IBA KermaX-plus 120-131 E Installation and operation manual

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

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KermaX-plus®Chamber |Notice |i
Notice
This OEM (Original Equipment Manufacturer) Manual is an integral part of the KermaX-plus®. 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®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-plus®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: [phone]
Fax: [phone]
www.iba-dosimetry.com
Last update: 2020-04-21
(Doc. ID: PD-07-001-510-005 03 UM-KermaXplus OEM.docx)

ii |Notice | KermaX-plus®Chamber
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KermaX-plus®Chamber |Table of Contents |iii
Table of Contents
Notice i
Table of Contents iii
1. Introduction 1
1.1. Intended Use 1
1.2. Product Description 1
1.3. About this Manual 1
1.3.1. Conventions 2
1.3.2. Intended User 2
1.3.3. Symbols Used 3
1.4. DAP Measurement 4
2. Health and Safety Information 5
2.1. General 5
2.2. Important Information 5
2.3. User Responsibility 6
2.4. Regulations 6
2.5. Safety Precautions 7
2.5.1. Device Handling 8
2.5.2. Protection from Fluids 8
2.5.3. Radiation Protection 9
2.5.4. Combination with Other Systems 9
2.5.5. Use of Accessories 9
2.6. Electromagnetic Compatibility (EMC) 12
2.6.1. Electromagnetic emissions compliance 13
2.6.2. Electromagnetic Immunity compliance 14
2.6.3. Immunity to proximity fields from RF wireless equipment 17
2.7. Labels 18
2.8. Regulatory Requirements 19
3. System Description 21
3.1. Standard Components 21
3.1.1. DAP Chambers 21
4. Unpacking and Installation 25
4.1. Unpacking 25
4.2. Installation 25

iv |Table of Contents | KermaX-plus®Chamber
4.2.1. Installing the Chamber in the X-Ray Machine 25
4.2.2. Electrical Configuration of KermaX-plus®26
4.2.3. Electrical Configuration of KermaX-plus®with SDP 27
5. Measurement 29
6. Quality Assurance 31
6.1. System Test (Stability Check) 31
6.1.1. Test Value 31
6.1.2. Test Value discussion 31
6.2. Calibration Check 31
6.2.1. Measurement Setup 32
6.2.2. Calibration Check procedure 33
6.3. Test the drift of indicated values 34
6.3.1. Positive drift 34
6.3.2. Negative drift 34
6.4. Test tolerance and interval 34
6.5. Recalibration 35
6.6. Test Value Adjustment 36
7. Air Density Correction 37
7.1. Air Density Fluctuation in the Ionization Chamber 37
7.2. Correction Overview 37
8. Service and Technical Support 39
8.1. Warranty 39
8.1.1. Warranty, General 39
8.1.2. Warranty, Limitations 39
8.2. Maintenance of KermaX-plus®40
8.3. Cleaning and Disinfection 40
8.4. Troubleshooting 41
8.5. Safety Inspection 42
8.6. Disposal and Recycling 42
8.7. Technical Support 43
8.8. Reporting Complaints 43
8.9. Returning device for repairs 43
9. Technical Specifications 45
9.1. Specifications of KermaX-plus®45
9.2. Interface Specification 46
9.3. Environmental Conditions and Requirements 48
9.4. Dimensions and Weight 49

KermaX-plus®Chamber |Table of Contents |v
9.4.1. KermaX-plus®standard size 49
9.4.2. KermaX-plus®compact size 50
9.5. Typical energy dependence 51
10. Index 53

vi |Table of Contents | KermaX-plus®Chamber
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KermaX-plus®Chamber |Introduction |1
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).
1.2. Product Description
The KermaX-plus®chambers are rectangular transparent ionization chambers with integrated
electronics to be used in one measuring mode to determine Dose Area Product (DAP). The integration
into the system is customer specific. The chamber is attached to the output opening of the X-ray
collimator.
The Interface, which is commonly used in connection with a counter device, generates current output
pulses. Each pulse is normalized to the device lowest resolution.
1.3. About this Manual
This manual contains information necessary to use the KermaX-plus® DAP Measurement system. It
describes safety information, functionalities and applications of the KermaX-plus®.
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.
IMPORTANT NOTICE
PICTURES AND SCREENSHOTS
All numbers and selections displayed in pictures and screenshots are only
examples and no recommendations for settings or entries.
IMPORTANT NOTICE
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.

2|Introduction | KermaX-plus®Chamber
1.3.1.Conventions
The functions of the device, dialog captions and dialog text are indicated by bold font.
Examples: Settings, Field size.
Referrals to chapter and section headings in this manual are indicated by italic font.
Examples: Notice, Technical Specifications.
Throughout this OEM manual, 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
Trained personnel:
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.

KermaX-plus®Chamber |Introduction |3
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:
ANSI/AAMI ES60601-1 (2012)
CAN/CSA-C22.2 No. 60601-1 (2014)
IEC 60601-1 (2012)
Symbol for Class II Equipment

DC current

Energy dependence, rated range of X-ray source voltage.
Radiation filter, quality equivalent filtration
Interference may occur in the vicinity of equipment marked with this symbol.
The users are not allowed to change the original factory values of the
parameters in the setup menus of the displays with this warning sign
Recycling
Separate collection of electrical and electronic devices in accordance with
EC Directive 2012/19/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.
Manufacturing date: this symbol is accompanied by a date to indicate the
date of manufacture, as four digits for the year
Serial Number
Catalogue Number
Medical Device

4|Introduction | KermaX-plus®Chamber
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. 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.
Principle of DAP Measurement

KermaX-plus®Chamber |Health and Safety Information |5
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.
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.
IMPORTANT NOTICE
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®.
If the KermaX-plus®is used in a way not specified in this OEM manual, the
protection provided by the equipment may be reduced.
2.2. Important Information
This manual is part of the measurement system for the Dose Area Product, KermaX-plus®and is
needed to ensure the correct functioning of this device. The KermaX-plus®including all the
accessories must not be used for any other purpose as described in this manual.
CAUTION
WITHDRAWN FROM SERVICE IF A INVOLVING HAZARDOUS INCIDENT
If this measuring unit is involved or associated directly or indirectly with a
hazardous incident it needs to be withdrawn from service instantly. Report the
details to your dealer or the manufacturer immediately.
IMPORTANT NOTICE
PATENTS
Several features of the KermaX-plus®and its components are subject to filed
patent applications.
IMPORTANT NOTICE
DO NOT MODIFY THIS PRODUCT
Modifications to this product or the content of this manual will invalidate the
product warranty and may compromise a safe operation. Therefore, do not,
under any circumstances, make any changes to the product or its components.

6|Health and Safety Information | KermaX-plus®Chamber
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.
CAUTION
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.
2.4. Regulations
The installer and operator are responsible for complying with all local regulations regarding installation
and operation 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.
CE mark:
This medical device is labeled with a CE mark and complies to the 93/42/EEC directive. Its design
guarantees provision to comply with all recommended standards, as with IEC 60601-1-2 for
electromagnetic compatibility (EMC), on the level of the system component. 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.
National regulations:
In all countries, the legally established regulations are to be observed.
Legally required tests:
All legally required tests must be performed at the prescribed time intervals, e.g. constancy test
according to the X-ray ordinance (§16 RöV) in the Federal Republic of Germany, e.g. tests based on
DHHS guidelines (Department of Health and Human Services) where applicable.

KermaX-plus®Chamber |Health and Safety Information |7
2.5. Safety Precautions
IMPORTANT NOTICE
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.
The KermaX-plus®should only be used by personnel which fulfils the following criteria:
Understanding of the functions and 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.
Competence of the security requirements of radiation and the relevant standards like
IEC 60601-1 and others.
Experience with the use of measuring systems for the Dose Area Product
Prior to the use of the measuring system, the correct connection between the chamber and the
accessories has to be ensured. The user has to check the general functionality and security of the
chamber as well as all the connection cables (also for mechanical damages).
The KermaX-plus®has to be used in a fire secured, clean, dry, and climatic room. Protect it from
mechanical and thermal pressure as well as dust and unneeded humidity.
CAUTION
USING ONLY DRY CHAMBERS
If condensation is build up in the chamber because of temperature changes, the
system has to be dried completely and should not be used.
The KermaX-plus®is not designed for patient contact in its intended use.
Do not remove any signs or labels of the KermaX-plus®. If labels become unreadable, the
corresponding parts have to be sent back to the manufacturer, in order to be identified and to be
relabelled.
Never open the chamber device in order to avoid contact with hazardous high voltage inside.
WARNING
HIGH VOLTAGE
Because of the high voltage, there is a risk of life!
The KermaX-plus®is not waterproof. If there is a risk of spray, device must be covered and
protected sufficiently.

8|Health and Safety Information | KermaX-plus®Chamber
The chamber is not completely sealed, due to the special mounting situation. When the device is
mounted and then used, make sure, that no foreign substances get into the measuring chamber.
Any foreign subjects could lead to errors.
Because of the high sensitivity of the measuring chamber, vibrations or touching the chamber could
cause partial discharge, which could lead to a wrong measuring result.
This is the reason, why it has to be guaranteed in the C-shaped system, that those impulses are
only evaluated during the exposure
2.5.1.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
device and cables.
Neither the KermaX-plus®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 device in order to avoid contact with hazardous high voltage.
The housing of the chamber device is not waterproof. When the risk of splashing fluid is present,
mount it under auxiliary covers.
The KermaX-plus®requires a voltage in the range of 15 - 24 V DC ±20%, which is normally
provided by a power supply with 4kV 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.
WARNING
ENSURE A SECURE INSTALLATION
When mounting the chamber and its accessories (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 or
cause personal injuries.
2.5.2.Protection from Fluids
Do not allow fluids to enter the converter either during normal operation or during cleaning and
disinfection as this may damage the system or cause a system malfunction.

KermaX-plus®Chamber |Health and Safety Information |9
2.5.3.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.
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.
2.5.4.Combination with Other Systems
In the interest of safety do not attach any products / components to the KermaX-plus®.
The use of accessory equipment 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
2.5.5.Use of Accessories
CAUTION
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.

10 |Health and Safety Information | KermaX-plus®Chamber
2.5.5.1. Positioning of Compensating Filters
Special accessory holders to slide-in of compensating filters, e.g. pediatrics or shoulder filters, in patient
operation only over the KermaX-plus®are available (3.1.1 Optional components for KermaX-plus®).
WARNING
USING FILTER IN CONSTANCY TEST
In patient operation never slide in filters in the “slide-in rails for constancy tests"!
2.5.5.2. Constancy Test
WARNING
FALLING DEVICE
Strictly follow the following instruction and take extreme care when installing the
testing device. The device may fall due to improper installation and cause
personal injury.
WARNING
LOCK THE DEVICE IN PLACE
To prevent devices falling down, ensure the accessory holder, chamber, and
filter, etc., are properly locked in place with screws, fitting springs or locking
mechanism when mounting them.
1. 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.
2. The “slide-in rails for constancy tests” must only be used for constancy tests.
3. It is not allowed to perform tube movements, e.g. during tomography, with filters fitted to the “slide-
in rails for constancy tests“.
4. Open the Lock for the consistency test filter by loosening the lock screw and turning it to the
horizontal position to open the left rail; press the fitting spring to open the right rail. Slide in the filter;
then release the fitting spring and turn the lock to the vertical position and tighten the screw.
Installing the filter for consistency test into the “slide-in rails for constancy tests" is only permitted in
the horizontally oriented and stationary tube.
Filter for constancy tests
KermaX®plus chamber
Compensating filter
Slide in rails for
constancy tests
X-ray tube
+
Collimator

KermaX-plus®Chamber |Health and Safety Information |11
5. 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 –0.25 mm
relative to the nominal dimension.
6. The locking screws always have to be fixed on both sides.
7. Daily control of the adapter that it is tightly installed and not damaged mechanically. If necessary,
replace the adapter.
8. Positioning of compensating filters as described above.
CAUTION
ENSURE FITTING SPRING IN PROPER WORKING CONDITION
Check the fitting spring regularly that it has not become loose for locking the
safeguard lever.
X-ray collimator
Adapter with
accessory holder for
compensating filters
KermaX-plus®
chamber
Fitting spring
Filter for constancy test
Opened Locked
Lock
screw
Lock for the consistency test filter
An example of settings for constancy test

12 |Health and Safety Information | KermaX-plus®Chamber
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.
IMPORTANT NOTICE
OPERATING IN NEAR OF HF SURGICAL EQUIPMENT
The Operation of KermaX-plus®equipment in a HF-SURGICAL ENVIRONMENT
is generally excluded. Its use in such Environment the manufacturer of the
diagnostic X-ray machine carries the full and entire responsibility to evaluate the
correct operating and measurement of the KermaX-plus®equipment.
IMPORTANT NOTICE
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.
IMPORTANT NOTICE
USE OF ACCESSORIES, TRANSDUCERS AND CABLES
The use of accessories, transducers and cables other than those specified or
provided by the manufacturer of the KermaX-plus®could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
IMPORTANT NOTICE
USE OF PORTABLE RF COMMUNICATIONS EQUIPMENT
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 KermaX-plus®, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.