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Summary of Contents for ConMed PlumeSafe X5
- Page 1 PlumeSafe ® Smoke Management System Operator’s Manual...
- Page 2 Foreword This Operator’s Manual provides the user with setup and operating instructions for the CONMED PlumeSafe X5 Smoke ® Management System (Smoke Evacuation Unit and Filters). The CONMED PlumeSafe X5 Smoke Management System is a part of the CONMED Multifunction Energy Platform and is ®...
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Page 3: Limited Warranty
CONMED. This warranty is void if the product is used in a manner or for purposes other than intended. Electronic Instructions For Use For the latest version of the CONMED PlumeSafe X5 Smoke Management System Operator’s Manual and for other languages,... -
Page 4: Table Of Contents
Major Components ...........................2 1.4.2 Front Panel ............................3 1.4.3 Rear Panel ............................3 1.4.4 Top Panel ............................4 1.4.5 Bottom Panel............................4 1.4.6 Explanation of Symbols........................5 1.5 Accessory Compatibility ..........................6 1.5.1 CONMED PLUMESAFE X5 Filters......................6 ® 1.5.2 Footswitch ............................6 1.5.3 Cables ............................6 1.5.4 Remote Activation..........................6 1.5.5 Fluid Trap ............................6... - Page 5 6.0 BASIC TROUBLESHOOTING ...........................20 6.1 Noise ...............................20 6.2 Suction ..............................20 6.3 Overheating ..............................20 6.4 Fault Messages ............................20 7.0 MAINTENANCE............................... 21 General Maintenance Information......................... 21 7.2 Equipment Cleaning ........................... 21 7.3 Periodic Inspection............................. 21 7.3.1 WARNING: For Testing or Servicing ....................21 7.4 Transportation, Storage, and Shipment......................
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Page 6: General
X5 Smoke Management System has been designed with a vacuum motor which is ® used to draw the surgical smoke from the surgical site via a smoke evacuation accessory and into the CONMED PlumeSafe ® Smoke Management Filter where the surgical smoke is processed by multiple stages of filtration. Each CONMED PlumeSafe ®... -
Page 7: System Overview
System Overview The CONMED PlumeSafe X5 Smoke Management System features a fully integrated capacitive touchscreen display which allows ® the selection of modes, changes to suction settings, and adjustment of additional settings such as occlusion detection, extended evacuation time, and brightness. This section will provide an overview of how to navigate the PlumeSafe X5 Smoke Management ®... -
Page 8: Front Panel
Product Label: Specifies model number, serial number, Unique Device Identification two-dimensional bar code, nominal line voltages, frequency, current, and CONMED contact information. c. Refer to Instruction Manual Prior to Placing Equipment in Service d. Power and Fuse Rating Label e. -
Page 9: Top Panel
Chassis ground connection is suitable for attachment of standard auxiliary grounding cable when required for additional protection against low-frequency risk current. 1.4.4 Top Panel Figure 1.3: Angled View a. Docking Ports: These ports are designed for electrical docking between the PlumeSafe X5 SEU and MEP-1 ESU. -
Page 10: Explanation Of Symbols
1.4.6 Explanation of Symbols Front Panel and Sides Stand-by push-button Alignment Arrows for docking and/or nesting the SEU and ESU. Touch Screen Display Extended Evacuation Time After Filter Empty Deactivation Service Required Filter Full Increase Suction/Time Extension Open Mode Decrease Suction/Time Extension Electrosurgical Pencil Mode Active continuous suction Laparoscopic Mode... -
Page 11: Conmed Plumesafe ® X5 Filters
NOTE: Refer to eSymbology List: P000022743 Accessory Compatibility As standard practice, CONMED suggests that when considering the use of other manufacturers’ accessories with the CONMED PlumeSafe X5 SEU, customers should consult with the manufacturer to obtain detailed instructions for use and warnings to ®... -
Page 12: Cautions And Warnings
A disposable biohazard bag is provided with each filter. Dispose of filters according to your institution’s hazardous waste procedures and local requirements. • Only CONMED PlumeSafe X5 Smoke Management Filters were demonstrated to be compatible with the CONMED ® PlumeSafe X5 Smoke Management System. Do not use any other filters with this system. -
Page 13: Cautions
X5 Smoke Management System other than replacement of the ® fuses. For all other matters, refer service to CONMED Service. Serious Incidents Immediately report any serious incidents with the use of this device to the CONMED Customer Service Department or your local CONMED representative. Email: CustomerExperience@conmed.com... -
Page 14: Conmed Plumesafe ® X5 Seu Installation
Unpack the smoke evacuation unit, power cord, and filter upon receipt and physically inspect for any obvious damage that may have occurred during shipment. A hospital-qualified biomedical technician should perform this inspection. Notify the carrier and your CONMED representative immediately if any damage is found. -
Page 15: Sealed Unit Connection To Central Evacuation Systems
X5 Smoke Management Filter into filter receptacle. Be sure that the filter is seated completely ® against the bottom of the filter chamber. WARNING: This device is not intended for evacuation of fluid. If fluid is expected to be aspirated using the CONMED PlumeSafe X5 Smoke Management Filter or the CONMED PlumeSafe X5 Smoke Management System, fluid collection devices ®... -
Page 16: Fluid Trap Installation
Press the fluid trap directly onto the 22 mm (7/8”) port. Make sure the fluid trap is secure. 3. The fluid trap may now be connected to any CONMED provided 22 mm (7/8”), 6.35 mm (1/4”), or 9.5 mm (3/8”) accessory at one of the three matching ports on the fluid trap. -
Page 17: Fuse Replacement
6. Replace both fuses using only the recommend voltage/amperage ratings. When placing the new fuses, make sure each fuse is fully seated towards the four exposed prongs of the fuse box. Fuses can be ordered through CONMED Customer Service. Smoke Evacuation Unit... - Page 18 Figure 3.7: Fuse Elements a. Fuse Box Door b. Fuse Box c. Fuse 1 of 2 d. Fuse Box Pry Recess e. Fuse Box Prongs Prying surface Figure 3.8: Fuse Location PRECAUTION: Fuses must be placed nearest the Fuse Box Prongs as shown. If the unit fails to power on, check the position of the fuses.
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Page 19: Touchscreen User Interface And System Controls
4.0 TOUCHSCREEN USER INTERFACE AND SYSTEM CONTROLS The CONMED PlumeSafe X5 SEU features a fully integrated touchscreen display which allows the selection of modes, changes to ® flow, and extended evacuation time settings. This section will provide an overview of how to navigate through the SEU’s touchscreen. -
Page 20: Filter Life Icons
The filter life indicator on the touch screen control panel provides a visual indication of the status of the life of the filter (Figure 4.2: Filter Life). As the filter is used, the filter life indicator for the CONMED PlumeSafe X5 Smoke Management System will ®... - Page 21 If this notification occurs and power-cycling the unit (pressing the standby button) or unplugging the unit from power does not resolve the issue, the unit has become inoperable. Contact CONMED to arrange service of the CONMED PlumeSafe X5 Smoke ®...
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Page 22: Setup For Clinical Use
Automatic Activation of the smoke evacuation unit is possible via the EZLink Automatic Activation Device, Direct Connect Cables, or direct docking with the CONMED MEP-1 ESU. The EZLink device attaches to the electrosurgical pencil cable, senses when the current is flowing through the cable, and then in turn activates smoke evacuation. Similarly, Direct Connect Cables can connect... -
Page 23: Occlusion Detection
Figure 1.2: Rear View. For directions on using the accessory, please see instructions for use that accompany that device. Occlusion Detection The CONMED PlumeSafe X5 Smoke Management System is equipped with occlusion detection for use in Open Tubing mode. ®... -
Page 24: Other Settings
3 seconds of extended suction time. The time extension on the smoke evacuation unit will be added to the time programmed into the EZLink. If the EZLink is programmed to 3 seconds of extension time, and the CONMED PlumeSafe ®... -
Page 25: Basic Troubleshooting
6.0 BASIC TROUBLESHOOTING Noise The higher the suction setting, the greater the noise. Minimize noise by using a lower suction setting. Effectiveness of a lower suction setting can be maximized by using a larger diameter tubing or positioning the tubing closer to the source of smoke, or both. -
Page 26: Maintenance
7.0 MAINTENANCE General Maintenance Information In order to guarantee the basic safety of the system, it is recommended that periodic inspection of the CONMED PlumeSafe ® SEU is performed. Refer to the instructions for use provided with reusable accessories for cleaning instructions. -
Page 27: Specifications
8.0 SPECIFICATIONS Input Power make a table like the one below. Same column for the SEU, add column for voltage (PX5-120 Mains Voltage: 100-240 V, 50-60 Hz and PX5-120NF 100V-120V and for the other 4 Mains Current: 10 A Max. 220V-240V), frequency (50-60Hz) same for all), and mains current (10 A Max same for all) Mains Internal... -
Page 28: Power Cord
PX5-220, PX5-220NF, PX5-220P1, and PX5-220P1NF units are supplied with an IEC-60320 250 V, 10 A. PX5-120 and PX5- 120NF units are supplied with an IEC-60320 125 V, 15 A mains inlet connector. Power cords can be ordered from CONMED. System Dimensions and Weight Smoke Evacuation Unit Weight: 9.53 kg (21.0 lb) - Page 29 Table 8.1: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions. The CONMED PlumeSafe ® SEU is intended for use in the electromagnetic environment specified below. The customer or the end user of the generator should assure that it is used in such an environment.
- Page 30 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The PlumeSafe X5 Smoke Management System is intended for use in the electromagnetic environment specified below. The ® customer or user of the PlumeSafe X5 Smoke Management System should assure that it is used in such an environment. ®...
- Page 31 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The PlumeSafe X5 Smoke Management System is intended for use in the electromagnetic environment specified below. The ® customer or user of the PlumeSafe X5 Smoke Management System should assure that it is used in such an environment. ®...
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Page 32: Radio Frequency Identificaiton
Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the Model @ 3 Vrms The PlumeSafe X5 Smoke Management System is intended for use in the electromagnetic environment in which radiated RF ® disturbances are controlled. The customer or the user of the PlumeSafe X5 Smoke Management System can help prevent ®... -
Page 33: Industry Canada Statement
8.11.2 Industry Canada Statement This device complies with Innovation, Science and Economic Development Canada’s license exempt RSS(s). Operation is subject to the following two conditions: • This device may not cause interference. • This device must accept any interference, including interference that may cause undesired operation of the device. IC ID: 26967-P000023166 HVIN: P000023166 8.11.3 RF Exposure Statement... -
Page 34: Output Characteristics
9.0 OUTPUT CHARACTERISTICS This section contains the CONMED PlumeSafe X5 SEU output characteristics. ® Output Characteristics 9.1.1 Flow, Capture, Sound Output for PX5-120, PX5-120NF, PX5-220, PX5-220NF Units Description Value Max Flow with 7/8 in (22 mm) x 6 ft (1.8 m) Tubing* Max flow with PlumePen Elite 3/8 in (9.5 mm) x 10 ft (3 m) with 7/8”... -
Page 35: Filter Life
9.1.2 Filter Life Illuminated Filter Life Filter Life Remaining Indicators Open Tubing Mode Electrosurgical/Diathermy Pencil Laparoscopic Mode Mode 15.75 to 18 hours 21.88 to 25 hours 30.625 to 35 hours 13.5 to 15.75 hours 18.76 to 21.88 hours 26.25 to 30.625 hours 11.25 to 13.5 hours 15.63 to 18.76 hours 21.875 to 26.25 hours... -
Page 36: Software License Agreement
“Software”); however the availability of some new features, functionality, and Add-Ons may require You to agree to supplemental terms and pay additional fees. In exchange for valuable consideration agreed to by CONMED and You, You are provided with the license rights set forth herein. For the avoidance of any doubt, the Software is licensed, not sold, to You. This Agreement can be superseded by an express written agreement between the CONMED and You. - Page 37 Software or components thereof shall be exclusively owned by CONMED, and Customer (i) agrees to assign and hereby assigns any and all rights, title, and interests in the foregoing to CONMED, (ii) will promptly sign any other documents necessary to perfect CONMED’s rights in and to the foregoing, and (iii) expressly waive any rights Customer may obtain inconsistent with the foregoing through application of law or otherwise;...
- Page 38 Software thereon to CONMED. b. CONMED may terminate this Agreement at any time and for any reason in its sole discretion by 30 days written notice to You. In addition, this Agreement will terminate immediately and automatically without any notice if You violate any of the terms and conditions of this Agreement or if there is a safety recall of the Product or Software.
- Page 39 Software. 22. Force Majeure. CONMED will not be responsible or liable to You, or deemed in default or breach hereunder by reason of any failure or delay in the performance of its obligations hereunder where such failure or delay is due to pandemics, strikes,...
- Page 40 24. Governing Law. This Agreement will be governed by Delaware law, without regard to its choice of law principles, and Customer and CONMED hereby agree to submit to the exclusive jurisdiction of the Delaware Court of Chancery in New Castle County, or in the event (but only in the event) that such court does not have subject matter jurisdiction over such action, the United States District Court for the District of Delaware, and each of the parties hereto hereby irrevocably submits to the jurisdiction of such courts for the purpose of any such suit, action or other proceeding.
- Page 41 Schiffgraben 41 Utica, NY 13502-5994 USA D-30175 Hannover, US: 1-866-4CONMED (426-6633) (US) or Germany CustomerExperience@conmed.com International: +1 727-219-3310 or UKRP InternationalCustomerExperience@conmed.com CONMED UK Ltd www.conmed.com 73/74 Shrivenham Hundred Business Park Swindon SN6 8TY Rx ONLY United Kingdom http://eifu.conmed.com PX5-SMS-EN Rev. A...
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