Hologic AQL-100, Инструкция по эксплуатации и руководство оператора

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10
Purpose of the System
EN
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. Conversely, when employing high disten-
sion pressures, the deactivation of the MyoSure® or other morcellator system
can lead to pressure spikes that can exceed 150 mmHg. These situations may oc-
cur for a short time as the system automatically adjusts the flow rate to return
to the set intrauterine pressure.
CAUTION!
The system may only be connected with hysteroscopes designed for and featur-
ing the technical specification permitting such a combined use. Any utilized hys-
teroscopes must comply with the most recent versions of EC 60601-2-18 and
ISO 8600.
CAUTION!
Electrical Interference: (See Chapter 11, Guidelines and manufacturer's state-
ment - 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 in-
terference, please follow these suggestions:
• Move the Aquilex System, the other device, or both devices to a different loca-
tion
• 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 Description of the Aquilex Fluid Control System
Technical application scope of the 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 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 in-
tegrating the pressure chamber into the tubing system. The pressure chamber
transmits the irrigation fluid pressure to the electronics of the device via a pres-
sure sensor. The pressure control circuit continuously compares the desired pre-
set 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.