Device Purpose; Application Scope - Stryker Flosteady Manual Del Usuario

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Device Purpose

3.1

Application Scope

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.
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.
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.
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:
Knee joint
Shoulder joint
Hip joint
Small joint
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.
When performing monopolar electrosurgery, only non-conductive irrigation flu-
ids may be used. Examples include glycine, sorbitol, mannitol, sorbitol plus man-
nitol, and dextran.
45 mm Hg
50 mm Hg
40 mm Hg
35 mm Hg
Device Purpose
Intended use
Contraindications
Pressure and flow regulation
Recommended pressure and flow ranges
Clinical use
EN
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