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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; all of these owned by or licensed to Medical Vision

AB.

SmartVision

is a registered trademark of Medical Vision

AB.

Valid from software version 3.0.1.

Doc ID: L-2012-013-10_EN
Date of issue: 2017-09-13

mechanical means without permission in writing from Medical Vision

AB, SWEDEN.

Содержание Double Pump RF

Страница 1: ...Operator s Manual ...

Страница 2: ...them When engaged the SmartVision function automatically controls flow through and pressure in the joint to obtain maximum visibility 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 DoublePumpRFsupportsinterfaceconnectiontoRFgeneratorsandm...

Страница 3: ...uide 26 The Pump does not power up after the power switch is set to On 26 Fuse Replacement 26 Replacement of the front visor 26 Error Codes 26 Symbols used 28 Symbols used front 28 Symbols used rear 28 Symbols used packaging 28 Controls and Indicators 11 13 Controls and indicators 11 Signal Tones 12 Foot Control 13 Adjustments for system devices 13 Unpacking Assembly and System Check 14 Unpacking ...

Страница 4: ...2 This page is intentionally blank ...

Страница 5: ...tte for handling aspiration of liquid from the joint through an outflow cannula shaver hand piece or RF Probe It comprises a cuvette with reflector for detecting blood and debris emerging from the joint Double Pump Patient Cassette Patient Cassette A disposable cassette for handling aspiration of liquid from the joint through an outflow cannula or shaver hand piece not RF Probe It comprises a cuve...

Страница 6: ...r ArthroCare Quantum 2 is used Connection Diagram 4 Shaver console 5 Shaver Hand piece 6 Shaver Interface Cable 7 RF Generators Foot Control 8 RF Generator 9 RF Cable A1 10 RF Probe 1 Double Pump RF 2 Mains Cable 3 Foot Control a Shaver Reverse b Shaver Forward c Cannula d Rinse ...

Страница 7: ...s used Connection Diagram 4 Shaver console 5 Shaver Hand piece 6 Shaver Interface Box 7 Shaver Foot Control 8 RF Generators Foot Control 9 RF Generator 10 RF Cable A1 11 RF Probe 1 Double Pump RF 2 Mains Cable 3 Foot Control A 4 pedal or 2 pedal Foot Control may be used a Shaver Reverse b Shaver Forward c Cannula d Rinse ...

Страница 8: ...r Stryker Serfas Energy is used Connection Diagram 4 Shaver console 5 Shaver Hand piece 6 Shaver Interface Cable 7 RF Generators Foot Control 8 RF Generator 9 RF Cable A2 10 RF Probe 1 Double Pump RF 2 Mains Cable 3 Foot Control a Shaver Reverse b Shaver Forward c Cannula d Rinse ...

Страница 9: ...s used Connection Diagram 4 Shaver console 5 Shaver Hand piece 6 Shaver Interface Box 7 Shaver Foot Control 8 RF Generators Foot Control 9 RF Generator 10 RF Cable A2 11 RF Probe 1 Double Pump RF 2 Mains Cable 3 Foot Control A 4 pedal or 2 pedal Foot Control may be used a Shaver Reverse b Shaver Forward c Cannula d Rinse ...

Страница 10: ... liquid from the joint into a waste container The Double Pump RF has the SmartVision feature SmartVision will detect blood and or debris when it emerges from the joint It will automatically elevate pressure into the joint and outflow when blood is detected or elevate outflow from the joint when debris is detected SmartVision can be disabled if desired The pump also has an Outflow Tracking feature ...

Страница 11: ...or to performing any procedure Evaluate patients for predisposing medical conditions that may become aggravated by the stress of surgery Use only high flow inflow arthroscope sheaths with the Double Pump RF to avoid risk of loss of distension When instruments and accessories from different manufacturers are employed together in a procedure verify compatibility prior to initiation of the procedure ...

Страница 12: ...the Patient Cassette If this occurs the debris should be put into motion by the non sterile personnel by tapping the cassette A temporarily increase in the outflow by pressing the Cannula Pedal or increasing the shaver delay should be favorable in the occurrence of accumulated debris Do not immerse the pump shaver interface boxes or any cables in liquid If the Double Pump RF is taken out of servic...

Страница 13: ...tions alarm situ ations pressure and outflow values 7 Flow Suction increase decrease buttons These buttons adjust the outflow settings through an out flow cannula shaver hand piece and RF probe A flow adjust ment is only relevant in double pump mode as it refers to the outflow through the Patient Cassette 8 SmartVision button This button activates deactivates the SmartVision function The green LED...

Страница 14: ...le The RF cable shall be connected to this receptacle and the Foot Control receptacle of the RF Generator if used 18 Equipotential Connection This connection can be used for potential equalization 19 Shaver Interface Cable Receptacle The shaver Interface Cable shall be connected to this recep tacle The cable shall also be connected to the foot control receptacle on the shaver console 20 Shaver Int...

Страница 15: ...ate counter clockwise Shaver Forward Pedal The second black pedal activates a shaver system that is connected with a Shaver Interface Cable The shaver blade will rotate clockwise Shaver Oscillate Pressing Reverse and Forward simultaneously will initiate the oscillating mode of the shaver Cannula Pedal The blue pedal activates the Cannula function of the pump while depressed Rinse Pedal The red ped...

Страница 16: ...e 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 A 4 pedal Foot Control REF No 1404176 must be used 8 If the shaver having a finger controlled hand piece is to control the Doub...

Страница 17: ...make sure that the expiry date not has been passed If it has the sterility and or the function cannot be guaranteed The procedure selection menu provides four options for joint type 1 Shoulder 2 Knee 3 Hip 4 Small Joint i e wrist elbow and anklejoints Eachoftheseproceduretypeshasspecificuserdefaultsettingsforpressure outflow shaversuctionandSmartVision Outflow Tracking on off Changing the user def...

Страница 18: ...etely over the pump wheel Stretch the tubing by pulling the cassette to the right Press the left side of the cassette in place first and then fit the right side by pressing it firmly in place Push each corner of the Cassette to ensure correct fitting The green LED light beside the Day Cassette button will blink when the Day Cassette is correctly positioned in the pump 2 Remove the cassette with tu...

Страница 19: ...erator Close the red clamp on the Irrigation Tubing and hand over the proximal end end with blue cap of the tubing to the non sterile operator 6 Non sterile operator If present from a previous procedure that day remove the used check valve from the Day Cassette 7 Non sterile operator Remove the blue cap from the Irrigation Tubing and connect the blue Luer connector to the transparent female Luer l...

Страница 20: ...If the LED is still blinking press Patient Cassette button again and ensure that the cassette has clicked in place by pressing the four corners of it 2 Non sterile operator Open the front visor of the Pump with both hands 3 Push the cassette tubing loop of the right hand pump straight in as illustrated 4 Fit the pump tubing completely over the pump wheel Stretch the tubing by pulling the cassette ...

Страница 21: ...he Pressure increase decrease buttons and the Flow increase decrease buttons Flow adjustment is only relevant if a Patient Cassette and an outflow cannula is being used double pump mode as the Flow settings refer to the outflow from the joint as controlled with the Patient Cassette Pressure can be set to 20 180 mmHg Outflow can be set to 0 600 ml min but will be reduced at high pressures Starting ...

Страница 22: ... lower right Soft Key will activate the Rinse mode for 120 seconds Rinse mode will increase the pressure in the joint in Single mode and also the outflow from the joint in double mode The pressure increase and outflow is delayed after Rinse activation The delays can be adjusted in Extended Setup factory setting is 0 delay for pressure and 2 seconds for outflow to avoid pressure drop This feature i...

Страница 23: ... On Off Knee 70 100 250 On Off Hip 100 130 250 On Off Small Joint 70 50 250 On Off Changing User Default Settings WhentheDoublePumpRFisturnedon userdefaultsettingswillbeset perdefinition Factorydefaultsettingsareappliedasuser 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...

Страница 24: ...ching them with the lever by the cassette and by pulling the cassette out and away from the pump 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 Cassette removal 1 Stop the pump with Run Stop and close all clamps on the ca...

Страница 25: ... console and starts the shaver in forward or reverse rotation or oscillating mode Shaver functions are activated by the 4 pedal foot control 3 with the following functions Left black pedal 3a Reverse Right black pedal 3b Forward Both black pedals Oscillating The shaver may be controlled by foot control of the shaver console or by fingertip control of the shaver hand piece The Double Pump RF needs ...

Страница 26: ... the acoustic tone is muted Check the saline bag and replace the bag if empty Check for kinked tubing or closed clamps by the spikes Press Run Stop button to continue High Pressure Warning The pressure in surgical site exceeds 250 mmHg This may occur if the outflow is obstructed and the joint is bent by the surgeon Acoustic tone sounds The pump stops To mute for one minute press Soft Key M High Pr...

Страница 27: ...Pump RF contains electronic printed circuit board assemblies and should not be disposed in any waste container It should be disposed of in accordance with any applicable national or institutional policies relating to obsolete electronic equipment Contact your Medical Vision AB representative for return of Double Pump RF for proper disposal Discard the disposables in accordance with local hospital ...

Страница 28: ...Double Pump RF If a fuse breaks again disconnect all power to the Double Pump RF and contact your Medical VisionAB representative If the front visor is cracked or broken it shall be replaced To do so open it fully grasp firmly at the hinges and pull it straight out Fit the new front visor as illustrated on page 14 If the Double Pump RF detects a technical failure a continuous two tone alarm is gen...

Страница 29: ...re 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 Length 39 7 cm 15 5 inches Mains Cable Length 3m 10 ft Foot Control Foot Control Cable Length 3m 10 ft Interface Cable for Shaver Optional For different shaver systems length 2m 6 5ft Shaver Interface Box Optional For diff...

Страница 30: ...er Interface Box Receptacle for Shaver Interface Cable Receptacle for RF Cable Serial communications port used for service only Tone volume control Caution Federal law restricts this device to sale by or on the order of a physician Symbols used front Symbols used packaging Symbols used rear Press to open close pump pressure arm for the Day Cassette Toggles the pump between On and Standby mode Acti...

Страница 31: ... requirements of IEC 60601 1 spillage of a liquid on the pump does not wet parts which may cause a safety hazard Foot Controls meet requirements of IEC 60601 1 watertight construction IPX8 Equipment is not suitable for use in the presence of a flammable anesthetic mixture Mode of operation capable of continuous operation An annual preventive maintenance of the Double Pump RF is required to assess ...

Страница 32: ...I 1407204 Interface Box B5 Stryker TPS 12K B BF Core Biomet Arthrotek PowerTek II Plus 1407205 Interface Box B6 FMS Duo Atlantech Revolution Arthrex APS II 1407208 Interface Box B10 Eberle C2 1407250 Interface Cable C1 ConMed Linvatec Advantage D3000 1407251 Interface Cable C2 S N Dyonics Power S N Dyonics Power II 1407254 Interface Cable C5 Arthrex APS II 1407255 Interface Cable C6 FMS Duo Atlant...

Страница 33: ...ship during this time period will be replaced or repaired without charge PLEASE NOTE Warranty is void if the Double Pump RF is shipped in any other transportation box case than those provided by Medical Vision AB All questions or concerns related to the quality reliability and or durability of this product should be directed to a Medical Vision AB representative Please contact your Medical Vision ...

Страница 34: ...P 1 2 where P maximum output nominal power of the transmitter Watts d separation distance meters Radiated Radio frequency 10 V m 26 MHz 1 GHz 3 V m 1GHz 2 5GHz 10 V m 3 V m d 0 35 P 1 2 from 80 MHz to 800 MHz d 0 7 P 1 2 from 800 MHz to 1 GHz d 0 7 P 1 2 from 1 GHz to 2 5 GHz where P maximum output nominal power of the transmitter Watts d separation distance meters The Double Pump RF is intended f...

Страница 35: ...ironment Supply voltage interruptions and supply voltage variation level 5 Ut 95 interruption for 0 5 cycles 40 Ut 60 interruption for 5 cycles 70 Ut 30 interruption for 25 cycles 5 Ut 95 interruption for 5 seconds 5 Ut 95 interruption for 0 5 cycles 40 Ut 60 interruption for 5 cycles 70 Ut 30 interruption for 25 cycles 5 Ut 95 interruption for 5 seconds Mains supply quality has to be typical of h...

Страница 36: ...635657 0001 EM001601824 0001 and EM001528464 0001 and other utility design continuation patents and patent applications in different geographical areas all of these owned by or licensed to Medical Vision AB SmartVision is a registered trademark of Medical VisionAB Valid from software version 3 0 1 Doc ID L 2012 013 10_EN Date of issue 2017 09 13 2017 Copyright Medical VisionAB All rights reserved ...

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