Hologic Aquilex Instructions For Use Manual

Instructions for Use

Gebrauchsanweisung

Instructions d‘utilisation

Instrucciones de uso

Istruzioni per l'uso

Gebruiksaanwijzing

Hologic and MyoSure are registered trademarks of Hologic, Inc.

endefr

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, regis-

respective owners.

These instructions for use contain information that is subject to copyright. All rights reserved. These instructions for use may not be photocopied, duplicated 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 symbol indicates that any given designation is not subject to trademark protection.

Users of this product should not hesitate to point out to us any errors or issues concerning these instructions for use.

tered trademarks, and product names are the property of their

Federal Law (only for U.S. market) Caution: Federal law restricts this device to sale by or on the

order of a physician.

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

getragene Warenzeichen und Produktnamen sind Eigentum der jeweiligen Inhaber.

Diese Gebrauchsanweisung enthält eigentumsrechtlich geschützte Informationen, die dem Urheberrecht unterliegen. Alle Rechte sind geschützt. Ohne ausdrückliche, schriftliche Genehmigung von W.O.M. WORLD OF MEDICINE GmbH darf diese Gebrauchsanweisung weder vollständig noch in Auszügen durch Photokopie, Mikrofilm oder andere Verfahren vervielfältigt oder verbreitet werden.

Durch die ständige Weiterentwicklung unserer Produkte behalten wir uns technische Änderungen ohne Ankündigung vor. Funktion oder Design können teilweise von der Beschreibung in der Gebrauchsanweisung abweichen. Bitte kontaktieren Sie uns, um weitere Informationen zu diesem oder anderen Produkten zu erhalten.

Bezeichnungen, die zugleich eingetragenes Warenzeichen sind, wurden nicht besonders gekennzeichnet. Es kann nicht aus dem Fehlen des Warenzeichens geschlossen werden, dass eine Bezeichnung ein freies Warenzeichen ist. Ebensowenig ist zu entnehmen, ob Patente oder Gebrauchsmuster vorliegen.

W.O.M. WORLD OF MEDICINE GmbH ist Anwendern von W.O.M. WORLD OF MEDICINE GmbH-Produkten dankbar für jeden Hinweis auf mögliche Fehler oder Unklarheiten dieser Gebrauchsanweisung.

Staaten und anderen Ländern. Alle anderen Warenzeichen, ein-

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 respectifs.

Cette instruction d'utilisation contient des informations protégées par la législation des droits de propriété et des droits d'auteur. Tous droits sont protégés. Il est interdit de reproduire ou de distribuer cette instruction d'utilisation

- que ce soit intégralement ou partiellement par photocopie, microfilm ou autres procédés de reproduction sans l'autorisation écrite expresse de l'entreprise W.O.M. WORLD OF MEDICINE GmbH.

En raison du perfectionnement permanent de nos produits, nous nous réservons le droit de procéder à des modifications techniques sans avis préalable. Il se peut que les fonctionnalités ou que le design des produits diffèrent partiellement de la description figurant dans cette instruction d'utilisation. Pour de plus amples informations concernant ce produit ou d'autres produits, n'hésitez pas à nous contacter.

Les désignations qui représentent en même temps des marques déposées n'ont pas été spécifiquement caractérisées. L'absence du logotype ne peut en aucun cas faire supposer que la désignation représente une marque non déposée. De la même manière, cela n'indique pas la présence de brevets ou de modèles déposés.

W.O.M. WORLD OF MEDICINE GmbH remercie d'avance les utilisateurs de ses produits qui lui fourniront des informations eu égard à des errata possibles ou à des imprécisions susceptibles d'être contenus dans cette présente instruction d'utilisation.

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 co-

tos son propiedad de sus respectivos dueños.

Estas instrucciones de uso contienen informaciones protegidas por el derecho de propiedad (copyright), que forma parte de los derechos de autor. Todos los derechos están protegidos. Sin autorización por escrito de W.O.M. WORLD OF MEDICINE GmbH, estas instrucciones de uso no podrá ser ni total ni parcialmente reproducidas ni divulgadas por medio de fotocopia, microfilm u otros medios y procedimientos.

Debido al desarrollo constante de nuestros productos, nos reservamos el derecho a llevar a cabo modificaciones técnicas sin aviso previo. El funcionamiento y el diseño podrán diferir parcialmente de la descripción en las instrucciones de uso. Rogamos establezcan contacto con nosotros, si desean adquirir más información sobre este o cualquier otro producto.

Las denominaciones que son, a su vez, marcas registradas, no han sido identificadas especialmente. La falta de la identificación con marca no implica que el producto en cuestión no posea marca comercial alguna. Asimismo, no pueden sacarse conclusiones de las presentes instrucciones de uso sobre la existencia o inexistencia de patentes ni modelos de utilidad.

W.O.M. WORLD OF MEDICINE GmbH agradecerá a los usuarios de los producto s de W.O. M. W ORL D OF MED ICI NE Gm bH c ual qui er a viso , in dic aci ón u obse rvación con respecto a posibles fallos, incongruencias o explicaciones poco claras que puedan encontrarse en las presentes instrucciones de uso.

merciales, marcas comerciales registradas y nombres de produc-

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

ve 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 commerciali, mar-

proprietario.

Le presenti istruzioni per l’uso contengono informazioni protette dal diritto di proprietà e soggette al diritto d'autore. Sono riservati tutti i diritti. Senza espresso consenso scritto da parte di W.O.M. WORLD OF MEDICINE GmbH non è consentito riprodurre né pubblicare, per intero o parzialmente, le presenti istruzioni per l’uso mediante fotocopia, microfilm o altri procedimenti

Grazie al continuo sviluppo dei nostri prodotti, ci riserviamo il diritto di apportare modifiche tecniche senza alcun preavviso. Sia la funzione che il design possono scostarsi in parte dalla descrizione contenuta nelle presenti istruzioni per l’uso. Vi preghiamo di volerci contattare per ulteriori informazioni su questo o altri prodotti.

Le designazioni indicanti marchi di fabbrica registrati non sono state particolarmente evidenziate. Dall’assenza di tale indicazione non si può dedurre che un’eventuale designazione rappresenti un marchio a libera disposizione e neppure si può dedurre se esistano o meno brevetti o modelli di utilità.

W.O.M. WORLD OF MEDICINE GmbH sarà grata a tutti gli utilizzatori dei prodotti W.O.M. WORLD OF MEDICINE GmbH per qualsiasi indicazione su possibili errori o punti poco chiari riscontrati nelle presenti istruzioni per l’uso.

chi registrati e nomi di prodotti sono di proprietà del rispettivo

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

delsmerken en productnamen zijn eigendom van de desbetreffende houders.

Deze gebruiksaanwijzing bevat auteursrechtelijk beschermde informatie waar copyright op bestaat. Alle rechten voorbehouden. Het is verboden om deze gebruiksaanwijzing zonder uitdrukkelijke, schriftelijke toestemming van W.O.M. WORLD OF MEDICINE GmbH geheel of gedeeltelijk door middel van fotokopieën, microfilm of met andere middelen te vermenigvuldigen of te verspreiden.

Door de voortdurende verdere ontwikkeling van onze producten behouden wij ons het recht voor, zonder aankondiging vooraf technische wijzigingen aan te brengen. De werking of het design kunnen in sommige gevallen afwijken van de beschrijving in het gebruiksaanwijzing. Neem voor meer informatie over dit of andere producten contact met ons op.

Benamingen die tegelijkertijd een gedeponeerd handelsmerk zijn, zijn niet speciaal gekenmerkt. Uit het ontbreken van het handelsmerk kan niet geconcludeerd worden dat het bij een benaming om een vrij handelsmerk gaat. Evenmin kan hieruit worden afgeleid of er sprake is van octrooien of gebruiksmodellen.

W.O.M. WORLD OF MEDICINE GmbH is gebruikers van W.O.M. WORLD OF MEDICINE GmbH-producten dankbaar voor elke melding van mogelijke fouten of onduidelijkheden in deze gebruiksaanwijzing.

andere landen. Alle andere handelsmerken, gedeponeerde han-

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@wom.group

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

CE marking according to Directive 93/42/EEC CE-Kennzeichnung gemäß Richtlinie 93/42/EWG 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

MAN-05183-4320 Rev.001 Type: H112/1201601/10000021387 00/2018-02/endefresitnl/Kubetzek

Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen

Follow instruc-

tions for use

(white image on

a blue back-

ground)

Consult instruc-

tions for use

Type BF applied

part

Equipotentiality

Degrees of pro-

tection Provided

by enclosures

(IP-Code)

Alternating Cur-

rent

Service Service

Gebrauchsanwei-

Gerät des Typs BF

sung befolgen

(weißes Bild auf

blauem Grund)

sung beachten

Potentialaus-

gleich

Gehäuseschutzklasse (IP-Code)

Wechselstrom

Respecter le mode

d’emploi (image

blanche sur fond

bleu)

Consulter pas les

instructions d'utili-

sation

Dispositif de type

Liaison

équipotentielle

Degrés de protection procurés par

les enveloppes

(Code IP)

Courant alternatif Corriente alterna

Service Servicio técnico Assistenza Service

Observar las inst-

rucciones de uso

(imagen blanca

sobre fondo azul)

Tener en cuenta

las instrucciones

de uso

Aparato del tipo BF

Conexión equipo-

tencial

Grado de protección de los envolventes (código IP)

Consultare le istruzioni per

l'uso (immagine

bianca su sfondo

blu)

Rispettare le

istruzioni per

l'uso

Apparecchio di

tipo BF

Collegamento equipotenziale

Grado di protezi-

one dell’involu-

cro (codice IP)

Corrente alter-

nata

Gebruiksaanwij-

zing opvolgen (witte afbeelding op blauwe onder-

grond)

Gebruiksaanwij-

zing opvolgen

Apparaat van het

type BF

Potentiaalveref-

fening

Beschermings-

klasse (IP-code)

behuizing

Wisselstroom

Catalogue num-

ber

Do not reuse

Do not resterilize

Sterilized using

ethylene oxide

Batch code

Serial number

Manufacturer Hersteller Fabricant Fabricante Fabbricante Fabrikant

Date

of manufacture

(YYYY-MM-DD)

Artikelnummer

Nicht wiederver-

wenden

icht resterilisie-

ren

Sterilisiert mit

Ethylenoxid

Chargencode

Seriennummer

Herstellungsda-

tum

(JJJJ-MM-TT )

Numéro d’article N.º de referencia Codice articolo Artikelnummer

Ne pas réutiliser No reutilizar Non riutilizzare

Ne pas restériliser No reesterilizar Non risterilizzare

Stérilisé à l’oxyde

d’éthylène

Codes de lot Código de lote Codice lotto Chargecode

Numéro de série Número de serie Numero di serie Serienummer

Date de fabrication (AAAA-MM-JJ)

Esterilizado por

óxido de etileno

Fecha

de fabricación

(AAAA-MM-DD)

Sterilizzato con

ossido di etilene

Data di fabbricazione (AAAA-MM-GG)

Niet voor hergeb-

ruik

Niet opnieuw ste-

riliseren

Gesteriliseerd met ethyleen-

oxide

Fabricagedatum

(YYYY-MM-DD)

Use by date

(YYYY-MM-DD)

Quantity

Verwe ndba r bis

(JJJJ-MM-TT )

Menge

Utilisable jusqu’au

(AAAA-MM-JJ)

Quantité Cantidad Quantità Hoeveelheid

Fecha de caducidad (AAAA-MM-

DD)

Da utilizzarsi entro (AAAA-

MM-GG)

Te gebruiken tot

(YYYY-MM-DD)

Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen

Not made with

phthalates

Contains DEHP Enthält DEHP Contient du DEHP Contiene DEHP Contiene DEHP Bevat DEHP

Keep dry

Top-Bottom

Fragile

Stacking limit by

number

Keep away from

sunlight

Enthält keine

Phthalate

Vor Nässe schüt-

zen

Oben-Unten

Zerbrechlich

Stapelung nach

Anzahl

Vor Sonnenlicht

schützen

Ce produit ne contient pas de phthala-

tes

Protéger de l’humi-

dité

Haut-Bas Arriba-Abajo Alto - basso Boven-Beneden

Fragile Frágil Fragile Breekbaar

Empilage en fonc-

tion du nombre

Protéger des rayons

du soleil

No contiene ftala-

tos

Proteger contra la

humedad

Apilamiento limitado por

número

Proteger de la luz

solar

Non contiene fta-

lati

Proteggere

dall’umidità

Quantità limite di

impilamento

Proteggere dalla

luce solare

Bevat geen ftala-

Beschermen

tegen vocht

Stapelen volgens aangegeven aan-

Uit het zonlicht

ten

tal

houden

Protect from

heat and radio-

active sources

Non-ionizing

electomagnetic

radiation

Do not use if

package is

damaged

Authorized for

sale or use by

physician only

Temperature

limit

Humidity limita-

tion

Vor Hitze und

radioaktiver

Strahlung schüt-

zen

Nicht ionisie-

rende elektromag-

netische

Strahlung

Inhalt beschädig-

ter Verpackung

cht verwenden

Nur für authori-

siertes Vertriebs-

personal oder Arzt

Temperaturbe-

grenzung

Luftfeuchte, Begrenzung

Protéger des sour-

ces chaleur et

radio actives

Rayonnement élec-

tromagnétique

non-ionisant

Ne pas utiliser si

l’emballage est

endommagé

Autorisé seule-

ment pour la vente

ou l’utilisation par

un médecin uni-

quement

Limitation de la

température

Limitation de

l'humidité

Proteger del calor

y de la radiación

radioactiva

Radiación electro-

magnética no ioni-

zante

No utilizar el contenido de envases

dañados

Sólo para distribui-

dores autorizados

o médicos

Limitación de tem-

peratura

Humedad del aire,

limitación

Proteggere dal

calore e da radia-

zioni

Radiazioni elett-

romagnetiche

non ionizzanti)

Non utilizzare il

contenuto di con-

fezioni dann-

eggiate

Solo per personale di vendita

autorizzato o

medici

Limitazione della

temperatura

Limitazione dell'umidità

dell'aria

Beschermen

tegen hitte en

radioactieve stra-

ling

Niet-ioniserende

elektromagneti-

sche straling

Inhoud van

beschadigde ver-

pakking niet

gebruiken

Uitsluitend voor

bevoegd perso-

neel of arts

Temperatuurbe-

grenzing

Luchtvochtig-

heid, begrenzing

Atmospheric

pressure limi-

tation

Waste Manage-

ment

Luftdruck, Begren-

zung

Entsorgung

Limitation de la

pression atmos-

phérique

Élimination

Presión atmos-

férica, limitación

Eliminación de

residuos

Limitazione della

pressione atmos-

ferica

Smaltimento Verwijdering

Luchtdruk,

begrenzing

Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen

MET

Reset Deficit

Button

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

Pause/Resume

Button

Increase

Decrease Verringern Décroissant Disminución Decrescente Verlagen

On/Off (push

button)

Non sterile Unsteril Non stérile No estéril Non è sterile Niet-steriel

Connection to

Scale

Input/Output Eingang/Ausgang Entrée/sortie Entrada/salida Non spingere! Ingang/uitgang

Tas te Res et De fizit

Tas t e

Pause/Resu me

Erhöhen

Ein/Aus (druckbe-

tätigt)

Anschluss Waage

Touche de remise à

zéro du déficit

Pause/Resume Pause/Resume

Croissant Aumento Crescente Verhogen

Marche/arrêt

(Interrupteur acti-

onné)

Raccordement

balance

Tecl a d e re se teo

del déficit

On/Off ( accionad o

por presión)

Conexión balanza

Tasto di reset per

deficit

Pause/Resume

(Pausa/Riprendi)

Interruttore ON/

OFF (a pressione)

Attacco unità di

pesatura

Resettoets voor

Pause/Resu me

Aan/Uit (druk-

weegsysteem

deficit

knop)

Aansluiting

Caution Vorsicht; Achtung Attention Atención Attenzione!

Do not use this

power output

Certification

Mark

Diesen Stromver-

sorgungsanschluss nicht

verwenden

Produktzertifizie-

rung

N'utilisez pas cette

connexion d'ali-

mentation en cou-

rant

Marque de certifi-

cation

No utilice esta

salida de corriente

Marca de certifica-

ción

Non utilizzare

questo attacco di

alimentazione

Marquio de certi-

ficazione

Voorzichtig; Let

Deze stroomaans-

luiting niet

gebruiken

Kwaliteitsmerk

Table of Contents

1 Important Operator/User Notes......................................................................................................................................... 3

2 Safety Information.............................................................................................................................................................. 4

3 Purpose................................................................................................................................................................................ 5

3.1 Warnings and Precautions .................................................................................................................................................... 5

3.1.1 Warnings .................................................................................................................................................................................... 5

3.1.2 Precautions................................................................................................................................................................................. 11

3.2 Description of the Aquilex Fluid Control System ............................................................................................................ 12

4 Initial System Set-up........................................................................................................................................................... 13

4.1 Preparing the System for Use............................................................................................................................................... 13

4.2 System Components................................................................................................................................................................ 14

5 System Operation ............................................................................................................................................................... 15

5.1 Front of Irrigation Pump Unit ............................................................................................................................................... 15

5.2 Rear of Irrigation Pump Unit................................................................................................................................................. 15

5.3 Fluid Monitoring Unit Set-up................................................................................................................................................ 16

5.3.1 Setting of the Container Scale.............................................................................................................................................. 18

5.3.2 Connecting the Vacuum Tube............................................................................................................................................... 19

5.4 Turning On the Aquilex System............................................................................................................................................ 20

5.5 Hanging the Fluid Bags........................................................................................................................................................... 21

5.6 Using Tube Sets......................................................................................................................................................................... 21

5.7 Tube Overview........................................................................................................................................................................... 22

5.8 Connecting the Outflow Tube Set....................................................................................................................................... 23

5.8.1 Connecting Outflow Tube of Tissue Removal Handpiece (e.g. MyoSure®).............................................................. 24

5.9 Inserting the Inflow Tube Set................................................................................................................................................ 25

5.10 Presetting the Intrauterine Pressure .................................................................................................................................. 26

5.11 Deficit Limit Setting................................................................................................................................................................. 26

5.12 Using the Pump during Surgery........................................................................................................................................... 27

5.13 Changing Bags during Surgery............................................................................................................................................. 28

5.14 Changing Container during Surgery................................................................................................................................... 28

5.15 Changing Instrument during Surgery................................................................................................................................ 29

5.16 Total Inflow Volume Displayed............................................................................................................................................. 29

5.17 Turning System Off.................................................................................................................................................................. 29

6 Functional Check................................................................................................................................................................. 30

7 Safety Functions.................................................................................................................................................................. 31

8 Care and Maintenance........................................................................................................................................................ 32

8.1 Cleaning the System................................................................................................................................................................ 32

8.2 Maintenance Carried out by Authorized Service Technician....................................................................................... 32

8.3 Replacing of the Fuse .............................................................................................................................................................. 33

9 Annual Inspection ............................................................................................................................................................... 34

9.1 Safety Test................................................................................................................................................................................... 34

9.2 Basic Function Tests................................................................................................................................................................. 34

9.2.1 Scale Test..................................................................................................................................................................................... 35

9.2.2 Flow Rate Test............................................................................................................................................................................ 35

9.2.3 Pressure Measuring Test ........................................................................................................................................................ 36

9.2.4 Fluid Deficit Measurement Test ........................................................................................................................................... 37

9.2.5 Testing the Vacuum Pump..................................................................................................................................................... 38

9.3 Determine the Software Version......................................................................................................................................... 39

10 Error and Warning Messages.............................................................................................................................................. 40

11 Technical Data..................................................................................................................................................................... 42

12 Guidelines and Manufacturer's Statement - Electromagnetic Compatibility ................................................................... 44

12.1

12.2 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions .............................................................. 45

12.3 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity........................................ 46

12.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity....................................... 47

12.5 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and Aqui-

13 Accessory List ...................................................................................................................................................................... 49

14 Warranty Information ........................................................................................................................................................ 50

15 Glossary............................................................................................................................................................................... 52

16 Appendix ............................................................................................................................................................................. 53

16.1 Test Log........................................................................................................................................................................................ 53

Index.................................................................................................................................................................................... 54

Electrical Connections............................................................................................................................................................. 44

lex Fluid Control System......................................................................................................................................................... 48

1Important Operator/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 using the device in the OR. Non-observance of the instructions listed in this manual can lead

• to life-threatening injuries of the patient,

• to severe injuries of the surgical team, nursing staff or service personnel, or

• damage or malfunction of the system and/or accessories.

The manual is only for the Aquilex fluid control system, consisting of pump, container scale and bag scale.

viating slightly from the delivered product due to further development of the products.

sections 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.

Important Operator/User Notes

Subject to technical changesThe manufacturer reserves the right to have illustrations and technical data de-

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

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.

Safety Information

2 Safety Information

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 operated and used by untrained personnel,

• the system and/or the accessories are improperly used, prepared, or maintained,

• the instructions and rules in the user/operator manual are not adhered to,

• unauthorized persons perform repairs, adjustments, or alterations on or to the system or accessories,

• unauthorized persons open the system,

• the prescribed inspection and maintenance schedule is 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.

Normal Use The system may be used only as intended.

Care and maintenance The service and maintenance of the device and its accessories 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 the operation.

Contamination Before shipping, decontaminate device and accessories in order to protect the

service personnel. Follow the instructions listed in this manual. 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 reject contaminated products for repair.

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

uterus during diagnostic and operative hysteroscopies 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

Intended UseThe Aquilex™ Fluid Control System is intended to provide fluid distension of the

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! 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 surgery. It is critical to closely monitor the input and outflow of the distending liquid at all times.

Purpose

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 11, 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 fluid distention medium is used, intrauterine instillation exceeding 2 liters should be followed with great care due to the possibility of fluid overload.

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! 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! A container change during surgery is only allowed, if the container holds at least 0,5 liters of fluid. Otherwise, the deficit value may be falsified. In this case, the

manufacturer recommends manual deficit calculation.

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.

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 a hysteroscopy if a liquid distention medium is used.

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.

Purpose

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

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! Functional test The functional test must be performed prior to each device use.

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 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! Additional equipment Additional equipment connected to medical electrical devices must be demonstrated to be compliant with their respective IEC or ISO standards (IEC 60601-1,

IEC 60950 or IEC 62368 for data processing equipment).

WARNING! Not explosion-proof The system is not explosion-proof. Do not use in an area where flammable anes-

thetic gases are present.

WARNING! Changes to the system are not allowed.

WARNING! To avoid risk of electrical shock, this system may only be connected to a supply

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.

Purpose

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 / 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.

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! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Refer servicing to qualified service personnel.

Purpose

WARNING! Replacing fuse Replace the fuse only with a fuse of the same type and rating (see Chapter 11,

Technical Data).

WARNING! Equipment should be positioned such that power cord can be easily disconnect-

ed.

WARNING! 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! Electrical Interference (see Chapter 12, Guidelines and Manufacturer's State-

ment - Electromagnetic Compatibility): 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 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

WARNING! The Aquilex Fluid Control System should not be used directly next to other devices as this could result in malfunctions. The Aquilex Fluid Control System was test-

ed for compliance with IEC 60601-1-2 as a stand alone system. Therefore, do not stack other devices (e.g. MyoSure® Control Unit) on the system or the Irrigation Pump Unit. In particular, do not place any other device than the AQL-100P on the trays of the AQL-100CBS. If usage in the manner described above is nevertheless required, this system and the other devices should be monitored to make sure they function properly.

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 isola-

tion transformer and retest the system.

WARNING! Always use the hooks of the bag scale to hang the fluid bags to ensure an accu-

rate determination of the fluid deficit. In addition, leave the empty fluid bags hanging on the bag scale until the end of surgery.

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.

CAUTION! Indoor climate Before switching on the device, sufficient time must have passed to adjust to the indoor climate.

CAUTION! When using the Aquilex 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 spikes that can exceed 150 mmHg.

Purpose

CAUTION! Do not use the covered power output at the rear of the irrigation pump unit.

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 IEC 60601-2-18 and ISO 8600.

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.

CAUTION! 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, re-

move all fluid bags from the hooks and make sure there are no containers or only completely 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. Always use the handle to move the system safely.

Purpose

CAUTION! 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. Remove full containers from the scale immediately after that.

Only for U.S. operators Only use a certified (UL-listed), removable mains connection cable, type SJT, min-

imal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 and IEC 16320-C13. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.

3.2 Description of the Aquilex Fluid Control System

Technical application scope of the system

Suggested distension media The Aquilex Fluid Control System can be used with hypotonic, electrolyte-free

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 tissue removal systems, e.g. MyoSure®.

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 has obvious defects, contact Hologic Technical Support (Chapter 14, Warranty Information).

temperature and humidity must meet the requirements mentioned in Chapter 11, Technical Data.

WARNING! Equipment should be positioned such that power cord can be easily disconnected.

CAUTION! Indoor climate Before switching on the device, sufficient time must have passed to adjust to the

indoor climate.

4.1 Preparing the System for Use

Initial System Set-up

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

WARNING! The Aquilex Fluid Control System should not be used directly next to other devices as this could result in malfunctions. The Aquilex Fluid Control System was test-

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.

uilex power cord to establish a connection between the wall outlet and the power cord connection located in the rear of the system.

Connection to the wall outlet

Grounding contactThe power connection must be equipped with a grounding contact. Use the Aq-

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.

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

(4)

(6)

(1)

(7)

(2)

(3)

(5)

Initial System Set-up

Precautionary measures Medical 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 instructions.

4.2 System Components

Fig. 4-1 System Components

(1) Bag scale (2) Fluid bag (3) Irrigation Pump Unit (4) Tr ay s (5) Container scale cable/connector (6) Container scale (7) Container holders (8) Container (9) Roller wheel base (10) Locking foot brake

The Aquilex Fluid Control System is divided into two separate boxes for shipping:

Box 1 contains:

• Irrigation Pump Unit

• Instructions for Use

•Power cord

• Aquilex system vacuum tube set (low and high vacuum)

Box 2 contains:

• Fluid Monitoring Unit (cart with scale)

•Container rings

5System Operation

(11)

(1)

(2)

(3)

(7)(4)

(5)

(6)

(8)

(9)

(10)

(13)

(16)

(17)

(15)

(14)

(12)

I G H

Potential

Equalization

Low

Medium

High

Aquilex Fluid Control System

Ser.Nr. WOM /

100-240V / 50-60 Hz

YYYY-MM

TYPE

SN / REF

MyoSure

only for

(6)

(5)

(4)

(9)

(1)

(2)

(3)

(8)

(10)

(11)

(12)

(7)

Please make sure that the functional check according to chapter 6 has been performed prior to each device use.

5.1 Front of Irrigation Pump Unit

Please familiarize yourself with the layout of the individual elements on the front of the pump.

5.2 Rear of Irrigation Pump Unit

System Operation

Fig. 5-1 Front of Irrigation Pump Unit

(1) Pump display (2) Intrauterine pressure display (3) Fluid deficit limit display (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

Please familiarize yourself with the layout of the individual elements at the rear of the pump.

Fig. 5-2 Rear of Irrigation Pump Unit

(1) Connection for low vacuum

(white)

(2) Product label (3) Performance data of the device (4) Adjustment controller for high

vacuum

(5) Connection for high vacuum

(green)

(6) Fuse holder (7) Covered power output (8) Power connection for pump (9) Potential equalization connection (10) Service interface (11) Connection for scale (12) Suction openings

(3)

(9)

(4)

(6)

(1)

(7)

(2)

(8)

(5)

System Operation

CAUTION! Do not use the covered power output at the rear of the irrigation pump unit.

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).

5.3 Fluid Monitoring Unit Set-up

Fig. 5-3 Fluid Monitoring Unit (cart

with scale)

(1) Bag scale (2) Fluid bags (3) Bag deflector (4) Container scale cable/connector (5) Container scale (6) Holder for upper container (Serres,

Medela)

(7) Holder for lower container

(Abbott, Bemis®, Medi-Vac®, DeRoyal®)

(8) Roller wheel base (9) Container

The fluid monitoring unit (cart/scale) consists of a weighing unit for fluid bags (1), a weighing unit for fluid containers (5), and a roller wheel base (8).

1. Remove the cart/scale from the cardboard shipping box.

2. Remove the pump and the power cords from the first cardboard box.

3. Loosen the handwheel (6) (Fig. 5-4, page 17) and pull bag scale upwards to stop. The screw (7) (Fig. 5-4, page 17) must be inserted into the provided opening. Secure the bag scale with the handwheel.

4. Depending on the type of container used, attach the container rings (included in the second box) to the upper (6) or lower (7) container holders ( Fig. 53, page 16).

5. Guide the power cord through the holes provided for this purpose and connect to pump (2) (Fig. 5-4, page 17) and plug into grounded, shockproof safety wall socket.

6. Attach the scale to the pump by connecting the connector of the bag scale with the connector of the container scale (4) (Fig. 5-4, page 17) and fix the connected cables below the lower pump tray by means of the provided wire clips. Connect the second connector of the bag scale to the port on the back of the pump (5) (Fig. 5-4, page 17).

System Operation

(1)

(2) (3)

(5)

(4)

(6)

(7)

NOTE! The pump's software automatically detects whether the container scale and bag

scale are connected or only the container scale.

Fig. 5-4 Scale and pump connection

(1) Bag deflector (2) Power cord/pump connection (3) Covered power output (4) Plug connection, bag scale with

container scale

(5) Bag scale connector, connection to

pump

(6) Handwheel (7) Screw

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

NOTE! The greater the consumption of irrigation fluid, the greater the deviation be-

tween the actual and the displayed deficit (see "Technical Data," deficit accuracy: ± 6%).

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.

to achieve the most exact deficit value possible.

Precise balancingTry to collect all the fluid running out of the uterine cavity during the procedure

Scale capacityThe container scale can be loaded with a weight of up to 25 kg (55 lbs). The max-

imum load of the bag scale is 12 kg (27 lbs). If the scales are loaded beyond these

System Operation

limits, the message Scale Overload/Check Scale is triggered and displayed. Three audible warning beeps are emitted as well (See Chapter 10, Error and Warning Messages.)

CAUTION! Make sure the containers and fluid bags hang freely, are not resting on some-

thing, and do not touch other objects except the bag deflectors. Failure to follow these instructions means the deficit cannot be calculated correctly.

NOTE! Connect the scale to the pump before turning the system on to ensure the system recognizes the scale.

5.3.1 Setting of the Container Scale

The container scale can be used with containers from different manufacturers.

Bemis®3 liters DeRoyal® Crystaline™ 2.1 l

Abbott 2 liters Serres 2 & 3 liters

Medi-Vac® 3 liters Medela 3 liters

Medi-Vac Flex Advantage 3000 cc

NOTE!

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Aquilex FluidControl System

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(3)

(4)

(2)

(1)

(5)

Ensure containers are positioned properly in the respective holders.

NOTE! Only use containers with overflow protection.

5.3.2 Connecting the Vacuum Tube

CAUTION! When using the Aquilex System with tissue removal systems, e.g. MyoSure®, the

Connect vacuum tube with hygiene filter to suction containers. The vacuum tube with hygiene filter must be replaced when dirty and after 30 days at the latest. The vacuum tube with hygiene filter should not be cleaned.

System Operation

• Connection for low vacuum (white)

· Connect vacuum tube with white connector to low vacuum port (white) (1) Fig. 5-5. This vacuum pump has a fixed vacuum pressure (~ 225 mmHg).

· Use the connecting tube ((5) Fig. 5-5) when two containers are serially con- nected to the same vacuum port.

• Connection for high vacuum (green)

· Connect vacuum tube set with the green connectors to the high vacuum port (green) (8) in Fig. 5-6. This vacuum can be adjusted to a maximum 500 mmHg using adjustment dial.

· Use the connecting tube ((12) Fig. 5-6) when two containers are serially connected to the same vacuum port.

Fig. 5-5 Low vacuum tube

(1) Connection for low vacuum

(white)

(2) Hygiene filter (3) Vacuum tube (4) container (5) Connecting tube

System Operation

yoSure

only for

(8)

(9)

(6)

(10)

(11)

(12)

Fig. 5-6 High vacuum tube

(6) Hygiene filter (7) Vacuum tube (green connectors) (8) Connection for high vacuum

(green)

(9) Container (10) Tissue trap (11) Adjustment dial (12) Connecting tube

5.4 Turning On the Aquilex System

1. Press the ON/OFF switch. The displays and indicators light up and system turns on.

2. The system now performs a device self-test. The device self-test is used by the system to check whether the container and

the bag scale are connected, among others. If the bag scale is not connected, the message "System OK. Bag Scale Not Connected” is displayed. In this case, please check the appropriate data connection of the scales with the pump according to chapter 5.3.

3. If a tube set is in the inflow tube holder when the pump is switched on, the

pump display (Fig. 5-1, Front of Irrigation Pump Unit (1)) shows the message Remove Tube Set. The device self-test resumes once the tube set is removed

from the roller wheel. If the device self-test is unsuccessful, the corresponding error messages are

displayed (see Chapter 10, Error and Warning Messages).

The system has successfully completed the device self-test when a single audible beep is heard. The message System OK is displayed for 5 secs followed by the message Insert Tube Set.

WARNING!

(1)

(2)

(3)

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.

5.5 Hanging the Fluid Bags

System Operation

Fig. 5-7 Fluid bag suspension

(1) Bag scale (2) Fluid bag on bag hook (3) Bag deflector

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 bipolar electrosurgical resective procedures.

Hang one or two fluid bags filled with distension fluid appropriate for procedure.

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.

5.6 Using Tube Sets

The Aquilex Fluid Control System is designed for use with sterile disposable inflow and outflow tube sets.

transponder detects the type of tube, whether it has been used, and its reliability automatically. The pump display indicates this information. This eliminates accidental reuse of tube sets on more than one patient (see Chapter 5.7, Tube Overview).

Tube set recognitionEach inflow tube set is equipped with tube set recognition technology. An RFID

System Operation

WARNING! Visual inspection of the tube set Before the operation, perform a visual inspection of the tube set and its packag-

ing. Damaged tube sets or tube sets from damaged packagings may not be used.

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-process or reuse single-use inflow or outflow tube sets.

NOTE! Comply with national disposal and hygiene rules when disposing of tubes, col-

lected fluid, and the containers or containers.

5.7 Tube Overview

Three different tube sets are necessary to operate the system. The following table lists each type of tube set and its application.

Article num-

Description

ber

AQL-110 Aquilex Fluid Control System inflow tube set, disposable,

AQL-111 Aquilex Fluid Control System outflow tube set, disposable,

AQL-112 Complete tube set (inflow and outflow) disposable, sterilized

AQL-114 Aquilex Fluid Control System high and low vacuum tube set:

sterilized using ethylene oxide

using ethylene oxide

re-usable, non-sterile

Table 5-1

+ 324 hidden pages

Hologic Aquilex Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual