2
SECTION 1 INTRODUCTION
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 INDICATIONS FOR USE
The ALLY Uterine Positioning System
®
(ALLY UPS
®
) 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 3 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 4 WARNINGS AND PRECAUTIONS
WARNINGS
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• The
ALLY UPS is only intended for use with CooperSurgical’s family of uterine manipulators.
For a complete list of the manipulators compatible with the ALLY 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 UPS.
- Do not install rail clamp across different rail sections.
• Surgical procedures requiring vaginal instrumentation are not sterile. Conventional Operating Room
procedures for maintaining sterility must be observed when the ALLY UPS is in use.
•
DO NOT USE EXCESSIVE FORCE.
If adequate range of motion is not obtained, reposition the ALLY UPS
(reference section 6.2 on proper positioning). If problem persists, discontinue use.
•
DO NOT
store the device in direct sunlight, at high temperatures or high humidity.
•
DO NOT
store this device in the shipping box.
•
ALWAYS
position the patient and the operating room table prior to attaching the ALLY UPS to the manipulator.
•
ALWAYS
have patient under general endotracheal anesthesia when ALLY UPS is attached to the manipulator.
•
ALWAYS
use caution when attaching and detaching the manipulator from the ALLY UPS.
•
DO NOT
move the foot end of the Operating Room table while the ALLY UPS is attached to the table.
•
ALWAYS
follow all instructions and recommendations discussed in the Uterine Manipulator
Directions for Use.
•
ALWAYS
handle the ALLY UPS with care. Avoid mechanical shock or stress that can cause damage
to the device.
•
DO NOT
carry the ALLY UPS using anything other than the blue handle and blue fixed arm area.
The foot pedal cover should be used to lift, carry, or reposition the foot pedal.
ALLY Uterine Positioning System
®
(ENGLISH)
