Motus Pure-Vu System 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 Kit ................................................................................................................ 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 Oversleeve to the 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........................................................................................................ 22
6.0 CLEANSING WORKSTATION AND FOOT PEDAL................................................................... 22
7.0 STORAGE AND TRANSPORTATION........................................................................................... 22
8.0 TROUBLESHOOTING....................................................................................................................... 23
9.0 TECHNICAL SPECIFICATIONS...................................................................................................... 24
9.1. Environmental Standards........................................................................................................... 24
9.2. Shipping and Storage.................................................................................................................. 24
9.3. Performance Specifications....................................................................................................... 24
9.4. Mechanical Properties and Sizes ............................................................................................. 24
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 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 shall 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 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 both 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 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 shall 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 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 Oversleeve, Umbilical Section, as well as the Workstation (WS), shall be used only with the
Pure-Vu EVS 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.
• A New, single use irrigation bag (IB) shall be used for each patient.
Precautions:
• Advance cautiously when performing anal retroflex and/or entering the ileocecal valve.
• Care shall 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.

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 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, ambulatory surgery centers,
ambulatory endoscopy centers, clinics and doctors’ oces.

5
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 colon cleansing during colonoscopy using a standard or slim colonoscope
with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve,
which fits over the colonoscope 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 Oversleeve into an
external waste container.
The Pure-Vu System consists 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 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
Colonoscope
5
Oversleeve
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 provide water or saline and gas for irrigation and suction to evacuate
debris & fluids out of the body during the colonoscopy 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

7
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 colon.
• Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line.
• Waste Containers/Bag for collecting the colon content & fluids that are suctioned from
the colon 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 - acts as Priming – when the Workstation is in standby mode where the Fluid being
primed to the Disposable tip. It also serves as “Empty Fluid” notification in case the water runs out
during a procedure.
• 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
issue with the setup as well as indicates the end of drain routine
• Error Light (Triangle) - turns red when there is 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
• 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 parallels to
the Workstation LED panel

9
MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
3.2. Pure-Vu® Disposable Kit
The Pure-Vu® Disposable Kit is comprised of the Oversleeve, and the Umbilical Section. The Pure-Vu
Oversleeve is a single use device, which fits over a standard or slim colonoscope with a length of
1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. Once mounted over the colonoscope
the eective outer diameter is less than 22mm.
The Pure-Vu Oversleeve consists of a single irrigation channel and a single suction channel which is
also used for in-line pressure sensing. The Oversleeve allows for proper connection to the colonoscope.
Proximal to the scope grip is the in-line connector that enables attachment to the Umbilical Section.
The Umbilical Section connects the Pure-Vu Oversleeve to the Workstation via the 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
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 disposable label specifications are compatible with the selected colonoscope (refer to
compatible colonoscope dimensions in section 3.2).
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 Oversleeve to the Workstation
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.

11 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS 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.

12 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
4.2.1. Oversleeve Assembly (cont...)
FIGURE 8: Insert colonoscope into the bottom of the loading handle. Carefully advance the colonoscope into the
handle while visualizing the lumen and keeping the internal tubing at the lower part of the screen parallel to horizon.
FIGURE 9: Align the arrow to the working 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 shown. If
needed, fine adjustments can be made. Inspect the distal tip to ensure that the colonoscope is aligned with the end
of the Pure-Vu oversleeve.

13 MOTUS GI PURE-VU SYSTEM 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.

14 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
4.2.1. Oversleeve 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

15 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
4.2.1. Oversleeve Assembly (cont...)
FIGURE 14: Gently grab 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.

16 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
4.2.1. Oversleeve Assembly (cont...)
FIGURE 16: Remove oversleeve sheath cover and discard.

LOW MED HIGH ERROR
A
B
C
D
E
Open Pump Head
or
FG
I
H
LOW MED HIGH ERROR
or
or
D
E
A
C
B
17
MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
FIGURE 17: Connect the main connector (A) to the main connector socket in the Workstation (B). Place the irrigation
tubing (C) into the irrigation pump marked with blue markers (D) between the marked blue lines of the tubing, then
close the irrigation pump head. Remove the irrigation tube spike’s cap (E), then either connect the irrigation tubing
to the irrigation bag (F) or place the spike in a bottle (G) and screw the provided water bottle cap (H) onto the
bottle securely. Ensure that the irrigation line clamp (I) is open. Ensure all tubing is free of any kinks.
4.2.2. Attaching 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 to the Workstation complete
the following steps:
FIGURE 18: Connect the suction line to the waste container (A) and ensure that at least one port, in addition to the
vacuum port (B), is open on the container or attach the suction line to a waste bag (C). Place the suction tubing (D)
into the suction pump (E) marked with a single black and double blue lines aligning the black line of tubing with
black line on pump head and blue lines on pump head to blue lines on tubing. Then close the suction pump head.

A
B
D
C
18 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS 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

19 MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
5.0 SYSTEM OPERATION
5.1. Pre-procedure Operations
1. Use a new, single-use irrigation bag/water bottle and new, single-use waste containers/bags.
2. Verify that all cords and cables, including Workstation and Foot Pedal, are assembled correctly.
3. Confirm that the waste containers and irrigation bag/bottle are replaced at the same time at the
beginning of or during the procedure.
4. Verify that the disposable kit is assembled correctly, that the irrigation line clamp is open, that
the pump heads are closed, and that the tubing is clear of any kinks.
5.2. Operating the Pure-Vu® Workstation
1. Turn on the Pure-Vu Workstation power button.
2. Turn on the colonoscope processor and light source.
3. Verify visually and functionally that the colonoscope functions properly (i.e. clear image, irrigation,
suation and suction). Refer to colonoscope manufacturer Instructions for Use.
4. For Auto Priming the system before the procedure, simply press the Fluid button. Its LED will blink
in Blue and after determining the Pure-Vu System is ready for use, 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 cleansing is
required per physician’s discretion.
7. Activate the cleansing mode by stepping on the right foot pedal. The cleansing selection mode
button is located on the foot pedal (above the cleansing pedal) and the cleansing mode indicator
on the workstation display. If a dierent cleansing mode is desired, depress the mode button to change
the cleansing mode. The switching between the modes is performed in a cyclic manner – Medium – High
– Low – Medium. This is reflected on the front of the system, as well as, on the foot pedal
8. If only suction is desired, depress the left foot pedal to activate the suction function.
9. To ensure eective suctioning, position the suction ports below the fluid line.
10. If the suction channels are blocked, depress the manual purge pedal to remove the blockage.
11. Upon completion of the colonoscopy procedure, disassemble the disposables as per Section 5.3.

CLEANSING
MODE
PURGE
SUCTION
CLEANSE
H
M
L
A
B
LOW MED HIGH ERROR
or
or
C
I
J
D
E
F
G
H
20
MOTUS GI PURE-VU SYSTEM INSTRUCTIONS FOR USE
FIGURE 20: Upon completion of the colonoscopy procedure, fill a container with 200cc of tap water (A). Point the
tip of the colonoscope down in the container and suction 200cc of tap water by depressing the suction pedal on
the Foot Pedal unit (B). Close the irrigation line clamp (C), press the drain button (D) and wait for the drain cycle
to complete. The drain 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 the umbilical
from the Workstation by depressing the main connector button (I). Disconnect the suction tubing from the waste
container or waste bag (J). Discard irrigation bag or bottle, waste container or bag and tubing per facility protocol.
5.3. Disassembling the Umbilical Section and Oversleeve