Cooper Surgical ALLY II UPS Instructions For Use Manual Download Page 16

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Phone: (800) 243-2974

Fax: (800) 262-0105

International:

Phone: +1 (203) 601-9818

Fax: +1 (203) 601-4747

www.coopersurgical.com

CLP4274203 • Rev. A • 11/22

CooperSurgical, Inc.

95 Corporate Drive

Trumbull, CT 06611 USA

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.

Symbol

Title

Manufacturer

Caution

Catalogue number

Serial number

Country of manufacture

Date of manufacture

Consult instructions for use

6D33

UL Rating/Approved MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARD

ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005, C1:2009, A2:2010 and CAN/CSA-C22.2 No. 60601-1 2008

Prescription Device

Medical device

Non-sterile

Equipotentiality

Packaging Unit

SECTION 21 GLOSSARY OF SYMBOLS

ISO 15223-1, ISO 7000, and ISO 60417

Summary of Contents for ALLY II UPS

Page 1: ...ning System Instructions for Use AU UPS2 CLP4274203 Rev A 11 22 English en 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 www coopersurgical com ...

Page 2: ...3 ATTACHING THE ADAPTER DRAPE 9 12 4 INTRA OPERATIVE USE 9 12 5 REMOVING THE ALLY II UPS 10 12 6 POWERING DOWN THE ALLY II UPS 10 12 7 CLEANING AND STORAGE 10 SECTION 13 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS for all Medical Equipment and Medical Equipment Systems 11 SECTION 14 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY for all Medical Equipment and...

Page 3: ...al 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 visuali...

Page 4: ...e separation between the interfering equipment and the ALLY II UPS Incrementally turn off equipment in the vicinity to identify the interfering device 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 Inspect the ada...

Page 5: ...ipulator in a desired position The ALLY II UPS consists of the ALLY II UPS and the manipulator adapter with built in sterile drape sold separately known as the adapter drape Figure 1 shows the system followed by descriptions of its various parts Figure 1 ALLY II Uterine Positioning System ALLY II UPS NON STERILE Must drape prior to use as shown Manipulator Adapter Sterile Drape Flexible Arm ALLY I...

Page 6: ...lling or removing the ALLY II UPS from the rail Refer to Section 12 2 for more information Power Cord A detachable power cord is included which supplies power to both the main unit and the foot pedal Grounding Post To access ground connection 2 ALLY II UPS RAIL CLAMP Used to mount the ALLY II UPS to the patient s right side rail of standard operating room tables Secure by tightening the knob 3 ADA...

Page 7: ...urer s instructions for proper use and positioning Ensure patient is placed such that the buttocks are as close to edge as possible 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 into the rail clamp 4 Tighten the knob by hand ...

Page 8: ...sonnel actuating theALLY II UPS It is recommended to position the ALLY II UPS foot pedal separately from other foot pedals CAUTION Securely hold arm or manipulator before depressing foot pedal 7 Turn the power on and verify that the green light indicator is lit Press and hold the foot pedal once Release to initialize the ALLY II UPS The ALLY II UPS arm can be moved by grasping the flexible arm and...

Page 9: ...flexible arm during the remaining patient preparation steps 3 It is recommended to drape the patient s legs at this step in the process NOTE Continue with necessary patient preparation steps 12 4 INTRA OPERATIVE USE 1 Grasp the handle of the manipulator or the ALLY II UPS flexible arm 2 Depressing the foot pedal allows for dynamic manipulation of the flexible arm 3 Maneuver to the desired position...

Page 10: ...the rail clamp and store it with the ALLY II UPS 12 7 CLEANING AND STORAGE 1 The ALLY II UPS system including main unit fixed arm handle and foot pedal should be cleaned after each use Only use Isopropyl Alcohol 70 percent 70 or higher or CaviWipes or equivalent not to exceed 28 ammonium chloride Wipe all surfaces free of debris Do not spray flexible arm Ensure flexible arm is locked in upright or...

Page 11: ... GHz b 80 AM at 1 kHz c 10 V m f 80 MHz 2 7 GHz b 80 AM at 1 kHz c Proximity fields from RF wireless communications equipment IEC 61000 4 3 See 8 10 IEC 60601 1 2 Ratedpowerfrequencymagnetic fields d e IEC 61000 4 8 30 A m g 50 Hz or 60 Hz a The interface between the patient physiological signal simulation if used and the ME equipment or ME system shall be located within 0 1 m of the vertical plan...

Page 12: ...r input of the converter g Applicable only to ME equipment and ME systems connected to single phase a c mains h E g 10 12 means 10 periods at 50 Hz or 12 periods at 60 Hz i ME equipment and ME systems with rated input current greater than 16 A phase shall be interrupted once for 250 300 cycles at any angle and at all phases at the same time if applicable ME equipment and ME systems with battery ba...

Page 13: ...lation b 217 Hz 2 0 3 28 5 240 5 100 5 800 WLAN 802 11 a n Pulse Modulation b 217 Hz 0 2 0 3 9 5 500 5 785 NOTE If necessary to achieve the immunity test level the distance between the transmitting antenna and the ME equipment or ME system may be reduced to 1 m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be mo...

Page 14: ... 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 free of charge SECTION 19 SERVICE Annual service by authorized CooperSurgical personnel is required to ensure proper device operation Please contact CooperSurgical Re...

Page 15: ... Slow Blow Classification I IP Rating Main Unit IP30 Foot Pedal IPX6 Average Duty Cycle Rating 5 seconds ON 300 seconds OFF No customer replaceable components inside the main unit assembly Environmental Conditions Operational Temperature 68 F to 75 F 20 C to 24 C Humidity 20 RH to 60 RH Shipping and Storage Temperature 14 F to 122 F 10 C to 50 C Humidity 10 RH to 85 RH 7 5 19 cm 15 4 39 0 cm 22 3 ...

Page 16: ...erSurgical is a registered trademark of CooperSurgical Inc 2022 CooperSurgical Inc Symbol Title Manufacturer Caution Catalogue number Serial number Country of manufacture Date of manufacture Consult instructions for use 6D33 UL Rating Approved MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARD ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 C1 2009 A2 2010 and CAN CSA C...

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