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ALLY II UPS™
SECTION 1 INTRODUCTION
The ALLY II UPS™ (Uterine Positioning System) is a non-patient contacting, electromechanical device that consists of
a single, multi-segmented, articulated arm that attaches to a standard operating room bed rail, and a separate, sterile,
disposable adapter that is used to secure a sterile uterine manipulator to the arm.
Read all information carefully.
Failure to properly follow all instructions, including those supplied with the CooperSurgical manipulator handles and
adapters may lead to injury and result in improper functioning of the device.
CAUTION:
U.S. Federal law restricts this device to sale by or on the order of a physician.
SECTION 2 INTENDED USE
The ALLY II UPS™ is intended to secure uterine manipulator devices for uterine positioning and to assist the surgical
staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgical procedures.
SECTION 3 INDICATIONS FOR USE
The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning, and
holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained
operating room personnel in an operating room environment.
SECTION 4 INTENDED USERS
Trained operating room personnel in an operating room environment
SECTION 5 TARGET PATIENT POPULATION
Women who have been assessed suitable by a gynecologist to undergo gynecological laparoscopic surgical procedures.
SECTION 6 PERFORMANCE CHARACTERISTICS
• The segmented design of the arm allows lateral/medial movement from a single point, allowing the system to be
attached to one side of the operating room table.
• Foot pedal release facilitates positioning – Lock arm in the desired position by releasing the foot pedal
• Connects to any operating table
• Provides static control, consistent cephalad pressure and stability
SECTION 7 CLINICAL BENEFIT
• Holds the uterus in the desired position and allows for visualization and access
SECTION 8 CONTRAINDICATIONS
CooperSurgical manipulator handles should not be used in patients who are pregnant or who are suspected of being
pregnant, planned gamete intrafallopian transfer procedures, in patients who have an IUD in place, in patients with
suspected pelvic infections and in cases where the surgeon deems it inadvisable or finds it difficult to insert the silicone
tip into the cervix or uterus.
SECTION 9 WARNINGS AND PRECAUTIONS
WARNINGS:
• Securely hold arm or manipulator before depressing foot pedal.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• The ALLY II UPS™ is only intended for use with CooperSurgical’s family of uterine manipulators. For a complete
list of the manipulators compatible with the ALLY II UPS™, please contact CooperSurgical Customer Service. Use
of this device in any configuration other than specified is not recommended, and could lead to injury and improper
functioning of each device
• Flammable Anesthetics: This device is not suitable for use in the presence of a flammable anesthetic mixture with
air, or in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide.
• Read all instructions carefully. Failure to properly follow instructions may cause improper functioning of the device.
• Use only the rail clamp supplied with the ALLY II UPS™.
