Hologic Aquilex Fluid Control System User manual

Form ENG-0034-T01, Rev. 003
TITLE
DOCUMENT NUMBER
REV
TEXT, IFU, AQUILEX FLUID
MANAGEMENT SYSTEM, 4320, NEW
SCALE
AW-16146-4320 005
SIZE A SHEET 1OF 1
REV AUTHORED BY
DATE
R MISTRY
08/18/23
REV DRAFTED BY
DATE
R MISTRY
08/18/23
PROPRIETARY: This document contains
proprietary data of Hologic, Inc. No
disclosure, reproduction or use of any part
thereof may be made except by written
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Aquilex® Fluid Control System
10000021387 04
Instructions for Use en

Manufacturer:
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
10587 Berlin, Germany
Phone:[phone]
Fax:[phone]
E-mail:[email protected]
Manufactured for:
HOLOGIC, INC.
250 Campus Drive, Marlborough
MA 01752 USA
1.800.442.9892 (US Toll Free)
1.508.263.2900 Type: H112 Bag scale / 1201601 / 10000021387 04 / TR
en Hologic and MyoSure are registered trademarks of Hologic,
Inc. and its subsidiaries in the United States and other coun-
tries. Aquilex is a trademark of Hologic, Inc. and its subsidiar-
ies in the United States and other countries. All other trade-
marks, registered trademarks, and product names are the
property of their respective owners.
These instructions for use contain information that is subject to copyright.
All rights reserved. These instructions for use may not be photocopied, du-
plicated on microfilm, or otherwise copied or distributed, completely or in
part, without the approval of W.O.M. WORLD OF MEDICINE GmbH.
We reserve the right to technical changes without prior notification due to
the continuous further development of our products. Function or design
may partially differ from the description in the instructions for use. Please
contact us for additional information about this or any of our other
products.
Some of the parts and equipment referred to in these instructions for use
are associated with registered trademarks but are not identified as such. It
should therefore not be assumed that the absence of the trademark sym-
bol indicates that any given designation is not subject to trademark protec-
tion.
Users of this product should not hesitate to point out to us any errors or is-
sues concerning these instructions for use.
Copyright © W.O.M. WORLD OF MEDICINE GmbH
Federal Law (only for U.S. market)
Caution: Federal law restricts this device to sale by or on the order of a physician.
Issued: 2023-0
MAN-05183-4320 Rev.005

Symbols and Descriptions
Symbols and Descriptions
Follow instructions for use
(white image on a blue back-
ground)
Consult instructions for use
Medical Device
Type BF applied part
Equipotentiality
Degrees of protection
provided by enclosures (IP-
Code)
Degrees of protection
provided by enclosures (IP-
Code)
Alternating current
Service
Catalogue number
Do not reuse
Do not resterilize
Sterilized using ethylene ox-
ide
Batch code
Serial number
Manufacturer
Date of manufacture (YYYY-
MM-DD)
Use by date (YYYY-MM-DD)
Quantity
Not made with phthalates
Made with phthalates
Keep dry
This way up
Fragile
Stacking limit by number
Keep away from sunlight
Protect from heat and
radioactive sources
Non-ionizing
electromagnetic radiation
en

Do not use if package is
damaged
Authorized for Sale or use by
Physician only
Temperature limit
Humidity limitation
Atmospheric pressure
limitation
Storage conditions
Transport conditions
Waste management
ON/OFF (push-push)
Max. use 30 days
Non sterile
Scale connection
Input/Output
Caution
Do not use this power
output
Certification Mark
RFID tag, general
Symbols and Descriptions
en

v
Table of Contents
1 Important Operator/User Notes ............................................................................................................................................................................ 7
2 Safety Information.....................................................................................................................................................................................................8
3 Purpose.......................................................................................................................................................................................................................... 9
3.1 Warnings and Precautions ...........................................................................................................................................................................9
3.1.1 General Warnings ....................................................................................................................................................................................... 9
3.1.2 Hysterosocopy Specific Warnings ........................................................................................................................................................13
3.1.3 Precautions .................................................................................................................................................................................................17
3.2 Description of the Aquilex® Fluid Control System...............................................................................................................................19
4 Initial System Set-Up ...............................................................................................................................................................................................21
4.1 Preparing the System for Use ....................................................................................................................................................................21
4.2 System Components ....................................................................................................................................................................................23
5 System Operation.....................................................................................................................................................................................................24
5.1 Front of Irrigation Pump Unit ....................................................................................................................................................................24
5.2 Rear of Irrigation Pump Unit......................................................................................................................................................................24
5.3 Fluid Monitoring Unit Set-up.....................................................................................................................................................................25
5.3.1 Setting of the Container Scale...............................................................................................................................................................28
5.3.2 Connecting the Vacuum Tube...............................................................................................................................................................29
5.4 Turning On the Aquilex® System..............................................................................................................................................................30
5.5 Hanging the Fluid Bags................................................................................................................................................................................31
5.6 Using Tube Sets..............................................................................................................................................................................................32
5.7 Tube Sets Overview ......................................................................................................................................................................................33
5.8 Connecting the Outflow Tube Set............................................................................................................................................................34
5.8.1 Connecting Outflow Tube of Tissue Removal Handpiece (e.g. MyoSure®)..............................................................................35
5.9 Inserting the Inflow Tube Set ....................................................................................................................................................................36
5.10 Presetting the Intrauterine Pressure .......................................................................................................................................................38
5.11 Deficit Limit Setting......................................................................................................................................................................................38
5.12 Using the Pump during Surgery................................................................................................................................................................38
5.13 Changing Bags during Surgery..................................................................................................................................................................40
5.14 Changing Container during Surgery........................................................................................................................................................40
5.15 Changing Instrument during Surgery .....................................................................................................................................................41
5.16 Total Inflow Volume Displayed .................................................................................................................................................................42
5.17 Turning System Off.......................................................................................................................................................................................42
6 Function Tests............................................................................................................................................................................................................43
6.1 General Function Test..................................................................................................................................................................................43
6.2 Scale Test .........................................................................................................................................................................................................43
7 Safety Functions........................................................................................................................................................................................................45
8 Care and Maintenance............................................................................................................................................................................................47
8.1 Cleaning the System.....................................................................................................................................................................................47
8.2 Maintenance Intervals.................................................................................................................................................................................47
8.3 Maintenance by Authorized Service Technician ..................................................................................................................................47
8.4 Replacing of the Fuse ...................................................................................................................................................................................48
9 Annual Inspection.....................................................................................................................................................................................................49
9.1 Electrical Safety Test.....................................................................................................................................................................................49
9.2 Basic Function Tests .....................................................................................................................................................................................49
9.2.1 Flow Rate Test ............................................................................................................................................................................................50
9.2.2 Pressure Measuring Test.........................................................................................................................................................................51
9.2.3 Scale Test.....................................................................................................................................................................................................52
9.2.4 Fluid Deficit Measurement Test............................................................................................................................................................52
9.2.5 Testing the Vacuum Pump.....................................................................................................................................................................53
9.3 Determine the Software Version..............................................................................................................................................................53
10 Error and Warning Messages................................................................................................................................................................................54
11 Technical Data...........................................................................................................................................................................................................56
12 Electromagnetic Compatibility.............................................................................................................................................................................58
12.1 Electrical Connections..................................................................................................................................................................................58
12.2 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ....................................................................................58
12.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity ...........................................................59
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vi
13 Accessory List.............................................................................................................................................................................................................61
14 Warranty Information.............................................................................................................................................................................................62
15 Appendix.....................................................................................................................................................................................................................63
15.1 Test log .............................................................................................................................................................................................................63
Glossary.......................................................................................................................................................................................................................65
Index.............................................................................................................................................................................................................................66
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Important Operator/User Notes
7 / 70
1 Important Operator/User Notes
Read the Instructions for Use carefully and become familiar with the operation and
function of the Aquilex® Fluid Control System (Aquilex® System) and the accessor-
ies before use during surgical procedures. Non-observance of the instructions listed
in this manual can lead to:
• life-threatening injuries to the patient,
• severe injuries of the surgical team, nursing staff or service personnel, or
• damage or malfunction of the system and/or accessories.
The Instructions for Use are only for the Aquilex® Fluid Control System, consisting
of pump, container scale and bag scale.
Subject to technical changes
The manufacturer reserves the right to modify the appearance, graphics, and tech-
nical data of the product through continued development of the product.
Please note
The words WARNING, CAUTION, and NOTE carry special meanings. Read these sec-
tions with special attention.
WARNING!
Warnings indicate risks to the safety of the patient or operator. Failure to follow
warnings may result in injury to the patient or operator.
CAUTION!
Warnings indicate risks to the equipment. Failure to follow cautions may result in
damage to the system.
NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.
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Safety Information
8 / 70
2 Safety Information
Exclusion of liability Hologic is not liable for indirect, incidental and consequential damages, including,
but not limited to, loss of profit. Any liability and applicable warranty become null
and void if:
• the system and/or the accessories/ peripherals are improperly used, transpor-
ted, stored, prepared, or maintained;
• the system and/or the accessories are improperly used, prepared, or main-
tained,
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the
device or accessories/peripherals;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedules are not adhered to.
Receipt of technical documentation from Hologic does not authorize individuals to
perform repairs, adjustments, or alterations on or to the system or accessories.
WARNING!Modification of the Aquilex® Fluid Control System is not permit-
ted.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or altera-
tions on the system or accessories/peripherals and use the service menu. Any viola-
tion will void any applicable warranty. Authorized service technicians are only
trained and certified by the manufacturer.
Normal Use The system may be used only as intended.
Care and maintenance The service and maintenance of the device and its accessories/ peripherals has to
be carried out as per instructions to ensure the safe operation of the device. For the
protection of the patient and the operating team, check that the device is complete
and functional before each use. Maintenance of the device may not be performed
during surgery or operation of the device.
NOTE!Service or maintenance work may not be carried out during surgery.
Contamination Before shipping, decontaminate the device and accessories/ peripherals in order to
protect the service personnel. Follow the instructions listed in these instructions for
use. If this is not possible,
• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to refuse the repair of contaminated devices or ac-
cessories/peripherals.
Waste management This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected separately. For
disposal of the device and its accessories, please consult Hologic or an authorized
disposal company, in compliance with legal or national regulations.
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Purpose
9 / 70
3 Purpose
Intended Use
The Aquilex® Fluid Control System is intended to provide fluid distension of the
uterus during diagnostic and operative hysteroscopies and to monitor the volume
differential between the irrigation fluid flowing into and out of the uterus.
Contraindications
The system may not be used to introduce fluids into the uterus when hysteroscopy
is contraindicated. See the operator’s manual of your hysteroscope for absolute
and relative contraindications.
Relative contraindications to endometrial ablation:
Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should not
be undertaken before adequate training, preceptorship, and clinical experience.
Additionally, tissue sampling is required prior to destruction of the endometrium.
The following are clinical conditions that can significantly complicate hysteroscopic
endometrial ablation:
• Adenomatous endometrial hyperplasia
• Uterine leiomyoma
• Severe adenomyosis
• Pelvic pain (subtle PID)
• Uterine anomalies
• Surgical skill (see above)
• Severe anemia
• Inability to circumnavigate the myoma (re: myoma size) - predominantly intra-
mural myomas with small submucous components.
3.1 Warnings and Precautions
3.1.1 General Warnings
WARNING!
Failure of scale connection
If the message “Check Scale Connection” appears, the deficit must be calculated
manually. The pump keeps displaying the last known deficit value determined prior
to the failure of the scale connection.
WARNING!
Scale error
Make sure that screw connections at cable and pump are fixed hand-tight to avoid
loosening of connection during move or use.
WARNING!
Scale error
Ensure that nothing weighs down the scale during system start-up. Doing so may
result in an inaccurate deficit value.
WARNING!
Instrument replacement
Stop the device using the Pause/Resume and Prime button if replacing the instru-
ment during surgery.
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Purpose
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WARNING!
Falls and crashes
Place the device on a stable and level surface. Cables must be laid safely. Tubes
between the device and the patient must not create any obstruction.
WARNING!
Function test
The function test must be performed prior to each device use.
WARNING!
Scale test
The scale test must be performed at the beginning of the day prior to device use
and whenever the scale has been exposed to shock (e.g. due to movement).
WARNING!
Obvious defects
Never use the system if it has suspected or confirmed defects, especially if these in-
volve the power plugs or the mains power supply connection cables. In this case
have the device repaired by authorized service personnel.
WARNING!
System error
Do not use the Aquilex® System if a defect is suspected or detected during the
function test. This also applies to any obvious defects, especially defects on the
power connector or plug and power cord.
WARNING!
Device setup
Device should be positioned outside of the sterile area in such a way that
• it can be easily disconnected,
• it is easy to use and switch off and on,
• it allows an easy monitoring of the display values, device functions, and access
to the control elements.
WARNING!
ON/OFF switch
For electrical safety reasons, do not touch the patient and the ON/OFF switch at
the same time.
WARNING!
Disconnect the power cord
Pressing the ON/OFF switch does not disconnect the system from the wall power
outlet. This requires pulling the power cord located in the rear of the system.
WARNING!
Unplug the power cord from the system before checking the fuse.
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Purpose
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WARNING!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient and
determine if the use of this device is indicated. The physician must determine the
specific technique and procedure that will accomplish the desired clinical effect.
WARNING!
Check all factory settings
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.
WARNING!
Original accessories
For your own safety and that of your patient, use only Aquilex® accessories (see
Chapter Accessory List [}61]).
WARNING!
Additional equipment
Additional equipment connected to medical electrical devices must be demon-
strated to be compliant with their respective IEC or ISO standards (IEC 60601-1,
IEC60950 or IEC62368 for data processing equipment). Furthermore, all configura-
tions must comply with the normative requirements for medical systems (see sec-
tion 16 of the last valid edition of IEC60601-1). Anyone who connects additional
devices to medical electrical equipment is a system configurator and as such is re-
sponsible for the system's compliance with the normative requirements for sys-
tems. Please contact the technical service if you have additional questions.
WARNING!
Acoustic signals
Different default settings of the warning message for identical or similar devices in
the operating room may cause a risk due to conflicting acoustic signals.
WARNING!
Not explosion-proof
The system is not explosion-proof. Do not use in an area where flammable anes-
thetic gases are present.
WARNING!
Risk of electrical shock
To avoid risk of electrical shock, this system may only be connected to a supply
mains with protective earth.
WARNING!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Notify the authorized service technicians of any required repairs.
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Purpose
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WARNING!
Professional qualification
The instructions for use do not include descriptions or instructions for surgical pro-
cedures/techniques. It is not suitable for training physicians in the use of surgical
techniques. Medical peripherals and devices may be used only by physicians or
medical assistants with the appropriate technical/medical qualifications working
under the direction and supervision of a physician.
WARNING!
Sterile media and accessories
Always work exclusively with sterile substances and media, sterile fluids, and
sterile accessories if so indicated.
WARNING!
Reprocessing of sterile disposable products
Reuse of inflow or outflow tube can cause an infection hazard for patients and/or
users as well as impair of product functionality. Contamination and/or impaired
functionality of the system can cause risk of injury, illness, or death. Do not re-pro-
cess or reuse single-use inflow or outflow tube sets.
WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected. Make
sure the device or/and accessories can no longer be operated until a qualified ser-
vice technician conducts the appropriate tests and repairs.
WARNING!
Replacement device and accessories
In case the system or any of the accessories fail during a procedure, an alternative
system and replacement accessories should be kept within easy reach to be able to
finish the operation with the replacement components.
WARNING!
Parameters and tolerances exceeded
If the specified parameters and tolerances are exceeded, the system must be re-
turned to Hologic for evaluation.
WARNING!
This product contains phthalates!
The vacuum tube sets for this device contain diethylhexylphthalate (DEHP), which
is classified as toxic to reproduction according to the EU Directive 1272/2008/EEC
on Classification, Labeling and Packaging of Dangerous Substances. DEHP may im-
pair fertility and may cause harm to the unborn child. Therefore, this product must
not be used for unauthorized applications. When applied within the intended use,
the potential risk to pregnant or breastfeeding women as well as to children result-
ing from the DEHP contained in this product is not critical.
WARNING!
Condensation / Water penetration
Protect system from moisture. Do not use if moisture has penetrated the system.
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Purpose
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WARNING!
Replace the fuse
Replace the fuse only with a fuse of the same type and rating (see Chapter Tech-
nical Data [}56]).
WARNING!
Electromagnetic emissions
Electromagnetic emissions may increase and rise above the permissible limits if
other equipment (e.g. MyoSure® Control Unit) is stacked onto or placed directly
next to the Aquilex Fluid Control System. The user is responsible for monitoring the
devices to make sure they function properly.
WARNING!
Portable HF communication equipment
Portable HF communication equipment can affect the performance characteristics
of the device Aquilex® Fluid Control System. Such equipment must therefore com-
ply with a minimum distance of 30 cm (regardless of all calculations) from the
device Aquilex® Fluid Control System, its components and cables.
WARNING!
If the Aquilex® Fluid Control System is configured as part of a ME SYSTEM, the en-
tire ME SYSTEM should be tested for compliance with IEC 60601-1-1, and any
equipment used with the Aquilex® Fluid Control System should be Type BF.
WARNING!
If the leakage current of the configured ME SYSTEM exceeds the limits of IEC
60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1 approved isolation
transformer and retest the system.
WARNING!
Touching containers and their holders
Touching the containers and their holders as well as vibrations of the balancing
system should be avoided during surgery to prevent false detection of the con-
tainer change and not negatively affect the accuracy of the deficit calculation.
3.1.2 Hysterosocopy Specific Warnings
WARNING!
Distension media
When performing monopolar hysteroscopic electrosurgery, the distension medium
must be electrically non-conductive. Examples include glycine, sorbitol and man-
nitol. Isotonic saline irrigation fluids may only be used when performing bipolar
electrosurgical resective procedures.
WARNING!
Pressure
The pressure should be kept as low as possible to allow for a sufficient intrauterine
distention and to reduce the forces that could allow fluid, ambient air, and/or gas
to enter the circulatory system.
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Purpose
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WARNING!
Risk of intravasation
If the intrauterine pressure does not react to an increase in the pressure setting
during the procedure, a perforation of the uterine cavity might be the cause. This
results in an increased risk of intravasation. Examine the uterine cavity for injuries.
WARNING!
Intrauterine distension
Intrauterine distension is usually possible with pressure values between 35 to
75mmHg. A pressure above 75mmHg is required only in rare cases or if the pa-
tient has an excessively high blood pressure.
WARNING!
Fluid overload
There is a risk of irrigation fluid reaching the circulatory system of the patient's soft
tissue by passing through the uterus. This can be affected by distention pressure,
flow rate, perforation of the uterine cavity and duration of the hysteroscopic sur-
gery. It is critical to closely monitor the input and outflow of the distending liquid
at all times.
WARNING!
Fluid deficit
The fluid left in the patient must be monitored. The deficit is the total amount of
fluid left in the patient or unaccounted for otherwise. Take notice of the measure-
ment tolerance of the system (see ChapterTechnical Data [}56]). Estimating the
fluid volume remaining in the patient is the physician’s responsibility.
WARNING!
Fluid intake and output surveillance
Strict fluid intake and output surveillance should be maintained due to the risk of
fluid overload. For healthy patients, the maximum fluid deficit of 1,000ml is sug-
gested when using a hypotonic solution (e.g. glycine, sorbitol and mannitol). If iso-
tonic solutions (e.g. saline, Lactated Ringer's) are used, the fluid deficit should not
exceed 2,500ml.
WARNING!
Containers and fluid bags
Make sure the containers and fluid bags hang freely, are not resting on something,
and do not touch other objects except the bag deflectors. Failure to follow these in-
structions means the deficit cannot be calculated correctly.
WARNING!
Accuracy of the deficit
To avoid affecting the accuracy of the deficit calculation ensure that the first step
of the container change is to disconnect tubing from the full containers. Reconnect
tubing to the new containers only if they are already inserted into the scale.
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Purpose
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WARNING!
Changing fluid bags
Fluid bags should be changed quickly to avoid affecting the accuracy of the deficit
calculation. Observe the occurrence of acoustic signals and message to avoid unre-
cognized bag changes during procedure which can affect the displayed deficit
value.
WARNING!
Touching containers and their holders
Touching the containers and their holders as well as vibrations of the balancing
system should be avoided during surgery to prevent false detection of the con-
tainer change and not negatively affect the accuracy of the deficit calculation.
WARNING!
Change of the containers
Containers should be changed quickly to avoid affecting the accuracy of the deficit
calculation.
WARNING!
Serum sodium concentration
It is also necessary to monitor the concentration of sodium in the blood of the pa-
tient to prevent electrolyte disturbances. Monitoring of the concentration of so-
dium in the blood must be performed by the physician and is not performed or sup-
ported by the system.
WARNING!
Idiosyncratic reactions
In rare cases, idiosyncratic reactions including
• intravascular coagulopathy
• allergic reaction including anaphylaxis
may occur while performing a hysteroscopy if a liquid distention medium is used.
WARNING!
Loss of deficit and inflow value
The deficit display value is lost in case of a power loss or “brownout.”
WARNING!
Fluid bag and container change during surgery
A fluid bag or container change during surgery is only allowed, if the fluid bag or
container holds at least 0,5liters of fluid or waste. Otherwise, the deficit value may
be falsified. In this case, the manufacturer recommends manual deficit calculation.
WARNING!
Irrigation fluid bags
The system is only intended for use with flexible fluid bags. Do not use glass con-
tainers as they might break. With rigid containers, fluid cannot flow quickly
enough due to the vacuum being generated inside of the containers. Risk of implo-
sion with rigid containers.
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Purpose
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WARNING!
Deficit displays and warnings
Deficit displays and warnings serve as a tool for the treating physician and do not
replace the monitoring of the patient's condition.
WARNING!
Resetting the deficit display
Filling the tubing with irrigation fluid and resetting the deficit display to zero are to
be done at the physician’s discretion.
WARNING!
Incorrect determination of fluid deficit
Always use the hooks of the bag scale to hang the fluid bags to ensure an accurate
determination of the fluid deficit. In addition, leave the empty fluid bags hanging
on the bag scale until the end of surgery.
WARNING!
Inflow volume limit
The Aquilex® Fluid Control System has a maximum allowable fluid inflow volume
of 30,000ml. When the inflow volume reaches 30,000ml, the pump stops fluid in-
flow. The inflow volume and deficit value freeze at the current values.
If the physician decides to continue the operation, manual count for continued de-
ficit monitoring must be performed.
WARNING!
Combination of low set pressures and excessive vacuum pressures
When using the Aquilex® Fluid Control System with tissue removal systems, e.g.
MyoSure®, the combination of low set pressures and excessive vacuum pressures
may result in a significant loss of intrauterine distension pressure which has the
potential to affect the visibility of the surgical field. Conversely, when employing a
high distension pressure, the deactivation of the tissue removal system can lead to
pressure peaks that can exceed 150mmHg.
WARNING!
Hyponatremia
Some distension fluids may lead to fluid overload and, consequently, hyponatremia
with its attending sequelae. This can be affected by the distending pressure, flow
rate, and duration of hysteroscopic procedure. It is critical to closely monitor the in-
put and outflow of the distending liquid at all times.
WARNING!
Pulmonary edema
Hysteroscopic surgery is associated with a risk of developing pulmonary edema res-
ulting from fluid overload with isotonic fluids. It is critical to closely monitor the in-
put and outflow of the distending liquid at all times.
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Purpose
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WARNING!
Cerebral edema
Hysteroscopic surgery is associated with a risk of developing cerebral edema result-
ing from fluid overload and electrolyte disturbances with hypoosmolar (non-ionic)
fluids such as glycine 1.5% and sorbitol 3.0%. It is critical to closely monitor the in-
put and outflow of the distending liquid at all times.
WARNING!
Hypothermia (monitoring body temperature)
Continuous flow of distention fluids can lead to a lowering of the patient's body
temperature during hysteroscopic surgery. Lower body temperatures can cause
coronary and cardiovascular problems. Always monitor the patient's body temper-
ature during the entire surgery. Make especially sure that the following, hypother-
mia promoting, operation conditions are avoided as best as possible:
• longer operating times
• use of cold irrigation fluid.
WARNING!
Rupture of the fallopian tube secondary to tubal obstruction
Distention of the uterus may lead to a tear of the fallopian tube should there be an
obstruction or permanent occlusion. The rupture could lead to irrigation fluid flow-
ing into the patient's peritoneal cavity, resulting in a fluid overload. It is critical to
closely monitor the input and outflow of the distending liquid at all times.
WARNING!
Air embolism
An air embolism can be the result of air contained in the tube set or connected in-
strument reaching the patient. Ensure there is always fluid in the bag to prevent air
from being pumped into the patient.
WARNING!
Hysteroscope
The system may only be connected with hysteroscopes designed for and featuring
the technical specification permitting such a combined use. Any utilized hystero-
scopes must comply with the most recent versions of IEC60601-2-18 and ISO8600.
3.1.3 Precautions
CAUTION!
Federal Law (only for U.S. market)
Federal law restricts this device to sale by or on the order of a physician.
CAUTION!
Indoor climate
Before switching on the device, sufficient time must have passed to adjust to the
indoor climate.
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Purpose
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CAUTION!
Instrument recognition
The instrument recognition must be performed outside and at the level of the pa-
tient.
CAUTION!
Continuous operation
After 24 hours of continuous operation, a device self-test must be carried out.
Switch device off and on again.
CAUTION!
Accessories
To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-
sion, the device Aquilex® Fluid Control System must be used only with the ac-
cessories listed in ChapterAccessory List [}61].
CAUTION!
Not to be used with a defibrillator
The device may not be used in conjunction with a defibrillator since it is not
equipped with corresponding safety elements. The manufacturer accepts no liabil-
ity in this case for ensuing damage.
CAUTION!
Mains Power Cable
Any power cables employed by the user that are not provided by the manufacturer
must meet the safety requirements of the national standards in the respective cur-
rent valid version.
CAUTION!
Ventilation of the device
• Avoid device overheating.
• Ensure free air circulation especially to the bottom and rear of the device (rear
panel distance of at least 10cm).
CAUTION!
Modifying the system
Modifying the system and/or its accessories is not permitted.
CAUTION!
Do not use the covered power output at the rear of the irrigation pump unit.
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Purpose
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CAUTION!
Electrical interference
(see Chapter Electromagnetic Compatibility [} 58]): Electrical interference with
other devices or instruments was considered when developing this system and
none was detected during testing. However, if you still detect or suspect such inter-
ference, please follow these suggestions:
• Move the Aquilex® System, the other device, or both devices to a different loc-
ation.
• Increase distance between devices used.
• Consult an electro-medical expert.
CAUTION!
Wall outlet voltage
Check to ensure the available wall outlet voltage matches the data listed on the la-
bel attached to the back of the pump. Incorrect voltage can cause errors and mal-
functions and may destroy the system.
CAUTION!
Transport
The device is transportable. The roller wheels of the Fluid Monitoring Unit (cart/
scale) are used for positioning at the place of use. To transport the device, remove
all fluid bags from the hooks and make sure there are no containers or only com-
pletely emptied containers on the cart/scale. Inflow and outflow tubes must be
completely removed. Make sure the power supply line does not touch the ground
and there are no other objects located on the Aquilex® Fluid Control System. Al-
ways use the handle to move the system safely.
CAUTION!
Combination of AQL-100PBS with AQL-100CBS
The irrigation pump unit AQL-100PBS may only be used with the fluid monitoring
unit AQL-100CBS as only this combination is approved to bear the MET NRTL mark.
CAUTION!
Cleaning the system / Sterilization not allowed
The pump and the cart/scale can be disinfected by wiping off the outer surfaces.
Do not sterilize the pump and the cart/scale.
CAUTION!
Filter
The vacuum tube with integrated filter is designed for maximum 30 days. The va-
cuum tube may not be sterilized. Replace the vacuum tube sooner if it is obviously
contaminated. The filter prevents body fluids from entering the interior of the
device.
3.2 Description of the Aquilex® Fluid Control System
Technical application scope of the
system
The intrauterine pressure can be adjusted on the front of the pump. It can be pre-
set to a range between 40 and 150mmHg. The maximum inflow rate is 800ml/
min and is reduced automatically by the pump once the pre-set intrauterine pres-
sure setting has been reached.
The system has been designed to provide both fluid and vacuum systems that max-
imize the performance of tissue removal systems, e.g. MyoSure®.
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