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Instructions For Use
Motus GI Medical Technologies LTD.
Keren Hayesod 22,
Tirat Carmel, 3902638
Israel
Tel +972 73 2627757
Fax +972 4 6214442
Pure-Vu® and Motus GI® are trademarks or registered trademarks of
Motus GI Holdings, Inc. © 2021
LOW
Motus GI Holdings, Inc.
1301 E. Broward Blvd., Suite 310
Fort Lauderdale, FL, 33301
United States
Tel 1 844 PUREVU1 (787-3881)
Fax 1 954 541 8265
MED
HIGH
ERROR

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Summary of Contents for Motus PURE-VU

  • Page 1 Fort Lauderdale, FL, 33301 Israel United States Tel +972 73 2627757 Tel 1 844 PUREVU1 (787-3881) Fax 1 954 541 8265 Fax +972 4 6214442 Pure-Vu® and Motus GI® are trademarks or registered trademarks of Motus GI Holdings, Inc. © 2021...
  • Page 2: Table Of Contents

    3.1.1. Pure-Vu Workstation Components ................3.1.2. Front Panel ........................3.1.3 Foot Pedal ........................3.2. Pure-Vu Disposable Kit ........................ 3.3. Accessories for Use with Pure-Vu System ................SETUP AND INTERCONNECTIONS ..................... 4.1. Unpacking ............................4.1.1. Unpacking the Disposables ..................4.1.2. Unpacking the Workstation ..................
  • Page 3: Warnings And Precautions

    “Operating the Pure-Vu Workstation”. • The Pure-Vu System shall never be stored in areas where the unit could get wet or be exposed to high temperature, humidity, direct sunlight, dust, salt, which could adversely affect the equipment.
  • Page 4: Symbols Used

    Serial number INTENDED USE The Pure-Vu System is intended to connect to standard or slim colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
  • Page 5: Product Description

    PRODUCT DESCRIPTION The Pure-Vu System enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up debris.
  • Page 6: Pure-Vu Workstation

    Irrigation Pump (Blue Markers) On/Off Power Button Cleansing Mode Indicators (Low / Med / High) Main Connector Error Light Foot Pedal Connector Fluid Button Power Cord Status Light Main Power Switch Drain Button MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 7: Pure-Vu Workstation Components

    • Error Light (Triangle) - turns red when there is non-recoverable system error where the Workstation stops its operation automatically MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 8: Foot Pedal

    3.1.3. Foot Pedal The Foot Pedal allows the physician to select the operating modes during the procedure. The operating modes are as follows (Figure 3: Pure-Vu Foot Pedal Unit): • Cleanse – simultaneous irrigation and suction, activated by the right foot pedal •...
  • Page 9: Pure-Vu Disposable Kit

    1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. Once mounted over the colonoscope the effective outer diameter is less than 22mm. The Pure-Vu Oversleeve consists of a single irrigation channel and a single suction channel which is also used for in-line pressure sensing. The Oversleeve allows for proper connection to the colonoscope.
  • Page 10: Assembly Of The Oversleeve To The Workstation

    Remove the Oversleeve from the tray. To load the Oversleeve onto the colonoscope complete the following steps: FIGURE 4: Secure colonoscope control body onto a scope holder or solid surface. FIGURE 5: Push plunger at the top of the loading handle into body of loading handle. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 11 (cont...) FIGURE 6: Remove and discard the clear plastic handle insert from the outer loading handle shell. FIGURE 7: Lubricate the distal end of the colonoscope with a lubricating jelly or like substance. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 12 FIGURE 9: Align the arrow to the working channel of the colonoscope and advance the distal portion of the colonoscope through the Pure-Vu oversleeve distal head all the way until it reaches the stopper. Make sure that the colonoscope is aligned with the distal flexible head by looking through the small window of the plunger. Ensure the colonoscope’s working/biopsy channel is aligned above the suction channel of the Pure-Vu Oversleeve as shown.
  • Page 13 4.2.1. Oversleeve Assembly (cont...) FIGURE 10: Remove plunger from loading handle and discard. FIGURE 11: Rotate the white collar counter clockwise from the loading handle body to unlock, remove and discard. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 14 FIGURE 12: Remove blue outer shell of loading handle and discard. FIGURE 13: Detach root brace clamp from top of loading handle and guide it up the length of the colonoscope toward the control body trying to keep the tube straight and untangled. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 15 4.2.1. Oversleeve Assembly (cont...) FIGURE 14: Gently grab the Pure-Vu oversleeve distal head in one hand and roll back the oversleeve sheath over the entire length of the colonoscope insertion tube with the other hand. FIGURE 15: Attach oversleeve sheath collar to the Pure-Vu oversleeve root brace clamp by placing the collar hook over the peg of the clamp.
  • Page 16 4.2.1. Oversleeve Assembly (cont...) FIGURE 16: Remove oversleeve sheath cover and discard. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 17: Attaching The Umbilical Section To The Workstation

    (E) marked with a single black and double blue lines aligning the black line of tubing with black line on pump head and blue lines on pump head to blue lines on tubing. Then close the suction pump head. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 18: Attaching The Oversleeve To The Umbilical Section

    4.2.3. Attaching the Oversleeve to the Umbilical Section FIGURE 19: Connect the Oversleeve to the Umbilical Section by the inline connector (A to B). Attach the inline connector clip to the colonoscope Umbilical Section (C to D). MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 19: System Operation

    For Auto Priming the system before the procedure, simply press the Fluid button. Its LED will blink in Blue and after determining the Pure-Vu System is ready for use, apply a water-based lubricant (as used in standard colonoscopy procedures) to the distal section of the Oversleeve just before the procedure begins.
  • Page 20: Disassembling The Umbilical Section And Oversleeve

    Workstation by depressing the main connector button (I). Disconnect the suction tubing from the waste container or waste bag (J). Discard irrigation bag or bottle, waste container or bag and tubing per facility protocol. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 21: Removing The Oversleeve From The Colonoscope

    FIGURE 21: Place the colonoscope (A and C) in the bottom of a basin (B) or sink in large circle(s). Disconnect the Oversleeve sheath collar from the Pure-Vu oversleeve root brace clamp by disconnecting the collar hook from the peg of the clamp.
  • Page 22: Discarding The Disposables

    (refer to Section 9.0 TECHNICAL SPECIFICATIONS). This equipment should never be installed or used in the presence of flammable or explosive gases or chemicals. The Pure-Vu Workstation should never be installed, used or transported in an inclined position nor should it be subjected to impact or vibrations.
  • Page 23: Troubleshooting

    • Verify that the Oversleeve suction port tip is not positioned against the colon wall. If so, direct the scope tip away from the wall. *If the above does not remedy the warning indication, contact a Motus GI representative. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 24: Technical Specifications

    Pressure Vacuum Up to (-) 0.5 Bar 9.4. Mechanical Properties and Sizes Following are the mechanical properties and size for the Pure-Vu Workstation: Workstation 250mm x 400mm x 280mm Dimensions [W x D x H] [10in x 15.7in x 11in] Weight 12kg (26.5lbs)
  • Page 25 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 26 Motus GI Holdings, Inc. 1301 E. Broward Blvd. Pure-Vu® and Motus GI® are trademarks or registered trademarks of Suite 310 Motus GI Holdings, Inc. ©2022 Fort Lauderdale, FL 33301 Tel: 1.800.PUREVU1 (787-3881) IU00008 Rev. A Fax: 1.954.541.8265 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...

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