the Reusable Tubing Set .......................................................................................................... 53 11.3 Disinfecting the Reusable Tube Set............................................................................................................. 53 11.4 Sterilization of Reusable Tube Set ............................................................................................................... 54 11.5 Annual Inspection............................................................................................................................................. 54 11.6 Maintenance Carried out by Authorized Service Technician ............................................................... 55 11.7 Replacing the Fuse............................................................................................................................................ 55 Annual Inspection......................................................................................................................................... 57 12.1 Safety Test........................................................................................................................................................... 57 12.2 Basic Function Test (in High Flow Mode)................................................................................................... 57 12.3 Test of the Pressure Sensors.......................................................................................................................... 58 12.4 Pressure Monitoring Test ............................................................................................................................... 59 12.5 Venting Valve Test............................................................................................................................................ 59 12.6 Max. Device Pressure Test.............................................................................................................................. 60 12.7 Gas Flow Rate Test............................................................................................................................................ 60 Technical Data .............................................................................................................................................. 61

EN

Contents EN

14

15

16 17 18

Electromagnetic Compatibility.................................................................................................................... 14.1 Impact of Mobile and Portable RF Communication Devices ............................................................... 14.2 Electrical Connections..................................................................................................................................... 14.3 Accessories ......................................................................................................................................................... 14.4 Guidelines and Manufacturer's Statement - Electromagnetic Emissions....................................... 14.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity .............. 14.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity 40 L Core Insufflator ........................................................................................................................................ 14.7 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and the 40 L Core Insufflator ...................................................................................................... Accessories ................................................................................................................................................... 15.1 Accessories for 40L Core Insufflator with integrated low flow, mode US....................................... 15.2 Accessories for 40L Core Insufflator with integrated low flow, mode EU....................................... 15.3 Remote Control (only for EU Version) ........................................................................................................ Error and Warning Messages....................................................................................................................... Appendix...................................................................................................................................................... 17.1 Test Record......................................................................................................................................................... 17.2 Return Form ....................................................................................................................................................... Index ............................................................................................................................................................

63 63 63 63 64 64 65 66 67 67 67 68 69 65 65 67 69

Important User Notes 1

Important User Notes

Read the manual carefully and become familiar with the operation and function of the device and the accessories before using either for surgical procedures. Noncompliance with the manual may lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing staff or service personnel, or • to damage or malfunction of device and/or accessories.

Reading this Manual

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

Subject to Technical Changes

EN

Paragraphs with the words DANGER, WARNING, and NOTE carry special meanings and should be read attentively. The safety and/or health of the patient, user, or a third party is at risk. Comply with this warning to avoid injury to the patient, user, or third party.

DANGER

These paragraphs contain information concerning the intended and proper use of the device or accessory. WARNING

Here you will read information about the maintenance of the device or accessories. NOTE

1

Important User Notes

EN

Left Blank on Purpose 2

Safety Instructions 2

Safety Instructions

U.S. federal law restricts use of this device by or on the order of a physician.

U.S. Federal Law (Only for U.S. Market)

The manufacturer does not assume any liability for direct or consequential damage if: • the device or the accessories are improperly used, prepared, or maintained; • the instructions and rules in the manual are not adhered to; • non-authorized persons perform repairs, adjustments, or alterations on the device or accessories; • non-authorized persons open the device; • the prescribed inspection and maintenance schedule is not adhered to.

No Liability

EN

Receiving technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations on the device or accessories/peripherals. Only an authorized service technician may perform repairs, adjustments, or alterations on the device or accessories and use the service menu. Authorized service technicians are only trained and certified by the manufacturer.

Authorized Service Technician

To guarantee safe operation, it is absolutely necessary to carry out proper care and maintenance of the device and accessories. For the protection of the patient and the operating team, check that the device is complete and functional before each use. New products as well as repaired products must be prepared and tested according to the manual instructions prior to use.

Care and Maintenance

For the protection of the service personnel and to maintain safety during transportation, all devices and accessory parts that are sent in to be repaired must be prepared for shipment as described in the manual.

Contamination

If this is not possible, • the product must be clearly marked with a contamination warning and • double-sealed in safety foil. The manufacturer has the right to refuse carrying out repairs if the product is contaminated. Observe national waste management regulations when disposing of device and accessories.

Disposal

3

Safety Instructions 2.1

EN DANGER

Dangers and Risks

Condensation / Water Penetration Protect device from moisture. Do not use if moisture or liquid has penetrated the device.

Original Accessories For your own safety and that of your patient, use only original accessories. DANGER

DANGER

Factory Settings Check all user menu settings and values (cf. chapter 7 User Menu, page 33). Such internal standard settings are not necessarily prescribed for the doctor. The doctor is responsible for all settings that pertain to the operation performed by him/her.

DANGER

Technique and Procedures Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect.

DANGER

Available Mains Voltage Check to make sure that the available mains voltage matches the data listed on the label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and destroy the equipment.

DANGER

Not Explosion-Proof Electrical components are not explosion-proof. Do not use in an area where flammable gases are present.

DANGER

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

Replacing Fuse Replace the fuse only with a fuse of the same type and rating. DANGER

4

Safety Instructions

Professional Qualification This manual does not include descriptions or instructions for surgical procedures/techniques. It is also not intended to introduce to or train physicians in the use of surgical techniques. 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. Only specially trained and qualified personnel may use this device on children.

EN DANGER

Function Test The function test must be performed prior to each operation. DANGER

Sterile Substances and Accessories Always work exclusively with sterile substances and mediums, sterile gas, and sterile accessories.

DANGER

Cleaning the Device Do not sterilize the device. DANGER

Replacement Device and Accessories In case the device or any of the accessories fail during an operation, a replacement device and replacement accessories should be kept within easy reach to be able to finish the operation using the replacement device or replacement accessory.

DANGER

Device-inherent Dangers Read the warnings specific to this device in chapter 3 Purpose of the Device, page 7.

DANGER

Device Defect If a device defect is suspected or confirmed, stop using the device until it has been checked by authorized service personnel.

DANGER

Endoscope The device may only be connected to endoscopes designed for use with the device for the intended medical procedure. The endoscopes must comply with the most recent versions of IEC 60601-2-18 and ISO 8600.

DANGER

5

Safety Instructions

EN

Left Blank on Purpose 6

Purpose of the Device 3

Purpose of the Device

The device serves to insufflate CO2 into the abdomen during a diagnostic or therapeutic laparoscopy. Please consult the instructional manual of your laparoscope for additional information and special application indications. The insufflator has two operating options.

Intended Use

The High Flow application limits the pressure to max. 30 mm Hg (mm mercury column) and the gas flow to max. 40 l/min. The device measures the pressure within the abdomen in short intervals and continuously compares the nominal with the actual abdominal pressure. The function of the device is to maintain the nominal or set point pressure. Any overpressure within the abdomen is lowered to the preset nominal pressure by the automatic venting system.

High Flow Application

The Low Flow application limits the pressure to max. 20 mm Hg (mm mercury column) and the gas flow to max. 20 l/min. The Low Flow application is specially designed for use on newborns, infants, and children. When used on children, it is recommended to control and adjust the device and the nominal flow based on the following factors:

Low Flow Application

Age Group

Weight

Flow Range

Children younger than 1 year

approx. 1-9 kg

0.1 -0.5 l/min

Children between 1 to 3 years

approx. 10-15 kg

0.5 -1.0 l/min

Children between 3 to 4 years

approx. 16-19 kg

1.0 -2.0 l/min

Children between 4 to 14 years

$ 20 kg

> 2.0 l/min

EN

The nominal pressure cannot be reached if the nominal flow is set too low. Check for possible leaks. Due to the special operating method used during the Low Flow application (optional), the speed of equalizing the leak is slower than when using the High Flow application (lower effective flow in Low Flow application). The device may not be used to fill an abdomen with CO2 if a laparoscopy is contraindicated. Please consult the instructional manual of your laparoscope for absolute and relative contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it may not be used to distend the uterus. The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kg.

Contraindications

7

Purpose of the Device 3.1

EN

DANGER

Device-inherent Dangers

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.

Pneumolabium/Pneumoscrotum Children are at risk of a pneumolabium or pneumoscrotum. DANGER

DANGER

DANGER

DANGER

DANGER

DANGER

8

Increased Airway Pressure/Compression of the Vena Cava When using the Low Flow application on children, an increased risk of high airway pressure and/or compression of the vena cava (low input syndrome) exists.

Positioning the Patient Always position the patient lower than the device to prevent body fluids from leaking into the device. Intra-abdominal pressure can be increased and fluid can penetrate the insufflation tube if the patient is repositioned during surgery. If this occurs, immediately disconnect the insufflation tube at the trocar. When the patient is placed on an angle, shifting of internal tissue may block the insufflation channel. Always insufflate through the elevated side of the patient.

Idiosyncratic Reactions Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reaction).

CO2 Absorption CO2 is absorbed during insufflation (intravasation). Intravasation causes the body to absorb part of the CO2 gas used for insufflation. CO2 concentrations in the blood or respiratory system that are too high can lead to death of the patient in extreme cases. To lower this risk, always carefully and closely monitor the patient’s vital signs during the entire insufflation process and make sure patient is breathing well. Sufficient respiration can help avoid or limit problems with CO2. High pressure or high gas flow promote CO2 absorption.

Metabolic and Cardiac Reactions A pressure of more than 20 mm Hg can result in metabolic acidosis. This can lead to cardiac irregularities and the following symptoms : •Reduced respiration with restricted diaphram function •Reduction of venous reflux •Reduced cardiac output •Metabolic acidosis

Purpose of the Device

Hypothermia/Monitoring Body Temperature The gas flow can lead to a lowering of the patient’s body temperature during insufflation. This in turn can cause heart and cardiovascular problems. Always monitor the patient’s body temperature during the entire insufflation. Make especially sure that the following, hypothermia promoting, 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.

Dehydration Insufflation can lead to dehydration of the tissue. This can result in organ tissue damage and cardiovascular reactions of the patient. Long surgeries and large leaks increase the risk of dehydration (especially at the insertion points of the trocars or when changing instruments).

Embolism Improper placement of the insufflation instrument could cause insufflation of gas into a vessel, resulting in air or CO2 embolisms. To reduce the risk of air or CO2 embolism, perform initial insufflation at a low flow rate and ensure that the insufflation instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value. CO2 embolisms can also be caused by a high intra-abdominal pressure. Avoid high pressure settings and close damaged blood vessels at once.

Additional Insufflation Sources The use of additional insufflation sources increases the intra-abdominal pressure. Continuously monitor intra-abdominal pressure over the course of the entire insufflation if additional sources are used.

Disconnecting the Insufflation Tube Always disconnect the insufflation tube after ending surgery and before switching off the device to prevent backflow of bodily fluids. Fluid may penetrate the insufflation tube whenever you change the gas cylinder and/or when you stop the gas flow during the operation. If this happens, you must immediately disconnect the insufflation tube from the trocar or from the device.

Backflow Body secretion or contaminated gas can result in a backflow into the device, if •a filter is not used, •the actual pressure is higher than the nominal pressure or •the automatic venting valve is activated.

EN DANGER

DANGER

DANGER

DANGER

DANGER

DANGER

9

Purpose of the Device

EN DANGER

DANGER

DANGER

DANGER

DANGER

DANGER

DANGER

DANGER

10

Gas Flow A high gas flow can be due to large leaks within the surgical system or instrument. This can result in an false actual pressure reading, which in turn may endanger the patient. In case of a disrupted gas flow you should therefore inspect device, tube, and instruments immediately. It is recommended to perform laparoscopies with the lowest gas flow possible.

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. chapter 16 Error and Warning Messages, page 69).

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 until a qualified service technician conducts the appropriate tests and repairs.

Fatigue Symptoms When there is a high level of CO2 consumption, you should make sure to supply the operating area with enough fresh air, since an increasing CO2 level in the air can cause the medical personnel to suffer fatigue symptoms, an inability to concentrate, unconsciousness, or even death.

Automatic Venting System The automatic venting system has a limited venting rate. Whenever you use additional insufflation sources, you should constantly monitor the intra-abdominal pressure.

Filter Use a new/sterile filter for each patient. You must work with a 0.2 µm two-way (retention rate 99.99 %) hydrophobic filter between patient and device. This should prevent bodily fluids from entering the device and also prevents impurities from possibly entering into the patient’s body. Reduced flow capacity should be considered when using a hydrophobic filter.

Contaminated Filter Exchange a contaminated filter immediately during surgery to ensure an unhindered gas flow.

Connecting the Tube The tube outlet may only be connected to instruments which are intended for intra-abdominal CO2-insufflation.

Purpose of the Device

Electronic Device Control The valve located at the trocar sleeve may not be closed intraoperatively. The electronic control unit of the device adjusts the intra-abdominal pressure as desired.

Medically Pure CO2 Make sure to use only medically pure CO2. Other gases (i. e., helium, N2O, argon), mixtures of gases, high pressure compressed gases, gases with entrapped liquids, or polluted gases may not be used with this device.

Service Connection Connected devices have to comply with the standard EN 60950. Devices may not be connected to the service connection during the surgical procedure.

Electromagnetic Interference (cf. chapter 14 Electromagnetic Compatibility, page 63) Electromagnetic interference with other devices or instruments was practically eliminated when developing this devices and none was detected during testing. However, if you still detect or suspect such interference, please follow these suggestions: •move this device to a different location or move the other device, •increase distances between all used devices, •consult an electromedicine expert.

Peripheral Devices Additional equipment connected to the interfaces of the device have to meet the following specifications: EN 60601-2-18 for endoscopic devices and EN 60601-1 for electrical medical devices. All configurations have to comply with EN 60601-1-1 specifications. 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.

EN DANGER

DANGER

DANGER

DANGER

DANGER

11

Purpose of the Device 3.2

EN

Manufacturer’s Notice: Device Versions

40L Core Insufflator with integrated low flow US (available in USA, Canada and South America) STRYKER article number

Version

Language

0620-040-503

NSTC

EN, ES, FR, DE

0620-040-504

SIDNE

EN, ES, FR, DE

40L Core Insufflator with integrated low flow EU (not for sale in USA)

12

STRYKER article number

Version

Language

0620-040-514

Standard

EN, NL, FR, DE

0620-040-515

Standard

EN, NO, SV, DA, FI

0620-040-516

Standard

EN, ES, IT, PT, EL

0620-040-505

PAL

EN, NL, FR, DE

0620-040-506

PAL

EN, NO, SV, DA, FI

0620-040-507

PAL

EN, ES, IT, PT, EL

0620-040-508

NSTC

EN, NL, FR, DE

0620-040-509

NSTC

EN, NO, SV, DA, FI

0620-040-510

NSTC

EN, ES, IT, PT, EL

0620-040-511

SIDNE

EN, NL, FR, DE

0620-040-512

SIDNE

EN, NO, SV, DA, FI

0620-040-513

SIDNE

EN, ES, IT, PT, EL

Initial Use of the Device 4

Initial Use of the Device

EN

Always check all parts and accessories of the device immediately after receiving the shipment. Inspect for external damage as well. The manufacturer considers only replacement claims that have been immediately submitted or reported to a sales representative or an authorized service company.

Input Control

If it becomes necessary to return the device, use of the original packaging is required. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging. Please fill out the return form enclosed at the end of the manual. Enclose the manual with the device. 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

Returning the Device

Place the device on a level surface in a dry environment. The ambient temperature has to range from 10 °C to 40 °C; the relative humidity has to be between 30% and 75%.

Setup

Electrical components are not explosion-proof. 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. Incorrect voltage can cause errors and malfunctions and destroy the equipment.

WARNING

Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The power cord may be plugged only into a properly installed safety wall plug (see DIN VDE 0107). Read the device label (device data plate) located in rear of device to determine the operating voltage of the device. The power supply has to be grounded. Use the original power cable to plug into the wall socket on one side and the rear device jack on the other.

Protective Contact

Use only an approved detachable power supply cable, type SJT, minimum 18 AWG, 3 conductors, one end configured for NEMA 5-15, other end for IEC 320/CEE22. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.

Only for US Operators

Integrate the device into the potential equalization system according to local safety rules and regulations.

Equipotential Bonding

13

Initial Use of the Device 4.1

EN

Gas Connection

Always use medical grade CO2. Never use any other type of gas. 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.

Gas Bottle Always use a high-pressure tube to connect gas bottle and device. WARNING

The gas bottle has to be in a vertical position. The gas bottle pressure may not exceed 80 bar.

Gas bottles with riser pipe can release dirt and oily fluids into the device. Do not use a gas bottle with riser pipe. WARNING

Gas Connection

14

1. Connect the high pressure tube to the gas connection. 2. Fix the high pressure tube with the nut. 3. Tighten the nut.

Operating the Device 5

Operating the Device

5.1

Front of the device

EN Fig. 5-1-1 Front of the Device

(2)

(1)

(3)

(1)

Start/stop key

(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)

5.2

Display

Fig. 5-2-1 Display

(1)

(2)

(3)

Insufflation stopped Bottle Gas

(7)

(6)

(5)

(1)

Status display/Error & warning messages

(2)

Actual pressure

(3)

Actual flow

(4)

Nominal gas flow

(5)

Gas consumption

(6)

Gas supply

(7)

Nominal pressure

(4)

15

Operating the Device

EN

5.3

Rear of the device

Fig. 5-3-1 Rear of the Device (1)

Type plate

(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)

(8)

Sockets for the VIDEO RGB/CSCC IN Signal (optional)

(9)

Socket for the VIDEO S-VHS IN Signal (optional)

(10)

Device plug

(11)

Fuse holder

(12)

Gas connection

(1)

(2)

(3)

(4)

(5)

(6)

(7)

CO 2

(12)

5.4

(11) (10)

(9)

(8)

Device Setup

1. Connect the gas supply to the gas connection port. 2. Open the gas supply line. 3. Press the ON/OFF key. The device switches on.

Device check

The device now conducts a self-test. Device ok followed by Select values appears in the display.

WARNING

16

The corresponding display is depicted after switching the device on again depending whether the device was last operated in the High Flow or Low Flow mode. Use the user menu option "Application" (cf. 7 User Menu, page 33) to switch between Low Flow or High Flow application.

Operating the Device 5.4.1 High Flow Application If the device was switched off while in High Flow mode, the following is displayed after the self-test has concluded after switching the device back on:

EN

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. The device test concluded successfully. The device is operational. 5.4.2 Low Flow Application (optional) If the device was switched off while in Low Flow mode, 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. With activated Low Flow mode, the displayed logo NEONATAL indicates that the device is still in Low Flow mode.

Insufflation stopped 8

Bottle Gas

0.1

The device test concluded successfully. The device is operational.

17

Operating the Device

EN

5.5 Gas Supply with Gas Bottle

House Gas Supply

Gas Supply Display

The following gas bottle pressures are displayed: Bottle Gas

> 40 bar

Bottle Gas

15-40 bar

Bottle Gas

< 15 bar

The following house gas supply pressures are displayed:

House Gas

House Gas

House gas supply pressure OK House gas supply pressure too low

The status of the house gas supply cannot be evaluated until after insufflation has started due to technical reasons. The display will show Check Gas Supply after approx. 5 seconds if the gas supply is insufficient. The gas supply display depicts the lower display (House Gas Supply Too Low). Once insufflation has stopped, the gas supply indicator returns to the upper display (House Gas Supply Pressure OK).

5.6

Presetting Nominal Flow/Nominal Pressure with High Flow Application

5.6.1 Presetting Nominal Pressure with High Flow Application

This setting is possible in standby mode and during operation of the device. Press the % key once to activate setting the values in increments of 1. Keeping the % key depressed longer than 1.5 seconds activates scrolling in increments of 1.

18

Operating the Device Press the &key to reduce the nominal pressure.

Decreasing Nominal Pressure

Press the %key to increase the nominal pressure. Select a nominal pressure between 1 - 30 mm Hg. The preset value is indicated in the nominal pressure display. A safety limit message is displayed starting with 15 mm Hg.

Increasing Nominal Pressure

EN

Safety limit

The nominal pressure of "15 mm Hg" is a threshold value. This is where the recommended range for the intra-abdominal pressure ends. Pressing the nominal pressure % key again does not increase the pressure any further. Release the key at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 30 mm Hg. Exceeding this safety limit is to be decided by and the responsibility of the user/operator. WARNING

5.6.2 Preselecting Nominal Flow with High Flow Application

This setting is possible in standby mode and during operation of the device. Keeping the %/& key depressed allows you to adjust 3 levels for the nominal gas flow. Factory setting: 1. Level 3 l/min 2. Level 20 l/min 3. Level 40 l/min The preset values of the user menu can be customized as well. Select a nominal gas flow between 1-40 l/min. The preset value is indicated in the nominal gas flow display. The values for the nominal gas flow refer to a device without connected tube, filter, or instrument. Tube, filter, and instrument can reduce gas flow.

19

Operating the Device

EN

Decreasing Nominal Gas Flow

Press the & key to reduce the nominal gas flow. The nominal gas flow is lowered in the range of 1 l/min - 40 l/min in increments of 1 l/min. Keeping the & key depressed allows you to adjust the nominal gas flow in increments of 40, 20 ,3 l/min (depending on the setting in the user menu).

Increasing Nominal Gas Flow

Press the % key to increase the nominal gas flow. The nominal gas flow is increased in the range of 1 l/min - 40 l/min in increments of 1 l/min. Keeping the key depressed allows you to adjust the nominal gas flow in increments of 3, 20, 40 l/min (depending on the setting in the user menu). The device monitors the gas flow in two different operating modes: • "Veress on" (1-5 l/min - 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. To minimize the risks of a faulty incision point , the manufacturer recommends using the "Veress" operating mode to start off a procedure (filling abdomen with CO2). Please note that the automatic venting system is not activated during the "Veress" operating mode and High Flow application. 1. Start the device again with the Start/Stop key.

Veress on

Insufflation Operating Mode

Pressure drops due to leaks are quickly equalized during the "Insufflation Operating Mode". The APC technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. In case of large volumes, the actual pressure does not exceed the nominal pressure (cf. chapter 6 Safety Functions, page 29). Tube, filter, and instrument can reduce the gas flow. 1. Press the %key to increase the nominal gas flow $ 6 l/min. 2. Start the device again with the Start/Stop key.

Insufflation on 6

20

Operating the Device 5.7

Preselecting Nominal Flow/Nominal Pressure with Low Flow Application

EN

The Low Flow application is specially designed for use on newborns, infants, and children. When used on children, it is recommended to control and adjust the device and the nominal flow based on the following factors: Age Group Children younger than 1 year Children between 1 to 3 years Children between 3 to 4 years Children between 4 to 14 years

Weight approx. 1-9 kg approx. 10-15 kg approx. 16-19 kg $ 20 kg

Flow Range 0.1 - 0.5 l/min 0.5 -1.0 l/min 1.0 -2.0 l/min > 2.0 l/min

Recommended Work Settings The Low Flow flow values listed here for laparoscopic procedures on newborns, infants, and children are only suggested values. The selection of the suitable flow and pressure values is solely the responsibility of the attending physician. However, adhering to the values listed above ensures an optimal performance of the Low Flow mode of the insufflator.

DANGER

Pneumolabium/Pneumoscrotum Children are at risk of a pneumolabium or pneumoscrotum. DANGER

Increased Airway Pressure When laparoscopic procedures are performed on children, the increased intra-abdominal pressure also increases the risk for higher airway pressures. Always strictly monitor respiration and airway function when performing laporoscopic procedures on children younger than 12 years of age.

Compression of the Vena Cava When insufflating the abdomen of a child with medical CO2, an increased risk of compressing the vena cava exists. This risk can be reduced by monitoring the systolic and diastolic blood pressure during the entire surgery.

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 with that to problems of the haemodynamic system. It is recommended to always ensure good ventilation and to work with low flow values and pressure values not exceeding 12 mm Hg. The patient's circulatory system should be monitored at all times.

DANGER

DANGER

DANGER

21

Operating the Device

EN DANGER

Hypothermia The insufflation gas flow usually drops significantly after the target pressure has been reached and is then only required to maintain the abdominal pressure. However, leaks within the abdomen or the instrument can lead to a constant gas flow of above 1 l/min. When operating on children younger than 12, a gas flow of more than 1 l/min poses an increased risk of hypothermia for the patient. Corresponding measures to prevent hypothermia include the use of blankets or prewarmed gas. The patient's body temperature has to be monitored at all times during surgery.

The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kg. DANGER

5.7.1 Preselecting Nominal Pressure with Low Flow Application

This setting is possible in standby mode and during operation of the device. Press the % key once to activate setting the values in increments of 1. Keeping the % key depressed longer than 1.5 seconds activates scrolling in increments of 1. Decreasing Nominal Pressure

Press the &key to reduce the nominal pressure.

Increasing Nominal Pressure

Press the %key to increase the nominal pressure. Select a nominal pressure between 1 - 20 mm Hg. The preset value is indicated in the nominal pressure display. A safety limit message is displayed in the status line starting at 12 mm Hg. The nominal pressure value "12 mm Hg" is a threshold value and should not be exceeded for newborns. Pressing the nominal pressure % key again does not increase the pressure any further. Exceeding this safety limit is to be decided by and the responsibility of the user/operator.

WARNING

Release the key at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 15 mm Hg.

22

Operating the Device

EN

Safety limit

The nominal pressure of "15 mm Hg" is a threshold value. This is where the recommended range for the intra-abdominal pressure ends. Pressing the nominal pressure % key again does not increase the pressure any further. Release the key at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 20 mm Hg. 5.7.2 Preselecting Nominal Flow with Low Flow Application

This setting is possible in standby mode and during operation of the device. Press the &key to reduce the nominal gas flow. The nominal gas flow is decreased in the range of • 0.1 l/min -2 l/min in increments of 0.1 l/min • 2 l/min -20 l/min in increments of 1 l/min

Decreasing Nominal Gas Flow

Keeping the & key depressed longer than 1.5 seconds activates scrolling. In the range of 20...2 l/min in increments of 1. In the range of 0.1 l/min ..< 2 l/min is rounded down to 1 or 2 l/min. Press the %key to increase the nominal gas flow. The nominal gas flow is increased in the range of • 0.1 l/min -2 l/min in increments of 0.1 l/min • 2 l/min -20 l/min in increments of 1 l/min

Increasing Nominal Gas Flow

Keeping the % key depressed longer than 1.5 seconds activates scrolling. In the range of 0.1 l/min ..< 2 l/min is rounded up to 1 or 2 l/min. Then in increments of 1 up to 20 l/min.

23

Operating the Device Increase the nominal gas flow. A safety limit message is displayed in the status line starting at 5 l/min. (This safety threshold can be deactivated in the user menu.) Release the key to increase the nominal gas flow further. The display switches back to the nominal value setting after 2 seconds. Now you can set a value of up to 20 l/min.

EN

Veress on

The "Veress" setting is intended for the gentle development of an aeroperitoneum. The nominal gas flow emitted by the device in this case is very low (in the range of 0.1 l/min -1 l/min). To minimize the risks of a faulty incision, the manufacturer recommends using the "Veress" operating mode to start off a procedure (filling abdomen with CO2).

WARNING

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, cf. Menu Level Venting System, page 37).

Venting system "In Veress mode off" or "Venting disabled" (High Flow and Low Flow Mode)

With a nominal flow setting of # 1 l/min, Veress on is displayed in the status line after pressing the Start/Stop key. Above 1 l/min, Insufflation on is displayed.

Venting System "In Veress mode on " (only in Low Flow Mode)

With this setting, Insufflation on is displayed after pressing the Start/Stop key even if the nominal flow is set to # 1 l/min. Start the device with the Start/Stop key.

Insufflation on

While in Insufflation on operating mode, any pressure loss due to leaks can be quickly equalized. The APC technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. The venting system is turned on. Tube, filter, and instrument can reduce the gas flow. With a nominal flow setting of >1 l/min, and after restarting insufflation by pressing the Start/Stop key, Insufflation on is displayed. Use the RESET- key to reset the volume counter. The display of the calculated insufflated volume is done in increments of 100 ml.

Bottle Gas

24

Operating the Device 5.8

Start/Stop Key

EN

Insufflation stopped Bottle Gas

1. Start insufflation: Press the Start/Stop key. The following values are displayed: •Actual pressure: current measured value •Gas consumption: current measured value 2. Stop insufflation: Press the Start/Stop key once again. The following values are displayed: •Actual pressure: current measured value •Gas consumption: last measured value. The nominal gas pressure is reset to the set values. The nominal gas flow is reset to the preset setting.

5.9

Actual Pressure Display

The actual pressure display depicts the current pressure within the abdomen in mm Hg.

25

Operating the Device 5.10 Gas Consumption Display

EN

5.0 l

The gas consumption display shows the CO2 volume in liters consumed since the last reset. Resetting the Gas Consumption Display

Press the Reset key to reset the gas consumption display to "0.0."

5.11 Insufflation Tube Connection 1. Always connect a hydrophobic filter to the silicone tube or use the PVC tube set with filter. 2. Connect the insufflation tube to the insufflation tube connection and to the Veress cannula/trocar.

5.12 Gas Heating Use the gas heater and the heating tube to insufflate lukewarm gas (37° C). Connect insufflation tube and heater plug with the device as depicted in Fig. 5-12-1 Connecting the Gas Heating, page 26, and subsequently described. Start insufflation. The gas is automatically heated. Fig. 5-12-1 Connecting the Gas Heating

(2)

26

(1)

Operating the Device The heating tube consists of an insufflation tube (2) with plug (1) for the gas heater.

EN

Do not subject the heater tube to direct heat (e.g., operating room lamp) or high room temperature. WARNING

1. Connect the filter and the heating tube. 2. Connect the plug of the heater tube with the gas heating connection. 3. If the gas heating is functioning properly, the following message is displayed:

Connecting the Gas Heating

The gas heating tube is automatically preheated to 33° C. 1. Start gas heating: Press the Start/Stop key. The gas heater warms the gas to 37° C in approx. 10 minutes (room temperature 22° C/gas flow rate higher than 1.0 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. 2. Stop gas heating: Press the Start/Stop key again. The gas heating returns to its preheating state. 3. Turn off gas heating: Pull the gas heating plug from the gas heating connection.

Gas Heating ON/OFF

Gas Heating Error

Heater defect/Call service

This message is displayed in case of a gas heating malfunction (e.g., broken cable, loose plug). Check gas heating using a different tube. Should the error message be displayed again, you can continue using the device without gas heating by observing the risks for hypothermia. Check gas heating after surgery using a different tube. If the message Heater defect /Call service persists, call an authorized service technician to check the device.

27

Operating the Device

EN

Gas Temperature Exceeds 42° C

DANGER

If the temperature sensor measures a gas temperature of > 42 °C, unplug the heating plug from the device. Hot gas in the abdomen can lead to serious injuries. A warning signal is audible. Gas heating and insufflation are deactivated. 1. Disconnect the insufflation tube from the trocar or Veress needle. 2. Unplug the plug for the gas heating from the device.

3. Press the Start/Stop key. The device insufflates without heating the gas. 4. Let hot gas escape until the tube is only warm to the touch. 5. Continue operation without connecting gas heating. 6. Check gas heater using a different tube after the operation. Switch the device off and back on after approx. 10 seconds have expired. The gas heater is reactivated. 7. Should the error message be displayed again, you can continue using the device without gas heating by observing the risks for hypothermia. 8. Call an authorized service technician to check the gas heating.

5.13 Switching Device Off 1. Press the ON/OFF key. The device switches itself off.

28

Safety Functions 6

Safety Functions

The device is equipped with an automatic venting system. When the insufflator detects an overpressure it automatically activates the venting system. The venting system releases gas until the set nominal value has been reached again. 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, cf. Menu Level Venting System ).

The automatic venting system has a limited venting rate. Whenever you use additional insufflation sources, you should constantly monitor the intra-abdominal pressure.

EN

Automatic Venting System

WARNING

DANGER

The manufacturer advises against using additional, non-pressure controlled insufflation sources during minimally invasive surgical procedures. The self-inflating property of lasers cooled with CO2 and argon beamers can lead to values exceeding the nominal pressure. 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). 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.

29

Safety Functions

EN

Nominal Pressure Threshold 30 mm Hg / 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). Is displayed whenever the actual pressure has reached 30 mm Hg / 20 mm Hg*LF. An audible warning signal is emitted. *LF=Low Flow Setting Gas Supply Display (cf. 5.5 Gas Supply Display, page 18)

Low gas level Bottle Gas

Displayed when the gas bottle pressure drops below 20 bar. An acoustic signal is emitted. However, insufflation is not interrupted.

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. Acoustic signals are emitted (3x, 1x again after 1 minute). Insufflation is cancelled. Check gas supply.

30

Safety Functions Warning Message "Occlusion"

EN

Displayed when tube, Veress cannula, or trocar experience a temporary blockage. An audible warning signal is emitted. The acoustic massage (warning signal) can be deactivated in the user menu. In Veress mode # 1 l/min, the warning signal is deactivated (in Low Flow mode). Error Message "Service"

The display depicted above is shown if the device is malfunctioning, can no longer be operated safely, and requires service. 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.

31

Safety Functions

EN

Error Message "Contamination"

Displayed when fluid has penetrated the device via the insufflation tube connection. Message is repeated with each Start/Stop. It is possible to conclude the current surgery with this device. Insufflation is not possible after turning the device off and back on using the ON/OFF key. This is to prevent cross-contamination.

Displayed when the device is being turned on while contaminated. The device can no longer be used. The contaminated device has to be clearly marked as contaminated and sealed in two separate protective layers of safety foil. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. Power Failure

32

If the power fails for less than 1 second, all settings are retained. If the power fails for an extended time period, the device will function as it does when it is being reactivated.

User Menu 7

User Menu

EN

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

33

User Menu

EN

Function of the Keys

Menu key:

Menu selection and confirming, "MENU" key Back to main level, “RESET” key Scroll function

Reset key: Nominal flow keys: How do I use the user menu?

1. Press the MENU key to access the selected menu.

User menu 10 mm Hg

Gas okok

esc

2. Scroll with the nominal gas flow % or nominal gas flow & key to select the user or service menu. Select the user menu and press the MENU key to display the first menu level. 3. Use the nominal gas flow % or & key to select the desired menu level. Press the MENU key to access the selected menu level. 4. Scroll with the nominal gas flow % or & to change the settings. Press the MENU key to save the desired setting. 5. To exit the user menu, press the RESET key twice. Sections marked with *LF apply only to devices with the Low Flow application option. 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. Confirm a selection to automatically exit the user menu and immediately access OP mode.

34

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. 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, 2 ,3). Menu Level Occlusion Warning

Factory Setting: ON Set the acoustic occlusion warning to ON or OFF in this menu level. "ON" means a sound is audible. In Veress mode 15 bar) is connected to the device, the gas supply display automatically switches as described in chapter 5.5 Gas Supply Display, page 18. 2. Select Bottle if you want to work with a gas bottle. The gas supply display is described in Chapter 5.5 Gas Supply Display, page 18. It is not possible to operate the device if "Bottle" is set and a house gas supply is actually connected.

38

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. The following positions are available: OFF ->Left Up -> Right Up -> Left Down -> Right Down -> Variation 1-> Variation 2. Factory Setting: US Version NTSC EU Version NTSC or PAL Select between PAL and NTSC.

TV Standard

Factory Setting: Y/C (S-VHS) Select: FABS -> Y/C (S-VHS) -> RGB (synchr. on green) -> RGB (extern. synchr.).

Video Input

Factory Setting: Pressure /Flow/Volume/Alarm Select: Alarm ->Pressure/Alarm ->Flow/Alarm ->Pressure/Flow/Alarm->Pressure /Flow/Volume/Alarm.

Video Text

Factory setting: White Select: white-> yellow -> green -> blue

Video Color

The color setting applies only while in RGB mode. NOTE

Factory Setting: 5 Select a setting between 0 and 15.

Video Offset Vertical

Factory Setting: 5 Select a setting between 0 and 15.

Video Offset Horizontal

39

User Menu

EN

Menu Level Display Actual Flow

Factory Setting: yes Select the display of the actual flow in this menu level (yes or no). 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. Menu Level Contrast

Factory Setting: 155 In this menu level, select a setting between 140 and 180. Set values by scrolling in increments of 1.

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

EN

Customer Version

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

42

Options 8

Options

8.1

Video Messaging (Superposition)

EN

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)). Use the user menu to select different video messaging settings. 1. Connect the video camera cable with the corresponding device jack. 2. Connect the video monitor cable with the corresponding device jack. 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)

(6)

(2)

(5)

WARNING

Connecting Video Messaging (Superposition)

(3)

(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

Function Test 9

Function Test

EN

The function test must be performed prior to each surgical procedure. Sterilize reusable instruments and tubing before surgery to prevent infections. Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid. For your own safety and that of your patient, use only original accessories.

9.1

DANGER

Testing the Device

1. The device is switched off. 2. Make sure the gas supply is connected and open. 3. Use the ON/OFF key to turn the device on.The device now conducts a self-test. Fig. 9-1-1 Setup to Check Device

(1)

(2)

(3)

(4)

(1)

Start/Stop key

(2)

Nominal pressure display

(3)

Gas consumption display

(4)

Nominal flow display

(5)

Gas consumption reset key

(5)

4. Connect the device with a hydrophobic filter, an insufflation tube, and a Veress cannula. 5. Attach the stopcock (valve) to the Veress cannula. 6. Select the nominal pressure to 15 mm Hg (2) and nominal flow (4) to 3 l/min. 7. Press the reset key (5) (display (3) has to show 0.0 l). 8. Start insufflation: Press the Start/Stop key (1). Insufflate for approx. 30 s. After max. 4 seconds, the message Occlusion and Actual Flow=0 is displayed. 9. Stop insufflation: Press the Start/Stop key (1). If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If this happens, use steps 10 to 12 outlined below to locate the leak.

DANGER

47

Function Test 10. Repeat items 7 to 9 without Veress cannula and with closed tube end. The previously connected Veress cannula has a leak if gas consumption is now below 0.4 l. 11.Repeat items 7 to 9 without Veress cannula and without tube if another leak becomes apparent. Close the end of the insufflation tube connection for this test. 12.Any still detected leak is located directly inside of the device. Make sure the device or system can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

EN

DANGER

Never work with an insufflation tube, accessory, and/or device that is leaking. This can lead to an incorrect measurement of the actual pressure values, which can cause an uncontrolled pressure increase in the abdomen.

9.2

Testing the Veress Cannula

It is also necessary to check that the Veress cannula is functioning properly before surgery. (1)

(2)

(3)

1. 2. 3. 4. 5. 6.

Open the stopcock (valve) at the Veress cannula. Select a gas flow rate of 10 l/min (2). Press the reset key (3). Press the Start/Stop key (1). Insufflate for approx. 30 s. Stop insufflation: Press the Start/Stop key (1).

A soiled or blocked Veress cannula is indicated if the actual gas consumption display shows a value of less than 0.5 l.

48

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. This will expel any air within the tube system and the device. 1. Start insufflation: Press the Start/Stop key. Wait until the gas consumption display shows "1.0." 2. Stop insufflation: Press the Start/Stop key. Press the reset key to reset the gas consumption display to 0.0 l.This ensures the gas consumption is correctly displayed during surgery. This concludes the function check. The device has been checked and is ready for surgery. Do not use this device if a defect is suspected or detected during the function check. This also applies to obvious defects, especially on power plug and power cable.

DANGER

49

Function Test

EN

Left Blank on Purpose 50

Use of the Device During Surgery 10

Use of the Device During Surgery

EN

The function test must be performed prior to each surgery. 1. The device is turned on. 2. The insufflation tube or the gas heating system is connected.

DANGER

Before Surgery

Always use a filter hydrophobic on both sides between device and patient.

10.1 Insufflating with Veress Cannula

DANGER

On delivery from the factory, a gas flow value of 3 l/min, High Flow mode and the Veress operating mode are set for insufflation through the Veress cannula (in Low Flow mode 0.1 l/min). Select "Veress Operating Mode" when using the Veress cannula. This manual does not include instructions for the safe use of the Veress cannula. Only when you have ensured endoscopically that an aeroperitoneum can be generated, should a gas flow of more than 3 l/min and a pressure of more than 10 mm Hg be selected (cf. chapter 3 Purpose of the Device, page 7, for corresponding settings for children). Insert the Veress cannula into the abdomen. Check to see if the Veress cannula is correctly positioned in the abdomen. 1. Connect the insufflation tube to the Veress cannula. 2. Select the desired nominal pressure and nominal gas flow. 3. Start insufflation: Press the Start/Stop key. Check the actual pressure display and the gas consumption display.

10.2 Insufflating with the Trocar 1. Insert the trocar into the abdomen. Connect the tube to the trocar. Stopping insufflation during surgery can diffuse CO2 through the wall of the tube, which results in a high negative tube pressure. This can damage the device. Therefore, the tube connection between patient and device has to be severed. This can be done at the trocar as well as directly at the device.

WARNING

1. Make sure the trocar is correctly positioned in the abdomen. Then select the desired pressure and desired gas flow as intraoperative conditions. 2. The actual pressure display depicts the measured abdominal pressure. As soon as this value approximates the desired value, the gas flow is automatically minimized. The gas consumption display shows the actual volume of gas consumed. 3. Check how the patient’s body reacts to the selected pressure and gas flow rate. Compare the abdominal filling rate to the selected nominal pressure. You can change the nominal gas flow and the nominal pressure during the operation without interrupting the insufflation process.

51

Use of the Device During Surgery

EN WARNING

The venting system is automatically triggered (not during Veress mode and not if the venting system has been deactivated in the user menu) if the measured actual pressure (cf. chapter 2 Safety Instructions, page 3) exceeds the set nominal pressure. In Low Flow mode, the venting system can be set to "always on." The device interrupts insufflation and releases gas until the set nominal value has been reached. 1. Stop insufflation: Press the Start/Stop key. 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. 2. Remove the tube set from the device. Observe applicable hygiene regulations when disposing of the tubing set. If the tube set remains connected to the device, there is the danger that leftover fluid in the tube or the instruments will be sucked into the device.

WARNING

1. Close the gas supply. 2. Use the ON/OFF key to turn the device off. Observe applicable hygiene regulations when disposing of the tubing set. NOTE

52

Care and Maintenance 11

Care and Maintenance

EN

Special care is necessary when servicing, maintaining and storing the device and additional equipment to maintain the functionality of the device and the equipment.

11.1 Cleaning the Device 1. Use the ON/OFF key to turn the device off. 2. Remove the power cable. 3. Wipe the surface of the device with a soft cloth moistened with the disinfectant. The concentration and the application duration of the disinfectant depend on the information provided by the manufacturer of the disinfectant. Make sure moisture does not enter the device. Do not sterilize the device. NOTE

11.2 Cleaning of the Reusable Tubing Set 1. 2. 3. 4.

Dismantle the tubing set. Wash the parts carefully with running water. Clean and rinse the parts with demineralized water. Let all parts drip off and dry them with a sterilized soft cloth.

1. Before cleaning: Dismantle the Veress cannula (unscrew the insertion cannula from the insufflation cannula with the stopcock open). 2. Wash the parts carefully under running cold and warm water. 3. Clean the inner chamber of the Veress cannula with a cleaning pistol. 4. For disinfection, open the stopcock at the Veress cannula. 5. The sterilization and disinfection rules apply as described in chapter 11 Care and Maintenance, page 53.

Notes about the Veress Cannula

11.3 Disinfecting the Reusable Tube Set Disinfection of the tube and instruments is insufficient to achieve a sterility of SAL 10-6. Further sterilization is absolutely required after the disinfecting process.

Do not place the plug of the reusable gas heating tube into the disinfectant solution. Should this happen once, ensure that the plug is thoroughly dried prior to sterilization.

DANGER

NOTE

1. Only a thoroughly cleaned tube set may be disinfected. 2. Place all tube set components into a disinfectant for a short period. The concentration and the application duration of the disinfectant depends on the information provided by the manufacturer of the disinfectant. The tube set can be damaged if the concentration is too high.

53

Care and Maintenance

EN WARNING

Do not leave tube set or other silicone parts in the solution for more than 30 minutes. Silicon absorbs various disinfectants and thus can be damaged when sterilized with steam. 3. Place the individual parts into the disinfection solution. Do not stack them on top of each other. 4. Remove the parts from the solution using forceps with a soft edge. 5. Any remaining disinfection solution should be rinsed off with sterile water under sterile conditions. 6. Dry all parts with a sterile cloth and wrap each part in a separate sterile cloth. 7. Assemble all components before sterilization. 8. Place the tube set in a sterile container if stored for a longer period of time.

11.4 Sterilization of Reusable Tube Set The maximum number of sterilization cycles for the tube set is determined by the manufacturer (see tube packaging). Never exceed the number of uses recommended by the manufacturer.

WARNING

WARNING

Using the tear-off tabs attached to the tube set to keep track of the number of sterilization cycles. The tube set may not be sterilized after the last tab has been removed.

Always check the reusable tube set for signs of deterioration before use and after sterilization. Never use a tube set which shows signs of deterioration, including cracking, brittleness, or signs of perforation.

Autoclave Sterilization

Only clean, dry, disinfected, and assembled tube sets should be sterilized in an autoclave. Please follow the instruction manual of the autoclave you are using. The manufacturer recommends autoclaving as follows: 134° C / 3 bar / 5 min

Gas Sterilization

Only clean, dry, disinfected, and assembled tube sets should be sterilized. Please follow your gas sterilizer's intruction manual for proper use.

Gamma Ray Sterilization

Do not perform gamma ray sterilization.

11.5 Annual Inspection Manufacturer's Specifications

54

The manufacturer stipulates that the user or a hospital technician must regularly test the device to assess its functionality and technical safety. These tests must be performed on an annual basis. The tests are described in chapter 12 Annual Inspection . Regular inspections will assist in early detection of possible malfunctions. This helps preserve the device and increases its safety and service life.

Care and Maintenance 11.6 Maintenance Carried out by Authorized Service Technician An authorized service technician has to inspect and service the device in appropriate intervals to ensure the safety and functionality of the unit. The minimum service interval is two years, depending on frequency and duration of use. If the service interval is not adhered to, the manufacturer does not assume any liability for the functional safety of the device. A sticker located on the rear panel of the device will remind you of the latest date for the next service or maintenance check. Authorized service technicians are only trained and certified by the manufacturer.

Two-Year Maintenance Interval

Ask the service technician for a certificate after he or she has inspected the unit or performed any service tasks. This certificate should list the type and scope of the performed services, date of service, and service company with signature.

Certification

EN

11.7 Replacing the Fuse The fuse may be defective and is in need of replacement if: • displays and LEDs do not light up, • the device does not function. Check to make sure • the main power supply cable is properly connected to the power supply input and to a safety socket, • the house power supply fuse is functioning. Unplug the power supply cable from the device before checking the fuse. 1. 2. 3. 4.

Undo the latch of the fuse holder with a small screwdriver. Remove the fuse holder. Check fuse. Insert a new fuse. Use only the specified types of fuses (cf. chapter 13 Technical Data, page 61). 5. Insert the fuse holder until it can be heard snapping into place. 6. Use the power cable to establish a connection between the protective contact socket and the connector plug located in the rear of the device.

DANGER

55

Care and Maintenance

EN

Left Blank on Purpose 56

Annual Inspection 12

Annual Inspection

EN

Each test conducted has to be documented with date and signature on the test log. The following measuring tools and resources were used by the manufacturer to determine the specified measurements and tolerance levels: • Manometer range 0-50 mm Hg, error class 1.6 • Syringe 60 ml • Silicone tube 8 x 2 mm • T adapter 8-8-8 mm • Veress cannula length 100 mm, opening diameter 1.4 mm, inner cannula diameter 1.6 mm

Measured Values and Tolerances

An authorized service technician has to check the device if the specified parameters and tolerances are exceeded.

12.1 Safety Test 1. Perform a visual inspection of the device. Of particular importance is that • the fuse corresponds with the specifications indicated by the manufacturer, • text and labels on the device are legible, • the mechanical condition of the device allows for its safe use, • no safety-impairing soiling is present. 2. Perform the measurement of the leakage current in accordance with DIN EN 60601-1. 3. Perform the measurement of the protective conductor resistance in accordance with DIN EN 60601-1. The protective conductor resistance is measured with the power cable connected. The maximum value is 0.2 Ω. 4. Perform the measurement of the insulation resistance with 500-700 V DC. The minimum value is 50 MΩ. The measurement of voltage stability should not be performed using high voltage. As an alternative, perform safety test according to DIN VDE 0751 Section 1.

12.2 Basic Function Test (in High Flow Mode) 1. Remove filter and insufflation tube from the device. 2. Use the ON/OFF key to turn the device on. The device now conducts a self-test. A short signal can be heard. Set to High Flow mode. 3. The factory default settings are 15 mm Hg for the nominal pressure and 3 l/min for the nominal flow. 4. The following values are displayed: Actual Pressure 15* [mm Hg] Nominal Gas Flow 3* l/min] Actual Pressure 0 [mm Hg] Gas Consumption 0.0 [l] *These values correspond with the factory setting. If values in the user menu were changed, these changed values are displayed.

57

Annual Inspection 5. Start insufflation: Press the Start/Stop key. The following values are displayed: Actual Pressure 0 [mm Hg] "Veress on" is displayed. Streaming gas can be heard at the insufflation tube. 6. Select the max. nominal gas flow. The following values are displayed: Nominal Gas Flow Max. Value [l/min] Actual Pressure 0 [mm Hg] "Insufflation on" is displayed. Streaming gas can be heard at the insufflation tube. 7. Stop insufflation: Press the Start/Stop key. The following values are displayed: Actual Pressure 0 [mm Hg] Gas Consumption >0.0 [l] 8. Press the reset key. Gas Consumption 0.0 [l]

EN

The basic function test of the device is complete.

12.3 Test of the Pressure Sensors

(1)

(3)

(2)

1. Select a nominal gas flow rate of 1 l/min. Do not press the Start/Stop key. Never use the syringe to extract gas from the device. WARNING

58

2. Connect a manometer (1) and an air-filled syringe (2) to the insufflation tube connection (3).

Annual Inspection 3. Use the syringe to generate a pressure of 10 mm Hg, which registers on the manometer. Actual Pressure Display 10 ± 2 [mm Hg] 4. Use the syringe to generate a pressure of 20 mm Hg, which registers on the manometer. Actual Pressure Display 20 ± 2 [mm Hg] 5. Use the syringe to generate a pressure of 30 mm Hg, which registers on the manometer. Actual Pressure Display 30 ± 2 [mm Hg]

EN

12.4 Pressure Monitoring Test See also 12.3 Test of the Pressure Sensors, page 58. 1. Select a nominal pressure of 15 mm Hg and a nominal gas flow of 1 l/min. 2. Use the syringe to generate a pressure of 19 mm Hg, which registers on the manometer. 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). 3. Reduce the pressure. The warning ends when the pressure falls below 19 mm Hg (nominal pressure plus 4 mm Hg). Stop insufflation. 4. Select a nominal pressure of 29 mm Hg. 5. Use the syringe to generate a pressure of 30 mm Hg, which registers on the manometer. Start insufflation: An acoustic warning sound is emitted without delay and the display depicts "Overpressure" with a pressure of more than 30 mm Hg. 6. Reduce the pressure. The warning ends when the pressure falls below 30 mm Hg. Stop insufflation.

12.5 Venting Valve Test See also 12.3 Test of the Pressure Sensors, page 58. 1. In the user menu Venting System, activate the venting system (set to In Veress mode off). 2. In the Venting Response Time menu, set a venting time of 3 seconds. 3. In the user menu Venting Pressure Limit set a venting pressure of 3 mm Hg. 4. Select a nominal pressure of 15 mm Hg and a nominal gas flow of 10 l/min. 5. Use the syringe to generate a pressure of at least 21 mm Hg, which registers on the manometer. Start insufflation. The venting valve is activated and the display depicts "Venting System Active" with a pressure of more than 18 mm Hg (for 5 seconds).

59

Annual Inspection 12.6 Max. Device Pressure Test

EN

(1)

(3) (2)

1. Select the max. nominal gas flow. 2. Connect a manometer (1) and an open Veress cannula (2) to the insufflation tube connection (3). 3. Start insufflation: Press the Start/Stop key. The manometer registers a pulsing pressure increase. When the pressure stabilizes, the manometer registers a maximum pressure of 40-60 mm Hg. 4. Stop insufflation: Press the Start/Stop key.

12.7 Gas Flow Rate Test Test setup with open connection. 1. Select a nominal gas flow rate of 14 l/min. 2. Start insufflation: Press the Start/Stop key. 3. Press the reset key (0.0 l has to be displayed). Now start measuring for one minute. 4. Stop the insufflation after one minute. The gas consumption should be at least 11-12 l. Each successfully conducted test has to be documented with the test log.

60

Technical Data 13

Technical Data

Power supply

EN 100-240 V~ Mains fuse T 3,15 A Connection for equipotential bonding

Frequency

50-60 Hz

Max. 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]/12.52 x 5.83 x 18.70 [in]

Weight

Approx. 9 kg

Operating conditions

10-40° C / 50-104° F 30-75 % rel. humidity

Storage and transportation conditions

-40 - +70° C /-40 - +158° F 10-85 % rel. humidity 85-100 % rel. air humidity (14 days)

Manufactured and tested acc. to

EN 60601-1

EMC

EN 60601-1-2

Insufflation medium

Medical CO2

Maximum output pressure

55 mm Hg (1 mm Hg V1,33 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 CSCC IN/OUT, Video RGB IN/OUT Data input/output, Device Interface RS232, SIDNE Interface

Infrared remote control (only for EU Version)

Transfer protocol R5 Code, Bank 30. Power supply with 2 batteries type AA (1.5V). Width x height x depth 64 x 22 x 119 [mm]

61

Technical Data

EN

Left Blank on Purpose

62

Electromagnetic Compatibility 14

Electromagnetic Compatibility

Medical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC). This device is to be used only for the purposes described in the manual and has to be installed, set up, and operated in compliance with the EMC notes and instructions.

EN

Precautionary Measures

14.1 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. Operating such devices (e.g., cell phones, GPS phones) in the proximity of the electrical medical device is prohibited.

14.2 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. The following are ESD precautionary measures: • Apply potential equalization (PE) to all devices to be connected. • Use only the listed equipment and accessories. Personnel have to be informed about and trained in ESD precautionary measures.

ESD Precautionary Measures

14.3 Accessories A serial cable RS 232 can be connected to the 40 L Core Insufflator to transfer data from/to an external computer. It should not be longer as 3 m.

Data Transfer

The 40 L Core Insufflator is equipped with the video interfaces IN/OUT and S-VHS IN/OUT, which can be connected to an additional video source or display unit with a video cable (SVHS cable 2m or RGB, CSCC cable).

Video Interface

For EU Version only A tube set with tube heating can be connected to the 40 L Core Insufflator (heatable tube set, reusable / Item No. Z1411-01 or Item No. Z1415-01, cable length < 3.0 m).

Tube Heating

63

Electromagnetic Compatibility

EN

14.4 Guidelines and Manufacturer's Statement - Electromagnetic Emissions The 40 L Core Insufflator is intended for use in an environment as described below. The user/operator of the insufflator should make sure the device is operated within such an environment. Emitted Interference Measurements

Compliance

Electromagnetic Environment Guidelines

RF emission according to CISPR 11

Group 1

The 40 L Core Insufflator uses electromagnetic energy only for its internal functions. Therefore, its RF emission is very low and it is unlikely that devices in close proximity will experience interference.

RF emission according to CISPR 11

Class B

Emission of harmonic oscillations according to IEC 61000-3-2

Class A

The 40 L Core Insufflator is suitable for use in all facilities including those in residential areas and those directly connected to a public utility network also supplying buildings used for residential purposes.

Emission of voltage fluctuations / flickers according to IEC 61000-3-3

In compliance

14.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity The 40 L Core Insufflator is intended for use in an electromagnetic environment such as the one described below. The user/operator of the insufflator should make sure the device is operated within such an environment. Electromagnetic Interference Immunity Tests

IEC 60601 Test Level

Compliance

Electromagnetic Environment Guidelines

Discharge of static electricity (ESD) according to IEC 61000-4-2

± 6 kV contact discharge ± 8 kV air discharge

In compliance

Floors should be made of wood or concrete or feature ceramic tiles. If the floor covering consists of synthetic material, the rel. humidity should be at least 30%.

Electrical fast transients / bursts according to IEC 61000-4-4

± 2 kV for AC power lines ± 1 kV for input and output lines

In compliance

The quality of the supply voltage should be the same as the voltage of a typical business or hospital environment.

Surges according to IEC 61000-4-5

± 1 kV differential mode ± 2 kV common mode voltage

In compliance

The quality of the supply voltage should be the same as the voltage of a typical business or hospital environment.

Blackouts, brownouts, and fluctuations of the power supply according to IEC 61000-4-11

5% UT* (> 95% dip of the UT) for ½ period 40% UT (60% dip of the UT) for 5 periods 70% UT (30% dip of the UT) for 25 periods < 5% UT (> 95% dip of the UT) for 5 s

In compliance

The quality of the supply voltage should be the same as the voltage of a typical business or hospital environment. If the user/operator of the insufflator requires the continuation of functionality after power interruptions/disruptions, it is recommended to provide the insufflator with power from an uninterruptible power supply.

Power frequency magnetic field (50/60 Hz) according to IEC 61000-4-8

3 A/m

In compliance

Magnetic fields of the mains supply should comply with the typical values of business and hospital environments

*Note: UT is the mains alternating voltage before applying the test levels.

64

Electromagnetic Compatibility 14.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity 40 L Core Insufflator (Non-Life Support)

EN

Electromagnetic Interference Immunity Tests

IEC 60601 Test Level

Compliance

Electromagnetic Environment Guidelines

Conducted RF interference quantities according to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

In compliance

3 V/m 80 MHz to 2.5 GHz

In compliance

Portable and mobile wireless devices should not be used in closer proximity to the insufflator (including cables/lines) than the recommended safety distance calculated based on the transmitting frequency and the applicable formula. Recommended safety distance: d = 1.2 √ P d = 1.2√ P for 80 MHz to 800 MHz d = 2.3 √ P for 800 MHz to 2.5 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]. Field strengths from fixed RF transmitter as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range (b). Interference is possible in the proximity of devices featuring the following pictograph.

Radiated RF interference quantities according to IEC 61000-4-3

Note 1: The higher frequency range applies for 80 MHz and 800 MHz. Note 2: These guidelines may not be applicable in all cases. The spread of electromagnetic quantities differs depending on the absorption and reflection of buildings, objects, and people. a

The field strength of stationary transmitters such as base stations of mobile phones and land mobile devices, amateur radio stations, AM and FM radio and TV broadcasters are theoretically not 100% predictable. A site study is recommended to determine the electromagnetic environment as it pertains to the stationary transmitters. If the measured field strength at the proposed 40 L Core Insufflator installation and operation site exceeds the compliance levels listed above, the insufflator should be monitored to documents proper functionality and operation as intended. Additional measures might become necessary, e.g., modifying orientation or a different location for the insufflator, if unusual performance characteristics are observed. b

The field strength should be less than 3 V/m for the frequency range of 150 kHz to 80 MHz.

65

Electromagnetic Compatibility

EN

14.7 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and 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. 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 - depending on the output power of the communication device listed below. Rated output of the transmitter [W]

Safety distance based on the transmitting frequency [m] 150 kHz to 80 MHz d = 1.2 √ P

80 MHz to 800 MHz d = 1.2 √ P

800 MHz to 2.5 GHz d = 2.3 √ P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

The safety distance d in meters [m] for transmitters with a max. rated output not listed in the table above can be calculated by applying the corresponding formula in the respective column. P is the max. rated output of the transmitter in watts [W] as specified by the transmitter manufacturer. Note 1: The higher frequency range applies for 80 and 800 MHz. Note 2: These guidelines may not be applicable in all cases. The distribution and spread of electromagnetic quantities differs depending on the absorption and reflection of buildings, objects, and people.

66

Accessories 15

Accessories

EN

15.1 Accessories for 40L Core Insufflator with integrated low flow, mode US Order No.

Items

1000-400-737

40L CORE Insufflator manual US,EN/ES/FR/DE

0620-040-002

DISS house gas connection, 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, 2,5m

0105-170-797

Needle Veress, 100 mm

0620-030-503

CO2 Switching valve

15.2 Accessories for 40L Core Insufflator with integrated low flow, mode EU Order No.

Items

Z0498-01

High pressure tube CO2, bottle connection: 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, 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, 2.5 m Miscellaneous

Z0500-01

Adapter PIN-Index for high pressure tube CO2

Z5040-01

Fuse T 3.15 A

Z0701-01

Veress cannula, 100 mm, chrome plated

1000-400-834

40L CORE Insufflator manual EU, EN/NL/FR/DE

1000-400-833

40L CORE Insufflator manual EU, EN/NO/SV/DA/FI

1000-400-832

40L CORE Insufflator manual EU, EN/ES/IT/PT/EL

Z5000-01

Video cable

Z0131

S-VHS cable, 2 m

Z0166-01

Remote control

Z0525-01

Sterile packing for remote control

For your own safety and that of your patient, use only original accessories.

Original Accessories

67

Accessories 15.3 Remote Control (only for EU Version)

EN

Use the remote control to operate the device from the operating table. Before surgery, check if the remote control influences other devices or if other existing remote controls influence the device. WARNING

Do not use the remote control without sterile cover within the sterile area. WARNING

Please put the remote control into a sterile bag before using it. You can disinfect the remote control by wiping it with a disinfectant. It is not possible to sterilize the remote control. 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. Depending on the selected application mode (Low Flow or High Flow), you cannot increase the nominal pressure once 12 mm Hg or 15 mm Hg has been reached. The nominal pressure value "12 mm Hg" *LF or "15 mm Hg" *HF is a threshold value. This is where the recommended range for the intra-abdominal pressure ends. Increasing the pressure further is initially not possible. This requires bypassing and exceeding the safety limit. In Low Flow mode, the safety limit is at 12 mm Hg. In High Flow mode, the safety limit is at 15 mm Hg. Exceeding this safety limit is to be decided by and the responsibility of the user/operator. Follow these steps: Release the key for 1 second; then you can continue increasing the pressure further (safety function).

68

Accessories • Press the (2) key to increase / reduce the nominal gas flow. In High Flow mode, the safety limit is at 5 l/min. The nominal flow value 5 l/min is a threshold value. Increasing the flow further is initially not possible. This requires bypassing and exceeding the safety limit. Exceeding this safety limit is to be decided by and the responsibility of the user/operator. Follow these steps: Release the key for 1 second; then you can continue increasing the flow further (safety function).

Increasing/Reducing Nominal Gas Flow

• Use the (3) key to reset the gas consumption display to zero.

Gas Consumption Display

• Use the (4) key to start/stop the insufflation.

Start/Stop

• Use the (5) key to switch video messaging (superpositioning) ON/OFF (optional)

Video Messaging (Superposition) ON/OFF

EN

Point the remote control in the direction of the receiver window at the left front of the device. Then press the desired key to operate the device.

69

Accessories

EN

Left Blank on Purpose 70

Error and Warning Messages 16

Error and Warning Messages

Error and Warning Messages

Gas supply empty

EN

Cause

Troubleshooting

After pressing the ON/OFF key: Existing gas supply pressure is too low.

• • • • • • • • • •

During surgery: The gas supply pressure has dropped below 15 bar.

Open gas bottle or replace with new bottle. Check the house supply. Terminate insufflation with the Start/Stop key. Detach the insufflation tube. Close gas supply valve. Replace gas supply. Open gas supply valve. Connect insufflation tube. Continue insufflation with the Start/Stop key.

The gas supply pressure has dropped below 20 bar.

• Prepare for changing the gas bottle.

The pressure monitor shows that the actual pressure is 2-5 mm Hg and 2-5 second above the nominal pressure.

Determine the cause for exceeding the nominal pressure. Check the electronic controls of the device if overpressure exists for a longer period of time (cf. chapter 12 Annual Inspection, page 57).

The actual pressure has reached 30 mm Hg / 20 mm Hg *LF.

Reduce the nominal pressure and determine the cause of exceeding the nominal pressure, if possible or necessary.

The actual pressure is at least 2-5 mm Hg and 2-5 s above the nominal pressure.

Determine the cause for exceeding the nominal pressure.

The pressure monitor indicates that the actual pressure is 2-5 mm Hg above the nominal pressure. The overpressure was not reduced within 5 seconds by the venting system.

Determine the cause for exceeding the nominal pressure. Check the electronic controls of the device if overpressure exists for a longer period of time (cf. chapter 12 Annual Inspection, page 55). Reduce the nominal pressure and determine the cause of exceeding the nominal pressure, if possible or necessary.

Tube, Veress cannula, or trocar occlusion.

Determine the cause and open/eliminate the occlusion.

Low gas level

Check the electronic controls of the device if overpressure exists for a longer period of time (see chapter 12 Annual Inspection, page 57).

Faulty Veress needle insertion.

Check that the Veress cannula is positioned correctly in the abdomen and make sure the instrument's stopcock is open.

Fluid has penetrated the device.

Message is repeated with each Start/Stop. It is possible to continue using the device with this error message until the device is turned off with the ON/OFF key.

The following messages are depicted on the display consecutively:

The device has to be checked by an authorized service technician or clearly marked with a label referring to the contamination and then twice enclosed in a safety foil, sealed, and returned to the manufacturer for repairs.

The device is contaminated with fluid.

69

Error and Warning Messages

EN

Error and Warning Messages

Cause

Troubleshooting

Gas heating malfunction.

Check that the plug is inserted correctly into the gas heating connection.

Heater defect/Call service

Check tube and cable for defects. Check gas heating using a different tube. If this error message is displayed again, have the device checked by a qualified service technician. It is possible to continue using the device without gas heating. The temperature of the gas exceeds 42° C.

The device terminates gas heating and insufflation.

• Unplug the insufflation tube at the trocar and the plug for the gas heater located at the device. • Press the Start/Stop key. The device insufflates without heating the gas. • Let hot gas escape until the tube is only warm to the touch. • Continue the operation without gas heating or use a different gas heating tube. Turn device off and on again. This reactivates the gas heating. • Check gas heating after surgery using a different tube. If this error message is displayed again, have the device checked by a qualified service technician. It is possible to continue using the device without gas heating.

The insufflation is stopped or cannot be started.

Valve defect/Call service

70

The device does not work properly and activates the internal safety system.

Switch the device off and back on after approx. 3 seconds have expired using the ON/OFF key.

The device temperature is above 70° C.

Switch the device off with the ON/OFF key and allow it to cool off for about 10 minutes. Make sure the device is not set up in the vicinity of heat sources.

The device temperature is below 10° C.

Turn the device off for about 10 minutes using the ON/OFF key. The surrounding room temperature must be above 10° C.

Venting system malfunctioning.

Use the ON/OFF key to turn the device off and turn device back on after approx. 3 seconds. If this error message is displayed again after the device self-test has concluded, have the device checked by an authorized service technician. The device can be still operated but without venting system. The error message is repeated with each Start/Stop.

The device is defective if the error message is displayed again. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

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

Index 18

Index

A Additional Insufflation Sources 9 Authorized Service Technician 3 Autoclave Sterilization 54 Automatic Venting System 10, 29 Available Mains Voltage 4 B Backflow 9 Before Surgery 51 C Care and Maintenance 3 Central Gas Supply 18 Certification 55 Changes 1 Cleaning the Device 5 CO2 Absorption 8 Compression of the Vena Cava 21 Condensation / Water Penetration 4 Connecting the gas heating 27 Connecting the Tube 10 Connecting Video Messaging (Superposition) 43 Contaminated Filter 10 Contamination 3, 10 Contraindications 7 D Decreasing Nominal Gas Flow 20, 23 Decreasing Nominal Pressure 19, 22 Dehydration 9 Delivered Device Check 13 Device Defect 5 Device-inherent Dangers 5, 8 Disconnecting the Insufflation Tube 9 Disposal 3 E Electromagnetic Interference 11 Electronic Device Control 11 Embolism 9 Endoscope 5 Error Message "Contamination" 32 Error Message "Service" 31 ESD Precautionary Measures 63 Exceeding Nominal Pressure 29 Exceeding nominal pressure for more than 5 seconds 29 F Factory Settings 4 Fatigue Symptoms 10 Filter 10 Function of the Keys 34 Function Test 5 G Gamma Ray Sterilization 54 Gas consumption display 69 Gas Flow 10 Gas Flow Limit 8 Gas heating error 27 Gas Heating ON/OFF 27

Gas Sterilization 54 Gas Supply Display 30 Gas Supply with Gas Bottle 18 Gas temperature exceeds 42° C 28 H Haemodynamic Stability 21 High Flow Application 7 How do I use the user menu? 34 Hypothermia 22 Hypothermia/Monitoring Body Temperature 9 I Idiosyncratic Reactions 8 Increased Airway Pressure 21 Increased Airway Pressure/Compression of the Vena Cava 8 Increasing Nominal Gas Flow 20, 23 Increasing Nominal Pressure 19, 22 Increasing/Reducing Nominal Gas Flow 69 Increasing/Reducing Nominal Pressure 68 Insufflation on 24 Insufflation Operating Mode 20 Intended Use 7 K Keep Filled CO2 Bottle on Hand 10 L Liability 3 Low Flow Application 7 M Maintenance Interval 55 Manual 1 Measured Values and Tolerances 57 Medically Pure CO2 11 Menu Level Application 34 Menu Level Display Actual Flow 40 Menu Level First Nominal Pressure 36 Menu Level Gas Flow Rate 1, 2, 3 36 Menu Level Gas Supply 38 Menu Level Language 35 Menu Level Max. Nominal Pressure 36 Menu Level Occlusion Warning 35 Menu Level Safety Limit Flow 40 Menu Level Venting Pressure Limit 38 Menu Level Venting Response Time 37 Menu Level Venting System 37 Menu Level Video Superposition (optional) 39 Menu Level Volume 35 Metabolic and Cardiac Reactions 8 N Nominal Pressure Threshold 30 Not explosion-proof 4 Notes about the Veress cannula 53 O Original Accessories 4, 67 P Peripheral Devices 11 Pneumolabium/Pneumoscrotum 8, 21 Positioning the Patient 8 Power Failure 32

69

EN

Index

EN

Power supply 13 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.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

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