Summary of Contents for ROCAMED ENDOFLOW II MEN01
- Page 1 ENDOFLOW®II Irrigation, Warming and Suction System Instruction For Use NOTE-MEN-EN rev07 (16.01.2020) 0459...
- Page 2 ENDOFLOW® II Instruction for Use. REF: MEN01, MEN01US, MEN02P, MEN02PUS CE marked on: 20 September 2013 This revision supersedes and replaces all previous revisions. Every effort has been made to ensure that the information in this manual is accurate and details provided are correct at the time of printing.
- Page 3 ENDOFLOW® II – INSTRUCTION FOR USE| 3...
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Page 4: Table Of Contents
Contents About this Instruction For Use ..........................6 Description ................................6 Symbols Used on Labeling ............................7 Indication for Use ..............................9 Important Safety Information ..........................9 Operating Instruction ............................. 11 6.1. Device Description ............................11 6.1.1. MEN01 & MEN01US ..........................11 6.1.2. - Page 5 9.5. Service Contacts ............................. 21 Maintenance ............................... 22 10.1. Fuse Change ..............................22 10.2. Manual Door Opening ..........................22 10.3. Other ................................22 Specification ............................... 23 11.1. Dimensions and Weight ..........................23 11.2. Electrical & Pneumatic ..........................23 11.3. Performance ............................... 23 11.3.1.
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Page 6: About This Instruction For Use
It has the characteristic of heat to body temperature the liquid used. This non-invasive method employs single-use, disposable, irrigating and suction sets. The ENDOFLOW® II has to be used exclusively with the ROCAMED Disposable Sets. ENDOFLOW® II range includes the following devices: MEN01 ENDOFLOW®... -
Page 7: Symbols Used On Labeling
Symbols Used on Labeling SYMBOL DESCRIPTION SYMBOL DESCRIPTION CE marking. Manufacturer Conforms to the European Union Standards. 0459 Serial number Catalog number Equipment Classification Only tank for user and accessories for Refer to instruction manual/booklet patient are considered as Type BF Applied Part. - Page 8 Symbol used only on packaging: SYMBOL DESCRIPTION SYMBOL DESCRIPTION This way up Temperature limit Fragile; handle with care Humidity limitation Keep away from rain Atmospheric pressure limitation Symbol used only on single use devices packaging: SYMBOL DESCRIPTION Do not reuse Sterilized using ethylene oxide Use by Batch code...
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Page 9: Indication For Use
Indication for Use The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill/wash the concerned working cavities. Important Safety Information WARNING Read and follow all instructions, labeling, and accompanying documents supplied with this medical device. - Page 10 SHOULD NEVER BE REUSED OR RE-STERILIZED AFTER AN INTERVENTION to reduce the risk of cross contamination; Use of other sets modifies the operation of the device. ROCAMED cannot be held responsible for the disturbance; Sets in which the integrity of the packaging does not guarantee the sterility should not be used.
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Page 11: Operating Instruction
③ = Automated opening door ⑨ = Equipotential connection ④ = Touch screen control panel ⑩ = Pneumatic connection ⑪ = ROCAMED footswitch connection ⑫ = USB connection for Software Update 6.1.2. MEN02P & MEN02PUS ① = Pressurization and Warming chamber ⑦... -
Page 12: Signification Of Touch Screen Icons
6.2. Signification of Touch Screen Icons SYMBOLS FUNCTIONS COMMENTS Provides access to the options menu of the Settings Menu machine In the Settings menu: Sound Enable or disable the beep of the machine. In the Settings menu: Brightness Adjusts the screen brightness (High or Low). In the Settings menu: Date/Hour Sets the date and time of the machine. -
Page 13: Set-Up For Use
6.3. Set-Up for Use 6.3.1. Electrical Connection Connect the equipment used using the power cord to the wall Cable Connection Device socket. Connection Do not interrupt the protective earth and do not use in combination with an adapter or an extension. 6.3.2. -
Page 14: Use The Endflow
6.4. Using the ENDFLOW®II 6.4.1. Irrigation ① = Spikes (pouches side) ② = Seal plugs ③ = Clamps The assistant located in the sterile area should hold the end of the set used for irrigation (patient side) and give the opposite end (pouch side) to the assistant in charge of connecting it to the ENDOFLOW®II. - Page 15 Close the door gently to the first click. Then the door locks automatically; The bag is pressurized; Open the clamp on the irrigation set. ENDOFLOW® II – INSTRUCTION FOR USE| 15...
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Page 16: Change The Fluid Bag
6.4.2. Changing the fluid Bag Close the clamp of the irrigation set; Open the door by pressing the door symbol When the button is pressed, button status change to and tank depressurization is in progress. Wait a few seconds during the chamber depressurization; The door opens automatically;... -
Page 17: Suction
6.4.3. Suction ① = Connection (patient side) ② = Flexible part of the pipe ③ = Keying system connector Set-up: Clip the keying system connector (3) to its housing; Place the flexible part of the pipe (2) in the pump head and close the cover;... -
Page 18: Peripherals
Select the desired speed; The pump starts at the selected speed. 6.5. Peripherals The foot switch connects to the connector on the rear panel. The yellow foot switch increases the irrigation for a given time (see Specifications); The red foot switch is used to control the suction speed (only with MEN02P). 6.6. -
Page 19: Troubleshooting
ERR33 No signal on Left chamber Pressure sensor ERR34 No signal on Right chamber Pressure sensor ERR35 Left chamber Temperature sensor Call ROCAMED customer service ERR36 Left bag Temperature sensor ERR40 Right chamber Temperature sensor ERR41 Right bag Temperature sensor... -
Page 20: Limited Warranty
Limited Warranty ROCAMED warrants to the Original Purchaser that ENDOFLOW® II shall be free from defects in materials and workmanship under normal use, if used in accordance with this Instruction for Use, for a period of one year from the actual date of sale to the Original Purchaser. -
Page 21: Service
Service All service must be performed by ROCAMED, or an authorized service representative. Service by any other person or organization voids the warranty and transfers liability for malfunctions of the device to the servicing organization. 9.1. Warranty Service Units received for repair which have not been obviously abused or impact damaged and are still under warranty will be promptly repaired and returned at no charge. -
Page 22: Maintenance
Maintenance 10.1. Fuse Change To replace the fuses, unplug the machine by removing the plug from the wall outlet, remove the fuse box door from the power supply plug on the back using a flat, straight tool, and replace the 2 used fuses with 2 new identical fuses. 10.2. -
Page 23: Specification
Specification 11.1. Dimensions and Weight Product References MEN01XX MEN02PXX Dimensions (mm) L=400 x P=425 x H=240 L=520 x P=450 x H=240 Weight (kg) 13 kg 21 kg Chamber capacity Standards bags from 1L to 3L. 11.2. Electrical & Pneumatic Products References MEN01 MEN01US MEN02P... -
Page 24: Suction
Actual flow rates achieved may vary because of changes in temperature, viscosity, inlet and discharge pressures, system configuration. 11.3.4. Boost (Irrigation) This function is only available with the Foot Switch ROCAMED Accessories. It increases temporarily the pressure according to the application. Application Increase of pressure... -
Page 25: Cleaning
Pressure: [59.5kPa ; 101.3kPa] 11.7. Shipping Keep the original packaging for future shipping requirements of the device. ROCAMED disclaims any liability for damage to the ENDOFLOW® II if it is not shipped in its original packaging. MEN01 & MEN01US MEN02P & MEN02PUS... -
Page 26: Electromagnetic Compatibility (Emc) Information
Electromagnetic Compatibility (EMC) Information Table 1 - MANUFACTURER'S guidelines and statement – ELECTROMAGNETIC EMISSIONS – for all EM DEVICES and SYSTEMS Manufacturer's guidelines and statement - electromagnetic emissions ENDOFLOW® II, a heating and sterile liquid irrigation system for endoscopic applications, was designed to be used in the electromagnetic environment described below. - Page 27 Table 2 - MANUFACTURER'S guidelines and statement – electromagnetic IMMUNITY – for all EM DEVICES and SYSTEMS Manufactures guidelines and statement - electromagnetic immunity ENDOFLOW® II, a heating and sterile liquid irrigation system for endoscopic applications, was designed to be used in the electromagnetic environment described below.
- Page 28 Table 4 - MANUFACTURER'S guidelines and statement – Electromagnetic IMMUNITY Manufactures guidelines and statement - electromagnetic immunity ENDOFLOW® II, a heating and sterile liquid irrigation system for endoscopic applications, was designed to be used in the electromagnetic environment described below. The client or user of the ENDOFLOW® II must ensure that it is used in such an environment.
- Page 29 Table 6 – Recommended separation distances between portable and mobile RF communication devices and the EM DEVICE or SYSTEM Recommended separation distances between portable and mobile RF communication devices and the ENDOFLOW® II ENDOFLOW® II is designed for use in an electromagnetic environment in which the radiated RF disturbances are controlled.
- Page 30 Distributed by ROCAMED S.A.M. Manufactured by ROCAMED France 9 Avenue Albert II Z.I. de Signes 98000 MONACO Allée de Stockholm 0459 Tel: +33 (0)4 94 90 21 00 83870 Signes, FRANCE Manufacturer www.rocamed.com...
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