The 37Company Fluido AirGuard System User manual

User Manual
Fluido® AirGuard System
Original instructions
Version: INT/R757-EN/3-06/21
INT/R757 - EN/4-09/21

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User Manual - Contents 3 of 71
Contents
1 General information .................................................................................................................. 6
1.1 About this manual ............................................................................................................... 6
1.2 Warning, caution and note .................................................................................................. 6
1.3 Intended use ....................................................................................................................... 7
1.4 Indications for use ............................................................................................................... 7
1.5 Contact ................................................................................................................................ 7
1.6 Frequently asked questions (FAQ) ...................................................................................... 7
1.7 Warranty .............................................................................................................................. 7
1.8 Authorisation of personnel and training ............................................................................... 8
1.9 Disclaimer and intellectual property statement .................................................................... 8
2 Contraindications, warnings, cautions, notes and symbols .................................................. 9
2.1 General safety precautions.................................................................................................. 9
2.1.1 Warnings ...................................................................................................................... 9
2.1.2 Cautions ..................................................................................................................... 11
2.1.3 Notes ......................................................................................................................... 11
2.1.4 Literature .................................................................................................................... 12
2.2 Device safety symbols....................................................................................................... 12
3 Description ............................................................................................................................... 17
3.1 Overview of the system ..................................................................................................... 17
3.2 Blood and Fluid Warmer ................................................................................................... 18
3.2.1 Overview .................................................................................................................... 18
3.2.2 Control panel ............................................................................................................. 19
3.3 AirGuard ............................................................................................................................ 22
3.3.1 Overview .................................................................................................................... 22
3.3.2 Control panel ............................................................................................................. 23
3.4 Pressure Chambers ........................................................................................................... 24
3.5 Compressor ....................................................................................................................... 25
3.6 IV Pole .............................................................................................................................. 25
3.7 Disposable sets ................................................................................................................. 26
3.7.1 Fluido® Standard Set ................................................................................................ 27
3.7.2 Fluido® Trauma Set .................................................................................................. 27
3.7.3 Fluido® Trauma Plus Set .......................................................................................... 28
4 Set-up ....................................................................................................................................... 29
4.1 Transport and storage ....................................................................................................... 29
4.2 Mounting heights for modules ........................................................................................... 29
5 Operation ................................................................................................................................. 30
5.1 Safety instructions before operation .................................................................................. 30
5.2 Preparation before operation ............................................................................................. 30
5.2.1 Preparing the Pressure Chambers ............................................................................ 32

User Manual - Contents 4 of 71
5.2.2 Suspending an IV bag ............................................................................................... 32
5.2.3 Switching on the Blood and Fluid Warmer................................................................. 33
5.2.4 Inserting and removing a disposable set ................................................................... 34
5.2.5 Priming the disposable set ........................................................................................ 35
5.2.6 Putting the AirGuard in standby mode ....................................................................... 37
5.2.7 Placing the deaeration chamber in the AirGuard ....................................................... 37
5.2.8 Placing the tube into the shut-off valve ..................................................................... 38
5.3 Operation ........................................................................................................................... 38
5.3.1 Switching on the Compressor .................................................................................... 38
5.3.2 Pressurising the bladders of the Pressure Chambers ................................................ 39
5.3.3 Switching on the AirGuard ......................................................................................... 39
5.3.4 Warming up blood and fluids ..................................................................................... 40
5.3.5 Deaerating the deaeration chamber .......................................................................... 40
5.3.6 Releasing the IV line from the AirGuard shut-off valve .............................................. 41
5.3.7 Suppressing the audible signal .................................................................................. 42
5.3.8 Extra functions of the Blood and Fluid Warmer ......................................................... 43
5.4 Post-operative procedures ................................................................................................. 44
5.4.1 Stopping the system .................................................................................................. 44
5.4.2 Resetting the Blood and Fluid Warming System ....................................................... 44
5.4.3 Putting the AirGuard in standby mode ....................................................................... 45
5.4.4 Switching off the Compressor .................................................................................... 45
6 Maintenance ............................................................................................................................. 46
6.1 Precautions ........................................................................................................................ 46
6.2 Cleaning ............................................................................................................................ 46
7 Troubleshooting ...................................................................................................................... 48
7.1 Power supply interruption .................................................................................................. 48
7.2 Blood and Fluid Warmer ................................................................................................... 48
7.3 AirGuard ............................................................................................................................ 53
7.4 Pressure Chambers ........................................................................................................... 57
7.5 Compressor ....................................................................................................................... 58
8 Specifications .......................................................................................................................... 60
8.1 Environmental conditions for operation ............................................................................. 60
8.2 Modules ............................................................................................................................. 60
8.2.1 Environmental conditions for transport and storage ................................................... 60
8.2.2 Blood and Fluid Warmer ............................................................................................ 60
8.2.3 AirGuard .................................................................................................................... 62
8.2.4 Pressure Chambers ................................................................................................... 63
8.2.5 Compressor ............................................................................................................... 63
8.2.6 IV Pole ....................................................................................................................... 64
8.3 Disposable sets ................................................................................................................. 64
8.3.1 Environmental conditions for transport ....................................................................... 64
8.3.2 Environmental conditions for storage ......................................................................... 65
8.3.3 Fluido® Standard Set ................................................................................................ 65
8.3.4 Fluido® Trauma Set .................................................................................................. 65

User Manual - Contents 5 of 71
8.3.5 Fluido® Trauma Plus Set .......................................................................................... 66
9 Electromagnetic compatibility ................................................................................................ 67
9.1 Electromagnetic immunity .................................................................................................. 68
9.2 Electromagnetic emissions ................................................................................................ 69
9.3 Recommended separation distances ................................................................................. 69

User Manual - General information 6 of 71
1 General information
1.1 About this manual
In this manual, you can find important information about how to operate the Fluido® AirGuard
System (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® AirGuard System technical manuals for maintenance, repair and
calibration instructions. The Fluido® AirGuard System 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]

User Manual - General information 7 of 71
1.3 Intended use
The system is developed to supply warm fluids to adult patients.
The system can be used to warm the following fluids:
• Crystalloid Intravenous (IV) fluids
• Synthetic Colloid Intravenous (IV) fluids
• Packed red blood cells and blood components
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.

User Manual - General information 8 of 71
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.

User Manual - Contraindications, warnings, cautions, notes and
symbols 9 of 71
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 7. [W053]
• Obey local regulations. [W057]
Materials
Warning!
• Use blood products that comply with local regulations. [W001]
• Do not use fluids with a temperature below 4 °C or above room temperature. The high
viscosity of blood at low temperatures increases the risk of blood clots. [W002]
• Do not mix red blood cells with drugs. See Literature on page 12, references 3 and 4.
[W003]
• Use saline solution (0.9% Sodium Chloride) to dilute red blood cells to reduce the
viscosity. See Literature on page 12, references 1 and 2. [W004]
• Do not mix dextrose solution (5%) with blood components. This can cause haemolysis.
See Literature on page 12, references 4 and 5. [W005]
• Do not use the device for warming whole blood, platelets, cryoprecipitates or
granulocyte suspension. [W006]
• Do not add calcium-rich supplements (such as Hartmann’s solution or Ringers lactate)
as priming solution before the infusion of blood to prevent blood clots. [W007]
Prior to operation
Warning!
• Unlock the brakes on the IV Pole before moving the device. [W009]
• Do not use the device if one or more of its modules are 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]

User Manual - Contraindications, warnings, cautions, notes and
symbols 10 of 71
• Use a new hospital IV administration set for every application with a Fluido® Standard
Set. (See Literature on page 12, reference 4). [W013]
• Use the device only with a Fluido® Standard Set, a Fluido® Trauma Set or a Fluido®
Trauma Plus Set. [W015]
• Use each disposable set for only one patient. [W017]
• Do not use a disposable set if the disposable has expired. [W018]
• Do not use a leukocyte reduction filter in combination with the disposable set. [W019]
• Follow the standard IV line protocols for priming the complete infusion set and the
disposable set before connecting to a patient. Take care to ensure there is no air in the
lines that may cause air embolism. [W020]
• 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]
Operation
Warning!
• Do not position the device close to the head of the patient if inhaler therapy is being
used. [W024]
• Warming IV fluids/blood may result in outgassing. Check the disposable set every 15
minutes for accumulated gas bubbles. These can cause air embolism. [W025]
• If the IV line runs dry, disconnect it from the patient, prime the system again and ensure
that all air is removed, and then reconnect it to the patient. [W026]
• The disposable set should not be used for longer than 24 hours. [W027]
• If a problem with the Fluido®AirGuard cannot be solved immediately, remove the IV and
de-aeration chamber from the AirGuard and perform a continuous check for foam and
bubbles. Refer to Releasing the IV line from the AirGuard shut-off valve on page 41.
Abort the procedure if necessary. Do not use the Fluido® AirGuard until the problem is
resolved. [W028]
• 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]
After operation
Warning!
• After applying blood products, clean the hospital administration set with saline. [W031]
• 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]

User Manual - Contraindications, warnings, cautions, notes and
symbols 11 of 71
2.1.2 Cautions
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 60. [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]
• 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® IV Pole are locked when using the device.
[C011]
• Do not use the device on surfaces with an inclination > 2.5°. [C013]
• Do not exceed the safe load of 6 kg. The maximum capacity of each hook of the IV Pole
is 1 kg. [C014]
• After any temporary interruption of the mains power supply, refer to Power supply
interruption on page 48. [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]

User Manual - Contraindications, warnings, cautions, notes and
symbols 12 of 71
2.1.4 Literature
1. Reserved operations Blood transfusion, Jacques, M.B., Directorate Education & Training,
2008, Leids Universitair Medisch Centrum; Reader, 2009-04-06.
2. Carson, J.L., Guyatt, G., Heddle, N.M., Grossman, B.J., Cohn, C.S., Fung, M.K.,
Gernsheimer, T., Holcomb, J.B., Kaplan, L.J., Katz, L.M. and Peterson, N., 2016. Clinical
practice guidelines from the AABB: red blood cell transfusion thresholds and storage. Jama,
316(19), pp.2025-2035.
3. D. Norfolk, Handbook of Transfusion Medicine, 5th Edition, United Kingdom Blood Services,
2013.
4. Blood and Transplant, NHS, December 2009 version 1.
5. Fantl, P. and Morris, K.N., 1965. Influence of dextrose on heparinized blood. Thorax, 20(4),
p.372.
2.2 Device safety symbols
This section contains a list of symbols used for the Fluido® AirGuard System.
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

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Manufacturer
MOD stands for the modification update (in this example: modification update 6)
Transport and storage ambient temperature limits
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. Do not use a pressure
device without pressure indicator or a manually driven pressure device.
Equipotentiality

User Manual - Contraindications, warnings, cautions, notes and
symbols 14 of 71
Read the user manual.
Consult the instructions for use.
CE marking of conformity
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

User Manual - Contraindications, warnings, cautions, notes and
symbols 15 of 71
Class II equipment
Quantity
Do not use the device if the package is damaged.
Keep away from sunlight.
Keep away from rain.
Low priority warning indication on control equipment
Medium priority warning indication on control equipment
High priority warning indication on control equipment
Temporarily audible signal suppression
Non-pyrogenic

User Manual - Contraindications, warnings, cautions, notes and
symbols 16 of 71
System power On/Standby
Repair required

User Manual - Description 17 of 71
Module Function
3 Description
The Fluido® AirGuard System is a Blood and Fluid Warming System. The system is suitable for
both moderate and high flow applications. For low flow applications the use of a Fluido® Compact
device is recommended.
The Fluido® AirGuard System uses infrared heating technology to warm blood and fluids. Based
on in-line sensors, the Fluido® Blood and Fluid Warming System calculates the energy required to
safely warm the perfusates.
3.1 Overview of the system
The Fluido® AirGuard System consists of the following modules:
Blood and Fluid Warmer Warms the fluid to the set temperature. This is the central
module of the system.
AirGuard Monitors the fluid for the presence of air bubbles and prevents
air bubbles from reaching the patient.
Pressure Chambers Hold the IV fluid or blood bags and control the flow of the fluid by
increasing or decreasing the pressure.
Compressor Supplies pressure to the Pressure Chambers.
IV Pole Ensures a stable operating platform for the system.

User Manual - Description 18 of 71
1. Pressure Chambers
2. Blood and Fluid Warmer
3. AirGuard
4. IV Pole
5. Compressor
These modules are intended to be used in combination. [N003]
3.2 Blood and Fluid Warmer
The Fluido® Blood and Fluid Warmer is an easy-to-operate blood and fluid warmer. This section
describes the different parts of the device.
3.2.1 Overview
The Fluido® Blood and Fluid Warmer is the module that uses infrared technology to warm up
the fluids. The Fluido® Blood and Fluid Warmer uses Fluido® disposable sets for intravenous
administration.

User Manual - Description 19 of 71
Warning!
Ensure that the air deflector is correctly installed in the device before operation. It prevents
air from blowing towards the operator. [W058]
Caution!
The top sticker is an integral part of the Fluido® Blood and Fluid Warmer 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. Air deflector
12. 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.

User Manual - Description 20 of 71
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 Blood and Fluid Warmer.
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.