Stryker Flosteady Arthroscopy Pump 200, Руководство пользователя

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Device Purpose
7
EN
3 Device Purpose
3.1 Application Scope
Intended use The FLOSTEADY Arthroscopy Pump (Model 200) is intended to provide fluid dis-
tention and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cav-
ities during diagnostic and operative arthroscopic procedures.
Contraindications Use of this device to inject fluid into a joint is prohibited whenever arthroscopy is
contraindicated. Refer to your endoscope's manual for absolute and relative con-
traindications.
Arthroscopy is contraindicated in the following cases:
• Ankylosis
• Inflammation or bacterial contamination
The device may not be used to inject medication.
The device is not designed or intended for use with gas.
Pressure and flow regulation The user can select the desired joint pressure.
The pump attempts to reach and maintain the preset pressure in the joint by sup-
plying irrigation fluid. If the joint cannot be drained (e.g. because closed valve at
instrument), and if the pre-selected pressure has been reached, the pump reduc-
es the influx of fluid and attempts to maintain the preset pressure. If the intra-
articular pressure falls below the selected value, fluid automatically continues to
be supplied.
Recommended pressure and flow ranges The nominal pressure can be preset to between 15 and 200 mm Hg. The preset
pressure should be based on the average blood pressure of the patient to prevent
bleeding in the joint. The manufacturer recommends the following pressure set-
tings for the following application areas:
Each surgery and each patient require different parameters. The values indicated
by the manufacturer are therefore only recommendations and are not intended
to substitute or replace the expertise of the surgeon.
The max. flow can be preset to between 0.1 and 3.0 l/min. The flow is secondary
to the pressure and is automatically reduced by the pump once the nominal pres-
sure has been reached.
Clinical use When performing monopolar electrosurgery, only non-conductive irrigation flu-
ids may be used. Examples include glycine, sorbitol, mannitol, sorbitol plus man-
nitol, and dextran.
Knee joint 45 mm Hg
Shoulder joint 50 mm Hg
Hip joint 40 mm Hg
Small joint 35 mm Hg