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".

ENDOFLOW® II –INSTRUCTION FOR USE| 7
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.

ENDOFLOW® II –INSTRUCTION FOR USE| 11
6. Operating Instruction
6.1. Device Description
6.1.1. MEN01 & MEN01US
① = Pressurization and Warming chamber
② = Housing for the seal plug
③ = Automated opening door
④ = Touch screen control panel
⑦= Nameplate
⑧ = Electrical connection
⑨ = Equipotential connection
⑩ = Pneumatic connection
⑪ = ROCAMED footswitch connection
⑫ = USB connection for Software Update
6.1.2. MEN02P & MEN02PUS
① = Pressurization and Warming chamber
② = Housing for the seal plug
③ = Automated opening door
④ = Touch screen control panel
⑤ = Suction pipe detection switch
⑥ = Peristaltic suction pump
⑦ = Nameplate
⑧= Electrical connection
⑨= Equipotential connection
⑩ = Pneumatic connection
⑪= ROCAMED footswitch connection
⑫= USB connection for Software Update

12 | ENDOFLOW® II –INSTRUCTION FOR USE
6.2. Signification of Touch Screen Icons
SYMBOLS
FUNCTIONS
COMMENTS
Settings Menu
Provides access to the options menu of the
machine
Sound
In the Settings menu:
Enable or disable the beep of the machine.
Brightness
In the Settings menu:
Adjusts the screen brightness (High or Low).
Date/Hour
In the Settings menu:
Sets the date and time of the machine.
Heater
RED HALO = ON
BLINK = Warming in progress
Door
Door closed
Chamber under pressure
Door closed
Depressurization of the chamber in progress
Door open
RFID
Used to validate the correct RFID detection of
the disposable set connected to the device.
Pressure
Allows you to increase or decrease the
pressure
(see Specifications)
Units
Allows you to change the units of pressure.
Suction speeds
Only with MEN02P & MEN02PUS
(see Specifications)
End of the
intervention
Used to finish the procedure. The chambers
are depressurized. A second END press button
will be display to validate the end of the
procedure.
Next screen
When this icon is present, several screens are
visible. Pressing this button will display one
by one the different screens.
Back
When this icon is present, return to the
previous screen is possible

ENDOFLOW® II –INSTRUCTION FOR USE| 13
6.3. Set-Up for Use
6.3.1. Electrical Connection
Connect the equipment used using the power cord to the wall
socket.
Do not interrupt the protective earth and do not use in combination
with an adapter or an extension.
Cable Connection
Device
Connection
6.3.2. Pneumatic Connection
Connect the air supply hose to the air medical wall socket.
For MEN01 and MEN02P, do not try to screw. Push until the clic.
For MEN01US and MEN02PUS, screw the connector.
Cable Connection
Device Connection
6.3.3. Turn ON
Turn on the switch on the rear panel.
A beep is heard. An orange light lights the chambers.
If no problem occurs during startup, the chambers are lit in blue and the touch screen is turn
on.
The firmware version is displayed.
6.3.4. Warming
Touch the heater symbol on the touch screen.
During the warm-up state, the heat button is
blinking.


14 | ENDOFLOW® II –INSTRUCTION FOR USE
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.
Close the clamp (3) of the irrigation set;
Remove the protective cap and place the spike (1) into the bag;
Place the seal plug (2) in its holder;
RFID detects the set and the associated application. Confirm by
pressing OK if the application is correct;
If the irrigation set detected is not the expected one,
disconnect the set and select the return button.
The following screen appears;
Select the desired pressure units;

ENDOFLOW® II –INSTRUCTION FOR USE| 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.

16 | ENDOFLOW® II –INSTRUCTION FOR USE
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;
REPLACE THE FLUID BAG;
You are free to disconnect the irrigation set. Reconnect it before placing the new bag inside the chamber
Close the door gently to the first click. Then the door locks
automatically;
Chambers is pressurized;
Open the clamp of the irrigation set.

ENDOFLOW® II –INSTRUCTION FOR USE| 17
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;
Speed Selection:
Press the pump symbol on the top left of the touch screen;
Header speed selection appears;

18 | ENDOFLOW® II –INSTRUCTION FOR USE
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. After Use
Close all clamps;
Press the END button and wait for complete chamber depressurization;
Press the END button again to confirm the end of the procedure;
When door is/are opened, remove the fluid bag;
Disconnect the Disposable Set.
Turn Off the device.
Close the door.
6.7. Cleaning after Use
Clean the external parts of the machine, the interior of the tank and the door in particular with disinfectants
by using a single-use cloth or a disinfecting wipe.
The disinfectant used must be approved and authorized by the National laws and hospitals.
The tanks of the ENDOFLOW® are designed in order to avoid any leakage on electronic or electrical parts.

ENDOFLOW® II –INSTRUCTION FOR USE| 19
7. Troubleshooting
ERR n°
Description
Actions required
ERR06
Irrigation set connected to Left chamber is Expired
Use another Irrigation set
ERR08
Application on Left chambers Different
Check that the two pipes are for the same application
ERR11
Irrigation set already used on Left chamber
Use another Irrigation set
ERR17
Irrigation set connected to Right chamber is Expired
Use another Irrigation set
ERR19
Application on Right chambers Different
Check that the two pipes are for the same application
ERR21
Irrigation set already used on Right chamber
Use another Irrigation set
ERR30
Left Lock Door System
Call ROCAMED customer service
ERR31
Right Lock Door System
ERR33
No signal on Left chamber Pressure sensor
ERR34
No signal on Right chamber Pressure sensor
ERR35
Left chamber Temperature sensor
ERR36
Left bag Temperature sensor
ERR40
Right chamber Temperature sensor
ERR41
Right bag Temperature sensor
ERR44
Left chamber Failure Pressure
ERR45
Right chamber Failure Pressure
ERR46
No Input Air
Check the air connection at the rear of the machine.
ERR47
Suction Pump Default
Verify that he Suction Set is correctly positioned.
ERR49
Left chamber pressurization failure
Call ROCAMED customer service
ERR50
Right chamber pressurization failure
ERR51
Left chamber depressurization failure
ERR52
Right chamber depressurization failure

20 | ENDOFLOW® II –INSTRUCTION FOR USE
8. 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. THERE ARE NO OTHER WARRANTIES.
Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its
discretion without charge (except for a minimal charge for postage and handling) any ENDOFLOW® II which is defective if a claim
is made during such one-year period.
The following conditions, procedures, and limitations apply to the Manufacturer's obligation under this warranty:
A. Parties Covered by this Warranty:
This warranty extends only to the Original Purchaser of the ENDOFLOW® II. This warranty does not extend to subsequent
purchasers. The Original Purchaser may be medical personnel, a hospital, or institution which purchases ENDOFLOW® II for
treatment of patients. The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of
purchase.
B. Warranty Performance Procedure:
Notice of the claimed defect must be made in writing or by telephone to the Manufacturer as follows:
Notice to the Manufacturer must include date of purchase, model, serial number, and a description of the claimed defect in
sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. AUTHORIZATION
MUST BE OBTAINED PRIOR TO RETURNING THE ENDOFLOW® II. If authorized, the ENDOFLOW® II must be properly and
carefully packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of
the sender.
C. Conditions of Warranty:
The warranty is void if the ENDOFLOW® II Irrigation, Warming and Suction System has been:
-repaired by someone other than the Manufacturer or its authorized agent;
-altered so that its stability or reliability is affected;
-misused;
-damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Instruction
for Use or use with non-approved accessories. Removal or damage to the ENDOFLOW® II serial numbers will invalidate
this warranty.
D. Limitations and Exclusions:
Repair or replacement of the ENDOFLOW® II or any component part thereof is the EXCLUSIVE remedy offered by the
Manufacturer. The following exclusions and limitations shall apply:
-No agent, representative, or unauthorized employee of the Manufacturer has authority to bind the Manufacturer to
any representation or warranty, expressed or implied;
-There is no warranty of merchantability or fitness or use of the ENDOFLOW® II for any particular purpose.
-The ENDOFLOW® II can only be used under the supervision of medical personnel whose skill and judgment determine
the suitability of the ENDOFLOW® II for any particular medical treatment.
-All recommendations, information, and descriptive literature supplied by the Manufacturer or its agents are believed
to be accurate and reliable, but do not constitute warranties.
The Manufacturer disclaims responsibility for the suitability of the ENDOFLOW® II for any particular medical treatment or for any
medical complications resulting from the use of the ENDOFLOW® II. The Manufacturer shall not be responsible for any incidental
damages or consequential damages to property, loss of profits, or loss of use caused by any defect or malfunction of the
ENDOFLOW® II.
This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights which may
vary from state to state.