CPI INDICO 100 Series Bedienungsanleitung

CPI INDICO 100 SERIES

X-RAY GENERATOR

IIIIII

Indico 100

OPERATOR’S MANUAL

PREPARED BY:

COMMUNICATIONS & POWER INDUSTRIES CANADA INC.

45 RIVER DRIVE

GEORGETOWN, ONTARIO, CANADA L7G 2J4

TELEPHONE: (905) 877-0161

OPERATOR’S MANUAL P/N 740953-00

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CPI Canada Inc

Indico 100 Series Operator Manual 740953-00 Rev. A Page 3

INTRODUCTION

1¾

INDICO 100

OPERATOR

SAFETY AND SPECIFICATIONS

2¾

MANUAL

CONSOLE CONTROLS

3¾

P.N. #740953

REMOTE FLUORO CONTROLLER

4¾

PROGRAMMING THE CONSOLE

5¾

ERROR CODES AND MESSAGES

6¾

GENERATOR EXPOSURE TABLES

7¾

MAINTENANCE SCHEDULE

8¾

X-RAY TUBE DATA

9¾

The original version of this manual (15 September 2000)

has been drafted in the English language by:

Communications & Power Industries

communications & medical products division.

CPI Canada Inc

Page 4 Rev. A Indico 100 Series Operator Manual 740953-00

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CPI Canada Inc

Indico 100 Series Operator Manual 740953-00 Rev. A Page 5

INTRODUCTION 1

Congratulations!

You have acquired the CPI Indico 100 series high frequency X-ray generator. This generator features

state-of-the-art computer-based control to ensure minimum patient dose, excellent repeatability, and

superior contrast. The operator control functions are designed to be simple and user-friendly.

The AEC (Automatic Exposure Control) and APR (Anatomical Programming) features give you controlled

exposure factors, automatically optimized for the radiological study selected.

INDICO 100 MAIN FEATURES

• Models available in maximum output power of 30 to 80 kW, in both radiographic and fluoroscopic models.

• Full 150 kV capability for all models.

• Smaller, lighter modular design.

• Constant dose output due to kVp and mA regulation during exposures.

• User-friendly controls.

• Large LCD panel display for APR and utility routines.

• User-friendly system configuration.

• APR techniques may be modified by the operator.

• ms and mAs limits for AEC may be operator set.

• Provisions for APR / tube downloading.

• Extensive self-diagnostics with operator prompt messages.

• Serial RS232 communications interface.

• May be programmed for APR operation only or both APR and manual technique selection.

• Time and mA / mAs selections are to IEC standards.

• Programmable setup, calibration and APR routines (using an external computer).

• Choice of six fluoro kV to rad kV transfer curves (R & F units only).

• Choice of four kV vs mA curves for ABS (automatic brightness stabilization) circuits (R & F units only).

OPTIONS

• Dual speed starter for automatic high / low speed selection.

• Two-tube capability.

• Pedestal mount for operator control console.

• Automatic Brightness Stabilization (ABS) for consistent imaging (AUTO kV / mA or kV only).

• Remote fluoro controller for R & F table side operation.

• Digital imaging interface.

• Trauma control console.

• Remote exposure hand switch.

• High level fluoro for therapy simulators.

SAFETY NOTICE: This manual contains important operating and safety information. An understanding

of this information is critical to the safe operation and long term reliability of your

equipment. Please ensure that you read the warning notices before using this

equipment.

1Introduction CPI Canada Inc

Page 6 Rev. A Indico 100 Series Operator Manual 740953-00

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CPI Canada Inc

Indico 100 Series Operator Manual 740953-00 Rev. A Page 7

FET

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Keep this operator’s manual with the equipment at all times, and periodically review the operating and safety

instructions.

SAFETY / WARNING SYMBOLS

Warning symbol used to indicate a potential hazard

to operators, service personnel or to the equipment.

It indicates a requirement to refer to the

accompanying documentation for details.

Radiation exposure symbol used on operator

console. Lights to indicate that an exposure is in

progress. This is accompanied by an audible tone

from the console.

Fluoro radiation exposure symbol used on operator

console and on optional remote fluoro control unit.

Lights to indicate that a fluoro exposure is in

progress. This is accompanied by an audible tone

from the console.

WARNING THIS X-RAY UNIT MAY BE

DANGEROUS TO PATIENT AND

OPERATOR UNLESS SAFE

EXPOSURE FACTORS AND

OPERATING INSTRUCTIONS

ARE OBSERVED.

Radiation warning label on console, used in certain

jurisdictions.

Never allow unqualified personnel to operate the X-

ray generator.

WARNING: PROPER USE AND SAFE OPERATING PRACTICES WITH RESPECT TO X-RAY

GENERATORS ARE THE RESPONSIBILITY OF THE USERS OF SUCH GENERATORS. CPI

CANADA INC. PROVIDES INFORMATION ON ITS PRODUCTS AND ASSOCIATED

HAZARDS, BUT ASSUMES NO RESPONSIBILITIES FOR AFTER-SALE OPERATING AND

SAFETY PRACTICES.

CPI CANADA INC. ACCEPTS NO RESPONSIBILITY FOR ANY GENERATOR NOT

MAINTAINED OR SERVICED ACCORDING TO THE SERVICE AND INSTALLATION MANUAL

OR ANY GENERATOR THAT HAS BEEN MODIFIED IN ANY WAY.

CPI CANADA INC. ALSO ASSUMES NO RESPONSIBILITY FOR X-RAY RADIATION

OVEREXPOSURE OF PATIENTS OR PERSONNEL RESULTING FROM POOR OPERATING

TECHNIQUES OR PROCEDURES.

WARNING: THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE

EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.

2Safety and Specifications CPI Canada Inc

Page 8 Rev. A Indico 100 Series Operator Manual 740953-00

X-ray radiation exposure may be damaging to health, with some effects being cumulative and extending over

periods of many months or even years. X-ray operators should avoid any exposure to the primary beam and

take protective measures to safeguard against scatter radiation. Scatter radiation is caused by any object in the

path of the primary beam and may be of equal or less intensity than the primary beam that exposes the film.

No practical design can incorporate complete protection for operators or service personnel who do not take

adequate safety precautions. Only authorized and properly trained service and operating personnel should

be allowed to work with this X-ray generator equipment. The appropriate personnel must be made aware of

the inherent dangers associated with the servicing of high voltage equipment and the danger of excessive

exposure to X-ray radiation during system operation.

• Wear protective clothing. Protective aprons with an equivalent of a minimum of 1/64” (0.35 mm) of lead are

recommended.

• To protect the patient against radiation, always use radiation protection accessories in addition to devices

which are fitted to the X-ray equipment.

• Keep as large a distance as possible away from the object being exposed and the X-ray tube assembly.

• This X-ray equipment may only be operated in medical rooms which meet IEC requirements.

• Never operate this X-ray equipment in areas where there is a risk of explosion. Detergents and disinfectants,

including those used on patients, may create explosive mixtures of gases. Please observe the relevant

regulations.

• The operator console, or anything electrically connected to it, must never be used within 6 ft (1.8 m) of the

patient environment.

• Only trained maintenance staff may remove the covers of the generator cabinet and the control console.

Do not connect unapproved equipment to the rear of the console: J5 is for the interconnect

cable to the generator main cabinet, J2 is a serial port for use by an external computer, and

J13 is for connection of an external hand switch and / or foot switch. INCORRECT

CONNECTIONS OR USE OF UNAPPROVED EQUIPMENT MAY RESULT IN INJURY OR

EQUIPMENT DAMAGE.

CONSULT YOUR SERVICE REPRESENTATIVE IF EXTERNAL EQUIPMENT IS TO

BE CONNECTED TO THIS SYSTEM. PERIPHERAL DEVICES SHOULD BE IEC 601-1

APPROVED IF LOCATED IN THE PATIENT AREA, AND IEC 950 APPROVED IF OUTSIDE

THE PATIENT AREA.

CAUTION: DO NOT EXCEED THE TUBE MAXIMUM OPERATING LIMITS SHOWN IN THE SECTION X-

RAY TUBE DATA AT THE END OF THE OPERATOR’S MANUAL. INTENDED LIFE AND

RELIABILITY WILL NOT BE OBTAINED UNLESS GENERATORS ARE OPERATED WITHIN

PUBLISHED SPECIFICATIONS.

CPI Canada Inc Safety and Specifications 2

Indico 100 Series Operator Manual 740953-00 Rev. A Page 9

APPLICABLE STANDARDS

The Indico 100 family of generators complies with the following regulatory requirements and design standards:

• FDA Center for Devices & Radiological Health (CDRH) - 21 CFR title 21 subchapter J (USA).

• Radiation Emitting Devices Act - C34 (Canada).

• Medical Device Regulations (Canada).

• EC Directive 93/42/EEC concerning Medical Devices (European Community).

• IEC 601.1, IEC 601.2.7:1998, CSA 601.1, UL2601.1

-Type of protection against electric shock: Class I equipment.

-Degree of protection against electric shock: Not classified.

-Degree of protection against harmful ingress of water: Ordinary equipment.

-Mode of operation: Continuous operation with intermittent loading (standby - exposure).

-Equipment not suitable for use in presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR

OR WITH OXYGEN OR NITROUS OXIDE.

• IEC 601.1.2

Immunity:

IEC1000-4-2 Electrostatic discharge

IEC1000-4-3 Radiated RF field

IEC1000-4-4 Electrical fast transient

IEC1000-4-5 Surge

IEC1000-4-6 Conducted RF immunity

IEC1000-4-8 Magnetic field immunity

IEC1000-4-11 Voltage dips, interrupts and variations

Emission:

EN55011 (CISPR Publications II Emission Standards, Group 1 Class A).

ELECTROMAGNETIC COMPATIBILITY (EMC)

In accordance with the intended use, this X-ray generator complies with the European Council Directive

concerning Medical Devices. The CE marking affixed to this product signifies this. One of the harmonized

standards of this Directive defines the permitted levels of electromagnetic emission from this equipment and its

required immunity from the electromagnetic emissions of other devices.

It is not possible, however, to exclude with absolute certainty the possibility that other high frequency electronic

equipment, which is fully compliant to the EMC regulations, will not adversely affect the operation of this generator.

If the other equipment has a comparatively high level of transmission power and is in close proximity to the

generator, these EMC concerns (the risk of interference) may be more pronounced. It is therefore recommended

that the operation of equipment of this type such as mobile telephones, cordless microphones and other similar

mobile radio equipment be restricted from the vicinity of this X-ray generator.

2Safety and Specifications CPI Canada Inc

Page 10 Rev. A Indico 100 Series Operator Manual 740953-00

OUTPUT PARAMETERS

• kVp range: Radiography 40 to 150 kVp.

Fluoroscopy 40 to 125 kVp.

• kVp accuracy: ±(5% + 1) kVp.

• mA range: Radiography 10 to 320 mA (30 kW), 10 to 400 mA (37.5 kW), 10

to 630 mA (50 kW), 10 to 800 mA (65 kW), and 10 to 1000 mA (80

kW).

Fluoroscopy 0.5 to 6.0 mA.

• mA accuracy: ±(5% +1.0) mA for all mA values.

• mAs range: Tube dependent, max 1000 mAs.

• Time range: Radiography 2.0 to 6300 ms.

Fluoroscopy 0 to 5 or 0 to 10 minutes.

• Lowest current - time

product:

0.5 mAs.

• Loading factors which

will allow lowest

current - time product:

All mA values ≤250 mA. Refer to table 1 in section 7.

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