Medical Vision Double Pump RF Operator's Manual
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Medical Vision Double Pump RF Operator's Manual

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  • Page 1 Operator’s Manual...
  • Page 2 Double Pump RF controls the Intra-Articular Pressure (IAP); not the pressure at the pump. The IAP is displayed on the pump display. The user can easily change the outflow/pressure settings during surgery, if needed. Double Pump RF supports interface connection to RF generators and most shaver systems.

  • Page 3: Table Of Contents

    Alarms and Warnings Principle of Operation System Care System Environmental Requirements Warnings, Precautions and Adverse Events 9-10 Equipment Disposal Warnings Surface Cleaning of Double Pump RF, Foot Controls and system Precautions devices Adverse Events Maintenance and Troubleshooting Controls and Indicators 11-13 Maintenance...
  • Page 4 This page is intentionally blank.

  • Page 5: Description, Indications For Use And Contraindications

    By controlling both inflow and outflow, the Double Pump RF accurately regulates pressure in the joint, and outflow from it. The Double Pump RF also provides suction when used in conjunction with a shaver and / or a RF generator.

  • Page 6: System Overview

    Connection Diagram Shaver control by use of the pump’s foot control. RF generator ArthroCare , Quantum 2 is used. ® 1 Double Pump RF 4 Shaver console 2 Mains Cable 5 Shaver Hand piece 3 Foot Control: 6 Shaver Interface Cable...
  • Page 7 Connection Diagram Shaver control by use of the shaver’s foot control or hand control. RF generator ArthroCare , Quantum 2 is used. ® 1 Double Pump RF 4 Shaver console 2 Mains Cable 5 Shaver Hand piece 3 Foot Control:...
  • Page 8 Connection Diagram Shaver control by use of the pump’s foot control. RF generator Stryker Serfas Energy is used. ® 1 Double Pump RF 4 Shaver console 2 Mains Cable 5 Shaver Hand piece 3 Foot Control: 6 Shaver Interface Cable...
  • Page 9 Connection Diagram Shaver control by use of the shaver’s foot control or hand control. RF generator Stryker Serfas Energy is used. ® 1 Double Pump RF 4 Shaver console 2 Mains Cable 5 Shaver Hand piece 3 Foot Control: 6 Shaver Interface Box...

  • Page 10: Principle Of Operation

    During Single mode, the Double Pump RF regulates the pressure using the Double Pump RF Day Cassette only. During double pump mode, the Double Pump RF controls the pressure and outflow using the Day and Patient Cassettes. For optimal performance in double pump mode, an Outflow Cannula is recommended. The Double Pump RF Day Cassette is connected to the sterile saline bags and the Irrigation Tubing.

  • Page 11: Warnings, Precautions And Adverse Events

    • The Double Pump RF is a Class I device with Type BF applied part, ensure that you are using only Medical Vision AB approved Interface Cables, Interface Boxes and RF cables when connecting to a Shaver and/or RF System. In the system configuration, the shaver hand piece shall comply with requirements for BF applied parts according to the standard IEC 60601-1.

  • Page 12: Adverse Events

    • To avoid risk of fire, only replace the fuses with the specified type and rating. • Avoid fluid contact with the Double Pump RF. In case of liquid spillage that results in a risk that liquid has entered the pump, it must be immediately turned off and mains cable removed. Contact a service technician authorized by Medical Vision AB.

  • Page 13: Controls And Indicators

    The green LED adjacent to the button will blink illuminate and blink when the pump is stopped and is ready in Standby and will be lit when the Double Pump RF is ‘On’. to Run. 10 Patient Cassette button...

  • Page 14: Signal Tones

    Controls and Indicators Controls and Indicators Rear Panel 13 On/Off Switch 17 Receptacle for RF Cable This switch turns the mains power On and Off. Note that the The RF cable shall be connected to this receptacle and the pump may be set in a standby mode with On/Standby but- Foot Control receptacle of the RF Generator, if used.

  • Page 15: Foot Control

    Two short tones: Rinse Mode is deactivated Adjustments for system devices If the Double Pump RF is part of a system as depicted in chapter “System Overview”, adjustments for the other devices shall be made according to specified procedures for those devices.

  • Page 16: Unpacking, Assembly And System Check

    4 -- 7. 7. If the shaver is to be controlled by the Double Pump RF an appropriate Shaver Interface Cable must be used. Refer to page 30 of this manual to select the right Shaver Interface Cable. Connect the Shaver Interface Cable (6) to the Shaver Interface Cable receptacle (19) on the rear panel of the Pump, and connect the other end to the foot control connector of the shaver console (4).

  • Page 17: Instructions For Use

    Double Pump RF Patient Cassette REF No. 1003059 must be used. This has a third suction port for the RF Probe. If a RF generator is not to be used, either a Double Pump RF Patient Cassette REF No. 1003059 or a Double Pump Patient Cassette REF No.

  • Page 18: Loading A Day Cassette

    Instructions for Use Loading a Day Cassette 1. Open the sterile package. The Day Cassette can be used for more than one patient during a whole operating day. Maximum use is eight hours. Use aseptic technique when opening the package. 2.

  • Page 19: Connecting The Irrigation Tubing/Single Tubing

    Instructions for Use Connecting the Irrigation Tubing/Single tubing 1. Use aseptic technique when opening the package. Sterile operator: Remove the Irrigation Tubing with check valve from the pouch for a Single tubing for Single mode, or from the package for a Patient Cassette (see below) for double pump mode.

  • Page 20: Loading A Patient Cassette For Double Pump Mode

    Instructions for Use Loading a Patient Cassette for double pump mode 1. Sterile operator: Remove the Patient Cassette from the package. Hold the Cannula, RF Probe and shaver tubing, and hand the cassette over to the non-sterile operator to load onto the pump. 2.
  • Page 21 SHAVER to the suction port of the shaver hand piece. If a shaver is not used, the tubing can remain disconnected. Connect the end of the tubing marked RF PROBE to the RF Probe. If a Double Pump RF Patient Cassette is used but a RF Generator is not used, this tubing can remain disconnected.

  • Page 22: Double Pump Rf Functions And Adjustments

    Cannula pedal will increase flow through the joint without increasing joint pressure. This feature is useful for eliminating The Double Pump RF will reset the procedure settings for the debris. The Display will indicate when Cannula function is last procedure to user default values for the next patient when active.

  • Page 23: Changing User Default Settings

    Changing User Default Settings When the Double Pump RF is turned on, user default settings will be set; per definition. Factory default settings are applied as user default settings when the Double Pump RF is delivered. These settings are based on experience and may be used as a guideline and are not intended to replace the experience and expertise of the user.

  • Page 24: Cassette Removal

    Unloading is verified in the Display. 5. Remove the spike(s) of the Day Cassette from the saline bag (s). 6. Discard the cassettes in accordance with local hospital procedures. 7. Turn off the Double Pump RF with the On/Standby button.

  • Page 25: Shaver Interface Instructions

    • Be sure you are using the correct Shaver Interface box when you are connecting the pump to a shaver The Double Pump RF needs to know when the shaver is controller. active for outflow control as described above.

  • Page 26: Alarms And Warnings

    The front visor is partially open, is not Display. closed. If this does not help, turn off pushed properly in place when installed, pump and contact your Medical Vision AB has a defective sensor for the front visor authorized representative. position or is defective.

  • Page 27: System Care

    System Environmental Requirements The Double Pump RF may be safely stored and transported at an ambient temperature range of -40°C (-40°F) to +70°C (+158°F), relative humidity between 10 and 85%, and atmospheric pressure of 500 hPa (7.2 psi) to 1060 hPa (15.3 psi).

  • Page 28: Maintenance And Troubleshooting

    Fuse Replacement The fuse holder is located on the back of the Double Pump RF in the fuse holder between the mains cable receptacle and the On/Off switch on the rear panel. To replace a fuse, turn off the power to the Pump and unplug the mains cable from the mains receptacle and at the rear of the Pump.

  • Page 29: Technical Specifications

    Only use certified fuse: e.g. CSA, ETL, or UL marked Pressure range 20-180 mmHg ± 10 mmHg Outflow range 0 – 600 ml/min ± 10 % Double Pump RF Dimensions Weight 18 kg (40.5 lbs) Height (front panel closed) 18.1 cm (7.1 inches) Width 47.1 cm (18.5 inches)

  • Page 30: Symbols Used

    Symbols used Symbols used - front Symbols used - rear Press to open/close pump pressure Name, Address and Country of arm for the Day Cassette Manufacturer Toggles the pump between On and Unit Serial Number Standby mode Reference number Activates/deactivates the Outflow Tracking function Caution, consult accompanying documents / Operator’s manual...

  • Page 31: Safety And Preventive Maintenance

    Safety and Preventive Maintenance Safety The Double Pump RF meets the requirements of the harmonised standard IEC 60601-1 (ed.3) and is classified as follows: • Type of protection against electrical shock: Class I equipment • Applied part type BF. Degree of protection against harmful ingress of water: •...

  • Page 32: Ordering Information

    For connection to RF generator ArthroCare , Quantum 2 ® 1402007 RF Cable A2 Stryker Serfas Energy ® Double Pump RF Shaver Interface Boxes and Compatible with Cables 1407200 Interface Box B1 ConMed-Linvatec Advantage D3000: Red shaver port. 1407201 Interface Box B2 S&N Dyonics Power;...

  • Page 33: Customer Service

    Warranty Information The Double Pump RF and Foot Control are warranted for one year from the date of shipment to the original purchaser. Any component of the system, which develops defects resulting from defective material or workmanship during this time period will be replaced or repaired without charge.

  • Page 34: Manufacturer's Declaration On Electromagnetic Interference

    The Double Pump RF is intended for use in normal domestic and hospital environments. The Double Pump RF uses RF energy for its internal function. Therefore, its RF emission is very low and is not likely to cause interference with nearby electronic equipment.
  • Page 35 Supply frequency magnetic field must be the same 3 A/m 3 A/m 50 Hz frequency as hospital or commercial environment. For further details please contact Medical Vision AB or your local Medical Vision AB representative. Manufactured by: Medical Vision AB Hästholmsvägen 32 SE-131 30 NACKA...
  • Page 36 The Double Pump RF and its disposables are covered by Swedish patents SE529738 and SE526008, European Patent Application 07748355, EPO patent 2265944, Japanese patent JP5623383, US Patents US746547, US7661582, US7981073, US8411266, US8608682, US8746547, USD721801, USD773037 and D745963, European Community design registrations EM001635657-0001, EM001601824-0001 and EM001528464-0001, and other utility-, design-, continuation patents and patent applications in different geographical areas;...

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