Motus Pure-Vu System User manual

Error
Low Medium
Cleansing Mode
High Warning System Test
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 GI Holdings, Inc.
Address: 1301 E. Broward Blvd.
Suite 310
Fort Lauderdale, FL 33301
Tel: [phone]
Fax: [phone]
E-mail: [email protected]om
OBELIS S.A
Address: Bd. Général Wahis, 53,
1030 Brussels, Belgium
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.obelis.net
Motus GI Medical Technologies LTD.
Address: Keren Hayesod 22,
Tirat Carmel, ZIP 3902638, Israel
Tel: [phone]
Fax: [phone]
EC REP
Motus Pure-Vu®System
Instructions For Use
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1.0 WARNINGS AND PRECAUTIONS ................................................................................................ 3
1.1. Symbols Used ................................................................................................................................... 4
2.0 INTENDED USE.............................................................................................................................................. 4
3.0 PRODUCT DESCRIPTION ............................................................................................................... 5
3.1. System Workstation ..................................................................................................................... 6
3.1.1. Workstation Components:........................................................................................... 7
3.1.2. Workstation Front Panel............................................................................................. 7
3.1.3. The Foot Pedal............................................................................................................... 8
3.2. Pure-Vu Oversleeve ..................................................................................................................... 9
3.2.1. The Oversleeve ............................................................................................................. 9
3.3. Accessories for Use with Pure-Vu............................................................................................. 9
4.0 SETUP AND INTERCONNECTIONS ............................................................................................. 9
4.1. Unpacking....................................................................................................................................... 9
4.1.1. Unpacking the Oversleeve and Workstation Connector ................................... 9
4.1.2. Unpacking the Workstation and Loading Fixture............................................... 9
4.2. Assembly of the Oversleeve on the Workstation............................................................... 10
4.2.1. Cleaning the Loading Fixture .................................................................................... 10
4.2.2. Oversleeve Assembly................................................................................................... 10
4.2.3. Attaching the Oversleeve to the Workstation ..................................................... 13
5.0 SYSTEM OPERATION ...................................................................................................................... 16
5.1. Pre-procedure Operations......................................................................................................... 16
5.2. Operating the Pure-Vu Workstation....................................................................................... 16
5.3. Disassembling the WS Connector and Oversleeve ............................................................ 17
5.4. Removing the Oversleeve from the Colonoscope.............................................................. 18
5.5. Discarding the Oversleeve and WS Connector ................................................................... 21
6.0 CLEANSING WORKSTATION AND FOOT PEDAL................................................................... 21
7.0 STORAGE AND TRANSPORTATION........................................................................................... 21
8.0 TROUBLESHOOTING....................................................................................................................... 22
9.0 TECHNICAL SPECIFICATIONS...................................................................................................... 23
9.1. Environmental Standards........................................................................................................... 23
9.2. Shipping and Storage.................................................................................................................. 23
9.3. Performance Limitations ............................................................................................................ 23
9.4. Mechanical Properties and Sizes ............................................................................................. 23
CONTENTS
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3
MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
1. WARNINGS AND PRECAUTIONS
Please read this manual and follow its instructions carefully.
Warnings:
• FDA (USA) law restricts this device to sale by or on order of a physician.
• The Pure-Vu System should only be used according to the instruction and operating conditions
described in this manual. Failure to do so could result in compromised safety, equipment malfunction
or instrument damage.
• The Pure-Vu System should only be used under the supervision of a licensed physician. Do not use for
any purpose other than the intended application.
• The Pure-Vu System is to be used only by trained medical personnel.
• The Pure-Vu Oversleeve and WS Connector are provided clean and intended for single patient use. Do
not sterilize, clean or re-use the Oversleeve or WS Connector. Discard both devices properly after use.
• Confirm that the other devices used with The Pure-Vu System function properly and that these other
devices will not adversely aect the operation or safety of this equipment. If any component of the
endoscopic system is not functioning properly, the procedure should not be performed.
• The Pure-Vu System should only be used with approved medical devices, complying with IEC 60601-1.
• The Pure-Vu System must only be connected to a supply main with protective 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 o, abort the procedure and follow the
instructions noted in section “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 aect the equipment.
• The Pure-Vu System should never be installed, used or transported in an inclined position nor should it
be subjected to impact.
• A minimum of 2 people are required to transport the Pure-Vu Workstation.
• The Pure-Vu Workstation should be maintained in a clean condition during storage and be ready for
subsequent use.
• Electrical safety checks shall be performed annually (or as required by institutional procedures). The
check must be performed only by Motus GI authorized technical personnel.
• The Oversleeve, WS Connector, Loading fixture, as well as the Workstation (WS), are intended to be
used only with Motus Pure-Vu System and its accessories.
• Avoid using the cleansing mode on the same area of tissue for an extended period of time.
• A new, single use waste receptacle should be used for each patient.
• A new, single use irrigation bag (IB) must be used for each patient.
Precautions:
• Use only new irrigation bag (IB).
• Advance cautiously when performing anal retroflex or/and entering the ileocecal valve.
• For optimal operation of the system, refrain from using the colonoscope suction and insuation
when The Pure-Vu System is activated.
• Care should be taken to avoid pinching the tubing during advancement through the colon and/or
when applying torque to the colonoscope.
• Only Motus GI personnel or a trained designee should service The Pure-Vu System.
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4MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
1.1. Symbols Used
The Pure-Vu System has a safety warning and compliance label located at the rear of the WS. For a
definition of individual symbols, see table below:
SYMBOL DESCRIPTION
FDA (USA) law restricts this device to sale by or on order
of a physician
NON
STERILE
Non-sterile
Do not use if package is damaged
!Caution! Consult accompanying documents for
safety instructions
Do not re-use
LOT Batch code (adjacent to the lot symbol)
Manufacturer
Date of manufacture
Consult Instructions For Use, symbols are meant to support, not
replace, operating instructions
Must not be treated as unsorted municipal waste
Type BF equipment
EC REP Authorized representative in the European Community
Temperature limit
Use-by-date
SN Serial number
CE compliance symbol
2.0 INTENDED USE
The Pure-Vu System is intended to connect to standard 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.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
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5
MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
FIGURE 1: Pure-Vu Workstation – General Design & Components
Error
Low Medium
Cleansing Mode
High Warning System Test
3.0 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 fits over
the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The
fecal matter & fluids are removed through the evacuation channels of the Oversleeve into an external
waste receptacle.
The Pure-Vu System consists of the following main components:
• The Oversleeve [O] is a disposable device that fits over the colonoscope and is connected to the
external Workstation., using the WS Connector [WSC].
• The Workstation [WS] is reusable and supplies an irrigation mixture of water/saline and gas, and
evacuates fecal material & fluids.
• WS Connector [WSC] is disposable and serves as an interface between the Oversleeve and the
Workstation.
• The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope.
Below is a drawing showing the various components of the system and where they connect to each other.
1
[WS] Workstation
2
[IB] Irrigation Bag
3
[C] Colonoscope
4
[O] Oversleeve
5
[V] Evacuation Canisters
6
[FP] Foot Pedal
7
[C] Connector
1
2
34
5
7
6
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