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REV AUTHORED BY
R MISTRY
08/18/23
REV DRAFTED BY
R MISTRY
08/18/23
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:
08/28/2023
File Name
DATE
DATE
TITLE
TEXT, IFU, AQUILEX FLUID
MANAGEMENT SYSTEM, 4320, NEW
Signature Mark-up File
WOM View Mark-up File
SCALE
Description
Signature File
Source / View File
DOCUMENT NUMBER
AW-16146-4320
SIZE A
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Form ENG-0034-T01, Rev. 003
REV
005
OF 1
1
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Summary of Contents for Hologic Aquilex Fluid Control System
- Page 1 DATE R MISTRY 08/18/23 PROPRIETARY: This document contains TITLE DOCUMENT NUMBER proprietary data of Hologic, Inc. No TEXT, IFU, AQUILEX FLUID disclosure, reproduction or use of any part AW-16146-4320 MANAGEMENT SYSTEM, 4320, NEW thereof may be made except by written SCALE permission from Hologic.
- Page 2 Instructions for Use Aquilex® Fluid Control System 10000021387 04...
- Page 3 Hologic and MyoSure are registered trademarks of Hologic, Inc. and its subsidiaries in the United States and other coun- tries. Aquilex is a trademark of Hologic, Inc. and its subsidiar- ies in the United States and other countries. All other trade- marks, registered trademarks, and product names are the property of their respective owners.
- Page 4 Symbols and Descriptions Symbols and Descriptions Serial number Follow instructions for use (white image on a blue back- ground) Manufacturer Consult instructions for use Date of manufacture (YYYY- MM-DD) Medical Device Use by date (YYYY-MM-DD) Type BF applied part Quantity Equipotentiality Degrees of protection provided by enclosures (IP-...
- Page 5 Symbols and Descriptions Do not use if package is Certification Mark damaged RFID tag, general Authorized for Sale or use by Physician only Temperature limit Humidity limitation Atmospheric pressure limitation Storage conditions Transport conditions Waste management ON/OFF (push-push) Max. use 30 days Non sterile Scale connection Input/Output...
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Page 6: Table Of Contents
Table of Contents 1 Important Operator/User Notes .................................... 7 2 Safety Information ........................................ 8 3 Purpose............................................ 9 Warnings and Precautions ................................... 9 3.1.1 General Warnings ....................................... 9 3.1.2 Hysterosocopy Specific Warnings ................................ 13 3.1.3 Precautions ......................................... 17 Description of the Aquilex® Fluid Control System.......................... 19 4 Initial System Set-Up ....................................... 21 Preparing the System for Use .................................. 21 System Components .................................... 23... - Page 7 13 Accessory List .......................................... 61 14 Warranty Information...................................... 62 15 Appendix ............................................. 63 15.1 Test log .......................................... 63 Glossary ............................................ 65 Index............................................. 66...
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Page 8: Important Operator/User Notes
Important Operator/User Notes Important Operator/User Notes Read the Instructions for Use carefully and become familiar with the operation and function of the Aquilex® Fluid Control System (Aquilex® System) and the accessor- ies before use during surgical procedures. Non-observance of the instructions listed in this manual can lead to: •... -
Page 9: Safety Information
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. For disposal of the device and its accessories, please consult Hologic or an authorized disposal company, in compliance with legal or national regulations. -
Page 10: Purpose
Purpose Purpose The Aquilex® Fluid Control System is intended to provide fluid distension of the Intended Use uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. The system may not be used to introduce fluids into the uterus when hysteroscopy Contraindications is contraindicated. - Page 11 Purpose WARNING! Falls and crashes Place the device on a stable and level surface. Cables must be laid safely. Tubes between the device and the patient must not create any obstruction. WARNING! Function test The function test must be performed prior to each device use. WARNING! Scale test The scale test must be performed at the beginning of the day prior to device use...
- Page 12 Purpose WARNING! Technique and procedures Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect. WARNING! Check all factory settings Factory settings are not mandatory settings for the physician.
- Page 13 WARNING! Parameters and tolerances exceeded If the specified parameters and tolerances are exceeded, the system must be re- turned to Hologic for evaluation. WARNING! This product contains phthalates! The vacuum tube sets for this device contain diethylhexylphthalate (DEHP), which is classified as toxic to reproduction according to the EU Directive 1272/2008/EEC on Classification, Labeling and Packaging of Dangerous Substances.
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Page 14: Hysterosocopy Specific Warnings
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. - Page 15 Purpose WARNING! Risk of intravasation If the intrauterine pressure does not react to an increase in the pressure setting during the procedure, a perforation of the uterine cavity might be the cause. This results in an increased risk of intravasation. Examine the uterine cavity for injuries. WARNING! Intrauterine distension Intrauterine distension is usually possible with pressure values between 35 to...
- Page 16 Purpose WARNING! Changing fluid bags Fluid bags should be changed quickly to avoid affecting the accuracy of the deficit calculation. Observe the occurrence of acoustic signals and message to avoid unre- cognized bag changes during procedure which can affect the displayed deficit value.
- Page 17 Purpose WARNING! Deficit displays and warnings Deficit displays and warnings serve as a tool for the treating physician and do not replace the monitoring of the patient's condition. WARNING! Resetting the deficit display 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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Page 18: Precautions
Purpose WARNING! Cerebral edema Hysteroscopic surgery is associated with a risk of developing cerebral edema result- ing from fluid overload and electrolyte disturbances with hypoosmolar (non-ionic) fluids such as glycine 1.5 % and sorbitol 3.0 %. It is critical to closely monitor the in- put and outflow of the distending liquid at all times. - Page 19 Purpose CAUTION! Instrument recognition The instrument recognition must be performed outside and at the level of the pa- tient. CAUTION! Continuous operation After 24 hours of continuous operation, a device self-test must be carried out. Switch device off and on again. CAUTION! Accessories To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-...
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Page 20: Description Of The Aquilex® Fluid Control System
Purpose CAUTION! Electrical interference (see Chapter Electromagnetic Compatibility [} 58]): 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 inter- ference, please follow these suggestions: •... - Page 21 Purpose Suggested distension media The Aquilex® Fluid Control System can be used with hypotonic, electrolyte-free me- dia (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.
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Page 22: Initial System Set-Up
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 War- ranty Information [} 62]). Place the system on a level surface and install in a dry environment. The ambient... - Page 23 Initial System Set-Up Grounding contact The power connection must be equipped with a grounding contact. Use the ori- ginal power cord to establish a connection between the mains wall socket and the non-heating device plug located in the rear of the device. The grounded, shockproof safety wall socket should be near the device and within easy reach.
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Page 24: System Components
Initial System Set-Up System Components Fig. 4–1 System Components Bag scale (2) Fluid bag (3) Irrigation Pump Unit (4) Trays (5) Container scale cable/connector (6) Container scale Container holders (8) Container (9) Roller wheel base (10) Locking foot brake (10) The Aquilex® Fluid Control System is divided into two separate boxes for shipping: Box 1 contains: •... -
Page 25: System Operation
Fig. 5–2 Rear of irrigation pump unit Connection for low vacuum (white) (2) Product Label (3) Performance data of the device High TYPE Aquilex Fluid Control System SN / REF Ser. Nr. WOM (4) Adjustment controller for high 100-240 V / 50-60 Hz YYYY-MM vacuum... -
Page 26: Fluid Monitoring Unit Set-Up
System Operation 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). Furthermore, all configura- tions must comply with the normative requirements for medical systems (see sec- tion 16 of the last valid edition of IEC ... -
Page 27: Fig. 5-4 Scale And Pump Connection
System Operation Guide the power cord through the holes provided for this purpose and connect to pump (2) (Fig. Scale and pump connection [} 26]) and plug into grounded, shockproof safety wall socket. Attach the scale to the pump by connecting and screwing the connector of the bag scale together with the connector of the container scale (4) (Fig. - Page 28 System Operation WARNING! Serum sodium concentration It is also necessary to monitor the concentration of sodium in the blood of the pa- tient to prevent electrolyte disturbances. Monitoring of the concentration of so- dium in the blood must be performed by the physician and is not performed or sup- ported by the system.
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Page 29: Setting Of The Container Scale
System Operation 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 28 / 70... -
Page 30: Connecting The Vacuum Tube
System Operation NOTE! Container position Ensure containers are positioned properly in the respective holders. NOTE! Containers with overflow protection Only use suction containers with overflow protection. 5.3.2 Connecting the Vacuum Tube WARNING! Combination of low set pressures and excessive vacuum pressures When using the Aquilex®... -
Page 31: Turning On The Aquilex® System
System Operation Fig. 5–6 High vacuum tube (11) (6) Hygiene filter Vacuum tube (green connectors) (8) Connection for high vacuum (green) (9) Container (10) Tissue trap (12) (11) Adjustment controller (12) Connecting tube onl y My oS ® (10) Turning On the Aquilex® System Fig. 5–7 Front of Device Press the ON/OFF switch. -
Page 32: Hanging The Fluid Bags
System Operation WARNING! Obvious defects Never use the system if it has suspected or confirmed defects, especially if these in- volve the power plugs or the mains power supply connection cables. In this case have the device repaired by authorized service personnel. Hanging the Fluid Bags Fig. 5–8 Fluid bag suspension Bag scale... -
Page 33: Using Tube Sets
System Operation Using Tube Sets The Aquilex® Fluid Control System is designed for use with sterile disposable inflow and outflow tube sets. RFID transponder technology Inflow tubes are equipped with a tube set recognition technology. An RFID transponder automatically detects the tube type, the validity, and reliability of each tube set. -
Page 34: Tube Sets Overview
System Operation Tube Sets Overview Three different tube sets are necessary to operate the system. The following table lists each type of tube set and its application. Article number Description Tube set for irrigation, single-use, AQL-110 for Aquilex® Fluid Control System Tube set for suction, single-use, AQL-111 for Aquilex®... -
Page 35: Connecting The Outflow Tube Set
System Operation Connecting the Outflow Tube Set WARNING! Combination of low set pressures and excessive vacuum pressures When using the Aquilex® Fluid Control 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. -
Page 36: Connecting Outflow Tube Of Tissue Removal Handpiece (E.g. Myosure®)
System Operation 5.8.1 Connecting Outflow Tube of Tissue Removal Handpiece (e.g. MyoSure®) Fig. 5–10 Port for tissue removal systems To high vacuum port (green) (2) Container (3) Connecting tube (4) Specimen tissue port (5) Tissue trap (6) Vacuum tube of tissue removal handpiece (yellow) (7) Tissue removal handpiece If intrauterine pathology is identified, the outflow tube of a tissue removal hand-... -
Page 37: Inserting The Inflow Tube Set
System Operation Inserting the Inflow Tube Set Fig. 5–11 Tube set elements Protective caps (2) Spikes (3) Clamps (4) Y-connector (5) Inflow tube (6) Roller wheel tube Pressure chamber with membrane and RFID transponder (8) Hysteroscope tube (9) Luer lock connector (blue) (10) (10) Roller wheel connector (See Fig. -
Page 38: Fig. 5-13 Attach Roller Wheel Tube
System Operation • To be carried out by non-sterile nurse: Open outer packaging – Ensure system is turned on. – Open outer packaging of the inflow tube set. • To be carried out by sterile nurse: Connect to hysteroscope – Remove the inner tube set package and open it. –... -
Page 39: Presetting The Intrauterine Pressure
System Operation 5.10 Presetting the Intrauterine Pressure Intrauterine pressure setting The intrauterine pressure setting can be adjusted while the system is in operation. The initial default pressure is 70 mmHg. Use the º and » buttons (Fig. Front of ir- rigation pump unit [} 24]). The pressure setting can be adjusted to between 40 to 150 ... - Page 40 System Operation • Three audible warning signals are heard once the automatic lumen calibration is finished. The pump display will show Prime Successful Close Stopcock for 5 seconds followed by Pump Operating. • Close hysteroscope inflow stopcock to stop fluid flow. Once all fluid has been removed from the drape, zero the deficit display.
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Page 41: Changing Bags During Surgery
System Operation 5.13 Changing Bags during Surgery Bag change during surgery The device system detects automatically the replacement of a bag. Brief fluctu- ations in the deficit calculation (< 10 s) may occur when a bag is replaced. The re- placement of a bag is indicated with the message Bag Change, Please Proceed. -
Page 42: Changing Instrument During Surgery
System Operation WARNING! Fluid bag and container change during surgery A fluid bag or container change during surgery is only allowed, if the fluid bag or container holds at least 0,5 liters of fluid or waste. Otherwise, the deficit value may be falsified. -
Page 43: Total Inflow Volume Displayed
System Operation • Three audible warning signals are heard once the automatic lumen calibration is finished. • The pump display depicts Prime Successful Close Stopcock for 5 seconds, fol- lowed by Pump Operating. • Close the stopcock for the hysteroscope inflow to stop the inflow. 5.16 Total Inflow Volume Displayed Total inflow volume displayed If a manual check of the fluid deficit is desired, the total fluid volume supplied from... -
Page 44: Function Tests
Function Tests Function Tests WARNING! Device defect If a device defect is suspected or confirmed, do not use it. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. Do the general function test before each procedure. Do the scale test at the beginning of the day prior to device use. - Page 45 Function Tests The pump display depicts the message Scale Test. The first option is the test of the container scale. Place the 1000 g weight on the container scale. The displayed value should be 1000 g. The tolerance range is ±20 g. If the displayed value is outside the tolerance range, the scale must be calib- rated by a service technician.
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Page 46: Safety Functions
Safety Functions Safety Functions The electronic components continuously monitor the proper function of the sys- tem. System malfunctions are indicated with audible warning signals, error mes- sages, and/or the blocking of system functions. A table listing a summary of pos- sible error and warning messages is provided in Error and Warning Messages [} 54]. - Page 47 Safety Functions Operation can be continued by pushing the pause/resume button. If the operation is continued, the pump display continues to show Inflow Volume Limit Reached and the user must perform manual counts for continued deficit monitoring. Serious system defect Some components of the system will be observed during operating and at the star- tup sequence.
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Page 48: Care And Maintenance
Care and Maintenance Care and Maintenance NOTE! Service and maintenance work may not be carried out during surgery. The service and maintenance of the system and its accessories has to be carried out Care and maintenance as per instructions to ensure the safe operation of the system. For the protection of the patient and the operating team, check that the system is complete and func- tional before each use. -
Page 49: Replacing Of The Fuse
Care and Maintenance Technical report Ask the service technician for a technical report after the service technician has in- spected the device or performed any service tasks. This technical report lists the type, the scope and the results of the service as well as the date and name of the servicing company together with the signature of the service technician. -
Page 50: Annual Inspection
WARNING! Parameters and tolerances exceeded If the specified parameters and tolerances are exceeded, the system must be re- turned to Hologic for evaluation. Electrical Safety Test Perform a visual inspection. Make sure that – the fuse corresponds with the specifications indicated by the manufac- turer, –... -
Page 51: Flow Rate Test
Annual Inspection 9.2.1 Flow Rate Test Fig. 9–1 Setup of the flow rate test Testing the flow rate Switch system on (see Chapter Turning On the Aquilex® System [} 30]). Insert tube set into pump and close clamps on the bags. Hang the fluid bags onto the fluid bag hooks. Insert spikes into the fluid bags and open clamps on the fluid bags. -
Page 52: Pressure Measuring Test
Annual Inspection 9.2.2 Pressure Measuring Test The test setup is depicted in Fig. Set-up of pressure measuring test [} 51]. Fig. 9–2 Set-up of pressure measuring test Height of the water line The pressure test checks the pressure chamber, the pressure sensor, and the accur- acy of the pressure measurement, to ensure that all elements function correctly. -
Page 53: Scale Test
Annual Inspection 9.2.3 Scale Test The scale test must be carried out as part of the annual inspection. See section Scale Test [} 43] for details. The test is successfully completed when the results are within the permissible tolerance limit. Enter the results into the test log (see Appendix [} 63]). 9.2.4 Fluid Deficit Measurement Test The test setup is depicted in Fig. -
Page 54: Testing The Vacuum Pump
This test is not designed as a performance test for the measurement of negative pressure. The test only indicates whether or not the vacuum pump is operational. Fig. 9–4 Vacuum pump exhaust ports Suction openings High TYPE Aquilex Fluid Control System SN / REF Ser. Nr. WOM 100-240 V / 50-60 Hz YYYY-MM Medium... -
Page 55: Error And Warning Messages
An alternative low vacuum source must be used in order to Low Vac Failed Use Alternative constantly repeating as continue the procedure. Contact Hologic Technical Support. long as the error occurs 3 audible warning signals, An alternative high vacuum source must be used in order to... - Page 56 1 audible warning signal the message appears again, you can use the system as inten- ded but with a lower accuracy for the deficit calculation. After finishing procedure please contact Hologic Technical Support. Remove and re-insert tube set. If the message reappears, in-...
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Page 57: Technical Data
0.3 A 72 VA Protection class (I, II, III) Application part type (B, BF, CF): BF (with Aquilex Fluid Control System inflow tube set) Defibrillator protection (yes/no) Protection class (IP code) IP41 (AQL-100PBS), IP21 (AQL-100CBS) Classification (I, IIa, IIb, III) in accordance... - Page 58 Technical Data Accuracy Pressure [mmHg] ± 10 mmHg ≤ 1 l: ± 60 ml, Deficit [ml] > 1 l: ± 6 % deficit accuracy related to provided inflow volume, but maximum 300 ml Suction pressure ± 20 % Total inflow volume [ml] ± 10 % Width x Height x Depth 295 mm x 130 mm x 320 mm / 11.6 in x 5.1 in x 12.6 in (AQL-100PBS), Dimensions [mm], [in] 660 mm x 1380 mm x 660 mm / 26.0 in x 54.3 in x 26.0 in (AQL-100CBS)
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Page 59: Electromagnetic Compatibility
Electromagnetic Compatibility Electromagnetic Compatibility CAUTION! Accessories To ensure compliance with the requirements of IEC 60601-1-2 in the current ver- sion, the device Aquilex® Fluid Control System must be used only with the ac- cessories listed in Chapter Accessory List [} 61]. CAUTION! Possible malfunctions The Aquilex®... -
Page 60: Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity
Electromagnetic Compatibility Emissions test Compliance Electromagnetic environment - guidance The device Aquilex® Fluid Control System uses RF energy solely for its internal function. Therefore, its RF emissions RF emissions CISPR 11 Group 1 are very low and are not likely to cause any interference in nearby electronic equipment. - Page 61 Electromagnetic Compatibility IMMUNITY to proximity fields from RF wireless communications equipment Test method IEC 61000-4-3 Test frequency Band Service Modulation Maximum power Distance IMMUNITY TEST LEVEL (V/m) (MHz) (MHz) Pulse modu- lation 380-390 TETRA 400 18 Hz GMRS 460, FRS ± 5 kHz de- 430-470 viation 1 kHz sinus...
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Page 62: Accessory List
Accessory List Accessory List The following accessories and peripherals are available: Article Order No. Tube set for irrigation, single-use, for Aquilex® Fluid Control System AQL-110 Tube set for suction, single-use, for Aquilex® Fluid Control System AQL-111 Aquilex® Fluid Control System complete tube set (inflow and outflow), disposable, sterilized using ethylene oxide AQL-112 Tube set for vacuum incl. -
Page 63: Warranty Information
The obligation of Hologic under this warranty shall be limited to the repair or replacement, each at no charge, at the option of Hologic within one year from the date of purchase. Alternatively, Hologic may elect to re- pay or credit the original purchaser an amount equal to the purchase price of the defective equipment. -
Page 64: Appendix
Appendix Appendix 15.1 Test log Date Result Comment Signature 63 / 70... - Page 65 Appendix 15.2 Return form Please fill out this form when returning the device: Name of owner: Sales partner: Address of person returning unit: Street: House number: ZIP/Postal code: City: Country: IMPORTANT! Serial number (see identification plate): Device type: Description of defect: Contact Signature Date...
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Page 66: Glossary
Glossary Glossary Contamination Soiling Pollution of rooms, water, foods, objects, or persons due to microorganisms or radioactive materials, biological poisons or chemical agents Contraindication Circumstances (e.g., age, pregnancy, certain illness, medica- tion) prohibiting the use of an otherwise indicated measure (contrary to an indication Embolism Sudden capillary blockage due to embolus... -
Page 67: Index
Index Index Authorized service technician 8 Unauthorized personnel 47 Authorized trained personnel 47 Waste management 8 Care and maintenance 8 Check Tube Set Installation 45 Contamination 8 Deficit limit 45 Deficit rate >300 ml/min 45 Exclusion of liability 8 Grounding contact 22 Inspection tests 49... - Page 68 List of Figures List of Figures Fig. 4–1 System Components.................................... Fig. 5–1 Front of irrigation pump unit................................Fig. 5–2 Rear of irrigation pump unit ................................Fig. 5–3 Fluid monitoring unit (cart with scale)............................Fig. 5–4 Scale and pump connection ................................Fig. 5–5 Low vaccum tube....................................Fig. 5–6 High vacuum tube....................................
- Page 69 List of Tables List of Tables Table 1 Tube sets ......................................... 68 / 70...