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.