Instructions for Use en D AF R Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures T P31693 Rev.
en This instructions for use contains information that is subject to copyright. All rights reserved. This instructions for use should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the approval of W.O.M. WORLD OF MEDICINE GmbH. We reserve the right to technical changes without prior notification due to the continuous further development of our products. Function or design may partially differ from the description in the instructions for use.
Symbols Symbols Follow instructions for use (white image on a blue background) Use by date (YYYY-MM-DD) en Quantity Caution Keep dry Type CF applied part D Top-Bottom Equipotentiality Degrees of protection provided by enclosures (IPCode) Fragile Keep away from sunlight Service Protect from heat and radioactive sources R Alternating current Do not use if package is damaged Serial number Humidity limitation Batch code Atmospheric pressure limitation Do not reuse Temperature limit Do not r
Symbols en Authorized for Sale or use by Physician only Stryker European Representative Non-ionizing electomagnetic radiation Complies with Australian regulatory requirements D Complies to IEC 60601-1 including US and Canadian deviations in their respective valid version Data transmission port (see Using Device Control instructions for detail) R Only for service Caution: Hot Air Out AF Quality Seal. Unbroken seal indicates the product has not been tampered with or serviced.
Table of Contents Important User Notes ............................................................................................................................................................................................... 7 2 Safety Information ..................................................................................................................................................................................................... 8 3 General Information ................................
en 10 Annual Inspection..................................................................................................................................................................................................... 58 10.1 Electrical Safety Test .................................................................................................................................................................................... 58 10.2 Basic Function Test (in Standard Operating Mode) .....................
Important User Notes 1 Important User Notes en Read the instructions for use carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing or service personnel, or • damages or malfunction of device and/or accessories.
Safety Information en 2 Safety Information Federal Law (only for U.S. market) CAUTION! Federal law restricts this device to sale by or on the order of a physician.
General Information 3 General Information 3.1 Device Description en The device PNEUMOCLEAR™ is an insufflator and serves to create a cavity through the insufflation of CO2 with a preset flow rate and pressure. The gas will be transported to the patient via a tube connected with a trocar. The insufflator limits the pressure to a maximum of 30 mmHg and the flow rate to a maximum of 50 l/min.
General Information during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery. en 3.2.2 Contraindications The device should not be used to fill a cavity with CO2 if an endoscopy is contraindicated. Please consult the manual of your endoscope for absolute and relative contraindications.
General Information en WARNING! Replace the fuse Replace the fuse only with a fuse provided by the manufacturer (see Chapter Accessories [} 69]). WARNING! Professional qualification The instructions for use do not include descriptions or instructions for surgical procedures/techniques. It is not suitable for training physicians in the use of surgical techniques.
General Information en WARNING! Removing the insufflation tube Always disconnect the insufflation tube after ending surgery and before switching off the device to prevent backflow of bodily fluids. Fluid may penetrate the insufflation tube whenever you change the gas bottle and/or when you stop the gas flow during the operation. If this happens, you must immediately disconnect the insufflation tube from the trocar or from the device.
General Information en WARNING! Insufflation of CO2 The insufflation of CO2 should be done carefully and while monitoring the patient's response. The user, particularly the anesthetist, should be informed about possible cardiovascular and respiratory problems of the patient and monitor these intra-operatively. WARNING! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (e.g.
General Information 3.3.2 en Warnings Standard and High Flow/Bariatric Operating Mode WARNING! Idiosyncratic reactions Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reaction). WARNING! CO2 absorption D CO2 is absorbed during insufflation (intravasation). This means the body absorbs a part the CO2 gas used for insufflation.
General Information en WARNING! Dehydration Insufflation can lead to dehydration of the tissue, especially if the surgery time is prolonged. This can lead to damage of peritoneal cell structures within the tissue. Insufflation, especially with unconditioned gas, is associated with post-operative pain. Long surgeries and large leaks increase the risk of dehydration especially at the insertion points of the trocars. The use of humidified and prewarmed gas can reduce risks associated with tissue dehydration.
General Information en WARNING! CO2 supersaturation To avoid generating CO2 supersaturation, an increased level of respiratory activity is required. An overweight patient's oxygen demand and carbon dioxide production are greater and increase faster under physical stress than do those of patients with normal body weight.
General Information en WARNING! Haemodynamic stability A laparoscopy performed on children younger than 12 years of age may result in problems of the haemodynamic system due to the CO2 content in the blood. It is recommended to increase the breathing rate of the patient and to work with low flow values and pressure values not exceeding 12 mmHg. The patient's circulatory system should be monitored at all times.
General Information en WARNING! Dehydration Insufflation can lead to dehydration of the tissue, especially if the surgery time is prolonged. This can lead to damage of peritoneal cell structures within the tissue. Insufflation, especially with unconditioned gas, is associated with post-operative pain. Long surgeries and large leaks increase the risk of dehydration especially at the insertion points of the trocars. The use of humidified and prewarmed gas can reduce risks associated with tissue dehydration.
General Information en WARNING! Lowest gas flow and pressure Depending on age and health condition of the patient, the smallest possible gas flow and pressure for establishing the cavity should be selected. It is not recommended to exceed insufflation pressures of 15 mmHg in transanal minimally invasive surgery procedures. 3.4 General Precautions CAUTION! Continuous operation D After 24 hours of continuous operation, a device self-test must be carried out. Switch device off and on again.
General Information en CAUTION! Service connection Service connection is reserved for service tasks . The connected equipment must comply with the standard EN 60950 in the currently valid version. Do not connect a device to the service connection during surgery.
Initial Device Setup 4 Initial Device Setup en The operation of the device PNEUMOCLEAR™ is reserved for medical staff with the relevant professional qualifications trained to use the device. NOTE! Locations The device may be used only in the hospital or operating rooms. Delivery inspection If it becomes necessary to return the device, always use the original packaging.
Initial Device Setup en CAUTION! Position of the user To ensure safe operations of the device, the user must be positioned correctly towards the device • within a display viewing angle of ±50° to operate the device, • up to 2 m/6.5 ft from the device front for monitoring the actual values. NOTE! Device Control The device may be optionally controlled via Stryker's central device control in the operating room.
Initial Device Setup 4.3 Rear of the Device en Fig.
Initial Device Setup en Angled gas connector An angled connector is available to reduce the depth needed for the installation of the device. This connector includes the exchangeable sinter filter and allows the use of the different gas supply adapters described below as well. Fig. 4–3 Connecting the gas supply to the angled gas connector D 4.4.1 Connecting a Gas Bottle WARNING! Keep filled CO2 bottle on hand R Always keep a filled CO2 bottle on hand ready for replacement.
Initial Device Setup Switching valve en There is a switching valve available that allows the connection of two gas bottles to the insufflator. This ensures uninterrupted insufflation particularly during the change of the gas bottle. 4.4.2 Connecting to Central Gas Supply The following low-pressure hoses are available for connecting to the central gas supply: Low-pressure hoses Designation Hose for CO2 central gas supply DISS-DISS, 0.
Initial Device Setup en Icon Description < 10 bar /145 psi - 4 bar /58 psi. Acoustic signals can be heard and a message is displayed. Replace the gas bottle. (red) < 4 bar /58 psi - 0 bar / 0 psi. Acoustic signals can be heard and a message is displayed. Immediately replace the gas bottle. (red) Central gas supply The following central gas supply icons are displayed: Icon Description D Central gas supply pressure OK (green) Central gas supply pressure too low (red) Switching Device On R 4.
Initial Device Setup en WARNING! Never pull on the cable Always hold on to the power plug when disconnecting the device from the power supply. Never pull on the cable itself. WARNING! Power supply Disconnection from the power supply is only guaranteed if the mains plug is pulled from the mains wall socket.
Operating the Device - General en 5 Operating the Device - General 5.1 Monitor with Touch Screen Fig.
Operating the Device - General Disposable tube set with: en • Filter SMOKE EVACUATION HIGH-FLOW TUBE SET • Lumen for smoke evacuation with filter To be used with the following operating modes: (0620050250/black) Standard, - Pediatric, - HighFlow/Bariatric, - Advanced Flow, - TAMIS Disposable tube set with: • Filter • Gas heating • Gas humidification HEATED HUMIDIFIED TUBE SET D To be used with the following operating modes: (0620050300/red) Standard, - Pediatric, - HighFlow/Bariatric, - Advanced
Operating the Device - General en WARNING! Air in the insufflation tube set Air in the insufflation tube set can cause an embolism. Start the insufflation before the tube set is connected to the patient to push the air out of the insufflation tube set. Stop the insufflation when at least 1 liter of CO2 has been insufflated. Connecting the tube set 1. Align the bottom of the tube set connector with the bottom of the receptacle on the front of the insufflator, 2.
Operating the Device - General Icon Description Information Gas heater OK Gas heating function is available. en (green) Insufflation is automatically stopped and the heating function is deactivated. There are three options to continue insufflation: Safety Feature Warning (red) Insufflation paused due to gas exceeding 43 °C/109 °F. Insufflation will resume shortly. • Wait until the temperature has decreased below 43 °C, insufflation and heating will resume automatically.
Operating the Device - General To enable this function, insert a valid tube set and then press the Smoke evacuation button (11). Use the +/- buttons (see Fig. Smoke evacuation indicator [} 31] (10)/(12)) to increase or reduce the extraction intensity. The smoke evacuation rate can be manually set to the following rates: 1, 2, 3, and 4. en Not all rates are available in all operating modes.
Operating the Device - General Smoke evacuation icons Description Information This icon means that the smoke evacuation function is paused. To switch off this function, press this icon. en Smoke evacuation is automatically paused if: Smoke evacuation function is paused. • the abdominal pressure is too low, • the insufflation line is plugged or closed, • or the smoke evacuation line is plugged or closed. (yellow) Smoke evacuation will automatically resume once the preconditions are restored again.
Operating the Device - General en Fig. 5–5 Insufflation gas humidification indicator (5) Humidification icon (blue) (5) D R Refilling NOTE! To refill the tube set AF The humidification tube set provides approximately 200 l of humidified gas when filled with water or saline. After 200 l of gas have been consumed, the tube set can still be used, however, in order to maintain a high level of humidity, the tube set should be refilled every 200 to 300 l of consumed gas.
Operating the Device - General 5.7 Using Device Control Please consult the additional documentation of SDC3 HD Information Management System for information about settings, use, and troubleshooting before connecting the insufflator to it. Physicians and medical or care and support personnel must be thoroughly familiar with the setup and operation of the Stryker Device Control. Documentation The insufflator is prepared for the Stryker Device Control which can be used optionally.
Operating the Device - General 5.8 en Unlocking Operating Modes The device can be equipped with up to 6 procedure modes.
Operating the Device - General 5.11 Setting the Nominal Flow - All Operating Modes en To set the nominal flow, press the + or - buttons (see Fig. Screen displays [} 28] (10)/(12)) on the display below the actual gas flow display. • With every touch of the + or - button the nominal flow is increased/reduced in steps of 1 l/min. When working within the range of 0.1 to 2 l/min in Pediatric Operating Mode, the value is increased/reduced by 0.1 l/min.
Operating the Device - General en WARNING! Functional test The functional test must be successfully completed prior to each surgery. WARNING! Fill the tube set with CO2 For the safety of the patient please fill the tube set with CO2 gas prior to beginning the insufflation by activating the insufflation for a few seconds and then turning it off again before introducing the insufflation instrument to the cavity and beginning the surgery.
Operating the Device - General en WARNING! Leaky insufflation tube Never work with a leaky insufflation tube, accessory, and/or device. This can lead to an incorrect measurement of the actual pressure values, which can cause an uncontrolled pressure increase in the abdomen. Choose desired operating mode, pressure and flow settings and continue with procedure. 5.
Operating the Device - General 5.15 en Desufflation The Desufflation function allows for the remaining CO2 in the cavity to be removed to a pressure of approximately 3 mmHg after insufflation has been stopped. Desufflation is available after the insufflation when a smoke evacuation tube is connected. After stopping, a query is displayed asking whether the desufflation function should be started. Fig. 5–7 Confirming or denying desufflation D R The display shows Desufflation active.
Operating Modes of the PNEUMOCLEAR™ Insufflator 6 Operating Modes of the PNEUMOCLEAR™ Insufflator en CAUTION! Deviation between cavity pressure and pressure display The insufflator measures the pressure via the tube set. Using a tight trocar/instrument combination limits the equalization of pressure between cavity and tube set. Consequently, the device potentially displays a pressure that is higher than the pressure in the cavity. This can lead to a decrease of the distention performance.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! CO2 absorption CO2 is absorbed during insufflation (intravasation). This means the body absorbs a part the CO2 gas used for insufflation. CO2 concentrations in the blood or respiratory system that are too high can lead to death of the patient in extreme cases. To lower this risk, always carefully and closely monitor the patient's vital signs during the entire insufflation process and make sure patient is breathing well.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! Embolism/insufflation of internal organs Improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! CO2 absorption CO2 is absorbed during insufflation (intravasation). This means the body absorbs a part the CO2 gas used for insufflation. CO2 concentrations in the blood or respiratory system that are too high can lead to death of the patient in extreme cases. To lower this risk, always carefully and closely monitor the patient's vital signs during the entire insufflation process and make sure patient is breathing well.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! Embolism/insufflation of internal organs Improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! Heart and cardiovascular insufficiency Constantly monitor all heart and cardiovascular parameters during surgery since morbidly obese patients have an increased risk of heart and cardiovascular insufficiencies. 6.3 Pediatric Operating Mode The Pediatric operating mode is used to distend the peritoneal cavity during laparoscopic procedures by insufflating CO2.
Operating Modes of the PNEUMOCLEAR™ Insufflator en CAUTION! Low nominal flow setting The nominal pressure cannot be reached in case of leaks if the nominal flow is set too low. WARNING! Procedures with children Only those who are specially trained and qualified for procedures with children or endoscopic vessel harvesting procedures may use this device for these purposes.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! Hypercapnia Because pediatric patients are especially susceptible to hypercapnia, it is recommended to establish an end-tidal CO2 monitoring routine. 6.4 Advanced Flow Operating Mode The Advanced Flow operating mode is used to distend the peritoneal cavity during laparoscopic procedures, including but not limited to robotic-assisted laparoscopies by insufflating CO2. The Advanced Flow operating mode is designed to compensate for large leaks e.
Operating Modes of the PNEUMOCLEAR™ Insufflator en WARNING! Metabolic and cardiac reactions Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregularities expressed with the following symptoms: • Reduced respiration with restricted diaphram function • Hypercapnia • Reduction of venous reflux • Reduced cardiac output • Metabolic acidosis WARNING! D Dehydration Insufflation can lead to dehydration of the tissue, especially if the surgery time is prolonged.
Operating Modes of the PNEUMOCLEAR™ Insufflator 6.6 en TAMIS Operating Mode The TAMIS operating mode is used to dilate and fill the rectum and colon by insufflating CO2 during transanal minimally invasive surgery. Patients The TAMIS operating mode is designed for patients over the age of 14. Insufflation parameters The maximum nominal pressure can be set to 20 mmHg and the maximum gas flow to 40 l/min.
Menu (Overview) 7 Menu (Overview) en Mode and user-dependent device settings can be changed in the menu.
Menu (Overview) en User Menu Display Audio Operating Mode All modes Options Default Brightness 3 Level 1-4 General Volume Level 1-4 3 Audible Occlusion Signal - ON ON - OFF Audible Smoke Evacuation paused Signal OFF - ON - OFF D Gas Supply All modes - House gas - English - Français - Suomi - Deutsch - Greek R Languages All modes House gas - Bottle gas - Español - Svenska - Português - Dansk - Italiano - Polski English - Nederlands - Românã - Korean - Norsk Software version
Safety Functions 8 Safety Functions 8.1 Automatic Venting System en Automatic venting system The device is equipped with an automatic venting system. When the insufflator detects an overpressure it automatically activates the venting system. The venting system releases gas from the cavity until the set nominal pressure has been reached again. The automatic venting system can be configured in the user menu individually for each operating mode.
Safety Functions 8.3 en Contamination WARNING! Contamination Do not use device and/or accessories if signs of contamination are detected. Make sure the device or/and accessories can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. Error message "Contamination" D Contamination When fluid has penetrated the device via the insufflation tube connection, the display depicts Contamination and gives an acoustic signal.
Care and Maintenance 9 Care and Maintenance en Special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories. NOTE! Service or maintenance work Service or maintenance work may not be carried out during surgery. 9.1 Cleaning the Device The manufacturer recommends that the device is cleaned after every procedure as follows: Use the ON/OFF button (push-push) to turn the device off. 2.
Care and Maintenance en Certification Ask the service technician for a certificate after he or she has inspected the unit or performed any service tasks. This certificate lists the type and scope of the service as well as the date and name of the servicing company together with the signature of the service technician. WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Notify the authorized service technicians of any required repairs.
Care and Maintenance The device does not have to be opened to replace the fuse. Fig. 9–1 Opening the fuse holder en D A B C Switch device off. 2. Disconnect device from power supply by pulling the mains plug from the mains socket. 3. Remove power connection cable from mains socket. 4. The fuse holder is located next to the mains socket. 5. Remove fuse holder as depicted in Fig. Opening the fuse holder [} 57]. 6. A Undo the latch of the fuse holder with two fingers. 7.
Annual Inspection en 10 Measured values and tolerances Annual Inspection Each test conducted must be documented with date and signature on the test log. The following measuring tools and resources are required to determine the listed measurements and tolerances: Manometer Range 0-100 mmHg, error class 1 (± 1 % of span) Syringe 60 ml PNEUMOCLEAR™ HIGH-FLOW TUBE SET Silicone tube 4 mm x 40 cm T-adapter 6/4/6 Veress cannula length 100 mm opening diameter 1.4 mm, inner cannula diameter 1.
Annual Inspection 7. Stop insufflation: Press the STOP button. en The following values are displayed: Actual pressure 0.0 (mmHg) Gas consumption > 0.0 (l) 8. Press the gas volume button. Gas consumption 0.0 (l) The basic function check of the device is complete. 10.3 Pressure Sensor Test (Standard Operating Mode) Fig.
Annual Inspection 10.4 en Pressure Monitoring Test (in Standard Operating Mode) See also Chapter Technical Data [} 67]. D 1. In the user menu activate the Venting Valve. 2. Go to the OP Screen. 3. Set the Standard operating mode. 4. Select a nominal pressure of 15 mmHg and a nominal gas flow of 3 l/min. 5. Use the syringe to create pressure between 27 mmHg and 30 mmHg, indicated on the manometer. Start insufflation: Press the START button.
Annual Inspection 3. Connect a manometer (1) and an open Veress cannula (3) to the insufflation tube connection (2). 4. Start insufflation: en Press the START button. The manometer registers a pulsing pressure increase. When the pressure stabilizes, the manometer registers a pressure between 55 and 65 mmHg 5. Stop insufflation: Press the STOP button. 10.7 Gas Flow Rate Test Test setup with open connection, without connected insufflation tube. • Select a nominal gas flow rate of 15 l/min.
Electromagnetic compatibility 11 en Electromagnetic compatibility CAUTION! Accessories To ensure compliance with the requirements of IEC 60601-1-2 in the current version, the device PNEUMOCLEAR™ must be used only with the accessories listed in Chapter Accessories [} 69]. Precautionary measures Medical devices are subject to special safety and protective measures concerning electromagnetic compatibility (hereafter abbreviated as EMC).
Electromagnetic compatibility Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic IEC 61000-3-2 emissions Voltage fluctuations/ emissions IEC 61000-3-3 flicker Compliance Electromagnetic environment - guidance Group 1 The device PNEUMOCLEAR™ uses RF energy solely for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Electromagnetic compatibility IMMUNITY to proximity fields from RF wireless communications equipment en Test method IEC 61000-4-3 Test frequency (MHz) Band (MHz) Service 385 380-390 TETRA 400 430-470 FM GMRS 460, FRS ±5 kHz devi2 460 ation 1 kHz sinus 704-787 LTE Band 13, 17 450 Modulation Maximum power (W) Distance IMMUNITY TEST LEVEL (V/m) (m) Pulse modulation 1.8 18 Hz 0.3 27 0.3 28 0.3 9 GSM 800/900, Pulse moduTETRA 800, IDEN lation 2 820, CDMA 850, 18 Hz LTE Band 5 0.
Error and Warning Messages 12 Error and Warning Messages Error and warning messages Cause en Troubleshooting Electronic error! Restart the device. If the error occurs again Malfunctions in the electronic Restart the device. If the error occurs again, contact switch off device and call ser- system. technical service. vice! Calibration error! The device The device is not calibrated The device must be re-calibrated. Contact technical must be re-calibrated. Call serproperly. service. vice! Serious fault.
Error and Warning Messages en Error and warning messages Cause Troubleshooting Insufflation can be continued in this case, but the heating function is not available. Gas heating defective! Gas heater malfunction. Restart the device if you want to use the heating function. If the gas heating is still defective, have an authorized service technician check or repair the device.
Technical Data 13 Technical Data en Type or model designation: FM300 Production location: W.O.M. WORLD OF MEDICINE GmbH Salzufer 8, 10587 Berlin See display during the automatic device self-test Mains voltage range: AC 100 to 240 V~ Supply frequency range: 50/60 Hz Fuse designation: 2x T 4 A H, 250 V Power consumption: Current (A) Power consumption (VA) Normal operation 100 V AC/60 Hz: 1.05 105 Normal operation 240 V AC/50 Hz: 0.
Technical Data en Essential performance: The function of this device is to maintain pressure in the cavity at the nominal pressure. (Limits, fully functional: 1 to 30 mmHg) Limit, total loss of the identified performance (Normal Condition): Pressure of > 45 mmHg can cause injury to patient and is identified as unacceptable risk. Pressure of < 0 mmHg in abdomen can cause injury to patient (due to instruments perforating tissue) and is identified as unacceptable risk.
Accessories 14 Accessories en Article 0620050800 Premium Upgrade for Advanced Flow and TAMIS Modes User Manual P31693 PNEUMOCLEAR™ User Manual (Americas Version) Language: EN, ES, FR, PT P31694 PNEUMOCLEAR™ User Manual (EU Version 1) Language: EN, DE, FR, NL, PL P31695 PNEUMOCLEAR™ User Manual (EU Version 2) Language: NO, SV, DA, FI P31696 PNEUMOCLEAR™ User Manual (EU Version 3) Language: ES, IT, PT, EL, RO D P31697 PNEUMOCLEAR™ User Manual (Asia version), Language: JA, KO, RU, TR, ZH P31698
Accessories en WARNING! Original accessories For your own safety and that of your patient, use only original accessories.
Warranty and Service 15 Warranty and Service en Warranty: Stryker Endoscopy warrants this product against defects in both materials and workmanship to the registered owner at the time of purchase. All components are covered by the warranty for a period of one year from the date of purchase.
Glossary 16 Glossary en EMC The electromagnetic compatibility describes the ability of a device to function satisfactorily within an electromagnetic environment without adding unacceptable electromagnetic interferences/disturbances to the environment that may cause problems for other devices or equipment located nearby.
Appendix 17 Appendix en Test log Date Result Comment Signature D T AF R 73 / 77
List of Figures en List of Figures Device front............................................................................................................................................................................................ 22 Fig. 4–2 Device rear.............................................................................................................................................................................................. 23 Fig.
Index Index en Measured values and tolerances A Angled gas connector Authorized service technician Authorized trained personnel Automatic venting system 24 8 55 53 C D Care and maintenance Central gas supply Certification Checking the device Connecting the tube set Contamination 8 26 56 38 30 8, 54 D Delivery inspection Disconnect device from power supply Documentation Error message Contamination Essential performance Exchangable sinter filter Exchange of the gas supply adapter Exclusion of liabi
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