MultiPlex II Controller with Variable Viscosity QUICK START GUIDE. For further information, please refer to the operating instructions

Transcription

1 MultiPlex II Controller with Variable Viscosity QUICK START GUIDE For further information, please refer to the operating instructions

2 CONTENTS Part 1 Set up the MultiPlex II Controller with Variable Viscosity (MPII VV) Part 2 Stopping and starting cement delivery Part 3 Turning off the MPII VV Part 4 Troubleshooting Page 2

3 MultiPlex II Controller REF SN SET UP THE MPII VV 3610 MPC MultiPlex II Controller REF SN 3610 MPC DATA 1. Insert the power cable of the MPII VV into the socket. DATA MultiPlex II Controller REF SN 3610 MPC FAULT WARNING RF ON FAULT WARNING RF ON DATA MultiPlex II Controller REF 3610 SN MPC FAULT WARNING RF ON DATA FAULT WARNING RF ON Page 3

4 SET UP THE MPII VV 2. Turn on the MPII VV by pushing the button on the backside of the back panel. MultiPlex II Controller REF 3610 SN MPC = OFF = ON DATA Page 4

5 SET UP THE MPII VV 3. Toggle between Fahrenheit or Celsius, if needed (selection will be remembered upon next start up). Select Temperature Range C C Toggle Fahrenheit or Celsius by pressing top button Select Temperature Range F F Toggle Fahrenheit or Celsius by pressing top button Page 5

6 SET UP THE MPII VV 4. Choose the proper temperature range and Confirm the temperature range selection. Select Temperature Range F F Select temperature range... Select Temperature Range F...If range selection is correct, press Confirm Page 6

7 SET UP THE MPII VV 5. Choose the viscosity level and Confirm the viscosity selection. Select Viscosity 20 High Low Toggle High or Low... Select Viscosity High...once desired viscosity is selected, press Confirm Note Viscosity can be changed during cement delivery Page 7

8 SET UP THE MPII VV 6. Connect the Hand Switch cable. Viscosity High Align black line on cable connector with black dot on Controller Page 8

9 SET UP THE MPII VV 7. Connect one end of the Activation Element (AE) cable to the MultiPlex II Controller and the other end to the Activation Element. Viscosity 20 High Align black line on cable connector with black dots on Controller and Activation Element Page 9

10 SET UP THE MPII VV 8. Once de-aired, connect the Hydraulic Syringe to the MultiPlex II Controller by pushing and turning clockwise. De-air Hydraulic Syringe prior to inserting into Controller MultiPlex II Controller REF 3610 SN MPC MultiPlex II Controller REF SN 3610 MPC Insert the Hydraulic Syringe into the Controller... DATA Viscosity 20 High DATA FAULT FAULT WARNING RF Page 10 RF ON ON FAULT DATA WARNING WARNING RF ON...and rotate clock-wise to secure.

11 SET UP THE MPII VV 9. Press the Timer button ( ) after saturating the cement to start the cement mixing time. The cement timer can be started prior to attaching cables and Hydraulic Syringe. Viscosity 20 High Page 11

12 SET UP THE MPII VV 10. The cement is polymerizing while the white bar is visible. Viscosity 20 High Page 12

13 SET UP THE MPII VV 11. Caution When the blue bar is visible, remove the funnel and filter from the Cement Syringe. Wipe to remove any excess cement. The cement is polymerizing and is not ready to be delivered. Viscosity 20 High Page 13

14 SET UP THE MPII VV 12. a) To de-air the hydraulic line keep the purge button ( ) on the MultiPlex II Controller pressed until the first drops of water emerge. b) Connect the Cement Syringe to the AE. c) Connect the Master Syringe to the Cement Syringe. d) Confirm that the cement has emerged from the AE. e) Press and hold the purge button ( ) until cement emerges from the AE. Viscosity 20 High Page 14

15 SET UP THE MPII VV 13. Green Bar = Go When the green bar is visible, the cement is ready to be delivered. Press and release the blue button on the Hand Switch cable. When cement emerges from the AE press and release the blue button again and wipe prior to connecting the locking delivery cannula (LDC) to the AE. Green bar may be visible at 1000 depending on temperature range selection Viscosity 20 High Page 15

16 STARTING AND STOPPING CEMENT DELIVERY 1. To start and stop cement delivery, press and release the blue button on the Hand Switch cable.! To avoid cement clogs, any time cement delivery must be stopped for periods longer than 60 seconds, remove the LDC from the Working Cannula and deliver a small amount of cement. Page 16

17 STARTING AND STOPPING CEMENT DELIVERY 2. To restart cement delivery, press and release the blue button on the Hand Switch cable again. Page 17

18 TURNING OFF THE MPII VV 1. Press the RETRACT button ( ) to retract the hydraulic piston and press the ENTER button ( ) to confirm. Viscosity 20 Low Press RETRACT...?...and CHECK MARK to confirm Page 18

19 TURNING OFF THE MPII VV 2. To remove the Hand Switch cable, pull (do not rotate) the plug connection from the socket on the Controller. Viscosity 20 Low Page 19

20 TURNING OFF THE MPII VV 3. To remove the Hand Switch cable, pull (do not rotate) the plug connection from the socket on the Controller. Viscosity 20 Low Page 20

21 TURNING OFF THE MPII VV DATA 4. The Hydraulic Syringe can be removed by turning it counterclockwise and pulling. FAULT WARNING RF ON Turn counterclockwise... Viscosity 20 Low FAULT WARNING RF ON MultiPlex II Controller REF SN 3610 MPC then remove. DATA DATA FAULT WARNING RF ON Page 21

22 TURNING OFF THE MPII VV 5. Turn off the MultiPlex II Controller using the toggle switch on the back panel of the device. MultiPlex II Controller REF 3610 SN MPC = OFF = ON DATA Page 22

23 TROUBLESHOOTING 1. If the MultiPlex II Controller displays error code 36 (ERROR_TEMP - on board temperature sensor fails during power on self test) during power-up, turn off the system and get the MultiPlex II Controller to within operating temperature range. 2. An acoustic signal indicates that there has been an increase in pressure within the system and will sound when four bars are shown on the display. Viscosity 20 Low RF Page 23

24 TROUBLESHOOTING 3. If there are four bars on the display, be aware that the pressure limit is approaching however, cement can still be delivered. If it is determined that there is an obstruction, press the blue button on the Hand Switch to stop cement delivery. Wait 5 seconds for the hydraulic shaft to pull back relieving pressure and reposition the Locking Delivery Cannula before resuming cement delivery. Viscosity 20 Low RF Page 24

25 StabiliT Vertebral Augmentation System Risks and Indications The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT Bone Cement in vertebral augmentation (kyphoplasty) procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). As with most surgical procedures, kyphoplasty procedures using the StabiliT System (also called Radiofrequency-Targeted Vertebral Augmentation, or RF-TVA) involve risks, some of which may be serious or even fatal. Patients undergoing RF-TVA are subject to risks associated with surgery including, but not limited to, complications from anesthesia/sedation as well as bleeding, bruising, pain, infection, blood clots, myocardial infarction, cardiac arrest, stroke, pulmonary embolism, as well as damage to normal tissue, nerves, the spinal cord or other structures, which could result in injuries, including paralysis. Not every patient is a good candidate for RF-TVA. The StabiliT System is contraindicated for patients with coagulation disorders, severe pulmonary insufficiency, and certain spinal conditions, or patients who are sensitive to components of StabiliT Bone Cement. Please review the Instructions for Use for a more detailed description of risks and contraindications. Merit Medical Systems, Inc West Merit Parkway South Jordan, Utah MERIT Merit.com Merit Medical Europe, Middle East, & Africa (EMEA) Amerikalaan 42, 6199 AE Maastricht-Airport The Netherlands Merit Medical Ireland Ltd. Parkmore Business Park West Galway, Ireland +353 (0) Austria Belgium (Dutch) (Français) Denmark Finland France Germany Ireland (Republic) Italy Luxembourg Netherlands Norway Portugal Russia Spain Sweden Switzerland (Deutsch) (Français) (Italiano) UK /A ID Merit Medical Systems, Inc. All Right Reserved.

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