ROCAMED ENDOFLOW II MEN01 User manual

ENDOFLOW®II
Irrigation, Warming and Suction System
Instruction For Use
NOTE-MEN-EN rev07 (16.01.2020)
0459

2 | ENDOFLOW® II –INSTRUCTION FOR USE
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. The company, however, reserves the right to improve the equipment shown.
ENDOFLOW® is a trademark from PROMEPLA SAM.

ENDOFLOW® II –INSTRUCTION FOR USE| 3

4 | ENDOFLOW® II –INSTRUCTION FOR USE
Contents
1. About this Instruction For Use.................................................................................................................................6
2. Description................................................................................................................................................................6
3. Symbols Used on Labeling........................................................................................................................................7
4. Indication for Use .....................................................................................................................................................9
5. Important Safety Information..................................................................................................................................9
6. Operating Instruction.............................................................................................................................................11
6.1. Device Description..........................................................................................................................................11
6.1.1. MEN01 & MEN01US ...............................................................................................................................11
6.1.2. MEN02P & MEN02PUS...........................................................................................................................11
6.2. Signification of Touch Screen Icons ...............................................................................................................12
6.3. Set-Up for Use ................................................................................................................................................13
6.3.1. Electrical Connection..............................................................................................................................13
6.3.2. Pneumatic Connection ...........................................................................................................................13
6.3.3. Turn ON...................................................................................................................................................13
6.3.4. Warming .................................................................................................................................................13
6.4. Use the ENDFLOW® ........................................................................................................................................14
6.4.1. Irrigation .................................................................................................................................................14
6.4.2. Change the fluid Bag ..............................................................................................................................16
6.4.3. Suction ....................................................................................................................................................17
6.5. Peripherals......................................................................................................................................................18
6.6. After Use.........................................................................................................................................................18
6.7. Cleaning after Use ..........................................................................................................................................18
7. Troubleshooting .....................................................................................................................................................19
8. Limited Warranty ...................................................................................................................................................20
9. Service.....................................................................................................................................................................21
9.1. Warranty Service............................................................................................................................................21
9.2. Non-Warranty Work.......................................................................................................................................21
9.3. Expected Service Life......................................................................................................................................21
9.4. Destruction .....................................................................................................................................................21

ENDOFLOW® II –INSTRUCTION FOR USE| 5
9.5. Service Contacts .............................................................................................................................................21
10. Maintenance.......................................................................................................................................................22
10.1. Fuse Change................................................................................................................................................22
10.2. Manual Door Opening................................................................................................................................22
10.3. Other...........................................................................................................................................................22
11. Specification .......................................................................................................................................................23
11.1. Dimensions and Weight .............................................................................................................................23
11.2. Electrical & Pneumatic ...............................................................................................................................23
11.3. Performance ...............................................................................................................................................23
11.3.1. Irrigation .................................................................................................................................................23
11.3.2. Temperature...........................................................................................................................................23
11.3.3. Suction ....................................................................................................................................................24
11.3.4. Boost (Irrigation) ....................................................................................................................................24
11.3.5. RFID.........................................................................................................................................................24
11.4. Normal Use.................................................................................................................................................24
11.5. Cleaning ......................................................................................................................................................25
11.6. Storage........................................................................................................................................................25
11.7. Shipping ......................................................................................................................................................25
12. Electromagnetic Compatibility (EMC) Information...........................................................................................26

6 | ENDOFLOW® II –INSTRUCTION FOR USE
1. About this Instruction For Use
This Instruction for Use describes the set-up and use of the ENDOFLOW® II Irrigation System.
The manual is intended for use by individuals trained in the healthcare and biomedical professions.
Y
Read and follow all instructions, labeling, and accompanying documents supplied with this medical device.
Failure to follow instructions, including all warnings and cautions could result in death or serious injury to the
patient or user.
2. Description
The ENDOFLOW® II Irrigation System is an irrigation device which can precisely control the intracavity pressure (isostatic pump).
It has the characteristic of heat to body temperature the liquid used.
This non-invasive method employs single-use, disposable, irrigating and suction sets.
Y
The ENDOFLOW® II has to be used exclusively with the ROCAMED Disposable Sets.
ENDOFLOW® II range includes the following devices:
-MEN01
ENDOFLOW® II single chamber (230V, 50Hz)
-MEN01US
ENDOFLOW® II single chamber (120V 60Hz, 100V 50/60Hz)
-MEN02P
ENDOFLOW® II double chamber with aspiration pump (230V, 50Hz)
-MEN02PUS
ENDOFLOW® II double chamber with aspiration pump (120V 60Hz, 100V 50/60Hz)
ENDOFLOW® II is provided with the following accessories:
-MENCAIR
AIR MEDICAL HOSE adapted to customers fittings;
-MENELEC
POWER SUPPLY CORD adapted to customers plug, socket and voltage.
ENDOFLOW® II can also be controlled for specific function by a footswitch.
-MENP2RY
DOUBLE FOOT-SWITCH "SUCTION SPEED AND BOOST PRESSURE".

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3. Symbols Used on Labeling
SYMBOL
DESCRIPTION
C
CE marking.
Conforms to the European Union
Standards.
0459
Catalog number
Refer to instruction manual/booklet
OFF
Main electrical power off.
Alternating Current.
Equipotential Terminal
IP20
Protection against ingress of fingers or
similar objects
Foot Switch
Radio-Frequency (RF) energy
(non-ionizing radiation)
RxOnly
U.S. federal law restricts this device to
sale by or on the order of a physician
SYMBOL
DESCRIPTION
Manufacturer
Serial number
Equipment Classification
Only tank for user and accessories for
patient are considered as Type BF Applied
Part.
ON
Main electrical power on.
Circuit breaker, fuse.
Input
DO NOT Allow Fingers to Contact Moving
Parts
Manual cleaning
2AFDC-MEN01US
2AFDC-MEN02PUS
20423-MEN01US
20423-MEN02PUS
This device complies with Part 15 of the FCC Rules
and with Industry Canada licence-exempt RSS
standard(s). Operation is subject to the following
two conditions: (1) this device may not cause
harmful interference, and (2) this device must
accept any interference received, including
interference that may cause undesired operation
Le présent appareil est conforme aux CNR
d'Industrie Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisée aux
deux conditions suivantes : (1) l'appareil ne doit pas
produire de brouillage, et (2) l'utilisateur de
l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.

8 | ENDOFLOW® II –INSTRUCTION FOR USE
Symbol used only on packaging:
SYMBOL
DESCRIPTION
This way up
Fragile; handle with care
Keep away from rain
SYMBOL
DESCRIPTION
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Symbol used only on single use devices packaging:
SYMBOL
DESCRIPTION
Do not reuse
Sterilized using ethylene oxide
Use by
Batch code
LOT number
Do not use if package is damaged
This device is not made with natural rubber latex

ENDOFLOW® II –INSTRUCTION FOR USE| 9
4. 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.
5. Important Safety Information
WARNING
-Read and follow all instructions, labeling, and accompanying documents supplied with this medical device. Failure to
follow instructions, including all warnings and cautions could result in death or serious injury to the patient or user
Environmental
- The conditions of use, storage and transport must be respected;
- The device is not designed to operate in areas with risk of explosion. This means among other things that, in case of use
of anesthetics by inhalation flammable and explosive, or mixtures in which they are contained, the device must not be
put into service within the area risks described. This also applies for flammable and explosive chemicals, such as
disinfectants and skin disinfectants fast surface.
Electrical
-Before use, make sure that the electrical installations of the operating room meet the standards (IEC) and make sure to
use only CE marked electrical connections and / or meets the standards for these connections (standard or ISO standard
in force in the country of use)
-ENDOFLOW® II requires caution with respect to Electromagnetic Compatibility (EMC) and must be operated according to
EMC information in this document;
-ENDOFLOW® II can be affected by portable and mobile Radio Frequency (RF) devices;
-ENDOFLOW® II should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary,
the ENDOFLOW® II should be observed to verify normal operation in the configuration in which it will be used;
-Use of accessories and peripherals other than those specified may result in increased EMISSIONS or decreased IMMUNITY
of the ENDOFLOW® II;
-Grounding reliability can only be achieved when MAINS power cords are connected to a properly grounded receptacle.
Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle;
-Exposed conductor on MAINS power cord can cause an electrocution hazard. Remove device from service if MAINS power
cord has exposed wires;
-The unit is equipped with a connector for equipotential whose connection must be made in accordance with national
regulations;
-Extreme precaution must be taken when handling liquids around electrical equipment. DO NOT operate the ENDOFLOW®
II if liquid has been spilled on the unit.
-Do not position the ENDOFLOW® II so that it difficult to operate the disconnection of the device.

10 | ENDOFLOW® II –INSTRUCTION FOR USE
Disposable Sets, Accessories, Peripherals
-The ENDOFLOW® II is for use only with ROCAMED supplied or approved parts, accessories, peripherals and Disposable
Sets. The device may not function as intended with the use of unapproved parts, accessories, peripherals or Disposable
Sets;
-All ROCAMED set are disposable products. They are supplied double bagged, sterilized with ethylene oxide gas and
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.
Cleaning
-Do not use bleach or industrial detergents;
-ENDOFLOW® II cannot be sterilized.
Service
-Do not modify this equipment without authorization of the manufacturer.
CAUTION
-Federal law (U.S.A.) restricts this device to be sale by or on the order of a physician.
-To ensure that the pressure displayed on the screen ENDOFLOW® II is the same as the pressure in the surgical cavity, the
machine must be placed at the same height as the patient.
-In case of accidental perforations, or fluid leaks from a defective fluid bag, or leaks due to improper handling, immediately
turn off the device (On/Off button on the rear panel) and ideally, disconnect the plug from the electrical outlet on the
wall.
In the event the machine shuts off for safety reasons before the door can be automatically opened, after disconnecting
the plug from the wall outlet, then use the hook located under the device to open the door.
Wipe up the fluid inside the machine as rapidly as possible and continue the operation with another machine or a gravity
feed.
ROCAMED highly recommends that the user return the machine to ROCAMED for an inspection of the product.