Aquilex Fluid Control Unit Instructions for Use Rev 003 April 2012

Symbols/Bildzeichen/Symoles/Símbolos/Simboli/Symbolen

EN Read Instructions Before Use

Bedienungsanleitung beachten

Lire la documentation jointe !

Observe la documentación adjunta

Leggere la documentazione allegata

Lees de begeleidende documentatie

BF Type Equipment

System des Typs BF

Système de type BF

Sistema del tipo BF

Sistema tipo BF

Syteem van het type BF

DE

FR Symbol for Potential Equalization

Symbol für Potentialausgleich

Symbole pour la fiche équipotentielle

Símbolo para la conexión equipotencial

Simbolo per il collegamento equipotenziale

Symbool voor de potentiaalvereffening

Degrees of Protection Provided by Enclosures (IPCode)

Gehäuseschutzklasse (IP-Code)

Degrés de protection procurés parles enveloppes (Code IP)

Grado de protección proporcionado por los envolventes (Código IP)

Grado di protezione degli involucri (Codice IP)

Beschermingsklasse (IP-code) behuizing

Alternating Current

Wechselstrom

Courant alternatif

Corriente alterna

Corrente alternata

Wisselstroom

Service

Service

Service

Servicio

Servizio

Service

Order Number

Bestellnummer

Numéro de commande

Número de pedido

Numero di ordinazione

Bestelnummer

Do not Reuse

Nicht zur Wiederverwendung

Usage unique

No reutilizable

Non riutilizzabile

Niet voor hergebruik

Sterilized using Ethylene Oxide

Sterilisiert mit Ethylenoxid

Stérilisés à l’éthylène oxide

Esterilizado con óxido de etileno

Sterilizzato con ossido di etilene

Sterilisatie met ethyleenoxide

Lot Number

Chargenbezeichnung

Numéro de lot

Número de lote

Numero di lotto

Chargenummer

Serial Number

Seriennummer

Numéro de série

Número de serie

Numero di serie

Serienummer

Date of Manufacture

Herstellungsdatum

Date de fabrication

Fecha de fabricación

Data di produzione

Fabricagedatum

Expiration Date

Verwendbar bis

Date limite d’utilisation

Utilizable hasta

Da utilizzarsi entro il

Te gebruiken tot

Pieces

Stück

Unités

Unidades

Pezzi

Eenheden

Quantity

Menge

Quantité

Cantidad

Quantità

Hoeveelheid

Not Made with Natural Rubber Latex

Nicht aus Naturkautschuklatex hergestellt

Ce produit ne contient pas de latex de caoutchouc naturel

ES

IT

NL

Producto no produ- Non prodotto in latNiet vervaardigd cido con látex de tice di caucciù van natuurlijke rubcaucho natural naturale berlatex

Table of contents 1

Important User Notes ... 3

2

Safety Information... 4

3

Purpose of the System ... 5 3.1 Warnings and Precautions ... 5 3.1.1 Warnings ... 5 3.1.2 Precautions... 9 3.2 Description of the Aquilex Fluid Control System ... 10

4

Initial System Set-up... 11 4.1 Preparing the System For Use... 11 4.2 System Set-up... 12

5

System Operation ... 13 5.1 Front of Pump... 13 5.2 Rear of Pump... 13 5.3 Cart/scale... 14 5.3.1 Scale Set-up... 15 5.3.2 Connecting the Vacuum Tubing... 16 5.4 Turning On the Aquilex System... 17 5.5 Hanging the Fluid Bags... 18 5.6 Using Tube Sets... 18 5.7 Tubing Overview... 19 5.8 Connecting the Outflow Tubing ... 19 5.8.1 MyoSure® Outflow Connection... 20 5.9 Inserting the Inflow Tube Set... 21 5.10 Presetting the Intrauterine Pressure ... 22 5.11 Setting the Deficit Limit ... 22 5.12 Using the Pump during Operation ... 23 5.13 Changing Canisters during Procedure ... 24 5.14 Total Volume Displayed ... 24 5.15 Turning System Off ... 24

6

Safety functions ... 25

7

Care and Maintenance... 26 7.1 Cleaning the System... 26 7.2 Authorized Service Technician Maintenance ... 26 7.3 Replacing the Fuse ... 26

8

Annual Inspection ... 28 8.1 Safety Test... 28 8.2 Basic Function Test... 28 8.3 Pressure Measuring Test ... 30 8.4 Pressure Sensor Test ... 31 8.5 Test of the Scale ... 31

9

Error and Warning Messages... 32

10

Technical Data ... 34

11

Guidelines and manufacturer's statement - electromagnetic compatibility ... 36 11.1 Impact of Mobile and Portable HF Communication Devices... 36 11.2 Electrical Connections... 36 11.3 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions ... 37 11.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 38 11.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 39 11.6 Recommended safety distances between portable and mobile HF telecommunications devices and the Aquilex Fluid Control System ... 40

12

Accessory List ... 41

13

Warranty Information ... 42

14

Glossary... 44

15

Appendix ... 45 15.1 Test Log... 45

EN

Index... 46

1

Important User Notes 1

Important 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 use during surgical procedures. Non-observance of the instructions listed in this manual can lead to: • life-threatening injuries to the patient, • severe injuries of the surgical team, nursing staff or service personnel, or • damage or malfunction of the system and/or accessories. The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product through continued development of the product.

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 user. Failure to follow warnings may result in injury to the patient or user.

CAUTION! Warnings indicate risks to the equipment. Failure to follow cautions may result in damage to the system.

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

3

Safety Information

EN

2

Safety Information

Federal Law (only for U.S. market)

Caution: Federal law restricts this device to sale by or on the order of a physician.

Exclusion of liability

Hologic is not liable for direct or consequential damage and the warranty is null and void if: • the system and/or the accessories are improperly used, prepared, or maintained, • the instructions in the manual are not adhered to, • non-authorized persons perform repairs, adjustments, or alterations on or to the system or accessories, • non-authorized persons open the pump housing, • the prescribed inspection and maintenance schedules are not adhered to. Receipt of technical documentation from Hologic does not authorize individuals to perform repairs, adjustments, or alterations on or to the system or accessories.

Authorized service technician

Only an authorized service technician may perform repairs, adjustments, or 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.

Intended use

The system may be used only as intended.

Care and maintenance

The service and maintenance of the system and its accessories has to be carried out as per instructions to ensure its safe operation. For the protection of the patient and the operating team, check that the system is complete and functional before each use.

Waste management

In the European Community, this symbol indicates that the waste of electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately instead. Please contact Hologic or an accordingly authorized disposal or waste management company for further information.

4

Purpose of the System 3

Purpose of the System

Aquilex™ Fluid Control System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

Indication for 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! When using the cart/scale, follow the exact operating instructions in this manual.

5

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

EN

WARNING! Fluid deficit The fluid left in the patient must be monitored. The deficit is the total amount of fluid left in the patient or unaccounted for otherwise. Take notice of the measurement tolerance of the system (see Chapter 10, Technical Data). Estimating the fluid volume remaining in the patient is the physician’s responsibility.

WARNING! Fluid intake and output surveillance Strict fluid intake and output surveillance should be maintained. If a low viscosity liquid distention medium is used, intrauterine instillation exceeding 2 liters should be followed with great care due to the possibility of fluid overload. If a high viscosity fluid (e. g. Hyskon) is used, the use of more than 500 ml should be followed with great care. See labeling for Hyskon for additional information.

WARNING! Serum sodium concentration It is also necessary to monitor the concentration of sodium in the blood of the 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! 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.

6

Purpose of the System 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 hysteroscopy if a liquid distention medium is used. Specifically, idiosynatric anaphylactoid reactions have been reported when using Hyskon as an irrigitaion fluid during hysteroscopy. These should be managed like any allergic reaction.

WARNING! Hypothermia (monitoring body temperature) Continuous flow of distention fluids can lead to a lowering of the patient's body temperature during hysteroscopic surgery. Lower body temperatures can cause coronary and cardiovascular problems. Always monitor the patient's body 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.

7

Purpose of the System WARNING! Place the system in such a way as to allow for easy visualization of the display values, system functions, and access to the control elements.

EN

WARNING! Do not use this system if a defect is suspected or detected during the function check. This also applies to obvious defects, especially defects and damage to the power plug and power cord.

WARNING! Pressing the ON/OFF switch does not disconnect the system from the wall power outlet. This requires pulling the power cord located in the rear of the system.

WARNING! Technique and procedures Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this system is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical outcome.

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

WARNING! Original accessories For your own safety and that of your patient, use only Aquilex accessories.

WARNING! Not explosion-proof The system is not explosion-proof. Do not use in an area where flammable anesthetic gases are present.

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

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.

8

Purpose of the System WARNING! Sterile media and accessories Always work exclusively with sterile substances and media, sterile fluids, and sterile accessories, if so indicated.

EN

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 Do not sterilize the system.

WARNING! Condensation / Water penetration Protect system from moisture. Do not use if moisture has penetrated the system.

WARNING! System defect If a system defect is suspected or confirmed, do not use the system. Ensure the system will no longer be used until a qualified service technician conducts the appropriate tests and repairs.

WARNING! Replacing fuse Replace the fuse only with a fuse of the same type and rating (see Chapter 10, Technical Data).

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! When using the Aquilex System with MyoSure® or other morcellation systems, the combination of low set pressures and high vacuum pressures may result in a significant loss of intrauterine distension pressure which has the potential to affect the visibility of the surgical field. Conversely, when employing high distension pressures, the deactivation of the MyoSure® or other morcellator system can lead to pressure spikes that can exceed 150 mmHg.

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 EC 60601-2-18 and

9

Purpose of the System ISO 8600.

EN

CAUTION! Electrical Interference: (See Chapter 11, Guidelines and manufacturer's statement - electromagnetic compatibility). Electrical interference with other devices or instruments was practically eliminated when developing this system and none was detected during testing. However, if you still detect or suspect such interference, please follow these suggestions: • Move the Aquilex System, the other device, or both devices to a different location • Increase distance between devices used • Consult an electro-medical expert

CAUTION! Check to ensure the available wall outlet voltage matches the data listed on the label attached to the back of the pump. Incorrect voltage can cause errors and malfunctions and may destroy the system.

3.2 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 preset to a range between 40 and 150 mmHg. The maximun inflow rate is 800 ml/ min and is reduced automatically by the pump once the pre-set intrauterine pressure setting has been reached. The system has been designed to provide both fluid and vacuum systems that maximize the performance of the MyoSure® Tissue Removal System.

Suggested distension media

The Aquilex Fluid Control System can be used with hypotonic, electrolyte-free media (e.g., glycine 1.5% and sorbitol 3.0%) and isotonic, electrolyte containing media (e.g., saline 0.9% and Lactated Ringer's).

Pressure measuring and regulating

The system operates with a completely non-contact pressure measurement of the irrigation medium. The contact-free pressure measurement is achieved by integrating the pressure chamber into the tubing system. The pressure chamber transmits the irrigation fluid pressure to the electronics of the device via a pressure sensor. The pressure control circuit continuously compares the desired preset intrauterine pressure with the actual intrauterine pressure. The function of this algorithm is to maintain the pre-set intrauterine pressure. Check for possible leaks if the pre-set intrauterine pressure cannot be achieved.

10

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 should show obvious defects, contact Hologic Technical Support (Chapter 13, 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 10, Technical Data.

4.1

Initial system set-up

Preparing the System For Use Connection to the wall outlet

CAUTION! Check to ensure the available wall outlet voltage matches the data listed on the label attached to the back of the system. Incorrect voltage can cause errors and malfunctions and may destroy the system.

Ensure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The wall outlet power supply cord must be plugged into a properly installed safety wall plug (see DIN VDE 0107). Read the device label located in rear of pump to determine the operating voltage of the system. 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.

Grounding contact

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.

Only for U.S. operators

Integrate the system into the potential equalization system as specified by local safety rules and regulations.

Potential equalization

Medical devices are subject to special safety and protective measures concerning electromagnetic compatibility (hereafter abbreviated as EMC).

Precautionary measures

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.

11

Initial System Set-up 4.2

EN Figure 4-1 Set-up of Aquilex Fluid Control System (1)

Cart

(2)

Bag holder

(3)

Pump

(4)

Fluid bag

(5)

Trays

(6)

Scale cable

(7)

MyoSure® Control Unit

(8)

Scale

(9)

Canister holders

(10)

Canister

(11)

Roller base

(12)

Locking foot brake

System Set-up

(1)

(2)

(4) (3) (5)

(7) (6)

(8)

(9) (10)

(11)

(12)

The Aquilex Fluid Control System is divided into two separate boxes for shipping. Box 1 contains: • Pump • Manual • Wall power cord • Aquilex vacuum tube set (low and high vacuum) • MyoSure® Control Unit power cord Box 2 contains: • Cart/scale • Canister rings

12

System Operation 5

System Operation

5.1

Front of Pump

EN Figure 5-1 Front of Pump

(1) (2) (3)

(4) (5) (6)

(7)

(17)

(16) (15)(14)

(13) (12)

(11) (10)

(9)

(8)

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

5.2

(1)

Pump display

(2)

Intrauterine pressure display

(3)

Fluid deficit limit

(4)

Deficit meter

(5)

Deficit display

(6)

Inflow tube holder

(7)

Roller wheel

(8)

Pressure sensor

(9)

Reset deficit button (Zero)

(10)

Decrease deficit limit

(11)

Increase deficit limit

(12)

Decrease intrauterine pressure setting

(13)

Increase intrauterine pressure setting

(14)

Intrauterine pressure setting display

(15)

ON/OFF switch

(16)

Pause/Resume button

(17)

Prime button

Rear of Pump (1)

(11)

(2)

(3)

(10) (9)

(4)

(8) (7)

(5)

Figure 5-2 Rear of Pump (1)

Low vacuum port (white)

(2)

Product ID label

(3)

Device performance data

(4)

Adjustment dial for high vacuum

(5)

High vacuum port (green)

(6)

Fuse holder(s)

(7)

Power cord connection

(8)

MyoSure® Control Unit Power Connection

(9)

Potential equalization connector

(10)

Service interface

(11)

Scale connection

(6)

Please familiarize yourself with the layout of the individual elements at the rear of the pump. CAUTION! Any devices to be connected via the interface have to comply with EN 60950.

13

System Operation 5.3

EN

Cart/scale (1)

Figure 5-3 Cart/Scale (1)

Fluid bag

(2)

Scale cable

(3)

Scale

(4)

Pole with bag hooks

(5)

Bag deflector

(6)

Canister

(7)

Upper canister holder (Serres, Medela, Baxter, Baxter flex)

(8)

Lower canister holder (Abbott, Bemis, Medi-Vac, DeRoyal)

(9)

Roller base

(4)

(5) (2)

(6) (3) (7)

(8) (9)

The cart/scale consists of a weighing scale for the canisters, a pole with hooks for irrigation fluid bags, and a roller base. 1. 2. 3. 4. 5. 6. 7. 8.

Remove the cart/scale from the cardboard shipper box. Extend the pole to stop position. Extend the bag deflector to stop position. Remove the pump and the power cords from the second cardboard box. Canister rings are included in this box. Install canister rings on upper (7) or lower (8) canister holders, in accordance with type of canister. Connect the wall power cord to the female outlet at the rear of the pump ((7) Figure 5-2, Rear of Pump) and a grounded safety wall outlet. Connect the scale to the pump by connecting the scale cable ((2) Figure 5-3, Cart/Scale) to the scale connection ((11) Figure 5-2, Rear of Pump). Use the enclosed MyoSure Control Unit power cord to connect the pump ((8) Figure 5-2, Rear of Pump) with the MyoSure® Control Unit.

WARNING! Scale error Ensure that nothing weighs down the scale during system start-up. Doing so may result in an inaccurate deficit value.

WARNING! Fluid deficit The fluid left in the patient must be monitored. The deficit is the total amount of fluid left in the patient or unaccounted for otherwise. Take notice of the measurement tolerance of the system (see Chapter 10, Technical Data). Estimating the fluid volume remaining in the patient is the physician’s responsibility.

14

System Operation 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.

EN

Try to collect all the fluid running out of the uterine cavity during the procedure to achieve the most exact deficit value possible.

Precise balancing

The scale can be loaded with a weight of up to 65 lbs (~30 kg). Weight above this value triggers the Scale Overloaded/Check Scale message. Three audible warning tones are emitted (See Chapter 9, Error and Warning Messages.)

Scale capacity

CAUTION! Ensure canisters hang freely and are not supported or in contact with anything; otherwise, the deficit calculated is inaccurate.

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

5.3.1

Scale Set-up

The scale can be equipped with different makes of canisters. Bemis®3 liters

DeRoyal®

Abbott 2 liters

Serres 2 & 3 liters

Medi-Vac® 3 liters

Medela 3 liters

15

System Operation

EN

Baxter flex

NOTE! Ensure canisters are positioned properly in the respective holders.

NOTE! Only use canisters with overflow protection.

5.3.2

Connecting the Vacuum Tubing

CAUTION! When using the Aquilex System with MyoSure® or other morcellation systems, the combination of low set pressures and high vacuum pressures may result in a significant loss of intrauterine distension pressure which has the potential to affect the visibility of the surgical field. Conversely, when employing high distension pressures, the deactivation of the MyoSure® or other morcellator system can lead to pressure spikes that can exceed 150 mmHg. 1. Connect vacuum to the suction containers (using vacuum tube with hygiene filter). This is done once during the initial set-up of the system, not prior to each procedure. • Low Vacuum Side (White) · Connect vacuum tube with white connectors to low vacuum port (1) Figure 5-4. This vacuum pump has a fixed vacuum pressure (~ 125 mmHg). · Use tandem tube ((5) Figure 5-4, Low vacuum tube) when two canisters are serially connected to the same vacuum port. Figure 5-4 Low vacuum tube (1)

Low vacuum port (white)

(2)

Hygiene filter

(3)

Vacuum tube

(4)

Canisters

(5)

Tandem tube

(1) (2)

(5)

(3)

(4) • High Vacuum Side (Green)

· Connect vacuum tube set with the green connectors to the high vacuum port (green) (8) in Figure 5-5. This vacuum can be adjusted to a maximum 500 mmHg using adjustment dial. · Use tandem tube ((12) Figure 5-5, High vacuum tube) when two canisters

16

System Operation are serially connected to the same vacuum port.

EN

(11)

Figure 5-5 High vacuum tube (12)

(6) (10)

(7)

(6)

Hygiene filter

(7)

Vacuum tube (green connectors)

(8)

High vacuum port (green)

(9)

Canisters

(10)

Tissue trap (MyoSure® procedures)

(11)

Adjustment dial

(12)

Tandem tube

(8) (9)

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 self-diagnostic test. 3. If a tube set is in the inflow tube holder when the pump switches on, the pump display (Figure 5-1, Front of Pump (1)) shows Remove Tube Set. The self-test resumes once the tube set is removed from the roller wheel. If the system self-test is unsuccessful, the corresponding error messages are displayed. (See Chapter 9, Error and Warning Messages, page 32). The system has successfully completed the self-diagnostic test when a single audible tone is heard. The message System OK is displayed for 5 secs followed by the message Insert Tube Set. WARNING! Do not use this system if a defect is suspected or detected during the function check. This also applies to any obvious defects, especially defects on the power plug and power cord.

17

System Operation 5.5

EN

Hanging the Fluid Bags

Figure 5-6 Fluid bag suspension (1)

Fluid bags

(2)

Pole with bag hooks

(3)

Bag deflector

(2) (1)

(3)

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.

Hang one or two fluid bags with distension media appropriate for procedure. (A MyoSure® procedure utilizes one or two 3000 cc saline bags.) 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 disposable inflow and outflow tube sets. Tube set recognition technology

Each inflow tube set is equipped with tube set recognition technology. An RFID transponder detects the type of tubing, whether it has been used, and its reliability automatically. The pump display indicates this information. This eliminates accidental reuse of tubing on more than one patient (see Chapter 5.7, Tubing Overview). WARNING! Reprocessing of sterile disposable products Reuse of inflow or outflow tubing 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 single-use inflow or outflow tubing.

NOTE! Comply with hygiene rules when disposing of tubing, fluid collected, and the canisters.

18

System Operation 5.7

Tubing Overview

EN

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

Part Number Description AQL-110

Aquilex Fluid Control System Inflow Tube Set

AQL-111

Aquilex Fluid Control System Outflow Tube Set

AQL-112

Complete tube set (Inflow and Outflow) disposable, sterile

AQL-114

Aquilex Fluid Control System High and Low Vacuum Tube Set: re-usable, non-sterile Table 5-1

5.8

Connecting the Outflow Tubing

CAUTION! When using the Aquilex System with MyoSure® or other morcellation systems, the combination of low set pressures and high vacuum pressures may result in a significant loss of intrauterine distension pressure which has the potential to affect the visibility of the surgical field. Conversely, when employing high distension pressures, the deactivation of the MyoSure® or other morcellator system can lead to pressure spikes that can exceed 150 mmHg.

(3)

Figure 5-7 Outflow Tubing

(4)

(1)

(5)

To low vacuum port (white)

(2) Canisters (3) Tandem tube (6)

(4) Patient port (5) Outflow tube set (6) Drape (7)

Removable Outflow Channel (MyoSure®) or hysteroscope outflow sheath stopcock

(1) (2)

(7) (5)

(1)

(3) Using Low Vacuum configuration of Figure 5-4, connect outflow tubing (Y-tube) to patient port (4) of second canister. Yellow flexible connector attaches to drape (6). Yellow luer fitting connects to stopcock (7) of Removable Outflow Channel (MyoSure®) or hysteroscope outflow sheath.

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