Instruction Manual INSUFFLATOR Highflow 45 2235 GA-A 274
Instruction Manual INSUFFLATOR Highflow 45 2235 GA-A 274 / en / 2012-12 V1.0 / PDG 00-0000 Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, and that maintenance and repair are only carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned applic ation and if the performance characteristics and safety requirements are not impaired. Do not alter the product in any way. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user and others. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give right to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments, the illustrations and technical data may deviate slightly. Safety instructions and levels of danger Symbols Level of danger WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product. . IMPORTANT! . NOTE! Failure to observe can result in damage to the product or surroundings. Tips for optimum use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-300 MANUFACTURER [email protected] www.richard-wolf.com BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com GA-A 274 USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33 UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com [email protected] [email protected] www.richard-wolf.com AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45 INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com 0 Contents 1 1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.5 1.5.1 1.5.2 1.5.3 1.6 1.7 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications and side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Instruments for INSUFFLATOR Highflow 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Potential equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Requirements for products / components of a combination . . . . . . . . . . . . . . . . . . . . . . . 7 Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Connection diagram - in dialog mode (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2 2.1 2.2 Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 3 3.1 3.2 3.2.1 3.2.2 3.3 3.3.1 3.3.2 3.4 3.4.1 3.4.2 3.4.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Language settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CO2 connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparation for CO2 operation with gas bottle/cylinder . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparation for CO2 operation using centralized gas supply . . . . . . . . . . . . . . . . . . . . . . Connecting the insufflation tube set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reprocessable insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposable insufflations tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Highflow insufflation tubes with heating wire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reprocessable highflow insufflation tube with heating wire . . . . . . . . . . . . . . . . . . . . . . . Disposable highflow insufflation tube with heating wire . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposable tube set for smoke gas evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 14 14 14 15 15 16 16 17 17 18 18 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Visual check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device function after switching on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking the gas supply (status message) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manual checks of the control function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking the pressure and flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 19 19 19 20 20 20 5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.3 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Controls and modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dispaly of remaining CO2 gas supply in the status display . . . . . . . . . . . . . . . . . . . . . . . Gas consumption in status display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indicator for gas heating (only 2235021, 2235031 / 2235621, 2235631) . . . . . . . . . . . . Footswitch for smoke gas evacuation (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Video on-screen display with dialog function (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control sequence and menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 22 22 22 22 22 23 23 23 24 GA-A 274 I 5.3.1 5.3.2 5.4 5.5 5.6 5.7 5.8 5.8.1 5.9 5.10 5.10.1 5.11 5.11.1 5.11.2 5.12 5.12.1 5.12.2 5.12.3 5.12.4 5.12.5 5.12.6 5.12.7 5.12.8 5.13 5.13.1 5.13.2 5.13.3 5.13.4 5.13.5 5.13.6 5.13.7 Overview - control sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview - menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Menu levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Menu control and touchscreen functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selection of main level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selection of device modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selection of Richard Wolf profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the standard profiles (default profiles) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjusting the device parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Display of actual and nominal values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation of INSUFFLATOR Highflow 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Important note for using the reprocessable highflow insufflation tube with heating wire Notes and instruction for using smoke gas evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . Creating a pneumoperitoneum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Highflow device mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measures after carrying out insufflation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Possible alarms during the application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Taking out of service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of operator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Structure of operator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Message types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Functionality of control elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operator's messages (green) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LOW error (turqoise) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MEDIUM error (yellow) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HIGH error (red) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 25 26 26 27 28 28 28 29 31 31 32 33 33 34 34 35 35 35 36 36 36 36 37 37 37 37 38 38 40 40 6 6.1 6.2 6.3 6.4 Operation within the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Functional principle within the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Combining and controlling the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting the system ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection to the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 41 41 41 42 7 7.1 7.2 7.2.1 7.2.2 7.3 7.4 7.4.1 7.5 7.5.1 7.5.2 Reprocessing and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reprocessing of device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reprocessing of reusable insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reprocessing of reusable highflow insufflation tube with heating wire . . . . . . . . . . . . . . Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quarterly check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measuring and test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking the pressure and flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 43 43 44 44 44 44 44 44 44 45 II GA-A 274 Contents 7.5.3 Leakage test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 8 8.1 8.1.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5 8.5.1 8.5.2 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fault in the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Application parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pressure and flow values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Optional device variants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operating, storage, transport and shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacing parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposal of product, packaging material and accessories . . . . . . . . . . . . . . . . . . . . . . . . GA-A 274 46 46 46 47 47 48 48 49 49 50 51 51 51 III 1 General information 1.1 Symbols Symbols Designation Attention, Caution Follow the instruction manual OFF (no power supply, separation from mains) ON (connection to the mains / line voltage) Potential equalization Power / Mains fuse μ Alternating current (AC) TYPE CF APPLIED PART Hygiene filter Gas heating Alarm Signal sound Signal sound switched off Footswitch Input connector for smoke gas evacuation / data input Output connector for insufflation / data output Recycle the product separately. Do not discard together with other waste. REF Order number Lot designation Manufacturer Manufacturing date Quantity Use-by date 1 GA-A 274 Symbols Designation Do not reuse. Latex-free Contains phthalates or phthalates are present: Diethylhexyl phthalate (DEHP) -25_C Maximum temperature range for shipment, transport and storage + 50_C Sterilized with ethylen oxide Steam sterilization - fractional method XX° XX° Permissible temperature range XXhPa Permissible atmospheric pressure range XXhPa XX% Permissible humidity range XX% Do not use mobile phone / radio intercom A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us) Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124). 1.2 Intended use The INSUFFLATOR Highflow 45 (2235) serves to create and maintain a pneumoperitoneum using CO2 gas. It can be used for both diagnostic and surgical laparoscopy. In conjunction with integrated smoke gas evacuation (2235011/2235031) and the "Continuous Flow" (2235104) software module, the system also serves to distend the colon (rectal cavity and lower portion of the sigmoid) in a pressure-controlled manner for the purpose of Transanal Endoscopic Microsurgery (TEM). This product is designed exclusively for use by specialized medical per sonnel and may only be applied by medically qualified and adequately trained doctors. GA-A 274 2 1.3 Indications and field of use The INSUFFLATOR Highflow 45 (2235) is primarily used in diagnostic and surgical laparoscopy but can also be used for TEM using the integ rated smoke gas evacuation (2235011/2235031) and the "Continuous Flow" (2235104) software module. For TEM applications please follow the latest instruction manual for the TEM system. On the basis of the patient’s general condition, the user in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature. CAUTION! In case of therapeutic applications an adequate backup device with the same capabilities must be available should the device fail. CAUTION! It is not allowed to use mobile phones or similar devices while the INSUF FLATOR Highflow 45 is used. . NOTE! We recommend reading relevant literature for the planned application. 1.4 Contraindications and side effects 1.4.1 Contraindications The use of this device is contraindicated whenever laparoscopy is con traindicated. WARNING! The device has a highflow rate. The device is not suitable for hysteroscopy. This device must not be used for distending the cavum uteri. Contraindications resulting from the patient's general condition and de scribed in the relevant literature must be observed. This device is contraindicated in the case of hysteroscopic insufflation do not use this device for intrauterine distension. Absolute contraindications: D Hypovolemic shock represents an absolute contraindication with the exception of laparoscopic surgeons who have adequate experience in procedures for blood extraction from the abdomen and for finding and stopping a hemorrhage site and can execute them safely and so can achieve hemostasis quicker than by laparotomy. D In the case of severe inflation of the intestine during intestinal obstruc tion, increased possibility of adhesions in the pelvis and in the abdomen as well as in the case of an elevated diaphragm, the required insuf flation is contraindicated and the space available for a visualization is severely limited and the probability of injuring the intestine is severely increased. D A further contraindication is the existence of a large mass in the pelvis or in the area of the pelvis and abdomen (which in general extends to the umbilicus or above). There is an increased risk of injuring this mass, and there is a high probability that endoscopic visualization is poor and that the extension and the nature of the mass cannot be determined. A mass of this size would probably have to be removed by a laparotomy. 3 GA-A 274 D A type 4 cardiac decompensation also represents a contraindication as the insufflation and its positioning could cause irreversible arrhythmia to the heart which is filled with congested blood and cause cardiac failure. Relative contraindications: D Septic peritonitis D Pelvic abscess D Multiple interventions in the abdomen D Diaphragmatic hernia D Obesity D Pregnancy TEM is contraindicated where a general contraindication against surgical interventions, a severe infection or severe metabolic disorders exist. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature. GA-A 274 4 1.4.2 Side effects Warnings: Metabolic acidosis and the resulting cardiac arrhythmia. Intraabdominal pressures of more than 20 mmHg (mercury column) for an extended period of time must be avoided. This may lead to the following complications: D Reduced breathing with impaired diaphragm excursion D Reduced venous backflow D Reduced cardiac output D Acidosis Excessive absorption of CO2 is either due to excessive flow or excessive pressure. The abdomen can be sufficiently distended with pressures between 15 - 20 mmHg (mercury column). Hardly ever abdominal pres sures of more than 20 mmHg are required. At these values only limited absorption should occur. Pressures of more than 20 mmHg (mercury column) are actually never necessary and will lead to increased and faster absorption. Adequate artificial respiration will help to avoid prob lems with regard to CO2. Z Idiosyncratic reactions. In patients suffering from sickle-cell disease or pulmonary insufficience the use of these devices can lead to an in creased risk of a metabolic imbalance due to excessive CO2 absorp tion. Z Hypothermia. Highflow rates bear the potential risk of hypothermia. Precautions: It is strongly recommended using a hydrophobic bacteria filter to prevent the transmission of microorganisms between patients. 5 GA-A 274 1.5 Combinations . IMPORTANT! In addition to this instruction manual, follow the manuals for the products used in combination with this product. WARNING! Danger of life-threatening gas or air embolism. Purge the connection tubes/hoses with a sufficient amount of CO2 before use. The use of devices using additional gaseous media in combination with the INSUFFLATOR Highflow 45 is exclusively within the responsibility of the user. WARNING! Danger of intrabdominal excess pressure when using a second gas source. When using argon plasma coagulators an additional visual or manual pressure monitoring device of the user is mandatory because the pressure monitoring function / pressure relief of the INSUFFLATOR High flow 45 can be inactive as a result of a kinked insufflation tube or a closed instrument stopcock. The preselected gas flow rates of the argon plasma coagulator should not exceed 2 l/min. Activate the argon plasma coagulator only briefly. 1.5.1 Instruments for INSUFFLATOR Highflow 45 The INSUFFLATOR Highflow 45 can be combined with the instruments used during a diagnostic and/or surgical laparoscopy and/or TEM. Follow the instruction manuals of the products used in conjunction with this product. On principle, the INSUFFLATOR Highflow 45 can be combined with all trocar sleeves available in the market. GA-A 274 6 1.5.2 Potential equalization The potential equalization cable establishes a direct connection between a medical electrical de vice and an equipotential bonding rail. It serves to equalize differences in potential between enclosures of electrical equipment and firmly installed conductive parts in the patient environment. 1.5.3 Requirements for products / components of a combination 1.5m 1.5m The general requirements depend on whether the products / components are inside or outside the patient environment. 1.5m IEC 60601-1, 3. Ed. Medically used room inside the patient environment MP MP ~ ~ MP MP ~ outside the patient environment - NMP ~ ~ Verification of the total patient leakage current ** NMP MP MP - Requirements / measures Leakage currents to section 16.6 IEC 60601-1:2005 / EN 60601-1:2006 * ** MP ~ Non-medically used room - Verification of leakage currents ** a) additional protective earth connection (consult the corresponding manufacturer), - or NMP b) additional isolating transformer for medical applications ** ~ MP NMP ~ MP / NMP MP ~ ** MP NMP ~ ~ MP MP / NMP ~ ~ additional "isolating transformer" to IEC/ EN60601-1 ** Functional connection MP NMP Verification of leakage currents a) no plugs with metal housing, or b) additional isolation device (to avoid voltage differentials) - ~ Verification of leakage currents a) common protective earth connection, or b) additional protective earth connection at MP (clarify with the corre ponding manufacturer), or c) additional isolation device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment additional isolating device to IEC/ EN 60601-1 Multiple socket strip Power supply grid = medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08 = non-medical electrical device in accordance with product-specific IEC/EN/UL standards * ** When connected via a multiple socket strip under standard conditions the earth leakage current of the power bar must not exceed 5 mA. e.g. Richard Wolf video cart with "isolating transformer" 7 GA-A 274 . 1.6 IMPORTANT! The persons combining products to form a system are responsible for not impairing the system's compliance with performance and safety requirements, and that the technical data and the intended use are adequately fulfilled. Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions. When selecting the system components, make sure that they meet the necessary requirements of the medical envi ronment they are used in, in particular IEC/ EN 60601-1 (3. Edition IEC/EN 60601-1, section 16). In case of doubt contact the manufacturer(s) of the system components. Do not touch connectors for electrical connections between various components (such as signal input connectors and signal output connectors for video signals, data exchange, controls etc.) and the patient at the same time. Electromagnetic compatibility (EMC) Please observe the following: The device/system in the following referred to as product always related to INSUFFLATOR Highflow 45. The product does not have any performance features classified as essential performance features in accordance with IEC/EN 60601-1. Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Emissions measurement / test Compliance Electromagnetic environment - Guidelines HF emissions to CISPR 11 Group 1 The product uses HF energy for its internal function. The HF emission level is extremely low and it is not likely to cause any interference in nearby electronic equipment. HF emissions to CISPR 11 Class B Harmonic emissions to IEC 61000-3-2 Class A In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker" The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Compliance Immunity tests IEC 60601 test level Electromagnetic environment - Guidelines Electrostatic discharge (ESD) to IEC 61000-4-2 6 KV contact discharge 8 KV air discharge Yes Floors should be wood, concrete or ceramic tile. With floors made of synthetic material, the relative humidity of the ambient air must be at least 30%. Electrical fast transience, bursts to IEC 61000-4-4 2 KV for power supply lines 1 KV for input and output lines Yes Mains/line power quality should be that of a typical commercial or hospital environment. Surge voltage (surges) to IEC 61000-4-5 1 KV line to line voltage 2 KV line to ground voltage Yes Mains/line power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and sup ply voltage variations to IEC 61000-4-11 Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles 60% UT * Voltage dip for 25 cycles 30% UT * Voltage dip for 5 sec > 95% UT * Yes Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupti ble power supply or battery. Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8 3 A/m Yes Power frequency magnetic fields should be at le vels characteristic of a typical location in a com mercial or hospital environment. * NOTE: UT is the line / mains voltage prior to application of the test level. GA-A 274 8 Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests IEC 60601 test level Compliance Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the product, including ca bles, than the recommended separation distance calculated from equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2 p P Conducted HF interference to IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz Radiated HF interference to IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz d = 1.2 p P for 80 MHz to 800 MHz Yes d = 2.3 p P for 800 MHz to 2.5 GHz P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer) d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol: REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec tromagnetic waves is affected by absorption and reflexion from buildings, objects and people. 1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m. Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica tions equipment and the product. Rated nominal output power of the transmitter (W) Separation distance as a function of transmitter frequency (m) 150 kHz to 80 MHz d = 1.2 p P 80 MHz to 800 MHz d = 1.2 p P 800 MHz to 2.5 GHz d = 2.3 p 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 For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec tromagnetic waves is affected by absorption and reflexion from buildings, objects and people. 9 GA-A 274 1.7 Connection diagram - in dialog mode (option) 1.1 1.1 1 2 Legend Direct connection 1 1.1 2 . CAN BUS connection cable (option) CAN BUS termination (option) Video cable to meet the signal requirements of the camera controller used IMPORTANT! The optional dialog function is only possible is only possible with enabled software module 3 of INSUF FLATOR Highflow 45. Connection of the CAN BUS connection cable (1) only with interactive camera controller. If the CAN BUS connection cable is connected, the free CAN BUS connectors of INSUFFLATOR Highflow 45 and the camera controller must be terminated with CAN BUS terminating resistors (1.1). GA-A 274 10 2 Illustration 2.1 Front view 6 5 4 3 2 1.1 1 Legend 1 Power ON/OFF switch 1.1 Power ON/OFF LED 2 Touchscreen 3 Connector for disposable highflow insufflation tube with heating wire ' only 2235021, 2235031 / 2235621, 2235631 4 Connector for reusable highflow insufflation tube with heating wire ' only 2235021, 2235031 / 2235621, 2235631 5 Connector for insufflation tube (type CF applied part) 6 Connector for smoke gas evacuation (type CF applied part) ' only 2235011, 2235031 / 2235611, 2235631 11 GA-A 274 2.2 Rear view 13 14 12 15 11 10 8 7 9 16 FEDERAL LAW RESTRICTS THIS UNIT TO BE USED OR SOLD, EXCEPT UNDER THE SUPERVISION OF A MEDICAL DOCTOR. Legend 7 Potential equalization connector 8 Connector for footswitch for smoke gas evacuation ' only 2235011, 2235031 / 2235611, 2235631 9 Service interface 10 Silencer ' only 2235011, 2235031 / 2235611, 2235631 11 Power input connector with fuse holder 12 Fuse plate 13 Device connector for gas supply 14 CAN BUS interface 15 Mounting points for bottle holding bracket 16 Identification plate GA-A 274 12 3 Setup WARNING! The device is not protected against explosions. Explosion hazard. Do not operate this device in areas where there is a danger of explosion. WARNING! Danger if a power supply without protective earth is used. Danger of electric shock! Connect the device only to a power supply with protective earth connec tor. . NOTE! The line / mains voltage must correspond with the voltage indicated on the identification plate. Connect the device only via the supplied power cable or a power cable with the same specifications. Do not block any ventilation slots! CAUTION! Danger of faults and malfunctions. To guarantee the safety of the user, patient and others, use only acces sories and spare parts as specified by the manufacturer of this product. Other accessories or spare parts can cause the emission of increased electromagnetic radiation or reduced immunity against interference. . IMPORTANT! Medical electrical equipment is subject to special precautions with regard to electromagnetic compatibility (EMC). Make sure you follow the notes on EMC for installation and operation. Medical electrical devices can be influenced by mobile HF communication devices. If it is necessary to stack the devices or place them next to each other and HF interference is observed, make sure that the devices are ope rated as specified in the intended use. WARNING! Use the device only with the insufflation tubes and filters specified by the manufacturer. Sterilize the insufflation tube before each use. Danger of infection due to unsterile accessories and possible malfunction (loss of gas pressure or gas flow) when using spare parts supplied by other manufacturers or in the case of wrong assembly. CAUTION! Disposable items have been designed for one single use only and are sterilely packed. Do not use disposable items if: ' the sterile packaging is damaged ' the use-by-date has been exceeded 13 . NOTE! For use, place the device on a level surface. . NOTE! Remove the protective foil from the touchscreen before the first use. GA-A 274 3.1 Language settings Fig. 1 The language is selected in the Device parameters menu (see section 5). When switching on the device for the first time (setup) as well as during a new start after having reset the device to "factory settings", the required language must be selected. ' Language selection for the “Standard profile”. ' For "User-specific operator profile" it is possible to define a separate language. If a wrong language was selected and it is impossible to select the language selection menu in this language, proceed as follows: Z Switch off the device and wait for at least 60 seconds. Z Switch on the device and press the device name on the touchscreen until the language selection menu is displayed. Z Let go of the button and select the required language. ' Language selection for the “Standard profile”. 3.2 CO2 connection 3.2.1 Preparation for CO2 operation with gas bottle/cylinder WARNING! Make sure that no liquid CO2 enters the INSUFFLATOR Highflow 45 as a result of incorrect positioning of the gas bottle/cylinder! This will endanger the patient as a result of possible malfunctions or fail ure of the INSUFFLATOR Highflow 45 during the surgical intervention. Operate the gas bottle/cylinder only in vertical position with the valve on top. . 18 Z Use mounting screws (15) to attach the bottle holding bracket (18) to the device if required ' Optionally, large gas bottles/cylinders can be fastened to a device cart. 15 . GA-A 274 IMPORTANT! Observe the manual for the pressure reducing valve. IMPORTANT! When using gas bottles with more than 2 l of volume, use a separate holding bracket (do not attach to the INSUFFLATOR Highflow 45) and secure the gas bottle/cylinder against falling over. 14 Z Place the gas bottle (max. 2 l of volume) into the bottle holding bracket and secure with the belt (18.1). 18.1 20.1 20 19.1 Z Connect the pressure reducing valve (20) to the gas bottle (19) and tighten the union nut (20.1) with your hand. 19 Z Connect the CO2 pressure tube (21) to the pressure reducing valve (20) and tighten the union nut (21.1) with your hand. 21.1 Z Open the bottle valve (19.1) by turning counterclockwise. 21 3.2.2 Preparation for CO2 operation using centralized gas supply Connection to a centralized gas supply 17.1 Z Connect the CO2 pressure tube (17) to the device connector for gas supply and hand-tighten the union nut (17.1). ' Then connect the CO2 pressure tube (17) to the wall connector for centralized gas supply. 17 3.3 Connecting the insufflation tube set CAUTION! Contamination of the device by a backflow of gas or body fluid. There must always be a hygiene filter between the device connector and the insufflation tube. . 15 IMPORTANT! To connect and disconnect the insufflation tube always hold it by the con nectors. GA-A 274 3.3.1 Reprocessable insufflation tubes D 8170.101: for Veress cannula/RIWO-ART trocar sleeve, dia. 10 mm (B1) + further models with luer lock fitting D 8170.232: for high-flow trocar sleeves, dia. 10 mm (B1, B2) Cut off the luer lock fitting on the insufflation tube and connect the end of the tube onto the connecting piece (x). B2 (X) B1 B1 B2 B1 3.3.2 B1 B1 B2 B2 Disposable insufflations tube CAUTION! The disposable insufflation tube is designed for one single use and is sterilely packed. Do not use single-use insufflation tubes if: - the sterile packaging is damaged - the use-by date has been exceeded D 4170.501: for Veress cannula/RIWO-ART trocar sleeve, dia. 10 mm and high-flow trocar sleeve, dia. 10 mm (B) + others with luer lock connector Cut off the luer lock fitting on the insufflation tube and connect the end of the tube onto the connecting piece (x). (X) B GA-A 274 B B 16 3.4 Highflow insufflation tubes with heating wire Optionally, a reprocessable high-flow insufflation tube with heating wire as well as a disposable insufflaction tube with heating wire and integrated hygiene filter can be connected to the device. The plugs are encoded accordingly and can only be connected to the re spective socket provided on the device. For gas heating mode see section 5. 3.4.1 Reprocessable highflow insufflation tube with heating wire . IMPORTANT! After autoclaving, the reprocessable highflow insufflation tube with heat ing wire must be allowed to cool down for at least 30 minutes. Otherwise, an overtemperature alarm is triggered after connecting the high-flow in sufflation tube to the device. The reprocessable highflow insufflation tube with heating wire is encoded and only allows a limited number of applications. The Device parameters - Device info menu allows the display of the num ber of applications already carried out as well as the maximum permiss ible number of applications (counts up, e.g. 100 of 100 = end of service life). In order to check the number of applications already carried out, the in sufflation tube can plugged on briefly without causing the service life to end. For manual control, the reusable/reprocessable insufflation tube is fitted with tear-off tabs. If there is no tear-off tab left on the tube, the reprocess able insufflation tube must not be sterilized again. 17 GA-A 274 3.4.2 Disposable highflow insufflation tube with heating wire The disposable highflow insufflation tube with heating wire is encoded and only allows one single use. Go to the Device parameters - Device info menu to display whether the insufflation tube can still be used (counts up, 1 of 1 = end of service life). 3.4.3 Disposable tube set for smoke gas evacuation . GA-A 274 IMPORTANT! The disposable tube set for smoke gas evacuation must only be used for evacuating smoke gas and not for suctioning out liquids. 18 4 Checks . 4.1 IMPORTANT! Run through the checks before and after each use. Do not use the products if they are damaged or incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself. Visual check Z Check the device and accessories for damage, loose or missing parts, hygiene and completeness. Z Check all connection cables, tubes and hoses for damage. Z Any inscriptions, lettering or labeling necessary for the safe intended use must be legible. ' Missing inscriptions, lettering or labeling leading to wrong handling or reprocessing must be reinstated. 4.2 Function check . IMPORTANT! Before you perform the function checks, make sure that the devices are in perfect technical condition and are set up correctly. This must also be guaranteed within the scope of the visual check. . IMPORTANT! Before each use, check the INSUFFLATOR Highflow 45 manually for proper control functions. This device is equipped with automatic function check routines which automatically detect and report various types of faults. The device detects faults and errors that occur during the self test or during operation. 4.2.1 Device function after switching on the device Z Switch on the device with the power switch. ' The LED on the power switch lights up. ' When the self test starts also listen to a signal being sounded for checking the speaker function. ' If during the selftest the gas supply is insufficient, a device message is displayed and the device is not ready for operation. ' After a successful self test the device is ready for operation. ' The mode selection is displayed. ' Select a suitable profile that suits the mode (see section 5.6). 19 GA-A 274 4.2.2 Checking the gas supply (status message) Z The CO2 gas supply is displayed in the status display. ' Check that the gas bottle is open and there is sufficient CO2 supply. ' For displaying the fill levels on the status display see section 5.2.2. 4.2.3 Manual checks of the control function Veress cannula (if used): Z Check the Veress cannula for patency (free passage) and function (snap-in mechanism). Pressure preselection: Z Change the nominal pressure using the pressure (+) and (-) buttons. ' When insufflation is on, the preselected pressure (nominal value) is displayed for approx. 2 s. Flow control (checking the flow): Z Use the flow (+) and (-) buttons to change the nominal flow. ' The preselected flow rate (nominal value) is displayed for approx. 2 s when insufflation is switched on. ' In baby mode (option) high flow cannot be selected. 4.2.4 Checking the pressure and flow control Primary insufflation: Z Preselect the following nominal pressure: 12 mmHg (mercury column) Z Connect the hygiene filter and insufflation tube to the insufflation con nector. Z Start insufflation. ' The current flow rate must agree with the preselected flow rate of 1 l/min. ' Permissible tolerance: ¦ 0.5 l/min Z Close the insufflation tube with your thumb. ' As soon as the current pressure exceeds the preselected pressure, the device must release pressure. Z Switch off insufflation and open the insufflation tube. GA-A 274 20 Highflow: Z Nominal pressure to be preselected: 12 mmHg Flow rate to be preselected: 10 l/min Z Select highflow. ' First switch on insufflation, then select highflow. ' The current flow rate must agree with the preselected flow rate of 10 l/min. ' Permissible tolerance: ¦ 2.0 l/min Z Close the insufflation tube with your thumb. ' As soon as the current pressure exceeds the preselected pressure, the device must release pressure. Z Open the insufflation tube. Z Switch back from highflow to primary insufflation. ' After 1.5 s at the latest, a flow rate of 1 l/min ¦0.5 l/min must be dis played. Z Switch off insufflation. 21 GA-A 274 5 Use 5.1 Operating principle A pneumoperitoneum is established by insufflating CO2 gas into the ab dominal cavity. The gas is supplied to the INSUFFLATOR Highflow 45 either from CO2 bottles/cylinders or from a centralized gas supply. The gas pressure and gas flow rate are controlled by INSUFFLATOR High flow 45 in accordance with the specifications of the user. Microprocessor control and display of the pressure and flow values as well as several independent safety functions guarantee safe insufflation. To heat the gas to body temperature, we recommend one of the following heating tubes (models 2235021, 2235031 / 2235621, 2235631). 5.2 Controls and modes 5.2.1 Operation and display 5.2.2 Dispaly of remaining CO2 gas supply in the status display Z The remaining CO2 gas supply is displayed in the status display. ' If during the selftest the gas supply is insufficient, a device message is displayed and the device is not ready for operation. The device is controlled via the touchscreen and the displays and mes sages are also displayed on the touchscreen. The following fill levels of the gas bottle/cylinder are displayed: 5.2.3 Display Description Lights up green Sufficient gas supply Lights up yellow Have spare gas bottle/cylinder ready or display when connected to centralized gas supply Blinks red Change the gas bottle or in the case of centralized gas supply: check connection Gas consumption in status display The gas consumption is displayed in liters on the touchscreen under status display and deleted automatically during switch-off (> 1 min). Reset serves to reset the consumption indicator. GA-A 274 22 5.2.4 Indicator for gas heating (only 2235021, 2235031 / 2235621, 2235631) Z When connecting a highflow insufflation tube with heating wire, the CO2 gas is heated to body temperature. The following operation modes are displayed in the status display: 5.2.5 Display Description Blinks green Heating Lights up green Operating temperature Blinks red Overtemperature Errors Heating module deactivated Symbol empty No heating tube connected Footswitch for smoke gas evacuation (option) The footswitch serves to switch smoke gas evacuation ON / OFF. The smoke gas evacuation pump is only active at pressures > 3 mmHg. 5.2.6 Video on-screen display with dialog function (option) In conjunction with an interactive (dialog-capable) camera controller, the dialog function allows the display of device parameters on the monitor. The above requires a connection between the devices using a CAN BUS connection cable (see connection diagram in section 1). For the dialog function optional software module3 must be activated. The on-screen display of the device parameters on the monitor is the standard setting (on-screen display can be deactivated in the service menu). 23 GA-A 274 5.3 Control sequence and menu structure 5.3.1 Overview - control sequence Mode selection and user-specific profile generated Switch on the device Selftest Mode selection Profile selection Main level Menu level Mode selection and no user-specific profile generated Switch on the device Selftest GA-A 274 Mode selection Main level (standard settings) Menu level 24 5.3.2 Overview - menu structure Line/ mains power ON User Selftest OK Not OK - error message Mode selection Standard profile Profile selection (option) User-specific profile Main level Main parameters Menu level Select Standard profile Selection Generate new profile Dialog profile name Change profile name - Dialog profile name Store profile parameters Delete profile Device-specific menu items Delete dialog e.g. parameter control Device parameters Display Settings Audio Settings Device info Display of device data Language Settings Factory setting Dialog resetting Service Authorized persons 25 General service Parameters, resets etc. Device service (protected) Dialog password input GA-A 274 5.4 Menu levels The device menu is subdivided into 4 areas: D D D D 5.5 Main level for user Menu level for user General service area for user Device service for authorized persons - with password only Menu control and touchscreen functions . IMPORTANT! When controlled via the touchscreen, it is sufficient to touch the monitor surface slightly. Do not touch the surface of the touchscreen monitor with sharp, pointed or contaminated objects as this will lead to reduced image quality or a damaged surface. . NOTE! The illustrations of the user interfaces are only exemplary and vary depending on the use. XXXX XXXX Touchscreen: The touchscreen monitor is used for information output and the input or selection of parameters. XXXXXXXX XXXXXXXXX - XXXX X XXXXX Touchscreen areas: Area for displays and settings: When the displayed function is active, the displayed numerical value is shown in red. The corresponding numerical value is adjusted using the (+) and (-) buttons or the slide control. Status area: For approx. 10 s the corresponding status message appears "!" and an acoustic signal (option) is sounded (e.g. when the lowest or highest permissible value of the adjustment is reached). Device parameters: Indicator for additional parameters, e.g. gas consumption in case of an insufflator. Line for main functions: Calling up the menus, switching on and off device functions, save, delete etc. XXX XXXXXXX 0 100 Status area Line for main functions A B Navigation: Navigation buttons A = up/down between individual menu items (single steps). Navigation buttons B = up/down by page or paragraph. Please note: The navigation buttons are only active if further menu items can be called up which are not visible on the first menu page. GA-A 274 26 Control elements: Parameter designation 0 Menu Selected: Button is highlighted, letters are black (button depressed). Menu Not selected: Button is dark, letters are white (button not depressed). Menu Selectable: Letters are white. Menu Not selectable: Letters are gray. 20 Unit 100 Back Display and parameter setting: The parameters are displayed as bars and as numbers. With the (+) and (-) buttons the value can be increased or decreased and, optionally changed using the slide control (nominal value). When you keep the (+) / (-) button depressed, the value changes incre mentally. XXXX Menu overview - calling up the menus: The Menu button serves to switch from the main level to menu level. In the menus, any changes in the settings are implemented immediately after the input. You may exit the menu items with the Back button. XXXX XXXXXXXX X mode - Pro file Back 5.6 Selection of main level The selection on the main level depends on the device version of the optional software modules and on the device mode. See table in section 8.2.3. . 27 GA-A 274 5.7 Selection of device modes Device mode Description Device operating mode In a device with several operating modes, the required mode must be selected each time after the device was started. The listing only contains the profiles that are assigned to the mode operation. Optionally, the device modes can be combined (see section 8.2.3). Default In the case of primary insufflation via a Veress cannula (1l/min). Highflow In the case of minilaparotomy – primary insufflation via Veress cannula is not applica ble. Baby mode (option) Special mode for newborns and babies. Precise pressure and generation of flow in steps of 0.1 l. TEM (option) Continuous flow mode with a maximum flow of 8 l/min (only in conjunction with smoke gas evacuation). Continuous flow (option) Continuous flow mode for laparoscopy/thoracic surgery at a maximum flow of 8 l/min. 5.8 Selection of Richard Wolf profiles Richard Wolf profile Description Richard Wolf profiles: The Richard Wolf profiles represent recommended settings for the corresponding field of application. The listing only contains the profiles that are assigned to the mode of operation. Except for the standard profile (default profile), the profiles can be deleted. New selfcreated profiles can be incorporated at any time. Default Recommended settings for standard laparoscopy. Gynecology Recommended settings for laparoscopic interventions in gynecology. Urology Recommended settings for laparoscopic interventions in urology. 5.8.1 Changing the standard profiles (default profiles) Profiles Description Standard profiles The profiles can be selected in the Operation - Profiles menu. After switch-off, the settings are reset to the initial values. Richard Wolf profiles The preconfigured Richard Wolf profiles (e.g. urology, gynecology) can be changed or deleted as required. After a reset to the "factory setting", the stored profiles are reinstated. Resetting the user-specific profiles During a reset to the factory settings, the custom profiles are deleted and the Richard Wolf profiles are reinstated. GA-A 274 28 5.9 Profiles Standard profile 1. Dr. Bones 2. TEP hernia 3. New profile Delete profile Save profile Back Custom profiles: In the Profile menu, additional custom profiles can be generated and edited. Please note: In order to store changed parameters, open the user profile again (dis play in red letters) and confirm the settings with Save profile (see the following overviews). Overview - Generating/editing and deleting profiles Select Single step Active Selection possible Up/down by page or paragraph Not active Selection not possible Delete profile Change profile name Generate profile Standard setting profile Standard Standardsetting profile Standard Standardsetting profile Standard 1. New profile 1. Dr. Bones 1. Dr. Bones 2. New profile 2. TEP hernia 2. TEP hernia 3. New profile 3. Save profile Please enter profile name: 2 1 3 F Q A Y 5 C D X Dr. Bones 4 E S 6 T F C Save profile Back Delete profile Z G V C U H B OK Accept new profile name K M P L A Ä Y - E S C D X 5 T F C 6 Z G V C U H B N K M P L Back Delete profile Do you really want to delete the profile? ´ 0 O I Y OK Cancel 9 8 7 New profile Save profile TEP hernia 4 3 F Q Ü Ö ,< . 2 Back Delete profile Please enter profile name: 1 ´ 0 O I Y N 9 8 7 3. New profile Ü Ö ,< . Cancel Accept changed profile name Ä OK Delete profile Cancel Cancel delete Select different profile Standardsetting profile Standard 1. 2. 3. Save profile Dr. Bones TEP hernia New profile Delete profile Back The selected profile is accepted. 29 GA-A 274 Select Overview - Changing the settings in a profile Active Selection possible Example: Change display brightness Not active Selection not possible Select profile Standard profile Select Device-specific functions 1. Dr. Bones Device parameters 2. TEP hernia 3. Dr. Muster Save profile Back Delete profile Back Display Select Device-specific functions Audio Device info Device parameters Language Dr. Bones Dr. Bones Back Back Adjust brightness Display Adjust brightness min. 80 max. Automatic brightness control Back Please note: After changing a parameter, the setting must be saved in the "Profile" menu. Display Audio A red profile name and the red "save profile" button indicate that the changed setting has not yet been saved. Any settings that haven't been saved are lost when changing between the profiles or in case of a restart. Device info Language Dr. Bones Back Select Standard profile 1. Dr. Bones Device-specific functions 2. TEP hernia Device parameters 3. Dr. Muster Dr. Bones Save profile Delete profile Back Back Accept setting GA-A 274 30 5.10 Device parameters Display Overview of device parameters: Via the Device parameters menu, call up the list of submenus for chan ging the parameters. Further parameters, if available, can be displayed using the navigation buttons. Audio Device info Language Back 5.10.1 Adjusting the device parameters Display Adjust brightness min. 80 max. Automatic brightness control Back Volume XXX min. 50 max. Acoustic operator's notes Button sound Back Adjusting the touchscreen brightness: In the Display submenu, the brightness or automatic brightness control of the touchscreen can be selected. The brightness of the touchscreen is adjusted using the (+) and (-) but tons or the slide control, respectively. In the "automatic brightness control" setting manual adjustment is not possible. In this mode, the brightness of the touchscreen is automatically adapted to the brightness of the environment. This avoids poor legibility (too dark) or glare (too bright) of the touchscreen. Volume adjustment: In the Audio submenu, the volume of the key tones, acoustic operator's notes and alarms can be adjusted. To adjust the volume of the audio signals, use the (+) and (-) buttons or the slide control. With the Key tone button or the acoustic operator's notes button acoustic signals for the operation of the keys or operator's notes can be switched off and on. The alarms cannot be switched off. RICHARD WOLF GMBH Device names: Highflow 45 Serial number: XXXXXXXXXX Device number: XXXX MAC address: XX-XX-XX-XX-XX-XX Device info: The device parameters are displayed in the Device info submenu. Back 31 GA-A 274 British English US English Language selection: The "Language" submenu displays the selected language. Here you may select the required language. The navigation buttons can be used to select other languages. German Français Back Selected menu language: Select language and confirm with OK or return to language selection using Cancel. If there is no input for 5 seconds the window will close automatically. XXXXX OK Cancel Do you want to reset the device to factory setting? OK 5.11 Cancel Factory setting: The Factory settings submenu resets all settings to the delivery state. Confirming the factory settings with OK resets all settings and deletes all Profiles (custom settings) and automatically the device is restarted. After the restart the language selection is displayed. This language setting defines the language of the "Standard profile". Display of actual and nominal values Display of numerical value in red = actual value Display of numerical value in gray = nominal value Bar indicator = actual value The nominal value cannot be adjusted via this slider. When touched, the nominal value is displayed in gray as a numerical value. The nominal can be adjusted via this slider. When touched, the nominal value is displayed in gray as a numerical value. GA-A 274 32 5.11.1 Service . General service Device service (protected) ! Message text ! Back 5.11.2 NOTE! All menu screens in the service area are exclusively in English. General service: Service area for the user. Device-related display, resets and settings. Please note: To leave the service area the device must be switched off and then on again. Device service (protected): Only for authorized persons with a password. General service Device info and "Device Info" resets: Display of device-specific parameters (e.g. type/SN). Information - Mainboard "Info WXB": Display of software/hardware information for the mainboard. Information - Function board "Info FB": Display of software/hardware information for the function board. "System Settings": Setting the system ID for the core system (standard = 1). Start and implementation of the touchscreen calibration. "Logfile" protocol: Certain events are recorded (e.g. resets, updates, faults etc.). Activation of software modules: Optional software modules can be activated at a later point in time. The license code for activation can be obtained from the manufacturer. For this purpose it is necessary to specify MAC address (Device Info) of the device. The license code generated by the manufacturer must be entered via the keyboard. Calibrating the touchscreen: Crosshairs appear consecutively in the corners of the display. Try to press on the crosshairs as precisely as possible. When all 4 crosshairs have been actuated, the calibration can be saved with the Confirm Touch Calibration button. The Restart button serves to restart the calibration. The Cancel button stops calibration. 33 GA-A 274 5.12 Operation of INSUFFLATOR Highflow 45 CAUTION! Danger of infection due to unsterile accessories. Sterilize the reprocessable containers and accessories as described in section 6. Discard used disposable items after each use as required by the laws and regulations valid in your country. Follow the sterilization rules for the different products! CAUTION! The products have only limited strength! Applying excessive force will lead to damage, impair the function and endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts. 5.12.1 . IMPORTANT! Before you start laparoscopy observe and carry out the measures de scribed in section 3 "Setup" and section 4 "Checks". . IMPORTANT! Before each use, check the INSUFFLATOR Highflow 45 manually for proper control functions. Important note for using the reprocessable highflow insufflation tube with heating wire The reprocessable highflow insufflation tube with heating wire heats the insufflation gas to body temperature. In the case of low gas flow rates (0.1 l/min - 1 l/min) the tube set temper ature on the outside may exceed 50 °C! The actual gas flow rate depends on the overpressure generated in the abdomen. The preset maximum nominal gas flow is only reached as long as no or only a very slight overpressure is measured in the abdomen. Otherwise, the gas flow is of secondary importance relative to the pres sure, i.e. it may be reduced to less than 1 l/min during the operation even though higher settings were chosen. To avoid possible injuries of the patient, user or others, make sure that the following precautions are observed: D Make sure that the tube set is not connected to the patient for more than 1 minute. D Avoid direct contact between the tube set and the patient. D Before the operation, place the tube set in such a way that it either does not touch the patient at all or that the contact surface is well insu lated (several layers of sterile cloth or gauze between the tube set and the patient). GA-A 274 34 5.12.2 Notes and instruction for using smoke gas evacuation . IMPORTANT! The disposable tube set for smoke gas evacuation must only be used for evacuating smoke gas and not for suctioning off liquids. D Smoke gas evacuation can only be activated in the "Highflow" device mode. D Smoke gas evacuation is not available in Baby mode (option). D The smoke gas evacuation pump is only switched on at pressures > 3 mmHg and is switched off automatically at pressures < 3 mmHg. D Smoke gas evacuation can be activated and deactivated via the touch screen using the Evacuation button or via the footswitch (option). 5.12.3 Creating a pneumoperitoneum Primarily the hospital's own specifications and routines must be followed (primary insufflation via Veress cannula or minilaparotomy (open ac cess)). Firstly select the device mode: "Standard" device mode (access with Veress cannula) D Start primary insufflation by pressing the Insufflation button. D Press the Highflow button to switch to highflow insufflation. "Highflow" device mode (access via minilaparatomy – open access) D Start highflow insufflation using the Insufflation button. 5.12.4 Highflow device mode WARNING! Danger of gas embolism. The "Highflow" device mode should only be used under endoscopic view. . 35 NOTE! If insufflation at a highflow rate is used over a prolonged period of time, the CO2 gas supply may cool down and cause a transitional drop in the gas pressure of the supply container. At the same time an operator's note is displayed. When insufflation is stopped, the original gas pressure will build up again in the supply tank/cylinder. GA-A 274 5.12.5 Measures after carrying out insufflation . IMPORTANT! Close the gas bottle/cylinder valve after the application. Any leaks at bottle/cylinder valve or on the connection can cause the gas bottle/cy linder to be completely emptied after some time. Z Close the gas bottle/cylinder valve. Z Remove and discard the hygiene filter. Z Discard or reprocess, respectively, the insufflation tube. 5.12.6 Possible alarms during the application Overpressure alarm: Possible causes: D The patient strains muscles as the anesthetic effect gets weaker. D The user exerts pressure onto the abdomen. D Additional gas or liquid flow into the abdomen. Gas supply alarm: D See section 5.2.2 5.12.7 Power failure 5.12.8 Taking out of service In the case of a power failure (< 30 s), the selected modes of operation are saved (and remain active). After reestablishing the power supply, you may continue with the setting previously selected. Z To take the device out of service, switch off the power switch and dis connect the device from the power supply / mains. GA-A 274 36 5.13 Overview of operator messages 5.13.1 Structure of operator messages There are 4 different types of messages. The device messages are displayed in the corresponding color together with a symbol and the associated message number, as required by the message type. For certain messages the core system will only display the "Follow messages on device" note. Please note: In the tables, only the last 3 digits of the message number are displayed. Message text XXX-XXX-XXX optional fault correction OK 5.13.2 Message types Symbol Color Green Turqoise Yellow Red 5.13.3 Message type Operator's note LOW error MEDIUM error HIGH error Description Informs about certain events. (Audio signal can be activated/deactivated in the "Audio" menu). Informs the user about imminent dangers. Error of low priority. Informs the user about imminent dangers. Error of medium priority. Indicates severe device errors which exclu des any further control of the device. High-priority faults. ------- 1 alarm pulse Symbol does not blink. 3 alarm pulses Symbol blinks 10 alarm pulses Symbol blinks Functionality of control elements Control element No button OK Description The message window is displayed until the conditions are fulfilled. The message window can be exited. The operation of the device may continue but with limited functions. Audio The audio alarm signals are activated. The audio alarm signals can be switched off by pressing the button. Audio The audio alarm signals are deactivated. Pressing the button switches on the acoustic alarm signals. Service 37 Alarm sequence Once this button is displayed, you can only switch to the "Service" submenu. The device can no longer be operated. GA-A 274 5.13.4 Operator's messages (green) Message number Message text xxx-xxx-005 Connection to core system established xxx-xxx-006 Possible cause Corrective action During the runtime a connection to the core system has been established ' Status message Connection to core system disconnected During the runtime the connection to the core system was inter rupted ' Status message xxx-xxx-007 Language switchover by core system successful Language switchover by the core system ' Status message xxx-xxx-008 Upper range limit reached ------- ' Status message xxx-xxx-009 Lower range limit reached ------- ' Status message xxx-xxx-010 Please wait, the device parameters are being reset! ------- ' Status message xxx-xxx-011 Memory access, please wait ------- ' Status message xxx-xxx-012 Please wait, profile is being deleted ------- ' Status message xxx-xxx-013 Please wait, a new profile is generated ------- ' Status message Maximum number of profile entries is reached xxx-xxx-014 To generate a new profile, an existing profile must Maximum profile entries reached be deleted. xxx-xxx-015 Invalid profile name Please enter profile name again. The name must contain at least 1 alphanumeric character. xxx-xxx-016 The profile name entered already exists Please enter a different name xxx-xxx-018 Incorrect profile name input ' Carry out message Double profile name ' Carry out message To exit the service menu, a device restart is requi Message when logging into the red. service area xxx-xxx-019 Wrong service password ' Carry out message ' Status message Password spelling error ' Status message xxx-xxx-020 Please wait ------- ' Status message xxx-xxx-021 Function cannot be activated ------- ' Status message xxx-xxx-027 Please restart device A device restart is necessary ' Carry out message Gas supply interrupted CO2 pressure sensor defective ' Open gas bottle/cylinder or connect full gas bottle/cylinder ' If this message occurs repeatedly although the gas bottle/cylinder is full and the valve is open, contact the ser vice department Possible cause Corrective action EEPROM memory error ' Confirm with OK button automatic device restart ' If fault occurs again, contact service department Device temperature too high ' Allow the device to cool down ' Carry out a device restart ' If fault occurs again, contact service department Device temperature too low (outside the permissible operating conditions) ' Wait until device temperature meets the required operating conditions Temperature sensor defective ' Contact service department. xxx-xxx-436 xxx-xxx-437 5.13.5 Insufficient gas supply Please check the gas supply LOW error (turqoise) Message number Message text xxx-xxx-017 Profile data not correctly initialized Press "OK" to delete the profile data and set to default values. xxx-xxx-028 xxx-xxx-029 Device temperature too high Please allow the device to cool down xxx-xxx-030 Device temperature too low Please allow the device to warm up xxx-xxx-031 Device error - Temperature sensor defective GA-A 274 38 Message number Message text xxx-xxx-033 Environment light sensor defective Automatic brightness control of display is swit ched off. xxx-xxx-034 to xxx-xxx-036 Device error - No connection to core system pos sible xxx-xxx-037 Possible cause Corrective action Environment light sensor defec tive ' Contact service department. Electronics error ' Carry out a device restart ' If fault occurs again, contact service department Faulty touchscreen calibration The default calibration is used, for recalibration switch to service menu. Saved EEPROM values of the touch calibration are not within the calibration range ' Carry out recalibration on the service level (general service). ' If fault occurs again, contact service department xxx-xxx-038 to xxx-xxx-042 Device error - Faulty initialization, device is not ready Electronics error ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-043 Device error - Data transmission Software error - Internal data transmision ' Contact service department. xxx-xxx-061 Device error - Device not ready Internal operating voltages not okay ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-062 Device error - Faulty initialization, device is not ready Hardware and software versions are not compatible ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-063 Device error - No connection to core system pos sible core processor update faulty ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-064 Device error - type number The type number/model number saved in the device is faulty ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-066 Device error - Initialization failed The device is not ready Electronics error ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-067 Device error - Data transmission Software error - Internal data transmision ' Contact service department. xxx-xxx-400 Device error - Hardware safety activated Device error ' Contact service department. xxx-xxx-403 to xxx-xxx-404 Device error - Pneumatic component Electronics error ' Contact service department. xxx-xxx-405 Device error - Pneumatic test Pneumatic component defective ' Contact service department. xxx-xxx-406 Device error - Hardware incompatible Electronics error ' Carry out a device restart ' If fault occurs again, contact service department xxx-xxx-407 Device error - Smoke gas evacuation module Electronics error ' Contact service department. xxx-xxx-408 Device error - Electronics Electronics error ' Contact service department. xxx-xxx-409 xxx-xxx-410 Device error - Pneumatic component Pneumatic component defective ' Contact service department. xxx-xxx-411 xxx-xxx-412 Device error - Electronics Electronics error ' Contact service department. xxx-xxx-413 Device error - Gas heating module Electronics error ' Contact service department. xxx-xxx-415 Device error - Electronics Electronics error ' Contact service department. xxx-xxx-428 Device error - Gas heating module Electronics error ' Contact service department. xxx-xxx-433 Device error - Data transmission Gas heating module is deactivated Software error - Internal data transmision ' When actuating the OK but ton, the gas heating module is deactivated ' If fault occurs again, contact service department 39 GA-A 274 5.13.6 MEDIUM error (yellow) Message number Message text xxx-xxx-032 Possible cause Corrective action Device error - Temperature sensor defective Temperature sensor defective ' Contact service department. xxx-xxx-044 Device error - Data transmission Software error - Internal data transmision ' Contact service department. xxx-xxx-068 Device error - Data transmission Software error - Internal data transmision ' Contact service department. xxx-xxx-414 Device error - Gas heating module Gas heating module is deactivated Electronics error ' When actuating the OK but ton, the gas heating module is deactivated ' If fault occurs again, contact service department xxx-xxx-417 to xxx-xxx-419 Device error - Pneumatic component Electronics error ' Contact service department. xxx-xxx-421 Device error - Smoke gas evacuation module Electronics error ' Contact service department. xxx-xxx-422 Device error - Pneumatic component Pneumatic component defective ' Contact service department. xxx-xxx-424 Device error - No input pressure Gas supply interrupted CO2 pressure sensor defective ' Open gas bottle/cylinder or connect full gas bottle/cylinder ' If this message occurs repeatedly although the gas bottle/cylinder is full and the valve is open, contact the ser vice department xxx-xxx-425 Device error - Pneumatic component Pneumatic component defective ' Contact service department. xxx-xxx-427 Device error - Electronics Electronics error ' Contact service department. xxx-xxx-429 xxx-xxx-430 Device error - Gas heating module Electronics error ' Contact service department. Possible cause Corrective action Device error ' Contact service department. Overpressure alarm pressure > 30 mmHg (mercury column) for more than 5 s ' Decrease intraabdominal pressure 5.13.7 HIGH error (red) Message number Message text xxx-xxx-401 Device error - Hardware safety activated xxx-xxx-402 Critical overpressure > 30 mmHg (mercury co lumn) xxx-xxx-416 Device error - Electronics Electronics error ' Contact service department. xxx-xxx-420 Device error - Pneumatic component Electronics error ' Contact service department. xxx-xxx-423 Device error - Electronics Electronics error ' Contact service department. xxx-xxx-426 Device error - Software Software error ' Contact service department. GA-A 274 40 6 Operation within the core system 6.1 Functional principle within the core system In normal operation, the device can be controlled via the core system using the touchscreen monitor, optional voice control as well as the con trols of the device itself. . 6.2 IMPORTANT! Should the core system fail, the device can still be controlled manually via the controls on the device itself. For a description please refer to the in struction manual of the respective device. Combining and controlling the device Via the integrated CAN BUS interface the device can be integrated in the Richard Wolf core system . At the CAN BUS interface only the components approved for use with the core system can be used. The components must fulfill the requirements in accordance with the cur rent instruction manual for the core system, section on "Possible combi nations". The control computer complies with IEC / EN 60601-1 and may therefore be used in the patient environment. Further descriptions of use: D Follow the latest instruction manual for the core system. D For the operation, menu structure, software updates and configurations follow the latest version of the core.software manual. D For a detailed understanding of the device and menu functions, follow the instruction manuals of the connected devices. 6.3 Setting the system ID Z Make sure that the same system IDs are set on the insufflator and on the camera controller as otherwise these devices cannot communicate with each other. ' The system ID for this device can be found/set in the Device para meters - Service - General service - System Settings menu (see sec tion 5). 41 GA-A 274 6.4 Connection to the core system Touchscreen monitor RIWO CONTROL core.control USB headset connector CAN BUS e.g. INSUFFLATOR Highflow 45 CAN BUS e.g. HIGHLIGHT X300 light projector CAN BUS e.g. Camera CAN BUS termination . IMPORTANT! The device system must be operated via a "galvanically isolated transformer". . IMPORTANT! The last device in the CAN BUS chain must be terminated using the supplied terminating resistor. GA-A 274 42 7 Reprocessing and maintenance 7.1 Reprocessing of device WARNING! Prevent humidity from entering the device. Danger of electric shock! Before reprocessing switch off and disconnect the device from the power supply / mains. Clean the device with a soft cloth moistened with surface disinfectant, alcohol or spirit. Follow the disinfectant manufacturer's instructions! 7.2 . NOTE! For a description of the surface cleaning and disinfecting agents for devices and universal device carts / trolleys and utility carts approved by Richard Wolf, please refer to manual GA-J020 "Reprocessing of RICHARD WOLF Heat-stable Instruments". . IMPORTANT! Make sure that no humidity enters the device. Do not use any cleaning agents, scouring agents or solvents on this device. Reprocessing of reusable insufflation tubes . IMPORTANT! Follow the latest notes and instructions in manual GA-J 020, “Reproces sing of RICHARD WOLF heat-stable instruments“. Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of Ri chard Wolf products. Strictly adhere to the maximum immersion time in the disinfectants used, as described by the manufacturers. WARNING! Do not reprocess disposable items! The service life of products marked as disposable i.e. for single use only, has been designed for only one use in or on a single patient. If disposable items are reprocessed to be used again, a deterioration of the product quality cannot be excluded, which will endanger the patient, the user and others. In this case, the manufacturer can no longer guarantee product safety and performance. 43 GA-A 274 7.2.1 Cleaning 7.2.2 Sterilization 7.3 Reprocessing of reusable highflow insufflation tube with heating wire Z Rinse out the tubes with a cleaning gun and dry with compressed air. Steam sterilization: Z Steam sterilization using a fractional pre-vacuum procedure at 134 C (272 F). Z For the reprocessing follow the manual of the reprocessable highflow insufflation tube with heating wire used. 7.4 Maintenance . IMPORTANT! In the case of inquiries or in your correspondence please always indicate the product number and the serial number listed on the identification plate. Further documentation is available from the manufacturer on re quest. Service hotline: 7.4.1 7.5 7.5.1 Phone: Fax: +49-(0)-7043/35-389 +49-(0)-7043/35-1209 Maintenance intervals . IMPORTANT! To avoid any incidents or damage caused by aging and wear it is neces sary to service the product and the accessories at adequate intervals. Depending on the frequency of use, but at least once a year, have an expert check the functional and operational safety of the equipment. . NOTE! A check may only be carried out by qualified operator staff. If the spe cified measured values and tolerances are not met, the device must be checked by an authorized service technician. . IMPORTANT! The device must not be used if the specified values are not displayed or functions are not fulfilled. Quarterly check Measuring and test equipment - Insufflation tube (8170.101), original length 2.5 m - Hygiene filter (4171.111) - Transparent container (measuring cup) GA-A 274 44 7.5.2 Checking the pressure and flow control Primary insufflation: Z Preselect the following nominal pressure: 12 mmHg (mercury column) Z Connect the hygiene filter and insufflation tube to the insufflation con nector. Z Start insufflation. ' The current flow rate must agree with the preselected flow rate of 1 l/min. ' Permissible tolerance: ¦ 0.5 l/min Z Close the insufflation tube with your thumb. ' As soon as the current pressure exceeds the preselected pressure, the device must release pressure. Z Switch off insufflation and open the insufflation tube. Highflow: D Preselect the following nominal pressure: 12 mmHg (mercury column) D Preselected the following flow rate: 10 l/min Z Start insufflation, then switch over to Highflow. ' The current flow rate must agree with the preselected flow rate of 10 l/min. ' Permissible tolerance: ¦ 2.0 l/min Z Close the insufflation tube with your thumb. ' As soon as the current pressure exceeds the preselected pressure, the device must release pressure. Z Open the insufflation tube. Z Switch back from highflow to primary insufflation. ' After 1.5 s at the latest, a flow rate of 1 l/min ¦0.5 l/min must be dis played. Z Switch off insufflation. 7.5.3 Leakage test Z Preselect the following nominal pressure: 12 mmHg (mercury column) Z Fill a transparent container (e.g. measuring cup) with water. Z Immerse the patient end of the insufflation tube approx. 5 - 10 cm into the water (5 - 10 cm below the surface). Z Start insufflation. ' Gas bubbles must be observed at the end of the tube. Z Switch off insufflation. ' No gas bubbles must emerge from the end of the tube. Z After the end of the test, the insufflation tube must be removed from the water container immediately as otherwise vacuum may pull water into the tube. 45 GA-A 274 8 Technical description 8.1 Troubleshooting . IMPORTANT! If the faults cannot be corrected with the help of this table, please contact our service department or return the device for repair. 'Do not attempt to do any repairs yourself! Errors Possible cause Corrective action Device is not functional Power switch is not on 'Actuate the power switch Power cable is not connected 'Connect the power cable Fuse in device is defective 'Replace the fuse No line voltage/mains 'Check in-house power supply Insufflation not activated 'Switch on insufflation Gas bottle/cylinder empty or not open 'Replace or open gas bottle/cylinder As a result of manipulations of the user, the abdominal pressure increa ses 'Remove cause Device defective 'Contact the service dept. No gas flow Preselected pressure is exceeded Other devices cause a pressure incre 'Remove cause ase Pressure won't build up Smoke gas evacuation won't start Tube system is leaking 'Check tube and connectors Flow preselection is to low 'Increase flow preselection Instrument stopcock is closed 'Open instrument stopcock Pressure < 3 mmHg 'Generate pressure > 3 mmHg Evacuation not actuated 'Actuate evacuation 'Open evacuation tube 8.1.1 Fault in the core system Errors Possible cause Corrective action 'Check connections Device is not logged in the core system Data transfer error 'Replace CAN BUS cable 'Set to the same system ID 'Contact the service dept. GA-A 274 46 8.2 Technical data Voltage Frequency Current rating A Fuse Hz Power consumption VA Vμ 2235001 2235011 100-240 50 / 60 60 0.6 - 0.2 T 3.15 H 2235021 2235031 100-127 / 220-240 50 / 60 80 0.8 - 0.3 T 3.15 H 2235601 (USA) 2235611 (USA) 100-240 50 / 60 60 0.6 - 0.2 T 3.15 H 2235621 (USA) 2235631 (USA) 100-127 / 220-240 50 / 60 80 0.8 - 0.3 T 3.15 H Product no. Electromagnetic compatibility EMC to IEC / EN 60601-1-2 Medical devices directive 93/42/EEC Class IIb Protection against electric shock Type CF applied part Safety class to IEC / EN 60601-1 ; (UL 60601-1 / CSA C22.2 No.601.1 - for USA) I Degree of protection against the ingress of liquids IP 20 (not protected) Mode / duty factor Continuous operation Degree of protection when flammable mixtures are present Dimensions WxHxD 300 mm x 160 mm x 455 Application parameters Insufflation medium Input pressures Intraabdominal pressure Gas flow rate, primary filling Gas flow rate highflow Consumption indicator Gas temperature with heating tube 47 This device is not protected against explosions (Do not operate this device in ignitable atmosphere) 8.9 kg (19.5 lbs) to 12.8 kg (28.1 lbs) (depending on configuration) Weight 8.2.1 A med. CO2 (degree of purity > 99.5 %) 4 bar to 7.5 bar 3 mmHg to 25 mmHg (¦ 2 mmHg) preselectable in increments of 1 mmHg (mercury column) 1 l/min (¦ 50 %) Depending on device mode 2 l/min to 45 l/min (¦ 20 %), selectable in increments of 1 l/min 0 l to 999 l (¦ 20 %) 37 ºC ¦ 2 ºC GA-A 274 8.2.2 Pressure and flow values Device mode Pressure values min. / max. Flow values min. / max. Default min.: 3 mmHg (mercury column) max.: 25 mmHg (mercury column) Primary insufflation (1l/min) min.: 2 l/min max.: 45 l/min Highflow min.: 3 mmHg (mercury column) max.: 25 mmHg (mercury column) min: 2 l/min max.: 45 l/min Baby mode (option) min.: 3 mmHg (mercury column) max.: 20 mmHg (mercury column) min.: 0,1 l/min max.: 2 l/min TEM (option) min.: 3 mmHg (mercury column) max.: 25 mmHg (mercury column) Primary insufflation (1l/min) min.: 2 l/min max.: 8 l/min Continuous flow (option) min.: 3 mmHg (mercury column) max.: 25 mmHg (mercury column) Primary insufflation (1l/min) min.: 2 l/min max.: 8 l/min Gynecology min.: 3 mmHg (mercury column) max.: 25 mmHg (mercury column) Primary insufflation (1l/min) min.: 2 l/min max.: 45 l/min Urology min.: 3 mmHg (mercury column) max.: 25 mmHg (mercury column) Primary insufflation (1l/min) min.: 2 l/min max.: 45 l/min 8.2.3 Interfaces Gas connection Connection for hygiene filter NIST connector to EN 739 for CO2 Conical connector, dia. 15.0 mm, DIN ISO 5356 T1 Power supply connection for highflow insufflation tube with heating wire, reprocessable 5-pin socket, small Power supply connection for disposable highflow insuf flation tube with heating wire 5-pin socket, large Connector for smoke gas evacuation CAN BUS interface Service interface GA-A 274 Conical connector, dia. 15.0 mm, DIN ISO 5356 T1 Sub-D socket, 9-pin RJ 45 48 8.2.4 Optional device variants Options INSUFFLATOR Highflow 45 BASIC INSUFFLATOR Highflow 45 EVAC INSUFFLATOR Highflow 45 HEAT INSUFFLATOR Highflow 45 EVAC + HEAT (Basic version) (Basic version with smoke gas evacuation) (Basic version with gas heating) (Basic version with smoke gas evacuation and gas heating) 2235001 2235011 2235021 2235031 Software module 1 Connection to core (CAN BUS) Software module 2 Baby mode Software module 4 Continuous flow mode (TEM + LAP max. 8 l/min) TEM LAP ---- ---- Device mode Default Device mode Highflow Device mode Baby mode * 1) 1) 1) 1) Device mode TEM ----- 2) ----- 2) Device mode Continuous flow 2) 2) 2) 2) Software module 3 Video on-screen display with dialog (CAN BUS) = standard equipment = option 1) = only in conjunction with software module 2 = possible ----- = not possible 2) = only in conjunction with software module 4 * = In "Baby mode" evacuation and highflow cannot be activated and are masked off. 8.3 Operating, storage, transport and shipping Operating conditions + 10ºC to + 40ºC , 30% to 75% rel. humidity atmospheric pressure 700 hPa to 1060 hPa Storage, transport and shipping conditions - 20ºC to + 60ºC, 10% to 90% rel. humidity atmospheric pressure 700 hPa to 1060 hPa . NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material. 49 GA-A 274 8.4 Spare parts and accessories Product no. Designation 64268.007 Device fuse T 3.15 H (pack of 10) 2440.03 Power cable (Europe), 3.0 m 8170.101 Insufflation tube, dia. 5.0 mm, length 2.5 m, reprocessable 8170.232 Highflow insufflation tube, dia. 8.0 mm, length 2.5 m, reprocessable 4170.501 Single-use insufflation tube, length 2.5 m, sterile (pack of 10) 8170202 Highflow insufflation tube with heating wire, length 3.0 m, reprocessable, only 2235021, 2235031 / 2235621, 2235631 4170502 Disposable highflow insufflation tube with heating wire and integrated hygiene filter, sterile (pack of 10), only 2235021, 2235031 / 2235621, 2235631 4170503 Disposable tube set for smoke gas evacuation, sterile (pack of 10), only 2235011, 2235031 / 2235611, 2235631 4170504 Smoke gas blow-off filter, sterile (pack of 10) 4171.111 Hygiene filter, single-use item, sterile (pack of 10) 74021.029 CO2 pressure tube, length 1.5 m 74021.030 Connection tube for centralized CO2 gas supply (Dräger), length 5.0 m 74021.035 Connection tube for centralized CO2 gas supply (Air Liquide), length 5.0 m 74007.056 Pressure reducing valve for CO2, ISO 5145 74007.054 Pressure reducing valve for CO2, DIN EN 738-1 74007.055 Pressure reducing valve for CO2, DIN EN ISO 707 (PIN Index) 74002.267 Space seal for bottle/cylinder connection on pressure reducing valve, ISO 5145 2221.951 Bottle holding bracket, houses CO2 bottles, ( 80 to 90 mm) 2221.952 Bottle holding bracket, houses CO2 bottles, ( 100 to 115 mm) 2046.961 0.75 kg CO2 bottle (approx. 350 l CO2) with DIN connector, ( 80 mm) 2030.1031 Single-pedal footswitch for smoke gas evacuation 35100.115 Silencer (pack of 3), only 2235011, 2235031 / 2235611, 2235631 ' Further accessories on request ISO connector (ISO 5145) DIN connector (DIN EN 738-1) PIN Index connector (DIN EN ISO 407) The products can be combined as required provided the relevant technical data and intended uses are observed. For the total overview please refer to the latest catalog sheets and brochures or contact Richard Wolf or your representative. GA-A 274 50 8.5 Replacing parts 8.5.1 Device fuses CAUTION! The specifications of the device fuses must correspond with the fuse ra tings on the identification plate. Use only the fuses specified in the spare parts list. L Power input connector with fuse holder 1 2 2 3 Z Switch off the device and disconnect the power cable from the wall socket and from the power input connector of the device. Z Unscrew the fuse holder [1] using a screwdriver. Z Take the fuses [2] out of the fuse holder [1] and replace. Z Reinsert the fuse holder and push until it clicks in place [3]. 8.5.2 51 Disposal of product, packaging material and accessories For the disposal follow the laws and regulations valid in your country. ' For further information please contact the manufacturer. GA-A 274
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