The 37Company Fluido Irrigation User manual

Original instructions
Version: INT/R347-EN/1-06/21
User Manual
Fluido® Irrigation
INT/R347 - EN/1-09/21

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User Manual - Contents
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Contents
1 General information..................................................................................................................5
1.1 About this manual ...............................................................................................................5
1.2 Warning, caution and note..................................................................................................5
1.3 Intended use .......................................................................................................................6
1.4 Indications for use...............................................................................................................6
1.5 Contact................................................................................................................................6
1.6 Frequently asked questions (FAQ)......................................................................................6
1.7 Warranty..............................................................................................................................6
1.8 Authorisation of personnel and training...............................................................................7
1.9 Disclaimer and intellectual property statement....................................................................7
2 Contraindications, warnings, cautions, notes and symbols.................................................. 8
2.1 General safety precautions..................................................................................................8
2.1.1 Warnings......................................................................................................................8
2.1.2 Cautions.......................................................................................................................9
2.1.3 Notes.........................................................................................................................10
2.1.4 Literature.................................................................................................................... 10
2.2 Device safety symbols.......................................................................................................11
3 Description............................................................................................................................... 15
3.1 Overview of the system..................................................................................................... 15
3.2 Irrigation ............................................................................................................................16
3.2.1 Overview....................................................................................................................16
3.2.2 Control panel.............................................................................................................16
3.3 Disposable sets.................................................................................................................19
3.3.1 Fluido® Irrigation URO Set........................................................................................20
3.3.2 Fluido® Irrigation URO Patient line............................................................................20
3.3.3 Fluido® Irrigation URO Spike Set..............................................................................21
3.3.4 Fluido® Irrigation connectors.....................................................................................21
4 Set-up.......................................................................................................................................22
4.1 Transport and storage....................................................................................................... 22
4.2 Attaching the Fluido® Irrigation PowerLifter II or IV Pole...................................................22
5 Operation ................................................................................................................................. 23
5.1 Safety instructions before operation..................................................................................23
5.2 Preparation before operation.............................................................................................23
5.2.1 Switching on the Irrigation.........................................................................................24
5.2.2 Inserting and removing a disposable set...................................................................25
5.2.3 Priming the disposable set ........................................................................................26
5.3 Operation...........................................................................................................................28
5.3.1 Warming up fluids......................................................................................................28
5.3.2 Deaerating the deaeration chamber ..........................................................................29

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5.3.3 Suppressing the audible signal..................................................................................29
5.3.4 Extra functions of the Fluido® Irrigation device..........................................................30
5.4 Post-operative procedures.................................................................................................31
5.4.1 Post-operative non-heated irrigation.......................................................................... 31
5.4.2 Stopping the system..................................................................................................32
5.4.3 Resetting the Fluid Warming System ........................................................................32
6 Maintenance............................................................................................................................. 34
6.1 Precautions........................................................................................................................ 34
6.2 Cleaning ............................................................................................................................34
7 Troubleshooting......................................................................................................................36
7.1 Power supply interruption..................................................................................................36
7.2 Fluido® Irrigation...............................................................................................................36
8 Specifications..........................................................................................................................41
8.1 Environmental conditions for operation .............................................................................41
8.2 Modules.............................................................................................................................41
8.2.1 Environmental conditions for transport and storage...................................................41
8.2.2 Irrigation.....................................................................................................................41
8.3 Disposable sets.................................................................................................................43
8.3.1 Environmental conditions for transport....................................................................... 43
8.3.2 Environmental conditions for storage.........................................................................43
8.3.3 Fluido® Irrigation URO Set........................................................................................44
8.3.4 Fluido® Irrigation URO Patient Line...........................................................................44
8.3.5 Fluido® Irrigation URO Spike Set..............................................................................44
8.4 Accessories.......................................................................................................................45
8.4.1 Fluido® IrrigationFemale Connector .........................................................................45
8.4.2 Fluido® IrrigationMale Connector............................................................................. 45
8.4.3 Fluido® IrrigationCatheter Connector........................................................................45
8.4.4 Fluido® IrrigationFunnel Connector.......................................................................... 46
8.4.5 Fluido® Irrigation URO Male Connection...................................................................46
9 Electromagnetic compatibility................................................................................................ 47
9.1 Electromagnetic immunity..................................................................................................48
9.2 Electromagnetic emissions................................................................................................49
9.3 Recommended separation distances................................................................................. 49

User Manual - General information
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1 General information
1.1 About this manual
In this manual, you can find important information about how to operate the Fluido® Irrigation
(hereafter referred to as ‘the device’).
The manual assists with the operation and maintenance of the device in a safe and responsible
manner.
Make sure that you have the most recent version of this manual. The updated manuals can be
found at the website: www.the37company.com. Read this manual carefully. Complete all the
procedures. Perform the procedures in the sequence given. Always keep the manual with the
device.
Please refer to the Fluido® Irrigation technical manuals for maintenance, repair and calibration
instructions. The Fluido® Irrigation technical manuals are available for download at the business
partner menu of the The 37Company website.
1.2 Warning, caution and note
Warning!
A "warning" tells you that there is a risk of personal injury or death. [W000]
Caution!
A "caution" tells you that:
•there is a risk of damage to the device, and/or
•there is a risk of damage to other equipment. [C000]
A "note" provides more information. [N000]
Every "warning", "caution" and "note" is identified by a unique number in the format
[W/C/N###]. [N015]

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1.3 Intended use
The system is developed to warm irrigation fluids to adult patients.
The system can be used to warm the following fluids:
•Crystalloid fluids
•Glucose fluids
•Distilled water
•Urea-based fluids
•Ringer’s lactate solution
•Glycine solution
•Mannitol solution
•Sorbitol solution
1.4 Indications for use
The system is indicated to be used in healthcare environments to help prevent hypothermia. The
devices can be used in the full clinical environment.
1.5 Contact
The Surgical Company International B.V. doing business as The 37Company:
The 37Company
Beeldschermweg 6F
NL-3821 AH Amersfoort
The Netherlands
Tel: [phone]
E-mail: [e-mail]
Website: www.the37company.com
Refer to the website for local distributors.
1.6 Frequently asked questions (FAQ)
Please contact your local distributor for an up-to-date overview of frequently asked questions with
respect to the Fluido® products.
1.7 Warranty
For the warranty provisions, refer to the website: www.the37company.com.

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1.8 Authorisation of personnel and training
Caution!
The instructions contained in this manual are solely intended for authorised and certified
personnel to work with and/or service the medical device(s) described herein. [C020]
1.9 Disclaimer and intellectual property statement
The information and/or instructions mentioned in this manual do not contain and may not be
construed as containing any advice regarding a medical treatment in the broadest sense of the
term. This manual is provided for general informational/educational purposes and is meant as a
guideline for the proper usage of the medical device(s) in question. Accordingly, before taking any
actions based on this manual, the user shall be obliged to consult with the appropriate medical and
healthcare professionals such as trained and certified clinicians. The use of or reliance upon any
information contained in this manual as medical advice is and shall solely remain at the user’s risk.
The 37Company cannot be held liable for the outcome of a patient’s treatment with the use of the
medical device(s) described herein.
The description and instructions regarding the medical device(s) mentioned in this manual have
been compiled with the greatest possible care. Nonetheless, the user should be aware that
The 37Company can and may have made certain alternations and/or improvements regarding
these medical device(s) which may not yet be adequately described in the current copy of the
manual. All users are therefore strongly advised to make sure that they consult the most recent
version of the manual. The updated manuals are available for download at the The 37Company
website: www.the37company.com.
This manual contains proprietary information of The 37Company and all data mentioned herein
are protected by copyright and patent laws and any other applicable statutory provisions regarding
the protection of intellectual property, and may therefore not be reproduced, republished,
disclosed to third parties, transmitted, displayed, broadcast or otherwise exploited in any manner
whatsoever without the explicit prior written consent of The 37Company. The name and logo of
The 37Company and all related trademarks, trade names, and other intellectual property are and
shall remain the exclusive property of The 37Company and cannot be used without the latter’s
express prior written consent.
The original instructions in this document were created in English. All other language versions are
translations of the original instructions. In the event of ambiguity and/or disputes, the English text
always takes precedence.

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2 Contraindications, warnings, cautions, notes and
symbols
The device was designed and built with safety in mind. Read and understand the contraindications,
warnings, cautions and notes before using the device.
2.1 General safety precautions
2.1.1 Warnings
Warning!
•Use the device as intended. Refer to Intended use on page 6. [W053]
•Obey local regulations. [W057]
Materials
Warning!
•Use irrigation products that comply with local regulations. [W008]
•Do not use irrigation products with a temperature below 4°C or above room
temperature. [W009]
Prior to operation
Warning!
•Unlock the brakes on the Fluido® PowerLifter II or the Fluido® IV Pole before moving
the device. [W010]
•Do not use the device if it is damaged (e.g. dents, cracks). Take the device out of
service and contact the hospital service department or the local supplier. [W011]
•Make sure that there is a physician's order for switching on and continued use of the
device. [W012]
•Use a new administration set for every application with a Fluido® Irrigation URO Set.
[W014]
•Use the device only with a Fluido® Irrigation URO Set and Fluido® Irrigation
accessories. [W016]
•Use each disposable set for only one patient. [W017]
•Do not use a disposable set if the disposable has expired. [W018]
•Check the patient’s condition and temperature at least every 15 minutes. [W021]
•Do not service the device while it is being used. [W022]
•Make sure that only authorised personnel use the device. [W023]

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Operation
Warning!
•Do not position the device close to the head of the patient if inhaler therapy is being
used. [W024]
•The disposable set should not be used for longer than 24 hours. [W027]
•Make sure that the pressure on the line does not exceed 300 mmHg when using the
device. Do not use a pressure device without pressure indicator or an in-line manually
driven pressure device. [W029]
•In case of Transurethral Resection of the Prostate (TURP) procedure, please refer
to the working pressures recommended by the specific guidelines. Elevated working
pressures may be related to a higher incidence of TURP syndrome. [W030]
After operation
Warning!
2.1.2 Cautions
The device and its disposables may be a potential biohazard during and
after use. Handle and dispose of in accordance with accepted medical
practice and applicable local regulations. [W032]
Caution!
•Do not use a sharp object to press the buttons on the control panel. [C002]
•The device must be securely mounted. [C003]
•Do not immerse the device in liquid. Immersing the device in liquid may damage the
device. [C004]
Prior to operation
Caution!
•Do not use the device outside the environmental specifications: see Specifications on
page 41. [C005]
•Keep the device away from portable and mobile radio-frequency communications
equipment and high-frequency surgical instruments or endocardial catheters. Portable
and mobile radio-frequency communication equipment and high-frequency surgical
instruments or endocardial catheters may cause the device to operate incorrectly.
[C006]

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•Do not modify the device. Use of power supply cords or spare parts for internal
components other than as specified by the manufacturer may lead to hazardous
situations. [C007]
•Connect the mains plug(s) to earthed wall socket(s) only. [C008]
•Install the device in such a way that you can easily disconnect the mains plug(s) from
the wall socket in the event of an emergency. [C009]
•Do not block the ventilation openings of the device. [C010]
•Make sure that the brakes on the Fluido® PowerLifter II or the Fluido® IV Pole are
locked when using the device. [C012]
•Do not use the device on surfaces with an inclination > 2.5°. [C013]
•After any temporary interruption of the mains power supply, refer to Power supply
interruption on page 36. [C015]
2.1.3 Notes
•In the event of a power interruption, the device will not produce any audible signal to
indicate the loss of power. [N001]
•The device is not equipped with an isolating switch. Temporary interruption of the mains
supply will place the device into standby mode and treatment will be discontinued.
[N002]
2.1.4 Literature
1. M. J. Pit, R. J. Tegelaar, and P. L. Venema, “Isothermic irrigation during transurethral
resection of the prostate: Effects on peri-operative hypothermia, blood loss, resection time and
patient satisfaction,” Br. J. Urol., vol. 78, no. 1, pp. 99–103, 1996.
2. J. W. H. Evans, M. Singer, S. W. V. Coppinger, N. Macartney, J. M. Walker, and
E. J. G. Milroy, “Cardiovascular performance and core temperature during transurethral
prostatectomy,” Journal of Urology, vol. 152, no. 6 I. pp. 2025–2029, 1994.
3. M. Monga, B. Comeaux, and J. A. Roberts, “Effect of Irrigating Fluid on Perioperative
Temperature Regulation during Transurethral Prostatectomy,” Eur. Urol., vol. 29, no. 1,
pp. 26–28, 1996.
4. S. Mirza, S. Panesar, K. J. AuYong, J. French, D. Jones, and S. Akmal, “The Effects of
Irrigation Fluid on Core Temperature in Endoscopic Urological Surgery,” J. Perioper. Pract.,
vol. 17, no. 10, pp. 494–503, Oct. 2007.
5. P. S. Heathcote and P. M. Dyer, “The Effect of Warm Irrigation on Blood Loss during
Transurethral Prostatectomy under Spinal Anaesthesia,” Br. J. Urol., vol. 58, no. 6, pp. 669–
671, Dec. 1986.

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2.2 Device safety symbols
This section contains a list of symbols used for the Fluido® Irrigation.
Caution: Federal US law restricts this device to sale by or on order of a physician.
The device is protected against falling water equivalent to 3-5 mm rainfall per
minute for a duration of 10 minutes, when the device is placed in its normal
operating position (according to IEC 60529).
Risk of electrical shock.
Connect the device to an earthed socket only. Risk of electrical shock exists if the
equipment is not connected to a properly grounded receptacle.
Serial number
Catalogue/article number/part number
Manufacturer
MOD stands for the modification update (in this example: modification update 6)
Transport and storage ambient temperature limits

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Transport and storage relative humidity limits
Transport and storage atmospheric pressure limits
Type CF applied parts (according to IEC 60601-1)
AC voltage
Fuse
Make sure that the pressure does not exceed 300 mmHg.
Equipotentiality
Read the user manual.
Consult the instructions for use.
CE marking of conformity

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Dispose according to local regulations.
Expiry date (year/month)
Caution. Consult the instructions for use for important cautionary information.
Single patient use only. Do not reuse disposable sets.
The disposable sets do not contain natural latex components.
The disposable sets are sterile. Method of sterilisation: ethylene oxide.
Batch code/lot number
Class II equipment
Quantity
Do not use the device if the package is damaged.

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Keep away from sunlight.
Keep away from rain.
Temporarily audible signal suppression
Non-pyrogenic
System power On/Standby
Repair required

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Module Function
3 Description
The Fluido® Irrigation is a Fluid Warming System. The system is suitable for all applications, from
moderate to high flows. The Fluido® Irrigation uses infrared heating technology to warm fluids.
Based on in-line sensors, the Fluido® Irrigation calculates the energy required to safely warm the
fluid.
3.1 Overview of the system
The Fluido® Irrigation consists of the following modules:
Irrigation Fluid Warmer Warms the fluid to the set temperature.
PowerLifter II Ensures a stable operating platform for the system and
regulates the flow.
1. Irrigation Fluid Warmer
2. PowerLifter II
The Fluido® PowerLifter II is a separate device to adjust the height of the irrigation fluid bags. This
allows flow regulation by generating pressure overhead. The description and instructions for use
for the Fluido® PowerLifter II are covered in a separate manual.
The Fluido® Irrigation can also be mounted on the Fluido® IV Pole or can be used
standalone on a table. [N004]

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3.2 Irrigation
The Fluido® Irrigation is an easy-to-operate fluid warmer. This section describes the different parts
of the device.
3.2.1 Overview
The Fluido® Irrigation is the module that uses infrared technology to warm up the fluids. The
Fluido® Irrigation uses Fluido® Irrigation disposable sets for fluid irrigation.
Caution!
The top sticker is an integral part of the Fluido® Irrigation and prevents fluid ingress from
the top of the device. Do not attempt to remove the top sticker. [C001]
3.2.2 Control panel
1. Control panel
2. Eject button for disposable
set cassette
3. Slot for disposable set
cassette
4. Deaeration chamber
holder
5. Ventilation openings
6. Power supply cord
connection
7. Cord anchor
8. Protective earthing pin
9. Mounting clamp
10. Ventilation openings
11. Top sticker
The control panel is located at the front of the device and can be operated by pressing the buttons
located in the panel. All settings are visible on the display and the desired temperature can be
selected by pressing the temperature selection buttons. By pressing the flow/volume button, the
display will indicate the total volume dispensed by the unit. When a fault condition is detected, an
audible signal will be triggered and the control thermometer turns red.

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Display Description
1. On/standby button and
indicator
2. Flow/volume button
3. Audible signal suppression
button
4. Temperature selection
buttons (+/-)
5. Control thermometer
6. Display
Display
This section explains the items shown on the display of the Irrigation.
Flow indicator (ml/min), increments of 1 ml/min (0-20 ml/min), 5
ml/min (20-150 ml/min) and 10 ml/min (above 150 ml/min)
Volume indicator (l)
Number of operating hours
Insert the disposable set into the device.
Remove the disposable set from the device.
Between 1000-1500 operating hours: If you switch on the
device, the display shows the symbol for 5 seconds. You can
still operate the device, but maintenance must take place before
2001 operating hours.
Between 1500-2000 operating hours: If you switch on the
device, the display shows the symbol continuously. You can still
operate the device, but maintenance must take place before
2001 operating hours.
After 2000 operating hours: If you switch on the device, the
display shows the symbol continuously and a continuous
audible signal will sound. You can still operate the device, but
maintenance must take place within 48 operating hours.

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Lamp replacement indicators (five lamps): If a specific bar
flashes, contact the hospital service department or the local
supplier to replace the relevant lamp.
Maintenance/malfunction. In the event of a malfunction: reset
the device or contact the hospital service department or the local
supplier if the issue persists.
Audible signal suppression
Set temperature at the end of the line.
Maximum temperature, monitored when the IV fluid leaves the
cassette
Tilt sensor error
Error code
The internal temperature is too high to switch on the device
(after safety temperature check).
Control Thermometer
The table below shows the different states of the temperature control thermometer.
Indication
State
Cause
The control thermometer is not
illuminated.
The device does not warm the fluid in the
cassette.
The lower section is green.
The end temperature is more than 1 °C
lower than the set temperature.
The lower and middle sections are
green.
The end temperature is equal to the set
temperature.
Display Description

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The top section is red. The input temperature or the output
temperature is higher than the set
temperature. An audible signal is
triggered.
The entire control thermometer is
red. There is a defect. An audible signal is triggered. The display shows the
maintenance/malfunction symbol to
indicate that maintenance must take
place.
•The end temperature cannot be guaranteed when an extension line is being used.
[N006]
•Refer to Troubleshooting: Fluido® Irrigation on page 36 for troubleshooting. [N007]
3.3 Disposable sets
A Fluido® disposable set consists of a cassette and tubing. In the cassette the fluid flow is warmed
and mixed. The flow range of the cassette is designed to be used for both moderate and high flow
applications.
The front of the Fluido® cassette is made of transparent plastic. The back of the cassette is made
of black plastic.
Caution!
Never use defective disposable cassettes. Check the transparent layer for damage such as
leakage, punctures and disconnected tubes. [C016]
The Fluido® Irrigation may only be used with the following Fluido® disposable sets and
accessories:
•Fluido® Irrigation URO Set
•Fluido® Irrigation URO Patient line
•Fluido® Irrigation URO Spike Set
Caution!
Do not use the Fluido® Standard Set, Fluido® Trauma Set, Fluido® Trauma Plus Set,
alternative types of de-aeration chambers or disposable sets in combination with the
Fluido® Irrigation. [C018]
Indication State Cause

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Warning!
The disposables are provided in a sterile state. Ensure that
they are handled in a sterile field. [W059]
3.3.1 Fluido® Irrigation URO Set
The Fluido® Irrigation URO Set is designed for urological interventions. It contains a deaeration
chamber integrated with a non-return valve. The set includes a separate patient line and a Luer
Lock bore cap.
This set must only be used in combination with the Fluido® Irrigation URO patient line, Irrigation
URO Spike Set and Irrigation URO Female Cap.
1. Spike
2. Clamp
3. Spike line
4. Drip chamber
5. Spike set Luer Lock
connection
6. Cassette
7. Air relief valve
8. Deaeration chamber
9. Clamp
10. Patient line connector
11. Patient line (separate)
12. Luer Lock bore cap
3.3.2 Fluido® Irrigation URO Patient line
The Fluido® Irrigation URO Patient line is a patient line with an extra Luer Lock cap. This patient
line must only be used in combination with the Fluido® Irrigation URO Set and/or URO Spike Set.
1. Clamp
2. Roller clamp
3. Patient line connector
4. Luer Lock cap