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Summary of Contents for Cooper Surgical ALLY II UPS
- Page 1 English CLP4274203 • Rev. A • 11/22 ALLY II UPS™ (Uterine Positioning System) Instructions for Use AU-UPS2 95 Corporate Drive • Trumbull, CT 06611 • USA Phone: (800) 243-2974 Fax: (800) 262-0105 International: Phone: +1 (203) 601-9818 Fax: +1 (203) 601-4747...
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Page 2: Table Of Contents
(3) ADAPTER DRAPE ............................SECTION 12 INSTRUCTIONS FOR USE ..................7 12.1 INSPECTION PRIOR TO USE ........................12.2 RECOMMENDED STEPS FOR MOUNTING THE ALLY II UPS™ ..............12.3 ATTACHING THE ADAPTER DRAPE ......................12.4 INTRA-OPERATIVE USE ..........................12.5 REMOVING THE ALLY II UPS™ ........................ -
Page 3: Section 1 Introduction
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. -
Page 4: Precautions
PRECAUTIONS: • Always ensure that the ALLY II UPS™ is tightly and securely attached to the table prior to the start of the surgical procedure. Improper or loose mounting of the system can lead to unintended movement and may lead to injury. -
Page 5: Section 11 Device Description
ALLY II UPS™ SECTION 11 DEVICE DESCRIPTION The ALLY II UPS™ attaches to the operating room table and will enable the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS™ enables access and provides the ability to maneuver and maintain the manipulator in a desired position. -
Page 6: Main Unit Assembly
Arm rotates out of the way to provide access between the patient’s legs as needed. ALLY II UPS™ Blue Handle • This is what is held onto (as well as the arm) when installing or removing the ALLY II UPS™ from the rail. Refer to Section 12.2 for more information. Power Cord •... -
Page 7: Section 12 Instructions For Use
2. Lower or remove foot end of the operating room table. 3. Attach the ALLY II UPS™ to the operating room table by placing the rail clamp on the patient’s right side near the stirrup. Lower the mounting tab of the ALLY II UPS™... - Page 8 ALLY II UPS™ Rail Clamp ALLY II UPS™ Main Unit Figure 2d: ALLY II UPS™ in position in the ALLY II UPS™ rail clamp (shown to the left of the stirrup clamp. Operating room staff may choose a different configuration or placement as appropriate.) 5.
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Page 9: Attaching The Adapter Drape
NOTE: It is recommended to have spare adapter drapes ready at the start of a case. 1. Once patient prep is complete, and prior to draping the patient, it is time to connect the adapter drape to the ALLY II UPS™. -
Page 10: Removing The Ally Ii Ups
2. Turn off the power switch and unplug from the wall outlet. 3. Fully loosen the knob on the operating room table rail camp until the ALLY II UPS™ is no longer firmly secured to the operating room table. The ALLY II UPS™ can be lifted off the rail clamp. Figure 4 shows how to remove the ALLY II UPS™... -
Page 11: Section 13 Guidance And Manufacturer's Declaration - Electromagnetic Emissions
(for all Medical Equipment and Medical Equipment Systems) The ALLY II UPS™ is intended for use in the electromagnetic environment specified below. The customer or the user of the ALLY II UPS™ should assure that it is used in such an environment. -
Page 12: Section 15 Guidance And Manufacturer's Declaration
(for all Medical Equipment and Medical Equipment Systems that are not Life-Supporting) The ALLY II UPS™ is intended for use in the electromagnetic environment specified below. The customer or the user of the ALLY II UPS™ should assure that it is used in such an environment. -
Page 13: Section 16 Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And Ally Ii Ups
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ALLY II UPS™ system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 14: Section 17 Disposal
CooperSurgical warrants that the ALLY II UPS™ will be free from defects in materials and workmanship for one year from the date of purchase. If CooperSurgical, Inc. determines that the ALLY II UPS™ fails to perform within that one year, as the sole remedy for that failure to perform, at CooperSurgical’s discretion, we will repair or replace the ALLY II UPS™... -
Page 15: Section 20 Specifications
ALLY II UPS™ SECTION 20 SPECIFICATIONS Dimensions (H x W x D): ........15.4 inches x 22.3 inches x 7.5 inches (39.0 cm x 56.5 cm x 19 cm) Depth of the Main Unit: .........................4.5 inches (11.4 cm) Weight: ........................approximately 30 pounds (13.6 kg) Power Requirement Main Supply: ...........................100-240VAC, 50/60Hz... -
Page 16: Section 21 Glossary Of Symbols
ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005, C1:2009, A2:2010 and CAN/CSA-C22.2 No. 60601-1 2008 6D33 Prescription Device Medical device Non-sterile Equipotentiality Packaging Unit ALLY II UPS is a trademark of CooperSurgical, Inc. ™ da Vinci is a registered trademark of Intuitive Surgical, Inc. ® CaviWipes™ is a trademark of Metrex Research LLC CooperSurgical is a registered trademark of CooperSurgical, Inc.
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