Hologic Aquiflex Instructions For Use And Operator's Manual

TITLE

DOCUMENT NUMBER

REV

TEXT, IFU, AQUILEX FLUID

MANAGEMENT SYSTEM, 4320

AW-07059-4320

009

ARTWORK

SIZE A

SHEET 1 OF 1

REV AUTHORED BY

DATE

K BUJOLD

4/29/16

REV DRAFTED BY

DATE

K BUJOLD

4/29/16

PROPRIETARY: This document contains proprietary data of Hologic, Inc. No disclosure, reproduction or use of any part thereof may be made except by written permission from Hologic.

REV. RELEASE DATE:

05/16/2016

File Name

Description

AW-07059-4320_009_02.pdf

View File

Artwork consists of:

 302 8.26 inch x 11.69 inch (A4) sheets attached.

Artwork contains the following file(s):

Artwork is black and white.

Form ENG-0034-T03, Rev. 004

Instructions for Use and Fluid Control System Operator’s Manual

Gebrauchs- und Bedienungsanweisungen 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

Hologic and MyoSure are registered trademarks of Hologic,

ENDEFRESIT

Inc. and its subsidiaries in the United States and other countries. Aquilex is a trademark of Hologic, Inc. and its subsidiaries in the United States and other countries. All other trademarks,

their respective owners.

zeichen, eingetragene Warenzeichen und Produktnamen sind Eigentum der jeweiligen Inhaber.

spectifs.

ductos son propiedad de sus respectivos dueños.

registered trademarks, and product names are the property of

Hologic und MyoSure sind eingetragene Warenzeichen der Hologic, Inc. und ihrer Tochtergesellschaften in den Vereinigten Staaten und anderen Ländern. Aquilex ist ein Warenzeichen der Hologic, Inc. und ihrer Tochtergesellschaften in den Vereinigten Staaten und anderen Ländern. Alle anderen Waren-

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-

Hologic y MyoSure son marcas comerciales registradas de Hologic, Inc. y sus subsidiarias en los Estados Unidos y otros países. Aquilex es una marca comercial de Hologic, Inc. y sus subsidiarias en los Estados Unidos y otros países. Todas las demás marcas comerciales, marcas comerciales registradas y nombres de pro-

Hologic e MyoSure sono marchi registrati di Hologic, Inc. e relative 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-

rispettivo proprietario.

gedeponeerde handelsmerken en productnamen zijn eigendom van de desbetreffende houders.

ciali, marchi registrati e nomi di prodotti sono di proprietà del

Hologic en MyoSure zijn gedeponeerde handelsmerken van Hologic, Inc. en haar dochtermaatschappijen in de Verenigde Staten en andere landen. Aquilex is een handelsmerk van Hologic, Inc. en haar dochtermaatschappijen in de Verenigde Staten en andere landen. Alle andere handelsmerken,

Manufacturer/Hersteller/Fabricant/Fabricante/ Fabbricante/Fabrikant:

W.O.M. WORLD OF MEDICINE GmbH

Salzufer 8 10587 Berlin, Germany Phone: +49 30 39981-550 Fax: +49 30 39981-545 E-mail: info.berlin@womcorp.com

W.O.M. WORLD OF MEDICINE GmbH

Alte Poststraße 11 96337 Ludwigsstadt, Germany Phone: +49 9263 877-0 Fax: +49 9263 877-152 E-mail: info.ludwigsstadt@womcorp.com

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)

1.508.263.2900

MAN-02570-4320 Rev.009 Model: H112/1201048/10000011593 07/2016-04/endefresitnl/marik

Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen

Read Instructions

Before Use

BF Type Equipment

Symbol for Poten-

tial Equalization

Degrees of Protec-

tion Provided by

Enclosures (IP-

Code)

Alternating Current

Service Service

Order Number

Bedienungsanlei-

tung befolgen

System des Typs BF

Symbol für Potenti-

alausgleich

Gehäuseschutz-

klasse (IP-Code)

Wechselstrom

Bestellnummer

Lire la documenta-

tion jointe !

Système de type BF

Symbole pour la fiche équipoten-

tielle

Degrés de protec-

tion procurés parles

enveloppes (Code

IP)

Courant alternatif Corriente alterna Corrente alternata Wisselstroom

Service Servicio Servizio Service

Numéro de commande

Observe la docu-

mentación adjunta

Sistema del tipo BF Sistema tipo BF

Símbolo para la

conexión equipo-

tencial

Grado de protec-

ción proporcio-

nado por los envolventes

(Código IP)

Número de pedido

Leggere la docu-

mentazione alle-

gata

Simbolo per il colle-

gamento equipo-

tenziale

Grado di prote-

zione degli involu-

cri (Codice IP)

Numero di ordina-

zione

Lees de begelei-

dende documenta-

tie

Syteem van het

type BF

Symbool voor de

potentiaalvereffe-

ning

Beschermings-

klasse (IP-code)

behuizing

Bestelnummer

Do not Reuse

Sterilized using Ethylene Oxide

Lot Number

Serial Number

Date of Manufac-

ture

Expiration Date

Pieces

Quantity

Not Made with Natural Rubber

Latex

Nicht zur Wieder-

verwendung

Sterilisiert mit

Ethylenoxid

Chargenbezeich-

nung

Seriennummer

Herstellungsdatum

Ver wendb ar bis

Stück

Menge

Nicht aus Natur-

kautschuklatex

hergestellt

Usage unique No reutilizable Non riutilizzabile

Stérilisés à l’éthy-

lène oxide

Numéro de lot Número de lote Numero di lotto Chargenummer

Numéro de série Número de serie Numero di serie Serienummer

Date de fabrication

Date limite d’utilisation

Unités Unidades Pezzi Eenheden

Quantité Cantidad Quantità Hoeveelheid

Ce produit ne con-

tient pas de latex

de caoutchouc

naturel

Esterilizado con óxido de etileno

Fecha de fabrica-

ción

Utilizable hasta

Producto no produ-

cido con látex de

caucho natural

Sterilizzato con

ossido di etilene

Data di produzione Fabricagedatum

Da utilizzarsi entro

Non prodotto in lat-

tice di caucciù

naturale

Niet voor herge-

bruik

Sterilisatie met

ethyleenoxide

Te gebruiken tot

Niet vervaardigd

van natuurlijke rub-

berlatex

Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen

NON

STERILE

Not Made with

Phthalates

Made with Phthala-

tes

Do Not Get Wet

Top-Bottom

Fragile

Waste Manage-

ment

Reset Deficit

Button

Dieses Produkt enthält kein Diethylhe-

xylphthalat (DEHP)

Dieses Produkt ent-

hält Diethylhe-

xylphthalat (DEHP)

Vor Nässe schützen

Oben-Unten

Zerbrechlich

Entsorgung

Tas te Res et D ef ici t

Ce produit ne con-

tient pas du

diethylhexyl phta-

late (DEHP)

Ce produit contient du diethylhexyl phtalate (DEHP)

Protéger de l’humi-

dité

Haut-bas Arriba-abajo Alto - basso Boven-Beneden

Fragile Frágil Fragile Breekbaar

Élimination des

déchets

Touche de remise à

zéro du déficit

Este producto no

contiene dietilhe-

xilftalato (DEHP)

Este producto con-

tiene dietilhexilfta-

lato (DEHP)

Proteger contra la

humedad

Gestión de residuos Smaltimento Verwijdering

Tecla de reseteo del

déficit

Questo prodotto

non contiene

diethylhexylftalato

(DEHP)

Questo prodotto

contiene

diethylhexylftalato

(DEHP)

Proteggere

dall'umidità

Tasto di reset per

deficit

Dit product bevat

geen di-ethylftalaat

Dit product bevat

di-ethylftalaat

Beschermen tegen

Resettoets voor

(DEHP)

(DEHP

vocht

deficit

Prime Button Taste Prime Touche Prime Tecla Prime Tasto Prime Toets Prime

Pause/Resume

Button

Increase

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

Data Transfer Datenübertragung

Tas t e

Pause/Resume

Erhöhen

Anschluss Contai-

newaage

Touche Pause/

Resum e

Croissant Aumento Crescente Verhogen

Raccord pour unité

de pesage à

container

Tra nsm iss ion d e

données

Tecla Pause/

Resum e

Conexión para la

balanza de cubetas

Transmisión de

datos

Tasto Pause/

Resume

Attacco per unità di

pesatura conteni-

tori

Trasmissione dati Datatransmissie

Aansluiting reservoirweegsysteem

Toets Pause/

Resume

Do not push! Schieben verboten Interdit de pousser! ¡No empujar! Non spingere! Duwen verboden

General Warning

Sign

SGS USTC Certifica-

tion Mark

Warnzeichen für

allgemeine Gefahr

SGS USTC Produkt-

zertifizierung

Signalisation

générale de danger

Marque de certifi-

cation SGS USTC

Señal de adverten-

cia general

Marca de certifica-

ción SGS USTC

Segnale generale di

pericolo

Marquio de certifi-

cazione SGS USTC

Waarschuwingsteken voor algemeen

gevaar

Kwaliteitsmerk SGS

USTC

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

1Important User Notes

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.

technical data of the product through continued development of the product.

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.

Important User Notes

Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and

Please noteThe words WARNING, CAUTION, and NOTE carry special meanings. Read these

NOTE! Notes provide special information to clarify instructions or present additional in-

formation.

Safety Information

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 maintained,

• 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 patient 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 accordingly authorized disposal or waste management company for further information.

3 Purpose of the System

us during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

py is contraindicated. See the operators 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 intramural myomas with small submucous components.

Purpose of the System

Indication for useAquilex® Fluid Control System is intended to provide liquid distension of the uter-

ContraindicationsThe system may not be used to introduce fluids into the uterus when hysterosco-

3.1 Warnings and Precautions

3.1.1 Warnings

WARNING! When performing monopolar hysteroscopic electrosurgery, the distension medium must be electrically non-conductive. Examples include glycine, sorbitol and

mannitol. Isotonic saline irrigation fluids may only be used when performing bipolar 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.

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 hystero-

Purpose of the System

scopic 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 measurement 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 sodium 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 monitor 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

WARNING! Cerebral edema Hysteroscopic surgery is associated with a risk of developing cerebral edema re-

sulting from fluid overload and electrolyte disturbances with hypoosmolar (nonionic) 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 using Hyskon as an irrigation 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 temperature during the entire surgery. Make especially sure that the following, hypothermia 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 critical 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 prevent 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.

Purpose of the System

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 determine the specific technique and procedure that will accomplish the desired clinical outcome.

WARNING! Check all factory settings. Factory settings are not mandatory settings for the physician. The physician is responsible 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 anesthetic 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.

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 surgical techniques. Medical instruments and systems may be used only by physicians or medical assistants with the appropriate technical/medical qualification 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.

Purpose of the System

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.

Purpose of the System

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 affect the visibility of the surgical field. Conversely, when employing high distension pressures, the deactivation of the MyoSure® or other morcellator system can lead to pressure spikes that can exceed 150 mmHg. These situations may occur 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 hysteroscopes 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 interference, please follow these suggestions:

• Move the Aquilex System, the other device, or both devices to a different location

• 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 integrating the pressure chamber into the tubing system. The pressure chamber transmits the irrigation fluid pressure to the electronics of the device via a pressure sensor. The pressure control circuit continuously compares the desired preset 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.

4 Initial System Set-up

Always check all parts and accessories of the system when performing initial setup. If the system should show obvious defects, contact Hologic Technical Support (Chapter 13, Warranty Information).

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 disconnected.

4.1 Preparing the System For Use

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.

Initial System Set-up

Initial system set-upPlace the system on a level surface and install in a dry environment. The ambient

Connection to the wall outlet

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.

The power connection must be equipped with a grounding contact. Use the Aquilex power cord to establish a connection between the wall outlet and the power cord connection located in the rear of the system.

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.

safety rules and regulations.

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 instructions.

Grounding contact

Only for U.S. operatorsUse only a certified (UL-listed), removable power cord, type SJT, minimal 18 AWG,

Potential equalizationIntegrate the system into the potential equalization system as specified by local

Precautionary measuresMedical devices are subject to special safety and protective measures concerning

+ 36 hidden pages

Hologic Aquiflex Instructions For Use And Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual