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Pure-Vu® and Motus GI® are trademarks or registered trademarks of Motus GI Holdings, Inc.

2019

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

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: [email protected]

www.obelis.net

Motus GI Medical Technologies LTD.

Address: Keren Hayesod 22,

Tirat Carmel, ZIP 3902638, Israel

Tel: +972.73.2627757

Fax: +972.4.6214442

EC REP

Motus Pure-Vu

System

Instructions For Use

Содержание Pure-Vu System

Страница 1: ...10 Fort Lauderdale FL 33301 US Tel 1 844 PUREVU1 787 3881 Fax 1 954 541 8265 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 Motus GI Medical Technologies LTD Address Keren Hayesod 22 Tirat Carmel ZIP 3902638 Israel Tel 972 73 2627757 Fax 972 4 6214442 EC REP Motus Pure Vu System Instructions For Use ...

Страница 2: ... Oversleeve Assembly 10 4 2 3 Attaching the Umbilical Section to the Workstation 13 4 2 4 Attaching the Oversleeve to the Umbilical Section 14 4 2 5 Operation and System Test 15 5 0 SYSTEM OPERATION 16 5 1 Pre procedure Operations 16 5 2 Operating the Pure Vu Workstation 16 5 3 Disassembling the Workstation Connector and Oversleeve 17 5 4 Removing the Oversleeve from the Colonoscope 18 5 5 Discard...

Страница 3: ...ntinually monitor the Pure Vu System and the patient for any signs of irregularity The Pure Vu System may cause radio interference or may disrupt the operation of nearby equipment If the system does not function properly turn the Workstation off abort the procedure and follow the instructions noted in section Operating the Pure Vu Workstation The Pure Vu System shall never be stored in areas where...

Страница 4: ...ture Follow instructions for use Consult Instructions for Use symbols are meant to support not replace operating instructions Must not be treated as unsorted municipal waste Type BF equipment Temperature limit Use by date Serial number EC REP Authorized representative in the European Community CE compliance symbol 2 0 INTENDED USE The Pure Vu System is intended to connect to standard or slim colon...

Страница 5: ...evice which includes an Oversleeve and an Umbilical Section The Oversleeve fits over the colonoscope and the Umbilical section is connected to the external Workstation Workstation that is reusable and supplies an irrigation mixture of water or saline and gas and evacuates fecal material fluids Loading Fixture that is reusable and aids in assembling the Oversleeve onto the colonoscope Additional co...

Страница 6: ...components 1 Irrigation Line Clamp 2 Irrigation Line Blue markers 3 Irrigation Pump Blue 4 Cleansing Mode Indicators Low Med High 5 Error Light 6 System Test Button 7 Status Light 8 Drain Button 9 Suction Pump Green 10 Suction Tube Green markers 11 Suction Pump Red 12 Suction Tube Red markers 13 Power Button 14 Main Connector 15 Foot Pedal Connector 16 Power Cord 17 Main Power Switch 18 Suction Tu...

Страница 7: ...is activated by using the cleansing mode selector button on the Foot Pedal shown in Figure 3 The system can be operated in three cleansing modes low medium default mode and high Two Suction Pumps remove the fecal material gas fluids from the colon into the waste containers Main Connector connects the Umbilical Section to the Workstation and supplies gas to the irrigation and sensing line System Te...

Страница 8: ...ct the operating modes during the procedure The operating modes are as follows Figure 3 Pure Vu Foot Pedal Unit Cleansing simultaneous irrigation and suction activated by the right foot pedal Suction activated by the left pedal Manual Purge activated by the left button Cleansing Mode Selector activated by the right button User can toggle between three cleansing modes low medium default mode and hi...

Страница 9: ... 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 DESCRIPTION Cardinal Health 65651 530 CRD disposable liner 3000cc Cardinal Health 65652 531 Wall to outer edge canister 10 in 3000cc 4 0 SETUP AND INTERCONNECTIONS 4 1 Unpacking 4 1 1 Unpacking the Disposables Prior to unpacki...

Страница 10: ... Loading Fixture with a viricidal cloth Opti cide Cavicide or similar surface disinfectant of choice that has an active ingredient of isopropyl alcohol 17 21 4 2 2 Oversleeve Assembly Remove the Oversleeve from the tray item 1 in tray and sealing plug item 3 in tray To load the Oversleeve onto the colonoscope complete the following steps FIGURE 4 Align the sealing plug A with the distal tip of the...

Страница 11: ...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 4 2 2 Oversleeve Assembly cont FIGURE 5 Place the Loading Fixture on a flat surface Ensure that the colonoscope control section and endoscope connector holders are in the open position Open the proximal cla...

Страница 12: ... insert the colonoscope tip into the proximal end of the inflation hub A wait until the bottom green 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 4 2 2 Oversleeve Assembly cont...

Страница 13: ...tion controller colonoscope light source and video processor FIGURE 9 Connect the main connector A to the main connector socket in the Workstation B Place the irrigation tubing 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 t...

Страница 14: ...f the Workstation and then place the suction tubing D into the suction pump marked in green E between marked green lines then place the suction tubing F into the suction pump marked in red G between marked red lines then close both suction pump heads FIGURE 11 Connect the Oversleeve to the Umbilical Section by the inline connector A to B Attach the inline connector clip to the colonoscope Umbilica...

Страница 15: ... Power On Off button A Confirm status indicator B is green 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 4 2 5 Operation and System Test ...

Страница 16: ...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 6 Place and prepare the patient for the procedure as per standard colonoscopy procedure It is recommended that an absorben...

Страница 17: ...lete The status indication E will switch from green to orange Disconnect the In Line Connector Clip F from the Colonoscope Disconnect the Oversleeve G from the Umbilical Section H by pressing the in line connector button I down and forward then separate the Oversleeve from the Umbilical Section by pulling apart the connectors Open the pump heads and pull the tubes out Then disconnect the Umbilical...

Страница 18: ...er 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 5 4 Removing the Oversleeve from the Colonoscope Remove the unloading components the sealing plug and the syringe 3 way stopcock assembly from the disposabl...

Страница 19: ... 60 cc of diluted detergent solution into the syringe attach the syringe to the stopcock and turn the off valve toward the side port of the stopcock and repeat step 5 Push the tip of the colonoscope back approximately 2 cm into the Oversleeve Advance the Sealing Plug D into the distal tip of the Oversleeve Ensure that the sealing plug locking ring is in the locked position Turn the stopcock off va...

Страница 20: ...ve and colonoscope away from each other B Note If at any point you see the Oversleeve bunch up creating pinch points simply grasp the Oversleeve on either side of the pinch point and pull apart from each other then proceed to remove the Oversleeve by pulling the Oversleeve and colonoscope away Point the colonoscope tip and Oversleeve Inflation Hub downward just before the colonoscope exits the Ove...

Страница 21: ...ngredient of isopropyl alcohol 17 21 7 0 STORAGE AND TRANSPORTATION Disconnect the Workstation electrical cord either from the inlet in the Workstation or from the socket in the wall The Workstation cords and loading fixtures should be stored in a clean condition This equipment should never be stored in areas exposed to high temperature humidity direct sunlight dust salt which could adversely affe...

Страница 22: ... click Refer to Figure 11 Verify that the irrigation line clamp is open Check all tubes are patent Ensure Oversleeve distal tip remains above the fluid level during the test Refer to Figure 12 After performing steps above reboot system and repeat system test Foot Pedal is Not Responding Verify the Foot Pedal is securely attached to the back of the Workstation Refer to Figure 2 Verify that there is...

Страница 23: ...ify system is outside optimal operating range by listening for audible indicators and confirming visual indicator System beeps twice and Status light blinks orange Be aware that the auto purge function may not be available while system is outside of optimal operating range Manual purge should be used until system returns to optimal operating range Check tubing for obstructions or bending and mitig...

Страница 24: ...otus GI are trademarks or registered trademarks of Motus GI Holdings Inc 2019 IU00004 Rev C Motus GI Holdings Inc 1301 E Broward Blvd Suite 310 Fort Lauderdale FL 33301 Tel 1 800 PUREVU1 787 3881 Fax 1 954 541 8265 ...

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