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ALLY II UPS™

SECTION 16 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND

MOBILE RF COMMUNICATIONS EQUIPMENT AND ALLY II UPS™

(for all Medical Equipment and Medical Equipment Systems that are not Life Supporting)
The ALLY II UPS™ is intended for use in an electromagnetic environment in which radiated RF disturbances

are controlled. The customer or the user of the ALLY II UPS™ can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the

ALLY II UPS™ as recommended below, according to the maximum output power of the communications equipment.

Test

Frequency

(MHz)

Band

(MHz)

Service

Modulation

Maximum

power

(W)

Distance

(m)

Immunity test

level

(V/m)

385

380 - 390

TETRA 400

Pulse modulation

18 Hz

1,8

0,3

450

430 - 470

GMRS 460,

FRS 460

± 5 kHz deviation

1 kHz sine

0,3

710

704 - 787

LTE Band 13, 17

Pulse Modulation

18 Hz

0,2

0,3

745

780
810

800 - 960

GSM 800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

Pulse Modulation

217 Hz

0,3

870
930

1 720

1 700 - 1 990

GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3, 4, 25;

UMTS

Pulse Modulation

217 Hz

0,3

1 845

1 970

2 450

2 400 - 2 570

Bluetooth,

WLAN,

802.11 b/g/n,

RFID 2450,

LTE Band 7

Pulse Modulation

217 Hz

0,3

5 240

5 100 - 5 800

WLAN 802.11 a/n

Pulse Modulation

217 Hz

0,2

0,3

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.

For some services, only the uplink frequencies are included.

The carrier shall be modulated using a 50 % duty cycle square wave signal.

As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it

would be worst case.

WARNING:

Use of this equipment adjacent to or stacked with other equipment should be avoided because it

could result in improper operation. If such use is necessary, this equipment and the other

equipment should be observed to verify that they are operating normally.

WARNING:

Use of accessories, transducers and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic emissions or decreased

electromagnetic immunity of this equipment and result in improper operation.

WARNING:

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.

Содержание ALLY II UPS

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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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