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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
Summary of Contents for Flosteady Arthroscopy Pump 200
Page 6: ......
Page 8: ...EN 18 Warranty and Service 47 19 Appendix 49 19 1 Test Log 49 Index 50 ...
Page 31: ...User Menu 25 EN User Menu Overview ...
Page 55: ...Appendix 49 EN 19 Appendix 19 1 Test Log Date Results Comment Signature ...
Page 58: ...DE 18 Garantie und Kundendienst 50 19 Anhang 52 19 1 Testprotokoll 52 Index 53 ...
Page 83: ...Anwendermenü 27 DE Übersicht zum Anwendermenü ...
Page 108: ...52 Anhang DE 19 Anhang 19 1 Testprotokoll Datum Ergebnis Bemerkung Unterschrift ...
Page 137: ...Menu de l utilisateur 27 FR Plan d ensemble ...
Page 161: ...Annexe 51 FR 19 Annexe 19 1 Procès verbal de tests Date Résultat Remarque Signature ...
Page 163: ...Index alphabétique 53 FR U Utilisation clinique 7 V Valeurs de mesure et tolérances 37 ...
Page 164: ......
Page 166: ...NL 18 Garantie en Klantenservice 50 19 Bijlage 52 19 1 Testprotocol 52 Index 53 ...
Page 191: ...Gebruikersmenu 27 NL Overzicht bij het gebruikersmenu ...
Page 216: ...52 Bijlage NL 19 Bijlage 19 1 Testprotocol Datum Resultaat Opmerking Handtekening ...
Page 218: ...54 Index NL Voorschrift van de fabrikant 33 38 Voorzorgsmaatregelen 13 ...
Page 220: ...PL 18 Gwarancja i obsługa klientów 49 19 Aneks 51 19 1 Protokół testowy 51 Skorowidz 52 ...
Page 245: ...Menu użytkownika 27 PL Przegląd menu użytkownika ...
Page 269: ...Aneks 51 PL 19 Aneks 19 1 Protokół testowy Data Wynik Uwagi Podpis ...
Page 271: ......