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REV AUTHORED BY
4/29/16
K BUJOLD
REV DRAFTED BY
4/29/16
K BUJOLD
PROPRIETARY: This document contains
proprietary data of Hologic, Inc. No
disclosure, reproduction or use of any
part thereof may be made except by
written permission from Hologic.
REV. RELEASE DATE:
05/16/2016
302 8.26 inch x 11.69 inch (A4) sheets attached.
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TEXT, IFU, AQUILEX FLUID
MANAGEMENT SYSTEM, 4320
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DOCUMENT NUMBER
AW-07059-4320
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Form ENG-0034-T03, Rev. 004
REV
009
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Table of Contents
Related Manuals for Hologic Aquiflex
Summary of Contents for Hologic Aquiflex
- Page 1 DATE 4/29/16 K BUJOLD PROPRIETARY: This document contains TITLE DOCUMENT NUMBER proprietary data of Hologic, Inc. No TEXT, IFU, AQUILEX FLUID disclosure, reproduction or use of any AW-07059-4320 part thereof may be made except by MANAGEMENT SYSTEM, 4320 written permission from Hologic.
- Page 2 Instructions for Use and Fluid Control System Operator’s Manual Gebrauchs- und Bedienungsanweisun- gen für Fluid Control System Manuel d‘instruction et d‘utilisation du Fluid Control System Manual de Instrucciones y de Utilización del Fluid Control System Istruzioni per l'uso e istruzioni operative del Fluid Control System Gebruiks- en bedieningsinstructies voor Fluid Control System...
- 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 subsidiaries in the United States and other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
- Page 4 Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen Leggere la docu- Lees de begelei- Lire la documenta- Observe la docu- Read Instructions Bedienungsanlei- mentazione alle- dende documenta- tion jointe ! mentación adjunta Before Use tung befolgen gata Syteem van het BF Type Equipment Système de type BF Sistema del tipo BF Sistema tipo BF System des Typs BF...
- Page 5 Symbols/Bildzeichen/Symboles/Símbolos/Simboli/Symbolen Ce produit ne con- Questo prodotto Dieses Produkt ent- Este producto no Dit product bevat Not Made with tient pas du non contiene hält kein Diethylhe- contiene dietilhe- geen di-ethylftalaat Phthalates diethylhexyl phta- diethylhexylftalato xylphthalat (DEHP) xilftalato (DEHP) (DEHP) late (DEHP) (DEHP) Questo prodotto...
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Page 6: Table Of Contents
Table of contents Important User Notes ................................. 3 Safety Information................................4 Purpose of the System ................................ 5 Warnings and Precautions ..............................5 3.1.1 Warnings ....................................5 3.1.2 Precautions....................................9 Description of the Aquilex Fluid Control System ......................10 Initial System Set-up................................11 Preparing the System For Use............................... -
Page 8: Important User Notes
Important User Notes Important User Notes Read the manual carefully and become familiar with the operation and function of the Aquilex® Fluid Control System (Aquilex System) and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead to: •... -
Page 9: Safety Information
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 main- tained, •... -
Page 10: Purpose Of The System
Purpose of the System Purpose of the System Aquilex® Fluid Control System is intended to provide liquid distension of the uter- Indication for use us during diagnostic and operative hysteroscopy, and to monitor the volume dif- ferential between the irrigation fluid flowing into and out of the uterus. The system may not be used to introduce fluids into the uterus when hysterosco- Contraindications py is contraindicated. - Page 11 Purpose of the System scopic surgery. It is critical to closely monitor the input and outflow of the distending liquid at all times. WARNING! Fluid deficit The fluid left in the patient must be monitored. The deficit is the total amount of fluid left in the patient or unaccounted for otherwise.
- Page 12 Purpose of the System WARNING! Cerebral edema Hysteroscopic surgery is associated with a risk of developing cerebral edema re- sulting from fluid overload and electrolyte disturbances with hypoosmolar (non- ionic) 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.
- Page 13 Purpose of the System WARNING! Place the system in such a way as to allow for easy visualization of the display values, system functions, and access to the control elements. WARNING! Do not use this system if a defect is suspected or detected during the function check.
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Page 14: Precautions
Purpose of the System 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 sur- gical techniques. Medical instruments and systems may be used only by physicians or medical assistants with the appropriate technical/medical qualifi- cation working under the direction and supervision of a physician. -
Page 15: Description Of The Aquilex Fluid Control System
Purpose of the System CAUTION! When using the Aquilex System with MyoSure® or other morcellation systems, the combination of low set pressures and high vacuum pressures may result in a significant loss of intrauterine distension pressure which has the potential to af- fect the visibility of the surgical field. -
Page 16: Initial System Set-Up
Initial System Set-up Always check all parts and accessories of the system when performing initial set- up. 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... -
Page 17: System Set-Up
Initial System Set-up System Set-up Figure 4-1 Set-up of Aquilex Fluid Control System Cart Bag holder Pump Fluid bag Trays Scale cable MyoSure® Control Unit Scale Canister holders Canister (10) (11) Roller base Locking foot brake (12) (10) (11) (12) The Aquilex Fluid Control System is divided into two separate boxes for shipping. -
Page 18: System Operation
System Operation System Operation Front of Pump Fig. 5-1 Front of Pump Pump display (1) (2) (3) (4) (5) (6) Intrauterine pressure display Fluid deficit limit display Deficit meter Deficit display Inflow tube holder Roller wheel Pressure sensor Reset deficit button (Zero) (10) Decrease deficit limit Increase deficit limit... -
Page 19: Cart/Scale
System Operation Cart/scale Figure 5-3 Cart/Scale Fluid bag Scale cable Scale Pole with bag hooks Bag deflector Canister Upper canister holder (Serres, Medela, Baxter, Baxter flex) Lower canister holder (Abbott, Bemis, Medi-Vac, DeRoyal) Roller base The cart/scale consists of a weighing scale for the canisters, a pole with hooks for irrigation fluid bags, and a roller base. -
Page 20: Scale Set-Up
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 supported by the system. -
Page 21: Connecting The Vacuum Tubing
System Operation Medi-Vac Flex Advantage 3000 cc 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 af- fect the visibility of the surgical field. -
Page 22: Turning On The Aquilex System
System Operation 500 mmHg using adjustment dial. · Use tandem tube ((12) Figure 5-5, High vacuum tube) when two canisters are serially connected to the same vacuum port. (11) Figure 5-5 High vacuum tube Hygiene filter Vacuum tube (green connectors) (12) High vacuum port (green) (10) -
Page 23: Hanging The Fluid Bags
System Operation Hanging the Fluid Bags Figure 5-6 Fluid bag suspension Fluid bags Pole with bag hooks 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 bi- polar electrosurgical resective procedures. -
Page 24: Tubing Overview
System Operation Tubing Overview Three different tube sets are necessary to operate the system. The following ta- ble 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... -
Page 25: Myosure® Outflow Connection
System Operation Channel (MyoSure®) or hysteroscope outflow sheath. 5.8.1 MyoSure® Outflow Connection Figure 5-8 MyoSure®Connection To High Vacuum port (green) (2) Canisters (3) Tandem tube (4) Specimen tissue port (5) Tissue trap (6) MyoSure® vacuum tube (7) MyoSure® Tissue Removal Device (TRD) If intrauterine pathology is identified, the MyoSure®... -
Page 26: Inserting The Inflow Tube Set
System Operation Inserting the Inflow Tube Set Figure 5-9 Tube set elements Protective caps (2) Bag spikes (3) Tubing clamps (4) Y-connector (5) Inflow section (6) Roller wheel section (7) Pressure chamber with membrane and RFID transponder (8) Hysteroscope section (9) Luer lock connector (blue) (10) Roller wheel connector (10) -
Page 27: Presetting The Intrauterine Pressure
System Operation Connect the blue Luer lock connector (9) with the hysteroscope inflow stop- cock. Open stopcock. Insert tube set 3. To be carried out by non-sterile nurse: Ensure system is turned on. Close the clamps (3) on the inflow tubing below the bag spikes (1). ... -
Page 28: Using The Pump During Operation
System Operation During the operation as the actual deficit climbs, the LEDs will light up sequen- tially representing the actual deficit volume until the deficit limit is reached. (See Section Deficit Limit in Chapter 6, Safety functions). 5.12 Using the Pump during Operation ... -
Page 29: Total Volume Displayed
System Operation Reconnect canister tubing. Press Pause/Resume button to resume procedure. CAUTION! If a filled canister is removed from scale without activating the " Pause/Resume" button, the message "Container Change, Press Resume" will appear, the pump will stop immediately and the deficit display locked to insure an accurate deficit count is maintained. -
Page 30: 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 tones, error mes- sages, and/or the blocking of system functions. A table listing a summary of possible error and warning messages is provided in Chapter 9, Error and Warning Messages. -
Page 31: Care And Maintenance
Care and Maintenance Care and Maintenance Care and maintenance The service and maintenance of the system and its accessories has to be carried out as per instructions to ensure the safe operation of the system. For the protec- tion of the patient and the operating team, check that the system is complete and functional before each use. - Page 32 Care and Maintenance 1. Turn system off. 2. Disconnect system from wall power outlet. 3. The fuse holder is located on the back of the pump, next to the male connec- tion. 4. Remove both fuse holders as depicted in Figure 7-1, using small flathead screwdriver.
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Page 33: Annual Inspection
WARNING! If the specified parameters and tolerances are exceeded, the system must be re- turned to Hologic for evaluation. Safety Test 1. Perform a visual inspection. Ensure: • the fuse corresponds with the specifications indicated by the manufactur- •... -
Page 34: Flow Rate Test
Annual Inspection Flow Rate Test Figure 8-1 Flow rate test The test set-up is depicted in Figure 8-1, Flow rate test. Performing flow rate test 1. Turn the system on. (See 5.4, Turning On the Aquilex System) 2. Insert the tube set into pump and close bag clamps. 3. -
Page 35: Pressure Measuring Test
Annual Inspection Pressure Measuring Test The test set-up is depicted in Figure 8-2, Set-up of pressure measuring test. Figure 8-2 Set-up of pressure measuring test Height of the water line The pressure test checks the pressure chamber, pressure sensor, and accurate measurement of pressure to ensure all elements are functioning properly. -
Page 36: Fluid Deficit Measurement Test
Annual Inspection Fluid Deficit Measurement Test The test setup is depicted in Fig. 8-3, page 31. It is critical that the collection can- ister be placed on the scale as shown in Fig. 8-3. 1. If Basic Function Tests 8.3 to 8.5 have been conducted, skip to step 2. If not, see Basic Function Tests 8.4 steps 1 to 11. -
Page 37: Vacuum Pump Operational Test
Annual Inspection Vacuum Pump Operational Test This test is not designed as a performance test to measure the vacuum pressure but only to assess if vacuum pumps are operational. 1. If Basic Function Tests 8.3 to 8.5 have been conducted, skip to step 2. If not, see Basic Function Tests 8.4 steps 1 to 9. -
Page 38: Error And Warning Messages
Connect Scale Restart System 3 audible tones Check scale connection. Reconnect scale and restart device. If message recurs, contact Hologic. Remove Tube Set for System Check 1 audible tone System check must be performed with tube set removed from the roller wheel assembly. - Page 39 Low Vac Failed Use Alternative 3 audible tones A substitute low pressure vacuum source is necessary to continue proce- dure. Contact Hologic Technical Support. High Vac Failed Use Alternative 3 audible tones A substitute high pressure vacuum source is necessary to continue proce- dure.
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Page 40: Technical Data
Technical Data Technical Data Model or type designation AQL-100 Mains voltage range [V] 100-240 V Supply frequency range [Hz] 50-60 Hz Fuse designation 2x T 3.15 AH, 250 V, UL- recognized Power consumption Current [A] Voltage [V] Power consumption [VA/W] Upper voltage range Normal operation 0.19 A... - Page 41 Technical Data Accuracy Flow [% measured value] ±7 % Pressure [mmHg] ±7.5 mmHg Deficit [% measured value]äöälölll ±10 % Interfaces: Signal IN/OUT components 1x scale port (flanged socket/5-pin round connector socket/ RS232) 1x service port (RS232 socket DSUB9/RS232) Mains connection IEC-60320-1 C14...
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Page 42: Guidelines And Manufacturer's Statement - Electromagnetic Compatibility
Guidelines and manufacturer's statement - electromagnetic compatibility Guidelines and manufacturer's statement - electromag- netic compatibility 11.1 Impact of Mobile and Portable HF Communication Devices The emission of high frequency energy by mobile communication devices may impact the function of the electrical medical device. Operating such devices (e.g., cell phones, GPS phones) in the proximity of the electrical medical device is pro- hibited. -
Page 43: Guidelines And Manufacturer's Statement - Electromagnetic Emissions
Guidelines and manufacturer's statement - electromagnetic compatibility 11.3 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions The Aquilex Fluid Control System is intended for use in the electromagnetic envi- ronment specified below. The user/operator of the Aquilex Fluid Control System should make sure the device is operated within such an environment. Emitted interference Compliance Electromagnetic environment guide-... -
Page 44: Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity
Guidelines and manufacturer's statement - electromagnetic compatibility 11.4 Guidelines and Manufacturer's Statement - Electromagnetic In- terference Immunity The Aquilex Fluid Control System is intended for use in an electromagnetic envi- ronment as described below. The user/operator of the Aquilex Fluid Control Sys- tem should make sure the device is operated within such an environment. -
Page 45: Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity
Guidelines and manufacturer's statement - electromagnetic compatibility 11.5 Guidelines and Manufacturer's Statement - Electromagnetic In- terference Immunity Electromagnetic Test level Compliance Electromagnetic environ- interference ment guidelines immunity tests Conducted HF In compliance Portable and mobile wire- interference 150 kHz to less devices should not be quantities 80 MHz... -
Page 46: Recommended Safety Distances Between Portable And Mobile Hf Telecommunications Devices And The Aquilex Fluid Control System
Guidelines and manufacturer's statement - electromagnetic compatibility The field strength should be less than 3 V/m for the frequency range of 150 kHz to 80 MHz. 11.6 Recommended safety distances between portable and mobile HF telecommunications devices and the Aquilex Fluid Control System The Aquilex Fluid Control System is intended for use in an electromagnetic envi- ronment where HF interferences are controlled. -
Page 47: Accessory List
Accessory List Accessory List The following accessories are available: Item Order No. Aquilex Fluid Control System Complete Tube Set (Inflow and AQL-112 Outflow) Aquilex Fluid Control System Vacuum Tube Set (high and low) AQL-114 Aquilex Fluid Control System Canister Rings AQL-200 Aquilex Fluid Control System MyoSure®... -
Page 48: Warranty Information
Technical Support and Product Return Information Contact Hologic Technical Support if the Aquilex Fluid Control System fails to op- erate as intended. If product is to be returned to Hologic for any reason, Technical Support will issue a Returned Materials Authorization (RMA) number. Return Aq- uilex System according to the instructions provided by Technical Support. - Page 49 Warranty Information Contact Hologic Technical Support to arrange for proper disposal of the Aquilex System in accordance with the WEEE Directive. Hologic Technical Support United States and Canada: Phone: 1.800.442.9892 (toll-free) or 1.508.263.2900 Fax: 1.508.229.2795 Authorized European Representative: Phone: +32 2 255 17 74...
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Page 50: Glossary
Glossary Glossary Term Statement Embolism Sudden capillary blockage due to embolus Flow rate Quantity (in ml) of irrigation fluid flowing through tube set per minute Hypervolemia An increased volume of circulating blood Hyponatremia A low concentration (< 130 mmol/l) of sodium in the patient’s bloodstream Hysteroscope Endoscope to look inside the uterus Intrauterine pressure... -
Page 51: Appendix
Appendix Appendix 15.1 Test Log Date Tests Performed Results Comment Signature... -
Page 52: Index
Index Index Authorized service technician 4 Care and maintenance 4, 26 Certification 26 Connecting the fluid bags 22 Connection to the wall outlet 11 Contraindications 5 Deficit rate >300 ml/min 25 ESD (Electrostatic Discharge) precautionary measures 37 Exclusion of liability 4 Federal Law 4 Grounding contact 11 Indication for use 5...
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