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Motus GI Medical Technologies LTD.
Address: Keren Hayesod 22,
Tirat Carmel, ZIP 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. © 2019
Motus Pure-Vu
Instructions For Use
LOW
MED
HIGH
ERROR
Motus GI Holdings, Inc.
Address: 1301 E. Broward Blvd.
Suite 310
Fort Lauderdale, FL 33301 US
Tel: 1.844.PUREVU1 (787-3881)
Fax: 1.954.541.8265
System
®
SYS TEST
STATUS
DRAIN
EC REP
OBELIS S.A
Address: Bd. Général Wahis, 53,
1030 Brussels, Belgium
Tel: +32.2.732.59.54
Fax: +32.2.732.60.03
E-mail: mail@obelis.net
www.obelis.net

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Summary of Contents for Motus GI Pure-Vu System

  • Page 1 Tirat Carmel, ZIP 3902638, Israel Fort Lauderdale, FL 33301 US Tel: +32.2.732.59.54 Tel: +972.73.2627757 Tel: 1.844.PUREVU1 (787-3881) Fax: +32.2.732.60.03 Fax: +972.4.6214442 Fax: 1.954.541.8265 E-mail: mail@obelis.net www.obelis.net Pure-Vu® and Motus GI® are trademarks or registered trademarks of Motus GI Holdings, Inc. © 2019...
  • Page 2: Table Of Contents

    3.1.1. Workstation Components:................... 3.1.2. Workstation Front Panel ..................... 3.1.3 The Foot Pedal ........................ 3.2. Pure-Vu Oversleeve ........................3.3. Accessories for Use with the Pure-Vu System ..............SETUP AND INTERCONNECTIONS ..................... 4.1. Unpacking ............................4.1.1. Unpacking the Disposable Kit ..................4.1.2. Unpacking the Workstation and Loading Fixture ..........
  • 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

    1.1. Symbols Used The Pure-Vu System has a safety warning and compliance label located on the Workstation, Loading Fixture, and Disposable Kit. For a definition of individual symbols, see table below: SYMBOL DESCRIPTION FDA (USA) law restricts this device to sale by or on order...
  • 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 – 13.3mm (slim) and 12.8mm – 13.7mm (standard). The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces.
  • Page 6: System Workstation

    Cleansing Mode Indicators (Low / Med / High) Power Button Error Light Main Connector System Test Button Foot Pedal Connector Status Light Power Cord Drain Button Main Power Switch Suction Pump (Green) Suction Tubing Clamp MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 7: Workstation Components

    Status Light - indicates status of the system; green light means ready to go and orange light indicates recoverable error with the setup, the irrigation bag is empty or the end of drain routine • Error Light (Triangle)- turns red when there is non-recoverable system error MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 8: The Foot Pedal

    Cleansing Mode Selector – activated by the right button. User can toggle between three cleansing modes; low, medium (default mode) and high Manual Purge Cleansing Mode Selector Suction Cleansing FIGURE 3: Pure-Vu Foot Pedal Unit MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 9: Pure-Vu Oversleeve

    Umbilical Section. The Umbilical Section connects the Pure-Vu Oversleeve to the Workstation via the main connector. 3.3. Accessories for Use with Pure-Vu® System The following waste containers and disposable liners are recommended for use with the Pure-Vu System. MANUFACTURER REFERENCE CODE...
  • Page 10: Assembly Of The Disposable On The Workstation

    FIGURE 4: Align the sealing plug (A) with the distal tip of the Oversleeve (B). Advance the sealing plug onto the distal tip of Oversleeve, then slide the locking ring (C) to the proximal end of the plug (locked position). MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 11 (E). Then place the colonoscope connector (C) and control section (F) on the Loading Fixture. Rotate the colonoscope holders (G) to lock. Ensure the colonoscope air/water, auxiliary water port, suction and biopsy valves (D) are in place and secure. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 12 LED light (B) illuminates. Begin to gently push the colonoscope into the Pure-Vu Oversleeve (C). Continue inserting the colonoscope until it reaches the distal end and will not advance with a gentle push. Place the colonoscope control section onto the scope support bracket (D). MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 13: Attaching The Umbilical Section To The Workstation

    (C) into the irrigation pump marked in blue (D) between marked blue lines, then close the irrigation pump head. Remove the irrigation tube spike’s cap (G), then connect the irrigation tubing to the irrigation bag (E) and ensure that the irrigation line clamp (F) is open. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 14: Attaching The Oversleeve To The Umbilical Section

    4.2.4. Attaching the Oversleeve to the Umbilical Section FIGURE 11: 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 15: Operation And System Test

    Point the tip of the colonoscope (C) and the Pure-Vu Oversleeve (D) toward a container (E). Ensure that the Oversleeve’s distal tip is not submerged in water, then press the system test button (F) for 3 seconds to verify irrigation. The Pure-Vu System is now ready for use. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 16: System Operation

    If no irrigation, refer to Section 8.0 TROUBLESHOOTING After determining the Pure-Vu System is ready for use, wet at least 30cm of the distal section of the Oversleeve and then apply a water-based lubricant (as used in standard colonoscopy procedures) to at least 30cm of the distal section of the Oversleeve just before the procedure begins.
  • Page 17: Disassembling The Workstation Connector And Oversleeve

    Open the pump heads and pull the tubes out. Then disconnect the Umbilical Section from the Workstation by depressing the main connector button (J). Disconnect the suction tubing from the waste containers (K). Discard irrigation bag, waste containers and tubing per facility protocol. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 18: Removing The Oversleeve From The Colonoscope

    2 part detergent solution (40 cc water, 20 cc detergent). Connect the stopcock and syringe assembly (E) to the Oversleeve luer hub. Flush the 60 cc volume of diluted detergent through the Oversleeve and look for the solution to exit the distal end. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 19 Oversleeve, and draw up 60 cc of air. Turn the off valve to the side port position and infuse the air. Close by turning the off valve towards the Oversleeve. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 20 Oversleeve by pulling the Oversleeve and colonoscope away. Point the colonoscope tip and Oversleeve Inflation Hub downward just before the colonoscope exits the Oversleeve. Discard per facility protocol. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 21: Discarding The Oversleeve And Workstation Connector

    The Pure-Vu Workstation should never be installed, used or transported in an inclined position nor should it be subjected to impact or vibrations. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 22: Troubleshooting

    The Status Light is Make sure that the system is set-up properly (check the pump heads are closed properly, all cables are Orange attached securely, all tubing is attached properly and is kink-free) MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
  • Page 23: Technical Specifications

    “Low” light • No other action is required of the operator. blinks green.) *If the above does not remedy the warning indication, contact a Motus GI representative. TECHNICAL SPECIFICATIONS 9.1. Environmental Standards The table below describes the recommended environmental standards required for correct operation of Motus Pure-Vu System.
  • Page 24 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. ©2019 Fort Lauderdale, FL 33301 Tel: 1.800.PUREVU1 (787-3881) IU00004 Rev. C Fax: 1.954.541.8265...

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