Motus GI PURE-VU EVS User manual

Instructions For Use
Motus GI Medical Technologies LTD.
Keren Hayesod 22,
Tirat Carmel, 3902638
Israel
Tel [phone]
Fax [phone]
Motus GI Holdings, Inc.
1301 E. Broward Blvd., Suite 310
Fort Lauderdale, FL, 33301
United States
Tel 1 844 PUREVU1 (787-3881)
Fax [phone]
Pure-Vu® and Motus GI® are trademarks or registered trademarks of
Motus GI Holdings, Inc. © 2021
LOW MED HIGH ERROR

2MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
1.0 WARNINGS AND PRECAUTIONS ................................................................................................ 3
1.1. Symbols Used ................................................................................................................................... 4
2.0 INTENDED USE.................................................................................................................................. 4
3.0 PRODUCT DESCRIPTION ............................................................................................................... 5
3.1. Pure-Vu Workstation.................................................................................................................... 6
3.1.1. Pure-Vu Workstation Components .......................................................................... 7
3.1.2. Front Panel....................................................................................................................... 7
3.1.3 Foot Pedal ........................................................................................................................ 8
3.2. Pure-Vu Disposable Kits .............................................................................................................. 9
3.3. Accessories for Use with Pure-Vu System............................................................................. 9
4.0 SETUP AND INTERCONNECTIONS ............................................................................................. 9
4.1. Unpacking....................................................................................................................................... 9
4.1.1. Unpacking the Disposables......................................................................................... 9
4.1.2. Unpacking the Workstation........................................................................................ 9
4.2. Assembly of the EVS Flex Channel to the Workstation ................................................... 10
4.2.1. EVS Flex Channel Assembly....................................................................................... 10
4.2.2. Attaching the Umbilical Section to EVS Flex Channel....................................... 15
4.2.3. Attaching the EVS Flex Channel to the Umbilical Section ............................... 16
5.0 SYSTEM OPERATION ...................................................................................................................... 17
5.1. Pre-procedure Operations......................................................................................................... 17
5.2. Operating the Pure-Vu Workstation....................................................................................... 17
5.3. Disassembling the Umbilical Section and EVS Flex Channel .......................................... 18
5.4. Removing the EVS Flex Channel from the Endoscope..................................................... 19
5.5. Discarding the Disposables........................................................................................................ 20
6.0 CLEANSING WORKSTATION AND FOOT PEDAL................................................................... 20
7.0 STORAGE AND TRANSPORTATION........................................................................................... 20
8.0 TROUBLESHOOTING....................................................................................................................... 21
9.0 TECHNICAL SPECIFICATIONS...................................................................................................... 22
9.1. Environmental Standards........................................................................................................... 22
9.2. Shipping and Storage.................................................................................................................. 22
9.3. Performance Specifications....................................................................................................... 22
9.4. Endoscope Compatilibity........................................................................................................... 22
9.5. Workstation Mechanical Properties and Sizes..................................................................... 22
CONTENTS

3
MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
1.0 WARNINGS AND PRECAUTIONS
Please read this manual and follow its instructions carefully.
Warnings:
• This device shall only be used by order of a licensed physician as governed by the FDA.
• The Pure-Vu System shall only be used according to the instructions and operating conditions
described in this manual. Failure to do so could impact the performance and safety profile of the
device, damage the device or the endoscope.
• The Pure-Vu System shall only be used under the supervision of a licensed physician. Do not use Pure
Vu system for any purpose other than the intended use.
• The Pure-Vu System shall be used only by trained medical personnel.
• The Pure-Vu Disposable Kits are provided clean and intended for single patient use. Do not sterilize,
clean or re-use the disposables. Discard all of the disposable device sections properly after use.
• Confirm that the other devices used with the Pure-Vu System function properly to their intended use
and that their operation or safety is not compromised and is compatible with the Pure-Vu System as
noted in these instructions. 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 shall be connected only to a supply main with protective earthing.
• 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 is compatible with EMC regulations, but 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 shall never be stored in areas where the unit could get wet or be exposed to high
temperature, humidity, direct sunlight, dust, or salt, which could adversely aect the equipment.
• The Pure-Vu System shall never be installed, used or transported in an inclined position nor should it
be subjected to impact.
• The Pure-Vu Workstation shall be maintained in a clean condition during storage and be ready for
subsequent use.
• The Pure-Vu disposables , as well as the Workstation (WS), shall be used only with the Pure-Vu System
recommended equipment and accessories.
• Avoid using the cleansing mode on the same area of tissue for an extended period of time.
• New, single use waste containers shall be used for each patient (Hospital approved canisters or Motus
GI Waste Bag).
• A New, single use irrigation bag (IB) or Irrigation bottle (water or saline) shall be used for each patient.
Precautions:
• Advance cautiously when performing retroflexion, entering the pylorus, duodenum, or ileocecal valve.
• Care shall be taken to avoid pinching the tubing during advancement through the GI tract and/or
when applying torque to the endoscope.
• Only Motus GI personnel or a trained Motus GI designee are allowed to service the Pure-Vu System.

4MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
1.1. Symbols Used
The Pure-Vu System has a safety warning and compliance label located on the Workstation
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
of a physician
NON
STERILE
Non-sterile
Do not use if package is damaged
!Caution! Consult accompanying documents for
safety instructions
General warning sign
Do not re-use
LOT Batch code (adjacent to the lot symbol)
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 and gastroscopes
to help facilitate intraprocedural cleansing of the GI tract by irrigating or cleaning and evacuating
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 doctors’ oces.

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MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
FIGURE 1: Pure-Vu Workstation – General Design & Components
3.0 PRODUCT DESCRIPTION
The Pure-Vu System enables cleansing of the GI tract during endoscopy using a standard or slim
colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.2mm or
gastroscope with length of 950-1030mm and an outer diameter of 9.2-10 mm . The EVS Flex Channel,
which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to
break up debris. The debris & fluids are removed through the suction channel of the EVS Flex Channel into
an external waste container/bag.
The Pure-Vu System consists of the following main components:
• Disposable device which includes an Flex Channel section and an Umbilical Section. The EVS Flex Channel
fits over the endoscope. The Umbilical Section connects the Flex Channel 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 drawing showing the various components of the system and where they connect to each other.
1
Workstation
2
Irrigation Bag/Water Bottle
3
Irrigation Line Clamp
4
Endoscope
5
EVS Flex Channel
6
In-Line Connector
7
Umbilical Section
8
Waste Containers/Waste Bag
9
Foot Pedal
10
Main Connector
LOW MED HIGH ERROR
or
or
CLEANSING
MODE
PURGE
SUCTION
CLEANSE
H
M
L
2
4
3
6
8
7
10
1
5
9

6MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
LOW MED HIGH ERROR
3.1. Pure-Vu® Workstation
The Workstation is designed to supply water or saline and gas for irrigation and provide suction to
evacuate debris & fluids out of the body during the endoscopy procedure. Care should be taken when
removing the 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/O Power Button
12
Main Connector
13
Foot Pedal Connector
14
Power Cord
15
Main Power Switch
FIGURE 2: Pure-Vu Workstation
1
4
3
5
10
11
12
13 14
15
6 8
7
2
FRONT BACK
9

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MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
3.1.1. Pure-Vu® Workstation Components:
• Monitoring & Control Unit control the delivery of irrigation fluids and gas into the colon,
and suction of fluids and debris from the GI tract.
• Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line.
• Waste Containers/Bag for collecting the Gi tract content & fluids that are suctioned
from the Gi tract through the suction lines.
• Foot Pedal that activates the cleansing, suction and purging functions, and enables switching
between cleansing modes used by the physician.
3.1.2. Front Panel:
• On/O Power Button - powers Workstation On/O.
• Irrigation Pump - pumps room temperature water or saline.
• Cleansing Mode Indicator - indicates the mode you are in and is activated by using the 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 - activates “irrigation Only” mode without simultaneous suction activity when
depressing the cleansing pedal.
• Drain Button - activates the draining of the fluids from the disposable prior to unloading from
the Workstation.
• Status Light - indicates status of the system; green light means ready to go and yellow light indicates
the setup is not performed properly as well as indicates the end of drain routine.
• Error Light (Triangle) - turns red when there is a non-recoverable system error where the Workstation
stops its operation automatically.

FIGURE 3: Pure-Vu Foot Pedal
CLEANSING
MODE
PURGE
SUCTION
CLEANSE
H
M
L
Manual Purge Cleansing Mode
Selector
Cleanse
Suction
8MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
3.1.3. Foot Pedal
The Foot Pedal allows the physician to select the operating modes during 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.
(If FLUID button is pressed and lit blue , only the irrigation is activated.)
• 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 indicates the modes in parallel
to the Workstation LED panel.

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MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
3.2. Pure-Vu® Disposable Kits
The Pure-Vu® Disposable Kits are comprised of an EVS Flex Channel , and the Umbilical Section. The Pure-Vu
Disposable is a single use device, which fits over a standard and slim colonoscope or gastroscope. The Pure-Vu
EVS Flex Channel consists of an irrigation lumen and a suction lumen. The EVS Flex Channel strips allow for a
secure connection to the endoscope. Proximal to the scope grip is the in-line connector that enables attachment
to the Umbilical Section.
The Umbilical Section connects the Pure-Vu EVS Flex Channel to the Workstation via its Main Connector.
3.3. Accessories for Use with Pure-Vu® System
The following water bottles, Motus waste bag, 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 ¾ in.) 3000cc
Braun R5000-01 Sterile water for irrigation 1000mL bottle
Baxter 2F7114 Sterile water for irrigation 1000mL bottle
Motus PV-WST-03-1 Pure-Vu EVS Waste Bag 3L
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 packaging
is open and/or damaged, DO NOT use the device.
Verify the date of expiry on the label.
Verify that the type of Disposable as indicated by its specifications is compatible with the endoscope
to be used (refer to compatible endoscope dimensions in section 3.0).
During set up, ensure that no packaging material remains on the device and that the device does
not touch the floor or other unclean surfaces that could compromise the cleanliness or intended use
of the product.
4.1.2. Unpacking the Workstation
Prior to unpacking the Workstation, verify that the packaging is not compromised. If the packaging is
open or damaged, DO NOT use the device.
During set-up ensure that no packaging material remains on the device and that the device does
not touch the floor or other unclean surfaces that could compromise the cleanliness or intended use
of the product.

10 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
4.2. Assembly of the EVS Flex Channel to the Workstation
4.2.1. EVS Flex Channel Assembly
STEP 2: Open the Tyvek lid (A) and remove the tray retainer (B).
STEP 1: Secure endoscope handle onto a scope holder or solid surface.
Attention: Make sure the endoscope is clean and dry before attaching the EVS Flex Channel.
AB