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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
This document is property of Motus GI Medical Technologies LTD, its contents are CONFIDENTIAL and shall not be disclosed, disseminated, copied or used,
without written permission. Pure-Vu® and Motus GI® are trademarks or registered trademarks of Motus GI Holdings, Inc. © 2018
Motus Pure-Vu
Instructions For Use
Cleansing Mode
Low
Medium
Error
Motus GI Holdings, Inc.
Address: 1301 E. Broward Blvd.
Suite 310
Fort Lauderdale, FL 33301
Tel: 954.541.8000
Fax: 954.541.8265
E-mail: mail@motusgi.com
System
®
High
Warning
System Test
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 Pure-Vu System
- Page 1 E-mail: mail@motusgi.com This document is property of Motus GI Medical Technologies LTD, its contents are CONFIDENTIAL and shall not be disclosed, disseminated, copied or used, without written permission. Pure-Vu® and Motus GI® are trademarks or registered trademarks of Motus GI Holdings, Inc. © 2018...
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Page 2: Table Of Contents
CONTENTS WARNINGS AND PRECAUTIONS ....................1.1. Symbols Used ........................... INTENDED USE .............................. PRODUCT DESCRIPTION ....................... 3.1. System Workstation ........................3.1.1. Workstation Components:................... 3.1.2. Workstation Front Panel ..................... 3.1.3. The Foot Pedal ....................... 3.2. Pure-Vu Oversleeve ........................3.2.1. The Oversleeve ......................3.3. -
Page 3: Warnings And Precautions
“Operating the Pure-Vu Workstation”. • The Pure-Vu System should 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 at the rear of the WS. For a defi nition 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 a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fi ts over the colonoscope and is connected to an external Workstation, generates fl uid to break up feces. -
Page 6: System Workstation
[CLU] Lock and Unlock [MM] Cleansing Mode (MED) Drain [HM] Cleansing Mode (HIGH) [WSC] Workstation Connector [WL] Warning Light [ET2] Evacuation Tube 2 [ST] System Test [PC] Foot Pedal Connector [EP1] Evacuation Pump 1 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... -
Page 7: Workstation Components
[PC]. The Pure-Vu System undergoes a system test when the System Test button [ST] is activated. The system test ensures The Pure-Vu System is functioning properly prior to the start of the procedure. The system can be operated in three cleansing modes; low, medium (default mode) and high. -
Page 8: The Foot Pedal
Cleansing Mode Selector – activated by the right button [CMS]. User can switch between three cleansing modes; low, medium (default mode) and high. Manual Purging Cleansing Mode [MP] Selector [CMS] Evacuation Cleansing [EP] [CP] FIGURE 3: Pure-Vu Foot Pedal Unit MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... -
Page 9: Pure-Vu Oversleeve
Oversleeve’s conduits which branch off and attach to the WS Connector [WSC]. The WS Connector [WSC] connects the Pure-Vu Oversleeve to the Workstation. 3.3. Accessories for Use with Pure-Vu The following waste receptacle accessories have been validated be used with The Pure-Vu System. MANUFACTURER REFERENCE CODE... -
Page 10: Assembly Of The Oversleeve On The Workstation
(D), distal channel cover (B) and distal end clamp (E). Place the Oversleeve (F) into the loading fi xture channel with the Oversleeve’s infl ation hub luer connector facing up. Close and lock the Proximal clamp (D). MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... - Page 11 Then place the colonoscope connector (C) and control section on the loading fi xture. Rotate the colonoscope holders to lock. Ensure all of the colonoscope valves (D) are in place and secure. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
- Page 12 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...
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Page 13: Attaching The Oversleeve To The Workstation
Turn on the Workstation by pressing the power button (A). Place the Workstation connector on front of the Workstation and slide down into place (B). Push the Workstation connector lock button (C). MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... - Page 14 FIGURE 11: Close pump heads (A). Snap evacuation funnels into connector (B). Connect the luer fi ttings on the umbilical tubing to the luer fi ttings (C) on the Workstation connector by matching the corresponding colors (Clear, Blue and Red). MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
- Page 15 FIGURE 13: Confi rm presence of green lights. Point the tip of the colonoscope (A) and Pure-Vu Oversleeve (B) toward a container (C) and press the system test button (D) for 2 seconds to verify irrigation. The Pure-Vu System is now ready to use. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
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Page 16: System Operation
[PW], disconnect and discard the Oversleeve. Assemble new Pure-Vu Oversleeve and repeat steps outlined in sections 4 & 5. After determining The Pure-Vu System is ready for use apply a water based gel (as used in standard colonoscopy procedures) to distal 30cm of the Oversleeve. -
Page 17: Disassembling The Ws Connector And Oversleeve
FIGURE 15: Cut the umbilical tubing (A) approximately 15 cm from the proximal end of the Oversleeve. Open Workstation pumps (B) and remove all tubing (C) then discard the Workstation connector (D) and umbilical tubing as per facility protocol. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... -
Page 18: Removing The Oversleeve From The Colonoscope
Connect the stopcock and syringe assembly 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 (do not clamp the endoscope). Turn the stopcock off valve toward the 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 endoscope away from each other) (B). Point the endoscope tip and Oversleeve hub downward just before the endoscope leaves the Oversleeve to avoid spray. Discard per facility protocol. MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE...
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Page 21: Discarding The Oversleeve And Ws Connector
The Pure-Vu Workstation and Oversleeve 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
• While maintaining pressure on the plunger, turn the off valve towards the Oversleeve • Proceed to separate the endoscope from the Oversleeve by pulling the Oversleeve and endoscope away from each other MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... -
Page 23: Technical Specifications
Following are the mechanical properties and size for Pure-Vu Workstation: Workstation Outer Dimensions W460 \ D480 (520 with pump head \ H340 m Workstation Weight 25kg Power Supply 100 - 240 VAC / 50 - 60 Hz MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE... - Page 24 This document is property of Motus GI Medical Holdings, its contents are Motus GI Holdings, Inc. CONFIDENTIAL and shall not be disclosed, disseminated, copied or used, 1301 E. Broward Blvd. without written permission. Suite 310 Fort Lauderdale, FL 33301 Tel: 954.541.8000 IU00002 Rev.
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