Summary of Contents for WORLD OF MEDICINE Stryker PNEUMOCLEAR
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Instructions for Use Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures P31693 Rev. K...
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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.
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Symbols Symbols Use by date (YYYY-MM-DD) Follow instructions for use (white image on a blue back- ground) Quantity Caution Keep dry Type CF applied part Top-Bottom Equipotentiality Degrees of protection Fragile provided by enclosures (IP- Code) Keep away from sunlight Alternating current Protect from heat and radio- Service...
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Symbols Authorized for Sale or use by Physician only Stryker European Represent- ative Non-ionizing electomagnetic radiation Complies with Australian regulatory requirements Complies to IEC 60601-1 in- cluding US and Canadian de- viations in their respective valid version Data transmission port (see Using Device Control in- structions for detail) Only for service...
Table of Contents 1 Important User Notes ....................................... 7 2 Safety Information ........................................ 8 3 General Information ........................................ 9 Device Description...................................... 9 Intended Use and Contraindications ................................. 9 3.2.1 Intended Use ........................................ 9 3.2.2 Contraindications ..................................... 10 Warnings......................................... 10 3.3.1 General Warnings CO Insufflation .............................. 10 3.3.2 Warnings Standard and High Flow/Bariatric Operating Mode.................... 14...
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10 Annual Inspection........................................ 58 10.1 Electrical Safety Test .................................... 58 10.2 Basic Function Test (in Standard Operating Mode) .......................... 58 10.3 Pressure Sensor Test (Standard Operating Mode) .......................... 59 10.4 Pressure Monitoring Test (in Standard Operating Mode) ........................ 60 10.5 Venting Valve Test...................................... 60 10.6 Maximum Device Pressure Test ................................
Important User Notes Important User Notes 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 •...
Safety Information 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. Exclusion of liability The manufacturer is not liable for direct or consequential damages, and the war- ranty becomes null and void if: •...
General Information General Information Device Description The device PNEUMOCLEAR™ is an insufflator and serves to create a cavity through the insufflation of CO with a preset flow rate and pressure. The gas will be trans- ported 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 CO gas during transanal minimally invasive surgery. 3.2.2 Contraindications The device should not be used to fill a cavity with CO...
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General Information WARNING! Replace the fuse Replace the fuse only with a fuse provided by the manufacturer (see Chapter Ac- cessories [} 69]). WARNING! Professional qualification The instructions for use do not include descriptions or instructions for surgical pro- cedures/techniques. It is not suitable for training physicians in the use of surgical techniques.
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General Information 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 insuffla- tion tube whenever you change the gas bottle and/or when you stop the gas flow during the operation.
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General Information WARNING! Insufflation of CO The insufflation of CO 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-op- eratively.
General Information 3.3.2 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 reac- tion). WARNING! absorption is absorbed during insufflation (intravasation). This means the body absorbs a part the CO gas used for insufflation.
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General Information 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.
General Information WARNING! supersaturation To avoid generating CO supersaturation, an increased level of respiratory activity is required. An overweight patient's oxygen demand and carbon dioxide produc- tion are greater and increase faster under physical stress than do those of patients with normal body weight.
General Information 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 CO content in the blood. It is re- commended to increase the breathing rate of the patient and to work with low flow values and pressure values not exceeding 12 mmHg.
General Information 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.
General Information 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 recom- mended to exceed insufflation pressures of 15 mmHg in transanal minimally invas- ive surgery procedures.
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General Information 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. CAUTION! Peripheral Devices Additional peripheral equipment connected to interfaces of the medical monitor has to meet the requirements of the following specifications in the respective cur-...
Initial Device Setup Initial Device Setup 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 Always check all parts and optional accessories of the device immediately after re- ceiving the shipment.
Initial Device Setup CAUTION! Position of the user To ensure safe operations of the device, the user must be positioned correctly to- wards 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...
Initial Device Setup Rear of the Device Fig. 4–2 Device rear (5) Type plate (7) (8) (9) (10) (6) Device data plate (7) USB port (only for authorized service technician) (8) Device Control Interface (9) Data input/output (only for au- thorized service technician) (10) Gas outlet (11) Fuse holder (12) Device mains socket...
Initial Device Setup 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 4.4.1...
Initial Device Setup Switching valve 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 Low-pressure hoses supply:...
Initial Device Setup Icon Description < 10 bar /145 psi - 4 bar /58 psi. Acoustic signals can be heard and a message is dis- played. 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.
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Initial Device Setup 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 Operating the Device - General Monitor with Touch Screen Fig. 5–1 Screen displays (1) Actual pressure display (2) (3) (6) (7) (2) Gas heating status (3) Operating mode display (4) Gas supply display (5) Gas humidification status (6) Reduce nominal gas flow (7) Actual gas flow display (8) Increase nominal gas flow...
Operating the Device - General Disposable tube set with: • Filter • Lumen for smoke evacuation with SMOKE EVACUATION HIGH-FLOW TUBE filter To be used with the following operating (0620050250/black) modes: Standard, - Pediatric, - HighFlow/Bariat- ric, - Advanced Flow, - TAMIS Disposable tube set with: •...
Operating the Device - General 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 CO has been insufflated.
Operating the Device - General Icon Description Information Gas heater OK Gas heating function is available. (green) Insufflation is automatically stopped and the heating function is deac- tivated. There are three options to continue insufflation: Safety Feature Warning • Wait until the temperature has decreased below 43 °C, insufflation Insufflation paused due to gas and heating will resume automatically.
Operating the Device - General To enable this function, insert a valid tube set and then press the Smoke evacu- ation 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.
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. Smoke evacuation is automatically paused if: • the abdominal pressure is too low, Smoke evacuation function is paused.
Operating the Device - General Fig. 5–5 Insufflation gas humidification indicator (5) Humidification icon (blue) Refilling NOTE! To refill the tube set 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 Using Device Control Please consult the additional documentation of SDC3 HD Information Manage- Documentation ment System for information about settings, use, and troubleshooting before con- necting 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.
Operating the Device - General Unlocking Operating Modes The device can be equipped with up to 6 procedure modes. Device Standard Version Device Plus Version High Flow/Bariatric Operating Mode High Flow/Bariatric Operating Mode Standard Operating Mode Standard Operating Mode Pediatric Operating Mode Pediatric Operating Mode Vessel Harvest Operating Mode Vessel Harvest Operating Mode...
Operating the Device - General 5.11 Setting the Nominal Flow - All Operating Modes 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. •...
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Operating the Device - General WARNING! Functional test The functional test must be successfully completed prior to each surgery. WARNING! Fill the tube set with CO For the safety of the patient please fill the tube set with CO 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 begin- ning the surgery.
Operating the Device - General 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 un- controlled pressure increase in the abdomen. Choose desired operating mode, pressure and flow settings and continue with pro- cedure.
Operating the Device - General 5.15 Desufflation The Desufflation function allows for the remaining CO in the cavity to be removed to a pressure of approximately 3 mmHg after insufflation has been stopped. Desuf- flation is available after the insufflation when a smoke evacuation tube is connec- ted.
Operating Modes of the PNEUMOCLEAR™ Insufflator Operating Modes of the PNEUMOCLEAR™ Insufflator CAUTION! Deviation between cavity pressure and pressure display The insufflator measures the pressure via the tube set. Using a tight trocar/instru- ment 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.
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Operating Modes of the PNEUMOCLEAR™ Insufflator WARNING! absorption is absorbed during insufflation (intravasation). This means the body absorbs a part the CO gas used for insufflation. CO concentrations in the blood or respirat- ory 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 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 CO embolisms. To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instru- ment is correctly positioned.
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Operating Modes of the PNEUMOCLEAR™ Insufflator WARNING! absorption is absorbed during insufflation (intravasation). This means the body absorbs a part the CO gas used for insufflation. CO concentrations in the blood or respirat- ory 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.
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Operating Modes of the PNEUMOCLEAR™ Insufflator 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 CO embolisms. To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instru- ment is correctly positioned.
Operating Modes of the PNEUMOCLEAR™ Insufflator 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 insuffi- ciencies. Pediatric Operating Mode The Pediatric operating mode is used to distend the peritoneal cavity during lap- aroscopic procedures by insufflating CO Patients The Pediatric operating mode is designed specifically for use on newborns, infants,...
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Operating Modes of the PNEUMOCLEAR™ Insufflator 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 WARNING! Hypercapnia Because pediatric patients are especially susceptible to hypercapnia, it is recom- mended to establish an end-tidal CO monitoring routine. 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 laparoscop- ies by insufflating CO .
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Operating Modes of the PNEUMOCLEAR™ Insufflator WARNING! Metabolic and cardiac reactions Insufflating CO may result in metabolic acidosis. This can lead to cardiac irregular- ities expressed with the following symptoms: • Reduced respiration with restricted diaphram function • Hypercapnia • Reduction of venous reflux •...
Operating Modes of the PNEUMOCLEAR™ Insufflator TAMIS Operating Mode The TAMIS operating mode is used to dilate and fill the rectum and colon by insuf- flating CO 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 ...
Menu (Overview) Menu (Overview) Mode and user-dependent device settings can be changed in the menu. User Menu Operating Mode Options Default Standard 1 - 15 mmHg 15 mmHg Starting pressure (Operat- High Flow/Bariatric 1 - 15 mmHg 15 mmHg ing mode dependent) Advanced Flow 1 - 15 mmHg 15 mmHg...
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Menu (Overview) User Menu Operating Mode Options Default Brightness Display Audio All modes Level 1-4 General Volume Level 1-4 Audible Occlusion Signal - ON - OFF Audible Smoke Evacuation paused Signal - ON - OFF - House gas Gas Supply All modes House gas - Bottle gas...
Safety Functions Safety Functions Automatic Venting System The device is equipped with an automatic venting system. 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 pres- sure has been reached again.
Safety Functions 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 ser- vice technician conducts the appropriate tests and repairs. Error message "Contamination"...
Care and Maintenance Care and Maintenance Special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories. NOTE! Service or maintenance work Service or maintenance work may not be carried out during surgery. Cleaning the Device The manufacturer recommends that the device is cleaned after every procedure as Manufacturer’s specifications...
Care and Maintenance 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.
Care and Maintenance The device does not have to be opened to replace the fuse. Fig. 9–1 Opening the fuse holder Switch device off. Disconnect device from power supply by pulling the mains plug from the mains socket. Remove power connection cable from mains socket. The fuse holder is located next to the mains socket.
Annual Inspection Annual Inspection Measured values and tolerances 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™...
Annual Inspection Stop insufflation: Press the STOP button. The following values are displayed: Actual pressure 0.0 (mmHg) Gas consumption > 0.0 (l) 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. 10–1 Pressure sensor test setup Manometer (2) Syringe...
Annual Inspection 10.4 Pressure Monitoring Test (in Standard Operating Mode) See also Chapter Technical Data [} 67]. In the user menu activate the Venting Valve. Go to the OP Screen. Set the Standard operating mode. Select a nominal pressure of 15 mmHg and a nominal gas flow of 3 l/min. Use the syringe to create pressure between 27 mmHg and 30 mmHg, indicated on the manometer.
Annual Inspection Connect a manometer (1) and an open Veress cannula (3) to the insufflation tube connection (2). Start insufflation: 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 Stop insufflation: Press the STOP button.
Electromagnetic compatibility Electromagnetic compatibility CAUTION! Accessories To ensure compliance with the requirements of IEC 60601-1-2 in the current ver- sion, 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).
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Electromagnetic compatibility Emissions test Compliance Electromagnetic environment - guidance The device PNEUMOCLEAR™ uses RF energy solely for its internal function. Therefore, its RF emissions are very low RF emissions CISPR 11 Group 1 and are not likely to cause any interference in nearby elec- tronic equipment.
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Electromagnetic compatibility IMMUNITY to proximity fields from RF wireless communications equipment Test method IEC 61000-4-3 Test frequency Band Service Modulation Maximum power Distance IMMUNITY TEST LEVEL (V/m) (MHz) (MHz) Pulse modu- lation 380-390 TETRA 400 18 Hz GMRS 460, FRS ±5 kHz devi- 430-470 ation 1 kHz sinus...
Error and Warning Messages Error and Warning Messages Error and warning messages Cause 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.
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Error and Warning Messages Error and warning messages Cause Troubleshooting Insufflation can be continued in this case, but the heating function is not available. Restart the device if you want to use the heating func- Gas heating defective! Gas heater malfunction. tion.
Technical Data Technical Data Type or model designation: FM300 Production location: W.O.M. WORLD OF MEDICINE GmbH Salzufer 8, 10587 Berlin Software version: 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...
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Technical Data 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 identi- fied as unacceptable risk.
Accessories Accessories 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™...
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Accessories WARNING! Original accessories For your own safety and that of your patient, use only original accessories. 70 / 77...
Warranty and Service Warranty and Service 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. This warranty does not apply to any unit which has been subject to misuse, neglect, improper installation or that which has been altered, adjusted, or tampered with by any person other than Stryker Endoscopy authorized personnel.
Glossary 16 Glossary The electromagnetic compatibility describes the ability of a device to function satisfactorily within an electromagnetic environment without adding unacceptable electromag- netic interferences/disturbances to the environment that may cause problems for other devices or equipment located nearby. ME Device Medical electrical device used for therapy, monitoring or diagnosis of patients, equipped with no more than one con- nection to a supply network and which necessarily comes...
Appendix Appendix Test log Date Result Comment Signature 73 / 77...
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List of Figures List of Figures Fig. 4–1 Device front......................................Fig. 4–2 Device rear......................................Fig. 4–3 Connecting the gas supply to the angled gas connector......................Fig. 4–4 Setting up the device................................... Fig. 5–1 Screen displays ...................................... Fig. 5–2 Smoke evacuation indicator................................Fig. 5–3 Connections of the tube set with smoke evacuation ........................ Fig. 5–4 Filling the gas humidification tube ..............................
Index Index Measured values and tolerances 58 Angled gas connector 24 Authorized service technician 8 Authorized trained personnel 55 Only for U.S. operators 22 Automatic venting system 53 Overpressure 53 Care and maintenance 8 Patients 41, 43, 46, 48 , 50 Central gas supply 26 Potential equalization...
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