background image

Instructions For Use

Motus GI Medical Technologies LTD.
Keren Hayesod 22, 

Tirat Carmel, 3902638 

Israel
Tel +972 73 2627757 

Fax +972 4 6214442

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

Pure-Vu® and Motus GI® are trademarks or registered trademarks of 

Motus GI Holdings, Inc. © 2021

LOW MED HIGH

ERROR

Содержание Pure-Vu System

Страница 1: ...8 Israel Tel 972 73 2627757 Fax 972 4 6214442 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 Pure Vu and Motus GI are trademarks or registered trademarks of Motus GI Holdings Inc 2021 LOW MED HIGH ERROR ...

Страница 2: ...Workstation 10 4 2 1 Oversleeve Assembly 10 4 2 2 Attaching the Umbilical Section to the Workstation 17 4 2 3 Attaching the Oversleeve to the Umbilical Section 18 5 0 SYSTEM OPERATION 19 5 1 Pre procedure Operations 19 5 2 Operating the Pure Vu Workstation 19 5 3 Disassembling the Umbilical Section and Oversleeve 20 5 4 Removing the Oversleeve from the Colonoscope 21 5 5 Discarding the Disposables...

Страница 3: ...ctive earth Check and confirm that all cords or cables are connected correctly and securely Continually 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 sec...

Страница 4: ...bol Manufacturer Date of manufacture 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 2 0 INTENDED USE The Pure Vu System is intended to connect to standard or slim colonoscopes to help facilitate intraprocedural clean...

Страница 5: ...sts of the following main components Disposable device which includes an Oversleeve section with an integrated loading element and an Umbilical Section The Oversleeve fits over the colonoscope The Umbilical Section connects the Oversleeve to the external Workstation Workstation that is reusable and supplies an irrigation mixture of water or saline and gas and evacuates debris fluids Below is a dra...

Страница 6: ... Workstation from the package so as not to damage any components 1 Irrigation Line Clamp 2 Irrigation Line Blue Markers 3 Irrigation Pump Blue Markers 4 Cleansing Mode Indicators Low Med High 5 Error Light 6 Fluid Button 7 Status Light 8 Drain Button 9 Suction Pump Blue Black Markers 10 Suction Tube Blue Black Markers 11 On Off Power Button 12 Main Connector 13 Foot Pedal Connector 14 Power Cord 1...

Страница 7: ...e cleansing mode selector button on the Foot Pedal shown in Figure 2 The system can be operated in three cleansing modes low medium default mode and high One Suction Pump removes debris gas fluids and other debris into the waste container bag Main Connector connects the Umbilical Section to the Workstation and supplies gas to the irrigation line Fluid Button acts as Priming when the Workstation is...

Страница 8: ...ring 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 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 high where the pedal LEDs ind...

Страница 9: ...l Health 65651 530 CRD disposable liner 3000cc Cardinal Health 65652 531 Wall to outer edge canister 10 in 3000cc Braun R5000 01 Sterile water for irrigation 1000mL bottle Baxter 2F7114 Sterile water for irrigation 1000mL bottle 4 0 SETUP AND INTERCONNECTIONS 4 1 Unpacking 4 1 1 Unpacking the Disposables Prior to unpacking the disposable units verify that the packaging is not compromised If the pa...

Страница 10: ...n 4 2 1 Oversleeve Assembly 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 ...

Страница 11: ...TIONS FOR USE 4 2 1 Oversleeve Assembly 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 ...

Страница 12: ... 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 s...

Страница 13: ...STEM INSTRUCTIONS FOR USE 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 ...

Страница 14: ...eeve Assembly cont 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 6 ...

Страница 15: ...ab 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 ...

Страница 16: ...16 MOTUS GI PURE VU SYSTEM INSTRUCTIONS FOR USE 4 2 1 Oversleeve Assembly cont FIGURE 16 Remove oversleeve sheath cover and discard ...

Страница 17: ...taching the Umbilical Section to the Workstation The Workstation should be cleaned prior to attaching the Umbilical Section to the Workstation by thoroughly wiping down the Workstation with a viricidal cloth Opti cide Cavicide or similar surface disinfectant of choice that has an active ingredient of isopropyl alcohol 17 21 Remove the Umbilical Section from the tray To attach the Umbilical Section...

Страница 18: ...TRUCTIONS FOR USE 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 4 2 3 Attaching the Oversleeve to the Umbilical Section ...

Страница 19: ...e apply a water based lubricant as used in standard colonoscopy procedures to the distal section of the Oversleeve just before the procedure begins 5 Place and prepare the patient for the procedure as per standard colonoscopy procedure It is recommended that an absorbent pad be placed around underneath the patient 6 Begin to perform the colonoscopy procedure Activate the Pure Vu System when cleans...

Страница 20: ...button light will blink in blue until complete Disconnect the in line connector clip E from the colonoscope Disconnect the Oversleeve F from the Umbilical Section G by pressing the proximal hinge of the in line connector H to open the connector clamps Then separate the Oversleeve from the Umbilical Section by pulling apart the connectors Open the pump heads and pull the tubes out Then disconnect t...

Страница 21: ... root brace clamp by disconnecting the collar hook from the peg of the clamp Holding the Oversleeve sheath collar roll the Oversleeve toward the distal end of the colonoscope 5 4 Removing the Oversleeve from the Colonoscope While securing the end of the colonoscope and pointing downward gently pull back the Oversleeve from the end of the colonoscope to disconnect the Oversleeve head Discard per fa...

Страница 22: ...has an active ingredient 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 and cords 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 affect...

Страница 23: ... System has automatically switched to a Water Only mode and no gas is being introduced to the irrigation system All irrigation modes will continue to operate without air Status light turns Blue including 5 audio beeps The Auto Purge function is no longer active and has been disabled Manual Purge can still be utilized Foot Pedal is Not Responding Verify the Foot Pedal is securely attached to the ba...

Страница 24: ...ping and Storage Recommended Shipping and Storage Temperature SPECIFICATIONS Shipping 14 to 140 F 10 to 60 C Storage 59 to 86 F 15 to 30 C 9 4 Mechanical Properties and Sizes Following are the mechanical properties and size for the Pure Vu Workstation Workstation Dimensions W x D x H 250mm x 400mm x 280mm 10in x 15 7in x 11in Weight 12kg 26 5lbs Power Supply 100 240 VAC 50 60 Hz 9 3 Performance Sp...

Страница 25: ...25 MOTUS GI PURE VU SYSTEM INSTRUCTIONS FOR USE ...

Страница 26: ...r registered trademarks of Motus GI Holdings Inc 2022 IU00008 Rev A 26 MOTUS GI PURE VU SYSTEM INSTRUCTIONS FOR USE 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 ...

Отзывы: