Hologic Aquilex User manual

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Instructions for Use and Fluid
Control System Operator’s Manual
Gebrauchs- und Bedienungsanweisun-
gen für Fluid Control System
Manuel d‘instruction et d‘utilisation du
Fluid Control System
Manual de Instrucciones y de Utilización
del Fluid Control System
Istruzioni per l'uso e istruzioni operative
del Fluid Control System
Gebruiks- en bedieningsinstructies voor
Fluid Control System

W.O.M. WORLD OF MEDICINE AG
10587 Berlin
Salzufer 8
GERMANY
[phone]
96337 Ludwigsstadt
Alte Poststraße 11
GERMANY
[phone]
Model: H112/1201048/10000011593 02/0812/endefresitnl/ama
Manufacturer/Hersteller/Fabricant/Fabricante/
Fabbricante/Fabrikant:
CE marking according to Directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/CEE
Marquage CE conforme à la directive 93/42/CEE
Identificación CE conforme a la directiva 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE
EG-markering conform Richtlijn 93/42/EEG
Distributor/Vertreiber/Distributeur/Distribuidor/
Distributore/Distributeur:
HOLOGIC, INC.
250 Campus Drive,
Marlborough
MA 01752 USA
1.800.442.9892 (US Toll Free)
1.505.263.2900
0124
MAN-02570-4320 Rev.004
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 subsidiaries
in the United States and other countries. All other trademarks,
registered trademarks, and product names are the property of
their respective owners.
Hologic und MyoSure sind eingetragene Warenzeichen der Ho-
logic, Inc. und ihrer Tochtergesellschaften in den Vereinigten
Staaten und anderen Ländern. Aquilex ist ein Warenzeichen
der Hologic, Inc. und ihrer Tochtergesellschaften in den Ver-
einigten Staaten und anderen Ländern. Alle anderen Waren-
zeichen, eingetragene Warenzeichen und Produktnamen sind Eigentum der
jeweiligen Inhaber.
Hologic et MyoSure sont des marques déposées de Hologic
Inc., de ses filiales aux États-Unis et d'autres pays. Aquilex est
une marque de Hologic Inc., de ses filiales aux États-Unis et
d'autres pays. Toutes les autres marques, marques déposées,
et noms de produits sont la propriété de leurs propriétaires re-
spectifs.
Hologic y MyoSure son marcas comerciales registradas de Ho-
logic, Inc. y sus subsidiarias en los Estados Unidos y otros países.
Aquilex es una marca comercial de Hologic, Inc. y sus subsidiar-
ias en los Estados Unidos y otros países. Todas las demás marcas
comerciales, marcas comerciales registradas y nombres de pro-
ductos son propiedad de sus respectivos dueños.
Hologic e MyoSure sono marchi registrati di Hologic, Inc. e re-
lative società affiliate negli Stati Uniti e in altri paesi. Aquilex è
un marchio registrato di Hologic, Inc. e relative società affiliate
negli Stati Uniti e in altri paesi. Tutti gli altri marchi commer-
ciali, marchi registrati e nomi di prodotti sono di proprietà del
rispettivo proprietario.
Hologic en MyoSure zijn gedeponeerde handelsmerken van
Hologic, Inc. en haar dochtermaatschappijen in de Verenigde
Staten en andere landen. Aquilex is een handelsmerk van Ho-
logic, Inc. en haar dochtermaatschappijen in de Verenigde Sta-
ten en andere landen. Alle andere handelsmerken,
gedeponeerde handelsmerken en productnamen zijn eigendom van de desbe-
treffende houders.
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Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen
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Read Instructions
Before Use Bedienungsanlei- tung befolgen Lire la documenta-
tion jointe ! Observe la docu- mentación adjunta
Leggere la docu-
mentazione alle-
gata
Lees de begelei-
dende documenta-
tie
BF Type Equipment System des Typs BF Système de type BF
Sistema del tipo BF Sistema tipo BF
Syteem van het
type BF
Symbol for Poten-
tial Equalization Symbol für Potenti-
alausgleich
Symbole pour la
fiche équipoten-
tielle
Símbolo para la
conexión equipo-
tencial
Simbolo per il colle-
gamento equipo-
tenziale
Symbool voor de
potentiaalvereffe-
ning
Degrees of Protec-
tion Provided by
Enclosures (IP-
Code)
Gehäuseschutz-
klasse (IP-Code)
Degrés de protec-
tion procurés parles
enveloppes (Code
IP)
Grado de protec-
ción proporcio-
nado por los
envolventes
(Código IP)
Grado di prote-
zione degli involu-
cri (Codice IP)
Beschermings-
klasse (IP-code)
behuizing
Alternating Current Wechselstrom Courant alternatif Corriente alterna Corrente alternata Wisselstroom
Service Service Service Servicio Servizio Service
Order Number Bestellnummer Numéro de
commande Número de pedido Numero di ordina- zione Bestelnummer
Do not Reuse Nicht zur Wieder-
verwendung Usage unique No reutilizable Non riutilizzabile Niet voor herge-
bruik
Sterilized using
Ethylene Oxide Sterilisiert mit
Ethylenoxid Stérilisés à l’éthy-
lène oxide Esterilizado con óxido de etileno Sterilizzato con ossido di etilene Sterilisatie met ethyleenoxide
Lot Number Chargenbezeich-
nung Numéro de lot Número de lote Numero di lotto Chargenummer
Serial Number Seriennummer Numéro de série Número de serie Numero di serie Serienummer
Date of Manufac-
ture Herstellungsdatum Date de fabrication Fecha de fabrica- ción Data di produzione Fabricagedatum
Expiration Date Verwendbar bis Date limite
d’utilisation Utilizable hasta Da utilizzarsi entro il Te gebruiken tot
Pieces Stück Unités Unidades Pezzi Eenheden
Quantity Menge Quantité Cantidad Quantità Hoeveelheid
Not Made with
Natural Rubber
Latex
Nicht aus Natur-
kautschuklatex
hergestellt
Ce produit ne con-
tient pas de latex
de caoutchouc
naturel
Producto no produ-
cido con látex de
caucho natural
Non prodotto in lat-
tice di caucciù
naturale
Niet vervaardigd
van natuurlijke rub-
berlatex

Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen
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Not Made with
Phthalates
Dieses Produkt ent-
hält kein Diethylhe-
xylphthalat (DEHP)
Ce produit ne con-
tient pas du
diethylhexyl phta-
late (DEHP)
Este producto no
contiene dietilhe-
xilftalato (DEHP)
Questo prodotto
non contiene
diethylhexylftalato
(DEHP)
Dit product bevat
geendi-ethylftalaat
(DEHP)
Made with Phthala-
tes
Dieses Produkt ent-
hält Diethylhe-
xylphthalat (DEHP)
Ce produit contient
du diethylhexyl
phtalate (DEHP)
Este producto con-
tiene dietilhexilfta-
lato (DEHP)
Questo prodotto
contiene
diethylhexylftalato
(DEHP)
Dit product bevat
di-ethylftalaat
(DEHP
Do Not Get Wet Vor Nässe schützen Protéger de l’humi-
dité Proteger contra la humedad Proteggere dall'umidità Beschermen tegen vocht
Top-Bottom Oben-Unten Haut-bas Arriba-abajo Alto - basso Boven-Beneden
Fragile Zerbrechlich Fragile Frágil Fragile Breekbaar
Waste Manage-
ment Entsorgung Élimination des déchets Gestión de residuos Smaltimento Verwijdering
Reset Deficit
Button Taste Reset Deficit Touche de remise à zéro du déficit Tecla de reseteo del déficit Tasto di reset per deficit Resettoets voor deficit
Prime Button Taste Prime Touche Prime Tecla Prime Tasto Prime Toets Prime
Pause/Resume
Button Taste Pause/Resume Touche Pause/ Resume Tecla Pause/ Resume Tasto Pause/ Resume Toets Pause/ Resume
Increase Erhöhen Croissant Aumento Crescente Verhogen
Decrease Verringern Décroissant Disminución Decrescente Verlagen
Fluid Bags Flüssigkeitsbeutel Poche de liquide Bolsa de líquido Sacche di liquido Vloeistofzak
Non-Sterile Nicht steril Non stérile No estéril Non è sterile Niet steriel
Connection for
Canister Scale Anschluss Contai- newaage
Raccord pour unité
de pesage à
container
Conexión para la
balanza de cubetas
Attacco per unità di
pesatura conteni-
tori
Aansluiting reser-
voirweegsysteem
Data Transfer Datenübertragung Transmission de
données Transmisión de datos Trasmissione dati Datatransmissie
Do not push! Schieben verboten Interdit de pousser! ¡No empujar! Non spingere! Duwen verboden
General Warning
Sign Warnzeichen für allgemeine Gefahr Signalisation générale de danger Señal de adverten- cia general Segnale generale di pericolo
Waarschuwingste-
ken voor algemeen
gevaar
SGS USTC Certifica-
tion Mark SGS USTC Produkt- zertifizierung Marque de certifi- cation SGS USTC Marca de certifica- ción SGS USTC Marquio de certifi- cazione SGS USTC Kwaliteitsmerk SGS USTC
NON
STERILE

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Table of Contents
1 Important User Notes ......................................................................................................................................................... 3
2 Safety Information.............................................................................................................................................................. 4
3 Purpose of the System ........................................................................................................................................................ 5
3.1 Warnings and Precautions .................................................................................................................................................... 5
3.1.1 Warnings .................................................................................................................................................................................... 5
3.1.2 Precautions................................................................................................................................................................................. 9
3.2 Description of the Aquilex Fluid Control System ............................................................................................................ 10
4 Initial System Set-up........................................................................................................................................................... 11
4.1 Preparing the System For Use............................................................................................................................................... 11
4.2 System Set-up............................................................................................................................................................................ 12
5 System Operation ............................................................................................................................................................... 13
5.1 Front of Pump............................................................................................................................................................................ 13
5.2 Rear of Pump.............................................................................................................................................................................. 13
5.3 Cart/scale.................................................................................................................................................................................... 14
5.3.1 Scale Set-up................................................................................................................................................................................ 15
5.3.2 Connecting the Vacuum Tubing........................................................................................................................................... 16
5.4 Turning On the Aquilex System............................................................................................................................................ 17
5.5 Hanging the Fluid Bags........................................................................................................................................................... 18
5.6 Using Tube Sets......................................................................................................................................................................... 18
5.7 Tubing Overview....................................................................................................................................................................... 19
5.8 Connecting the Outflow Tubing .......................................................................................................................................... 19
5.8.1 MyoSure® Outflow Connection............................................................................................................................................ 20
5.9 Inserting the Inflow Tube Set................................................................................................................................................ 21
5.10 Presetting the Intrauterine Pressure .................................................................................................................................. 22
5.11 Setting the Deficit Limit ......................................................................................................................................................... 22
5.12 Using the Pump during Operation ...................................................................................................................................... 23
5.13 Changing Canisters during Procedure ............................................................................................................................... 23
5.14 Total Volume Displayed .......................................................................................................................................................... 24
5.15 Turning System Off .................................................................................................................................................................. 24
6 Safety functions .................................................................................................................................................................. 25
7 Care and Maintenance........................................................................................................................................................ 26
7.1 Cleaning the System................................................................................................................................................................ 26
7.2 Authorized Service Technician Maintenance ................................................................................................................... 26
7.3 Replacing the Fuse ................................................................................................................................................................... 26
8 Annual Inspection ............................................................................................................................................................... 28
8.1 Safety Test................................................................................................................................................................................... 28
8.2 Basic Function Tests................................................................................................................................................................. 28
8.3 Scale Test..................................................................................................................................................................................... 28
8.4 Flow Rate Test............................................................................................................................................................................ 29
8.5 Pressure Measuring Test ........................................................................................................................................................ 30
8.6 Fluid Deficit Measurement Test ........................................................................................................................................... 31
8.7 Vacuum Pump Operational Test........................................................................................................................................... 32
9 Error and Warning Messages.............................................................................................................................................. 33
10 Technical Data..................................................................................................................................................................... 35
11 Guidelines and manufacturer's statement - electromagnetic compatibility .................................................................... 37
11.1 Impact of Mobile and Portable HF Communication Devices....................................................................................... 37
11.2 Electrical Connections............................................................................................................................................................. 37
11.3 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions .............................................................. 38
11.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity....................................... 39
11.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity....................................... 40
11.6 Recommended safety distances between portable and mobile HF telecommunications devices and the
Aquilex Fluid Control System................................................................................................................................................ 41
12 Accessory List ...................................................................................................................................................................... 42
13 Warranty Information ........................................................................................................................................................ 43
14 Glossary............................................................................................................................................................................... 45
15 Appendix............................................................................................................................................................................. 46
15.1 Test Log........................................................................................................................................................................................ 46
Index.................................................................................................................................................................................... 47

Important User Notes
3
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1ImportantUserNotes
Read the manual carefully and become familiar with the operation and function
of the Aquilex™ Fluid Control System (Aquilex System) and the accessories 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.
Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and
technical data of the product through continued development of the product.
Please noteThe words WARNING, CAUTION, and NOTE carry special meanings. Read these
sections with special attention.
WARNING!
Warnings indicate risks to the safety of the patient or user. Failure to follow
warnings may result in injury to the patient or user.
CAUTION!
Warnings indicate risks to the equipment. Failure to follow cautions may result
in damage to the system.
NOTE!
Notes provide special information to clarify instructions or present additional in-
formation.

4
Safety Information
EN 2 Safety Information
Federal Law (only for U.S. market) Caution: Federal law restricts this device to sale by or on the order of a physician.
Exclusion of liability Hologic is not liable for direct or consequential damage and the warranty is null
and void if:
• the system and/or the accessories are improperly used, prepared, or main-
tained,
• the instructions in the manual are not adhered to,
• non-authorized persons perform repairs, adjustments, or alterations on or to
the system or accessories,
• non-authorized persons open the pump housing,
• 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.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or al-
terations on the system or accessories. Any violation will void the manufacturer's
warranty. Authorized service technicians are trained and certified only by the
manufacturer.
Intended use The system may be used only as intended.
Care and maintenance The service and maintenance of the system and its accessories has to be carried
out as per instructions to ensure its safe operation. For the protection of the pa-
tient and the operating team, check that the system is complete and functional
before each use.
Waste management In the European Community, this symbol indicates that the waste of electrical
and electronic equipment must not be disposed of as unsorted municipal waste
and must be collected separately instead. Please contact Hologic or an according-
ly authorized disposal or waste management company for further information.

Purpose of the System
5
EN
3 Purpose of the System
Indication for useAquilex™ Fluid Control System is intended to provide liquid distension of the
uterus during diagnostic and operative hysteroscopy, and to monitor the volume
differential between the irrigation fluid flowing into and out of the uterus.
ContraindicationsThe system may not be used to introduce fluids into the uterus when hysterosco-
py is contraindicated. See the operators manual of your hysteroscope for abso-
lute 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 experi-
ence. Additionally, tissue sampling is required prior to destruction of the endo-
metrium. The following are clinical conditions that can significantly complicate
hysteroscopic endometrial ablation:
• Adenomatous endometrial hyperplasia
•Uterineleiomyoma
• 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 Warnings
WARNING!
When performing monopolar hysteroscopic electrosurgery, the distension medi-
um must be electrically non-conductive. Examples include glycine, sorbitol and
mannitol. Isotonic saline irrigation fluids may only be used when performing bi-
polar electrosurgical resective procedures.
WARNING!
The pressure should be kept as low as possible to allow for a sufficient intrauter-
ine distension and to reduce the forces that could allow fluid, ambient air, and/
or gas to enter the circulatory system.
WARNING!
Intrauterine distention is usually possible with pressure values between 35 to 70
mmHg. A pressure above 75 to 80 mmHg is required only in rare cases or if the
patient has an excessively high blood pressure.
WARNING!
When using the cart/scale, follow the exact operating instructions in this manu-
al.

6
Purpose of the System
EN 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 pres-
sure, flow rate, perforation of the uterine cavity and duration of the hys-
teroscpopic surgery. 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 mea-
surement tolerance of the system (see Chapter 10, Technical Data). 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. If a low viscos-
ity liquid distention medium is used, intrauterine instillation exceeding 2 liters
should be followed with great care due to the possibility of fluid overload. If a
high viscosity fluid (e. g. Hyskon) is used, the use of more than 500 ml should be
followed with great care. See labeling for Hyskon for additional information.
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
supported by the system.
WARNING!
The deficit display value is lost in case of a power loss or “brownout.”
WARNING!
Hyponatremia
Some distension fluids may lead to fluid overload and, consequently, hyponatre-
mia with its attending sequelae. This can be affected by the distending pressure,
flow rate, and duration of hysteroscopic procedure. It is critical to closely moni-
tor the input and outflow of the distending liquid at all times.
WARNING!
Pulmonary edema
Hysteroscopic surgery is associated with a risk of developing pulmonary edema
resulting from fluid overload with isotonic fluids. It is critical to closely monitor
the input and outflow of the distending liquid at all times.

Purpose of the System
7
EN
WARNING!
Cerebral edema
Hysteroscopic surgery is associated with a risk of developing cerebral edema re-
sulting 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 input and outflow of the distending liquid at all times.
WARNING!
Idiosyncratic reactions
In rare cases, idiosyncratic reactions, including:
• intravascular coagulopathy
• allergic reaction including anaphylaxis
may occur while performing hysteroscopy if a liquid distention medium is used.
Specifically, idiosynatric anaphylactoid reactions have been reported when us-
ing Hyskon as an irrigitaion fluid during hysteroscopy. These should be managed
like any allergic reaction.
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 tem-
perature during the entire surgery. Make especially sure that the following, hy-
pothermia 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
flowing into the patient's peritoneal cavity, resulting in a fluid overload. It is crit-
ical to closely monitor the input and outflow of the distending liquid at all times.
WARNING!
An air embolism can be the result of air contained in the tube set or connected
instrument reaching the patient. Ensure there is always fluid in the bag to pre-
vent air from being pumped into the patient.
WARNING!
The system is only intended for use with flexible fluid containers. Do not use
glass containers as they might break. With rigid containers, fluid cannot flow
quickly enough due to the vacuum being generated inside of the containers. Risk
of implosion with rigid containers.
WARNING!
Filling the tubing with irrigation fluid and resetting the deficit display to zero are
to be done at the physician’s discretion.

8
Purpose of the System
EN WARNING!
Place the system in such a way as to allow for easy visualization of the display
values, system functions, and access to the control elements.
WARNING!
Do not use this system if a defect is suspected or detected during the function
check. This also applies to obvious defects, especially defects and damage to the
power plug and power cord.
WARNING!
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!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this system is indicated. The physician must deter-
mine the specific technique and procedure that will accomplish the desired clin-
ical outcome.
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.
WARNING!
Not explosion-proof
The system is not explosion-proof. Do not use in an area where flammable anes-
thetic gases are present.
WARNING!
No modification of this equipment is allowed.
WARNING!
To avoid risk of electric shock, this equipment must only be connected to a sup-
ply mains with protective earth.

Purpose of the System
9
EN
WARNING!
Professional qualification
This manual does not include descriptions or instructions for surgical proce-
dures/techniques. It is also not suitable for training physicians in the use of sur-
gical techniques. Medical instruments and systems may be used only by
physicians or medical assistants with the appropriate technical/medical qualifi-
cation 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!
Replacement system and accessories
In case the system or any of the accessories fail during a procedure, an alterna-
tive system and replacement accessories should be kept within easy reach to be
able to finish the operation with the replacement components.
WARNING!
Cleaning the system
Do not sterilize the system.
WARNING!
Condensation / Water penetration
Protect system from moisture. Do not use if moisture has penetrated the system.
WARNING!
System defect
If a system defect is suspected or confirmed, do not use the system. Ensure the
system will no longer be used until a qualified service technician conducts the
appropriate tests and repairs.
WARNING!
Replacing fuse
Replace the fuse only with a fuse of the same type and rating (see Chapter 10,
Technical Data).
WARNING!
Equipment should be positioned such that power cord can be easily disconnect-
ed.
3.1.2 Precautions
CAUTION!
Federal Law (only for U.S. market)
Federal law restricts this device to sale by or on the order of a physician.

10
Purpose of the System
EN CAUTION!
When using the Aquilex System with MyoSure® or other morcellation systems,
the combination of low set pressures and high vacuum pressures may result in a
significant loss of intrauterine distension pressure which has the potential to af-
fect the visibility of the surgical field. Conversely, when employing high disten-
sion pressures, the deactivation of the MyoSure® or other morcellator system
can lead to pressure spikes that can exceed 150 mmHg. These situations may oc-
cur for a short time as the system automatically adjusts the flow rate to return
to the set intrauterine pressure.
CAUTION!
The system may only be connected with hysteroscopes designed for and featur-
ing the technical specification permitting such a combined use. Any utilized hys-
teroscopes must comply with the most recent versions of EC 60601-2-18 and
ISO 8600.
CAUTION!
Electrical Interference: (See Chapter 11, Guidelines and manufacturer's state-
ment - electromagnetic compatibility). Electrical interference with other devices
or instruments was practically eliminated when developing this system and
none was detected during testing. However, if you still detect or suspect such in-
terference, please follow these suggestions:
• Move the Aquilex System, the other device, or both devices to a different loca-
tion
• Increase distance between devices used
• Consult an electro-medical expert
CAUTION!
Check to ensure the available wall outlet voltage matches the data listed on the
label attached to the back of the pump. Incorrect voltage can cause errors and
malfunctions and may destroy the system.
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 maximun inflow rate is 800 ml/
min and is reduced automatically by the pump once the pre-set intrauterine
pressure setting has been reached.
The system has been designed to provide both fluid and vacuum systems that
maximize the performance of the MyoSure® Tissue Removal System.
Suggested distension media The Aquilex Fluid Control System can be used with hypotonic, electrolyte-free
media (e.g., glycine 1.5% and sorbitol 3.0%) and isotonic, electrolyte containing
media (e.g., saline 0.9% and Lactated Ringer's).
Pressure measuring and regulating The system operates with a completely non-contact pressure measurement of
the irrigation medium. The contact-free pressure measurement is achieved by in-
tegrating the pressure chamber into the tubing system. The pressure chamber
transmits the irrigation fluid pressure to the electronics of the device via a pres-
sure sensor. The pressure control circuit continuously compares the desired pre-
set intrauterine pressure with the actual intrauterine pressure. The function of
this algorithm is to maintain the pre-set intrauterine pressure. Check for possible
leaks if the pre-set intrauterine pressure cannot be achieved.

Initial System Set-up
11
EN
4 Initial System Set-up
Always check all parts and accessories of the system when performing initial set-
up. If the system should show obvious defects, contact Hologic Technical Support
(Chapter 13, Warranty Information).
Initial system set-upPlace the system on a level surface and install in a dry environment. The ambient
temperature and humidity must meet the requirements mentioned in Chapter
10, Technical Data.
WARNING!
Equipment should be positioned such that power cord can be easily disconnect-
ed.
4.1 Preparing the System For Use
Connection to the wall outlet
CAUTION!
Check to ensure the available wall outlet voltage matches the data listed on the
label attached to the back of the system. Incorrect voltage can cause errors and
malfunctions and may destroy the system.
Ensure the connection data and technical specifications of the power supply
comply with DIN VDE or national requirements. The wall outlet power supply
cord must be plugged into a properly installed safety wall plug (see DIN VDE
0107). Read the device label located in rear of pump to determine the operating
voltage of the system.
Grounding contact
The power connection must be equipped with a grounding contact. Use the Aqui-
lex power cord to establish a connection between the wall outlet and the power
cord connection located in the rear of the system.
Only for U.S. operatorsUse only a certified (UL-listed), removable power cord, type SJT, minimal 18 AWG,
3 leads. The plug connectors must comply with NEMA 5-15 or IEC 320/CEE22.
Grounding will only be reliable if the equipment is connected to a corresponding
hospital grade outlet.
Potential equalizationIntegrate the system into the potential equalization system as specified by local
safety rules and regulations.
Precautionary measuresMedical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
This system is to be used only for the purposes described in the manual and has
to be installed, set up, and operated in compliance with the EMC notes and in-
structions.

12
Initial System Set-up
EN 4.2 System Set-up
The Aquilex Fluid Control System is divided into two separate boxes for shipping.
Box 1 contains:
•Pump
•Manual
• Wall power cord
• Aquilex vacuum tube set (low and high vacuum)
• MyoSure® Control Unit power cord
Box 2 contains:
• Cart/scale
• Canister rings
Figure 4-1 Set-up of Aquilex Fluid Control
System
(1) Cart
(2) Bag holder
(3) Pump
(4) Fluid bag
(5) Trays
(6) Scale cable
(7) MyoSure® Control Unit
(8) Scale
(9) Canister holders
(10) Canister
(11) Roller base
(12) Locking foot brake
(10)
(5)
(7)
(8)
(11)
(1)
(9)
(12)
(4)
(2)
(3)
(6)

System Operation
13
EN
5SystemOperation
5.1 Front of Pump
Please familiarize yourself with the layout of the individual elements on the front
of the pump.
5.2 Rear of Pump
Please familiarize yourself with the layout of the individual elements at the rear
of the pump.
CAUTION!
Any devices to be connected via the interface have to comply with EN 60950.
Figure 5-1 Front of Pump
(1) Pump display
(2) Intrauterine pressure display
(3) Fluid deficit limit
(4) Deficit meter
(5) Deficit display
(6) Inflow tube holder
(7) Roller wheel
(8) Pressure sensor
(9) Reset deficit button (Zero)
(10) Decrease deficit limit
(11) Increase deficit limit
(12) Decrease intrauterine pressure set-
ting
(13) Increase intrauterine pressure set-
ting
(14) Intrauterine pressure setting dis-
play
(15) ON/OFF switch
(16) Pause/Resume button
(17) Prime button
(11)
(1) (2) (3) (7)(4) (5) (6)
(8)
(9)
(10)
(13)
(16)
(17)
(15)(14) (12)
Figure 5-2 Rear of Pump
(1) Low vacuum port (white)
(2) Product ID label
(3) Device performance data
(4) Adjustment dial for high vacuum
(5) High vacuum port (green)
(6) Fuse holder(s)
(7) Power cord connection
(8) MyoSure® Control Unit Power Con-
nection
(9) Potential equalization connector
(10) Service interface
(11) Scale connection
(12) Exhaust ports
(6)
(5)
(4)
(9)
(1) (2) (3)
(7)
(8)
(10)
(11)
(12) (12)

14
System Operation
EN 5.3 Cart/scale
The cart/scale consists of a weighing scale for the canisters, a pole with hooks for
irrigation fluid bags, and a roller base.
1. Remove the cart/scale from the cardboard shipper box.
2. Extend the pole to stop position.
3. Extend the bag deflector to stop position.
4. Remove the pump and the power cords from the first cardboard box.
5. Install canister rings (included in the second box) on upper (7) or lower (8)
canister holders, in accordance with type of canister.
6. Connect the wall power cord to the male outlet at the rear of the pump ((7)
Figure 5-2, Rear of Pump, page 13) and a grounded safety wall outlet.
7. Connect the scale to the pump by connecting the scale cable ((2) Figure 5-3,
Cart/Scale) to the scale connection ((11) Figure 5-2, Rear of Pump).
8. Use the enclosed MyoSure Control Unit power cord to connect the pump ((8)
Figure 5-2, Rear of Pump) with the MyoSure® Control Unit.
WARNING!
Scale error
Ensure that nothing weighs down the scale during system start-up. Doing so
may result in an inaccurate deficit value.
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 mea-
surement tolerance of the system (see Chapter 10, Technical Data). Estimating
the fluid volume remaining in the patient is the physician’s responsibility.
Figure 5-3 Cart/Scale
(1) Fluid bag
(2) Scale cable
(3) Scale
(4) Pole with bag hooks
(5) Bag deflector
(6) Canister
(7) Upper canister holder (Serres,
Medela, Baxter, Baxter flex)
(8) Lower canister holder (Abbott,
Bemis, Medi-Vac, DeRoyal)
(9) Roller base
(1)
(3)
(6)
(7)
(4)
(8)
(5)
(9)
(2)

System Operation
15
EN
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
supported by the system.
Precise balancingTry to collect all the fluid running out of the uterine cavity during the procedure
to achieve the most exact deficit value possible.
Scale capacityThe scale can be loaded with a weight of up to 65 lbs (~30 kg). Weight above this
value triggers the Scale Overloaded/Check Scale message. Three audible warning
tones are emitted (See Chapter 9, Error and Warning Messages.)
CAUTION!
Ensure canisters hang freely and are not supported or in contact with anything;
otherwise, the deficit calculated is inaccurate.
NOTE!
Connect the scale to the pump before turning the system on to ensure the sys-
tem recognizes the scale.
5.3.1 Scale Set-up
The scale can be equipped with different makes of canisters.
Bemis®3 liters DeRoyal®
Abbott 2 liters Serres 2 & 3 liters
Medi-Vac® 3 liters Medela 3 liters

16
System Operation
EN
NOTE!
Ensure canisters are positioned properly in the respective holders.
NOTE!
Only use canisters with overflow protection.
5.3.2 Connecting the Vacuum Tubing
CAUTION!
When using the Aquilex System with MyoSure® or other morcellation systems,
the combination of low set pressures and high vacuum pressures may result in a
significant loss of intrauterine distension pressure which has the potential to af-
fect the visibility of the surgical field. Conversely, when employing high disten-
sion pressures, the deactivation of the MyoSure® or other morcellator system
can lead to pressure spikes that can exceed 150 mmHg. These situations may oc-
cur for a short time as the system automatically adjusts the flow rate to return
to the set intrauterine pressure.
1. Connect vacuum to the suction containers (using vacuum tube with hygiene
filter). This is done once during the initial set-up of the system, not prior to
each procedure.
•Low Vacuum Side (White)
·Connect vacuum tube with white connectors to low vacuum port (1) Fig-
ure 5-4. This vacuum pump has a fixed vacuum pressure (~ 125 mmHg).
·Use tandem tube ((5) Figure 5-4, Low vacuum tube) when two canisters
are serially connected to the same vacuum port.
•High Vacuum Side (Green)
·Connect vacuum tube set with the green connectors to the high vacuum
port (green) (8) in Figure 5-5. This vacuum can be adjusted to a maximum
Medi-Vac Flex Advantage
3000 cc
Figure 5-4 Low vacuum tube
(1) Low vacuum port (white)
(2) Hygiene filter
(3) Vacuum tube
(4) Canisters
(5) Tandem tube
(3)
(4)
(2)
(1)
(5)