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IBA KermaX-plus 120-131 E Oem Manual

Dap measurement system
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DAP Measurement System
KermaX-plus
Model Types:
120-131 E
120-131 HS
120-131RS-ZK
120-131 IS
120-131 IS HS
120-131 MICRO Rev01
OEM Manual
®
Chamber
120-131 OEM HS
120-131 HS E
120-131 OEM
120-131RSZKHS
120-131RSZKO

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Summary of Contents for IBA KermaX-plus 120-131 E

  • Page 1 DAP Measurement System ® KermaX-plus Chamber Model Types: 120-131 E 120-131 OEM HS 120-131 HS 120-131 HS E 120-131RS-ZK 120-131 OEM 120-131 IS 120-131RSZKHS 120-131 IS HS 120-131RSZKO 120-131 MICRO Rev01 OEM Manual...
  • Page 2 This page is intended to be empty.
  • Page 3 (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.
  • Page 4 This page is intended to be empty. ® Notice | KermaX-plus Chamber...

  • Page 5: Table Of Contents

    Table of Contents Notice Table of Contents Introduction 1.1. Intended Use 1.2. Product Description 1.3. About this Manual 1.3.1. Conventions 1.3.2. Intended User 1.3.3. Symbols Used 1.4. DAP Measurement Health and Safety Information 2.1. General 2.2. Important Information 2.3. User Responsibility 2.4.
  • Page 6 4.2.1. Installing the Chamber in the X-Ray Machine ® 4.2.2. Electrical Configuration of KermaX-plus ® 4.2.3. Electrical Configuration of KermaX-plus with SDP Measurement Quality Assurance 6.1. System Test (Stability Check) 6.1.1. Test Value 6.1.2. Test Value discussion 6.2. Calibration Check 6.2.1.
  • Page 7 ® 9.4.1. KermaX-plus standard size ® 9.4.2. KermaX-plus compact size 9.5. Typical energy dependence 10. Index ® KermaX-plus Chamber | Table of Contents...
  • Page 8 This page is intended to be empty. ® Table of Contents | KermaX-plus Chamber...

  • Page 9: Introduction

    1. Introduction 1.1. Intended Use ® The KermaX-plus is designed to be installed in diagnostic X-ray units (attached at the collimator) and is intended to be used for the measurement of Dose Area Product (DAP), for standard and pediatric procedures and longtime fluoro applications. The system and its accessories must not be used for any other purpose than described in the accompanying documentation (intended use).

  • Page 10: Conventions

    Any personnel who have received a training for using this medical device as described in this User’s Guide by the expert or other trained personnel. Experts: Assigned person by IBA Dosimetry who received a specific training for this medical device as described in this User’s Guide. ®...

  • Page 11: Symbols Used

    1.3.3. Symbols Used The following symbols are used on the product and in this manual: Consult the User's Guide before use The device meets the essential requirements of Council Directive 93/42/EEC concerning medical devices. UL Recognized Component, E352291. Investigated to: ...

  • Page 12: Dap Measurement

    1.4. DAP Measurement ® The KermaX-plus 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.

  • Page 13: Health And Safety Information

    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.

  • Page 14: User Responsibility

    2.3. User Responsibility ® The personnel, using the KermaX-plus in order to record the Dose Area Product; carry the full responsibility to judge each measurement result critically. ® The KermaX-plus should be stored in a clean, dry environment. Protect it from mechanical and thermal stress, dust and unnecessary moisture.

  • Page 15: Safety Precautions

    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.

  • Page 16: Device Handling

    X-ray machine. The range and type of the voltage provided shall be checked and, if necessary, discussed with IBA Dosimetry GmbH. W AR NI NG ENSURE A SECURE INSTALLATION When mounting the chamber and its accessories (holder, filter, etc.) on a X-ray...

  • Page 17: Radiation Protection

    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.
  • Page 18 It is only allowed to use filters with a maximum of 1 kg in the “slide-in rails for constancy tests”, e.g., the DEDX detector from IBA Dosimetry GmbH. The “slide-in rails for constancy tests” must only be used for constancy tests.
  • Page 19 X-ray collimator ® KermaX-plus chamber Adapter with accessory holder for compensating filters Lock screw Opened Locked Fitting spring Lock for the consistency test filter Filter for constancy test An example of settings for constancy test The width of the filter plate must be 176 mm or 167 mm depending on the collimator tail spacing. The filter may not to be deformed and may have a maximum tolerance of + 0.5 mm and –...

  • Page 20: Electromagnetic Compatibility (Emc)

    2.6. Electromagnetic Compatibility (EMC) The electromagnetic environment of intended use is the professional healthcare facility environment, except for the RF shielded room of a medical electrical system for magnetic resonance imaging, where the intensity of electromagnetic disturbances are high. (See chapter Intended Use). Due to electromagnetic disturbances, the measurement performance of dose area product meter can be degraded or lost.

  • Page 21: Electromagnetic Emissions Compliance

    2.6.1. Electromagnetic emissions compliance manufacturer’s declaration – electromagnetic emissions Basic EMC standard Phenomenon EMISSIONS class and group or test method radiated RF EMISSIONS CISPR 11 Class B <1GHz Group 1 Harmonic distortion IEC 61000-3-2 not applicable, no connection to public mains network. Voltage fluctuations IEC 61000-3-3 not applicable,...

  • Page 22: Electromagnetic Immunity Compliance

    2.6.2. Electromagnetic Immunity compliance manufacturer’s declaration – electromagnetic immunity ENCLOSURE PORT Basic EMC standard Phenomenon IMMUNITY TEST LEVELS or test method ELECTROSTATIC IEC 61000-4-2 severity level 3 DISCHARGE Contact discharge: ± 6 kV Air discharge: ± 8 kV Radiated RF EM fields IEC 61000-4-3 3 V/m 80 MHz –...
  • Page 23 manufacturer’s declaration – electromagnetic immunity Input d.c. power PORT Basic EMC standard Phenomenon IMMUNITY TEST LEVELS or test method Electrical fast transients / IEC 61000-4-4 not applicable a) g) bursts No DC Power port cable longer than Surges IEC 61000-4-5 not applicable a) b) g) Line-to-line...
  • Page 24 manufacturer’s declaration – electromagnetic immunity Signal input/output parts PORT Basic EMC standard Phenomenon IMMUNITY TEST LEVELS or test method ELECTROSTATIC IEC 61000-4-2 severity level 3 DISCHARGE Contact discharge: ± 6 kV Air discharge: ± 8 kV Electrical fast transients / IEC 61000-4-4 not applicable b) f)

  • Page 25: Immunity To Proximity Fields From Rf Wireless Equipment

    2.6.3. Immunity to proximity fields from RF wireless equipment manufacturer’s declaration – IMMUNITY to RF wireless communications equipment Test Maximum IMMUNITY Band Service Modulation Distance power TEST LEVEL frequency [MHz] [MHz] [V/m] Pulse modulation 380 –390 TETRA 400 217 Hz GMRS 460, 430 –...

  • Page 26: Labels

    2.7. Labels The label indicates the identification and electrical ratings. Another label indicates the device model number and serial number. They are located on the rear side of the chamber. An example is shown as below: OEM specific label ID label UDI label (acc.

  • Page 27: Regulatory Requirements

    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. The following standards apply:...
  • Page 28 This page is intended to be empty. ® Health and Safety Information | KermaX-plus Chamber...

  • Page 29: System Description

    3. System Description 3.1. Standard Components 3.1.1. DAP Chambers ® The KermaX-plus chambers are rectangular, transparent ionization chambers with integrated electronics and connection cable with RJ45 plug, having a DAP resolution of 0.1 (standard) or 0.01 µGym² (high sensitivity) depend from Model type. They are available in two sizes: Standard size, dimension: 179 ×...
  • Page 30 ® Optional components for KermaX-plus Power pack Part No.: 120805 input 100-240 VAC, 50/60 Hz, 310 mA; output 15 VDC, 800 mA Including one power line: Part No.: 12080501, Euro plug 12080502, UK plug 12080503, US plug 12080504, no plug AKP-cable, with Y-connector Part No.: 120900105, 5 m / 16 ft 120900106, 6 m / 20 ft...
  • Page 31 Remote Single Line DisPlay SDP KermaX®- plus [only for Chambers with Pulse-Interface] Part No.: 120-210 optional RIS/KIS-Set SDP 5m Part No.: 120-RIS_SDP Calibration Tool Part No.: 120-100-001 Adapters with accessory holder for standard size chambers Part No.: 120103030, Dist. between collimator rails 176 mm Part No.: 120103040, Dist.
  • Page 32 GE OPTIMA200 IM PO RT ANT N O T IC E SPECIAL ADAPTORS We have a variety of special adapters. Please contact us at: IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck Germany Phone: +49 9128 607 911...

  • Page 33: Unpacking And Installation

    4. Unpacking and Installation 4.1. Unpacking IM PO RT ANT N O T IC E PERSONNEL QUALIFICATIONS Only qualified personnel is permitted to unpack, install and operate the KermaX- ® plus IM PO RT ANT N O T IC E TRANSPORTATION ®...

  • Page 34: Electrical Configuration Of Kermax-Plus

    C AUT IO N DO NOT EXCEED THE ACTIVE AREA OF THE CHAMBER The size of the radiation field at the surface of the centered chamber may not exceed the active area of the chamber (see Chapter 9, Technical Specifications). IM PO RT ANT N O T IC E REFERENCE DIRECTION OF INICIDENT RADATION The central beam direction of incident radiation must be orthogonal to the...

  • Page 35: Electrical Configuration Of Kermax-Plus With Sdp

    ® 4.2.3. Electrical Configuration of KermaX-plus with SDP Power pack Y-Connector AKP cable In-Line connector To mains power supply ® KermaX-plus Diagram and photo of the connection of the KermaX®-plus The setup procedure: Connect chamber cable to the AKP cable connections with the help of the modular connector plug and the Y-connector.

  • Page 37: Measurement

    5. Measurement Before starting a measurement, check the System stability and Error State to be ready for measurement. (see also section 6.1) Depend from the counter interface; reset the last measurement values for new a session resp. study. Make an exposure and read out the accumulated dose area product from counter interface / display. C AUT IO N DO NOT EXCEED THE ACTIVE AREA OF THE CHAMBER! The size of the radiation field at the surface of the centered chamber may not...
  • Page 38 This page is intended to be empty. ® Measurement | KermaX-plus Chamber...

  • Page 39: Quality Assurance

    6. Quality Assurance 6.1. System Test (Stability Check) To check the functionality and stability of the DAP-measurement system, a test sequence is carried out. ® Depending of KermaX-plus model type it will be done automatically after power up or triggered by simultaneous sending of 200ms pulse on CAL UP and CAL DOWN line (see Chap.

  • Page 40: Measurement Setup

    6.2.1. Measurement Setup To ensure correct measurements, the operator should check the systems compliance with the calibration conditions in the table below. Reference Conditions for Calibration 50 % (relative humidity, no Air humidity condenstation) 1013 hPa Air pressure 5 x 5 cm at chamber level Field size (max.

  • Page 41: Calibration Check Procedure

    6.2.2. Calibration Check procedure ® Switching on the X-ray machine, the KermaX-plus system is switched on simultaneously (depending on the wiring/connecting of the system), and is able to measure after about 20 seconds. Only after the specified stabilization time period, the system measures within the specifications Perform a stability check as described in previous chapter 6.1 System Test (Stability Check).

  • Page 42: Test The Drift Of Indicated Values

    DAP meter was initialized. 6.4. Test tolerance and interval The radiological and electrical calibration of the DAP-measuring system is already done by IBA Dosimetry. The check of the calibration can be done on-site by a competent person or in our calibration laboratory at IBA Dosimetry.

  • Page 43: Recalibration

    If the DAP exceeds the tolerance defined in previous Chap.6.4, please contact Customer Service Dept., IBA Dosimetry GmbH for recalibration. With the Recalibration you have the possibility to adjust the DAP for the plane in which the radiation is incident on the patient in case where absorbing materials (e.g.

  • Page 44: Test Value Adjustment

    IM PO RT ANT N O T IC E AIR DENSITY CORRECTION Due to variable reference sensors, air density correction for the chamber and / or the reference detector may be indicated for best accurateness (section 7 Air Density Correction). IM PO RT ANT N O T IC E DEVIATIONS TO EXPECTED MEASUREMENTS If you observe significant deviations from the expected results please verify that no...

  • Page 45: Air Density Correction

    7. Air Density Correction ® This KermaX-plus DAP meter types are not available with an optional built-in sensor (temperature and air pressure) for automatically correction of air density fluctuation in the ionization chamber. Which means that the DAP Values are not corrected for air density. For the best accuracy, the user has to follow the procedure described in following Chapter.
  • Page 46 This page is intended to be empty. ® Air Density Correction | KermaX-plus Chamber...

  • Page 47: Service And Technical Support

    IBA Dosimetry GmbH. IBA Dosimetry GmbH is not liable for damages caused from the use or operation, which is not approved by the manufacturer and not described in this manual.

  • Page 48: Maintenance Of Kermax-Plus

    IM PO RT ANT N O T IC E RESPONSIBILITY, PROFESSIONAL PRACTICE It is the OEM’s responsibility to follow the guidance given in this OEM manual and to use established professional practice to ensure the product is in usable condition and is being used correctly. This manual is not intended for the use by end users.

  • Page 49: Troubleshooting

    Sprays could cause damage to electrical parts or create a flammable air / vapour mixture. Phenol based disinfectants and chlorine releasing preparations can weaken materials and are generally not recommended. C AUT IO N INCORRECT CLEANING CAN REDUCE THE LIGHT PERMEABILITY Incorrect cleaning can lead to a reduction of the light permeability of the chamber or other malfunctions.

  • Page 50: Safety Inspection

    To avoid environmental damage and/or injury and if you have no facility to convert the device to electronic waste at the end of its life cycle, please return it to IBA Dosimetry GmbH . We will ensure an environmentally correct recycling.

  • Page 51: Technical Support

    The Quality Management system of IBA Dosimetry GmbH includes a routine to handle any reported complaints. The user shall report all complaints about the system to any representative of IBA Dosimetry GmbH or directly to the address above. 8.9. Returning device for repairs...
  • Page 52 This page is intended to be empty. ® Service and Technical Support | KermaX-plus Chamber...

  • Page 53: Technical Specifications

    9. Technical Specifications C AUT IO N MAXIMUM AIR KERMA RATE / DAP RATE The maximum Air Kerma rate at the chamber position and DAP rate must not be exceeded. ® 9.1. Specifications of KermaX-plus Item Characteristic ® square area 140 x 140 mm [ KermaX-plus standard size Active area...

  • Page 54: Interface Specification

    Item Characteristic +15 – +24 V Power supply ± 20%, 100 mA Power consumption < 3 W 9.2. Interface Specification Interface Specification  pulse current loop output > 20mA  pulse width 1,2- 1,5 µs  max. frequency 30kHz standard model types 300kHz high sensitivity model types ...
  • Page 55 Pin assignment RJ-45 Pulse ® KermaX-plus Chamber | Technical Specifications...

  • Page 56: Environmental Conditions And Requirements

    9.3. Environmental Conditions and Requirements Operational Condition Range +10°C – +70°C Ambient temperature 700 hPa – 1060 hPa Atmospheric pressure 20% – 75% (without condensation) Relative humidity range Applicable for the following KermaX-plus® Chambers: 120-131RSZKO 120-131 HS 120-131 OEM 120-131 OEM HS 120-131 MICRO Transportation and Storage Conditions Range...

  • Page 57: Dimensions And Weight

    9.4. Dimensions and Weight ® 9.4.1. KermaX-plus standard size Item Value Dimension (L x W x H) [mm] 179 x 166* x 17 Weight [g] app. 225 * included mounting bolts Drawing mechanical Dimensions standard Housing [tolerance ISO 2768 m] ®...

  • Page 58: Kermax-Plus Compact Size

    ® 9.4.2. KermaX-plus compact size Item Value Dimension (L x W x H) [mm] 158 x 144,5* x 17 Weight [g] app. 195 * included mounting bolts Drawing mechanical Dimensions compact Housing [tolerance ISO 2768 m] ® Technical Specifications | KermaX-plus Chamber...

  • Page 59: Typical Energy Dependence

    9.5. Typical energy dependence The DAP measuring device is calibrated without any absorber (see Table Reference Conditions for Calibration, Section 6.2, Calibration Check). In the following sections is the table for typical correction factors in dependence from tube voltage with 2,5mm Al Filtration: Tube voltage 40 kV...

  • Page 61: Index

    Humidity Range .............. 48 ANSI/AAMI ..............3, 19 Atmospheric Pressure ............ 48 IBA Dosimetry GmbH..i, 7, 8, 9, 10, 19, 24, 35, 39, 42, 43 IEC 60580 ..............19, 45 Cables ................22 IEC 60601 .......... 6, 7, 8, 9, 19, 26, 27 Calibration ............
  • Page 62 Quality Assurance ............31 Technical Specifications ..........45 Quality Management ............43 Technical Support ............. 39, 43 Temperature ..............32 Test tolerance and interval ..........34 Test Value ..............31 Test Value Adjustment ............ 36 Radiation Protection ............9 Test Value Adjustment ............ 31 Rails .................

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