Hologic FluentPro Bedienungsanleitung Seite 16

1.2.2.2
English
Fluent Pro Fluid Management System
distention medium is used. Specifically, idiosyncratic anaphylactoid reactions have been
reported when using Hyskon as a distension fluid during hysteroscopy. These should
be managed like any allergic reaction.
Distention of the uterus may lead to a tear of the fallopian tube should there be an
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obstruction or permanent occlusion. The rupture could lead to distension fluid flowing
into the patient's peritoneal cavity, resulting in a fluid overload.
To avoid fluid overload, closely monitor the volume of distending fluid flowing into and
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out of the patient at all times. Fluid overload is associated with a risk of developing:
o Hyponatremia with its attending sequelae.
o Pulmonary edema resulting from fluid overload with isotonic fluids.
o Cerebral edema resulting from fluid overload and electrolyte disturbances with
hyperosmolar (nonionic) fluids such as glycine 1.5% and sorbitol 3.0%.
Ensure the patient's body temperature is monitored throughout the entire surgery.
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Continuous flow of distention fluids during hysteroscopic surgery can lead to a lowering
of the patient's body temperature. Low body temperatures can cause coronary and
cardiovascular problems. Longer operating times and the use of cold distension media
should be avoided.
• For your own safety and that of your patient, use only Fluent Pro accessories
referenced in Table 9: Disposables and Accessories.
The system is not explosion-proof. Do not use in an area where flammable anesthetic
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gases are present.
If a system defect is suspected or confirmed, do not use the system. Ensure the system
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is fully functional as described in Section 6.1, Annual Inspection.
Fluent Pro Procedure Kits are single use disposables. Do not re-use or reprocess any
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of the components contained within the single-use Procedure Kit. Re-use or
reprocessing of such components may result in infection or product failure due to material
degradation.
List of Precautions
Caution!
Do not sterilize or immerse the Fluent Pro Fluid Management System in disinfectant.
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Electrical safety testing should be performed by a biomedical engineer or other
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qualified person.
The Fluent Pro Fluid Management System requires special precautions regarding
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electromagnetic safety and needs to be installed and put into service according to the
electromagnetic safety information provided in this manual.
Portable and mobile RF communications equipment, including cellular telephones and
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other wireless devices, can affect medical electrical equipment. To avoid damage to or
malfunction of the system, do not operate communications equipment or cellular
telephones at a distance closer than specified in Section 6.4 Electromagnetic
Compatibility.
• Use of the Fluent Pro Fluid Management System adjacent to or stacked with other
equipment should be avoided because it could result in improper operation. If such use
is necessary, the Fluent Pro Fluid Management System and the other equipment
should be observed for proper operation before performing a procedure.
• This equipment is designed and tested to minimize interference with other electrical
equipment. However, if interference occurs with other equipment, it may be corrected
by one or more of the following measures:
Reorient or relocate this equipment, the other equipment, or both.
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o Increase the separation between the pieces of equipment.
o Connect the pieces of equipment into different outlets or circuits.
o Consult a biomedical engineer.
Introduction 3