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Form ENG-0034-T03, Rev. 004

TITLE

DOCUMENT NUMBER

REV

TEXT, IFU, AQUILEX FLUID

MANAGEMENT SYSTEM, 4320

AW-07059-4320

009

ARTWORK

SIZE A

SHEET 1 OF 1

REV AUTHORED BY

DATE

K BUJOLD

4/29/16

REV DRAFTED BY

DATE

K BUJOLD

4/29/16

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

Artwork consists of:

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302 8.26 inch

11.69 inch (A4) sheets attached.

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AW-07059-4320_009_02.pdf

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Содержание Aquiflex

Страница 1: ...UJOLD 4 29 16 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...

Страница 2: ...enungsanweisun gen f r Fluid Control System Manuel d instruction et d utilisation du Fluid Control System Manual de Instrucciones y de Utilizaci n del Fluid Control System Istruzioni per l uso e istru...

Страница 3: ...gic Inc und ihrer Tochtergesellschaften in den Ver einigten Staaten und anderen L ndern Alle anderen Waren zeichen eingetragene Warenzeichen und Produktnamen sind Eigentum der jeweiligen Inhaber Holog...

Страница 4: ...ice Service Servicio Servizio Service Order Number Bestellnummer Num ro de commande N mero de pedido Numero di ordina zione Bestelnummer Do not Reuse Nicht zur Wieder verwendung Usage unique No reutil...

Страница 5: ...icit Resettoets voor deficit Prime Button Taste Prime Touche Prime Tecla Prime Tasto Prime Toets Prime Pause Resume Button Taste Pause Resume Touche Pause Resume Tecla Pause Resume Tasto Pause Resume...

Страница 6: ...em 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 2...

Страница 7: ......

Страница 8: ...nd or accessories Subject to technical changes The manufacturer reserves the right to modify the appearance graphics and technical data of the product through continued development of the product Plea...

Страница 9: ...e system or accessories Authorized service technician Only an authorized service technician may perform repairs adjustments or al terations on the system or accessories Any violation will void the man...

Страница 10: ...e above Severe anemia Inability to circumnavigate the myoma re myoma size predominantly intra mural myomas with small submucous components 3 1 Warnings and Precautions 3 1 1 Warnings WARNING When perf...

Страница 11: ...uld 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 pa...

Страница 12: ...tem perature during the entire surgery Make especially sure that the following hy pothermia promoting operation conditions are avoided as best as possible longer operating times use of cold irrigatio...

Страница 13: ...he clinical factors involved with each patient and determine if the use of this system is indicated The physician must deter mine the specific technique and procedure that will accomplish the desired...

Страница 14: ...ng a procedure an alterna tive system and replacement accessories should be kept within easy reach to be able to finish the operation with the replacement components WARNING Cleaning the system Do not...

Страница 15: ...rt 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 t...

Страница 16: ...upply 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 Grounding contact...

Страница 17: ...er cord Aquilex vacuum tube set low and high vacuum MyoSure Control Unit power cord Box 2 contains Cart scale Canister rings Figure 4 1 Set up of Aquilex Fluid Control System 1 Cart 2 Bag holder 3 Pum...

Страница 18: ...lder 7 Roller wheel 8 Pressure sensor 9 Reset deficit button Zero 10 Decrease deficit limit 11 Increase deficit limit 12 Decrease intrauterine pressure set ting 13 Increase intrauterine pressure set t...

Страница 19: ...Cart Scale to the scale connection 11 Figure 5 2 Rear of Pump 8 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 Sca...

Страница 20: ...value possible Scale capacity 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 emi...

Страница 21: ...cur for a short time as the system automatically adjusts the flow rate to return to the set intrauterine pressure 1 Connect vacuum to the suction containers using vacuum tube with hygiene filter This...

Страница 22: ...rom the roller wheel If the system self test is unsuccessful the corresponding error messages are displayed See Chapter 9 Error and Warning Messages The system has successfully completed the self diag...

Страница 23: ...e 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...

Страница 24: ...mHg These situations may oc cur for a short time as the system automatically adjusts the flow rate to return to the set intrauterine pressure Using Low Vacuum configuration of Figure 5 4 connect outfl...

Страница 25: ...RD can be connected to the Aquilex System as shown in Figure 5 8 The MyoSure vacuum tube 6 is con nected to the tissue trap 5 located in the second canister Figure 5 8 MyoSure Connection 1 To High Vac...

Страница 26: ...urse then removes the inner tube set package and opens it Connect to hysteroscope 2 To be carried out by sterile nurse Keep the blue Luer lock connector 9 in the sterile area and hand the tube end wit...

Страница 27: ...djusted while the system is in opera tion Use the and buttons Fig 5 1 Front of Pump The pressure setting can be adjusted to between 40 to 150 mmHg in steps of 5 mmHg The intrauterine pressure is shown...

Страница 28: ...how Prime Successful Close Stopcock for 5 secs followed by System Operating Close hysteroscope inflow stopcock to stop fluid flow Once all fluid has been removed from the drape zero the deficit displa...

Страница 29: ...ual check of fluid deficit is desired the total fluid volume can be obtained by simultaneously pressing and holding both the up and down arrows 10 11 in Fig 5 1 Front of Pump underneath the Fluid Defi...

Страница 30: ...ne and Check Tube Set Installation is displayed The roller wheel does not start to turn Errors of the pressure measuring system If a malfunction is detected in the pressure measurement electronics Sen...

Страница 31: ...cian inspects and services the system at appropriate intervals to ensure safety and functionality The mini mum service interval is two years depending on frequency and duration of use If this interval...

Страница 32: ...connec tion 4 Remove both fuse holders as depicted in Figure 7 1 using small flathead screwdriver 5 Pull out the fuse holders 6 Check the fuses 7 Insert new fuses Use only the specified type of fuse s...

Страница 33: ...the ground leakage current max 500 A and contact current max 100 A in normal state and max 500 A on first error according to IEC 60601 1 EN 60601 1 3 Measure protective conductor resistance according...

Страница 34: ...7 Press the Prime button 8 The roller wheel starts to turn to purge air from tubing and complete auto matic lumen calibration 9 Once automatic lumen calibration finishes 20 sec press Pause Resume butt...

Страница 35: ...l the calibration sequence is completed Press the Pause Resume button to stop the roller wheel The Intrauterine Pres sure display displays 0 mmHg 3 Close the hysteroscope end of the tube use finger on...

Страница 36: ...t see Basic Function Tests 8 4 steps 1 to 11 2 Zero the fluid deficit display by pressing the Zero button see Fig 5 1 Item 9 3 Press the Pause Resume button 4 Let system run for 1 minute The canister...

Страница 37: ...have been conducted skip to step 2 If not see Basic Function Tests 8 4 steps 1 to 9 2 Check canisters to be sure at least one port is open 3 Press the Pause Resume button 4 Place a finger adjacent to...

Страница 38: ...stopcock or other occlusion to relieve pressure Overpressure Check Stopcock 5 tones repeatedly continuously until pressure reduced Pressure has exceeded 200 mmHg safety limit and must be reduced Most...

Страница 39: ...Support Motor Error 5 audible tones Contact Hologic Technical Support Low Vac Failed Use Alternative 3 audible tones A substitute low pressure vacuum source is necessary to continue proce dure Contac...

Страница 40: ...601 1 2 2007 IEC 60601 1 2 2007 Operating conditions 10 to 40 C 50 to 104 F 30 to 75 rel humidity 70 to 106 kPa air pressure 3000 m max altitude above sea level for device use Use possible with flamma...

Страница 41: ...red value 7 Pressure mmHg 7 5 mmHg Deficit measured value l lll 10 Interfaces Signal IN OUT components 1x scale port flanged socket 5 pin round connector socket RS232 1x service port RS232 socket DSUB...

Страница 42: ...of the electrical medical device is pro hibited 11 2 Electrical Connections Do not touch electrical connections identified with this warning label Do not es tablish a connection between these plugs an...

Страница 43: ...ssion according to CISPR 11 Group 1 The Aquilex Fluid Control System uses HF energy solely for its internal functions Therefore the camera s HF emission is very low and it is unlikely that devices in...

Страница 44: ...s 1 kV for input and output lines In compli ance The quality of the sup ply voltage should be the same as the voltage of a typical business or hospital environment Surges according to IEC 61000 4 5 1...

Страница 45: ...usual performance characteristics are observed additional measures may be required such as changing orientation or the location of the Aquilex Fluid Control System Electromagnetic interference immunit...

Страница 46: ...the output power of the communication device listed below The safety distance d in meters m for transmitters with a max rated output not listed in the table above can be calculated by applying the co...

Страница 47: ...and Outflow AQL 112 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 Power Cord AQL 213 Aquile...

Страница 48: ...OR THAT HAS BEEN REPAIRED MOVED OR ALTERED BY ANYONE OTHER THAN AN AUTHORIZED HOLOGIC SERVICE PERSON HOLOGIC MAKES NO WARRANTY WHATSOEVER WITH REGARD TO ACCESSORIES OR PARTS USED IN CONJUNCTION WITH T...

Страница 49: ...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 2...

Страница 50: ...us Intrauterine pressure Pressure in uterine cavity Intravasation Entry of foreign matter into a blood vessel Contamination Soiling Pollution of rooms water foods objects or persons due to microorgani...

Страница 51: ...46 Appendix EN 15 Appendix 15 1 Test Log Date Tests Performed Results Comment Signature...

Страница 52: ...rt tube set 22 Inspection tests 28 Intended use 4 L Loading unloading scale while in operation 25 M Manufacturer s specification 28 O Only for U S operators 11 Open outer packaging 21 P Performing bas...

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