Instructions for Use
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REV AUTHORED BY
DATE
S.BHAMMAR
6/6/18
REV DRAFTED BY
DATE
S.BHAMMAR
6/6/18
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:
10JULY2018
TITLE
TEXT, IFU, AQUILEX FLUID MANAGEMENT SYSTEM, 4320, NEW SCALE
DOCUMENT NUMBER
AW-16146-4320 SIZE A
REV
002
SHEET 1 OF 1 Form ENG-0034-T01, Rev. 005
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Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen
Follow instructions for use (white image on a blue background)
Gebrauchsanweisung befolgen (weißes Bild auf blauem Grund)
Respecter le mode d’emploi (image blanche sur fond bleu)
Observar las instrucciones de uso (imagen blanca sobre fondo azul)
Consultare le istruzioni per l'uso (immagine bianca su sfondo blu)
Gebruiksaanwijzing opvolgen (witte afbeelding op blauwe ondergrond)
en
Consult instructions for use
Gebrauchsanweisung beachten
Consulter pas les instructions d'utilisation
Tener en cuenta las instrucciones de uso
Rispettare le istruzioni per l'uso
Gebruiksaanwijzing opvolgen
de
Type BF applied part
Gerät des Typs BF
Dispositif de type BF
Aparato del tipo BF
Apparecchio di tipo BF
Apparaat van het type BF
Equipotentiality
Potentialausgleich
Liaison équipotentielle
Conexión equipotencial
Collegamento equipotenziale
Potentiaalvereffening
Degrees of protection Provided by enclosures (IP-Code)
Gehäuseschutzklasse (IP-Code)
Degrés de protection procurés par les enveloppes (Code IP)
Grado de protección de los envolventes (código IP)
Grado di protezione dell’involucro (codice IP)
Beschermingsklasse (IP-code) behuizing
Alternating Current
Wechselstrom
Courant alternatif
Corriente alterna
Corrente alternata
Wisselstroom
Service
Service
Service
Servicio técnico
Assistenza
Service
fr
es
it
nl Catalogue number
Artikelnummer
Numéro d’article
N.º de referencia
Codice articolo
Artikelnummer
Do not reuse
Nicht wiederverwenden
Ne pas réutiliser
No reutilizar
Non riutilizzare
Niet voor hergebruik
Do not resterilize
Nicht resterilisieren
Ne pas restériliser
No reesterilizar
Non risterilizzare
Niet opnieuw steriliseren
Sterilized using ethylene oxide
Sterilisiert mit Ethylenoxid
Stérilisé à l’oxyde d’éthylène
Esterilizado por óxido de etileno
Sterilizzato con ossido di etilene
Gesteriliseerd met ethyleenoxide
Batch code
Chargencode
Codes de lot
Código de lote
Codice lotto
Chargecode
Serial number
Seriennummer
Numéro de série
Número de serie
Numero di serie
Serienummer
Manufacturer
Hersteller
Fabricant
Fabricante
Fabbricante
Fabrikant
Date of manufacture (YYYY-MM-DD)
Herstellungsdatum (JJJJ-MM-TT)
Date de fabrication (AAAA-MM-JJ)
Fecha de fabricación (AAAA-MM-DD)
Data di fabbricazione (AAAA-MM-GG)
Fabricagedatum (YYYY-MM-DD)
Use by date (YYYY-MM-DD)
Verwendbar bis (JJJJ-MM-TT)
Utilisable jusqu’au (AAAA-MM-JJ)
Fecha de caducidad (AAAA-MMDD)
Da utilizzarsi entro (AAAAMM-GG)
Te gebruiken tot (YYYY-MM-DD)
Quantity
Menge
Quantité
Cantidad
Quantità
Hoeveelheid
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Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen
en
de
Not made with phthalates
Enthält keine Phthalate
Ce produit ne contient pas de phthalates
No contiene ftalatos
Non contiene ftalati
Bevat geen ftalaten
Contains DEHP
Enthält DEHP
Contient du DEHP
Contiene DEHP
Contiene DEHP
Bevat DEHP
Keep dry
Vor Nässe schützen
Protéger de l’humidité
Proteger contra la humedad
Proteggere dall’umidità
Beschermen tegen vocht
Top-Bottom
Oben-Unten
Haut-Bas
Arriba-Abajo
Alto - basso
Boven-Beneden
Fragile
Zerbrechlich
Fragile
Frágil
Fragile
Breekbaar
Stacking limit by number
Stapelung nach Anzahl
Empilage en fonction du nombre
Apilamiento limitado por número
Quantità limite di impilamento
Stapelen volgens aangegeven aantal
Keep away from sunlight
Vor Sonnenlicht schützen
Protéger des rayons du soleil
Proteger de la luz solar
Proteggere dalla luce solare
Uit het zonlicht houden
Protect from heat and radioactive sources
Vor Hitze und radioaktiver Strahlung schützen
Protéger des sources chaleur et radioactives
Proteger del calor y de la radiación radioactiva
Proteggere dal calore e da radiazioni
Beschermen tegen hitte en radioactieve straling
Non-ionizing electomagnetic radiation
Nicht ionisieRayonnement élec- Radiación electrorende elektromagtromagnétique magnética no ioninetische non-ionisant zante Strahlung
Radiazioni elettromagnetiche non ionizzanti)
Niet-ioniserende elektromagnetische straling
Do not use if package is damaged
Inhalt beschädigter Verpackung nicht verwenden
Ne pas utiliser si l’emballage est endommagé
No utilizar el contenido de envases dañados
Non utilizzare il contenuto di confezioni danneggiate
Inhoud van beschadigde verpakking niet gebruiken
Authorized for sale or use by physician only
Nur für authorisiertes Vertriebspersonal oder Arzt
Autorisé seulement pour la vente ou l’utilisation par un médecin uniquement
Sólo para distribuidores autorizados o médicos
Solo per personale di vendita autorizzato o medici
Uitsluitend voor bevoegd personeel of arts
Temperature limit
Temperaturbegrenzung
Limitation de la température
Limitación de temperatura
Limitazione della temperatura
Temperatuurbegrenzing
Humidity limitation
Luftfeuchte, Begrenzung
Limitation de l'humidité
Humedad del aire, limitación
Limitazione dell'umidità dell'aria
Luchtvochtigheid, begrenzing
Atmospheric pressure limitation
Luftdruck, Begrenzung
Limitation de la pression atmosphérique
Presión atmosférica, limitación
Limitazione della pressione atmosferica
Luchtdruk, begrenzing
Waste Management
Entsorgung
Élimination
Eliminación de residuos
Smaltimento
Verwijdering
fr
es
it
nl
1
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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 ... 16 5.1 Front of Irrigation Pump Unit ... 16 5.2 Rear of Irrigation Pump Unit ... 16 5.3 Fluid Monitoring Unit Set-up... 17 5.3.1 Setting of the Container Scale... 19 5.3.2 Connecting the Vacuum Tube... 20 5.4 Turning On the Aquilex System... 21 5.5 Hanging the Fluid Bags... 22 5.6 Using Tube Sets... 23 5.7 Tube Overview... 23 5.8 Connecting the Outflow Tube Set ... 24 5.8.1 Connecting Outflow Tube of Tissue Removal Handpiece (e.g. MyoSure®)... 25 5.9 Inserting the Inflow Tube Set... 26 5.10 Presetting the Intrauterine Pressure ... 27 5.11 Deficit Limit Setting... 27 5.12 Using the Pump during Surgery... 28 5.13 Changing Bags during Surgery... 29 5.14 Changing Container during Surgery ... 29 5.15 Changing Instrument during Surgery ... 30 5.16 Total Inflow Volume Displayed... 30 5.17 Turning System Off ... 30
6
Functional Check... 31
7
Safety Functions... 32
8
Care and Maintenance... 33 8.1 Cleaning the System... 33 8.2 Maintenance Carried out by Authorized Service Technician ... 33 8.3 Replacing of the Fuse ... 34
9
Annual Inspection ... 35 9.1 Safety Test... 35 9.2 Basic Function Tests... 35 9.2.1 Scale Test... 36 9.2.2 Flow Rate Test... 36 9.2.3 Pressure Measuring Test ... 37 9.2.4 Fluid Deficit Measurement Test ... 38 9.2.5 Testing the Vacuum Pump ... 39 9.3 Determine the Software Version ... 40
10
Error and Warning Messages... 41
11
Technical Data ... 43
12
Guidelines and Manufacturer's Statement - Electromagnetic Compatibility ... 45 Electrical Connections... 45 12.1 12.2 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions ... 46 12.3 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity ... 47 12.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 48 12.5 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and Aquilex Fluid Control System... 49
13
Accessory List ... 50
14
Warranty Information ... 51
15
Glossary... 53
16
Appendix ... 54 16.1 Test Log... 54
en
Index... 54
1
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Important Operator/User Notes 1
Important Operator/User Notes
en
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. The manufacturer reserves the right to have illustrations and technical data deviating slightly from the delivered product due to further development of the products.
Subject to technical changes
The words WARNING, CAUTION, and NOTE carry special meanings. Read these sections with special attention.
Please note
WARNING! Warnings indicate risks to the safety of the patient or operator. Failure to follow warnings may result in injury to the patient or operator.
CAUTION! Warnings indicate risks to the equipment. Failure to follow cautions may result in damage to the system.
NOTE! Notes provide special information to clarify instructions or present additional information.
3
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Safety Information
en
2 Exclusion of liability
Safety Information
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 alterations 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
4
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.
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Purpose 3
Purpose
The Aquilex® Fluid Control System is intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
Intended Use
The system may not be used to introduce fluids into the uterus when hysteroscopy is contraindicated. See the operators manual of your hysteroscope for absolute and relative contraindications.
Contraindications
en
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.
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 intrauterine 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.
5
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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.
en
WARNING! Fluid intake and output surveillance Strict fluid intake and output surveillance should be maintained. If a low viscosity 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 patient 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, hyponatremia with its attending sequelae. This can be affected by the distending pressure, flow rate, and duration of hysteroscopic procedure. It is critical to closely monitor the 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.
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Purpose WARNING! Cerebral edema Hysteroscopic surgery is associated with a risk of developing cerebral edema resulting 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.
en
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.
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.
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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.
en
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 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! 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 anesthetic gases are present.
8
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Purpose WARNING! Changes to the system are not allowed.
en
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 procedures/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 alternative 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.
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Purpose WARNING! Replacing fuse Replace the fuse only with a fuse of the same type and rating (see Chapter 11, Technical Data).
en
WARNING! Equipment should be positioned such that power cord can be easily disconnected.
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 Statement - 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 tested 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-100PBS 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 entire ME SYSTEM should be tested for compliance with IEC 60601-1-1, and any equipment used with the Aquilex Fluid Control System should be Type BF.
WARNING! If the leakage current of the configured ME SYSTEM exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1 approved isolation transformer and retest the system.
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Purpose WARNING! Always use the hooks of the bag scale to hang the fluid bags to ensure an accurate determination of the fluid deficit. In addition, leave the empty fluid bags hanging on the bag scale until the end of surgery.
3.1.2
en
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.
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 featuring 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, remove 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.
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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.
en
CAUTION! Combination of AQL-100PBS with AQL-100CBS The irrigation pump unit AQL-100PBS may only be used with the fluid monitoring unit AQL-100CBS as only this combination is approved to bear the MET NRTL mark. Only for U.S. operators
Only use a certified (UL-listed), removable mains connection cable, type SJT, minimal 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 Technical application scope of the system
Description of the Aquilex Fluid Control 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 tissue removal systems, e.g. MyoSure®.
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.
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Initial System Set-up 4
Initial System Set-up
en
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). Place the system on a level surface and install in a dry environment. The ambient temperature and humidity must meet the requirements mentioned in Chapter 11, Technical Data.
Initial system set-up
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
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 tested 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-100PBS 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.
CAUTION! Combination of AQL-100PBS with AQL-100CBS The irrigation pump unit AQL-100PBS may only be used with the fluid monitoring unit AQL-100CBS as only this combination is approved to bear the MET NRTL mark. Connection to the wall outlet CAUTION! Check to ensure the available wall outlet voltage matches the data listed on the label attached to the back of the system. Incorrect voltage can cause errors and malfunctions and may destroy the system.
Ensure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The wall outlet power supply cord must be plugged into a properly installed safety wall plug (see DIN VDE 0107). Read the device label located in rear of pump to determine the operating voltage of the system.
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Initial System Set-up
en
Grounding contact
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.
Only for U.S. operators
Use only a certified (UL-listed), removable power cord, type SJT, minimal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 or IEC 320/CEE22. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade outlet.
Potential equalization
Integrate the system into the potential equalization system as specified by local safety rules and regulations.
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 Fig. 4-1
System Components
(1)
Bag scale
(2)
Fluid bag
(3)
Irrigation Pump Unit
(4)
Trays
(5)
Container scale cable/connector
(6)
Container scale
(7)
Container holders
(8)
Container
(9)
Roller wheel base
(10)
Locking foot brake
System Components
(1) (2)
(3)
(4) (5)
(6) (7)
(8) (9) (10)
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OBJ_BUCH-0000000505-010.book Seite 15 Freitag, 8. Juni 2018 12:28 12
Initial System Set-up The Aquilex Fluid Control System is divided into two separate boxes for shipping:
en
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
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