KermaX plus C Model 120 series Users Guide July 2013

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Notice ®

This User's Guide is an integral part of the KermaX plus C model 120-121, 122, 123 and 126. To ensure proper use of this product, please read this manual carefully and keep it for the future reference. Do not carry out any adjustment or procedure other than those described in the manual. The attempt to do so may result in hazardous situation such as fire, explosion or electric shock to patient, operator or service engineer. ®

KermaX plus C and its accessories must not be used for any other purpose than described in the accompanying documentation (intended use). Violation will result in loss of warranty. IBA Dosimetry GmbH does not accept liability for injury to personnel or damage to equipment that may result from misuse of this equipment, failure to observe the hazard notices contained in this manual, or failure to observe local health and safety regulations. IBA Dosimetry GmbH shall under no circumstances be liable for incidental or coincidental damage arising from use of the equipment described in this document. No part of the accompanying documentation may be translated or reproduced without written permission of IBA Dosimetry GmbH, unless reproduction is carried out for the sole purpose to be used by several people in the same department. The user must treat the accompanying documentation like any other copyrighted material. Especially, if part of the accompanying documentation is provided in electronic form, these files shall not be modified in any way. IBA Dosimetry GmbH and its suppliers retain title and all ownership rights to the accompanying documentation including those of translation into other languages, either in electronic or printed form. ®

Several key functions of the KermaX plus and its associated components are protected by international patents. ®

KermaX is a registered trademark of IBA Dosimetry GmbH. All other brands, trademarks and trade names mentioned in this documentation are the property of the applicable manufacturers and companies. IBA Dosimetry GmbH renounces all claims of possession to rights in brands, trademarks and trade names mentioned in this documentation, which are not their property.

IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck Germany Phone: +49 9128 607- 0 Fax:

+49 9128 607- 10

www.iba-dosimetry.com

Last update: 2013-07-08 (Doc-ID: P-KermaX plus C 120-121 122 123 126-510-001 01)

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Table of Contents 1.

Introduction

1

1.1. 1.2. 1.3. 1.3.1. 1.3.2. 1.3.3. 1.3.4.

Intended Use Product Description About this Manual Conventions Intended User Symbols Used DAP Measurement

1 1 1 2 2 3 4

2.

Health and Safety Information

5

2.1. 2.2. 2.3. 2.3.1. 2.3.2. 2.3.3. 2.3.4. 2.3.5. 2.4. 2.4.1. 2.4.2. 2.4.3. 2.5. 2.6. 2.7. 2.8.

General Operator Safety Device Handling Protection from Fluids Radiation Protection Combination with Other Systems Use of Accessories Electromagnetic Compatibility (EMC) Electromagnetic emissions Electromagnetic Immunity Recommended separation distances Labels Transportation Environmental requirements Regulatory Requirements

5 5 5 6 6 6 7 7 8 8 9 11 12 12 12 13

3.

System Components

15

3.1. Standard Components 3.1.1. The DAP Chambers 3.2. Optional Components

15 15 16

4.

Installation

17

4.1.

Standard Setup

17

5.

Applications with SDP

19

5.1. 5.2. 5.3. 5.4.

Main Functions of the Single Line Display (SDP) Stability Check Measurement Internal Display Setup

19 19 20 20

6.

Calibration and Quality Assurance

25

6.1. 6.2.

Time Table and Tolerance for Quality Assurance Verification

25 26

KermaX® plus C OEM Manual | Introduction| iii

6.2.1. 6.2.2. 6.2.3. 6.2.4.

Reference conditions for calibration Putting the System into Operation ® Stability Check of KermaX plus C Measurement

26 26 27 27

7.

Service

31

7.1. 7.1.1. 7.1.2. 7.2. 7.3. 7.4. 7.5. 7.6.

Warranty Warranty, General Warranty, Limitations ® Maintenance of KermaX plus C Cleaning and Disinfection Troubleshooting Safety Inspection Disposal and Recycling

31 31 31 32 32 33 34 34

8.

Technical Specifications

35

®

8.1. 8.2. 8.3. 8.3.1. 8.3.2. 8.3.3. 8.4. 8.4.1. 8.4.2. 8.5.

Technical Specifications of KermaX plus C Environmental Conditions Dimensions of Chambers Chamber Model 120-121 Chamber Model 120-122 Chamber Model 120-126 Electrometer Module Dimensions standard version (120-126 C and 120-210) slim-line version for 120-126_HS/RS485 Pin-Assignment of the chamber and Commands

35 36 37 37 38 39 40 40 40 41

9. 10.

Index Technical Support

43 47

10.1. 10.2. 10.3.

Technical Support Reporting Complaints Returning device for repairs

47 47 47

iv| Introduction | KermaX® plus C OEM Manual

1. Introduction 1.1. Intended Use ®

The KermaX plus C model 120-121, -122, -123, -126 are designed to be installed in diagnostic X-ray units (mounted on the collimator) for the measurement of air kerma product (AKP), also called Dose Area Product (DAP) and DAP rate, exposure time. The system and its accessories must not be used for any other purpose than described in the accompanying documentation (intended use).

1.2. Product Description ®

The KermaX plus C chambers are circular, non-transparent ionization chambers with detached measurement electronics. They are available with external display (Single line DisPlay, SDP) or without display. The chambers are very robust constructed, some with backlight display and different interfaces for printers, RIS/HIS, generator or imaging system connection.

1.3. About this Manual ®

This manual describes safety information, functionalities and applications of KermaX plus C measurement systems. To ensure proper use of this product, please read this manual carefully and keep it for future reference. Do not carry out any adjustment or procedure other than those described in the manual. The attempt to do so may result in hazardous situation such as fire, explosion or electric shock to the patient, operator or service engineer. The operator must be trained in the proper operation of the product. IM PO RT ANT N O T IC E PICTURES AND SCREENSHOTS All numbers and selections displayed in pictures and screenshots are only examples and no recommendations for settings or entries. IM PO RT ANT N O T IC E NOT ALL PARTS OF THE MANUAL CORRESPOND TO THE DELIVERED PRODUCTS This manual describes the typical configuration of this product. However, due to customer specific requirements not all parts of this manual, e.g. the chapter concerning the displays, may correspond to the delivered products.

KermaX® plus C OEM Manual | Introduction| 1

1.3.1. Conventions The functions of the device, dialog captions and dialog text are indicated by bold font. Examples: Photon Settings, Field size. Referrals to chapter and section headings in this manual are indicated by italic font. Examples: Notice, Technical Specifications. Throughout this User's Guide, hazardous situations or operations are identified by DANGER, WARNING, CAUTION and NOTICE. They are indicated by specific signs and colors, described below:

Sign

Meaning DANGER indicates a hazardous situation, which, if not avoided, will result in death or serious injury of the operator or patient. WARNING indicates a hazardous situation, which, if not avoided, could result in death or serious injury of the operator or patient. CAUTION, used with a safety alert symbol, indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury of the operator or patient. CAUTION, without the safety alert symbol, used to address issues related to possible hardware damage. IMPORTANT NOTICE used to address operational issues not related to personal injury or hardware damages.

1.3.2. Intended User This manual is intended for personnel with the following expertise: Area

Expertise

Installation

Experts

Start-up, operation and shutdown

Experts Trained personnel

Maintenance

Experts

Troubleshooting

Experts

2| Introduction | KermaX® plus C OEM Manual

1.3.3. Symbols Used The following symbols are used in this manual:

Consult the User's Guide before use Symbol for Class II Equipment 0124

The device meets the essential requirements of Council Directive 93/42/EEC concerning medical devices. The device meets the essential requirements of UL 60601-1 and CSA, C22.2 No.601.1 Energy dependence Equivalent filtration DC current Recycling Separate collection of electrical and electronic devices in accordance with EC Directive 2002/96/EC: Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose in an environmentally safe way in compliance with local regulations. Interference may occur in the vicinity of equipment marked with this symbol. Manufacturing date This symbol is accompanied by a date to indicate the date of manufacture, as four digits for the year Device Part Number Serial Number

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1.3.4. DAP Measurement ®

The KermaX plus C indicates the product of dose and radiation field area in air irrespective of patient distance from the X ray tube as shown in the figure below. This is a convenient phenomenon, which allows a remote collimator mounted chamber to measure the Air Kerma Product (AKP) respectively Dose Area Product (DAP) as it is more commonly known in the patient plane. There are numerous published papers on DAP reference levels and their relationship to short term radiation injury and long term risk for different examinations, thus avoiding the need for additional calculations.

If the real time display of DAP values and perhaps the DAP rate is available, the physician will rapidly become familiar with factors which affect DAP levels. Learning to keep the radiation field collimated to the area under investigation can have a remarkable influence on total examination DAP (up to 50% reduction in some cases). Using fluoroscopy for the minimum period can also show similar reductions.

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2. Health and Safety Information 2.1. General The purpose of this chapter is to identify the hazards associated with the equipment. This information is presented by displaying all safety and rating labels, which are attached to the equipment, and by providing instructions to avoid the associated hazards. IM PO RT ANT N O T IC E ALL PERSONNEL MUST READ THIS CHAPTER All personnel must read this chapter and be fully aware of its contents before ® commencing installation work, and before operating or servicing the KermaX plus C. If the KermaX® plus C is used in a way not specified in this User's Guide, the protection provided by the equipment may be reduced.

2.2. Operator ®

The KermaX plus C should only be used by people who are aware of and understand the limitations of the device as they relate to the measurement of radiation output, knowledgeable about safety procedures to be observed when working with radiation sources.

2.3. Safety IM PO RT ANT N O T IC E LIABILITY As manufacturer, IBA Dosimetry GmbH will not be held responsible for the safety features, reliability and performance of the system if: The system is used in a manner other than that specified in the operating manual. Installation, upgrades, resetting or repairs are performed by unauthorized personnel. Components affecting product safety are not replaced with original IBA Dosimetry GmbH spare parts.

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2.3.1. Device Handling Before using the system, the operator must ensure that the chamber and all accessories are in proper working condition. The user must verify the general functionality, safety, and condition of the display unit, the cables and the detector(s). ®

Neither the KermaX plus C chamber nor any peripheral device must be used in direct contact to the patient. Do not remove any labels from parts of the system components or its accessories. Do not open the chamber in order to avoid contact with hazardous high voltage. The housing of the chamber is not waterproof. When the risk of splashing fluid is present, mount the chamber under auxiliary covers. ®

The KermaX plus C chamber requires a voltage in the range of 15 - 24 V DC ± 20%, which is normally provided by a power supply with 4 kV isolation according to IEC 60601-1. Connecting the chamber to another external power supply shall only be done with the approval and under the sole responsibility of the manufacturer of the diagnostic X-ray machine. The range and type of the voltage provided shall be checked and, if necessary, discussed with IBA Dosimetry GmbH. C AUT IO N ENSURE A SECURE INSTALLATION When mounting the chamber and its accessarires (holder, filter, etc.) on a X-ray machine, make sure the devices are locked securely in place to prevent falling down of the device when the collimator rotates. It may damage the device. C AUT IO N HIGH VOLTAGE INSIDE THE CHAMBER Be careful with high voltages. Danger of electrical shock!

2.3.2. Protection from Fluids Do not allow fluids to enter the system either during normal operation or during cleaning and disinfection as this may damage the system or cause a system malfunction.

2.3.3. Radiation Protection Please adhere to the following recommendations to keep the absorbed dose for the patient as low as possible: When available, always use the automatic dose rate and / or exposure control since these contribute considerably to the reduction of radiation exposure for the patient and the operator. Collimate the exposure field as small as possible, or use the automatic collimation if available. Keep the fluoroscopic time as short as possible. Protect the patient using gonad shields or lead lined rubber covers when using radiation for examinations near the reproductive organs. Wear protective clothing when working in the examination area. Use a radiation-monitoring badge or a pen dosimeter.

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Maintain the maximum possible distance from the source of radiation. Maintain the maximum possible focus-skin-distance. Be aware that certain materials can lead to increased dose exposure, e.g. parts of a patient table, when located in the beam path. Components that are brought into the beam path, e.g. patient table, will attenuate radiation and may degrade image quality.

2.3.4. Combination with Other Systems ®

In the interest of safety, do not attach any products / components to the KermaX plus C. The use of accessory equipment like compensating filters not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: Use of the accessory in the patient vicinity Evidence that the safety certification of the accessory has been performed in accordance with the appropriate IEC 60601-1 harmonized national standards.

2.3.5. Use of Accessories C AUT IO N ACCESSORIES AND SPARE PARTS No other accessories and spare parts than those provided or approved by the manufacturer must be used, otherwise operator safety, specified measuring accuracy, and interference free operation cannot be guaranteed. Violation of this prescription will result in loss of warranty. IBA Dosimetry GmbH cannot be held liable for any damages resulting from the use of accessories or consumables that are not provided or approved by the manufacturer.

2.3.5.1. Positioning of Compensating Filters These filters are usually integrated into the cosmetic cover of the X-ray tube assembly or are integrated into the X-ray collimator. C AUT IO N INTEGRATED FILTERS CAN CAUSE WRONG DAP VALUES Filters which are integrated in the over of the X-ray tube assembly may cause wrong DAP values. Please apply appropriate correction factors (see chapter 0 DAP Correction, page 23) or contact IBA Dosimetry GmbH for further assistance in this matter (see Chapter 10 for contact information) W AR NI NG USING FILTER IN CONSTANCY TEST In patient operation never use filters for constancy tests!

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2.4. Electromagnetic Compatibility (EMC) Medical electrical devices demand special precautions regarding EMC (electromagnetic compatibility), and need to be installed and put into service according to the information detailed below. Portable and mobile radio frequency (RF) communication equipment can afflict medical electrical equipment. IM PO RT ANT N O T IC E NO OTHER EQUIPMENT CLOSE TO THE OPERATING DEVICE The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. ®

The use of cables with the KermaX plus C other than those described in this document may result in an increased emission or decreased immunity of the KermaX® plus. Please be advised that other mobile electronic devices, e.g. cellular telephones, exceeding the established emission limits in the EMC standard may disrupt the function of the device.

2.4.1. Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions ®

The KermaX plus C is intended for use in the electromagnetic environment specified below. The ® customer or the user of the KermaX plus C should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Class B

The KermaX plus C uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Group 1 IEC/CISPR 11

Harmonic emissions

®

Not applicable

No connection to public mains network.

Not applicable

No connection to public mains network.

IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3

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2.4.2. Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity ®

The KermaX plus C is intended for use in the electromagnetic environment specified below. The ® customer or the user of the KermaX plus C should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD)

±6 kV contact

±6 kV

IEC 61000­4­2

±8 kV air

±8 kV

±2 kV for power supply lines

±2 kV

Electrical fast transient / burst

±1 kV for input/output lines ±1 kV differential mode

±1 kV

IEC 61000-4-4

Surge IEC 61000­4­5

±2 kV common mode <5 % U T (>95 % dip in U T ) for 0,5 cycle

Voltage dips, short interruptions and voltage variations on power supply input lines

40 % U T (60 % dip in U T ) for 5 cycles

IEC 61000­4­11

70 % U T (30 % dip in U T ) for 25 cycles

Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Not applicable

Only DC powered equipment.

Not applicable

No connection network.

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

to

public

mains

<5 % U T (>95 % dip in U T ) for 5 sec Power frequency (50/60 Hz) magnetic field IEC 61000­4­8

3 A/m

NOTE: U T is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity ®

The KermaX plus C is intended for use in the electromagnetic environment specified below. The ® customer or the user of the KermaX plus C should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used not closer to any part ® of the KermaX plus C, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF IEC 61000­4­6

3 V rms 150 kHz to 80 MHz

10V

Radiated RF IEC 61000­4­3

3 V/m 80 MHz to 2.5 GHz

10 V/m

Recommended separation distance: d = 0.35 √ P d = 0.35 √ P 80 MHz to 800 MHz d = 0.70 √ P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey 1, should be less than the compliance level in each frequency range 2. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is afflicted by absorption and reflection from structures, objects and people

1

Field strengths from fixed transmitters, such as base stations from radio (cellular / cordless) telephone and land mobile radios, amateur radio, AM, FM broadcast, and TV cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be ® considered. If the measured field strength in the location in which the KermaX plus C is used exceeds the ® applicable RF compliance level above, the KermaX plus C should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ® KermaX plus C. 2 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

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2.4.3. Recommended separation distances

Recommended separation distances between portable and mobile RF communications ® equipment and the KermaX plus C ®

The KermaX plus C is intended for use in an electromagnetic environment in which radiated RF ® disturbances are controlled. The customer or the user of the KermaX plus C can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF ® communications equipment (transmitters) and the KermaX plus C as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

(W)

d = 0.35 √ P

d = 0.35 √ P

d = 0.70 √ P

0.01

0.035

0.035

0.070

0.1

0.111

0.111

0.221

1

0.35

0.35

0.70

10

1.11

1.11

2.21

100

3.5

3.5

7.0

Separation distance according to frequency of transmitter (m)

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is afflicted by absorption and reflection from structures, objects and people.

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2.5. Labels The labels are located on either side of the electronic box and the chamber. On one side of the electronic box, the label indicates the identification electrical ratings. On the other side, the label indicates the device model number and serial number. The latter label is attached to the chamber as well. An example (Part No.:120–126 C) is shown as below. The upper picture is for the chamber with display and the lower for the chamber with integrated Serial Interface:

D-90592 Schwarzenbruck Bahnhofstrasse 5, Germany 120 - 126 C

2.6. Transportation IM PO RT ANT N O T IC E TRANSPORTATION ®

During transportation the KermaX plus C should be adequately protected in the originally supplied or equivalent packing.

2.7. Environmental requirements ®

The KermaX plus C should be stored in a clean, dry room. Protect it from mechanical and thermal stress, dust and unnecessary moisture. See Section 8.2 for Environmental Conditions. C AUT IO N WET DEVICES Devices on which moisture (condensation) has developed as a result of temperature changes must not be used unless they have been completely dried.

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2.8. Regulatory Requirements The KermaX® plus C fulfils the requirements of the Medical Device Directive 93/42/EEC. It is a medical device class llb according to annex IX, classification rule 10. The quality management system in IBA Dosimetry GmbH is certified according to EN ISO 13485.

0124 The following standards apply: IEC/EN 60601-1 IEC/EN 60601-1-2 IEC 60580 UL 60601-1 21 CFR 1020.30 CSA, C22.2 No.601.1 The KermaX® plus C is manufactured by: IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck Germany

IM PO RT ANT N O T IC E COMPLY WITH ALL LOCAL REGULATIONS The installer and operator are responsible for complying with all local regulations ® regarding installation and operation of the KermaX plus C. The overall safeguard of EMC test, radiation protection and other safety features of the X-ray system and the respective test results have to be guaranteed and documented by the system manufacturer.

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