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 aect 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 aect 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 insuation
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.
133592 Motus GI_IFU_Manual_2018_R5.indd 3 9/5/2018 4:54:30 PM
