Idi Aspect100RT Manual de usuario

Aspect100RT

Mobile Fluoroscopic Table

Operator Manual

Made in the USA

Operator Manual 
Aspect 100RT 
 
 
L100-3061 REV A www.imagediagnostics.com ii 
 
Table of Contents 
PRODUCT DATA............................................................................................................................................ 1 
INTRODUCTION ............................................................................................................................................ 2 
CUSTOMER SUPPORT................................................................................................................................... 3 
SYMBOLS AND DATA PLATE......................................................................................................................... 4 
SPECIFICATIONS............................................................................................................................................ 3 
ELECTROMAGNETIC COMPATIBILITY STATEMENT...................................................................................... 4 
SETUP............................................................................................................................................................ 5 
SAFETY HAZARDS.......................................................................................................................................... 6 
SAFETY HAZARD ALERTS .............................................................................................................................. 7 
SAFETY INSTRUCTIONS................................................................................................................................. 7 
ACCESSORIES ..............................................................................................................................................10 
OPERATOR CONTROLS ............................................................................................................................... 16 
EMERGENCY STOP SWITCH........................................................................................................................ 19 
EQUIPOTENTIAL TERMINAL ....................................................................................................................... 19 
ELECTRIC SYSTEM .......................................................................................................................................20 
BATTERY FUNCTION (MOTORIZED TABLES) .............................................................................................. 21 
GENERAL CLEANING ................................................................................................................................... 21 
MAINTENANCE ........................................................................................................................................... 24 
USER REPLACEMENT ITEMS ....................................................................................................................... 25 
TROUBLE-SHOOTING..................................................................................................................................26 
DISPOSAL OF COMPONENTS...................................................................................................................... 27 
WARRANTY.................................................................................................................................................28 
 
Linak documentation can be found at their web site: www.linak-us.com 
Select “Products | User manuals” and click on “Actuators & Electronics”. 
 
The text of this manual was originally written, approved 
 and published by the manufacturer in English. 

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 1

PRODUCT DATA

•Low attenuation carbon fiber tabletop

•Low attenuation patient pad

•Standard Tabletop: 61cm x 203cm (24in x 80in)

•Trendelenburg: ±15°

•Height range: 77cm to 107cm (30.4in to 42.2in)

•Patient capacity: 204kg (450lbs)

•Table weight: ~172kg (~380lbs)

•Locking swivel casters

•Hand & foot operator controls standard

•Emergency Stop Switch

•Equipotential Terminal

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 2

INTRODUCTION

Overview

This manual pertains to the specified product only. It is intended for qualified medical

personnel who have been trained in the use of medical equipment. It is not designed to

replace or substitute for certified training in the application of this equipment.

Functional capabilities and operation of the equipment described herein which can be

employed in a variety of diagnostic, therapeutic, and surgical applications. It is designed

for use as either a fluoroscopic or radiographic table.

Owner Responsibilities

The owner is responsible to ensure system compatibility, the qualifications of the

operator and maintenance personnel. The operator must be properly trained and have

obtained credentials from the appropriate authorities.

This equipment should only be installed in an area provided with the proper electrical

power.

The owner is responsible for verifying continued compliance with all applicable

regulations and standards. Consult local, state, federal and/or international agencies

regarding specific requirements and regulations applicable to the use of this equipment.

Image Diagnostics, Inc. certifies this equipment. After-sale operating practices and safety

are the responsibility of the owner and operator. Image Diagnostics, Inc. assumes no

liability or responsibility for after-sale operating or safety practices; nor can it be

responsible for personal injury or damage resulting from misuse.

Never make modifications or adjustments to the equipment unless directed by a qualified

Image Diagnostics representative. This equipment, when properly assembled, meets US

federal regulations and international standards. Unauthorized modifications to the

equipment may impact adherence to these standards and make the equipment unsafe to

operate.

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 3

CUSTOMER SUPPORT

Image Diagnostics will make available, on request, circuit diagrams,

component part lists, calibration instructions, or other information which

will assist the user’s appropriately qualified technical personnel to repair

those parts of equipment which are designated by the manufacturer as

repairable.

For technical assistance, call IDI at (978) 829-0009 or send fax to (978)

829-0027. Be prepared to give the complete model and serial number

found on the dataplate on the table base at the time of contact.

This X-ray component manufactured by Image Diagnostics, Inc. complies

with applicable FDA performance standards contained in 21CFR at date of

manufacture.

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 4

SYMBOLS AND DATA PLATE

Intertek Testing Service

The system was tested and found to be in compliance with the

requirements of all relevant directives and standards in effect within

the European Union at the time of manufacture.

Attention! Consult accompanying documents.

Failure to follow these instructions can cause accidents resulting in

serious personal injury or damage to equipment. CD ROMs

containing file copies of all relevant drawings, BOMs, and

documentation are included with this manual, one for general

operators and one for the BIOMED department.

Type B equipment

Alternating current

Data Plate

Maximum Patient Weight

Equipotential Terminal (Featured on some models)

Indicates the Equipotential terminal of the table. Provides for a

connection between the table and the equipotential bus bar of the

facility.

Emergency Stop Button

204 kg

450 LBS

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 2

LATEX

Recycle

Some of the material can be recycled rather than discarded.

Not for Patient Transport. The table should not be relocated with a

patient on it nor should it be used to move a patient.

Do Not Sit

This label is found on parts that are not designed to support the

sitting weight of a patient.

Not made with natural rubber latex.

Single Use item.

This symbol, when used in this manual, indicates the potential of

exposure to harmful x-rays. Be sure to read and comply with all

warnings.

European Authorized

Representative

Warning! Information or instructions shown near this symbol must

be adhered to in order to prevent a potentially hazardous situation

which if not avoided, could result in death, personal injury or

damage to the equipment.

Protective Ground

This is the common tie point between the AC cord ground, frame

ground, and controller ground.

REP

Advena Ltd. Tower Business Centre, 2nd Flr.,

Tower Street, Swatar, BKR 4013 Malta

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 3

SPECIFICATIONS

Mode of Operation:

For continuous operation with short time loading

Duty Cycle: 10% (6 min/hr)

Type of Equipment:

Class I Type B (as defined by IEC 60601-1, UL 60601-1,

EN 60601-1, CSA 601.1, IEC 60601-2-32:1994 and IEC 60601-2-46)

Type B protection against electrical shock

Complies with FDA standards

Electrical:

Supply Voltage: 120±5% Vac 60Hz or 23010% Vac 50Hz

Duty Cycle: 10% (6 min/hr)

Current Rating: Less than 10 Amps

Internally Battery Powered

Environmental:

Operating Temperature Range: -10C to +40C

Operating Humidity Range: 30% to 75% relative humidity, noncondensing

Operating Pressure Range: 700hPa to 1060 hPa

Transport & Storage Temperature Range: -40C to +60C

Transport & Storage Humidity Range: 30% to 75% relative humidity, noncondensing

Transport & Storage Pressure Range: 500hPa to 1060 hPa

Rated IPX4 (Protected against splashing water)

Meets EMC requirements of EN 60601-2 (1993)

Tabletop:

The tabletop is made of carbon fiber and is certified to meet all the requirements of 21

CFR Subchapter J

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 4

ELECTROMAGNETIC COMPATIBILITY STATEMENT

This equipment may generate and use radio frequency energy. The equipment must be

installed and used according to the manufacturer’s instructions in order to avoid radio

frequency interference.

If this equipment generates or receives interference:

•Verify that the equipment is the cause by turning the system off and on.

•In the event of unintended motor actuation, immediately remove power to the

equipment.

•Use only cables supplied by Image Diagnostics, Inc.

Operator Manual

Aspect 100RT

L100-3061 REV A www.imagediagnostics.com 5

SETUP

Unpack

No special handling is required for unpacking this equipment at the site. Conventional

shipping materials are used.

To remove the table from the shipping pallet, roll the table down a temporary ramp or lift

off pallet with a forklift. When using a forklift, pad the forks to protect the paint. Lift

from under the metal base. When rolling the table off the pallet by hand, grip the handles

attached to the tabletop to guide the table after releasing the caster brakes.

Install

Mobile tables are equipped with four locking caster brakes. Unlock brakes while positioning.

Hand controls are standard with this table with foot controls as optional. The operator should

become familiar with the controls before using.

The table operates on 110Vac (or 230Vac) or on internal battery backup. Plug the power cord into

a properly grounded hospital grade outlet. The green indicator will illuminate. The green

indicator can be seen through the port in the large side cover.

The outlet used should be visible and accessible to the user. The cord should be routed where it

will not be subject to damage or be a hazard. Check that the power cord ground pin is in good

condition. Check that the cord ground wire is securely connected to the ground stud inside the

unit.

During an AC failure, the table will automatically run on battery backup without any manual

switching required. It is recommended that power be applied at all times, even when not in use, to

keep a proper charge on the batteries and achieve maximum battery life. (Batteries are being

charged during normal use).

Where the integrity of the external protective earth conductor is in doubt, this equipment shall be

operated from its internal electrical power source by unplugging the power cord from the mains.

Recycle or dispose of shipping

material per local regulations.

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