Direct Patient Dosimeter DPD-12 Users Guide Nov 2014

Notice

IM PO RT ANT N O T IC E Throughout this User's Guide, hazardous situations or operations are identified by DANGER, WARNING and CAUTION notices, where: 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.

This manual is intended for personnel with the following expertise:

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Area

Expertise

Installation

Experts

Start-up, operation and shutdown

Experts Trained personnel

Maintenance

Experts

Troubleshooting

Experts

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Table of Contents

Table of Contents 1.

Introduction ... 1

1.1. 1.2. 1.3. 1.4.

Intended Use... 1 Expected Service Lifetime ... 1 User’s Guide ... 1 Amendment Procedure ... 2

1.4.1. 1.4.2.

1.5.

2.

Symbols Used with the Detector ... 3

Health and safety information ... 5

2.1. 2.2.

General ... 5 Power Connection and Environment ... 5

2.2.1. 2.2.2. 2.2.3. 2.2.4. 2.2.5.

2.3. 2.4.

2.5. 2.6. 2.7.

Electromagnetic emissions ... 12 Electromagnetic Immunity ... 13 Recommended separation distances ... 15

Regulatory Requirements ... 16

Detectors ... 17

3.1. 3.2. 3.3.

4.

Storing ... 11 Transporting ... 11

Electromagnetic compatibility ... 12

2.8.1. 2.8.2. 2.8.3.

2.9.

Operator ... 7 Computer... 8 Detectors ... 8 Detector Support ... 9

Operation ... 9 Calibration ... 10 Handling... 11

2.7.1. 2.7.2.

2.8.

Electrical Installation and Main Power Connections ... 5 Rating Labels ... 6 Warning Labels ... 6 Environmental Stress ... 7 Radiation Stress ... 7

Responsibility ... 7 Safety precautions ... 7

2.4.1. 2.4.2. 2.4.3. 2.4.4.

3.

Amendment Facilities ... 2 Support Documentation ... 3

Photon Detectors, external beam ... 18 Electron Detectors, external beam ... 18 Detector Support ... 18

Installation ... 19

4.1.

Introduction ... 19

4.1.1. 4.1.2.

4.2.

Safety Precautions ... 19 General Instructions ... 20

Hardware Installation ... 21

4.2.1. 4.2.2. 4.2.3.

Electrometer ... 21 Extension Cable ... 21 Communication Cable ... 21

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Table of Contents

4.2.4. 4.2.5. 4.2.6.

4.3.

Detector Support ... 23

4.3.1. 4.3.2. 4.3.3. 4.3.4. 4.3.5. 4.3.6.

5.

Display Unit ... 21 Detectors ... 22 Power Cord ... 22 General... 23 Mounting of the Standard Detector Support ... 23 Advanced Detector support (option) ... 24 Mounting of the Advanced Detector Support ... 24 Mobile Detector Support (option)... 32 Mounting of the Mobile Detector Support ... 34

Operation ... 43

5.1. 5.2. 5.3. 5.4. 5.5.

6.

Introduction ... 43 Education ... 43 Environment ... 43 Measurement Operation ... 43 Steps of Operation ... 44

Calibration ... 47

6.1. 6.2.

General ... 47 Calibration Philosophy ... 47

6.2.1. 6.2.2.

6.3.

Preparation for Calibration ... 49

6.3.1. 6.3.2.

6.4.

MU-Chamber as Reference... 49 External or Internal Detector as Reference ... 50

Setup and Calibration... 51

6.4.1.

7. 8.

Multiple Detector Configuration ... 48 Replacement of Detectors ... 48

Calibration ... 51

Temperature Calibration Phantom (option)... 53 Specifications... 55

8.1. 8.2. 8.3. 8.4. 8.5.

General ... 55 Standard Equipment ... 55 Accessories... 55 Application Area of Detectors ... 57 Technical Data – Basic Equipment... 59

8.5.1. 8.5.2. 8.5.3. 8.5.4. 8.5.5. 8.5.6. 8.5.7. 8.5.8.

8.6. 8.7.

9.

Technical Data of Detector Support ... 61 Temperature Calibration Phantom ... 62

Maintenance ... 63

9.1. 9.2. 9.3. | IV |

Electrometer ... 59 Connections ... 59 Electrometer Specifications ... 59 Design Features ... 59 Environmental Requirements ... 60 Dimensions... 60 Detector Connection ... 60 Measurement Characteristics ... 61

General ... 63 Annual Electrical Adjustment... 63 Cleaning and Disinfection of In-Vivo Detectors ... 63 P-06-001-510-001 05

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9.4. 9.5.

10.

Replacing Mains Fuse... 64 Disposal of equipment... 64

Technical Support ... 65

10.1. 10.2. 10.3.

11. 12. 13.

Contact for Technical Support ... 65 Reporting Complaints ... 65 Returning Device for Repair ... 66

Appendix A – Operation Form ... 67 Appendix B – Complaint Report... 71 Glossary of Terms ... 75

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Introduction

1.

Introduction

1.1. Intended Use The intended use of the DPD-12 Direct Patient Dosimeter (DPD-12) is to monitor radiation dosage during treatment. The DPD-12 can also be used for quality control measurement of therapeutic radiation devices. The DPD-12 provides multi-channel dose or dose-rate measurements utilizing up to 12 semiconductor detectors. The device function is accessed by using the keyboard on the user interface personal computer. Measured parameters may be stored in the personal computer.

1.2. Expected Service Lifetime The expected service lifetime of the DPD-12 is 5 years.

1.3. User’s Guide The DPD-12 manual assumes that the operator has knowledge in physics and a working knowledge of the terminology used in the area of dosimetry. This manual contains seven major sections. The contents of these are summarised as follows:

INTRODUCTION A brief introduction (this section) - this chapter introduces the DPD-12 with the intended use, the product description and the Operation Manual. In addition, the amendment procedure by which the integrity of the manuals is maintained is described, and logic and typographical conventions are specified.

HEALTH AND SAFETY INFORMATION Describes the hazards associated with the equipment. All personnel must read this chapter and be fully aware of its contents.

DETECTORS Provides information about the detectors used in combination with the DPD12.

INSTALLATION This section describes the DPD-12 installation and system verification procedure.

OPERATION This section contains a fundamental description of all functions of the DPD12 system and their use.

CALIBRATION This section describes the philosophy of the calibration procedure of the DPD-12 system.

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Introduction

CALIBRATION PHANTOMS Description of the calibration phantoms, the intended use and how to perform the setup for calibration of detectors. SPECIFICATIONS This section provides an overview of the main parts and functions of the DPD-12, with standard or optional equipment. It also summarizes technical data for the DPD-12.

ERROR MESSAGES Provides instructions required of a malfunction at the DPD-12 equipment.

MAINTENANCE Provides instructions required to maintain the DPD-12 equipment.

APPENDIX A Operation form

APPENDIX B Contains complaint report forms whose can be used to report any complaint about the DPD-12 system.

1.4. Amendment Procedure A well-managed amendment policy is essential to maintain the integrity of published manuals. The objectives of the policy are to ensure that errors, which may exist in, published manuals can be corrected, and that the manuals include details of the most recent technical modifications to the equipment that they support. This is particularly important with regard to health and safety information in the manuals.

1.4.1. Amendment Facilities The operation manual, in this document set includes features that permit amendments to be incorporated easily, namely:

1.4.1.1.

■

On each page of each manual (including preliminary material) the issue status and date of publication of the page is shown. Whenever a page is amended its issue status and date of publication is updated.

■

In order to maintain an effective amendment procedure, it is necessary for participants to accept certain responsibilities. These can be generally considered in two main categories, namely the responsibility of the publisher and of the copyholders.

Publisher The responsibilities of IBA Dosimetry as publisher of this operation manual set include the following:

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The production of manuals to the required technical and editorial standards

■

Distribution of the requisite number of copies to the Copyholders of the manuals

■

Maintenance of the master copies of the manuals

■

Servicing of the associated amendment procedures

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1.4.1.2.

Copyholders The responsibilities of the copyholders in maintaining the amendment procedure should include the following: ■

The incorporation of amendments into the manuals

■

The maintenance of the Amendment Record in each manual

1.4.2. Support Documentation A number of standard administrative documents are used to support the amendment policy. Of these, the following is of interest to copyholders.

1.4.2.1.

Amendment Notices All amendments are issued in the form of Amendment Notices, which permit the publisher formally distributes amendment instructions and new material. Amendment Notices comprise copies of all amended pages, and specific instructions for the incorporation of each amendment in its appropriate manual. By giving priority to Amendment Notices, urgent amendments (health and safety information and cautionary material) can be rapidly distributed. Each Amendment Notice carries a unique reference number, so that its incorporation can be recorded in the Amendment record among the preliminary pages of each manual.

1.4.2.2.

Priority Amendment Notices Urgent amendments are issued as Priority Amendment Notices. These are distributed promptly as required and must be incorporated into the manuals by the copyholders immediately upon receipt of the notice.

1.4.2.3.

Routine Amendment Notices Amendments that are not deemed urgent are distributed as Routine Amendment Notices. These are issued periodically and should be incorporated into the manuals by the copyholders within 30 days of receipt.

1.5.

Symbols Used with the Detector 0124

The device meets the essential requirements of Council Directive 93/42/EEC concerning medical device. Manufacturing date This symbol is accompanied by a date to indicate the date of manufacture, as four digits for the year and two digits for the month. Serial number This symbol is accompanied by the manufacturer's serial number adjacent to it. 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.

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Health and safety information

2.

Health and safety information

2.1. General The following health and safety information are valid for the complete DPD12 system including accessories, and should be read attentively. Every owner/user of the DPD-12 system should have understood the complete condense and be aware of potential direct or indirect hazards of operators, other parties, stationary or mobile equipment or environmental and facilities by disregarding of warnings. DPD-12 has been designed by IBA Dosimetry to ensure that, provided the equipment is operated properly, the health and safety of hospital personnel and patients is maintained at all times. However, the operator should have understood that there are a number of dangerous and potentially lethal hazards associated with electrical equipment and radiation therapy. IBA Dosimetry considers it imperative that all hospital personnel are fully aware of the hazards associated with this equipment. The purpose of this chapter is therefore to identify all such hazards within the system. A series of Warning and Caution notes is present as information.

2.2. Power Connection and Environment 2.2.1. Electrical Installation and Main Power Connections The DPD-12 complies with the IEC/EN 60601-1 standards. The electrical installations in the rooms where the DPD-12 and connected equipment is used must comply with these IEC recommendations. Always use a power cord with a grounding pin. W AR NI NG PROTECTIVE EARTH To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. IM PO RT ANT N O T IC E GROUNDING PIN All equipment must be connected to mains power outlets with protective earth. For the mains connection of the electrometer and associated equipment, use a power cord and multi-outlet power strip with a grounding pin. C AUT IO N MAINS SUPPLY To avoid influence from the mains supply, connect the electrometer and other DPD-12 equipment to a mains outlet separated from other equipment e.g. a Linac. C AUT IO N LINE VOLTAGE SETTINGS Prior to use, check if the line voltage settings of the electrometer, electrometer is in accordance with the local mains voltage.

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Health and safety information

IM PO RT ANT N O T IC E DEVICE LOCATION The DPD-12 shall be positioned in a way that the power cord can be conveniently disconnect to the mains power supply. Ensure the person in the room does not easily stumble with the power cord.

2.2.2. Rating Labels Normally, the labeling consists of identification and electrical rating.

Label example for 110V

Label example for 220V

W AR NI NG HAZARDOUS VOLTAGE Pay attention to the voltage ratings on the rating labels. These determine the safety hazards for components connected to the supply voltages. Do not open covers.

2.2.3. Warning Labels General warning sign Read the documentation for information before using the equipment. Type BF Equipment - Equipment providing a particular degree of protection against electric shock, particularly regarding: ■

Allowable Leakage current

■

Reliability of the protective earth connection (if present)

The detectors used with the DPD-12 are the applied parts of type BF that are isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault conditions is not exceeded when a voltage equal to 1.1 times the highest rated mains voltage is applied between the applied part and earth. Consult the User's Guide before use.

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Health and safety information

2.2.4. Environmental Stress C AUT IO N ENVIRONMENTAL STRESS Keep the DPD-12 system out of direct sunlight, high or low temperature; avoid chemicals, high humidity, high pressure and power shocks.

2.2.5. Radiation Stress C AUT IO N RADIATION STRESS Keep the electrometer, along with extension cables and cable support, out of the primary beam.

2.3. Responsibility W AR NI NG DATA EVALUATION RESPONSIBILITY The person managing the DPD-12 bears the full responsibility for critically evaluating every calibration, measurement result and/or manipulating measurements before transferring the data to a treatment documentation system. C AUT IO N SIGNAL QUALITY The operator has to check the sensor signal for its quality. C AUT IO N ASSEMBLY AND REPAIRS, ACCESSORIES Only by IBA Dosimetry authorized persons, whose do have sufficient knowledge; skills shall carry out assembly, extension, modification or repair. For repairs, use only spare parts provided or approved by the manufacturer, otherwise operator safety specified measuring accuracy and interference free operation could not be guaranteed. Violation of this prescription will result in loss of warranty. IBA Dosimetry cannot be held liable for any damages resulting from the use of accessories or consumables, which are not provided or approved by the manufacturer.

2.4. Safety precautions 2.4.1. Operator The DPD-12 should only be used by people who are:

DPD-12 User’s Guide

■

Aware of and understand the limitations of the device as they relate to the measurement of radiation output.

■

Knowledgeable about safety procedures observed when working with radiation sources such as Cobalt-60 machines or linear accelerators.

■

Aware of safety precautions required to avoid possible injury when using electrical / electronic equipment.

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Health and safety information

Before using the DPD-12, the operator must ensure that it is correctly connected and in proper working condition. The user must verify the general functionality, safety and duly condition of the tank, the mechanics, electronics and the detector(s). The DPD-12 including all accessories is a sensitive measuring system and must be stored in a clean, dry, preferably air-conditioned area at room temperature. Protect it from mechanical and thermal stress and unnecessary moisture. Mount the protection caps where provided. IM PO RT ANT N O T IC E MOISTURE Devices on which moisture has developed because of temperature changes must not be used unless they have been completely dried.

2.4.2. Computer IM PO RT ANT N O T IC E COMPUTER REQUIREMENT The DPD-12 may only be used on computers which are in compliance with applicable IEC 60601-1 or IEC 60950 standards.

2.4.3. Detectors C AUT IO N USE SPECIFIED DETECTORS IBA Dosimetry will not be responsible for the performance of the DPD-12 if: ■

Other detectors than specified in this manual are used

■

The selection of detector type does not follow the recommendation

■

The detector are positioned differently in the beam than during calibration

■

Incorrect correction factors are used with the detector.

C AUT IO N PATIENT SAFETY IBA Dosimetry will not be responsible for the patient safety if ■

Other detectors than specified are used

■

If the insulation is damage, the insulation should be better than 4kV

C AUT IO N It is important that a detector is replaced by one of the same type otherwise correction factors corresponding to the detector set is not correct resulting in error in measured dose.

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Health and safety information

2.4.4. Detector Support C AUT IO N The counterweights in the detector support are made of lead. Always use protection gloves during installation of detector support and new detectors.

2.5. Operation C AUT IO N WARM-UP TIME 20 MINUTES FOR MEASUREMENT To allow the DPD-12 to reach a stable operating temperature, turn it on at least 20 minutes prior to measurement. W AR NI NG The DPD-12 has a Sound Alarm. When using the alarm, verify that correct alarm level is enabled before measurement W AR NI NG DISCREPANCY IN MEASURED AND PLANNED DOSE There can be a discrepancy in measured and planned dose due to the need for estimation of equivalent field size. W AR NI NG The values of the displayed measurements are dependent upon the configuration. Before starting the measurements, check that the configuration have been correctly chosen. W AR NI NG ERROR IN MEASURED DOSE DUE TO WRONG POSITIONED DETECTOR It is important that the detector be positioned in the planned position. Check that the detector(s) are correctly positioned after the treatment. W AR NI NG ERROR IN MEASURED DOSE DUE TO NON-RESET ELECTROMETER The electrometer must be reset before each exposure to show correct value.

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Health and safety information

W AR NI NG ERROR IN MEASURED DOSE DUE TO SATURATED ELECTROMETER When the display indicates saturation (red/yellow display), the displayed dose is wrong. W AR NI NG ERROR IN MEASURED DOSE DUE TO POWER FAILURE Power failure might cause an error in the dose measurement. C AUT IO N Dose and dose rate values are displayed as absolute values relaying on accurate dark current measurement. Justify the dark current measurements to see if they are reasonable. C AUT IO N It is important that that the user has a routine / checklist for identifying possible error conditions in case of unexpected measured dose levels. C AUT IO N USING COMPUTER WITH TOUCH SCREEN Make sure that the pointer is pointing on the right icon or button before activating by a double click, otherwise wrong command can be given. W AR NI NG MAINS FAILURE IBA Dosimetry will not accept responsibility if the DPD-12 is not reset after a main failure.

2.6. Calibration C AUT IO N During calibration, it is important that the system is correctly setup according to the specified reference condition. C AUT IO N The measurement result of a DPD-12 system relies on a regularly performed calibration. C AUT IO N WARM-UP TIME 1 HOUR FOR CALIBRATION To get best result in calibration, turn it on at least 1 hour prior to measurement.

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Health and safety information

2.7. Handling Handle the DPD-12 system with care – avoid impact, excessive weight on the surface, and strong vibrations. Do not handle the electrometer with wet hands. If a handling incident occurs, always perform a device check before using the electrometer again. If the device has been covered with water, un-power the device, and wait approx. one minute before touching it. W AR NI NG MATERIAL ACTIVATION When irradiating the DPD-12 system with high energies, for a short time radioactivity may occur. Wait a few minutes after beam-off before touching the irradiated parts of the DPD-12 system.

2.7.1. Storing When the system is not in use, unplug the power supply from the mains connector. Store the DPD-12 system in a radiation-protected area. Never irradiate other parts than the marked sensor area. Do not place the system near equipment generating a strong magnetic field. Further information regarding storage conditions can be found in the chapter Technical Data, Standard Equipment. C AUT IO N DO NOT STORE THE DPD-12 SYSTEM IN THE ACCELERATOR ROOM Due to the sensitivity of the electronics against radiation, never store the DPD-12 in the accelerator room. This would considerably shorten its lifetime. Move the device into the accelerator room only if you intend to make measurements.

2.7.2. Transporting When transporting the equipment e.g. for repair, always use the original transport case and transport locking to avoid damage on the equipment. In addition, take care about the recommended environmental conditions during transport (see also Environmental requirements under Specifications). IM PO RT ANT N O T IC E TRANSPORT CRATE Parts of the DPD-12 equipment are the transport crates, designed to warrant the highest possible protection of the equipment during transport and storage. The original packaging (shipping crate, packing materials, transport protections etc.) should be kept for possible shipment. If you recognize a transport damage even if the original box has been used, please contact the transport company, our distributor and the IBA service department next to you to inform them concerning this incident. Preferably, use the Complaint Report form from Appendix B to submit your inquiry.

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Health and safety information

2.8. Electromagnetic compatibility 2.8.1.

Electromagnetic emissions

Guidance and Manufacturer's Declaration - Electromagnetic Emissions The DPD-12 is intended for use in the electromagnetic environment specified below. The customers or the users should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 RF emissions CISPR 11

Compliance

The DPD-12 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 Class A

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations / flicker emissions IEC 61000-3-3

Not applicable

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Electromagnetic environment - guidance

The DPD-12 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage supply network that supply buildings used for domestic purposes.

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Health and safety information

2.8.2.

Electromagnetic Immunity

Guidance and Manufacturer's Declaration - Electromagnetic Emissions The DPD-12 is intended for use in the electromagnetic environment specified below. The customers or the users should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD) IEC 61000­4­2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Electrical fast transient/burst IEC 61000­4­4

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV line(s) to lines ±2 kV line(s) to earth

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV line(s) to line(s) ±2 kV line(s) to earth

<5 % U T (>95 % dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (>95 % dip in U T ) for 5s 3 A/m

<5 % U T (>95 % dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (>95 % dip in U T ) for 5s 3 A/m

Surge IEC 61000­4­5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000­4­11

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. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the DPD-12 requires continued operation during power mains interruptions, it is recommended that the DPD-12 is powered from an uninterruptible power supply or a battery.

Power Power frequency magnetic frequency fields should be at levels (50/60 Hz) characteristic of a typical magnetic field location in a typical commercial IEC 61000­4­8 or hospital environment. NOTE: U T is the a.c. mains voltage prior to application of the test level.

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Health and safety information

Guidance and Manufacturer's Declaration - Electromagnetic Emissions The DPD-12 is intended for use in the electromagnetic environment specified below. The customers or the users 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 no closer to any part of the DPD12, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF IEC 61000­4­6

3 V rms 150 kHz to 80 MHz

3 V rms

Radiated RF IEC 61000­4­3

3 V/m 80 MHz to 2.5

3 V/m

d = 0.35 P

10 V/m (TD)

d = 0.7 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 meters (m). Field strengths from fixed RF transmitters, as determined by an a electromagnetic site survey, should be less than the compliance level in b each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

d = 1. 2 P 80 MHz to 800 MHz

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 affected by absorption and reflection from structures, objects and people a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 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 DPD-12 used exceeds the applicable RF compliance level above the DPD-12 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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2.8.3.

Recommended separation distances

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the DPD-12 The DPD-12 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the COMPASS system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DPD-12 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = 1.2 P

d = 0.35 P

d = 0.7 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

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 affected by absorption and reflection from structures, objects and people.

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Health and safety information

2.9. Regulatory Requirements The DPD-12 system fulfils the requirements of the following European directive and standards: ■

The Medical Device Directive 93/42 EEC (Annex II, Class IIb)

■

EN 60601-1 Safety requirements for Medical electrical systems

■

EN 60601-1-2 Electromagnetic compatibility - requirements and tests

The DPD-12 system is also in accordance with the US Medical Device Regulation, CFR Title 21. The DPD-12 system fulfils the requirements of the European Medical Device Directive 93/42/EEC (MDD). The quality assurance system at IBA Dosimetry GmbH is certified according to EN ISO 13485.

0124

This device is manufactured by: IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck Germany Tel: +49 9128 607-0 Email: [email protected] http://www.iba-dosimetry.com/

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